Course Materials

Materials for each session are listed below in chronological order and can be previewed and downloaded in advance of the meeting date and time.

Monday July 10

Medicine Quality-Definitions and Public Health Impact Parts I and II  – P. Newton

Pharmaceutical Supply Chains in Low and Middle-Income Countries – R. Ravinetto

Readings:

• Substandard medicines in resource-poor settings: a problem that can no longer be ignored
• Do changes to supply chains and procurement processes yield cost savings and improve availability of pharmaceuticals, vaccines or health products? A Systematic Review

GMP, MQAS for Procurement Agencies and Prequalification – R. Ravinetto

Readings:

• Impact of poor-quality medicines in the ‘developing’ world
• Fighting poor-quality medicines in LMICs: the importance of advocacy and pedagogy
• Norms and Standards: 70 years of WHO standards on medicines quality
• Access to Quality Medicines in Developing Countries: A Selection of Literature

Epidemiology and Sampling with Group Exercise – C. Caillet

Tuesday July 11

Medicine Regulations in LMICs: Parts I and II – S. Phanouyoung

Useful Links:

• Pharamacide: Mekong documentary film (full)
• Pharmacide: Mekong documentary film (1/3)
• Pharmacide: Mekong documentary film (2/3)
• Pharmacide: Mekong documentary film (3/3)

Protecting the U.S. Drug Supply Chain – S. Vaswani Chatterjee

Useful Links:

• Recalls, Withdrawals, Safety Alerts
• Medwatch
• Drug Shortages
• Office of Drug Security, Integrity, and Response Warning Letters
• FDA Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs

Quality of Medicines: An Ethical Issue? – R. Ravinetto

Readings:

• The quality of medicines: an ethical issue?
• Ethical challenges in designing and conducting medicine quality surveys
• International Ethical Guidelines for Health-related Research Involving Humans

Group Exercise – R. Ravinetto

Substandard and Falsified Medical Products– M. Deats

Wednesday July 12

Group Exercise (MQAS) led by R. Ravinetto

Readings:

• Model quality assurance system for procurement agencies
• Quality assurance of medicines supplied to LMICs: poor products in shiny boxes?

Promoting the Quality of Medicines – J. Nwokike

Readings:

• Medicines Quality Database: A Free Public Resource
• Survey of the Quality of Medicines Identified by the United Nations Commission on Life Saving Commodities for Women and Children
• Johnston and David Holt Article: Substandard drugs: a potential crisis for public health
• Comparative Analysis of Pharmacovigilance Systems in Five Asian Countries 

Medical Devices and Vaccines – R. Ravinetto

Readings:

• Rapid Diagnostic Tests for Neglected Infectious Diseases: A Case Study
• WHO Global Model for Regulatory Framework MDs IVDs
• WHO Global Model for Regulatory Framework for Medical Devices

Field Screening of Medicines – M. Lieberman

High Performance Liquid Chromatography (HPLC) – M. Lieberman

Thursday July 13

Group Exercise: Epidemiology and Sampling – C. Caillet

Readings:

• Fake artesunate in southeast Asia
• The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives
• The Quality of Medicines in Community Pharmacies in Riyadh, Saudi Arabia: A Lot Quality Assurance Sampling (LQAS)-Based Survey

Review of the Different Technologies and Devices – S. Zambrzycki and C. Caillet

Chemical Analysis: Mass Spectrometry and Forensic Techniques – D. Gaul

Internet Pharmacies & Medicine Quality- T. Muntinga

Friday July 14

Robust Technology Development for Drug Quality Testing: Lessons from the lab, boardrooms and field – M. Zaman and D. Desai

Counterfeit Medicines: A North American Perspective – B. Donnelly

Medicines for NCDs – R. Laing and V. Wirtz

Continued Reading

Bostonia recently published an article on the topic of substandard drugs and describes work that Muhammad Zaman, Veronika Wirtz and Paul Newton have done exploring and addressing this topic.