NTA Level 5 • Semester 1 • PST05105

Rational Use of Medicines – Complete Full Notes

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UNITED REPUBLIC OF TANZANIA

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Ministry of Health, Community Development, Gender, Elderly and Children

Facilitator Guide

Children – 2018

Table of Contents

Background 5

Acknowledgment 6

Introduction 8

Session 1: Introduction to Rational use of Medicines 13

Session 2: Introduction to Irrational Use of Medicines 23

Session 3: Factors Contributing to Irrational Use of Medicines 30

Session 4: Problems Associated with Irrational Medicine Usage 36

Session 5: Control Measures for Irrational Medicines Use 42

Session 6: Concept of National Essential Medicines 47

Session 7: Essential Medicines Concept in Promotion of Rational Medicines

Use 53

Session 8: Types of Interventions in Promoting Rational Medicines Use

Session 9: Factors Hindering Promotion of Rational Use of Medicine 68

Session 10: Importance of (STG) and (EML) in Reducing Irrational Use of

Medicines 74

Session 11: Legal limitations on Medicines Marketing and Promotion 82

Session 12: Significances of Uncontrolled Medicines Marketing and Promotion

Session13: Role of information in Medicines marketing and promotion 97

Session 14: Ethical Issues in Medicines Marketing and Promotion 103

Session 15: Role of Pharmaceutical Personnel in Promoting Rational Use of

Medicines 109

Background

There is currently an ever increasing demand for pharmaceutical personnel

in Tanzania. This is due to expanding investment in public and private

pharmaceutical sector. Shortage of trained pharmaceutical human resource

contributes to poor quality of pharmaceutical services and low access to

medicines in the country (GIZ, 2012).

Through Public-Private-Partnership (PPP) the Pharmacy Council (PC) together

with Development Partners (DPs) in Germany and Pharmaceutical Training

Institutions (PTIs)worked together to address the shortage of human

resource for pharmacy by designing a project named “Supporting Training

Institutions for Improved Pharmaceutical Services in Tanzania” in order to

improve quality and capacity of PTIs in training, particularly of lower

cadre pharmaceutical personnel.

The Pharmacy Council formed a Steering committee that conducted a

stakeholders workshop from18th to 22ndAugust 2014 in Morogoro to initiate

the implementation of the project.

Key activities in the implementation of this project included carrying out

situational analysis, curriculum review and harmonization, development of

training manual/facilitators guide, development of assessment plan,

training of trainers and supportive supervision.

After the curricula were reviewed and harmonized, the process of developing

standardized training materials was started in August 2015 through Writer’s

Workshop (WW) approach.

The approach included two workshops (of two weeks each) for developing

draft documents and a one-week workshop for reviewing, editing and

formatting the sessions of the modules.

The goals of Writers Workshops were to build capacity of tutors in the

development of training materials and to develop high-quality, standardized

teaching materials.

The training package for pharmacy cadres includes a Facilitator Guide,

Assessment plan and Practicum. There are 12 modules for NTA level 4 making

12 Facilitator guides and one Practicum guide.

Acknowledgment

The development of standardized training materials of a competence-based

curriculum for pharmaceutical sciences has been accomplished through

involvement of different stakeholders.

Special thanks go to the Pharmacy Council for spearheading the

harmonization of training materials in the pharmacy after noticing that

training institutions in Tanzania were using different curricula and train

their students differently.

I would also like to extend my gratitude to Christian Social Service

Commission (CSSC) for their tireless efforts to mobilize funds from

development partners. Special thanks to Multi Actors Partnership (MAP)

for the financial and technical support.

Particular thanks are due to those who led this important process to its

completion, Centre for Education Development in Health Arusha (CEDHA), Ms.

Diana Gamuya, Mr. Dickson Mtalitinya and Members from the secretariat of

National Council for Technical Education (NACTE) for facilitating the

process.

Finally, I very much appreciate the contributions of the tutors and content

experts representing PTIs, hospitals, and other health training

institutions. Their participation in meetings and workshops, and their

input in the development of this training manual/facilitators guide have

been invaluable.

These participants are listed with our gratitude below:

Ms. Elizabeth Shekalaghe Registrar, Pharmacy Council of Tanzania

Dr. Catherine Jincen Principal, CEDHA

Dr. Saitore Laizer Deputy Principal, CEDHA

Dr. Sungwa N. Kabissi Project Manager – MAP, CSSC

Ms. Diana Gamuya CEDHA

Ms. Emily Mwakibolwa Pharmacy Council

Ms. Tumaini H. Lyombe MUHAS

Ms. Dilisi J. Makawia KSP

Director of Human Resources Development

Ministry of Health, Community Development, Gender, Elderly and Children

Introduction

Module Overview

This module content is a guide for tutors of Pharmaceutical schools for

training of students. The session contents are based on sub-enabling

outcomes and their related tasks of the curriculum for Basic Technician

Course in Pharmaceutical Sciences. The module sub-enabling outcomes and

their related tasks are as indicated in the in the Basic Technician

Certificate in Pharmaceutical Sciences (NTA Level 5) Curriculum

Target Audience

This module is intended for use primarily by tutors of pharmaceutical

schools. The module’s sessions give guidance on the time, activities and

provide information on how to teach the session. The sessions include

different activities which focus on increasing students’ knowledge, skills

and attitudes.

Organization of the Module

The module consists of fifteen (15) sessions; each session is divided into

several parts as indicated below:

• Session Title: The name of the session

• Total Session Time: The estimated time for teaching the session,

indicated in minutes

• Pre-requisites: A module or session which needs to be covered before

teaching the session.

• Learning Tasks: Statements which indicate what the student is expected to

learn by the end of the session

• Resources Needed: All resources needed for the session are listed

including handouts and worksheets

• Session Overview: The session overview box lists the steps, time for each

step, the activity or method used in each step and the step title

• Session Content: All the session contents are divided into steps. Each

step has a heading and an estimated time to teach that step as shown in

the overview box. Also, this section includes instructions for the tutor

and activities with their instructions to be done during teaching of the

contents

• Key Points: Key messages for concluding the session contents at the end

of a session This step summarizes the main points and ideas from the

session, based on the learning tasks of the session

• Evaluation: The last section of the session consists of short questions

based on the learning tasks to check the understanding of students.

• Handouts: Additional information which can be used in the classroom while

teaching or later for students’ further learning. Handouts are used to

provide extra information related to the session topic that cannot fit

into the session time. Handouts can be used by the students to study

material on their own and to refer to them after the session. Sometimes,

a handout will have questions or an exercise for the participants

including the answers to the questions.

Instructions for Use and Facilitators Preparation

• Tutors are expected to use the module as a guide to train students in the

classroom and skills laboratory

• The contents of the modules are the basis for teaching and learning

dispensing.

• Use the session contents as a guide

• The tutors are therefore advised to read each session and the relevant

handouts and worksheets as preparation before facilitating the session

• Tutors need to prepare all the resources, as indicated in the resource

section or any other item, for an effective teaching and learning process

• Plan a schedule (timetable) of the training activities

• Facilitators are expected to be innovative to make the teaching and

learning process effective

• Read the sessions before facilitation; make sure you understand the

contents in order to clarify points during facilitation

• Time allocated is estimated, but you are advised to follow the time as

much as possible, and adjust as needed

• Use session activities and exercises suggested in the sessions as a guide

• Always involve students in their own learning. When students are

involved, they learn more effectively

• Facilitators are encouraged to use real life examples to make learning

more realistic

• Make use of appropriate reference materials and teaching resources

available locally

Preparation with Handouts and Worksheets

• Go through the session and identify handouts and worksheets needed for

the session

• Reproduce pages of these handouts and worksheets for student use while

teaching the session. This will enable students to refer to handouts and

worksheets during the session in the class. You can reproduce enough

copies for students or for sharing

• Give clear instructions to students on the student activity in order for

the students to follow the instructions of the activity

• Refer students to the specific page in the student manual as instructed

in the facilitator guide

Using Students Manual When Teaching

• The student manual is a document which has the same content as the

facilitator guide, which excludes facilitator instructions and answers

for exercises.

• The student manual is for assisting students to learn effectively and

acts as a reference document during and after teaching the session

• Some of the activities included in facilitator guide are in the student

manual without facilitator instructions

Abbreviations/Acronym

STG’s Standard treatment guidelines

EML Essential medicines list

OTC Over the counter

TFDA Tanzania food and drug authority

NEMLT National essential medicine list

WHO World health organization

EM Essential medicine

INN International non-proprietary name

CME Continue in – service medical education

RA Regulatory authority

DIC Drug information center

DTC Drug therapeutic committee

Session 1: Introduction to Rational use of Medicines

Total Session Time: 120minutes

Prerequisites

None

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Figure 1.1: The cycle of rational medicine use

Learning Tasks

By the end of this session students are expected to be able to:

• Give introduction of rational use of medicines

• Define common terms in rational use of medicines.

• Identify characteristics of medical prescription

• Outline six steps of rational prescribing.

• Describe avoidable mistakes in prescribing.

• Describe how to promote rational use of medicines.

• Explain criteria for assessing rational drug use

SESSION OVERVIEW

| | | |Use |

SESSION CONTENTS

STEP1: Presentation of Session Title and Learning Tasks (05 Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Introduction to Rational Use of Medicines(15 Minutes)

• The rational use of drugs requires that Patients receive medications

appropriate to their clinical needs, in doses that meet their own

individual requirements, for an adequate period of time, and at the

lowest cost to them and their community.

• It focuses on four important aspects of the rational use of medicines:

correct medication, correct dose, correct duration of treatment and

correct cost, irrational use occurs when one or more of these conditions

are not met.

• Rational use of medicine has three components and they are

o Availability of essential medicines

o Access and affordability of medicines

o Rationality of prescription

• In public health service system, free access of low cost medicine to all

patient is an important element in ensuring implementation of rational drug

use guidelines

• Rational Use of Medicines has several importance such as:

o Reducing the incidences of drug resistance

o Improving patience adherence to medicines

o Reducing unnecessary cost of drug acquisition

o Reducing incidences of treatment failure

o Reducing the incidences of drug adverse reaction

STEP 3: Definitions of common terms in Rational Use of Medicines.(20

Minutes)

• Irrational use of medicines

• Rational prescribing

• Irrational prescribing

• Rational dispensing

• Irrational dispensing

• Brand or trade name

• Generic name

• Adherence to treatment (compliance)

• Expirations date

• Shelf life

• International nonproprietary name (INN)

• Labeling

• Prescription

• Irrational or non-rational use of medicines:

o This is s the use of medicines in a way that is not compliant with

rational use of medicines.

• Rational Prescribing:

o The process in which the prescriber make accurate diagnosis of the

condition, selects the most suitable medication from those

available, prescribes the medicine in the right dosage for a

sufficient length of time according to the standard treatment

guidelines.

• Irrational Prescribing:

o Prescribing that does not conform to good standards of treatment

–for example, extravagant prescribing, overprescribing, incorrect

prescribing, and multiple prescribing or under prescribing.

• Rational dispense:

o To prepare and distribute/supply to a patient a course of therapy

with appropriate instructions, on the basis of prescription.

• Irrational dispensing;

o The preparation and distribution of a course of therapy to a

patient, without appropriate instructions, based on a prescription.

• Brand or Trade Name;

o This is a name given to a drug product by its manufacturer.

• Generic Name;

o A generic name is the unique INN given to the active ingredients of

a drug and is recognized worldwide.

• Adherence to treatment (Compliance);

o The degree to which patients adhere/comply to medical advice and

take medicines as directed.

• Expiration Date;

o The date after which the manufacturer can no longer guarantee the

stability, safety and potency of a drug.

• Shelf Life;

o The length of time a drug may be stored without affecting its

stability, safety, purity or potency.

• International Nonproprietary Name (INN);

o Internationally recognized name for a chemical entity.

• Labeling;

o Placing written or symbolic instructions on the immediate container

in which drugs are dispensed.

• Prescription;

o A set of instructions written by a qualified or authorized

prescriber to a dispenser for supply of drugs and provision of

information to the patient.

STEP4 : Characteristics of Medical Prescription (15 Minutes)

|Activity: Buzzing (05 Minutes) |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

|What are the characteristics of medical prescription? |

| |

|ALLOW few pairs to respond and let other pairs to add on points not |

|mentioned |

|WRITE their response on the flip chart/board |

|CLARIFY and SUMMARIZE by using the content below |

Characteristics of medical prescriptions:

• Prescriptions should promote the rational use of drugs.

• Prescription should be written after a diagnosis or a health problem has

been identified.

• The prescription will present the necessary drugs and measures sufficient

to heal or improve the state of the patient.

• The prescription must contain all necessary information clearly written.

STEP 5: Avoidable Mistakes in Medical Prescribing.(10minutes)

• Prescribing multiple drugs

• Prescribing to keep up with the latest fashion

• Prescribing an older drug out of habit

• Prescribing in order to satisfy the expectations of the patient

• Prescribing out of pressure from drug companies, other prescribers or

media.

STEP 4: Steps to Improve Rational Drug Prescribing (15 Minutes)

|Activity: Brainstorming (05 Minutes) |

|Ask students to brainstorm on the following question: |

|What are thesteps to improve rational drug prescribing? |

|ALLOW few students to respond? |

|WRITE their responses on the flip chart/ board |

|CLARIFY and SUMMARISE by using the content below |

Steps to improve rational drug prescribing:

• Identify the patient’s problem based on symptoms & recognize the need for

action.

• Diagnosis of the disease. Identify underlying cause & motivating factors.

This may be specific as in infectious disease or nonspecific.

• List possible intervention or treatment. This may be non-drug treatment

or drug treatment. Drug must be chosen from different alternatives based

on efficacy, convenience & safety of drugs including, drug inter-actions

&high risk group of patients.

• Start the treatment by writing an accurate and complete prescription e.g.

name of drugs with dosage forms, dosage schedule and total duration of

the treatment.

• Given proper information instruction and warning regarding the treatment

given e.g. side effects (ADR), dosage schedule and dangers/risk of

stopping the therapy suddenly.

• Monitor the treatment to check, if the particular treatment has solved

the patient’s problem. It may be:

o Passive monitoring – done by the patient himself. Explain to him what

to do if the treatment is not effective or if too many side effect

occurs

o Active monitoring _ done by physician or pharmaceutical personnel they

make an appointment to check the response of the treatment.

STEP 7: Promoting Rational Use of Medicines. (25 minutes)

The following are the strategies of promoting rational use of medicines

• Rational prescribing

• Rational dispensing

• Use of calibrated and graduated equipment and apparatus to improve

rational use of medicines.

Rational prescribing;

The following steps will ensure rational prescribing:

• Define the patient’s problems by doing thorough diagnosis

• Specify the therapeutic objective, Identify a suitable drug

• Write a prescription as per standard treatment guidelines

• Give the patient proper instruction and warning

• Monitor and (stop) the treatment

• Better training of practitioner’s in pharmacology and therapeutics,

• Regular supervision of auxiliaries,

• The availability of current drug information through reference manuals

and drug news periodicals,

• More active involvement of hospital and regional drug committees,

• Prescribing and dispensing restrictions,

• The promotion of cost consciousness among prescribers.

Rational dispensing

• Dispensing is a process of supplying drug(s) to a patient.

• The process requires adequate knowledge, skill and a caring attitude.

• Careful dispensing is an important component in managing drug supplies

because it is the last step which ensures that the patient has received

the right drug.

• Steps necessary for rational dispensing are:

o Approach patient cordially and receive the prescription

o Analyze prescription

o Calculate required quantities for each drug to be dispensed

o Dispense right quantity for each drug

o Check if right medicines are dispensed

o Label each dispensed medicine adequately

o Counter check dispensed medicines

o Counsel patient on medication use

o Retain prescription for records

Use of calibrated and graduated equipment and apparatus to improve rational

use of medicines

• The use of appropriate equipment and apparatus for drug dispensing and

administration will improve the rational use of medicines.

• These apparatus include those that enable correct measures of medicines

to be dispensed and/or administered. E.g. graduated measuring cylinders

of different capacities made of glass or plastic,

• Measuring spoons calibrated to dispense specified volumes e.g. 2.5ml,

5ml, 10ml, etc

• Tablet counters to enhance counting accuracy and prevent contamination

Figure 1.1: The cycle of rational medicine use[pic]

Illustration of the above cycle

• Diagnosis/follow up: It emphasizes the need for prescribers to follow a

standard process of prescribing, which starts with a diagnosis to define

the problem that requires intervention.

• Prescribing: The prescriber must decide which treatment is required,

based on up-to-date drug and therapeutics information, to achieve the

desired goal for an individual patient.

• Dispensing: Pharmaceutical personnel should dispense to the patient the

prescribed medicines in safe and hygienic manner

• Patient adherence: Making sure that the patient understands the dosage

and course of therapy then the patient takes the drug. Patient use the

medicines according to the instruction from prescriber and pharmaceutical

personnel.

STEP 6: Criteria for Assessing Rational Drug Use (10 minutes)

Rational drug use can be assessed by using the following criteria:

• Appropriate dose that is, the correct dose is given;

• appropriate indication, that is, the reason to prescribe is based on

sound medical considerations;

• Appropriate drug that is, considering efficacy, safety, suitability for

the patient, and cost.

• Correct dosage that is, with the correct administration, and for the

correct duration of treatment;

• Appropriate patient that is, no contraindications exist, and the

likelihood of adverse reactions is minimal;

• Correctly dispensed drug to the patient that is, including appropriate

information for patients about the prescribed medicines

• Adherence or compliance that is, patient use the drug accordingly

STEP 7: Key Points (05 minutes)

• The aim of any medicine management system is to deliver the right

medicine to the patient who needs the medicine.

• The steps of selection, procurement, and distribution are necessary

precursors to the rational use of medicines.

• It implies the selection of an appropriate drug for the correct

patient, given in the correct dose, dosage form, route, frequency and

duration.

• The patient must also receive appropriate instructions on how to use

the drugs.

STEP 8: Evaluation (05 minutes)

• Define rational use of drug.

• listcharacteristics of medical prescription

• What are the steps to improve rational drug prescribing?

References:

Rees, J. A., Smith, I., & Watson, (2012) J. Pharmaceutical practice (5th

ed.). London, United Kingdom: Churchill Livingstone

GoT (2013). Standard Treatment Guidelines&National Essential Medicines List

Tanzania MainLand ( 4th ed). Dar-es-salaam, Tanzania: MOHSW.

Hogerzeil HV.(1995). Promoting rational drug use: an international

perspective. 8. Br J Clin Pharmac; 39: 1-6.

Session 2: Introduction to Irrational Use of Medicines

Total Session Time: 120 Minutes

Prerequisites

• None

Students Learning Tasks

By the end of this session students are expected to be able to:

• Give over view of irrational medicines use

• Identify types of irrational Medicines use

• Describe dispenser’s influence on irrational use of medicines

• Describe prescriber’s influence on irrational use of medicines

• Give reasons for irrational use of medicines to continue

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Handout 2.1:Factors underlying irrational Use of Medicines

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Introduction to Irrational Use of Medicines (20Minutes)

Irrational use of medicines:

• Is the use of medicines in a way that is not compliant with rational use,

this incorrect use may take the form of overuse, underuse and misuse of

prescription or non-prescription medicines

Irrational use of medicines is a serious public health problem worldwide

and can be seen as:

• Use of too many medicines per patient

• Inappropriate use of antimicrobials, often in inadequate dosage and

insufficient duration;

• Overuse of injections when oral medication would be more appropriate;

• Failure to prescribe in accordance with clinical guidelines including

standard treatment guidelines and prescribing policy; and

• Inappropriate self-medication, often of prescription-only medicines.

STEP 3: Types of Irrational Medicines Use Based on Prescribing Practice (30

Minutes)

|Activity: Small Group Discussion ( 05 minutes) |

|DIVIDE students into small manageable groups |

|ASK students to discuss on the following question |

|Give types of irrational medicine use base on prescribing practice |

|ALLOW students to discuss for 10 minutes |

|ALLOW few groups to present and the rest to add points not mentioned |

|CLARIFY and SUMMARIZE by using the contents below |

The following are some types of irrational use of medicines based on

prescribing practices that observed in health institutions:

• Under-prescribing;

• Over-prescribing

• Incorrect prescribing or dispensing

• Extravagant prescribing

• Multiple prescribing

• Poly-pharmacy

• Under-prescribing:

o Occurs when needed medications are not prescribed and the dosage

prescribed is inadequate

• Over-prescribing:

o Occurs when the prescribed drug is not needed by the patient and the

quantity of drug dispensed is too much for current course of treatment

• Incorrect prescribing or dispensing:

o Occurs when prescribing the wrong drug, dispensing the wrong drug due

to the prescription being prepared improperly and adjustments are not

made for existing medical, genetic, environmental or other conditions

• Extravagant prescribing:

o Occurs when prescribing a more expensive branded drug when there is a

less expensive generic drug of good quality available and treating the

patient symptomatically instead of treating the serious illness, hence

making the patient use a lot of his funds.

• Polypharmacy

o The use of too many medicines per patient when more than one medicine

is used unnecessarily to treat same condition.

STEP 4: Dispenser’s Influence on Irrational Use of Medicines (20 Minutes)

The dispenser plays a crucial role in the therapeutic process, on the other

hand:

• Dispensing quality may be affected by training and supervision the

dispenser has received and the medicine information available to the

dispenser.

• A shortage of dispensing materials and short dispensing time caused by

heavy patient load may also have an adverse impact on dispensing.

• As with prescribers, dispensers, especially private drug sellers, may

have a financial incentive to dispense irrationally.

• Drug sellers in retail outlets are rarely trained and there is little

knowmonitoring or supervision.

• Low status of dispensers affects the quality of dispensing.

Dispensing characteristics that lead to Irrational Medicine Use are:

• Incorrect interpretation of the prescription

• Retrieval of wrong medicines/ingredients

• Inaccurate counting, compounding, or pouring

• Inadequate labelling

• Unsanitary procedures packaging:

o Poor-quality packaging materials

o Odd package size, which may require repackaging

o Unappealing package

Pharmaceutical personnel promoting irrational use of medicines by: –

• Recommending prescription medicines even though the law does not permit

it.

• When recommending Over-The-Counter (OTC) medicines, he may

recommend/provide:

o Irrational medicines and combinations.

o Inappropriate dosage.

o Improper medicine for a particular condition.

o Insufficient or inappropriate information about the medicines,

dosages, timing set leading to improper dosing by the patient.

• By being tempted to stock and push/recommend medicines that are costly,

or those which offer better schemes/profit margins, but compromise on

genuine need and rationality.

• By following/copying prescribing patterns similar to those of physicians.

• By passing on misleading information from pharmaceutical

companies/medical representatives to clients.

[pic]

STEP 5: Prescriber’s Influence on Irrational Use of Medicines (20 Minutes)

Prescriber can be affected by internal and external factors such as:

• He or she may have received inadequate training either pre-service or in-

service, or his or her prescribing practices may have become outdated

because of a lack of continuing education and a poor supervisory system.

• Prescribing role models who are imitated may not prescribe rationally.

Objective information on medicines may be lacking, and the information

provided by supplier representatives may be unreliable.

• Temptation can be strong to generalize inappropriately about the

effectiveness or side effects of medicines on the basis of limited

personal experience.

• Externally, a heavy patient load and pressure to prescribe from peers,

patients, and pharmaceutical company representatives all complicate

prescribing decisions.

• Profit may affect a prescriber’s choice if the prescriber’s income is

dependent on medicine sales.

Prescriber’s Characteristics that Lead to Irrational Medicine Use are:

• Inadequate examination of patient

• Incomplete communication between patient and prescriber

• Lack of documented medical history

• Inadequate laboratory Resources which lead to incomplete patient

examinations.

Handout 2.1: Factors Underlying Irrational Use of Medicines

|Patients |Drug misinformation |

| |Misleading beliefs |

| |inability to communicate problems |

| |Patient demands/expectations |

|Prescribers |Lack of education and training. |

| |Inappropriate/poor role models. |

| |Lack of objective/inadequate drug |

| |information. |

| |Generalization of limited experience. |

| |Misleading beliefs about drug efficacy. |

| |Marketing pressures and lucrative |

| |offers/financial interest |

| |Pressure to prescribe |

| |Heavy patient load |

|Dispenser |Poor training |

| |Financial interest |

| |No supervision |

| |Shortage of dispensing materials |

| |Patient load |

|Health Supply system |Unreliable supply |

| |Medicine shortages. |

| |Supplying expired medicines. |

| |Inefficient management |

| |Supplying substandard or counterfeit |

| |medicines |

| |Supplying wrong medicines |

|Pharmaceutical industry |Over promotion – Promotional activities |

| |through advertisements or medical |

| |representatives) |

| |Misleading claims. |

| |Large number of preparations |

|Drug regulation |Availability of non-essential medicines.|

| |Presence of non-formal /informal |

| |prescribers (Quacks). |

| |Lack of regulation enforcement. |

| |Sluggish judiciary. |

| |Absence of Essential drug list |

| |Absence of standard treatment guidelines|

STEP 6: Reasons for Irrational Use of Medicine to Continue (15Minutes)

|Activity: Brainstorming (10 Minutes) |

|Ask students to brainstorm on the following question: |

|Why does irrational use of medicines continue? |

|ALLOW few students to respond? |

|WRITE their responses on the flip chart/ board |

|CLARIFY and SUMMARISE by using the content below |

Very few countries regularly monitor drug use and implement effective

nation-wide interventions this is because:

• They have insufficient funds or personnel

• They lack of awareness about the funds wasted through irrational use

• There is insufficient knowledge concerning the cost-effectiveness of

interventions

• They do not bear the cost of irrational use

STEP 7: Key Points (05 Minutes)

• Health professionals have a responsibility to ensure that the right drug

is prescribed, dispensed and taken.

• Prescriber’s characteristics that lead to Irrational Medicine Use are

inadequate examination of patient, incomplete communication between

patient and prescriber and lack of documented medical history.

• Dispensing characteristics that lead to irrational medicine use are:

incorrect interpretation of the prescription, retrieval of wrong

medicines/ingredients, inaccurate counting, compounding, or pouring,

inadequate labeling, unsanitary procedures

• Improving drug use improves the quality of care and frequently lowers

cost.

STEP 8: Evaluation (05 Minutes)

• What is irrational use of medicines

• What are the types of irrational use of medicines?

• List reasons for irrational use of medicines to continue

References:

Dean, B., Schachter, M., Vincent, C, Barber, N (2002).Lancet: Causes of

prescribing errors in hospital inpatients: a prospective study.

359:1373–8. 7

Dean, B., Vincent, C, Schachter, M., Barber, N (2005).Drug Saf:The

incidence of prescribing errors in hospital inpatients: an overview of

the research methods.. 28:891–900.

Knudsen, P., Herborg, H., Mortensen, A,R., Knudsen, M., Hellebek, A

.(2007). QualSaf Health Care:Preventing medication errors in community

pharmacy: root-cause analysis of transcription errors.16:285–290.

Lesar, T.S., Briceland, L., Stein, D, S. (1997). JAMA:Factors related to

errors in medication prescribing.. 277:312–317.

Rees, J. A., Smith, I., & Watson, (2012) J. Pharmaceutical practice (5th

ed.). London, United Kingdom: Churchill Livingstone

Session 3: Factors Contributing to Irrational Use of Medicines

Total Session Time: 120 minutes

Prerequisites

• None

Students Learning Tasks

By the end of this session students are expected to be able to:

• Give Overview of Factors Contributing to Irrational Use of Medicines

• Identify Factors Contributing to Irrational Use of Medicines

• Explain Factors Contributing to Irrational Use of Medicines

Resources Needed:

• flip charts, marker pens, and masking tape

• black/white board and chalk/whiteboard markers

• Figure 3.2:Factors influence use of medicines

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Factors Contributing to Irrational Use of Medicines (30 Minutes)

• There are many factors that contribute to the irrational prescribing or

use of medicines.

• These factors can be traced to various stages of the medicine use cycle,

and can be broadly categorized into those emanating from patients,

prescribers, workplace (health system), supply system (including industry

influences), regulation, drug information or misinformation, or a

combination of these factors.

• Uninformed patients who may have the perception that there exists a pill

for every ailment can exert undue pressure on health providers to

prescribe medicines, even when this is not needed.

STEP 3: Factors Contributing to Irrational Use of Medicines (30 Minutes)

|Activity: Brainstorming (15 Minutes) |

|Ask students to brainstorm on the following question: |

|What are the factors contributing to irrational use of medicines? |

|ALLOW few students to respond? |

|WRITE their responses on the flip chart/ board |

|CLARIFY and SUMMARISE by using the content below |

The following are the factors contributing to irrational use of medicines

• Lack of skills and knowledge.

• Inappropriate unethical promotion of drugs

• Overworked of health workers.

• Lack of coordinated national pharmaceutical policy.

• Poor communication skills.

• Inadequate supervision

• Misleading beliefs.

• Irrational self-medication

• Inability to communicate problems

STEP 4: Factors Contributing to Irrational Use of Medicines (45 Minutes)

The following are the explanations of Factors Contributing to Irrational

Use of Medicines:

Lack of skills and knowledge

• Diagnostic uncertainty, lack of prescriber knowledge of optimal

diagnostic approaches, lack of independent information such as clinical

guidelines, lack of opportunity for patient follow-up, or fear of

possible litigation, lead to improper prescription and dispensing of

medicines

Inappropriate unethical promotion of drugs

• Most prescribers get medicine information from pharmaceutical companies

rather than independent sources such as clinical guidelines.

• Some countries allow direct-to-consumer advertising of prescription

medicines, which may lead to patients pressuring doctors for unnecessary

medicines, these can lead to inappropriate usage of medicines.

Profit from selling medicines

• In many countries, drug retailers prescribe and sell medicines over-the-

counter.

• The more they sell the more income they generate, leading to overuse of

medicines, particularly the more expensive medicines

Overworked and patient load to health workers

• Many prescribers have too little time with each patient, which can result

in poor diagnosis and treatment.

• In such circumstances prescribers rely on prescribing habit as they do

not have the time to update their knowledge on medicines.

• A prescriber may be forced to prescribe without proper diagnosis and thus

prescribe inappropriate medication.

• Too many patients also for dispensers may lead to medication errors and

irrational dispensing.

Lack of coordinated national pharmaceutical policy

• Less than half of all countries implement the basic policies recommended

by WHO to ensure the appropriate use of medicines.

• These include appropriate measures and infrastructure for monitoring and

regulation of medicines use, and training and supervision for prescribing

health workers.

Poor communication skills

• Rudeness of the dispenser or language barrier between the dispenser and

the patient leading to misunderstanding of the use of medicines by the

patient.

• Medical practitioners & other health professional giving less time to the

patient & not explaining some basic information about the use of drugs.

Inadequate supervision

• Poor or inadequate supervision may lead to irrational dispensing, such as

not following good dispensing practice (e.g. adequate labelling, adequate

instructions, adequate dose, etc.)

Misleading beliefs

• People tend to think for example that injectables are better than

tablets, or imported medicines or expensive medicines are better than

locally manufactured or cheap medicines respectively.

Irrational self-medication

• Taking medicines without prescription or consultation

Demand from the patient

• To satisfy the patient expectations and demand of quick relief, clinician

prescribe drug for every single complaint. Also, there is a belief that

“every ill has a pill” All these increase the tendency of polypharmacy.

Inability to communicate problems;

• Communication barriers, which lead to wrong diagnosis and therefore wrong

prescription, consequently wrong dispensing.

• Communication barriers may include language, or/and stigma.

Figure 1.2 Factors Influence Use of Medicines

STEP 5: Key Points (05 Minutes)

• Many interrelated factors influence medicine use.

• The health system, prescriber, dispenser, patient, and community are all

involved in the therapeutic process, and all can contribute to irrational

use in a variety ways.

• Less than half of all countries implement the basic policies recommended

by WHO to ensure the appropriate use of medicines.

• These include appropriate measures and infrastructure for monitoring and

regulation of medicines use, and training and supervision for prescribing

health workers.

STEP 6: Evaluation (05 Minutes)

• What are the factors contributing to irrational use of medicines?

• Outline five demands from the patient which can lead to irrational use of

medicines

References:

Cooper, J. W., Gunn, C., & Carter, S. J. (2008). Cooper and Gunn's

dispensing for pharmaceutical students (12th ed.). New Delhi, India: CBS.

Rees, J. A., Smith, I., & Watson, (2012) J. Pharmaceutical practice (5th

ed.). London, United Kingdom: Churchill Livingstone

Bentley, A. O., & Rawlins, E. A. (1977). Bentley's textbook of

pharmaceutics (8th ed.). London, United Kingdom: Bailliere Tindall.

Session 4: Problems Associated with Irrational Medicine Usage

Total Session Time: 120 minutes

Prerequisites

• None

Students Learning Tasks

By the end of this session students are expected to be able to:

• Give overview of problems associated with Irrational Medicine Usage

• List Problems Associated with Irrational Medicine Usage

• Explain Problems associated with irrational medicine usage

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Figure 4.3 complications related to irrational use of medicines

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks(05 Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Introduction of Problems Associated with Irrational Medicine Usage

(30 Minutes)

• Medicines play an important role in healthcare delivery, and when used

properly, can help cure diseases, relieve symptoms, and alleviate

patient suffering.

• Irrational use of medicines remains a major issue facing most health

systems across the world.

• Worldwide more than 50% of all medicines are prescribed, dispensed, or

sold inappropriately, while 50% of patients fail to take them

correctly and about one-third of the world's population lacks access

to essential medicines.

• The problem of irrational medicine use is known to be worse in

developing countries with weak health systems, where mechanisms for

routine monitoring of medicine use are often not well developed or are

at times non-existent.

STEP 3: Types of Problems Associated with Irrational Medicine Usage (30

Minutes)

|Activity: Buzzing (10 minutes) |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

|What are the problems associated with irrational medicine usage? |

| |

|ALLOW few pairs to respond and let other pairs to add on points not |

|mentioned |

|WRITE their response on the flip chart/board |

|CLARIFY and SUMMARIZE by using the content below |

Incorrect use of medicines occurs in all countries, causing harm to people

and wasting resources, consequences include:

• Antimicrobial resistance.

• Adverse drug reactions and medication errors.

• Lost resources.

• Eroded patient confidence

• Treatment failure leading to unnecessary financial burden

• Increase of toxicity risk

• Non-compliance to drug regimen.

STEP 4: Problems Associated with Irrational Medicine Usage (45 Minutes)

The following are the explanation of the problems associated with

irrational medicine usage

Antimicrobial resistance

• Overuse of antibiotics increases antimicrobial resistance and the

number of medicines that are no longer effective against infectious

disease.

• Many surgical procedures and cancer therapies are not possible without

antibiotics to fight infection.

• Resistance prolongs illnesses and hospital stays, and can even cause

disability and death.

Adverse drug reactions and medication errors

• Harmful reactions to medicines caused by wrong use, or allergic

reactions to medicines can lead to increased illness, suffering and

death.

• Adverse drug reactions have been estimated to increase treatment cost

each year.

Lost resources

• Out-of-pocket purchases of medicines can cause severe financial

hardship to individuals and their families.

• If medicines are not prescribed and used properly, the income of

public and personal funds are wasted.

Eroded patient confidence

• Exacerbated by the overuse of limited medicines, drugs may be often

out of stock or at unaffordable prices and as result erode patient

confidence.

• Poor or negative health outcomes due to inappropriate use of medicines

may also reduce confidence.

Treatment failure leading to unnecessary financial burden

• Misuse, underuse and over-use of medicines waste resources – often out-

of-pocket payments by patients and result in significant patient harm

in terms of poor patient outcomes/treatment and adverse drug

reactions.

Increase of toxicity risk

• Drug toxicity can occur as a result of over-ingestion of a

medication—having too much of a drug (irrational use) in a person's

system at once.

• Drug toxicity occurs when a person has accumulated too much of a drug

in his bloodstream, leading to adverse effects on the body.

• Drug toxicity may occur when the dose given is too high or the liver

or kidneys are unable to remove the drug from the bloodstream,

allowing it to accumulate in the body

• In this case, irrational use of medicines can cause morbidity or

mortality in the society

Non-compliance to drug regimen

• Treatment regimens are only effective if the patient is willing to

follow the plan.

• Compliance is the extent to which a patient adheres to a treatment

regimen, primarily involves following the medication instructions, but

it also can include lifestyle modifications, as well as keeping follow-

up medical appointments

• Noncompliance may lead to relapse, aggravation of the disease state,

hospitalization, escalating health care costs, and even death.

• Pharmaceutical personnel have a major impact on compliance rates

through fighting against irrational use of medicines.

Figure 4:3Complications related to irrational use of medicines

[pic]

STEP 5: Key Points (05 Minutes)

• Promoting the rational use of medicines requires effective policies

as well as efficient collaboration between health professionals,

patients, and entire communities.

• Adequate understanding regarding the relevant aspects of medicine use

on the part of all stakeholders is essential to drive collaborative

efforts towards addressing the problem of irrational medicine use.

• Tackling the issue of irrational medicine use is considered to be

essential not only to improve healthcare delivery towards ensuring

patient safety, but also to allow for optimal utilization of

resources.

STEP 6: Evaluation (05 Minutes)

• What are the problems associated with irrational medicine usage?

• What are manifestations which hinder patient confidence in health

institutions?

References:

Dean, B., Schachter, M., Vincent, C, Barber, N (2002).Lancet: Causes of

prescribing errors in hospital inpatients: a prospective study.

359:1373–8.

Knudsen, P., Herborg, H., Mortensen, A,R., Knudsen, M., Hellebek, A

.(2007). QualSaf Health Care:Preventing medication errors in community

pharmacy: root-cause analysis of transcription errors.16:285–290.

Lesar, T.S., Briceland, L, Stein, D, S. (1997). JAMA:Factors related to

errors in medication prescribing.. 277:312–317.

Session 5: Control Measures for Irrational Medicines Use

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Give overview of control measures for irrational medicines use

• Identify control measures for irrational medicines use

• Explain control measures for irrational medicines use

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Introduction to Control Measures for Irrational Medicines Use (15

Minutes)

• The first step to correcting irrational use of medicines is to

measure it.

• Prescribing, dispensing and patient use should be regularly monitored

in terms of:

o Types of irrational use of medicines, so that strategies can be

targeted towards changing specific problems

o Amount of irrational use, so that the size of the problem is known

and the impact of the strategies can be monitored

o Reasons why medicines are used irrationally, so that appropriate,

effective and feasible strategies can be chosen.

• People often have very rational reasons for using medicines

irrationally

• Medicines cannot be used rationally unless everyone involved in the

pharmaceutical supply chain has access to objective information about

the drug they buy and use.

• Knowledge and ideas about drugs are constantly changing,

pharmaceutical personnel and physician are expected to know about the

new development in drug therapy.

STEP 3: Types of Control Measures for Irrational Medicines Use (30 Minutes)

|Activity: Brainstorming (15 Minutes) |

|Ask students to brainstorm on the following question: |

|What are the control measures for irrational medicines use? |

|ALLOW few students to respond |

|WRITE their responses on the flip chart/ board |

|CLARIFY and SUMMARISE by using the content below |

World Health Organization (WHO) advises countries to implement national

programmes to combat irrational use of medicines through policies,

structures, information and education. These include:

• Educational Strategies

• Printed Materials

• Approaches Based on Face-to-Face Contact

• Managerial Strategies

• Prescribing and Dispensing Approaches

• Financing

• Regulatory Strategies

STEP 4: Control Measures For Irrational Medicines Use (60 Minutes)

The following are the control measures for irrational medicines use

Educational strategies

• There should be training of prescribers and dispensers through:

o Formal education (pre-service)

o Continuing education (in-service)

o Supervisory visits

o Group lectures, seminars, and workshops

Printed materials

• The following materials should be available in the health institutions

and health training institutions.

o Clinical literature and newsletters

o Treatment guidelines and drug formularies

o Illustrated materials (flyers, leaflets)

Approaches based on face-to-face contact

o Educational outreach

o Patient education

o Influencing opinion leaders

Managerial strategies

There should be special attention in Selection, Procurement, and

Distribution of medicines and medical supplies such as

o Limited procurement lists

o Drug utilization review and feedback

o Hospital and regional drug committees

o Cost information

Prescribing and dispensing approaches

• They should have the following documents

o Structured drug order forms

o Standard diagnostic and treatment guidelines

o Course-of-therapy packaging

Financing

• Health institution should have

o Price setting

o Capitation-based budgeting

Regulatory strategies

• The responsible drug authorities should pay more attention in:

o Drug registration

o Limited drug lists

o Prescribing restrictions

o Dispensing restrictions

STEP 5: Key Points (05 Minutes)

• The most effective approach to improve medicines use is a combination of

education and supervision of health personnel, consumer education, and

ensuring an adequate supply of appropriate medicines.

• There should be special attention in selection, procurement, and

distribution of medicines and medical supplies such as: limited

procurement lists, drug utilization review and feedback, hospital and

regional drug committees.

• Approaches based on face-to-face Contact should be applied such as:

educational outreach, patient education and influencing opinion leaders

STEP 6: Evaluation (05 Minutes)

• What are the control measures for irrational medicines use?

• List responsibilities of drug authorities in promoting rational use

of medicines.

References:

Rees, J. A., Smith, I., & Watson, (2012) J. Pharmaceutical practice (5th

ed.). London, United Kingdom: Churchill Livingstone

Dean, B., Schachter, M., Vincent, C, Barber, N (2002).Lancet: Causes of

prescribing errors in hospital inpatients: a prospective study.

359:1373–8

Knudsen, P., Herborg, H., Mortensen, A,R., Knudsen, M., Hellebek, A

.(2007). QualSafealthCare:Preventing medication errors in community

pharmacy: root-cause analysis of transcription errors.16:285–290.

Lesar, T.S., Briceland, L., Stein, D, S. (1997). JAMA:Factors related to

errors in medication prescribing..277:312–317.

Session 6: Concept of National Essential Medicines

Total Session Time: 120 minutes

Prerequisites

• None

Students Learning Tasks

By the end of this session students are expected to be able to:

• Define essential medicine list

• Give overview of model list of essential medicines list

• Describe national concept of essential medicines list

• Outline advantages of a limited list of essential medicines

• Identify problems of national essential medicines list

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Essential Medicines list (10 minutes)

• Essential medicines are those that satisfy the priority health care

needs of the population, they are selected with due regard to disease

prevalence and public health relevance, evidence of clinical efficacy

and safety, and comparative costs and cost-effectiveness.

STEP 3: Introduction of Model List of Essential Medicines (25 Minutes)

• The concept of essential medicines has been worldwide accepted as a

powerful tool to promote health equity and its impact is remarkable

as the essential medicines are proved to be one of the most cost-

effective elements in health care.

• World Health Organization (WHO) introduced the concept of essential

medicines in 1977 and develops the first essential medicines list in

1977 and since then the list has been revised every 2 years.

• Lists of essential medicines are also used by UNICEF, the United

Nations high commissioner for refugees, and many non-governmental

organizations.

• The WHO Model List of Essential Medicines is a useful reference,

derived from the consensus of recognized international experts and

updated.

• The model list of WHO serves as a guide for the development of

national and institutional essential medicine list. Both its content

and the process by which it is updated are intended as a model for

developing countries.

STEP 4: National Concept of Essential medicines list (30 minutes)

• Essential medicines are intended to be available within the context of

functioning health systems at all times in adequate amounts, in the

appropriate dosage forms, with assured quality and adequate

information, and at a price the individual and the community can

afford.

• The implementation of the concept of essential medicines is intended

to be flexible and adaptable to many different situations;

• Medicines which are regarded as essential remains a national

responsibility.

• Experience has shown that careful selection of a limited range of

essential medicines results in a higher quality of care, better

management of medicines (including improved quality of prescribed

medicines), and a more cost-effective use of available health

resources.

• Medicines are integral parts of the health care and the modern health

care is unthinkable without the availability of necessary medicines.

• They not only save lives and promote health, but prevent epidemics and

diseases too.

• The medicines are undoubtedly one of the weapons of mankind to fight

disease and illness. Accessibility to medicines is too the fundamental

right of every person.

STEP 3: Advantages of a Limited List of Essential Medicines(20 minutes)

|Activity: Brainstorming (10 Minutes) |

|Ask students to brainstorm on the following question: |

|What are the advantages of a limited list of essential medicines? |

|ALLOW few students to respond |

|WRITE their responses on the flip chart/ board |

|CLARIFY and SUMMARISE by using the content below |

The following are the advantages of having limited list of essential

medicines in different aspect:

Supply

Medicines and medical suppliers benefit by:

• Easier procurement, storage, and distribution

• Lower stocks

• Better quality assurance

• Easier dispensing

Prescribing and Dispensing

Pharmaceutical personnel and prescribers benefit it because:

• Training more focused and therefore simpler

• More experience with fewer medicines

• Non availability of irrational treatment alternatives

• Reduction of antimicrobial resistance

• Focused drug information

• Better recognition of adverse drug reactions

Cost

• Lower prices, more competition

Patient use

Patients and other consumers of medicines and medical suppliers benefit it

because they:

• Focused education efforts

• Reduced confusion and increased adherence to treatment

STEP 4: Problems of National Essential Medicine List (20 Minutes)

|Activity: Buzzing (10 Minutes) |

|Ask students to brainstorm on the following question: |

|What are the problems of national essential medicine list? |

|ALLOW few students to respond |

|WRITE their responses on the flip chart/ board |

|CLARIFY and SUMMARISE by using the content below |

The following are problems of national essential medicine list

• Range of diseases covered by the Model List is not clear

• Discrepancies between Model List and treatment guidelines

• Selection is more consensus-based than evidence-based

• Use of data on cost and cost-effectiveness unclear

• Reasons for selection is insufficiently recorded

• Drugs included without pharmacopoeia standard or supplier

• Official report comes out too late, and in English only

STEP 6: Key Points (05 Minutes)

• Establishing and using a limited list of carefully selected essential

medicines is perhaps the single most cost-effective action that any

health care system or health care provider can take to promote regular

supply and rational use of medicines.

• Patients can be better informed about the effective use of medicines when

the number of medicines they are confronted with is limited.

• Medicines and medical suppliers benefit with EML because of easier

procurement, storage, and distribution, lower stocks, better quality

assurance and easier dispensing

STEP 7: Evaluation (05 Minutes)

• Define essential medicines

• List advantages of a limited list of essential medicines

• How medicines and medical suppliers benefit from EML?

References:

Kar SS1,Pradhan HS2,Mohanta GP3, (2010). Concept of essential medicines and

rational use in public health.Indian Journal of Community Medicine.

Tripathi KD. (2010), Aspects of Pharmacotherapy; Clinical pharmacology and

DrugDevelopement In: Essentials of medical pharmacology. Jay pee brothers

medical publishers (p) ltd, New Delhi 6th ed.

Bentley, A. O., & Rawlins, E. A. (1977). Bentley's textbook of

pharmaceutics (8th ed.). London, United Kingdom: Bailliere Tindall.

Session 7: Essential Medicines Concept in Promotion of Rational Medicines

Use

Total Session Time: 120 minutes

Prerequisites

• None

Students Learning Tasks

By the end of this session students are expected to be able to:

• Identify key factors for developing essential medicine list

• Identify important of essential medicine list

• Describe essential medicine list in promoting rational use of

medicines

• List criteria for selection of essential medicines

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing

STEP 2: Key Factors for Developing an Essential Medicines List (30

Minutes)

|Activity: Brainstorming (10 Minutes) |

|Ask students to brainstorm on the following question: |

|What are the key factors for developing an essential drug list? |

|ALLOW few students to respond |

|WRITE their responses on the flip chart/ board |

|CLARIFY and SUMMARISE by using the content below |

The following are factors for developing of an essential medicines list

|Establishing a transparent process for creating and updating the list |

|of essential medicines, provide a voice for key stakeholders, but |

|ensure a scientific, evidence-based process |

|Linkage with standard clinical guidelines and involvement of both |

|specialists and primary care providers |

|Garner support from senior clinicians, academic institutions, public |

|health professionals, professional organizations, non-governmental |

|organizations and community members |

|Making the list available (essential medicines, formulary manuals and |

|clinical guidelines) in all health care facilities/health care |

|providers in both printed and electronic format |

|Consider launching of new or revised lists with the involvement of |

|concerned government officials with adequate publicity |

|Making clear the specific legal or administrative authority of the |

|essential medicines list for training, procurement, reimbursement and |

|public information |

|Establishing an administrative or budgetary “safety valve” for the |

|limited supply and use of non-listed medicines |

|Regular Updating of the list so that it reflects therapeutic advances |

|and changes in cost, resistance patterns and public health relevance. |

STEP 3: Important of Essential Medicine List (25 Minutes)

|Activity: Brainstorming (10 Minutes) |

|Ask students to brainstorm on the following question: |

|What are important of essential medicine list? |

|ALLOW few students to respond |

|WRITE their responses on the flip chart/ board |

|CLARIFY and SUMMARISE by using the content below |

A list of essential medicines is an immensely useful tool for:

• Policy making.

• Selection, procurement, distribution and quality assurance.

• For financing.

• For training health professionals:

o A selected list of essential medicines can form the basis for training

health professionals in the proper use of medicines.

• For providing information and imparting education relating to medicines:

o Patient education and efforts to promote proper use of medicines by

patients are enhanced when centred on specific medicines.

STEP 4: Essential Medicine List in Promoting Rational Use of Medicines (25

Minutes)

Essential medicine list can promoting rational use of medicines for the

reason that:

• When a limited list of essential medicines represents the physician's

consensus on the treatment of first choice, the quality of care improves.

• Irrational treatments are avoided.

• Physicians and dispensers become familiar with a smaller number of

medicines – thus promoting rational drug use

STEP 5: Criteria for Selection Essential Medicines (25 Minutes)

Essential medicines should be selected on the basis of:

• Relevance to the pattern of prevalent diseases; Having medicines

available for the treatment of most prevalent diseases, ailments,

sicknesses and so forth at the levels of care provided.

• Proven efficacy and safety

• Adequate scientific data and evidence of performance in a variety of

settings

• Adequate good quality

• Affordable and cost-effectiveness so as to optimize the use of financial

resources. (Favorable cost-benefit ratio )

• Desirable pharmacokinetic properties

STEP 6: Key Points (05 Minutes)

The essential medicines concept embraces the following guiding

principles such as:

• The vast majority of health problems for most members of the

population can be treated with a small, carefully selected number of

medicines.

• In practice, most doctors and other health professionals routinely

use a small fraction of medicines produced.

• Training and clinical experience should focus on the proper use of

these few medicines.

• Procurement, distribution and other supply activities can be carried

out most economically and most efficiently for a limited list of

pharmaceutical products.

STEP 7: Evaluation (05 minutes)

• List the importance of essential medicine list

• What are Key factors for developing of an essential medicines list?

• What are criteria for selection of essential medicines

References

Kar SS1,Pradhan HS2,Mohanta GP3, (2010). Concept of essential medicines and

rational usein public health.Indian Journal of Community Medicine.

Tripathi KD. (2010), Aspects of Pharmacotherapy; Clinical pharmacology and

DrugDevelopement In: Essentials of medical pharmacology. Jay pee brothers

medical publishers (p) ltd, New Delhi 6th ed.

Bentley, A. O., & Rawlins, E. A. (1977). Bentley's textbook of

pharmaceutics (8th ed.). London, United Kingdom: Bailliere Tindall.

Session 8: Types of Interventions in Promoting Rational Medicines Use

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Give overview of national interventions in promoting rational

medicines use

• Identify types of national interventions in promoting rational

medicines use

• Explain national interventions in promoting rational medicines use

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Introduction to National interventions in promoting rational

medicines use (15 Minutes)

• Subsequent are some of the major and supreme roles and strategies in

order to eliminate the irrational use of the medicines, the

contribution of WHO, Pharmaceutical personnel, prescribers and

government is important in this regard.

• Based on this evidence, WHO has developed recommendations for twelve

core national policies and structures that are needed to promote

rational use of medicines.

STEP 2: Types of National interventions in promoting rational medicines use

(30 minutes)

|Activity: Buzzing (15 minutes) |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

|What are the types of national interventions in promoting rational |

|medicines use? |

| |

|ALLOW few pairs to respond and let other pairs to add on points not |

|mentioned |

|WRITE their response on the flip chart/board |

|CLARIFY and SUMMARIZE by using the content below |

The following are twelve core national interventions to promote rational

use of medicines

• A mandated multi-disciplinary national body to coordinate medicine use

policies

• Clinical guidelines

• Essential medicines list based on treatments of choice

• Drugs and therapeutics committees in districts and hospitals

• Problem-based pharmacotherapy training in undergraduate curricula

• Continuing in-service medical education as a licensure requirement

• Supervision, audit and feedback

• Independent information on medicines

• Public education about medicines

• Avoidance of perverse financial incentives

• Appropriate and enforced regulation

• Sufficient government expenditure to ensure availability of medicines

and staff

STEP 3: Explanation of the Types of National Interventions in Promoting

Rational Medicines Use (60 minutes)

The following are the explanation for twelve National core interventions in

promoting rational medicines use

A mandated multi-disciplinary national body to coordinate medicine use

policies

• Many societal and health system factors, as well as professionals and

many others, contribute to how medicines are used.

• Therefore, a multi-disciplinary approach is needed to develop, implement

and evaluate interventions to promote more rational use of medicines.

• A national regulatory authority (RA) is the agency that develops and

implements most of the legislation and regulation on pharmaceuticals.

• Ensuring rational use will require many additional activities which will

need coordination with many stakeholders.

• Thus a national body is needed to coordinate policy and strategies at

national level, in both the public and private sectors.

• The form this body takes may vary with the country, but in all cases it

should involve government (ministry of health), the health professions,

academia, the RA, pharmaceutical industry, consumer groups and non-

governmental organizations involved in health care.

• The impact on medicine use is better if many interventions are

implemented together in a coordinated way, single interventions often

having little impact.

Clinical guidelines:

• Clinical guidelines i.e. standard treatment guidelines or prescribing

policies consist of systematically developed statements to help

prescribers make decisions about appropriate treatments for specific

clinical conditions.

• They provide a benchmark of satisfactory diagnosis and treatment against

which comparison of actual treatments can be made.

• They are a proven way to promote more rational use of medicines provided

they are:

o developed in a participatory way involving end-users;

o easy to read;

o introduced with an official launch, training and wide dissemination;

o Reinforced by prescription audit and feedback.

• Guidelines should be developed for each level of care ranging from

paramedical staff in primary health care clinics to specialist doctors in

tertiary referral hospitals, based on prevalent clinical conditions and

the skills of available prescribers.

• Evidence-based treatment recommendations and regular updating help to

ensure credibility and acceptance of the guidelines by practitioners.

• Sufficient resources are needed to reimburse all those who contribute to

the guidelines, and to cover the costs of printing, dissemination and

training.

Essential medicines list based on treatment of choice:

• Essential medicines are those that satisfy the priority health care needs

of the population.

• Using an essential medicines list (EML) makes medicine management easier

in all respects; procurement, storage and distribution are easier with

fewer items and prescribing and dispensing are easier for professionals

if they have to know about fewer items.

• A national EML should be based upon national clinical guidelines.

• Medicine selection should be done by a central committee with an agreed

membership and using explicit, previously agreed criteria, based on

efficacy, safety, quality, cost and cost-effectiveness.

• EMLs should be regularly updated and their introduction accompanied by an

official launch, training and dissemination.

• Public sector procurement and distribution of medicines should be limited

primarily to those medicines on the EML, and it must be ensured that only

those health workers approved to use certain medicines are actually

supplied with them.

• Government activities in the pharmaceutical sector like quality

assurance, insurance reimbursement policies and training, should focus on

the EML.

• The WHO Model List of Essential Medicines can provide a starting point

for countries to develop their own national EML.

Drug and therapeutic committees in district and hospitals:

• A drugs and therapeutics committee (DTC), also called a pharmacy and

therapeutics committee, is a committee designated to ensure the safe and

effective use of medicines in the facility or area under its

jurisdiction.

• DTC committees are well-established in industrial countries as a

successful way of promoting more rational, cost-effective use of

medicines in hospitals.

• Governments encourage hospitals to have DTCs by making it an

accreditation requirement to various professional societies.

• DTC members should represent all the major specialties and the

administration; they should also be independent and declare any conflict

of interest.

• A senior doctor would usually be the chairperson and the chief

pharmacist, the secretary.

• Factors critical to success include: clear objectives; a firm mandate;

support by the senior hospital management; transparency; wide

representation; technical competence; a multidisciplinary approach; and

sufficient resources to implement the DTC’s decisions.

Problem-based training in pharmacotherapy in undergraduate curricula:

• The quality of basic training in pharmacotherapy for undergraduate

medical and paramedical students can significantly influence future

prescribing.

• Rational pharmacotherapy training, linked to clinical guidelines and

essential medicines lists, can help to establish good prescribing habits.

• Training is more successful if it is problem-based, concentrates on

common clinical conditions, takes into account students’ knowledge,

attitudes and skills, and is targeted to the students’ future prescribing

requirements.

• The Guide to Good Prescribing describes the problem-based approach, which

has been adopted in a number of medical schools.

Continuing in-service medical education as a licensure requirement:

• Continuing in-service medical education (CME) is a requirement for

licensure of health professionals in many industrialized countries.

• Continuing in-service medical education (CME) is a requirement for

licensure of health professionals in many countries.

• In many developing countries opportunities for CME are limited and there

is also no incentive since it is not required for continued licensure.

• CME is more effective if it is problem-based, targeted, involves

professional societies, universities and the ministry of health, and is

face-to-face.

• Printed materials that are unaccompanied by face-to-face interventions,

have been found to be ineffective in changing prescribing behaviour.

• CME need not be limited only to professional medical or paramedical

personnel, but may also include people in the informal sector such as

medicine retailers.

• Governments should therefore support efforts by university departments

and national professional associations to give independent CME.

Supervision, audit and feedback:

• Supervision is essential to ensure good quality of care. Supervision that

is supportive, educational and face-to- face, will be more effective and

better accepted by prescribers than simple inspection and punishment.

• Effective forms of supervision include prescription audit and feedback,

peer review and group processes.

• Prescription audit and feedback consists of analyzing prescription

appropriateness and then giving feedback.

• Prescribers may be told how their prescribing compares with accepted

guidelines or with that of their peers.

• In hospitals, such audit and feedback is known as drug use evaluation.

• Group process approaches amongst prescribers consist of health

professionals themselves identifying a medicine use problem and

developing, implementing and evaluating a strategy to correct the

problem.

• Community case management is a special type of supervised group process

involving community members in treating patients.

Independent medicine information

• Often, the only information about medicines that practitioners receive is

provided by the pharmaceutical industry and may be biased.

• Provision of independent (unbiased) information is therefore essential.

• Drug information centres (DICs) and drug bulletins are useful ways to

disseminate such information.

• Both may be run by government or a university teaching hospital or a

nongovernmental organization, under the supervision of a trained health

professional.

• Whoever runs the DIC or bulletin must

o Be independent of outside influences and disclose any financial or

other conflict of interest,

o Use evidence-based medicine and transparent deduction for all

recommendations made

The WHO Model Formulary provides independent information on all medicines

in the WHO Model List of Essential Medicines.

Public education about medicines:

• Without sufficient knowledge about the risks and benefits of using

medicines and when and how to use them, people will often not get the

expected clinical outcomes and may suffer adverse effects.

• Governments have a responsibility to ensure both the quality of

medicines and the quality of the information about medicines available to

consumers. This will require:

o Ensuring that over-the-counter medicines are sold with adequate

labelling and instructions that are accurate, legible, and easily

understood by laypersons.

o The information should include the medicine name, indications, contra-

indications, dosages, drug interactions, and warnings concerning

unsafe use or storage.

o Monitoring and regulating advertising, which may adversely influence

consumers as well as prescribers, and which may occur through

television, radio, newspapers and the internet.

o Running targeted public education campaigns, which take into account

cultural beliefs and the influence of social factors.

Education about the use of medicines may be introduced into the health

education component of school curricula or into adult education programmes,

such as literacy courses.

Avoidance of perverse financial incentives:

Financial incentives may strongly promote rational or irrational use.

Examples include:

o Prescribers who earn money from the sale of medicines like dispensing

doctors will prescribe more medicines, and more expensive medicines, than

prescribers who do not; therefore the health system should be organized

so that prescribers do not dispense or sell medicines.

Patients prefer medicines that are free or reimbursed, If only essential

medicines are provided free by government or reimbursed through insurance,

patients will pressure prescribers to prescribe only essential medicines.

If medicines are only reimbursed when the prescription conforms to clinical

guidelines, there may be an even stronger pressure on prescribers to

prescribe rationally.

Appropriate and enforced regulation

o Regulation of the activities of all actors involved in the use of

medicines is critical to ensuring rational use

o If regulations have any effect, they must be enforced, and the

regulatory authority must be sufficiently funded and backed up by the

judiciary.

Regulatory measures to support rational use of medicines:

|Activity: Small Group Discussion ( 15 minutes) |

|DIVIDE students into small manageable groups |

|ASK students to discuss on the following question |

|What are regulatory measures to support rational use of medicines |

|ALLOW students to discuss for 10 minutes |

|ALLOW few groups to present and the rest to add points not mentioned |

|CLARIFY and SUMMARIZE by using the contents below |

The following are regulatory measures to support rational use of medicines

• Registration of medicines to ensure that only safe efficacious

medicines of good quality are available in the market and that

unsafe non-efficacious medicines are banned;

• Limiting prescription of medicines by level of prescriber; this

includes limiting certain medicines to being available only with a

prescription and not available over-the-counter;

• Setting educational standards for health professionals and

developing and enforcing codes of conduct; this requires the

cooperation of the professional societies and universities;

• Licensing of health professionals – doctors, nurses, paramedics – to

ensure that all practitioners have the necessary competence with

regard to diagnosis, prescribing and dispensing;

• Licensing of medicine outlets – retail shops, wholesalers – to

ensure that all supply outlets maintain the necessary stocking and

dispensing standards;

• Monitoring and regulating medicine promotion to ensure that it is

ethical and unbiased. All promotional claims should be reliable,

accurate, truthful, informative, balanced, up-to-date, capable of

substantiation and in good taste.

i. Sufficient government expenditure to ensure availability of medicines

and staff:

• Lack of essential medicines leads to the use of nonessential

medicines, and lack of appropriately trained personnel leads to

irrational prescribing by untrained personnel.

• Without sufficient competent personnel and finances, it is

impossible to carry out any of the core components of a national

programme to promote rational use of medicines.

• Governments are responsible for investing the necessary funds to

ensure that all public health facilities have sufficient,

appropriately trained health professionals and enough essential

medicines at affordable prices for all the population, with specific

provisions for the poor and disadvantaged.

• Achieving these will require limiting government procurement and

supply to essential medicines only, and investing in adequate

training, supervision and health staff salaries.

STEP 6: Key Points (05minutes)

• Monitoring medicine use and using the collected information to

develop, implement and evaluate strategies to change inappropriate

medicine use behaviour are fundamental to any national programme to

promote rational use of medicines.

• A mandated multi-disciplinary national body to coordinate all

activities and sufficient government funding are critical to success.

• Without sufficient competent personnel and finances, it is impossible

to carry out any of the core components of a national programme to

promote rational use of medicines.

STEP 7: Evaluation (05minutes)

• List five national interventions in promoting rational medicines use

• What are the regulatory measures to support rational use of medicines

References:

World Health Organization (2001).How to Develop and Implement a National

DrugPolicy.2nd ed. Geneva.

World Health Organization, (1985).The Rational Use of Drugs.Report of the

Conference of Experts. Geneva:

Grand AL1, Hogerzeil HV2, and Haaijer-Ruskamp FM3,(1999), Intervention

research in rational use of drugs: a review. HEALTH POLICY AND PLANNING;

14(2): 89–102. Oxford University Press

Session 9: Factors Hindering Promotion of Rational Use of Medicine

Total Session Time: 120 minutes

Prerequisites

• None

Students Learning Tasks

By the end of this session students are expected to be able to:

• Give overview of factors hindering promotion of rational use of

medicine

• List factors hindering promotion of rational use of medicine

• Explain Factors hindering promotion of rational use of medicine

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Introduction to Factors Hindering Promotion of Rational Use of

Medicine (15 Minutes)

• Promoting the correct and appropriate use of medicinal products is

the main goal of pharmaceutical personnel activities.

• The pharmaceutical personnel activities can be summarized as

following: consulting, selection of drugs, drug information,

formulation and preparation, drug use studies and research,

pharmacokinetics/ therapeutic drug monitoring, clinical trials,

pharmacoeconomy, dispensing & administration, teaching & training.

• The aims of these activities are to maximize rational use of

medicines, clinical effect of medicines, to minimize the risk of

treatment-induced adverse events and to minimize the expenditures for

pharmacological treatments for the national health systems and for

the patients

STEP 3: Types of Factors Hindering Promotion of Rational Use of Medicine

(30 Minutes)

|Activity: Buzzing (10 minutes) |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

|What are the factors hindering promotion of rational use of Medicine? |

| |

|ALLOW few pairs to respond and let other pairs to add on points not |

|mentioned |

|WRITE their response on the flip chart/board |

|CLARIFY and SUMMARIZE by using the content below |

The following are the factors hindering promotion of rational use of

Medicine

• Poor communication between professionals and patients/clients

• Lack of objective information

• Inadequate public education

• Cost of medicines

• Proliferation of brands

• Prescribing errors

• Defective drug supply system and ineffective drug regulation

• Promotional activities of pharmaceutical industries

STEP 4: Explanation of Factors Hindering Promotion of Rational Use of

Medicine (60 Minutes)

The subsequent are the explanations of factors hindering promotion of

rational use of medicine

Poor communication between professionals and consumers

• Communication between professionals and patients is fundamental to the

improvement of rational use of medicines by patients.

• The following information should be provided to patients: the name of the

medicine, the purpose for which the medicine is being taken, dose,

frequency of use, and duration of use.

• The adverse effects due to medicines for chronic disease like cancer and

HIV/AIDS should be explained clearly to patient to avoid confusion and

irrational use of medicines.

• The shortage of qualified health personnel in public health facilities

has resulted in inadequate labelling of medications by prescribers and

dispensers, and in insufficient time spent by them to inform the patients

on how to take the medicine.

Lack of objective information

• The pharmaceutical market has been saturated by medical representatives

whose aim is to achieve higher sales for the companies they represent.

• These sales professionals have become the principal source of information

for many

Prescribers and dispensers despite the fact that the information they

provide is geared towards promoting the sales of pharmaceutical

companies.

• The essential medicines list, standard treatment guidelines, national

drug policies

are often good sources of literature on medicines use, but these

reference materials are not widely disseminated.

• Media can play a key role in raising awareness on problems with drugs and

publicizing serious health hazards related to drugs; however the media

has at times been used by pharmaceutical companies to covertly promote

their medicines.

• The existence of counterfeits has sometimes been used to discredit

generic products by some media houses as a result consumers end up with

mixed reactions on the use of generics and irrational use of medicines.

Inadequate public education

• Developing countries have ineffective public education programmes.

The most important sources of information for consumers about medicines

are

Doctors; followed by the pharmaceutical personnel, then nurses and other

healthcare personnel.

• Medical professionals must not only know the correct information to

convey, but the skill and the time to do it well, However, skill and time

are scarce resources.

• Patients may not be aware of the kind of information they need or what

questions they should ask, so there is a significant, general educational

challenge.

• The emergence of HIV/AIDS and other chronic diseases has exacerbated the

problem since there are higher patient numbers but fewer of them are able

access the medicines they require.

• In the event that the prescribed medicines are dispensed, the HIV/AIDS

patients

go back home but most of them do not get regular outpatient support to

encourage them to take the medicines.

• A successful patient follow up mechanism has been put in place in many

countries to encourage the rational use of TB medicines; unfortunately no

similar mechanisms have been designed at the international and national

level for other diseases.

Cost of medicines

• In economic terms, inappropriate use has led to the wastage of limited

resources and to non-availability of essential medicines where they may

be needed.

• Most of the people live below poverty line as a result: many patients who

go to public health facilities or private sectors for treatment often go

back home without getting the medicines they need which lead the

situations where a family ends up sharing medicines that were prescribed

to treat one person – a classic example of irrational use of medicines.

• Some sections of the population have developed a misconception that the

expensive medicines are more effective than the cheaper generic versions.

• Middle class patients in developing countries that may have the

purchasing power to buy medicines often have limited knowledge on the use

of medicines and therefore sometimes end up pressurizing the prescribers

and dispensers for the expensive branded medicines in preference to

cheaper generics which are just as effective.

Proliferation of brands

• Irrational drug use is directly related to the number of brands on the

market and to their promotion.

• Many medicines are variations of prototype drugs and offer no therapeutic

advantage over drugs already available.

Prescribing errors

• Some doctors are rarely use the prescription form approved by the

Ministry of Health for writing medicine prescriptions rather they use

form-notebooks, known as blanks, which are distributed by pharmaceutical

representatives, so as to receive a share of the profits made by the

pharmaceutical representatives.

o Prescription without dose indication is also a common prescribing

error. For instance, a Prescription may give only the name of the

preparations without indicating the dose, the turnout form or the mode

of application.

o Children’s prescriptions errors are areas where many errors are likely

to occur, the prescribing of drugs which are contraindicated in

children or which should not be prescribed to children below a certain

age is a common mistake. For instance: Famotidin is prescribed to

younger children in doses of a half and a quarter pill daily. However

it is not advisable to prescribe the drug to children less than 16

years old.

• Defective drug supply system & ineffective drug regulation: Absence of a

well organized drug regulatory authority (TFDA) and presence of large

numbers of drugs in the market leads to irrational use of drugs.

• Promotional activities of pharmaceutical industries: The lucrative

promotional programs of various pharmaceutical industries influence the

drug prescribing and dispensing which lead irrational use of medicines.

STEP 6: Key Points (05 minutes)

• The shortage of qualified health personnel coupled with inadequate staff

time in public health facilities has resulted in inadequate labelling of

medications by prescribers and dispensers

• Medical professionals must not only have the information to convey, but

the skill and the time to do it well

• Day-to- day tests and regular analysis of prescriptions would reform the

treatment and reduce the risk of adverse reactions which appear as a

result of misuse of the preparations.

• It is necessary to resume cooperation of family physicians and

pharmaceutical personnel regarding correct and efficient drugs

prescribing, this cooperation would reform treatment.

STEP 7: Evaluation (05 minutes)

• List factors hindering promotion of rational use of Medicine?

• What are the promotional activities of pharmaceutical industries that

hinder rational use of medicine

References:

Lesar, T.S., Briceland, L., Stein, D, S. (1997). JAMA:Factors related to

errors in medication prescribing.. 277:312–317.

Velo, G, P., &Minuz, P. (2009). British Journal of Clinical Pharmacology:

Medication errors: prescribing faults and prescription errors. 67:6

http://www.med.rug.nl/pharma/who-cc/ggp/homepage.html.Published by:

WHO/EDM, WHO; 1994

Session 10: Importance of (STG) and (EML) in Reducing Irrational Use of

Medicines

Total Session Time: 120 minutes

Prerequisites

• None

Students Learning Tasks

By the end of this session students are expected to be able to:

• Give overview of Tanzania STGs and EML

• Outline Importance of STGs

• Describe the Relation between STGs and EML

• Identify Advantages of Using Generic Names or INN in Medicine Use.

• List potential benefits of standard treatment guidelines

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Figure 10.1: Relationship between treatment guidelines and

essential medicine list

SESSION OVERVIEW

| | | |EML |

|8 | | | |

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing

STEP 2: Introduction to Tanzania STGs and EML (20 Minutes)

• The Standard Treatment Guidelines (STG) and the National Essential

Medicine List for Tanzania (NEMLIT) was first published in 1991, the

second edition was published in 1997.

• The third edition, published in 2013 incorporates the essential current

medical knowledge and new developments in medicines.

• It has incorporated major changes in the care and treatment of disease

conditions such as Tuberculosis and Leprosy, Malaria and HIV/AIDS due to

new scientific updates.

• Treatment guidelines (Standard treatment guidelines (STGs), treatment

protocols, clinical guidelines) are systematically developed statements

that assist prescribers in deciding on appropriate treatments for

specific clinical problems.

• These guidelines usually reflect the consensus on the optimal treatment

options within a health facility or health system.

• The information is disease centered, emphasizing the common diseases and

complaints and the various treatment alternatives.

• Information on medicines is usually limited to strength, dosage, and

duration. Most guidelines indicate a treatment of first choice. Some

include diagnostic criteria for starting the treatment or for choosing

among treatment alternatives.

• Standard clinical guidelines are an effective tool for assisting health

professionals to choose the most appropriate medicine for a given

condition. These should be developed and updated on a regular basis. It

is not sufficient to develop standard clinical guidelines without an

education and training program to encourage their use.

STEP 3: Importance of STG’s (20 Minutes)

|Activity: Buzzing (10 minutes) |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

|What are the Importance of Standard Treatment Guidelines (STG’s) |

|ALLOW few pairs to respond and let other pairs to add on points not |

|mentioned |

|WRITE their response on the flip chart/board |

|CLARIFY and SUMMARIZE by using the content below |

The following are the important of standard treatment guidelines (STG’s) in

the health management:

• Providing guidance to health professionals on the diagnosis and

treatment of specific clinical conditions

• Orienting new staff about accepted norms in treatment.

• Providing prescribers with justification for prescribing decisions

made in accordance with STGs

• Providing a reference point by which to judge the quality of

prescribing and dispensing

• Aiding efficient estimation of drug needs and setting priorities for

procuring and stocking drugs.

STEP 4: Relationship Between Treatment Guidelines and Essential Medicine

List (25 Minutes)

The subsequent are the relationship between Treatment guidelines and

Essential medicine list:

• The NEMLIT attached to the STG retains its purpose of identifying

medicines that are considered to be essential for the treatment of common

disease conditions in Tanzania.

• Treatment Guideline follows the principles and concepts of essential

medicines so as to simplify the management of medicines supply and

support a streamlined logistics system.

• Medicines in Treatment Guidelines are selected using the WHO Essential

medicines List (EM) as a model.

Choice of medicines in STG’s and EMLIT is based on:

• National health policy

o Free health care

o Subsidized health care

o Managed health care

• National medicine policy

o Free medicine policy

o Subsidized cost of medicines or cost recovery

o Cost sharing

• Patterns and prevalence of diseases

Quality and type of care provided at

o Primary health care institution

o Secondary health care institution

o Tertiary health care institution

• Available human resources

o Medical care (general MD and specialist care)

o Nursing care (nursing, midwifery, psychiatry)

o Pharmaceutical care (pharmacists, pharmacy technicians, Pharmaceutical

assistants)

• Financial resources.

• International Nonproprietary Names (INNs), also known as generic

names, are normally used in identifying selected medicines.

• INNs are intended for use in pharmacopoeias, labeling,

production information, advertising and other promotional

material, pharmaceutical regulation, and as a basis for generic

product names

• The choice of medicines by generic names requires the existence

of an effective Drug Regulatory Authority (i.e. TFDA) to ensure

the availability of good-quality, safe, effective and affordable

drugs

Figure 10.1: Relationship between treatment guidelines and essential

medicine list

[pic]

STEP 5: Advantages of Using Generic Names or INN in Medicines (20Minutes)

|Activity: Small Group Discussion ( 15minutes) |

|DIVIDE students into small manageable groups |

|ASK students to discuss on the following question |

|What are the advantages of Using Generic Names or INN in Medicines? |

|ALLOW students to discuss for 10 minutes |

|ALLOW few groups to present and the rest to add points not mentioned |

|CLARIFY and SUMMARIZE by using the contents below |

The medicines on the essential medicines list are referred to by their INN

or generic names. The generic name is used in writing prescriptions as well

as in purchasing medicines. The use of the generic name for these purposes

has certain advantages

• There is easy recognition of the type of medicines, especially where many

selected drugs exist in that class (e.g. all benzodiazepines have INNs

ending with “-zepam”).

• Generic names are more informative than brand names and facilitate the

purchase from multiple sources, thus giving the advantage of buying at a

competitive price.

• Generic prescribing facilitates product substitution where

bioavailability presents a clinical problem.

• The confusion associated with the use of brand names can be avoided.

• Generic products are often cheaper than products sold by brand name.

• The use of generic names for pharmaceutical purchasing as well as

prescribing carries considerations of clarity, price and quality, With

regard to clarity, the generic name helps identify the class of

medication.

Examples of generic names and brand names

|Generic names (INNs) |Brand Names |

|Acetyl Salicylic Acid |Aspirin®,Aspro® |

|Albendazole |Zentel® |

|Ampicillin |Penbritin® |

|Cimetidine |Tagamet® |

|Diazepam |Valium® |

|Paracetamol |Panadol® |

|Metronidazole |flagyl |

|Brufen + paracetamol |Ibuprofen |

|Amoxacilline + |Flucamox |

|flucloxacin | |

STEP 6: Potential Benefits of Standard Treatment Guidelines (20 Minutes)

The following are potential benefits of standard treatment guidelines

For Health officials:

• Permits identification of cost-effective treatments for common health

problems

• Provides basis for assessing and comparing quality of care

• Identifies most effective therapy in terms of quality and combats

antimicrobial resistance

• Provides information for practitioners to give to patients concerning the

institution’s standards of care

• Is a vehicle for integrating special programs (control of diarrheal

disease, acute respiratory infection, tuberculosis, malaria and so on) at

the point of the primary health care provider

For supply management staff

• Identifies which medicines should be available for the most commonly

treated problems.

• Facilitates prepackaging of course-of-therapy quantities of commonly

prescribed items

• Makes medicine demand more predictable, so forecasting is more reliable.

For health care providers

• Provides expert consensus on most effective, economical treatment for a

specific setting.

• Gives providers the opportunity to concentrate on correct diagnosis

• Sets a quality-of-care standard

• Provides a basis for monitoring and supervision

For Patients

• Encourages adherence to treatment through consistency among prescribers

at all locations within the health care system

• Ensures most cost-effective treatments are provided

• Improves availability of medicines

• Improves treatment and outcomes

STEP 7: Key Points (05 Minutes)

Patients can be better informed about the effective use of medicines when

the number of medicines they are confronted with is limited

Establishing and using a limited list of carefully selected essential

medicines is perhaps the single most cost-effective action that any health

care system or health care provider can take to promote regular supply and

rational use of medicines.

Treatment guidelines (Standard treatment guidelines (STGs), treatment

protocols, clinical guidelines) are systematically developed statements

that assist prescribers in deciding on appropriate treatment for specific

clinical problems.

STEP 8: Evaluation (05 Minutes)

• What are the advantages of using generic names or INN in medicines

• What is the importance of STG’s

• What are the relationship between Standard Treatment Guide and Essential

Medicine List?

References:

GoT (1998). Tanzania National Formulary (1st ed.). Dar es salaam, Tanzania:

MOHSW.

GoT (2013). Standard Treatment Guidelines& National Essential Medicines

List Tanzania MainLand ( 4th ed). Dar-es-salaam, Tanzania: MOHSW.

Session 11: Legal limitations on Medicines Marketing and Promotion

Total Session Time: 120 minutes

Prerequisites

• None

Students Learning Tasks

By the end of this session students are expected to be able to:

• Define the terms used in legal limitations on medicines marketing and

promotion.

• Give general understanding of legal limitations on medicines

marketing and promotion.

• Identify responsibilities of TFDA on medicines marketing and

promotion

• Describe pharmaceuticals promotion control

• Identify importance of promotion and marketing in pharmacy

• Describe pharmaceuticals advertisement control

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Terms inLegal limitations on Medicines Marketing and

Promotion. (20 Minutes)

• Pharmaceuticals Promotion: refers to all informational and convincing

activities by manufacturers and distributors, the effect of which is to

encourage the prescription, supply, purchase and/or use of medicinal

drugs.

• The important of Promotion is to create an image, to modify attitudes to

support sales increases and to create awareness

• Marketing: creating customer value and satisfaction. It is a process by

which individuals or groups obtain what they need and want through

creating and exchanging products and value with others. i.e. It is simply

the delivery of customer satisfaction at a profit

• Advertising: Any form of communication using any form of mass media or a

controlled message in purchased time or space. It is non-personal and

paid. The forms of advertising include journals, direct mail & e-mail,

bill boards, newspapers and TV. It includes every form of advertising,

whether in a publication, or by the display of any notice or by means of

any catalogue, price list, letter, whether circular or addressed to a

particular person, or by the exhibition of a photograph or a

cinematograph film, or by way of sound recording, sound broadcasting, or

television or any other means of communication.

STEP 3: Introduction to Legal Limitations on Medicines Marketing and

Promotion. (15 Minutes)

• Medicines have the potential for benefit to individuals who use them and

to the public health. But all effective medicines may be associated with

adverse effects.

• The law recognizes that medicines should not be treated as an ordinary

general commodity by placing specific restrictions on them.

• Activities conducted as part of pharmaceutical marketing and promotions

are an important component of educating and informing consumers and

health care professionals about new treatments.

• Direct-to-consumer (DTC) advertisements aim to inform patients of

important treatment options, while pharmaceutical sales representatives

work to get accurate, up-to-date information on medicines to health care

professionals.

STEP 4: Responsibilities of TFDA on Medicines Marketing and Promotion

(30minutes)

|Activity: Brainstorming (15 Minutes) |

|Ask students to brainstorm on the following question: |

|What are the responsibilities of TFDA on medicines marketing and |

|promotion? |

|ALLOW few students to respond |

|WRITE their responses on the flip chart/ board |

|CLARIFY and SUMMARISE by using the content below |

TFDA is the effective medicines regulatory body which promotes and protects

public health by ensuring that:

• Medicines are of the required quality, safety and efficacy, medicines are

appropriately manufactured, stored, distributed and dispensed, illegal

manufacturing and trade are detected and adequately sanctioned, health

professionals and patients have the necessary information to enable them

to use medicines rationally.

• Ensure that promotion and advertising is fair, balanced and aimed at

rational drug use, access to medicines is not hindered by unjustified

regulatory work.

STEP 5: Pharmaceuticals Promotion Control (10 Minutes)

• Product promotion means any activity undertaken by a company or

individual to promote and encourage the prescription, supply, sale,

administration or purchase of food, drugs, herbal drugs, cosmetics, and

medical devices. (in relation to products regulated by TFDA such as

medicines)

• Such promotion can be presented in various forms like:

o Brochures, posters, leaflets, TV, radio, newspaper, magazine, and

internet advertisement, Journal or direct mail advertising,

supply of free samples, sponsorship of promotional meeting and

sponsorship of scientific meeting

• Product promotion Control section of the TFDA routinely scrutinizes

promotional materials before approval is granted.

• Promotion of food, drugs, herbal drugs, cosmetics, and medical devices is

controlled under the Tanzania Food, Drugs and Cosmetics Act, 2003

sections 95 to 98 and 122(1) (r) regulations, 2010.

• No promotional activity should be conducted in Tanzania mainland unless

it is approved by the TFDA.

• In order to get approval, two copies of the promotional materials should

be submitted to the Director General, TFDA. Upon approval, one copy will

remain with the TFDA.

STEP 6: Importance of Promotion and Marketing in Pharmacy (20 Minutes)

|Activity: Buzzing (10 minutes) |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

|What are the Importance of promotion and marketing in Pharmacy? |

|ALLOW few pairs to respond and let other pairs to add on points not |

|mentioned |

|WRITE their response on the flip chart/board |

|CLARIFY and SUMMARIZE by using the content below |

The following are the importance of promotion and marketing in Pharmacy

• It informs healthcare professionals about new treatment options, helping

them to provide the most appropriate solutions for each of their

patients.

• It simplifies the direct purchase of drugs, due to the information

provided on the drug’s price and location to the public

• It updates pharmaceutical personnel with the information about the new

products of drugs in the market

• Marketing ensures a good lasting connection with customers.

• The marketing activities stimulates exchange with patients who need and

likely benefit from the services provided by the pharmacy

• It helps companies to identify the need for the community with respect to

diseases in an area

• It helps companies to obtain an adequate return on their sizeable

Research &Development investment during the limited period of market

exclusivity granted by intellectual property rights – so that they can

continue to invent new treatments.

• Campaigns to promote the rational use of medicines have much less money

to spend if promotion and marketing is conducted ethically.

• Drug promotion and marketing creates demand for medicines as it defines

illness conditions that need treatment.

• It promotes the idea that medicines are the best remedy as opposed to non-

drug alternatives.

• It tends to emphasize a medicine’s efficacy while minimizing possible

health risks.

Targets of pharmaceuticals promotion

The subsequent are the target workforces to be promoted with medicine:

• Pharmaceutical personnel,

• Doctors

• Nurses

• Dentists

• Insurance companies

• Hospital managers

• Company managers

STEP 7: Pharmaceuticals Advertisement Control (10 Minutes)

• Drug advertised need to be checked if it’s essential on sense of

efficacy, safety and quality also affordable to the public

• Drug advertisement needs to care on the clients benefits first before

owners’ benefits.

• No drugs must be advertised if the information and side effects of the

drug are unknown.

• Advertising of medicines is acceptable provided it is in line with

legislation and agreed standards of good practice.

• Society demands that advertising of any commodity, service or anything

that may be of interest to the consumer, should be of a high standard.

• It should not include anything that could cause serious or widespread

offence, create unrealistic expectations in the consumer or be

misleading.

• Rules and regulations need to be taken into account when advertising a

medicine, to ensure required standards are met and that consumer

protection is not compromised.

• All advertising and promotion of medicines, both for self-medication

and to healthcare professionals where medical prescription is

required, must be responsible and of the highest standard.

• All means and media used in the promotional marketing of medicines are

subject to the legislation controlling advertising. This includes

evolving digital communications channels as well as more conventional

communications.

• The legislation lays down the requirements and restrictions for

advertising, aimed at either prescribers or suppliers of medicines to

the public, or at the public as purchasers of over-the-counter

medicines.

• Central to this is the principle that advertising of prescription only

medicines to the public is prohibited.

• The decision to prescribe a certain medicine is taken by a qualified

healthcare professional on the basis of informed discussion with the

patient

• Advertised drug must be authorized by the Drug authority (i.e. TFDA)

STEP 8: Key Points ( 05 Minutes)

• Rules and regulations need to be taken into account when advertising

medicines, to ensure required standards are met and that consumer

protection is not compromised.

• Advertising of medicines is acceptable provided it is in line with

legislation and agreed standards of good practice.

• In the absence of effective regulation of drug promotion, community

interventions to promote rational drug use will have insufficient

impact hence, leading to irrational use of medicines.

STEP 9: Evaluation (05 Minutes)

• What is pharmaceutical promotion?

• List the importance of promotion and marketing in pharmacy?

• What are the responsibilities of TFDA on medicines marketing and

promotion?

References:

MoHSW (2003), Tanzania, Food, Drugs and Cosmetics Act, Government Printer,

Dar essalaam Tanzania.

Caudill T, Johnson M, Rich E, McKinney W. (1996), Physicians,

Pharmaceutical Sales representatives, and the Cost ofPrescribing. Archives

of Family Medicine; 5: 201-206.

Session 12: Significances of Uncontrolled Medicines Marketing and Promotion

Total Session Time: 120 minutes

Prerequisites

• None

Students Learning Tasks

By the end of this session students are expected to be able to:

• Define the terms used in uncontrolled medicines marketing and

Promotion

• Identify Significances of uncontrolled Medicines marketing and

promotion

• Explain the effects of medicines marketing and promotion on

prescribing and dispensing behaviour

• Identify guiding principles to fight for significance of uncontrolled

medicines marketing and promotion

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

|2 |20 |Presentation |Definition of Terms Used in Uncontrolled |

|3 |35 |Presentation |Significances of Uncontrolled Medicines |

|4 |30 |Presentation |Effectsof Medicines Marketing and |

|5 |20 |Presentation |Guiding Principles to Fight For |

|6 |05 |Presentation |Key Points |

| 7 |05 |Presentation |Evaluation |

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05 minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Terms used in Uncontrolled Medicines Marketing and

Promotion (20 Minutes)

Medicines:

• Medicines have an integral part in the health care system all over the

world. When the appropriate use of medicine is done, they can cure the

different ailments and promote the health of the patients and results in

the wellbeing of the patients. However, the irrational use of medicines

is the major issue in this regard and it is practiced all over the world.

Pharmaceutical marketing:

• These are activities focused on making physicians as well as the general

public aware of new and existing pharmaceutical brands,

• It can include giveaway samples, detailed product literature, disease

management programs, and support material for patients, internet

initiatives, and events/meetings for physicians.

• Also can be defined as a management process that serves to identify and

meet patients’ needs in a profitable way.

Uncontrolled Medicinal Marketing and Promotion:

o This is when the medicines which are promoted and marketed are not

regulated and authorized by regulatory body such as: TFDA

STEP 3: Significances of Uncontrolled Medicines Marketing and Promotion (35

Minutes)

|Activity: Brainstorming (15 Minutes) |

|Ask students to brainstorm on the following question: |

|What are the Significances of uncontrolled Medicines marketing and |

|promotion? |

|ALLOW few students to respond |

|WRITE their responses on the flip chart/ board |

|CLARIFY and SUMMARISE by using the content below |

The following are significances of uncontrolled marketing and promotion:

• May encourage inappropriate use of expensive drugs that are incorrectly

perceived to be more efficacious than existing cheaper alternatives

• Creates an opportunity cost for the health service

• Reduces the available resources for the provision of other essential

services.

• Encourages further expenditure on drug promotion, reducing the proportion

of the total company budget available for research and development as a

result of increased revenue generated by altered prescribing practices in

response to drug promotion as interpreted by pharmaceutical companies

• Reliance on drug promotion for revenue generation by pharmaceutical

companies has a negative impact on the size of the pipeline of new drugs

to deal with pressing medical problems.

• Reduces the choice for prescribers and patients in which drug promotion

is required at greater levels to increase market penetration of existing

drugs to the detriment of the development of new ones.

• In the absence of effective regulation of drug promotion, community

interventions to promote rational drug use will have insufficient impact

hence, leading to irrational use of medicines.

• For the case of antibiotic uncontrolled medicines can lead to drug

resistance due to improper use of medicines.

• Encourage community to use medicines without proper diagnosis which

results to chronic disease.

STEPS 4: Effects of Medicines Marketing and Promotion on Prescribing and

Dispensing Behavior(30Minutes

|Activity: Small Group Discussion ( 15 minutes) |

| |

|DIVIDE students into small manageable groups |

| |

|ASK students to discuss on the following question |

|What are the effect of medicines marketing and promotion on prescribing|

|and dispensing behaviour? |

| |

|ALLOW students to discuss for 10 minutes |

| |

|ALLOW few groups to present and the rest to add points not mentioned |

| |

|CLARIFY and SUMMARIZE by using the contents below |

Pharmaceutical marketing and promotions Influence prescriber behaviors.

• Medical practitioners’ attitudes to the pharmaceutical industry, their

knowledge about pharmaceutical products, and prescribing behavior are

influenced by industry promotion and gift-giving.

• Most of pharmaceutical personnel who work at community pharmacies

encourage patients to buy medicines from certain pharmaceutical

manufacturers for their personnel interest

• Spending on prescription drugs by different countries is increasing

continuously by significant margin every year and one of the

identified and most prominent cause of this increase is continuing

switch to new drugs which is an outcome of increasing promotional

influence.

• Pharmaceutical marketing is a unique as decision-making of buying of

medicine lies in the hand of intermediate customer (prescriber) rather

than final customer (patient), therefore pharmaceutical companies

influence the customer (prescriber) rather than the final customer

(patient).

• Prescriber are the most important players in pharmaceutical marketing

system, Prescriber write the prescriptions that determined which drugs

(brands) will be used by consumer (patient). Thus, influencing the

prescriber is a key to the pharmaceutical sales.

• Pharmaceutical companies try to influence prescription pattern on

favor of their brands by offering various kinds of promotion inputs

such as samples, gifts, travel subsidies, and sponsorships.

• Some of pharmaceutical personnel prefer to purchase medicines from

certain pharmaceutical companies due to incentives like free sample,

gifts, sponsorships and workshops.

STEP 5: Guiding principles to Fight Uncontrolled Medicinal Marketing and

Promotion. (20 Minutes)

The following are guiding principles to fight uncontrolled marketing and

promotion

• Risks and safety information in promotion should be presented in clear

and understandable language.

• Medicine promotion should be submitted to the TFDA before releasing the

ads for broadcast.

• Medicine advertisements television and print advertisement should include

information about the availability of other options such as diet and life

where appropriate for the advertised condition.

• Companies are encouraged to include information about programs to help

the uninsured patients in promotion.

• Promotion should not air until a reasonable amount of time has elapsed so

that health care providers have sufficient time to learn about the new

medicine.

• Medicines advertisements television and print advertisements should be

targeted to avoid audiences that are not age appropriate for the messages

involved.

STEP 6: Key Points (05 Minutes)

• Medicines have an integral part in the health care system all over the

world.

• When the appropriate use of medicine is done, they can cure the different

ailments and promote the health of the patients and results in the

wellbeing of the patients, however, the irrational use of world is the

major issue in this regard and it is practiced all over the world.

• Dependence on drug promotion for revenue generation by pharmaceutical

companies has a negative impact on the size of the pipeline of new drugs

to deal with pressing medical problems.

• In the absence of effective regulation of drug promotion, community

interventions to promote rational drug use will have insufficient impact

hence, leading to irrational use of medicines.

STEP 7: Evaluation (05 Minutes)

• Define pharmaceutical marketing

• What are the Significances of uncontrolled Medicines marketing and

promotion?

• List guiding principles to fight for uncontrolled medicinal marketing

and promotion

Reference:

Idris KM, Yousif MA, Mustafa AF. (2009) Influence of pharmaceutical

industry's promotion on the doctors' prescribing patterns J Med Use Dev

Ctries;1:3-13. in Sudan.

Kotler, P. and Armstrong, G. (2004) “Principles of Marketing” 10th

edition. Upper Saddle River, NJ: Pearson Education. New York

Doole, I. and Lowe, R. (2004) “International Marketing Strategy:

Analysis, Development and Implementation” 4th edition. London:

Kotler, P. and Keller, K.L. (2006) “Marketing Management” 12th edition.

Upper Saddle River, NJ: Pearson Education.New York

MoHSW (2003), Tanzania, Food, Drugs and Cosmetics Act, Government

Printer, Dar essalaam Tanzania.

Session13: Role of information in Medicines marketing and promotion

Total Session Time: 120 minutes

Prerequisites

• None

Students Learning Tasks

By the end of this session students are expected to be able to:

• Give overview of role of information in medicines marketing and

promotion

• List types of information available in medicinal marketing

• Explain the types of information available in medicinal marketing and

promotion

• Describe role of information in Medicines marketing and promotion

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing

STEP 2: Introduction to the Role of Information in Medicines Marketing and

Promotion (20 Minutes)

• The pharmaceutical companies must observe ethical criteria for medicinal

drug marketing and promotion with clear responsibility for providing

unbiased information about their own pharmaceutical products.

• Marketing and promotion of medicinal drugs must be in conformity with

accepted ethical standards.

• Various types of information should be provided to prescribers,

dispensers and consumers to ensure the safe and effective use of drugs.

• Adequate information on the use of medicinal drugs should be made

available to patients. Such information should be provided by physicians

or pharmaceutical personnel.

• All packaging and labeling material should provide appropriate

information to ensure the rational use of drugs consistent with that

• If package inserts or leaflets are used for promotional purposes, they

should comply with the ethical criteria enunciated

• The wording of the package inserts or leaflets, if prepared specifically

for patients, should be in lay language on condition that the medical and

scientific content is properly reflected.

• To approved package inserts and leaflets wherever available, the

preparation and distribution of booklets and other informational material

for patients and consumers should be encouraged as appropriate, such

material should also comply with the ethical criteria enunciated

STEP 3: Types of Information Available in Medicinal Marketing

(25 Minutes)

|Activity: Brainstorming (15 Minutes) |

|Ask students to brainstorm on the following question: |

|What are the types of information available in medicinal marketing and |

|promotion? |

|ALLOW few students to respond |

|WRITE their responses on the flip chart/ board |

|CLARIFY and SUMMARISE by using the content below |

The following are the types of information available in medicinal marketing

and promotion

• International Non-proprietary Name (INN) of each active substance

• Pharmacological data

• Clinical Information

• Pharmaceutical information

STEP 4: Explanations of the Information Available in Medicinal Marketing

and Promotion (30 Minutes)

• International Non-proprietary Name (INN) of each active substance.

• Pharmacological data:

o A brief description of pharmacological effects and mechanism of

action.

• Clinical Information:

o Indications: whenever appropriate, simple diagnostic criteria should

be provided.

o Dosage regimen and relevant pharmacokinetic data:

▪ Average and range for adults and children;

▪ Dosing interval

▪ Average duration of treatment

▪ Special situations, e.g., renal, hepatic, cardiac, or nutritional

▪ Insufficiencies that require either increased or reduced dosage.

o Contra-indications.

o Precautions and warnings (reference to pregnancy, lactation, etc.).

o Adverse effects (quantify by category, if possible).

o Drug interactions (include only if clinically relevant; drugs used for

self-medication should be included).

o Over dosage:

▪ Brief clinical description of symptoms;

▪ Non-drug treatment and supportive therapy;

▪ Specific antidotes.

Pharmaceutical information:

• Dosage forms.

• Strength of dosage form.

• Excipients.

• Storage conditions and shelf-life (expiry date).

• Pack sizes.

• Description of the product and package.

• Legal category (narcotic or other controlled drug, prescription or non-

prescription.

• Name and address of manufacturer(s) and importer(s).non-prescription.

• Name and address of manufacturer(s) and importer(s).

STEP 5: Role of the Information in Medicines Marketing and Promotion (30

Minutes)

The following are the role of information in medicines marketing and

promotion:

• Drug information creates awareness of diseases and treatment options and

empowers patients and health-workers with information.

• Is to inform and educate consumers about diseases, their symptoms, and

available therapies.

• Providing information on marketing and promoting medicines makes people

better-informed by prompting them to seek more information about a

disease or drug and helping them to recognize that the problems they have

can be treated.

• Allow people to be more involved with their healthcare” and “tell people

about new treatments.

• Provides information to the patients about the risks as well as benefits

of medicines.

• Through drug information provision patient know more about the medicines

and the precautions to be observed when taking them.

STEP 6: Key Points (05 minutes)

• Adequate information on the use of medicinal drugs should be made

available to patients. Such information should be provided by physicians

or pharmaceutical personnel.

• To approved package inserts and leaflets wherever available, the

preparation and distribution of booklets and other informational material

for patients and consumers should be encouraged as appropriate, such

material should also comply with the ethical criteria enunciated

• Providing information on marketing and promoting medicines makes people

better-informed by prompting them to seek more information about a

disease or medicine and helping them to recognize that the problems they

have can be treated.

STEP 7: Evaluation (05 Minutes)

• List types of information available in medicinal marketing and promotion

• What are the role of Information in Medicines Marketing and promotion

References:

Chaudhury RR et al, (2005). Improvingmedicines usage through patient

information leaflets in India. Tropical Doctor,35(3):164-166.

Hubley J. 2006 Apr;Patient education in the developing world – a discipline

comes of age. Patient Education and Counseling, 61(1):161-4.

Malone PM. MosdellKW.Kicr KL. Stanovich JE.(200I), Drug information: a

guide for pharmacists. 2"".ed. New York, McGraw-HilI..

Quick JD et al.(eds.). (1997) Drug and therapeutics information (chap.30) .

In. Managing drug supply. 2~.ed. rev. and exp. West Hartford (Connccticut):

Kumarian

Session 14: Ethical Issues in Medicines Marketing and Promotion

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Give introduction of ethical issues in medicines marketing and

promotion

• List objectives of ethical issues in medicines marketing and

promotion

• Identify ethical issues in medicines marketing and promotion

• Identify ethical issues in medicines marketing and advertisement

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Introduction to Ethical Criteria in Medicines Marketing and

Promotion (25 minutes)

• Ethical issues for drug promotion should lay the foundation for proper

behaviour concerning the promotion of medicinal drugs, consistent with

the search for truthfulness and righteousness.

• The criteria should thus assist in judging if promotional practices

related to medicinal drugs are in keeping with acceptable ethical

standards.

• WHO ethical criteria for medicinal drug promotion of 1988 require

promotion of prescription and over-the-counter drugs to contain reliable

claims without misleading or unverifiable statements.

• The ethical promotion of medicine is vital to the pharmaceutical

industry’s mission of helping patients for better healthcare.

• The pharmaceutical industry has an obligation and responsibility to

provide accurate information about its products to healthcare

professionals in order to establish a clear understanding of the

appropriate use of medicines.

• The criteria could be used by people in all walks of life; by

governments; the pharmaceutical industry (manufacturers and

distributors); the promotion industry (advertising agencies, market

research organizations and the like)health personnel involved in the

prescription, dispensing, supply and distribution of drugs; universities

and other teaching institutions; professional associations; patients' and

consumer groups.

• There is evidence that drug utilization problems are increasing

encountered in many developing countries due to unethical practices of

medicine promotion.

STEP 3: Objective of Ethical Criteria in Medicines marketing and Promotion

(25 Minutes)

The following are the objectives of ethical criteria for medicines

marketing and promotion:

• To support and encourage the improvement of health care through the

rational use of medicinal drugs and discourage unethical practices.

• To lay the foundation for proper behavior concerning the promotion of

medicinal drugs, consistent with the search for truthfulness and

righteousness.

• To assist in judging if promotional practices related to medicinal drugs

are in keeping with acceptable ethical standards.

• To ensure that healthcare professionals have access to information they

need and that medicines are prescribed and used in a manner that provides

the maximum healthcare benefit to patients.

STEP 4: Ethical Issues in Medicines Marketing and Promotion

(30 minutes)

|Activity: Buzzing (10 minutes) |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

|What are the ethical criteria in medicines marketing and promotion? |

|ALLOW few pairs to respond and let other pairs to add on points not |

|mentioned |

|WRITE their response on the flip chart/board |

| |

|CLARIFY and SUMMARIZE by using the content below |

The following are the ethical criteria in medicines marketing and promotion

• Healthcare professionals should not be influenced to prescribe,

recommend, purchase, supply or administer a product because of any

benefits offered (financial or otherwise).

• Promotion should encourage the appropriate use of pharmaceutical

products by presenting them objectively and without exaggeration.

• Ethical criteria for Medicines marketing and Promotion call for promotion

of prescription drugs, non-prescription drugs (over-the-counter drugs),

traditional medicines and any other product promoted as a medicine to

contain reliable claims without misleading statements.

• The criteria also state that promotion should not contain omissions that

could lead to health risks

• The criteria state that promotion should not contain unverifiable

statements or omissions likely to induce medically unjustifiable drug use

or to give rise to undue risks.

• They emphasize that promotion should not be disguised as educational or

scientific activities.

• Active promotion within a country should take place only with respect to

drugs legally available in the country.

• Promotion should be in keeping with national health policies and in

compliance with national regulations.

• All promotion making claims concerning medicinal drugs should be

reliable, accurate, truthful, informative, balanced, up-to-date, and

capable of substantiation and in good taste.

• The word "safe" should only be used if properly qualified. Comparison of

products should be factual, fair and capable of substantiation.

• Promotional material should not be designed so as to disguise its real

nature.

• Scientific data in the public domain should be made available to

prescribers and any other person entitled to receive it, on request, as

appropriate to their requirements.

• Promotion in the form of financial or material benefits should not be

offered to or sought by health care practitioners to influence them in

the prescription of drugs.

• Scientific and educational activities should not be deliberately used for

promotional purposes

STEP 5: Ethical Issues in Medicines marketing and Drug Advertisement

(25 minutes)

• Advertisements to the general public should help people to make rational

decisions on the use of drugs determined to be legally available without

a prescription.

• They should not generally be permitted for prescription drugs or to

promote drugs for certain serious conditions that can be treated only by

qualified health practitioners, for which certain countries have

established lists.

• To fight drug addiction and dependency, scheduled narcotic and

psychotropic drugs should not be advertised to the general public.

• While health education aimed at children is highly desirable, drug

advertisements should not be directed at children.

• Advertisements may claim that a drug can cure, prevent, or relieve an

ailment only if this can be substantiated.

STEP 6: Key Points (05 minutes)

• Ethical issues for drug promotion should lay the foundation for proper

behaviour concerning the promotion of medicinal drugs, consistent with

the search for truthfulness and righteousness.

• Promotion should encourage the appropriate use of pharmaceutical products

by presenting them objectively and without exaggeration.

• Advertisements to the general public should help people to make rational

decisions on the use of drugs determined to be legally available without

a prescription.

STEP 7: Evaluation (05 Minutes)

• What are the ethical issues in medicines marketing and promotion?

• List objectives of ethical issues in medicines marketing and

promotion?

References

MoHSW (2003), Tanzania, Food, Drugs and Cosmetics Act, Government Printer,

Dar essalaam Tanzania

Ross-Degnan, D, Laing RO, Quick, JD et al, (1992)A strategy for promoting

improved pharmaceutical use: The International Network for Rational Use of

Drugs. SocSci and Med. 35 (11) 1329–41.

MoHSW (2005), The Pharmacy (Education and Training) Regulations; Government

Printer, Dar essalaam Tanzania

Session 15: Role of Pharmaceutical Personnel in Promoting Rational Use of

Medicines

Total Session Time: 120 minutes

Prerequisites

• None

Students Learning Tasks

By the end of this session students are expected to be able to:

• Give overview of roles of pharmaceutical personnel in promoting

rational use of medicines

• List roles of pharmaceutical personnel in promoting rational use

medicines.

• Explain roles of pharmaceutical personnel in promoting rational use

medicines.

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Introduction to Roles of Pharmaceutical Personnel in Promoting

Rational Use Medicines. (25 Minutes)

• The pharmaceutical personnel take part in enhancing sound medication

treatment, when he is a section for the patient care group is to

ensure that the patient is getting the correct utilization of the best

medications accessible.

• Pharmaceutical personnel have an important role to play in health care

more than just selling medicines at pharmacies.

• Pharmaceutical personnel play an integral part in the health care team

and assume various functions ranging from the procurement and supply

of medicines to provision of pharmaceutical care services helping to

ensure the best treatment for the patients.

• The pharmaceutical care process involves establishment relationship

between the patient and the pharmaceutical personnel, developing an

evidence-based care plan for medicine therapy and follow-up on the

patient's expected health outcome.

STEP 3: Roles of Pharmaceutical Personnel in Promoting Rational Use of

Medicines. (30 minutes)

|Activity: Buzzing (10 minutes) |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

|What are the roles of pharmaceutical personnel in promoting rational |

|use of medicines? |

|ALLOW few pairs to respond and let other pairs to add on points not |

|mentioned |

|WRITE their response on the flip chart/board |

| |

|CLARIFY and SUMMARIZE by using the content below |

The following are the role of pharmaceutical personnel in promoting

rational use of medicines:

• Patient medication counselling

• Rational use of medicines

• Specialist in preventing drug/medicine abuse

• Role in self-care and self-medication

• Combating counterfeit drugs

STEP 4: Explanation of the Roles of Pharmaceutical Personnel in Promoting

Rational Use Medicines (50 minutes)

The following are clarification of the roles of pharmaceutical personnel in

promoting rational use of medicine:

Patient medication counseling

• A pharmaceutical personnel can set up a different counselling space for

guiding the patients.

• He can keep up points of interest of patient history, hypersensitivities

and other vital information for the treatment.

• In addition, he encourages the patients to take the measurements in

appropriate time in order to keep any antagonistic results.

Rational use of medicines

• A pharmaceutical personnel is one of the inevitable members of healthcare

team who can help in achieving the goal of rational use of drugs.

• Promoting the rational use of medicines will result in improved quality

and increased accessibility of drugs leading to better quality of life

for the community.

Specialist in preventing drug/medicine abuse

• Investigating may not be part of a pharmaceutical personnel official job

description, but most druggists call on their detective skills when they

suspect a customer is abusing a prescription drug.

• Knowing the possible signs of addiction and how to respond to them will

give pharmaceutical personnel the best chance of helping customers who

may be in trouble.

• Although it's wise to give customers the benefit of the doubt,

pharmaceutical personnel should be alert to warning signals that someone

is abusing a drug.

• Pharmaceutical personnel should be careful about labeling someone as an

addicted, they may be taking a large amount of narcotics but have a

legitimate reason to do so, but that doesn't negate the fact that one of

our roles is to make sure drugs are taken appropriately.

• The most commonly abused prescription drugs include pain medications like

hydrocodone or oxycodone, anti-anxiety medications such as benzodiazepine

and muscle relaxants such as carisoprodol,

Role in self-care and self-medication

• Pharmaceutical personnel can assume an imperative part in self-care and

self-medicine of the patient by giving them the vital data about the

medications, particularly over the counter (OTC) drugs.

• The need of great importance is that, drug specialist acknowledge these

difficulties strikingly and fearlessly to guarantee safe utilization of

solutions notwithstanding amid self-care and self-pharmaceutical

Combating counterfeit drugs

• A pharmaceutical personnel is required to be ready and side by side in

separating the nature of valid pharmaceutical items from the spurious

ones, and ought to confine and withhold supply of the medication, once

suspected to be fake

STEP 6: Key Points (05 minutes)

• The irrational use of drugs is the worldwide issue. The rational

medication is promoted when all the health care professionals along with

the regulatory authorities play their effective role and must promote the

safe use of medications.

• A pharmaceutical personnel is one of the inevitable members of healthcare

team who can help in achieving the goal of rational use of drugs.

• Promoting the rational use of medicines will result in improved quality

and increased accessibility of drugs leading to better quality of life

for the community.

STEP 7: Evaluation (05 minutes)

• What are the responsibility of pharmaceutical personnel in preventing

drug/ medicine abuse?

• List theroles of pharmaceutical personnel in promoting rational use of

medicines?

References:

SubashChowdhury (2015) Role of the pharmacist in medication safety. Health

& Medicine pp: 1-20.

Creese A, Gasman N, Mariko M, Hernandez P, Poullier J, et al. (2004) The

World Medicines Situation 2004/World Health Organization: Geneva,

Switzerland pp: 1-151.

Almarsdottir AB, Traulsen JM (2005) Rational use of medicines-an important

issue in pharmaceutical policy. Pharm World Sci 27: 76-80.

———————–

PST 05105 Rational Use of Medicines

NTA Level 5 Semester 1

December 2018

Treatment Choices

Prior Knowledge

Habits

Scientific Information

Relationships

With Peers

Influence

of Drug

Industry

Workload & Staffing

Infra-

structure

Authority & Supervision

Societal

Information

Intrinsic

Workplace

Workgroup

Social &

Cultural

Factors

Economic &

Legal Factors

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