Group Moves To Stop Supply Of Sub-standard HIV/AIDS Drugs

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A coalition of HIV treatment activists in Nigeria, Treatment Action Movement (TAM), in collaboration with the AIDS Healthcare Foundation (AHF-Nigeria) has instituted a campaign to eliminate the supply of sub-standard ARVs at treatment centres in Nigeria.

The group, while appreciating actions by the federal government to increase access to HIV treatment, stated that there seemed to be clear failure to protect citizens living with HIV/AIDS.

TAM alleged that Tyonex Nigeria Limited for example, supplies the AZT/3TC/NVP and the TDF/3TC combinations of ARVs with funding from the Millennium Development Goals (MDGs) funds through the Federal Ministry of Health, noting however that distributing a product meant to save and prolong lives could easily be bogged by an integrity deficit in basic physical requirements.

The National Coordinator, Obatunde Oladapo, in a statement made available to journalists yesterday, said: “The strongest signal, to date, about a lack of true commitment to promises made is the unending controversy surrounding the purchase and supply of a local brand of ARVs, TYONEX, the AZT/3TC/NVP and TDF/3TC combinations produced by Ikotun Egbe, Lagos based Tyonex Nigeria Limited which was funded through the MDGs pool and being supplied by the Federal Ministry of Health.

“The drug, among other concerns, is deemed substandard, while TAM had requested stoppage to its continued supply until a panel of experts that has representatives of key stakeholders pronounce on its efficacy and safety based on several observations about this drug presented to the Ministry of Health.”

The statement added that TAM concerns were discernible from the grave implication to treatment outcomes and what it represents to the modest gains that Nigeria has recorded “if our fear about the quality of this brand of ARVs comes true.”

The group said the dosage information provided under “Dose” is also confusing and unprofessional.

“Most importantly, our concerns hovers around justified skepticism among ART patients and healthcare providers that if this product could easily fail requisite physical composition, will it not fail the bigger test of chemical composition in quality and content?

“We note the risks posed to patients in terms of poor compliance, adherence and poor treatment outcomes which can lead to unfavourable results for many Nigerians who have had no choice than to swallow what Tyonex is now supplying.”

The physical presentation of Tyonex triple combination drugs (AZT/3TC/NVP), the statement noted, are brittle and dissolve easily in the mouth before swallowing, adding that: “The package presentation is substandard, the labelling is amateurish, resembling the work of professional counterfeits and street drugs peddlers.
“Some of the labels were actually upside down with conflicting and incorrect instructions for use.”

Oladapo alleged that Advocacy and Marketing Manager with AHF-Nigeria, Oluwakemi Gbadamosi, said: “One of our patients observed that one of the packages she collected in a treatment centre contained 54 tablets and a broken half instead of 60. This is 27-day supply of drugs with a half tablet that is of no use for a pack that is expected to last for 30 days. The drug literature was also stuffed inside the same plastic pack as the ARVs giving little assurance for hygienic handling of the tablets during packaging.”

Oladapo, therefore, noted that there was no justification for the supply of sub-standard HIV medicines to the people of Nigeria.

According to him, “Given this style of packaging and drug information dissemination, there’s no doubt that the people living with HIV in Nigeria are denied access to quality treatment.

“We therefore urge the Federal Ministry of Health to apply the World Health Organisation (WHO) prequalification precondition for pharmaceuticals to trade in essential drugs in Nigeria.”

TAM, a civil society movement spearheading activities on access to care and treatment on HIV/AIDS, tuberculosis among other infectious diseases in Nigeria, stated that the Ministry of Health has a high level of commitment towards improving treatment, care and support for people living with HIV/AIDS, therefore precaution must be applied as “the ministry must not be seen to be shirking away from this responsibility on the altar of pecuniary gains.

“We further call for the establishment of a drug monitoring mechanism that is more transparent which would include civil society organisations, treatment advocates and patients’ organisations and openness and accountability in the procurement processes must be applied with regards to ARVs in the country and specifically the involvement of representatives of TAM and other partners as observers.” [Thisday]

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