The childhood BCG TB vaccine as well as drugs for the treatment of schizophrenia and epilepsy are among about 50 essential medicines the National Department of Health says have been abandoned by international drug makers.

Due to a mix of local and international problems, South Africa has run short of everything from prenatal iron supplements to HIV and tuberculosis (TB) medications this year.

In response, the Department of Health will now require drug suppliers to provide frequent reports about production pipelines via a new online risk analysis tool created in partnership with the international health non-profit the Clinton Health Access Initiative.

“We experience the problem that orders are placed with suppliers but suppliers only deliver part of the order or not at all,” said Department of Health Deputy Director General Dr Anban Pillay, who said the department’s access to updated information about supplier’s production pipeline will allow it to identify and mitigate stock outs proactively.

“For example, if a supplier’s stock on hand plus stock in quality control cannot fulfil the provinces’ monthly projected demand quantity plus any quantity on order for that product, the system triggers a chain of events,” explained Pillay adding that these events could include requesting additional stock from an alternate supplier or procuring medicines that could be used in lieu of those running low.

Pillay told Health-e News that this system is may be the first of its kind in the world. Other systems, such as that employed by US drug regulator the Food and Drug Administration, rely on suppliers to notify regulators once drug supplies are already low.

Eight-month supply of combination ARV a bid to ease ongoing stock outs

[quote float= right]There are other manufacturers of the product however the current patent on Aluvia prevents the sale of these products in South Africa”

The Department of Health’s announcement comes on the heels of a large shipment of the antiretroviral (ARV) Aluvia into South Africa in an attempt to solve on-going stock outs of the drug. Since August 1 520 000 units of the drug – about an eight months supply of the drug – has been shipped into the country.

According to Pillay, South Africa’s supply of the drug, which combines the ARVs lopinavir and ritonavir, is at risk due to the country’s dependence on a single supplier.

“There are other manufacturers of the product however the current patent on Aluvia prevents the sale of these products in South Africa,” said Pillay, how added that Aluvia manufacturer AbbVie has established a 24-hour hotline for health professionals reporting stock outs.

Aluvia shortages this year recently led international humanitarian organisation Médecins Sans Frontières (MSF) to call for the Department of Health to pursue a compulsory license for Aluvia, which would allow the importation of generic formulations of the drug.

The Department of Health responded that it was pursuing voluntary licensing by AbbVie of their Aluvia patents through the Medicines Patent Pool, an international mechanism that allows drug makers to voluntarily share their patents with generic manufacturers to produce affordable medicines for developing countries. MSF has cautioned that this process may be lengthy and will depend on AbbVie’s willingness to share its patents.

The National Department of Health has also suggest that it could explore parallel importation, or importing supplies of AbbVie’s Aluvia drugs from other countries.

Task team tackles international, local stock out causes

In the meantime, the department has also appointed a task team of local and international experts to review drug shortages. After reviewing Public Service Commissions reports as well as those generated by the civil society Stop Stock Outs coalition, the task team identified several major causes of drug shortages including unpaid supplier accounts, incorrect deliveries by provincial medicine depots to clinics and poor forecasting.

The task team also noted that South Africa, like other developing countries, remains at the mercy of pharmaceutical companies who are increasingly abandoning research and development as well as production for drugs to treat conditions in poor countries where the ability to set high prices is limited.

“We currently have a list of some 50 essential medicines in South Africa that are in the abandoned category – example BCG vaccine for prevention of TB, injectable penicillin to treat infections, haloperidol for mental disease, ferrous sulphate for anaemia, phenobarbitone injection for epilepsy…” he told Health-e News. “These medicines are produced in limited quantities which are inadequate for the needs of South Africa and similar developing countries.”

As the government continues to explore programmes to deliver medicines directly to patients at points such as private doctors rooms, churches or mosques, the task team has also suggested ring-fencing medicine tenders. Drug companies tendering to supply the country with medicine will also now be required to commit to supplying buffer stock of drugs. – Health-e News.

An edited version of this story also appeared on Health24.com and the Voice of the Cape radio website

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