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Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06106 Basic Pharmacotherapy

PST06106 Basic Pharmacotherapy – Complete Full Notes

NTA Level 6 • Semester 1 • PST06106 Basic Pharmacotherapy – Complete Full Notes Complete educational source text in one page Completeness safeguard: this page keeps the complete educational module/source wording in one place so learning material is not lost when browsing topic by topic. Presenter/tutor metadata is intentionally excluded. PST 06106 BASIC PHARMACOTHERAPY Session 1: Introduction to Pharmacotherapy Learning objectives By the end of this session students are expected to be able to: Define terminologies used in Pharmacotherapy Describe principles and concepts applied in Pharmacotherapy Explain importance of Pharmacotherapy in the management of common diseases Definition of Common Terminologies used in Pharmacotherapy Pharmacotherapy is application of knowledge in making therapeutic decisions that are most likely to have maximum positive benefit for a specific patient. Pharmacotherapy specialist: is an individual who is specialized in administering and prescribing medication, and requires extensive academic knowledge in pharmacotherapy. Pharmaceutical personel are experts in pharmacotherapy and are responsible for ensuring the safe, appropriate, and economical use of pharmaceutical drugs. Definition of Common Terminologies used in Pharmacotherapy Cont.….. Pathophysiology is the physiology of abnormal states; specifically: the functional changes that accompany a particular syndrome or disease. Also is the study of changes in the way the body works that result from disease or injury Pharmaceutical care involves the process through which a pharmacist/ other pharmaceutical personnel cooperates with a patient and other professionals in designing, implementing, and monitoring a therapeutic plan that will produce specific therapeutic outcomes for the patient Principles and Concepts applied in pharmacotherapy There are three steps that are involved in the Pharmacotherapy process which are ; Patient assessment Development of the pharmacotherapy care plan Evaluation of the impact or results of the care plan Principles and Concepts applied in pharmacotherapy Cont ….. Fig 1.1 Patient Care Process in the Pharmacotherapy Patient Assessment The focus is on drug therapy problems in which case it is important to assess if the patient’s problem(s) is/are be caused by drug therapy and can be managed by a change in drug therapy The following is the list of drug therapy problems that should be identified; Inappropriate drug selection, Need for additional drug therapy Unnecessary drug therapy Incorrect drug regimen Therapeutic duplication Drug allergy/adverse drug event Drug Interactions Medication adherence issues Patient Assessment Cont ….. Once a drug therapy problem is identified and categorized, it is then necessary to identify the cause of the problem, thereby leading to potential solutions. The process of drug therapy problem identification is to assessing the patient’s drug therapy needs and ensuring appropriateness, effectiveness and safety of medications, and the patient’s adherence Pharmacotherapy Care Plan The pharmacotherapy care plan is important in order to achieve improved pharmacotherapy outcomes. It is the action plan developed from assessment of patient described above. Each item in the patient’s problem list must be addressed in the care plan, and the care plan should be prioritized in the same way as the problem list. The pharmacotherapy care plan has several key components for each problem: Current drug regimen Drug therapy problems Therapy goals, desired endpoints Pharmacotherapy Care Plan Cont … The goals of therapy must be achievable and realistic for the patien Drug therapy may aim to cure a disease; reduce or eliminate signs and/or symptoms slow or halt the progression of a disease prevent a disease normalize laboratory values and/or assist in the diagnostic process Therapeutic recommendations Rationale Therapeutic alternatives Monitoring Pharmacotherapy Care Plan C ont … Monitoring helps in determining whether treatment goals and endpoints (achieving positive goals and avoiding negative endpoints) are being reached. An effective monitoring plan must be realistic for the patient setting and include specific monitoring parameters (clinical and laboratory/diagnostic test) frequency of monitoring, and When the patient needs to be seen again for follow-up. Patient education Evaluation The patient care process involves continuous follow-up. As the pharmacotherapy care plan is implemented, the patient’s response to therapy is monitored, and changes in therapy may be necessary. Changes in previous problems or the development of new signs and symptoms will require the assessment process and changes in the pharmacotherapy care plan During the Pharmacotherapy process, it is important to consider/review the following factors for optimal therapeutic outcome ; Evaluation Cont ……. Patient Dermographics —name, age, etc. Chief Complaint—why the patient is seeking help, in the patient’s own words History of Present Illness (HPI)—the patient’s story about why they are seeking help Past Medical History (PMH)—including all significant illnesses, surgical procedures, injuries Family History—age and health of immediate family (parents, siblings, children); for deceased relatives, the age and cause of death are included; any hereditary diseases should be noted E valuation Cont ……. Social History—may include where the patient is from or lives, ethnicity/race, marital status, number of children, educational background, occupation, diet Tobacco/Alcohol/Substance Use Allergy/Intolerances/Adverse Drug Events (ADEs)—a common area where information from the patient is missing or incomplete Medication History—should include current (or medications prior to admission if hospitalized) and previous medications; the list should include what the patient actually is taking, not just what is prescribed, and must include OTC drugs and dietary supplements (including herbal and complementary/alternative products ). Evaluation Cont ……. Signs and symptoms Laboratory and Other Diagnostic Tests Diagnosis . Treatment (Drug) plan Follow-up plan Activity: Small Group Discussion What is the importance of Pharmacotherapy? Importance of pharmacotherapy Helps in optimization of drug treatment in complex pharmacotherapy patients such as; Patients with multiple medications Patients with multiple disease states or conditions Patients on narrow therapeutic index medications Patients on medications requiring laboratory monitoring Helps in optimization of drug therapy in patients with high risk for loss of continuity of care such as; Patients with multiple prescribers Patients with recent transitions of care (e.g., hospital discharge, rehabilitation, skilled nursing facility discharge) Importance of pharmacotherapy cont… Helps in reduction of medication nonadherence especially in patients with; Irregular refill history History of failure to pick up new prescriptions Stockpiling or incorrect pill counts Financial burden (e.g., uninsured or underinsured) Low health literacy Patient’s beliefs indicate resistance to treatment High-cost

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06105 Health Financing

PST06105 Health Financing – Complete Full Notes

NTA Level 6 • Semester 1 • PST06105 Health Financing – Complete Full Notes Complete educational source text in one page Completeness safeguard: this page keeps the complete educational module/source wording in one place so learning material is not lost when browsing topic by topic. Presenter/tutor metadata is intentionally excluded. PST 06105: HEALTH FINANCING Session 1: Introduction to Health Financing Learning Tasks At the end of this session students are expected to be able to : Explain the historical background of health financing Describe various concepts of health financing Historical Background of Health Financing H ealth financing has been one of the most important policy agenda nationally and internationally among health leaders and policy-makers. Health financing has risen on agenda of policy- makers due to the fact that health systems , especially developing countries, are facing what is known as a problem of financial (fiscal) sustainability. Historical Background of Health Financing Problem of financial sustainability: exists when health system or government is unable to meet its obligations due to its inability or unwillingness to generate sufficient revenue to meet them . Historical Background of Health Financing Key symptoms of the problem of financial sustainability: ( World Bank, 1987, 1993): Misallocation and insufficient spending on cost-effective health interventions needed by the population: public money was/is spent on health interventions of low cost effectiveness Internal inefficiency: much of the money spent on health is wasted: brand-name pharmaceuticals are purchased instead of generic drugs, health workers are badly deployed and supervised, and hospital beds are underutilized. Historical Background of Health Financing Key symptoms of the problem of financial sustainability: ( World Bank, 1987, 1993): Inequity in the distribution of benefits from health services: The better-off in most had and continue to have better access to health care ; the poor lack access to basic health services and receive low-quality care Difficulty in achieving or maintaining acceptable quality services within the government budget Historical Background of Health Financing As result of these problems, world bank and others proposed health sector reforms policies that were intended to improve performance of health systems; These reforms, among, other recommended that health financing should be strengthening by introducing the following: new financing mechanisms such as user fees, health insurance and other sick coverage; and improved management of public health services. Activity: Brainstorming What is the meaning of the term “health financing” and “sources of finances”? 8 Health financing is defined variously by different experts: R efers to collection of funds from various sources (e.g . government, individual, businesses, donors); pooling fund to share financial risks across larger population groups; and using them to pay for services from public and private health-care providers. (WHO, 2000) Is the process by which revenues are collected from primary and secondary sources, accumulated in fund pools and allocated to provider activities. ( Mossialos et al,2003 ), It is defined also as a process of raising financial resources to finance and pay for health services Sources of finances T he main sources of finances for health care are: Individuals , households and employees Firms , corporate entities and employers Foreign and domestic NGO‟s and charities Foreign governments, companies multilateral agencies Contribution Mechanisms The contribution mechanisms are the ways in which individuals, households, firms and governments do contribute funds to collecting agents. The main contributing mechanisms are : Direct and indirect taxes Compulsory insurance premiums Voluntary insurance premiums Out-of-pocket payment(user charges) Donations , grants and loans Medical savings accounts Importance or significance of health financing The importance or significance of health financing has been stated by WHO (2003) as follows : Adequate and sustained financing is a critical factor in the creation of a viable health system . Fair financing mechanisms allow people to access health services at the right time and prevent people against impoverishment Financing is the mechanism by which plans and policies are translated into action through the allocation of resources Importance or significance of health financing Without adequate financing, plans remain in the realm of rhetoric and good intentions With adequate financing, a resource base can be created for the operations and delivery of services, the development and deployment of a trained workforce and the required infrastructure and technology Financing is a fundamental building block on which the other critical aspects (services, human resources, medicines and equipment, health information and leadership and management) of the health system rest Also, financing is a powerful tool with which policy-makers can develop and shape health services and their impact in improving health of the population Key points Health financing is an important topic and sub-component of health system that facilitate delivery of health service and improvement of health of the population There are number of concepts that need to be understood for better understanding of health financing Evaluation What is the meaning of the following terms h ealth financing, health financing functions, sources of finance, contributing mechanism, and financing option/ mechanism What are the symptoms the problem of financial sustainability? Reference Gottret , P. Schieber , G. (2006). Health financing revisited: a practioner’s guide. Washington DC , USA. World Bank Green , A. (2007). An introduction to health planning for developing countries (3rd Ed.) London : Oxford University Press. Gruen , R and Howarth , A. (2005). Financial management for health services. London: Open University . Jiyenze , M. K. (2013). Health care financing and resource allocation: handout for teaching health care financing. Arusha : CEDHA. [Notes: Unpublished] Kutzin , J (2001). A descriptive framework for country-level analysis of health care financing arrangements . Health Policy; 56, 171–204. Reference Tanzania . MoHSW (2014). DHM Healthcare financing module. Dar es Salaam: MoHSW . Mossialos , et al ( ed ) (2002). Funding health care: options for Europe. Buckingham: Open University Press. WHO (2003). Mental health financing. Geneva. Switzerland: WHO. World Bank (1987). Financing health services in developing countries: an agenda for reform . Washington, D.C: World Bank ,. World Bank (1993). World Development Report 1993: investing in health. Oxford, UK: Oxford University Press. PST

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06104 Health and Medicine Policy

PST06104 Health and Medicine Policy – Complete Full Notes

NTA Level 6 • Semester 1 • PST06104 Health and Medicine Policy – Complete Full Notes Complete educational source text in one page Completeness safeguard: this page keeps the complete educational module/source wording in one place so learning material is not lost when browsing topic by topic. Presenter/tutor metadata is intentionally excluded. Session 1: Introduction to Health System in Tanzania 1 Learning Tasks By the end of this session students are expected to be able to: Define terms related to health system State the vision and mission of the MoHCDGEC List levels of health care in Tanzania List roles of the MoHCDGEC (Ministry of Health, Community Development, Gender, Elderly and Children) in Health care System in Tanzania 2 Definition of Terms Related to Health System Health is a state of complete physical, mental, and social well being, and not merely the absence of disease or infirmity. (WHO) Policy is a law, regulation, procedure or administrative action created by government or non-government institution Health policy is a visionary program of action adopted by the government to have a healthy society, with improved social wellbeing that will contribute effectively to personal and national development. 3 Definitions Cont… Medicines Policy is a written document specifying the medium – to long – term goals set by the government for the pharmaceutical sector, their relative importance, and their main strategies for attaining them. It is a political commitment to a goal and a guide for action. It provides a framework for coordinating activities for pharmaceutical sector. 4 Vision and Mission of Ministry of Health in Health and Medicine system Vision To improve health and wellbeing of all Tanzanian, with a focus on those most at risk, and to encourage the health system to be more responsive to the needs of the people 5 Cont… Mission To facilitate the provision of basic health services that are good, quality, equitable, accessible, affordable, sustainable and gender sensitive 6 Levels of Health Care in Tanzania Community health services Dispensaries: village/ street level Health centres: ward level District hospitals: district level Regional/referral hospitals: regional level (are consultant hospitals) National, Consultant and specialized hospitals: national level 7 Community Health Services It is the responsibility of each individual and/or household to take care of its own health Village Government should recognize and enhance the essential role of communities in directing local health services. The community will have the mandate to choose their own community health worker who will be the main linkage between the community and the nearest health facility. 8 Dispensary Services This is the first formal health unit of level one health services. It is a primary health facility which offers outpatient services including reproductive and child health services, and diagnostic services. A dispensary caters for 5,000 people and oversees all the village health services. Dispensaries shall provide primary health care services to the community. Refer the references to identify the primary health services to be provided at dispensary level 9 Health Center Services This is the second formal health unit of level one-health services. It is a primary health facility, which offers Outpatient and In-patient services, maternity care, laboratory, dispensing and mortuary services. A Health Centre shall cater for 50,000 people and supervise all the dispensaries in the Division. 10 District Hospital Services It is also a level one health services and plays the following roles: Out-patient and In-patient care Act as the second referral level f or the primary health care facilities in the district or catchment’s area Perform general surgical and obstetric operations Conduct teaching, training and research programs in the district concerning community health Give supportive supervision and inspection and provide technical skills to lower health facilities in the district and refers patients to the regional hospital. 11 Regional Hospital Services This is a hospital establishment providing level two (Secondary) referral services from level one hospital This level have the following functions: To provide all services offered at district level but at a higher level of expertise Conduct health research programs in the Region Provide technical skills to lower health facilities in the Region and offer specialized treatment in Medicine, Surgery, Obstetrics and Gynaecology and Paediatric, and shall include Eye, Dental, Mental illnesses, Orthopaedics and Trauma 12 National, Consultant and Specialized Hospital Services This is level three and the highest level of hospital services in the country It acts as referral centre for level two hospitals. 13 National Hospital Muhimbili is the currently national hospital It also acts as Eastern zonal referral hospital 14 Zonal Consultant Hospitals At present there are four zonal referral or consultant hospitals. Muhimbili National Hospital Two voluntary agency hospitals: Bugando Medical Centre and Kilimanjaro Christian Medical Center (KCMC) Mbeya Referal Hospital (owned by the government) 15 Specialized Hospitals There are two specialized hospitals Mirembe Hospital (Dodoma) and Kibongoto ( Moshi ) They provide services to the mentally sick and TB patients respectively 16 Roles of the MoH in Health and Medicine Policy Policy formulation, health legislation, regulation and control Resource mobilization and allocation Management support of level three hospitals including National, Consaltant and Special Hospitals Supervision and Monitoring of special and Consultant Hospitals owned by NGOs Monitoring and evaluation of health services countrywide Activity: Use the given references for extra roles of MoH 17 Key Points Health Policy is important in a country like ours where resources and technology are more limited than in other countries. Medicines Policy is a written document specifying the medium – to long – term goals set by the government for the pharmaceutical sector, their relative importance, and their main strategies for attaining them. MoHCDGEC mission is to facilitate the provision of basic health services that are good, quality, equitable, accessible, affordable, sustainable and gender sensitive 18 Review Questions What is the vision and mission of the MoH of health care in Tanzania? What are the levels of health care in Tanzania. 19 References URT (2007): The National Health Policy , Dar es Salaam, Tanzania. Government Printer URT (2016): Task sharing policy guidelines for health

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06103 Pharmaceutical Production

PST06103 Pharmaceutical Production – Complete Full Notes

NTA Level 6 • Semester 1 • PST06103 Pharmaceutical Production – Complete Full Notes Complete educational source text in one page Completeness safeguard: this page keeps the complete educational module/source wording in one place so learning material is not lost when browsing topic by topic. Presenter/tutor metadata is intentionally excluded. | | UNITED REPUBLIC OF TANZANIA [pic] Ministry of Health, Community Development, Gender, Elderly and Children Facilitator Guide Copyright © Ministry of Health, Community Development, Gender, Elderly and Children – 2019 Table of Contents Background iv Acknowledgment v Introduction vii Abbreviations x Session 1: Introduction to Pharmaceutical Production 1 Session 2: Registration and Regulation of Pharmaceutical Manufacturing in Tanzania 8 Session 3: Environmental Impact Assessment (EIA) 15 Session 4: Standard Operating Procedure (SOP) 25 Session 5: SOP on SOPs (SOP on Standard Operating Procedures) 37 Session 6: Validation of Pharmaceutical Raw Materials 43 Session 7: Dispensing of Pharmaceutical Materials 49 Session 8: Pharmaceutical Powders 55 Session 9: Mixing of Pharmaceutical Powders 65 Session 10: Introduction to Capsules 74 Session 11: Gelatin Capsule Shells 80 Session 12: Formulation of Capsule Content 86 Session 13: Filling Hard Gelatin Capsules 93 Session 14: Soft Gelatin Capsules 101 Session 15: Introduction to Tablets 109 Session 16: Formulation of Tablets 117 Session 17: Granulation 124 Session 18: Compression 133 Session 19: Tablet Coating 141 Session 20: Packaging of Tablets and Capsules 150 Session 21: Quality Assurance nd Quality Control 157 Session 22: In-process Quality Control (IPQC) 173 Session 24: GMP for Pharmaceutical Equipments 187 Session 25: Management of Pharmaceutical Wastes 194 Background There is currently an ever increasing demand for pharmaceutical personnel in Tanzania. This is due to expanding investment in public and private pharmaceutical sector. Shortage of trained pharmaceutical human resource contributes to poor quality of pharmaceutical services and low access to medicines in the country (GIZ, 2012). Through Public-Private-Partnership (PPP) the Pharmacy Council (PC) together with Development Partners (DPs) in Germany and Pharmaceutical Training Institutions (PTIs) worked together to address the shortage of human resource for pharmacy by designing a project named “Supporting Training Institutions for Improved Pharmaceutical Services in Tanzania” in order to improve quality and capacity of PTIs in training, particularly of lower cadre pharmaceutical personnel. The Pharmacy Council formed a Steering committee that conducted a stakeholder’s workshop from18th to 22ndAugust 2014 in Morogoro to initiate the implementation of the project. Key activities in the implementation of this project included carrying out situational analysis, curriculum review and harmonization, development of training manual/facilitators guide, development of assessment plan, training of trainers and supportive supervision. After the curricula were reviewed and harmonized, the process of developing standardized training materials was started in August 2015 through Writer’s Workshop (WW) approach. The approach included two workshops (of two weeks each) for developing draft documents and a one-week workshop for reviewing, editing and formatting the sessions of the modules. The goals of Writers Workshops were to build capacity of tutors in the development of training materials and to develop high-quality, standardized teaching materials. The training package for pharmacy cadres includes a Facilitator Guide, Assessment plan and Practicum. There are 12 modules for NTA level 6 making 12 Facilitator guides and one Practicum guide. Acknowledgment The development of standardized training materials of a competence-based curriculum for pharmaceutical sciences has been accomplished through involvement of different stakeholders. Special thanks go to the Pharmacy Council for spearheading the harmonization of training materials in the pharmacy after noticing that training institutions in Tanzania were using different curricula and train their students differently. I would also like to extend my gratitude to Christian Social Service Commission (CSSC) for their tireless efforts to mobilize funds from development partners (German Ministry of Industry and action medeor). It is through the implementation of the Multi-Actors Partnership (MAP) project, CSSC has been able to provide the financial and technical support needed during the development of this training material. Many thanks go to the Centre for Educational Development in Health Arusha (CEDHA) experts on health material development and training who coordinated the development of these module sessions particularly Ms. Diana H. Gamuya for her commitment in coordinating and facilitating the planning and development to its completion. Particular acknowledgements are sent to Mr. Dickson Mtalitinya and Members from the secretariat of National Council for Technical Education (NACTE) for facilitating and providing their expertise to the success of this work. It will be unfair if I will not recognize the efforts and contributions of all CEDHA supportive staff that made this process a success; accountant, secretary, drivers and printers Finally, I very much appreciate the contributions of the tutors and content experts representing PTIs, hospitals, and other health training institutions. Their participation in meetings and workshops, and their input in the development of this training manual/facilitators guide have been invaluable. These participants are listed with our gratitude below: Ms. Elizabeth Shekalaghe Registrar, Pharmacy Council of Tanzania Dr. Fadhili Lyimo Assistant Director Allied Health, MoHCDGEC Dr. Jacqueline Uriyo Acting Principal, CEDHA Dr. Sungwa N. Kabissi Project Manager – MAP, CSSC Ms. Diana H. Gamuya CEDHA Ms. Grace Mallange PC Ms. Emily Mwakibolwa Pharmacy Council Ms. Tumaini H. Lyombe MUHAS Ms. Dilisi J. Makawia KSP Director of Human Resources Development Ministry of Health, Community Development, Gender, Elderly and Children Introduction Module Overview This module content is a guide for tutors of Pharmaceutical schools for training of students. The session contents are based on sub-enabling outcomes and their related tasks of the curriculum for Basic Technician Course in Pharmaceutical Sciences. The module sub-enabling outcomes and their related tasks are as indicated in the in the Basic Technician Certificate in Pharmaceutical Sciences (NTA Level 6) Curriculum Target Audience This module is intended for use primarily by tutors of pharmaceutical schools. The module’s sessions give guidance on the time, activities and provide information on how to teach the session. The sessions include different activities which focus on increasing students’ knowledge, skills and attitudes. Organization of the Module The module consists of twenty five (25) sessions; each session is divided into several parts

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06102 Counselling and Guidance

PST06102 Counselling and Guidance – Complete Full Notes

NTA Level 6 • Semester 1 • PST06102 Counselling and Guidance – Complete Full Notes Complete educational source text in one page Completeness safeguard: this page keeps the complete educational module/source wording in one place so learning material is not lost when browsing topic by topic. Presenter/tutor metadata is intentionally excluded. COUNSELLING AND GUIDANCE SKILLS Introduction to Counselling and Guidance Complete learning session 1 / 20 Counselling and Guidance Skills Learning outcomes • Define Introduction to Counselling and Guidance. • Explain its main principles and classifications. • Apply the concept safely in pharmaceutical practice. • Recognise common errors and appropriate corrective action. 2 / 20 Counselling and Guidance Skills Why this topic matters • Counselling is a purposeful helping relationship that supports informed choices. • Confidentiality, respect and non-judgment build trust. • Correct understanding supports safe, effective and accountable practice. 3 / 20 Counselling and Guidance Skills Core definition • Introduction to Counselling and Guidance is studied as a structured concept within Counselling and Guidance Skills. • Counselling is a purposeful helping relationship that supports informed choices. • Use precise terms before attempting application or calculation. 4 / 20 Counselling and Guidance Skills Foundational principles • Confidentiality, respect and non-judgment build trust. • Active listening uses attention, reflection, clarification and summarising. • Each principle should be linked to a practical decision. 5 / 20 Counselling and Guidance Skills Key components • Counselling is a purposeful helping relationship that supports informed choices. • Active listening uses attention, reflection, clarification and summarising. • Open questions encourage clients to explore concerns and options. 6 / 20 Counselling and Guidance Skills Classification and organisation • Group the subject by function, structure, source, risk or stage as appropriate. • Use one classification system consistently. • State the feature that separates one category from another. 7 / 20 Counselling and Guidance Skills How the process works • Confidentiality, respect and non-judgment build trust. • Active listening uses attention, reflection, clarification and summarising. • Follow the sequence from input or cause to outcome. 8 / 20 Counselling and Guidance Skills Professional terminology • Distinguish related terms that are often confused. • Use names, units and abbreviations consistently. • Define technical words before using them in explanations. 9 / 20 Counselling and Guidance Skills Practical application • Open questions encourage clients to explore concerns and options. • Prepare the required materials, information or records before starting. • Complete each step in order and document important observations. 10 / 20 Counselling and Guidance Skills Quality requirements • Referral is necessary when needs exceed the counsellor’s competence. • Check identity, accuracy, completeness and fitness for purpose. • Record deviations and take corrective action promptly. 11 / 20 Counselling and Guidance Skills Safety and risk control • Identify hazards before beginning the task. • Use appropriate protective, ethical and legal safeguards. • Stop and refer when the situation exceeds competence or available resources. 12 / 20 Counselling and Guidance Skills Common errors • Using an incorrect definition, unit, category or sequence. • Skipping verification, documentation or a final reasonableness check. • Applying a general rule without considering the patient, material or research context. 13 / 20 Counselling and Guidance Skills Preventing avoidable mistakes • Use a written procedure or checklist. • Independently verify high-risk calculations and decisions. • Communicate unclear or abnormal findings before proceeding. 14 / 20 Counselling and Guidance Skills Worked application • Start with a clearly stated problem related to Introduction to Counselling and Guidance. • Select the correct principle from the earlier slides. • Show the decision or calculation step by step. • Confirm that the final answer is reasonable and professionally usable. 15 / 20 Counselling and Guidance Skills Practice scenario • A routine situation requires the learner to apply Introduction to Counselling and Guidance. • Identify the information that must be collected first. • Explain the safest action and the record that should be completed. 16 / 20 Counselling and Guidance Skills Decision points • What finding confirms that the chosen approach is suitable? • What warning sign requires correction, referral or further investigation? • What evidence must be documented to support the decision? 17 / 20 Counselling and Guidance Skills Connection to patient care • Accurate practice reduces preventable harm. • Clear communication helps patients and colleagues use information correctly. • Monitoring outcomes shows whether the intended benefit was achieved. 18 / 20 Counselling and Guidance Skills Session summary • Counselling is a purposeful helping relationship that supports informed choices. • Confidentiality, respect and non-judgment build trust. • Active listening uses attention, reflection, clarification and summarising. • Open questions encourage clients to explore concerns and options. • Referral is necessary when needs exceed the counsellor’s competence. 19 / 20 Counselling and Guidance Skills Self-check questions • Define Introduction to Counselling and Guidance in your own words. • List three important principles or components. • Describe one practical application and one common error. • Explain one quality or safety control. 20 / 20 PST 06102 : Counselling and Guidance Session 2: Principles of Counselling and Guidance 1 Learning tasks At the end of this session, students are expected to be able to : • Define principles of counseling and guidance • Explain principles of quality counseling • Identify principles of quality guidance • Explain the differences between guidance and counseling 2 Definition of Principles of counselling and guidance Principles are fundamental norms, rules, or values that represent what is desirable and positive for a person, group, organization, or community, which help in determining the rightfulness or wrongfulness of its actions. Principles are more basic than policy and objectives, and are meant to govern both. 3 Activity: Buzzing What are the principles of Quality Counselling 4 The principles of quality counseling The following are the principles of quality counseling Establish and maintain rapport with the client Assess the client's needs and personalize discussions accordingly Work with the client interactively to establish a plan Provide information that can be understood and retained by the client Confirm

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06101 Leadership and Management

PST06101 Leadership and Management – Complete Full Notes

NTA Level 6 • Semester 1 • PST06101 Leadership and Management – Complete Full Notes Complete educational source text in one page Completeness safeguard: this page keeps the complete educational module/source wording in one place so learning material is not lost when browsing topic by topic. Presenter/tutor metadata is intentionally excluded. UNITED REPUBLIC OF TANZANIA Ministry of Health, Community Development, Gender, Elderly and Children PST 06101 Leadership and Management NTA Level 6 Semester 1 Facilitator Guide Table of Contents March 2019 PST 06101 Leadership and Management NTA L 6 Semester 2 Facilitator Guide i Table of Contents Background ……………………………………………………………………………………………….. iii Acknowledgment ………………………………………………………………………………………….v Introduction ………………………………………………………………………………………………. vii Abbreviations/Acronym ………………………………………………………………………………. ix Session 1: Leadership Concept ……………………………………………………………………….1 Session 2: Leadership Theories ………………………………………………………………………9 Session 3: Leadership Attributes in Provision of Pharmaceutical Services …………17 Session 4: Management Concepts …………………………………………………………………22 Session 5: Management Theories ………………………………………………………………….27 Session 6: Management Roles to Pharmaceutical Services ……………………………….32 Session 7: Management Functions…………………………………………………………………37 Session 8: Principles of Management …………………………………………………………….46 Session 9: Planning Concepts ……………………………………………………………………….51 Session 10: Participatory Planning Concept in Provision of Health Care Services ……………………………………………………………………………………………………..57 Session 11: Health Care Team ………………………………………………………………………62 Session 12: The Role of Pharmaceutical Personnel in Health Care Teams …………67 Session 13: Organization ……………………………………………………………………………..72 Session 14: Organizations Structures …………………………………………………………….79 Session 15: System Theory of Organization to the Health System …………………….85 Session 16: Organization Behaviour in Relation to Workplace …………………………92 Session 17: Health Organization Productivity …………………………………………………97 Session 18: Delegation ……………………………………………………………………………….103 Session 19: Supportive Supervision …………………………………………………………….108 Session 20: Supportive Supervision Report…………………………………………………..114 Session 21: Coaching …………………………………………………………………………………120 Session 22: Mentorship Concept …………………………………………………………………125 Session 23: Networking Techniques in Delivery of Health Care Services ………..130 Session 24: Introduction to Negotiations ………………………………………………………134 Session 25: Negotiation Process in Delivery of Health Care Services ………………139 PST 06101 Leadership and Management NTA L 6 Semester 2 Facilitator Guide ii Background There is currently an ever-increasing demand for pharmaceutical personnel in Tanzania. This is due to expanding investment in public and private pharmaceutical sector. Shortage of trained pharmaceutical human resource contributes to poor quality of pharmaceutical services and low access to medicines in the country (GIZ, 2012). Through Public-Private-Partnership (PPP) the Pharmacy Council (PC) together with Development Partners (DPs) in Germany and Pharmaceutical Training Institutions (PTIs) worked together to address the shortage of human resource for pharmacy by designing a project named “Supporting Training Institutions for Improved Pharmaceutical Services in Tanzania‖ in order to improve quality and capacity of PTIs in training. CSSC prepared a Multi-actor Partnership (MAP) project proposal on how to sustain and strengthen health care in Tanzania through improvement of pharmaceutical training and an inter-institutional coordination of actors. This will harmonize and improve access to quality pharmaceutical service in Tanzania. The project has a various key stakeholders like; CSSC, NACTE, PC, TCU, CEDHA and Pharmaceutical Training Institutions (PTIs). Through this project, few PTIs will receive infrastructural improvements to increase the quantitative and qualitative capacities (CUHAS, RUCU and KSP). Furthermore this project will train Pharmaceutical tutors from different PTIs on teaching and assessment methods in Tanzania and thus improved health delivery through increased qualified human resource. It was also observed that in the previous stakeholder‘s meetings there was a need for the development of training manuals and assessment plans for NTA Level 5 & 6, in order to support the establishment and implementation of the curriculum in PTIs. During MAP kick- off workshop done in February 2018, Stakeholders agreed that there was a need for development of the said manuals and it was among the highest priority in Pharmacy education in Tanzania. Therefore this project aims at developing facilitator‘s guide and assessment plans for NTA Level 5 & 6. Pharmacy Council, CSSC and action medeor developed the Terms of Reference and selected a qualified service provider with experience in material development to develop the mentioned training manuals and assessment plan. Centre for Educational Development in Health Arusha (CEDHA) was selected and offered a contract to develop Facilitators guide for NTA level 5 & 6 and assessment plan. Centre for Educational Development in Health Arusha (CEDHA) was offered a leading role with the instructions to include experts who have developed teaching materials for NTA Level 4. These experts are primarily experienced pharmaceutical and non-pharmaceutical tutors. The mode of operation used by CEDHA to develop facilitator‘s guide and assessment plan was participatory approach which included a number of activities through various workshops such as planning, and orientation of material development. After these preliminary PST 06101 Leadership and Management NTA L 6 Semester 2 Facilitator Guide iii workshops, experts developed materials individually and in-groups. Thereafter, developed draft materials were reviewed, edited and formatted and draft one was finalized and shared to stakeholders for inputs. Finally, CEDHA submitted the finalized Facilitator‘s guides and assessment plans for NTA level 5 and 6 to CSSC for endorsement, printing, dissemination and sharing with relevant authorities. There are 12 modules for NTA level 6 making 12 Facilitator guides and one Practicum guide. PST 06101 Leadership and Management NTA L 6 Semester 2 Facilitator Guide iv Acknowledgment The development of standardized training materials of a competence-based curriculum for pharmaceutical sciences has been accomplished through involvement of different stakeholders. Special thanks go to the Pharmacy Council for spearheading the harmonization of training materials in the pharmacy after noticing that training institutions in Tanzania were using different curricula and train their students differently. I would also like to extend my gratitude to Christian Social Service Commission (CSSC) for their tireless efforts to mobilize funds from development partners (German Ministry of Industry and action medeor). It is through the implementation of the Multi-Actors Partnership (MAP) project, CSSC has been able to provide the financial and technical support needed during the development of this training material. Many thanks go to the Centre for Educational Development in Health Arusha (CEDHA) experts on health material development and training who coordinated the development of these module sessions particularly Ms. Diana H. Gamuya for her commitment in coordinating and facilitating the planning and development to its completion. Particular acknowledgements are sent to Mr. Dickson Mtalitinya and Members from the secretariat of National Council for

Pharmaceutical Sciences Notes, PST Level 5 Semester 2, PST NTA Level 5, PST05210 Basic Pharmacognosy

PST05210 Basic Pharmacognosy – Complete Full Notes

NTA Level 5 • Semester 2 • PST05210 Basic Pharmacognosy – Complete Full Notes Complete educational source text in one page Completeness safeguard: this page keeps the complete educational module/source wording in one place so learning material is not lost when browsing topic by topic. Presenter/tutor metadata is intentionally excluded. | | UNITED REPUBLIC OF TANZANIA Ministry of Health, Community Development, Gender, Elderly and Children Facilitator Guide Copyright © Ministry of Health, Community Development, Gender, Elderly and Children – 20 Table of Contents Background iii Acknowledgment iv Introduction vi Abbreviations/Acronym viii Session 1: Introduction to Pharmacognosy 1 Session 2: The Plant Cell 7 Session 3: Plant Tissues 14 Session 4: Plant Tissue Systems 23 Session 5: Morphology of the Roots 28 Session 6: Morphology of Stems 36 Session 7: Morphology of the Leaf 44 Session 8: Morphology of the Flower 52 Session 9: Morphology of the Fruit 58 Session 10: Morphology of the Seed 64 Session 11: Pharmaceutical Barks 69 Session 12: Cultivation of medicinal plants 74 Session 13: Collection, Processing and Storage of Medicinal Plants 83 Session 14: Extraction of Active Medicinal Principals from Natural Sources 90 Session 15: Adulteration of Medicinal Plants 97 Session 16: Introduction to Ergastic Substances 102 Session 17: Gum, Mucilage and Pectins 109 Session 18: Introduction to Alkaloids 115 Session 19: Classification, Uses and Extraction of Alkaloids 120 Session 20: Tropane Alkaloids 127 Session 21: Lobelia and Tobacco 133 Session 22: Quinoline Alkaloids 137 Session 23: Isoquinoline Alkaloids 141 Session 24: Indole and Imidazole Alkaloids 146 Session 25: Purine Alkaloids 153 Session 26: Proto alkaloids 158 Session 27: Introduction of Glycosides 162 Session 28: Cardiac Glycosides 166 Session 29: Anthraquinone Glycosides 172 Session 30: Introduction to Volatile Oils and Resins 177 Session 31: Alcoholic and Hydrocarbon Volatile Oils 183 Session 32: Ketonic and Aldehydic Volatile Oils 188 Session 33: Phenolic ether, Phenolic, Oxide and Ester Volatile Oils 194 Session 34: Introduction to Fixed oils and Fats 200 Session 35: Castor, Olive, Cod-liver and Peanut Oils 205 Session 36: Almond, Linseed, Coconut and Cottonseed Oils 210 Session 37: Fats 215 Session 38: Waxes 219 Background There is currently an ever-increasing demand for pharmaceutical personnel in Tanzania. This is due to expanding investment in public and private pharmaceutical sector. Shortage of trained pharmaceutical human resource contributes to poor quality of pharmaceutical services and low access to medicines in the country (GIZ, 2012). Through Public-Private-Partnership (PPP) the Pharmacy Council (PC) together with Development Partners (DPs) in Germany and Pharmaceutical Training Institutions (PTIs) worked together to address the shortage of human resource for pharmacy by designing a project named “Supporting Training Institutions for Improved Pharmaceutical Services in Tanzania” in order to improve quality and capacity of PTIs in training, particularly of lower cadre pharmaceutical personnel. The Pharmacy Council formed a Steering committee that conducted a stakeholder’s workshop from18th – 22ndAugust 2014 in Morogoro to initiate the implementation of the project. Key activities in the implementation of this project included carrying out situational analysis, curriculum review and harmonization, development of training manual/facilitators guide, development of assessment plan, training of trainers and supportive supervision. After the curricula were reviewed and harmonized, the process of developing standardised training materials started through Writer’s Workshop approach. The approach included a number of workshops for developing, reviewing, editing and formatting the sessions of the modules. The goals of writer’s workshops were to build capacity of tutors in the development of training materials and to develop high-quality, standardized teaching materials. The training package for pharmacy cadres includes a facilitator guide, assessment plan and practicum. There are 11 modules for NTA level 5 making 11 facilitator guides including one practicum guide. Acknowledgment The development of standardized training materials of a competence-based curriculum for pharmaceutical sciences has been accomplished through involvement of different stakeholders. Special thanks go to the Pharmacy Council for spearheading the harmonization of training materials in the pharmacy after noticing that training institutions in Tanzania were using different curricula and train their students differently. I would also like to extend my gratitude to Christian Social Service Commission (CSSC) for their tireless efforts to mobilize funds from development partners (German Ministry of Industry and action medeor). It is through the implementation of the Multi-Actors Partnership (MAP) project, CSSC has been able to provide the financial and technical support needed during the development of this training material. Many thanks go to the Centre for Educational Development in Health Arusha (CEDHA) experts on health material development and training who coordinated the development of these module sessions particularly Ms. Diana H. Gamuya for her commitment in coordinating and facilitating the planning and development to its completion. Particular acknowledgements are sent to Mr. Dickson Mtalitinya and Members from the secretariat of National Council for Technical Education (NACTE) for facilitating and providing their expertise to the success of this work. It will be unfair if I will not recognize the efforts and contributions of all CEDHA supportive staff that made this process a success; accountant, secretary, drivers and printers Finally, I very much appreciate the contributions of the tutors and content experts representing PTIs, hospitals, and other health training institutions. Their participation in meetings and workshops, and their input in the development of this training manual/facilitators guide have been invaluable. These participants are listed with our gratitude below: Ms. Elizabeth Shekalaghe Registrar, Pharmacy Council of Tanzania Health,MoHCDGEC Dr. Catherine Jincen Acting Principal, CEDHA Dr. Sungwa N. Kabissi Project Manager – MAP, CSSC Ms. Diana H. Gamuya CEDHA Ms. Grace Mallange PC Ms. Emily Mwakibolwa Pharmacy Council Ms. Tumaini H. Lyombe MUHAS Ms. Dilisi J. Makawia KSP Director of Human Resources Development Ministry of Health, Community Development, Gender, Elderly and Children Introduction Module Overview This module content is a guide for tutors of Pharmaceutical schools for training of students. The session contents are based on sub-enabling outcomes and their related tasks of the curriculum for Technician Course in Pharmaceutical Sciences. The module sub-enabling outcomes and their related tasks are as indicated in the in the Technician Certificate in Pharmaceutical Sciences

Pharmaceutical Sciences Notes, PST Level 5 Semester 2, PST NTA Level 5, PST05209 Health Information Management

PST05209 Health Information Management – Complete Full Notes

NTA Level 5 • Semester 2 • PST05209 Health Information Management – Complete Full Notes Complete educational source text in one page Completeness safeguard: this page keeps the complete educational module/source wording in one place so learning material is not lost when browsing topic by topic. Presenter/tutor metadata is intentionally excluded. HMIS NOTES B.Boy Session 1: Organization of Health Related Data Using Computer Packages Learning Tasks By the end of this session students are expected to be able to: • Explain concepts of electronic data storage and arrangement • Demonstrate electronic filing and application of security to electronic data • Explain the methods of summarizing data What is Data Storage • Data storage Data storage is the recording (storing) of information (data) in a storage medium. Numerate four (4) storage media i. Handwriting ii. Phonographic recording iii. Magnetic tape iv. Optical discs List four (4) electronic Data storage formats i. Music ii. Video iii. Document iv. Pictures HMIS NOTES B.Boy List five (5) storage devices i. CD ii. DVD iii. Internal Hard disk iv. External Hard disk v. Flash vi. FDD vii. Memory card Numerate Three (3) common type’s data storage i. Hard drive ii. USB flash drive iii. Memory card. Explanation of each type of Storage • Hard drive (HD) o The term "hard drive" is actually short for "hard disk drive." o The term "hard disk" refers to the actual disks inside the drive. o The hard drive is a non-volatile memory hardware device that permanently stores and retrieves data on a computer.  Non-volatile memory is a term used to describe any memory or storage that is saved regardless if the power to the computer is on or off.  The best example of non-volatile memory and storage is a computer hard drive, flash memory, and ROM. HMIS NOTES B.Boy o A hard drive is a secondary storage device that consists of one or more platters to which data is written using a magnetic head, all inside of an air-sealed casing. o A typical hard drive is only slightly larger than a human hand and can hold over 100 GB of data. • USB flash drive o A USB flash drive is a device used for data storage that includes a flash memory and an integrated Universal Serial Bus (USB) interface. o Most USB flash drives are removable and rewritable. o Physically, they are small, durable and reliable. o The larger their storage space, the faster they tend to operate. o USB flash drives are mechanically very robust because there are no moving parts. o They derive the power to operate from the device to which they are connected (typically a computer) via the USB port. o A USB flash drive may also be known as a flash drive or USB drive. • Memory card o A memory card is a type of storage device that is used for storing media and data files. o It provides a permanent and non-volatile medium to store data and files from the attached device. Define the Term Memory Card Memory cards are commonly used in small, portable devices, such as cameras and phones. List five (5) most popular forms of memory cards are: i. Secure Digital (SD) card ii. Compact Flash (CF) card iii. Smart Media iv. Memory Stick v. Multi Media Card (MMC) HMIS NOTES B.Boy In the healthcare system, data are store in the electronic systems, and these systems are called electronic health records (EHR) and electronic medical records (EMR) Define the following Terms • Electronic Health Records o An electronic health record (EHR) is a digital version of a patient’s paper chart. o It contains a patient’s medical history, diagnoses, medications, treatment plans, immunization dates, allergies, radiology images, and laboratory and test results in electronic format. o It is health information that is created and managed by authorized providers in a digital format capable of being shared with other providers across more than one health care organization. • Electronic Medical Records o Electronic medical records (EMRs) are a digital version of the paper charts in the clinician’s office. o EMR contain medical information used by clinicians mostly for diagnosis and treatment.. o An EMR contains the medical and treatment history of the patients in one practice. o Information in EMRs cannot easily be shared out of the medical practice. o The patient’s record can easily be printed out and shared with other members of the care team. HMIS NOTES B.Boy ELECTRONIC FILLING Filling A filing system is a plan or method of arranging documents in a prescribed order. The purpose of filing documents is to enable a quick retrieval of complete information Whenever it is required. Requirements of a good filing system o Simplicity-The filing method must be easy to understand and simple to operate. o Easy access-Documents should be easily identified and located to enable speedy pulling and filing. o Security-Documents should be safely kept and well preserved. o Tracer system-The whereabouts of documents removed from the storage must be known. Methods of Filing in Medical Records There are four common methods of filing patient records used in health facilities o Alphabetical o Chronological o Geographical o Numerical HMIS NOTES B.Boy Explanation of each method Alphabetical Filing System • Alphabetical filing is a very commonly used method for filing in general. • Examples of alphabetical filing system are, Abdallah, followed by Bakari, then Charles. Chronological Filing System Chronological filing means filing in time order. • It is used in combination with another method. • Letters for example are usually filed alphabetically according to name or subject and within each group in date order. Example of chronological filing system is, those patients who are expected to be admitted on 14th February 2010, Abdallah/14, Bakari/14, Charles/14. The 14 is a filing position in filing waiting list. • The waiting list is having filing position from 1 up to 31 according to dates. Geographical Filing System Geographical filing is based on geographical units like countries, regions, and town.

Pharmaceutical Sciences Notes, PST Level 5 Semester 2, PST NTA Level 5, PST05208 Pharmaceutics Theory and Compounding

PST05208 Pharmaceutics Theory and Compounding – Complete Full Notes

NTA Level 5 • Semester 2 • PST05208 Pharmaceutics Theory and Compounding – Complete Full Notes Complete educational source text in one page Completeness safeguard: this page keeps the complete educational module/source wording in one place so learning material is not lost when browsing topic by topic. Presenter/tutor metadata is intentionally excluded. UNITED REPUBLIC OF TANZANIA Ministry of Health, Community Development, Gender, Elderly and Children PST 05208 Pharmaceutics Theory and Compounding NTA Level 5 Semester 2 Facilitator Guide March 2019 Copyright © Ministry of Health, Community Development, Gender, Elderly and Children – 2019 PST 05208 Pharmaceutics Theory & Compounding NTA Level 5 Semester 2 Facilitator Guide ii Table of Contents Background …………………………………………………………………………………………………………………… iv Abbreviations/Acronym …………………………………………………………………………………………………. xii Session 1: Introduction to Sterile Pharmaceutical Preparations …………………………………………….. 1 Session 2: Aseptic Processing…………………………………………………………………………………………… 8 Session 3: Requirements for Preparation of Sterile Pharmaceutical Products ……………………….. 13 Session 4: Percutaneous Absorption ………………………………………………………………………………… 19 Session 5: Semi Solid Preparations………………………………………………………………………………….. 27 Session 6: Reference and Formula in Pharmaceutical production………………………………………… 34 Session 7: Compounding of Ointments ……………………………………………………………………………. 47 Session 8 Compounding of Pastes …………………………………………………………………………………… 57 Session 10: Compounding of Gels/ Jellies………………………………………………………………………… 74 Session 11: Introduction to Isotonicity …………………………………………………………………………….. 84 Session 12: Determination of Isotonicity by Freezing Point Method ……………………………………. 92 Session 13: Determination of Isotonicity by Sodium Chloride Equivalent Method ……………….. 98 Session 14: Determination of Isotonicity by Molecular Concentration Method …………………… 104 Session 15: Calculations Involving Milliequivalent …………………………………………………………. 108 Session 16: Calculations Involving Millimoles ……………………………………………………………….. 115 Session 17: Calculations Involving Milliosmoles (mOsmol) …………………………………………….. 120 Session 18: Calculations Involving Osmolarity……………………………………………………………….. 125 Session 19: Calculations Involving Constituted Solutions ………………………………………………… 131 Session 20: Calculations Involving Intravenous Admixture ……………………………………………… 140 Session 21: Calculations Involving Rate of Flow of Intravenous Fluid ………………………………. 145 Session 22: Calculations Involving Buffer Solutions ……………………………………………………….. 150 Session 23: Preservation of Pharmaceutical Product ………………………………………………………… 157 PST 05208 Pharmaceutics Theory & Compounding NTA Level 5 Semester 2 Facilitator Guide iii Background There is currently an ever-increasing demand for pharmaceutical personnel in Tanzania. This is due to expanding investment in public and private pharmaceutical sector. Shortage of trained pharmaceutical human resource contributes to poor quality of pharmaceutical services and low access to medicines in the country (GIZ, 2012). Through Public-Private-Partnership (PPP) the Pharmacy Council (PC) together with Development Partners (DPs) in Germany and Pharmaceutical Training Institutions (PTIs) worked together to address the shortage of human resource for pharmacy by designing a project named “Supporting Training Institutions for Improved Pharmaceutical Services in Tanzania” in order to improve quality and capacity of PTIs in training. CSSC prepared a Multi-actor Partnership (MAP) project proposal on how to sustain and strengthen health care in Tanzania through improvement of pharmaceutical training and an inter-institutional coordination of actors. This will harmonize and improve access to quality pharmaceutical service in Tanzania. The project has a various key stakeholders like; CSSC, NACTE, PC, TCU, CEDHA and Pharmaceutical Training Institutions (PTIs). Through this project, few PTIs will receive infrastructural improvements to increase the quantitative and qualitative capacities (CUHAS, RUCU and KSP). Furthermore this project will train Pharmaceutical tutors from different PTIs on teaching and assessment methods in Tanzania and thus improved health delivery through increased qualified human resource. It was also observed that in the previous stakeholder‟s meetings there was a need for the development of training manuals and assessment plans for NTA Level 5 & 6, in order to support the establishment and implementation of the curriculum in PTIs. During MAP kick- off workshop done in February 2018, Stakeholders agreed that there was a need for development of the said manuals and it was among the highest priority in Pharmacy education in Tanzania. Therefore this project aims at developing facilitator‟s guide and assessment plans for NTA Level 5 & 6. Pharmacy Council, CSSC and action medeor developed the Terms of Reference and selected a qualified service provider with experience in material development to develop the mentioned training manuals and assessment plan. Centre for Educational Development in Health Arusha (CEDHA) was selected and offered a contract to develop Facilitators guide for NTA level 5 & 6 and assessment plan. Centre for Educational Development in Health Arusha (CEDHA) was offered a leading role with the instructions to include experts who have developed teaching materials for NTA Level 4. These experts are primarily experienced pharmaceutical and non-pharmaceutical tutors. The mode of operation used by CEDHA to develop facilitators guide and assessment plan was participatory approach which included a number of activities through various workshops PST 05208 Pharmaceutics Theory & Compounding NTA Level 5 Semester 2 Facilitator Guide iv such as planning, and orientation of material development. After these preliminary workshops, experts developed materials individually and in-groups. Thereafter, developed draft materials were reviewed, edited and formatted and draft one was finalized and shared to stakeholders for inputs. Finally, CEDHA submitted the finalized Facilitator‟s guides and assessment plans for NTA level 5 and 6 to CSSC for endorsement, printing, dissemination and sharing with relevant authorities. There are 11 modules for NTA level 5 making 11 facilitator guides including one practicum guide. PST 05208 Pharmaceutics Theory & Compounding NTA Level 5 Semester 2 Facilitator Guide v PST 05208 Pharmaceutics Theory & Compounding NTA Level 5 Semester 2 Facilitator Guide vi Acknowledgment The development of standardized training materials of a competence-based curriculum for pharmaceutical sciences has been accomplished through involvement of different stakeholders. Special thanks go to the Pharmacy Council for spearheading the harmonization of training materials in the pharmacy after noticing that training institutions in Tanzania were using different curricula and train their students differently. I would also like to extend my gratitude to Christian Social Service Commission (CSSC) for their tireless efforts to mobilize funds from development partners (German Ministry of Industry and action medeor). It is through the implementation of the Multi-Actors Partnership (MAP) project, CSSC has been able to provide the financial and technical support needed during the development of this training material. Many thanks go to the Centre for Educational Development in Health Arusha (CEDHA) experts on health material development and training who coordinated the development of these module sessions

Pharmaceutical Sciences Notes, PST Level 5 Semester 2, PST NTA Level 5, PST05207 Quality Assurance of Pharmaceutical Products

PST05207 Quality Assurance of Pharmaceutical Products – Complete Full Notes

NTA Level 5 • Semester 2 • PST05207 Quality Assurance of Pharmaceutical Products – Complete Full Notes Complete educational source text in one page Completeness safeguard: this page keeps the complete educational module/source wording in one place so learning material is not lost when browsing topic by topic. Presenter/tutor metadata is intentionally excluded. UNITED REPUBLIC OF TANZANIA Ministry of Health, Community Development, Gender, Elderly and Children PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 Facilitator Guide March 2019 Copyright © Ministry of Health, Community Development, Gender, Elderly and Children – 2019 Table of Contents Background ………………………………………………………………………………………………………………. iv Introduction ……………………………………………………………………………………………………………..viii Abbreviations/Acronyms …………………………………………………………………………………………….. x Session 1: Introduction to Good Manufacturing Practices: ………………………………………………. 1 Session 2: Components of GMP …………………………………………………………………………………… 7 Session 3: GMP -Personnel requirements……………………………………………………………………. 13 Session 4: GMP Requirements on Raw Materials …………………………………………………………. 20 Session 5: GMP Documentations Requirements …………………………………………………………… 31 Session 6: GMP Equipments Requirements …………………………………………………………………. 38 Session 7: Quality Control and Assurance in Relation to Preparation of Pharmaceutical Products…………………………………………………………………………………………………………………… 45 Session 8: The Operating Principles of Equipments and Machines …………………………………. 56 Session 9: Standard Operating Procedures for Equipments and Machines ……………………….. 67 Session 10: Preventive Maintenance Procedures for Equipments and Machines……………….. 72 Session 11: Procedures for Quality Testing of Pharmaceutical Products ………………………….. 79 iii PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 Background There is currently an ever-increasing demand for pharmaceutical personnel in Tanzania. This is due to expanding investment in public and private pharmaceutical sector. Shortage of trained pharmaceutical human resource contributes to poor quality of pharmaceutical services and low access to medicines in the country (GIZ, 2012). Through Public-Private-Partnership (PPP) the Pharmacy Council (PC) together with Development Partners (DPs) in Germany and Pharmaceutical Training Institutions (PTIs) worked together to address the shortage of human resource for pharmacy by designing a project named “Supporting Training Institutions for Improved Pharmaceutical Services in Tanzania” in order to improve quality and capacity of PTIs in training. CSSC prepared a Multi-actor Partnership (MAP) project proposal on how to sustain and strengthen health care in Tanzania through improvement of pharmaceutical training and an inter-institutional coordination of actors. This will harmonize and improve access to quality pharmaceutical service in Tanzania. The project has a various key stakeholders like; CSSC, NACTE, PC, TCU, CEDHA and Pharmaceutical Training Institutions (PTIs). Through this project, few PTIs will receive infrastructural improvements to increase the quantitative and qualitative capacities (CUHAS, RUCU and KSP). Furthermore this project will train Pharmaceutical tutors from different PTIs on teaching and assessment methods in Tanzania and thus improved health delivery through increased qualified human resource. It was also observed that in the previous stakeholder‟s meetings there was a need for the development of training manuals and assessment plans for NTA Level 5 & 6, in order to support the establishment and implementation of the curriculum in PTIs. During MAP kick- off workshop done in February 2018, Stakeholders agreed that there was a need for development of the said manuals and it was among the highest priority in Pharmacy education in Tanzania. Therefore this project aims at developing facilitator‟s guide and assessment plans for NTA Level 5 & 6. Pharmacy Council, CSSC and action medeor developed the Terms of Reference and selected a qualified service provider with experience in material development to develop the mentioned training manuals and assessment plan. Centre for Educational Development in Health Arusha (CEDHA) was selected and offered a contract to develop Facilitators guide for NTA level 5 & 6 and assessment plan. Centre for Educational Development in Health Arusha (CEDHA) was offered a leading role with the instructions to include experts who have developed teaching materials for NTA Level 4. These experts are primarily experienced pharmaceutical and non-pharmaceutical tutors. The mode of operation used by CEDHA to develop facilitators guide and assessment plan was participatory approach which included a number of activities through various workshops such as planning, and orientation of material development. After these preliminary workshops, experts developed materials individually and in-groups. Thereafter, developed iv PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 draft materials were reviewed, edited and formatted and draft one was finalized and shared to stakeholders for inputs. Finally, CEDHA submitted the finalized Facilitator‟s guides and assessment plans for NTA level 5 and 6 to CSSC for endorsement, printing, dissemination and sharing with relevant authorities. There are 11 modules for NTA level 5 making 11 facilitator guides including one practicum guide. v PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 Acknowledgment The development of standardized training materials of a competence-based curriculum for pharmaceutical sciences has been accomplished through involvement of different stakeholders. Special thanks go to the Pharmacy Council for spearheading the harmonization of training materials in the pharmacy after noticing that training institutions in Tanzania were using different curricula and train their students differently. I would also like to extend my gratitude to Christian Social Service Commission (CSSC) for their tireless efforts to mobilize funds from development partners (German Ministry of Industry and action medeor). It is through the implementation of the Multi-Actors Partnership (MAP) project, CSSC has been able to provide the financial and technical support needed during the development of this training material. Many thanks go to the Centre for Educational Development in Health Arusha (CEDHA) experts on health material development and training who coordinated the development of these module sessions particularly Ms. Diana H. Gamuya for her commitment in coordinating and facilitating the planning and development to its completion. Particular acknowledgements are sent to Mr. Dickson Mtalitinya and Members from the secretariat of National Council for Technical Education (NACTE) for facilitating and providing their expertise to the success of this work. It will be unfair if I will not recognize the efforts and contributions of all CEDHA supportive staff that made this process a success; accountant, secretary, drivers and printers Finally, I very much appreciate the contributions of the tutors and content experts representing PTIs, hospitals, and other health training institutions. Their participation in meetings

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