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NTA Level 6 • Semester 2 • PST06211 Introduction to Adverse Drug Reactions (ADRs) Monitoring and Evaluation of Medicine Use • Source Session/Topic 12 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 12: Introduction to Adverse Drug Reactions (ADRs) Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Define ADRs • Explain the predisposing factors for ADRs • Classify ADRs • Explain each class of ADRs Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Computer and LCD Projector SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction to Learning Tasks 10 minutes Presentation 2 Definition of ADRS Buzzing 3 20 minutes Presentation Predisposing Factors for ADRs 20 minutes Presentation 4 Classification of ADRS Brainstorming 5 55minutes Presentation Explanations on each Class of ADRs 6 05 minutes Presentation Key Points 7 05 minutes Presentation Evaluation PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 91 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 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 ADRS (10 minutes) Activity: Buzzing (10 minutes) ASK students to pair up and buzz on the following question • What is Adverse drug reaction? 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 • Adverse drug reaction is a noxious and unintended reaction that occurs at a dose used for the treatment, diagnosis and prevention of disease, disorder or syndrome. • Side effects and ADRs are associated with drug use posing serious health consequences. Sometimes the word side effect and ADR are used alternatively but there is a clear difference between them. Side effect is often termed as type A ADR. • Sid effect is also an undesirable effect of drug and comes under ADR. STEP 3: Predisposing Factors for ADRs (20 minutes) • Age:The incidence of adverse drug reaction appears to be highest in the very young and very old people. In these two extreme periods of life, there is poorly developed and altered physiological function respectively. Therefore, metabolism and elimination of some drugs may be delayed. • Pathophysiological conditions:Diseases may alter the pharmacokinetic handling of a drug, its tissue sensitivity or the response to a drug. That is, diseases can alter drug absorption, metabolism, elimination and the body‘s response to drugs. • Amount of drug administered:An excessive response to drug or prolonged therapy may be a predisposing factor for ADRs. Over dosage is often relative rather than absolute because the individual response to a drug varies. PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 92 • Sex:several studies have shown that for some drugs women are more likely to suffer from ADRs than men. This is due to pharmacokinetic and or pharmacodynamic sex-related factors. • Previous history of allergy:Patients who have previously suffered an allergic drug reaction appear to be more susceptible than others to allergic ADRs in general. Heredity may make some people more susceptible to the toxic effects of certain drugs • Racial or Genetic Factors: There may be racial differences in the incidence of some type of ADRs or some individuals have a genetically determined response to development of ADRs. e. g. Ethno-pharmacological difference such as glucose 6-phosphate dehydrogenise deficiency, which predisposes to some drug induced haemolytic anaemia, is commoner amongst Africans. • Multiple Drug Therapy (Polypharmacy) The incidence of ADRs increases with the number of drugs given due to risk of interactions. Interaction between prescribed drugs is therefore an area, which is of concern to every health care professional. STEP 4: Classification of ADRS (20 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What are classes of adverse drug reactions? 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 • There are four basic systems used to classify ADRs o Alphabetical or ABCDE system – by Rawlins and Thompson o According to intensity o Underlying mechanism mode o ADR according to frequency STEP 5: Explanations on each class of ADRs (55 minutes) • ABCDE SYSTEM – classify ADRs into five types o Type A („augmented―)  These ADR are expected PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 93  They can be predicted on the base of pharmacodynamic properties of drug  They depend on drug dose, they appear at higher doses  Frequency is high > than 1%  Mortality is low  Therapy consists in dose adjustment  e.g.: cough after ACEI, bleeding from GIT after NSAIDs, aspirin, corticoids o Type B (bizard―)  Idiosyncratic reactions  These ADR are not expected  They can be hardly predicted  Doesn´t depend on dose  Occur in predisposed, intolerant patients – can be explained by rare genetic polymorphism, allergic reactions  Frequency is low < than 0,1%  Mortality is high o Type C continuous)  This type of ADR increases number of ―spontaneous― diseases  They occur usually after long-lasting administration  They are often serious and persistent  Mechanism of genesis is unclear  They are unexpected, not predictable  They can´t be verified experimentally  e.g.: oral contraceptives and increased occurrence of thromboembolia. o Type D (delayed)  Adverse effect may be presented years after a drug was used (years resp. generations)  Teratogenity  Carcinogenetic  Mutagenity  e.g.: cancer of vagina at daughters of

NTA Level 6 • Semester 2 • PST06211 Reporting Pharmacovigillance Data Monitoring and Evaluation of Medicine Use • Source Session/Topic 11 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 11: Reporting Pharmacovigillance Data Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Explain ways of reporting pharmacovigillance data • List expedited reporting requirements • List necessary information in pharmacovigillance Reports Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Computer and LCD Projector SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 35 minutes Presentation 2 Ways of Reporting pharmacovigillance Data Buzzing 3 25 minutes Presentation Expedited Reporting Requirements 45 minutes Presentation Necessary Information in pharmacovigillance 4 Brainstorming Reports 5 05 minutes Presentation Key Points 6 05 minutes Presentation Evaluation PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 84 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing. STEP 2: Ways of Reporting Pharmacovigilance Data (35 minutes) Activity: Buzzing (10 minutes) ASK students to pair up and buzz on the following question • What are ways of reporting pharmacovillance data? 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 ways of reporting pharmacovigillance data • Spontaneous reporting o Spontaneous reports are termed spontaneous as they take place during the clinician's normal diagnostic appraisal of a patient, when the clinician is drawing the conclusion that the drug may be implicated in the causality of the event. o Spontaneous reporting system relies on vigilant physicians and other healthcare professionals who not only generate a suspicion of an ADR, but also report it. o It is an important source of regulatory actions such as taking a drug off the market or a label change due to safety problems. o Spontaneous reporting is the core data-generating system of international pharmacovigillance, relying on healthcare professionals to identify and report any adverse events o One of the major weaknesses of spontaneous reporting is that of under-reporting. o Spontaneous reports are a crucial element in the worldwide enterprise of pharmacovigillance and form the core of the World Health Organization Database • Clinical trial reporting o Also known as SAE (serious adverse event) reporting from clinical trials, safety information from clinical studies is used to establish a drug's safety profile in humans PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 85 and is a key component that drug regulatory authorities consider in the decision-making as to whether to grant or deny market authorization (market approval) for a drug. o SAE reporting occurs as a result of study patients (subjects) who experience serious adverse events during the conducting of clinical trials. (Non-serious adverse events are also captured separately.) o SAE information, which may also include relevant information from the patient's medical background, are reviewed and assessed for causality by the study investigator. This information is forwarded to a sponsoring entity (typically a pharmaceutical company) that is responsible for the reporting of this information, as appropriate, to drug regulatory authorities. • Expedited reporting o This refers to ICSRs (individual case safety reports) that involve a serious and unlisted event (an event not described in the drug's labelling) that is considered related to the use of the drug. o Spontaneous reports are typically considered to have a positive causality, whereas a clinical trial case will typically be assessed for causality by the clinical trial investigator and or the license holder. • Periodic Safety Update Reporting o Periodic Safety Update Reports (PSURs) are important pharmacovigillance documents. o They provide an opportunity for Marketing Authorization Holders (MAHs) to review the safety profile of their products and ensure that the Summary of Product Characteristics (SPC) and Package Leaflets are up to date. o They also provide a valuable source of pharmacovigillance data. o MAHs should submit PSURs to regulatory outhority example TFDA. • PSURs should as a minimum contain the following information: o Information on the product (i.e. brand name, dosage form, strength, manufacturer and country of origin), o The scope of drug safety data and the surveillance period, o Collection of adverse drug reaction (ADR) information (i.e. local serious ADRs, local non-serious ADRs, foreign serious ADRs, foreign non-serious ADRs, case reports published on international or local literatures including academic conferences). • Patient reporting o A simplified reporting form (Annex 5 of TFDA) should be used by patients to report information on suspected adverse drug reactions. o Patients should be encouraged to report adverse events and seek medical attention through their health care providers. o Further information on the report can be sought from the health care provider for serious and/or unknown reaction reported directly from patients. PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 86 PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 87 STEP 3: Expedited reporting requirements(25 minutes) • All serious reactions must be reported on an expedited basis using the same ADR reporting form (Annex 1of TFDA). • Expedited reports should be submitted to TFDA immediately and not later than 15 calendar days from receipt of the minimum information required for an adverse reaction report by a health care provider or personnel of the manufacturer. • Serious suspected adverse reactions occurring in all post-marketing studies of which the manufacturer is aware should be reported to the TFDA on an expedited basis. • When additional medically relevant information is received for a previously reported case, the

NTA Level 6 • Semester 2 • PST06211 Documentation of Pharmacovigillance Data Monitoring and Evaluation of Medicine Use • Source Session/Topic 10 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 10: Documentation of Pharmacovigillance Data Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Explain pharmacovigillance tools • Explain handling pharmacovigillance data • List characteristic of good documentation practices in pharmacovigillance Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Computer and LCD Projector SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks Presentation 2 10 minutes Pharmacovigillance Tools Brainstorming 50 minutes Handling Pharmacovigillance Data 3 Presentation 45 minutes Presentation Characteristic of Good Documentation 4 Buzzing practices in Pharmacovigillance 5 05 minutes Presentation Key Points 6 05 minutes Presentation Evaluation PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 78 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing. STEP 2: Pharmacovigillance Tools (10 minutes) Activity: Brainstorming (5 minutes) Ask students to brainstorm on the following question: • What are the Guidelines for Monitoring of Medicines safety? ALLOW few students to respond? WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • Guidelines for Monitoring of Medicines safety o These are guidelines provided regulatory authority (TFDA) that facilitate the collection of pharmacovigillance information • Tanzania Pharmacovigillance Training Manual- manual for training stakeholders who are involve in documenting and reporting of pharmacovigillance information • Other tools include; o Yellow forms (ADR forms)  The Yellow card system for collecting information on suspected adverse drug reactions (ADRs) to medicines.  The system allows the safety of the medicines and vaccines that are on the market to be monitored.The system was founded in 1964 after the thalidomide disaster.  Yellow Cards are available from TFDA and a few are presented near the back of the BNF as tear-off pages. o Patient reporting forms –are used by patients to report any ADRs during the cause of treatment o Poor Quality Products reporting forms-they are used to report medicines that show poor efficacy or poor quality products o Patient alert cards-are carried by patient to identify them as patient with hypersensitive or allergic to particular kind of drug PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 79 STEP 3: Handling Pharmacovigillance Data (50 minutes) • Companies are required to take appropriate measures against unauthorised or unlawful processing of personal data and against accidental loss, destruction or damage. • Documentation containing Pharmacovigillancedata should not be left unattended and companies should adopt a clear desk policy for Pharmacovigillance documents. • Hard copies of documents, including those in workflow progress should be stored in a secure and robust area such as fire- retardant cupboards/archives. • Any database containing personal data used in PV should be fully validated or tested, as appropriate, to ensure changes to data can be identified and access to these systems should be restricted to named individuals. Companies may also consider configuring Pharmacovigillance databases to restrict access to sensitive personal data so only the country of collection has access, although this is not a requirement of the law. • Sensitive data should be encrypted to ensure the integrity of data transmissions. • Data and record management o All data, documents and records related to pharmacovigillance system are physically and electronically stored in designated folders and databases, and retained in accordance with the relevant legislation and requirements of the regulatory integrated quality management system on data and record management. o Acknowledgement on receipt of the Pharmacovigillance information o Entering the data into Vigi Flow  Done by trained officer  Manager review and audit the data before commitment  A web based data management tool used to manage ADR database.  All data are stored on a database server in Uppsala, Sweden. o Receipt of pharmacovigillance data and follow up  Companies collect data using a variety of tools and sources.  When an Adverse Effect is reported to a company it is important that some personal data is collected to meet the Pharmacovigillance requirements of having an identifiable patient and reporter.  Good Vigilance Practices requires that companies ensure individual case safety reports (ICSRs) contain a minimum set of information.  It also specifies that information relating to the patient is as complete as possible, in accordance with local privacy laws.  However, data subjects (persons who have experienced an Adverse Effect and if different, the persons making the Adverse Effect reports) must understand what personal data relating to them is being collected, by whom and for what purposes.  Data subjects should be allowed to give their consent.  Company follow-up request forms or Adverse Effect forms sent to a reporter for completion. PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 80  Data entered into safety databases must only be processed for Pharmacovigillance purposes and should not be processed for purposes not disclosed to the data subject. STEP 4: Characteristics of Good Documentation practices in Pharmacovigillance (55 minutes) Activity: Buzzing (10 minutes) ASK students to pair up and buzz on the following question • Which are characteristics of good pharmacovigillance practices in documentation? 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 • To ensure good pharmacovigillance practices, it is essential to have documentation with the following characteristics : • They must be designed, prepared, reviewed, and distributed on the basis of

NTA Level 6 • Semester 2 • PST06211 Pharmacovigillance Methods Monitoring and Evaluation of Medicine Use • Source Session/Topic 9 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 9: Pharmacovigillance Methods Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Define pharmacovigillance methods • List pharmacovigillance methods • Explain each pharmacovigillance methods • Compare reporting methods in pharmacovigillance Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Computer and LCD projector • Handout 9.1 pharmacovigillance methods SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 2 05 minutes Presentation Definition of PharmacovigilanceMethods 45 minutes Presentation 3 Small group Pharmacovigillance Methods discussion 4 20 minutes Presentation Explanations on Pharmacovigillance Methods 25 minutes Presentation Comparing the Reporting Methods of 5 Buzzing Pharmacovigillance 6 10 minutes Presentation Key Points 7 10 minutes Presentation Evaluation PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 69 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing. STEP 2: Definition of Pharmacovigillance Methods (5 minutes) • Pharmacovigillance methods are those methods used in pharmacovigillance in conducting surveillance of adverse events or any other drug related problem. It can be either active surveillance or passive surveillance • It‘s a way to monitor drug safety. • Are methods for gathering information STEP 3: Pharmacovigillance Methods (45 minutes) Activity: Small Group Discussion (20 minutes) DIVIDE students into small manageable groups ASK students to discuss on the following questions • What are the pharmacovigillance methods? ALLOW students to discuss for 15 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 pharmacovigillance methods used in monitoring drug safety; o Spontaneous reporting o Intensified ADR reporting o Targeted reporting o Cohort Event Monitoring o Electronic health record(EHR) mining PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 70 • Also pharmacovigillance methods can be categorized into; o Passive surveillance methods include; Spontaneous reports, Case series, Stimulated reporting o Active surveillance methods include; Sentinel sites, Medicine event monitoring, Cross- sectional study (survey) ,Case-control study Refer students to Handout9.1: pharmacovigillance methods STEP 4:Explanations on PharmacovigillanceMethods(20 minutes) • Spontaneous reporting o A system to monitor the safety of all medicines on the market o Voluntary submission of ICSRs by health professionals, pharmaceutical manufacturers and patients to the nationalpharmacovigillance centre o Requires two initial steps:  A reporter  Suspects that an undesirable medical event may have been caused by exposure to a medicine o Reports the suspicion to the national pharmacovigillance centre o Reports may include;  Serious ADRs  Severe ADRs  New drug  Unknown (unlabelled reactions)  ADRs in vulnerable groups (children, pregnant women, elderly o Advantages of this method  Most commonly used method  Easiest method to establish  least labour intensive  relatively inexpensive o Disadvantages of this method  Inherent under‐reporting  Captures only suspected ADRs  Possibility ofReporting bias • Intensified ADRs reporting o To enhance ADR reporting of specific medicines in early post‐marketing phase o Extension of Spontaneous Reporting Programme o Medicines under additional monitoring include, medicines contain new active substance, biologicalmedicines that require additional studies e.g. more data on long term use or on rare side effects in clinical trials PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 71 • Targeted reporting o intensified ADR Reporting within a defined cohort o it target specific medicines, population, ADR, and clinics • Cohort event monitoring o To gather more information on the safety profile of a new chemical entity in early post‐ marketing phase o Observational cohort study design o Patients enrolled into cohort and actively followed‐up during treatment to record all adverse events (not just suspected ADRs)Characterise known reactions o Detect signals of unrecognised reactions o Identify interactions with other medicines o Detect inefficacy of medicine o Assess safety in pregnancy and lactation • Electronic health record(EHR) mining o Make use of existing health records to supplement pharmacovigillance activities o Potentially rich source of ADR data o Mining of the THIN data base is currently being evaluated • Which method and when?Routine pharmacovigillance (spontaneous reporting) is recommended for all products focused pharmacovigillance is better out under specified conditions when safety issues or potential safety issues need to be addressed .Active studies are undertaken when data is needed quickly STEP 5: Comparing the Reporting Methods (25 minutes) Activity: Buzzing (10minutes) ASK students to pair up and buzz on the following question • Which methods report all types of ARDs? 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 PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 72 METHOD MEDICINES POPULATION REPORTS Spontaneous Reporting All medicines life, All exposure All ADRs cycle of products individuals but denominator unknown Intensified ADR Reporting Specific medicines All exposure All ADRs individuals but denominator unknown Targeted Reporting Specific medicines Defined cohort Specific ADRS All ADRs Cohort Event Monitoring Specific medicines Defined cohort All events Electronic health record All medicines Defined cohort All events mining STEP 6: Key Points (10 minutes) • Pharmacovigillance methods are ways to monitor drug safety. • Pharmacovigillance method spectrum include;Spontaneous Reporting, Intensified ADR Reporting, Targeted Reporting and Cohort Event Monitoring • Pharmacovigillance methods can be categorized into passive and active surveillance • Spontaneous reporting involves a system to monitor all medicines • Intensified ADR reporting involves reporting of specific medicines at early

NTA Level 6 • Semester 2 • PST06211 The Concept of Pharmacovigillance Monitoring and Evaluation of Medicine Use • Source Session/Topic 8 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 8: The Concept of Pharmacovigillance: Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Explain pharmacovigillance • Define terminologies used in pharmacovigillance • List the aims of pharmacovigillance • List key partners in pharmacovigillance • Explain the importance of pharmacovigillance Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Computer and LCD projector SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 2 05 minutes Presentation Explanation of Pharmacovigillance 3 15 minutes Presentation Definition of Terms in Pharmacovigillance 15 minutes Presentation and 4 Aims of Pharmacovigillance Buzzing 5 10 minutes Presentation Key Partners in Pharmacovigillance 50 minutes Presentation and 6 Importance of Pharmacovigillance Group discussion 7 10 minutes Presentation Key Points 8 10 minutes Presentation Evaluation PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 62 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing. STEP 2: Pharmacovigillance(5 minutes) • The etymological roots for the word "pharmacovigillance" are: pharmakon (Greek for drug) and vigilare(Latin for to keep watch). As such, pharmacovigillance heavily focuses on adverse drug reactions. • Pharmacovigillance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem(According to WHO definition) • Why Pharmacovigillance is needed? The processes involved in the clinical development of medicines once put onto the market; a medicine leaves the secure and protected scientific environment of clinical trials and is legally set free for consumption by the general population. At this point, most medicines will only have been tested for short-term safety and efficacy on a limited number of carefully selected individuals. STEP 3: Definition of Terms in Pharmacovigillance (15 minutes) The following are some of pharmacovigillance terminologies as adopted in TFDA guideline: • Adverse Drug Reactions (ADRs) a response to a medicinal product that is noxious or potentially harmful and unintended and which occurs at doses normally used in human for prophylaxis, diagnosis or therapy of a disease or for the modification of physiological function in which individual factors may play an important role. • Adverse eventAny unfavourable medical occurrence that in coincidence may present during treatment with a pharmaceutical product, but which does not necessarily have a causal relationship with the treatment. • Benefit/risk analysis Examination of the favourable and unfavourable results of undertaking a specific course of action. • Life-threatening reaction isa reaction in which the patient was at risk of death at the time of the event and does not refer to an event, which hypothetically might have caused death if it was more severe. • Serious adverse drug reaction A noxious and unintended response to a drug that at any dose, may result in death, is life threatening (such as Stevens-Johnson Syndrome), requires patient hospitalization or prolongation of existing hospitalization, causes a congenital PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 63 anomaly or birth defect, results in persistent or significantly is ability or incapacity, or require intervention to prevent permanent impairment or damage. • Side effect any unintended effect of a pharmaceutical product occurring at doses used in man for medical treatment which is related to the pharmacological properties of the product and in which there is no deliberate overdose. • Unexpected adverse drug reaction An adverse reaction, the nature or severity of which is not mentioned in the summary of product characteristic or market authorization, or expected from characteristics • Biological products Medical products prepared from biological material of human, animal or microbiologic origin (such as blood products, vaccines, insulin). • Clinical trial A systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or to study the absorption, distribution, metabolism and excretion of the products with the objective of ascertaining their efficacy and safety. • Efficacy The ability of a drug to produce the intended effect as determined by scientific methods, for example in pre-clinical research conditions (opposite of hazard). • Potency is a measure of drug activity expressed in terms of the amount required to produce an effect of given intensity. • Individual case safety reports (ICSR)A report that contains ‗information describing a suspected adverse drug reaction related to the administration of one or more medicinal products to an individual patient. • Post-marketing The stage when a drug is generally available on the market. • Pre-marketing The stage before a drug is available for prescription or sale to the public. • Poly-pharmacy The concomitant use of more than one drug, sometimes prescribed by different practitioners. • Placebo An inactive substance (often called a sugar pill) given to a group being studied to compare results with the effects of the active drug. • Cohort study – A study that identifies defined populations and follows them forward in time, examining their rates of disease. • National pharmacovigillance centre – A single, governmentally recognized centre within a country with the clinical and scientific expertise to collect, collate, analyse and give advice on all information related to drug safety. PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 64 STEP 4: Aims of Pharmacovigillance (15 minutes) Activity: Buzzing (5minutes) ASK students to pair up and buzz on the following questions for 5 minutes • What are the aims of pharmacovigillance? ALLOW few pairs to

NTA Level 6 • Semester 2 • PST06211 Tools for Monitoring and Evaluation of Medicine Monitoring and Evaluation of Medicine Use • Source Session/Topic 7 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 7: Tools for Monitoring and Evaluation of Medicine Use Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • List tools used in monitoring and evaluation of medicine use • Describe tools used in monitoring and evaluation of medicines use Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Computer and LCD projector • Handout 7.1. Description of tools used in monitoring and evaluation of medicines use SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 25 minutes Presentation Tools used in Monitoring and Evaluation of 2 Buzzing Medicine use 80 minutes Presentation Description of Tools used in Monitoring and 3 Small Group Evaluation of Medicines use Discussion 4 05 minutes Presentation Key Points 5 05 minutes Presentation Evaluation PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 54 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning task and clarify ASK students if they have any questions before continuing. STEP 2: Tools used in Monitoring and Evaluation of Medicine use (25 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What are tools used in monitoring and evaluation of medicine 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 WHO Operational Package for Assessing, Monitoring and Evaluating Country Pharmaceutical Situations is intended as a useful tool for researchers, policy-makers, planners and others who need to use standardized measurement tools to gather data and other information. • The tools presented here have already been used for several years at global and country levels. • The listed below are tools used in monitoring and evaluation of medicine use as per WHO operational package for assessing and monitoring; o Level I questionnaire.The Level I questionnaire, which is sent to countries once every four years to update global pharmaceutical data, is included in the annexes. It can also serve as a rapid assessment and checklist for countries to check current the pharmaceutical structure and processes of their national pharmaceutical systems. o Level II survey forms. The annexes contain the technical descriptions of Level II facility indicators and the sampling process. Survey forms are included, and graphs and tables can be from the analysis template. o Medicine use indicators-prescribing indicator form o A Guide for Coordinators and Data Collectors of the Level II Facility Survey Checklist for data collectors PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 55 o Coordinator checklist o Copies of the National Medicines List. o Patient records and stock cards. • The above are necessary tools use to gather information that are brought together with WHO operational package. • A diskette that contains Level II facility survey forms, summary forms and training slides. STEP 3: Description of Tools used in Monitoring and Evaluation of Medicines use (80 minutes) Activity: Small Group Discussion ( 30 minutes) DIVIDE students into small manageable groups ASK students to discuss on the following question • What are the Tools used in Monitoring and Evaluation of Medicines use? ALLOW students to discuss for 20 minutes ALLOW few groups to present and the rest to add points not mentioned CLARIFY and SUMMARIZE by using the contents below • Level I questionnaire o The Level I questionnaire, which is sent to countries once every four years to update global pharmaceutical data, is included in the annexes. It can also serve as a rapid assessment and checklist for countries to check current the pharmaceutical structure and processes of their national pharmaceutical systems o Level I questionnaire is a questionnaire on theexisting infrastructures and key processes of each component of the pharmaceutical sector. The completion of the questionnaire can be accomplished in a relatively short time after identifying sourcesof accurate information. o The survey of Level II indicators is a very important part of monitoring the pharmaceutical sector because these indicators measure the outcome and impact of pharmaceutical programmes in a country. • Level II Survey Forms numbered 1—17; these are various forms used for gathering data in monitoring and evaluation of medicine use. o Adequate preparation is needed and data collectors must be trained. PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 56 o The forms are given below together with their indicators use to monitor and assess medicine use • Survey Forms 1-6 o in Public health facility pharmacies/dispensaries • Survey form 1 o percentage key medicines available o percentage medicines expired • Survey form 2 o Price of key medicine o Price of paediatric medicines • Survey form 3 o Affordability of treatment for adults and children under 5 years of age • Survey form 4 o Average stock out duration o Adequate record keeping • Survey form 5 o Adequate conservation conditions and handling of medicines in the storeroom and dispensing area • Survey form 6 o Average number of medicines per prescription o percentage medicines dispensed or administered o percentage medicines adequately labelled o percentage patients knowing how to take medicines o Average cost of medicines o Geographical accessibility of dispensing facilities • Survey Forms 7–9Gather information regardingRational medicine use – Prescribing indicator form • Indicators: o prescribed medicines on EML o percentage patients prescribed antibiotics/injections o percentage medicines prescribed by generic name o public health facilities

NTA Level 6 • Semester 2 • PST06211 Indicators in Monitoring and Evaluation Monitoring and Evaluation of Medicine Use • Source Session/Topic 6 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 6: Indicators in Monitoring and Evaluation Medicines Use Total Session Time: 120 minutes + 2 hours of Assignment Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • List indicators used in monitoring and evaluation of medicines use • Explain application of each indicator in monitoring and evaluation of medicines use Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Computer and LCD Projector SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 35 minutes Indicators used in Monitoring and Evaluation Presentation 2 of Medicines use Buzzing 65 minutes Presentation Application of Each Indicator in Monitoring 3 Small Group and Evaluation of Medicines use Discussion 4 05 minutes Presentation Key Points 5 05 minutes Presentation Evaluation PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 47 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing. STEP 2: Indicators used in Monitoring and Evaluation of Medicines use (35 minutes) Activity: Buzzing (10 minutes) ASK students to pair up and buzz on the following question for 5 minutes • What are indicators used in monitoring and evaluation of medicine use? ALLOW few pairs to respond and let other pairs add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below • Medicine use indicators were developed to be used as measures of performances in three general areas related to the rational use of medicine in primary care o Pharmaceutical prescribing practices by health providers o Key elements of patient care covering both clinical consultation and pharmaceutical dispensing o Availability of facility specific factors which support rational use such as key essential drugs and minimum pharmaceutical information • The medicine use indicators would typically be measured within a defined geographic or administrative area either to describe medicine use at a given point in time or to monitor changes over time • Usually they tend to measure the rational use of medicine measured by facilities • The level II indicators are used to monitor and evaluate medicine uses and they can be group into the following aspects as from the WHO operational package ; o Prescribing Indicators  Average number of medicines per encounter  Percentage of medicines prescribed by generic name  Percentage of encounters with an antibiotic prescribed  Percentage of encounters with an injection prescribed  Percentage of medicines prescribed which are from the essential medicines list or formulary list PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 48 o Patient Care Indicators  Average consultation time  Average dispensing times  Percentage of medicines actually dispensed  Percentage of medicines that are adequately labeled  Percentage of patients who know how to take their medicines o Health Facility Indicators  Availability of essential medicine list or formulary  Availability of key set of indicator medicines  Availability of standard treatment guideline (STG)  The above indicators are the minimum set of measures to be calculated during a single medicine use indicators survey o Complementary Indicators (this have less standardization and less experience in actual use  Percentage of patients treated without medicines  Average medicine costs per encounter  Percentage of medicine cost spent on antibiotics  Percentage of medicine cost spent on injections  Percentage of prescriptions in accordance with STG  Percentage of patients satisfied with care provided  Percentage of facilities with access to impartial information STEP 3: Application of Each Indicator in Monitoring and Evaluation of Medicines Use (65 minutes) Activity: Small Group Discussion ( 30 minutes) DIVIDE students into small manageable groups ASK students to discuss on the following question • What are applications of medicine use indicators? ALLOW students to discuss for 15 minutes ALLOW few groups to present and the rest to add points not mentioned CLARIFY and SUMMARIZE by using the contents below PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 49 Below is the description of application of each indicator for motoring and evaluation of medicine use; • Prescribing Indicators o The indicators of prescribing practices measure the performance of healthcare providers in several key dimensions related to appropriate use of medicines  Average number of medicines per encounter  Purpose-To determine the prevalence of polypharmacy, which is one measure of unnecessary prescribing. o Percentage of medicines prescribed by generic name  Purpose -To measure the degree to which prescribing practice conforms to the principles of generic prescribing. o Percentage of encounters with an antibiotic prescribed  Purpose -To determine the prevalence of antibiotic prescribing, since over- prescribing of antibiotics is one common type of inappropriate medicine use. o Percentage of encounters with an injection prescribed  Purpose -To determine the prevalence of injection use, since over-prescribing of injections is one common type of inappropriate medicine use. o Percentage of medicines prescribed which are from the essential medicines list or formulary list  Purpose -To measure the degree to which prescribing practice conforms to the national essential medicines list (EML). The essential medicines concept is one of the main strategies being promoted in medicines policy. More and more countries are formulating national EMLs. For most countries, this should be the basis for all public medicines procurement and prescribing. • Patient Care Indicators o Patient care indicators address key aspects of what patients experience at health facilities and how well they have been prepared to

NTA Level 6 • Semester 2 • PST06211 Factors Hindering Monitoring and Evaluation of Medicines Use Monitoring and Evaluation of Medicine Use • Source Session/Topic 5 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 5: Factors Hindering Monitoring and Evaluation of Medicines Use Total Session Time: 60 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • List factors hindering monitoring and evaluation of medicines use • Explain factors hindering monitoring and evaluation of medicines use • Identify measures to improve monitoring and evaluation of medicines uses Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Computer and LCD projector SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 15 minutes Factors Hindering Monitoring and Evaluation Presentation 2 of Medicines Use Buzzing 15 minutes Explanation on Factors Hindering Monitoring 3 Presentation and Evaluation of Medicines Use 15 minutes Presentation Measures to Improve Monitoring and 4 Brainstorming Evaluation of Medicines Uses 5 05 minutes Presentation Key Points 6 05 minutes Presentation Evaluation PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 42 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing. STEP 2: Factors Hindering Monitoring and Evaluation of Medicines Use (15 minutes) Activity: Buzzing (5minutes) ASK students to pair up and buzz on the following question for 5 minutes • What are the factors hinder monitoring and evaluation of medicine uses? ALLOW few pairs to respond and let other pairs add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below • Poor record keeping, availability and accessibility of medical records • Unsustainable system of regular monitoring and evaluation of medicine use • There is limited advocacy for culture of monitoring and evaluation of medicine use • Economic factors • Patient factors such as a delay of patient to be included in the sampling frame • Inadequate number of human resource • Lack of expertise • Most monitoring tools include indicators that are difficult to collect data especially if done regularly • Limited resources that are not consistently allocated STEP 3: Factors hindering Monitoring and Evaluation of Medicines Use (15 minutes) • Poor record keeping, availability and accessibility of medical records. Difficulties in assessing the patient‘s medical files it becomes a challenge in obtaining data during monitoring and evaluation of medicine use although others might be available but accessibility becomes also a challenge. • Unsustainable system of regular monitoring and evaluation of medicine use. Many established systems for monitoring and evaluation of medicine use they do not sustain for long time therefore it becomesdifficult to establish it again. PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 43 • There is limited advocacy for culture of monitoring and evaluation of medicine use. Many facilities have no tendency or behaviour of carrying out monitoring and evaluation of medicine use this lack support from facilities, pharmacies and the government itself have no tendency of promoting monitoring and evaluation of medicine use • Economic factor. Economy stability to support the monitoring and evaluation of medicine use also have become unreliable due to inadequate funds to take people to field for data collection • Patient factors. Delay of patient to be included in the sampling frame. Delay of patients to participate in interview during data collection on the field is ain obtaining information from some medicine use indicators in monitoring and evaluation of medicine use. • Inadequate number of human resource. Lack of expertise and adequate number of personnel to perform monitoring and evaluation of medicine use • Most monitoring tools include indicators that are difficult to collect data especially if done regularly. • Limited resources that are not consistently allocated. The allocation of resource for conducting monitoring and evaluation of medicine use are not consistently allocated which becomes difficult in conducting the assessments and monitoring of medicine uses. STEP 4: Measures to Improve Monitoring and Evaluation of Medicines Uses (15 minutes) Activity: Brainstorming (5 minutes) Ask students to brainstorm on the following question: • What are the measures to improve monitoring and evaluation of medicine uses? ALLOW few students to respond? WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • Establishment of sustainable system of monitoring and evaluation • There should be a clear communication of plans and targets • To promote advocacy on culture of monitoring and evaluation of medicine use • Training personnel on importance of monitoring and evaluation of medicine use well as how to carry it • To put a clear availability and accessibility of medical record this will enable expertise to carry the task easily. PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 44 • To allocate resources consistently • To increase more number of human resource to coordinate the activity. STEP 6: Key Points(5 minutes) • Factor hindering monitoring and evaluation of medicine uses includes; lackof expertise, economic factors, patient factors and insufficient human resource. • Measures to improve monitoring evaluation of medicine uses is by allocation of more resources consistently, making availability and accessibility of medical records STEP 7: Evaluation (5 minutes) • What are factors hindering monitoring and evaluation of medicine uses? • What are measures to improve monitoring and evaluation of medicine uses? PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 45 References Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007). The Global Fund to Fight AIDS, Tuberculosis and Malaria.

NTA Level 6 • Semester 2 • PST06211 Performance Indicators for Monitoring and Evaluation Monitoring and Evaluation of Medicine Use • Source Session/Topic 4 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 4: Performance Indicators for Monitoring and Evaluation Total Session Time: 120 minutes + 2 hours Assignment Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • List performance indicators in monitoring and evaluation of different pharmaceutical situations • Explain each performance indicators in monitoring and evaluation of different pharmaceutical situations Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Pointer • Computer and LCD projector • Handout 4.1:Summary list of performance indicators SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 20 minutes Performance Indicators in Monitoring and Presentation 2 Evaluation of Pharmaceutical Situations Buzzing 80 minutes Explanation on Performance Indicators in Presentation Small 3 Monitoring and Evaluation of Pharmaceutical group discussion Situations 4 10 minutes Presentation Key Points 5 05 minutes Presentation Evaluation PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 31 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing. STEP 2: Performance Indicators in Monitoring and Evaluation of PharmaceuticalSituations (20 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What are performance indicators in monitoring and evaluation of different pharmaceutical situations? 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 WHO process for pharmaceutical monitoring and assessment uses a hierarchical approach with three groups of indicators: Level I, Level II and Level III. This provides a standard methodology to follow progress over time and to compare situations in different facilities, districts and countries • Level of core indicators are shown on diagram below PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 32 Level II indicators (outcome) Level III • WHO NDP indicators • Indicators for specific pharm • How to investigate drug • Assessing regulatory ca Level I • TRIPS, Drug pricing, Tra indicators (structure& process) • Level I indicators provide a rapid means of obtaining information on the existing infrastructure and key processes of each component of the pharmaceutical sector. • Level II health facility indicators provide systematic data to measure outcomes on access (affordability and availability of key medicines and geographical accessibility of dispensing facilities) and rational use of quality medicines, including some indication of the quality of medicines at health facilities and pharmacies. • Level III indicators are a more detailed and expanded list of indicators covering key components and areas such as those elaborated in several indicator documents in medicine pricing, medicine supply management, HIV/AIDS, TRIPS, rational drug use (RDU) and regulatory capacity assessment. STEP 3: Performance Indicators in Monitoring and Evaluation of Pharmaceutical Situations (80 minutes) PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 33 Activity: Small Group Discussion ( 30 minutes) DIVIDE students into small manageable groups ASK students to discuss on the following question • What components are in level I indicators? ALLOW students to discuss for 15 minutes ALLOW few groups to present and the rest to add points not mentioned CLARIFY and SUMMARIZE by using the contents below • Level I core indicators o The Level I core indicators are used to assess existing structures and processes of national pharmaceutical system. They provide a method to rapidly assess the implementation of NMPs and their components. o Indicators, a knowledgeable informant can coordinate the gathering of information. Most data will be available within the Ministry of Health, although data on intellectual property rights protection may require consultation with the responsible ministry. Data collection does not require field surveys and information can easily be updated periodically, for example every two years. o The questionnaire on Level I indicators is included as Annex of the WHO operational package for assessing and monitoring pharmaceutical situations. The indicators in this questionnaire are summarized below. • Pharmaceutical components in Level I indicators o National Medicines Policy (NMP)- An NMP document that covers the public and private sectors, a written implementation plan and the integration of medicine and health policies provide a basic framework to organize and improve the pharmaceutical system.  They also assist in coordinating the functions and strategies of each component as they are being implemented. Regular monitoring helps to inform the NMP and its implementation. o Regulatory system-Regulations on medicine manufacturing, promotion and advertising, sales, distribution, dispensing and prescribing must be in place. Legislation directed at generic prescribing, dispensing and substitution can help increase access to essential medicines in both the private and public sectors o Medicines supply system- Access and availability of essential medicines, especially at public sector facilities, are affected by how medicines are purchased and distributed and how medicines are managed in the health system. PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 34 o Medicines financing- Access and availability are also affected by how much money the government can allocate to medicines, pricing policies, financing schemes (such as insurance programmes and user fees) and medicine donations. o Production and trade – Activities ranging from repackaging to formulation of products to developing new medicines are important in assessing the pharmaceutical sector. Implementing TRIPS flexibilities in public health can increase access to medicines. o Rational use of medicines – Medicines policies can often have greater impact with effective use of strategies to improve the prescribing and dispensing practices

NTA Level 6 • Semester 2 • PST06211 Assessing Monitoring and Evaluation of PharmaceuticalsServices Monitoring and Evaluation of Medicine Use • Source Session/Topic 3 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 3: Assessing Monitoring and Evaluation of PharmaceuticalsServices Total Session Time: 120 minutes + 2 hours of Assignment Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • List components of WHO operational package for assessing monitoring and evaluation of country pharmaceutical situations • Explain each component of WHO operational package for assessing monitoring and evaluation of country pharmaceutical situations Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Computer and LCD projector • Handout 3.1 :Components of the WHO Operational Package for Assessing, Monitoring and Evaluation CountryPharmaceutical Situation SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 20 minutes List of Components of WHO Operational Presentation 2 Package for Assessing Monitoring and Buzzing Evaluation of Pharmaceutical 85 minutes Presentation Explanation of Component of WHO 3 Small Group Operational Package for Assessing Monitoring Discussion and Evaluation of Pharmaceutical 4 05 minutes Presentation Key Points 5 05 minutes Presentation Evaluation PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 19 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing. STEP 2: Components of WHO Operational Package for Assessing Monitoring and Evaluation of Pharmaceutical (20 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What are the components of WHO operational package for assessing monitoring and evaluation of pharmaceutical situations? 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 WHO Operational Package for Assessing, Monitoring and Evaluating Country Pharmaceutical Situations is intended as a useful tool for researchers, policy-makers, planners and others who need to use standardized measurement tools to gather data and other information. • The WHO process for pharmaceutical monitoring and assessment uses a hierarchical approach with three groups of indicators. • The components of the WHO Operational Package for Assessing, Monitoring and Evaluationof CountryPharmaceutical Situations include the following; o Pharmaceutical indicators for monitoring and assessment  Level I core indicators.  Level II facility-based core indicators  Level III indicators o Preparing the survey (Level II – facility survey) o Training data collectors o The survey o Data processing, analysis and reporting PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 20 STEP 3: Explanation on Each Component of WHO Package for Assessing Monitoring and Evaluation of Pharmaceutical(85minutes) Activity: Small group discussion (30 minutes) ASK students to form small manageable group and discuss the following questions • What are pharmaceutical indicator for monitoring and assessment? 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 • Pharmaceutical indicators for monitoring and assessment o Given the complexity of the pharmaceutical sector, a systematic method of gathering data is very important for assessing access, quality and rational use of medicines. o There are multiple, cross-cutting factors that can influence access and rational use of quality medicines, and a variety of strategies that countries can adopt and implement to improve their pharmaceutical situations. o Indicators have been developed for monitoring national medicines policies (NMPs) that enable systematic assessment, evaluation and monitoring of the formulation and implementation of pharmaceutical policies and programmes. o These can be used to:  Assess country capacity, such as available infrastructure, logistics and human resources to support the pharmaceutical sector and implement NMPs;  monitor the implementation of NMPs;  measure the impact of implementation strategies; and  Evaluate progress towards identified objectives. o All stakeholders in the pharmaceutical sector can use indicator-based assessment of the pharmaceutical situation to inform priorities and set targets. o Indicators provide policy-makers and managers with a clear picture of national and institutional problems. Policy-makers and managers can refer to study results when developing strategies to strengthen the pharmaceutical sector o Information and data can be used to:  Formulate or revise the NMP.  Assess the quality of governance, such as systems and mechanisms that would safeguard against vulnerability to corruption. PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 21  Encourage and facilitate cooperation between the different main players in a o Level I indicators provide a rapid means of obtaining information on the existing infrastructure and key processes of each component of the pharmaceutical sector.  These indicators are assessed using a short questionnaire completed at the national level. o Level IIindicators  Provide systematic data on access and rational use of quality medicines through facility-based surveys.  Systematic survey processes to collect data on these indicators are contained in WHO package.  A population-based survey has been developed as part of the current process and is discussed in a separate document, Manual for the Household Survey to Measure Access and Use of Medicines. o Preparing the survey (Level II – facility survey)  The survey of Level II indicators is a very important part of monitoring the pharmaceutical sector because these indicators measure the outcome and impact of pharmaceutical programmes in a country.  Adequate preparation is needed and data collectors must be trained. o Coordination and survey coordinator  A national coordinator should be selected to take charge of the overall coordination of the Level II survey, to oversee the survey process, data analysis, reporting and presentation