Substandard drugs: lives not in danger

The Pharmacy, Medicines and Poisons Board (PMPB) has said chances of patients taking Aspirin and Ringers Lactate drugs that have been recalled due to defects are low due to stringent measures taken by legal drug handlers before subscribing them to clients. Aspirin is a tablet drug while Lingers Lactate is a solution administered intravenously. PMPB Acting Registrar, Wilford Mathiya, told Zachimalawi on Friday that the extent of the risk posed by the recalled drugs was minimal. “The advantage is that, before drugs are administered, health professionals check them thoroughly. Perhaps the tricky part could be with the solution but, again, health professionals check for clarity of the solution by asking the question: Is this solution clear against sunshine? Does it have particles, which may be an indication that something is wrong?” Mathiya said. Mathiya indicated that the affected medicines are Aspirin tablets manufactured by Pharmanova Limited, with an expiry date of July 2014, while Lingers Lactate, manufactured by Nirma Limited, has December 2013 as the expiry date. Some of the tablets were found at Lightcane Pharmaceuticals in Blantyre while some of the Ringers Lactate drugs were found at Chiradzulu District Health Office. However, the Acting Registrar said the board is not sure whether the recalled drugs are counterfeits or drugs duly manufactured by registered dealers. “We will learn whether the drugs are genuine or counterfeit. As of now, we are still looking for information from the companies because it’s them, and not us, who handle the recall process. We are only a regulator, and do not bear the costs of the drugs’ recall process. “But it is clear that the drugs did not meet specifications. When the Aspirin bottles were opened, they produced a bad spell while the Ringers Lactate developed mould. We need to find out why the drugs are faring poorly: Is it because of poor storage conditions? Is it because of a manufacturing fault? It may be possible that storage, and not the manufacturer, may be the problem,” Mathiya said. Mathiya expressed concern that chances of the sub-standard drug being used could be perpetuated by illegal drug handlers who ply their trade on the black market. He said, while PMPB tries to arrest the situation by seizing medicines, the efforts were being hampered by low penalties. “The Act we use, the Pharmacy, Medicines and Poisons Act Number 15 of 1988, is outdated and very lenient on penalties. So, when we take people caught with illegal medicines, what happens is that magistrates sometimes marry several Acts. But, sometimes, offenders are fined K50,000,” Mathiya said. Mathiya said, while efforts were made to amend the statutes and the proposed amendments are currently in the hands of the Ministry of Justice and Constitutional Affairs, there is need to review the amendments again since it has taken a long time. PMPB carries out quarterly (post-marketing) inspections and general inspections.