Quality Assurance in Procurement of Medicines and Medical – PST05101 Medicines and Medical Supplies Management
NTA Level 5 • Semester 1 • PST05101 Quality Assurance in Procurement of Medicines and Medical Medicines and Medical Supplies Management • 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: Quality Assurance in Procurement of Medicines and Medical Supplies Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • List sources of medicines and medical supplies for procurement • Explain the quality assurance in procurement of medicines and medical supplies Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 | |Presentation |Sources of Medicines and Medical | | |35 minutes |Buzzing |Supplies for Procurement | |3 | |Presentation |Quality Assurance in Procurement of | | |40 minutes |Small Group |Medicines and Medical Supplies | | | |Discussion | | |4 |20 minutes |Presentation |Critical Elements in Quality Assurance | | | |Buzzing |for Pharmaceutical Procurement | |5 |10 minutes |Presentation |Key Points | |6 |10 minutes |Presentation |Evaluation | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing. STEP 2: Sources of Medicines And Medical Supplies For Procurement (35 minutes) |Activity: Buzzing (5minutes) | | | |ASK students to pair up and buzz on the following question for 3 | |minutes | | | |What are the Sources of medicines and medical supplies for procurement?| | | |ALLOW few pairs to respond on the question and let other pairs add on | |points not mentioned WRITE their response on the flip chart/board | | | |CLARIFY and SUMMARIZE by using the content below | The following are the Sources of medicines and medical supplies for procurement: They could be primary or secondary sources: • Primary sources o Manufacturers o Industries • Secondary sources o Distributors o Agencies o Others eg individuals or private pharmacy These are examples of common Sources of medicines and medical supplies for procurement; • Medical Stores Department (MSD) • Private pharmacies • Donors (Non Governmental Organization-NGOs) ie Bilateral Aid programs eg. DANIDA,USAID, JICA • United Nation Organizations (United Nations International Children’s Emergency Fund-UNICEF, UNDP) • World Health Organization (WHO) • At the global level, United Nations agencies such as UNICEF, United Nations Population Fund, and United Nations Development Programme have long functioned as pooled procurement systems serving their country programs • In recent years, a number of new global procurement mechanisms have emerged, such as the Stop TB Global Drug Facility, the U.S. President’s Plan for Emergency AIDS Relief (PEPFAR)–funded Supply Chain Management System (SCMS), and the Global Fund to Fight AIDS, Tuberculosis and Malaria’s voluntary pooled procurement system STEP 3: Quality Assurance in Procurement of Medicines and Medical Supplies (40 minutes) |Activity: Small Group Discussion ( 15 minutes) | | | |DIVIDE students into manageable groups | | | |ASK students to discuss in groups on the following question: | | | |What is quality assurance in procurement of medicines and medical | |supplies? | | | |ALLOW students to discuss for 15 minutes | | | |ALLOW each groups to present | | | |CLARIFY and SUMMARIZE by using the contents below | Quality assurance in procurement of medicines and medical supplies: • The purpose of quality assurance in pharmaceutical supply systems is to help ensure that each medicine procured and that reach a patient is safe, effective, and of acceptable quality. • A comprehensive quality assurance program includes both technical and managerial activities, spanning the entire supply process from pharmaceutical selection to patient use. • For the purposes of primary health care, the most important characteristics of a pharmaceutical product are identity, purity, strength, potency, uniformity of dosage form, bioavailability, and stability. • Pharmaceutical quality is affected by starting materials, manufacturing process, packaging, transportation and storage conditions, and other factors; these influences may be cumulative. • If a pharmaceutical product does not meet established quality standards, passes its expiration date, or has been degraded by storage conditions, the possible consequences are; o Lack of therapeutic effect, leading to prolonged illness or death o Toxic and adverse reactions o Waste of limited financial resources o Loss of credibility of the health care delivery system • A comprehensive quality assurance program must ensure the following; o Pharmaceuticals selected have been shown to be safe and efficacious for their intended use, are presented in an appropriate dosage form, and have the longest possible shelf life o Suppliers with acceptable quality standards are selected o Pharmaceuticals received from commercial suppliers and donors meet specified quality standards at the time of delivery o Packaging meets contract and usage requirements o Repackaging activities and dispensing practices maintain quality o Storage and transportation conditions do not compromise product quality o Product quality concerns reported by prescribers, dispensers, and consumers are properly cataloged and addressed o Product recall procedures are implemented to remove defective products STEP 4: Critical Elements in Quality Assurance for Pharmaceutical Procurement (20 minutes) |Activity: Small Group Discussion ( 15 minutes) | | | |DIVIDE students into manageable groups | | | |ASK students to discuss in groups on the following question: | | | |What are the critical elements for quality assurance for pharmaceutical| |procurement? | | | |ALLOW students to discuss for 15 minutes | | | |ALLOW each groups to present | | | |CLARIFY and SUMMARIZE by using the contents below | • Product selection: products with longer shelf life (for example, powders for reconstitution rather than oral suspensions), avoidance of products with bioavailability problems, when possible • Product certification: supplier prequalification, recent GMP inspection reports from national drug authorities, formal supplier-monitoring system,