Pharmaceutical Sciences Notes

NTA Level 5 • Semester 1 • PST05105 Introduction to Irrational Use of Medicines Rational Use of Medicines • Source Session/Topic 2 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 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 |Step |Time |Activity/ |Content | | | |Method | | |1 |05 Minutes |Presentation |Introduction, Learning Tasks | |2 |20 Minutes |Presentation |Introduction to Irrational Use Of | | | | |Medicines | |3 |30 Minutes |Presentation |Types Of Irrational Medicines Use | | | |Buzzing |Based on Prescribing Practice | |4 |20 Minutes |Presentation |Dispenser’s Influence on Irrational | | | | |Use of Medicines | |5 |20 Minutes |Presentation |Prescriber’s Influence on Irrational| | | | |Use of Medicines | |6 |15Minutes |Presentation |Reasons For Irrational Use of | | | |Brainstorming |Medicine to Continue | |7 |05 Minutes |Presentation |Key Points | |8 |05 Minutes |Presentation |Evaluation | 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

NTA Level 5 • Semester 1 • PST05105 Factors Contributing to Irrational Use of Medicines Rational Use of Medicines • 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: 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 |Step |Time |Activity/ |Content | | | |Method | | |1 |5 minutes |Presentation |Introduction, Learning Tasks | |2 |30 minutes |Presentation |Introduction to Factors Contributing| | | | |to Irrational Use of Medicines | |3 |30minutes |Presentation |Factors Contributing to Irrational | | | |Buzzing |Use of Medicines | |4 |45 minutes |Presentation |Factors Contributing to Irrational | | | | |Use of Medicines | |6 |05 minutes |Presentation |Key Points | | 7 |05 minutes |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: 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

NTA Level 5 • Semester 1 • PST05105 Problems Associated with Irrational Medicine Usage Rational Use of Medicines • 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: 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 |Step |Time |Activity/ |Content | | | |Method | | |1 |5 minutes |Presentation |Introduction, Learning Tasks | |2 |30 minutes |Presentation |Introduction of Problems Associated | | | | |with Irrational Medicine Usage | |3 |30 minutes |Buzzing |List Types ofProblems Associated | | | |Presentation |with Irrational Medicine Usage | |4 |45 minutes |Presentation |Problems Associated with irrational | | | | |Medicine Usage | |5 |05 minutes |Presentation |Key Points | | 6 |05 minutes |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: 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

NTA Level 5 • Semester 1 • PST05105 Control Measures for Irrational Medicines Use Rational Use of Medicines • 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: 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 |Step |Time |Activity/ |Content | | | |Method | | |1 |5 minutes |Presentation |Introduction, Learning Tasks | |2 |15 minutes |Presentation |Introduction to Control measures for| | | | |irrational medicines use | |3 |30 minutes |Presentation |Types of Control Measures for | | | |Brainstorming |Irrational Medicines Use | |4 |60 minutes |Presentation |Control Measures for Irrational | | | | |Medicines Use | |5 |05 minutes |Presentation |Key Points | | 6 |05 minutes |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: 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. ← Previous TopicNext Topic →View all Rational Use of Medicines topicsOpen Complete Full Notes PDF / OFFLINE NOTES Unataka kutumiwa notes hizi kupitia WhatsApp?Kwa notes zilizopangiliwa vizuri kwa kusoma offline au PDF, bonyeza kitufe hapa chini. Ujumbe wenye Level, Semester, Module na Topic utaandaliwa moja kwa moja.TUMIWA NOTES WHATSAPP WhatsApp: 255620339260

NTA Level 5 • Semester 1 • PST05105 Concept of National Essential Medicines Rational Use of Medicines • 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: 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 |Step |Time |Activity/ |Content | | | |Method | | |1 |5 minutes |Presentation |Introduction, Learning Tasks | |2 |10 Minutes |Presentation |Define Essential Medicine List | |3 |25 Minutes |Presentation |Introduction of Model List of | | | | |Essential medicines | |4 |30 Minutes |Presentation |National Concept of Essential | | | | |medicines List | |5 |20 Minutes |Brainstorming |Advantages of a Limited List of | | | |Presentation |Essential Medicines | |6 |20 Minutes |Buzzing |Problems of National Essential | | | |Presentation |Medicine list | |7 |05 Minutes |Presentation |Key Points | | 8 |05 Minutes |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 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

NTA Level 5 • Semester 1 • PST05105 Essential Medicines Concept in Promotion of Rational Medicines Rational Use of Medicines • 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: 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 |Step |Time |Activity/ |Content | | | |Method | | |1 |5 minutes |Presentation |Introduction, Learning Tasks | |2 |30 minutes |Presentation |Key Factors for Developing Essential| | | |Buzzing |Medicine list | |3 |25 minutes |Presentation |Important of Essential Medicine List| | | |brainstorming | | |4 |25 minutes |Presentation |Essential Medicine List in | | | | |Promoting Rational Use of Medicines | |5 |25 minutes |Presentation |Criteria for Selection of Essential | | | | |Medicines | |6 |05 minutes |Presentation |Key Points | | 7 |05 minutes |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: 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.).

NTA Level 5 • Semester 1 • PST05105 Types of Interventions in Promoting Rational Medicines Use Rational Use of Medicines • 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: 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 |Step |Time |Activity/ |Content | | | |Method | | |1 |5 Minutes |Presentation |Introduction, Learning Tasks | |2 |15 Minutes |Presentation |Introduction to National | | | | |Interventions in Promoting Rational | | | | |Medicines Use | |3 |30 Minutes |Buzzing |Types of National Interventions in | | | |Presentation |Promoting Rational Medicines Use | |4 |60 Minutes |Presentation |National Interventions in Promoting | | | |Group |Rational Medicines Use | | | |Discussion | | |6 |05 Minutes |Presentation |Key Points | | 7 |05 Minutes |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: 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

NTA Level 5 • Semester 1 • PST05105 Factors Hindering Promotion of Rational Use of Medicine Rational Use of Medicines • 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: 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 |Step |Time |Activity/ |Content | | | |Method | | |1 |5 Minutes |Presentation |Introduction, Learning Tasks | |2 |15 Minutes |Presentation |Introduction to Factors Hindering | | | | |Promotion of Rational Use of | | | | |Medicine | |3 |30 Minutes |Presentation |Types of Factors Hindering Promotion| | | |Buzzing |of Rational Use of Medicine | |4 |60 Minutes |Presentation |Factors Hindering Promotion of | | | | |Rational Use of Medicine | |5 |05 Minutes |Presentation |Key Points | | 6 |05 Minutes |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: 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 to 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

NTA Level 5 • Semester 1 • PST05105 Importance of (STG) and (EML) in Reducing Irrational Use of Medicines Rational Use of Medicines • 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: 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 |Step |Time |Activity/ |Content | | | |Method | | |1 |05 Minutes |Presentation |Introduction, Learning Tasks | |2 |20 Minutes |Presentation |Introduction to Tanzania STGs and | | | | |EML | |3 |20 Minutes |Buzzing |Importance of STGs | | | |Presentation | | |4 |25 Minutes |Presentation | Relationship Between STGs and EML | |5 |20 Minutes |Presentation |Advantages of Using Generic Names or| | | |Group Discussion|INN in Medicine Use. | |6 |20 Minutes |Presentation |Potential Benefits of Standard | | | | |Treatment Guidelines | |7 |05 Minutes |Presentation |Key Points | | |05 Minutes |Presentation |Evaluation | |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

NTA Level 5 • Semester 1 • PST05105 Legal limitations on Medicines Marketing and Promotion Rational Use of Medicines • 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: 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 |Step |Time |Activity/ |Content | | | |Method | | |1 |5 Minutes |Presentation |Introduction, Learning Tasks | |2 |10 Minutes |Presentation |Definition of Terms used in Legal | | | | |Limitations on Medicines Marketing | | | | |and Promotion. | |3 |15 Minutes |Presentation |Introduction to Legal Limitations on| | | | |Medicines Marketing and Promotion. | |4 |30 Minutes |Presentation |Responsibilities of TFDA on | | | |Brainstorming |Medicines Marketing and Promotion | |5 |10 Minutes |Presentation |Pharmaceuticals Promotion Control | |6 |20 Minutes |Presentation |Important of Promotion and Marketing| | | |Buzzing |in Pharmacy | |7 |10 Minutes |Presentation |Pharmaceuticals Advertisement | | | | |Control | |8 |05 Minutes |Presentation |Key Points | | 9 |05 Minutes |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 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