detecting and removing poor quality medicines that harm the most vulnerable patients and damage public health

Medicrime Alert Africa Project

Medicrime Alert Africa

Medicrime Alert International and its lead partner at the University of Notre Dame will pioneer a new approach in the fight against the proliferation of bad quality medicines.  The developing world suffers from ineffective national regulatory bodies, the lack of cohesive auditing strategies, absent policies, corruptible institutions, and high rates of illiteracy.  These factors create an atmosphere of carte blanche that contributes to the proliferation of medicrime Current solutions include creation of new supply chains (e.g., PEPFAR and the WHO pre-qual program), but the proliferation of controlled supply chains does not address the large volume of medicine sold outside that system and itself creates inefficiencies and opportunities for corruption.  Our goal is to set into place a global system that can quickly detect and remove poor quality medicines that harm the most vulnerable patients and damage public health.  The key elements of the project are:

  1. Field screening of all essential medications and medical devices at the market level, 
  2. Dissemination of information to help countries, companies, and consumers choose good quality medical products at every step of the supply chain, and 
  3. Development of national and international legal standards and regulatory capacity to discourage and punish medicrime.  

Scale/Scope

The project will access expertise from several disciplines, including but not limited to statistics, policy and regulation, regulatory affairs, quality assurance, good manufacturing practice, and quality control. It will also involve data collection from various destinations within and outside Africa, strategically identified as countries of origin, transit, or destination. Also, countries noticeably taking compliance steps will be visited to investigate the efficacy of the steps taken. All this will be undertaken using Ghana and Nigeria, two of he biggest economies in Africa and also two of the hotspots for medicrime on the continent as pilot nations.

Specific Aim

The objective of this project is to develop cohesive strategies for continent to continent starting with Africa to combat medicrime.  The study will embrace effective practices from other regions while recognizing that this public health threat cannot be combated with a one-size-fits-all approach. Furthermore, a proposal will be made to the African Union (AU) for perpetuators of the crime to be prosecuted as with any major criminal activity instead the issuance of derisory fines which serve as no deterrent whatsoever considering the profit margins of the trade.

The specific aims/objectives of the project are:

  • Train health care workers, pharmacists, business people, educators, civil society activists and journalists to recognize problems that can be caused by poor quality medical products.  Develop active and passive reporting systems using the cell phone system and social media and educational activities and materials.
  • Conduct systematic post-market screening of the 343 WHO essential drugs in every LMIC.  New technologies developed specifically for use in low-resource settings will be implemented to make this large scale screening possible.
  • Develop capacity for confirmatory analysis, including regional pharmaceutical analysis centres which offer masters-level training programs for analytical technicians and instrument maintenance and repair technicians, and support for academic researchers and advanced research facilities in analytical chemistry.  
  • Understand pharmaceutical supply chains, from manufacture to marketplace.  We want to develop tools and metrics that will enable countries and international organizations to track the flows of medicine and money.   
  • Develop guidelines and guidance for creating an effective regulatory and legislative policy based on best practices.  For example, many countries lack criminal statutes for prosecuting types of medicrime.  
  • Develop a model framework for better cooperation between health authorities, regulatory agencies, and police at all levels
  • Raise awareness through positive communication avoiding scaring people.
  • Discourage the public from purchasing medicines via illegal distribution channels
  • Train healthcare professionals to communicate the counterfeit medicines risk to patients
  • Consider counterfeit and substandard medicines in the supply chain systems to survey medicines’ safety on the market
  • Enable the traceability of a medicine to patient level