SOUTH AFRICA: Alarm over drug recalls

A packaging error by a factory worker a year ago has led to a nationwide recall of two types of antiretroviral (ARV) drugs manufactured by Adcock Ingram, a major supplier of ARV medicines to the private and public sectors.

The error occurred when the worker put blister packs of Nevirapine into nine boxes marked as containing Zidovudine (AZT). Both drugs are commonly prescribed as part of first-line ARV treatment regimens.

Adcock became aware of the problem in June, but only notified the Medicines Control Council (MCC), South Africa's drug regulatory authority, in July and announced the recall of the two batches of drugs on 8 August.

The AIDS lobby group, Treatment Action Campaign, issued a statement on Monday noting that "many cases of people taking the wrong medication could have been avoided had this delay to alert the public not occurred".

Kuben Pillay, an Adcock executive, explained that the period between June and August was used to investigate how the error had occurred and what quantity of stock had been affected.

"The incident was determined to be contained and isolated to the nine units that were uncovered during investigations," he told IRIN/PlusNews in an email. The decision to recall both batches completely was "purely as a precautionary measure".
Patients whose regimen includes both Nevirapine and AZT may have taken double doses of Nevirapine, leading to an increased risk of liver toxicity; those not prescribed Nevirapine but who took it inadvertently may have developed resistance to the drug, eliminating it as a future treatment option.

In media statements both Adcock and the health department urged all patients taking Nevirapine and AZT to consult a doctor about possible side effects.

But the TAC's Victor Lakay worried that not enough was being done to ensure the recall announcement had reached all affected patients. "A large proportion of our membership don't have access to TV and Internet or even newspapers, which is why we are pushing that messages must be put up in public health facilities so that patients will see that information on their next visit to a clinic," he said.

A health department spokesperson said a notice had been sent to all nine of the country's provinces to be distributed to health facilities. "We hope that the drug companies can be much more careful with issues of quality and not put the lives of patients at risk," said Health Minister Manto Tshabalala-Msimang.

Adcock, a local company, recently won a 21 percent stake in a government tender to supply the public sector with ARV drugs over the next two years.

On Monday, the health department also withdrew batches of two widely prescribed combinations of tuberculosis (TB) drugs after an initial investigation revealed that long-term storage appeared to affect their potency levels.

Stocks of a four-in-one combination of the drugs PZA, Ethambutol, Isoniazid and Rifampicin, and of a two-in-one combination of Isoniazid and Rifampicin, found to be older than four months are being withdrawn and replaced.

These medicines for treating primary TB are made by Pharmascript, one of two companies supplying TB drugs to public health facilities. According to a statement, the department conducted tests on the drugs after a tip-off from a whistleblower about possible quality problems.

Further tests are underway to determine the reasons for the problem, with results expected by the end of October.

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