Who queries lethal drugs
Some drugs which are administered in public hospitals are ending up doing the exact opposite of their functions, thus killing patients instead of relieving their pain and curing them, Malawi News has learnt.
Ideally drugs in hospital pharmacies are supposed to pass laboratory tests of the Pharmacy, Medicines and Poisons Board (PMPB), but strangely those that fail the tests allegedly end up in pharmacies under questionable circumstances.
Some officials of Mzimba and Chitipa District hospitals have confided in this paper that one of such drugs is Chloramphenicol Sodium PPR injection, which they suspect to have contributed to the death of some patients.
A health official at Chitipa District Hospital, who opted for anonymity, said it was last year that they got this drug.
“What was happening is that once a patient had been administered the drug, they were dying there and then,” he said explaining that they suspect the drug contributed to the fatalities.
Meanwhile the World Health Organisation (WHO) is currently waiting for the Pharmacy, Medicines and Poisons Board (PMPB) to report on what transpired with Chloramphenicol.
This is according to the communication from Pernette Bourdillion Esteve who is analyst for Global Substandard, Spurious, Falsely Labelled, Falsified and Counterfeit Medical Product (SSFFC) Monitoring Project under the Essential Medicines and Health Products of WHO.
“We also look forward to your feedback on the Chloramphenicol incident,” Esteve wrote the board.
It is alleged that Chloramphenicol injection killed about three patients in the two district hospitals forcing the authorities to report it to the board.
Another drug which is under investigation is Benzathine Benzyl Penicillin 2.4 MIU BP Injection manufactured by one of the Chinese companies. The drug raised question marks when a 14-year-old female in 2014 died soon after its administration.
Malawi News has been reliably informed that there have been 10 quality control incidences of drugs which have been referred to PMPB for investigations including some questionable waivers sanctioned by few individuals of the board.
There are also allegations that the board dilly-dallies in enforcing drug recalls resulting in some sick people consuming sub-standard drugs earmarked for recall.
Commenting on the developments, PMPB Registrar, Godfrey Kadewele, said the board continues to discipline suppliers that are failing to meet stipulated requirements.
Kadewele said quality of medicines is managed in order to assure the same to the consumer.
“The medicine in question was duly imported under the prevailing permit scheme and also applied for registration as factors that mitigate against risk to the consumer,” he said.
Kadewele further said quality of medicines is managed through quality assurance mechanisms from manufacture to procurement, distribution, storage and dispensing stages and by nature quality can fail at any stage after manufacture of a medicine due to various reasons.
He said through vigilance, once quality failure is discovered, there is a recall process that can be instigated by distributor or regulator.
“It is also very important to mention that the quality control Laboratory test results in the process of quality assurance of medicines are performed to confirm the contents of a certificate of analysis from the manufacturer,” he said adding that the disclosure of the quality specifications come from the manufacturer.
In the event of disagreement, he said, the results are challengeable until confirmed otherwise and that in some cases it involves a third party laboratory.
Therefore, Kadewele said it is not uncommon to see tests being redone to rule out oversights or mistakes.
He said one malaria drug in April this year was earmarked for recall due to its initial failure to comply with the uniformity of weight, but the recall was not implemented as advice from the QC laboratory indicated that confirmatory tests that followed showed uniformity of weight to be in order on the basis of BP 2015 Standard that happens to be the latest standard in use.
Leaked minutes of some meetings of Pharmacy, Medicines and Poisons Board show that some officials are behind questionable waivers on drugs and temporary certificates to medical suppliers without approval of the relevant authorities.
Sources claim that through their actions, they act as agents of death as the substandard drugs end up working as poison killing patients.
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