University:
Boston University
Course:
SAR HP 151 | Introduction to Health Professions
Academic year:

2020
Views:

98

Pages:

18
Author:

uprostid41h

Why is Medicine Quality Important? Objectives of Seminar: Part 1 • Medicines play an important role in maintaining and/ or improving the health and well-being of individuals and populations • To work effectively, they must exhibit three fundamental characteristics: quality, efficacy, & safety • A medicine’s quality can be evaluated through the following characteristics: Identity; Purity; Strength; Performance; Packaging; Labeling Objectives of Seminar: Part 2 • Key concepts & definitions related to ensuring the quality of medicines • Introduction to medicines quality standards • Estimated prevalence of poor quality medicines worldwide • Negative impact of utilizing poor quality medicines • Activities implemented by Promoting the Quality of Medicines (PQM) program Key Medicine Quality Terms • Quality Assurance (QA) encompasses quality control and more. It is the sum of all activities, individually or collectively, intended to ensure that pharmaceutical products meet all applicable quality standards. • Quality Control (QC) is the process of ensuring that all materials utilized to manufacture a pharmaceutical product conform to established manufacturer or pharmacopeial specifications for identity, strength, purity, and other characteristics. Prevalence of Poor Quality Medicines • Availability of poor quality medicines is a vast and underreported problem – Estimated up to 25% of medicines in developing countries are substandard or counterfeit • Obtaining precise estimates is difficult due to several limiting factors – weak or absent regulatory/legal oversight – lack of adequate and/or standardized detection and reporting methodologies – counterfeiting is clandestine in nature – poor dissemination of info/lack of education on medicine quality (more focus on access) Tales from the Field: Oddar Meanchey, Province, Cambodia My colleagues: hmmm rush hour here is a bit different But it may be better than this! HCMC, Vietnam Consequences of Poor Quality Medicine Use • Increased morbidity & mortality via treatment failure and adverse drug events (ADE) – 2008 Baxter recalled heparin from the US market due to a contaminant. • Development of antimicrobial resistance – Fake artesunate, joint investigation with INTERPOL and SE Asia medicine regulatory authorities • Waste of financial resources • Erode the public’s trust in national and regional health systems USP Global Sites Current Global Reality There is no shortage of medicines … BUT, there is a shortage of quality-assured medicines Quality Standards – Cannot talk about quality without the concept of standards – Cannot talk about standards without the authority to enforce them PQM Program Objectives Build capacity and strengthen QA systems - Strengthen medicines quality control labs - Establish Medicines Quality Monitoring programs Help increase supply of QA medicines - Improve manufacturers’ GMP compliance - Support WHO Prequalification Programme Promoting the Quality of Medicines Combat counterfeit and substandard medicines - Collaborate with IMPACT, INTERPOL, RAS & other initiatives - Raise awareness w/PSAs, communication campaigns Provide technical leadership - Advocate globally about importance of medicines quality - Promote new counterfeit/substandard detection technologies PQM Countries (as of 2015) Africa } Angola, Benin, Burkina Faso, Burundi, Ethiopia, Ghana, Guinea, Kenya, Liberia, Mozambique, Nigeria, Senegal, Zimbabwe Asia } Bangladesh, Burma, Cambodia, China, India, Indonesia, Laos, Nepal, Pakistan, Philippines, South Korea, Thailand, Vietnam Latin America and Caribbean } Brazil, Colombia, Ecuador, Guatemala, Guyana, Peru, Suriname Europe/Eurasia } Kazakhstan, Ukraine, Uzbekistan Monitoring Medicines Quality Quality failures of medicines -Physical/Visual inspection -Verification and Confirmatory testing Lack of registration – – Leakage (donated medicines being sold on black market) Deficiencies in procurement practices and supply chain Minilab Training: Philippines Good Laboratory Practice Training: Philippines FDA Raising Awareness: Public Service Annoucements and Artwork in Cambodia