Raffaella’s Literature Update
Ref: Qaiser M, Hilton T, Saeed Bukhari SK, Zloh M, Phanouvong S. How a tragedy became a catalyst for sustainable improvement in medicine safety. Lancet Glob Health. 2024 Mar;12(3):e376-e377.
Dear Friends,
on …18 July 2012 (!) I shared a short article from the Lancet, “Pakistan’s deadly cocktail of substandard drugs”, analyzing the possible causes of an incident reported by WHO: in Lahore, 107 patients had died and more than 450 suffered from serious adverse reactions, because they received an antianginal medicine (isosorbide mononitrate) which erroneously contained pyrimethamine in quantities large enough to cause substantial overdose.
Now, in 2024, I am sharing a short Lancet Global Health correspondence, where Qaiser and colleagues share an example of a “build back better” initiative that led to improvements in the pharmaceutical industry standards in Pakistan, starting from the 2012 incident. First, they describe how a causal link was established between life-threatening or fatal bicytopaenia and one batch of isosorbide-5-mononitrate (brand name Isotab) heavily contaminated with pyrimethamine. Second, they describe the short-and middle-term actions, including the national recall of the concerned Isotab batch, and a WHO gap analysis which highlighted (a) the need for the Drug Regulatory Authority to be reformed centrally, and (b) that many provincial quality control laboratories were not meeting prequalification requirements. Third, they describe the partnership with a UK-based NGO to strengthen the quality control laboratories, and with the US Pharmacopeia’s Promoting the Quality of Medicines (PQM) programme to build a sustainable regulatory, quality assurance, and quality control system for the Drug Regulatory Authority of Pakistan – which in the future will hopefully lead the Authority to reach a Maturity Level 3 or 4. .
Fatal incidents with poor quality medicines should be prevented, but this experience shows that if they happen, they should trigger a set of coordinated corrective actions, to prevent similar incidents in the future. Have a nice reading,
Raffaella