W-DRUG: Substandard propofol supplied by UNIMED in Zambia (16)
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Response to [e-drug] Substandard propofol supplied by UNIMED in Zambia Originally posted by Rafaella Ravinetto on Thu, 16 Aug 2018
Dear e-drug colleagues and friends,
The case of substandard propofol in Zambia once again brings to light some of the many challenges related to ensuring the quality of medicines in LMICs.
Given that five different propofol products are already registered in Zambia, it is unclear why the MOH decided to procure a nonregistered product; and particularly did so without seeking a waiver from ZAMRA. Countries should only import medicines that have been approved or granted a temporary waiver by their national regulatory authority (NRA). Parallel medicines procurement and distribution mechanisms that sidestep this vetting and approval process are a major risk to medicines quality and prevent NRAs from fully carrying out their mandates.
Thankfully, Zambia's MOH has indicated that it is now applying for waivers from ZAMRA to import unregistered medicines. The vetting of waivers should follow a thorough process that involves risk-benefit analysis and approvals should only be granted for a limited period of time. If ZAMRA's waiver process had included enough safeguards, it would have likely prevented importation of the substandard propofol. But, such safeguards require close coordination between the registration and post-marketing surveillance units.
As some of our e-drug colleagues have pointed out, proactive post-marketing surveillance could also have been successful in identifying the substandard propofol. However, we know that it is not feasible for regulatory authorities to monitor the quality of every product on the market, especially in resource-constrained settings. A risk-based approach to post-marketing surveillance is an important solution to this challenge because it allows countries to focus efforts on the medicines, locations, and drug samples that present the greatest health risks, thereby optimizing limited human and financial resources while still protecting the public. Such approaches are not new and have been applied to different aspects of sampling and testing, but few countries have institutionalized robust post-marketing surveillance programs.
Several critical risk factors would have raised red flags in Zambia. Namely, the propofol product in question was unregistered; it was procured from an unknown supplier (UNIMED) and an unknown manufacturer (Kwality Pharmaceuticals); and was formulated as an injectable instead of a safer oral dosage form. A risk-based approach would have thus designated this product as high-risk and would have led to a high level of regulatory scrutiny.
The PQM program recently published a guidance document for regulatory authorities in LMICs that are attempting to address these issues and strengthen their post-marketing surveillance programs. The document can be viewed and downloaded here:
http://www.usp-pqm.org/sites/default/files/pqms/article/risk-based-post-marketing-surveillance-feb-2018.pdf
Our colleague, Paul Nkansah, will also be presenting the topic of risk-based post-marketing surveillance at the Medicines Public Health Conference in Oxford on Tuesday, September 25 from 14:00 to 15:30 as part of a session entitled "Optimizing survey techniques and data sharing."
The authors of this note-Mustapha Hajjou, PhD and Aubrey Clark, MPH-wish to thank the e-drug moderators for facilitating such a fruitful discussion on this important topic.
Paul Crystal
Program Communications Manager, Promoting the Quality of Medicines program
U.S. Pharmacopeia | Rockville, MD
paul.crystal@usp.org