A worldwide shortage of an active pharmaceutical ingredient is the reason behind the anti-retroviral (ARV) medication shortfall across the country, the department of health confirmed.

The anti-retroviral drug called Lamivudine is currently in short supply globally and this has affected ARVs that contain this ingredient, Deputy Director General for Health Regulation and Compliance Dr Anban Pillay told Health-e News.

Lamivudine is separately combined with Abacavir and Zidovudine to make the two combination drugs that are in shortage, which are mainly supplied by international drug manufacturer Mylan under the brand names Dumiva and Zovilam. According to tender documents, Mylan was awarded 53% and 28% of these combination HIV drugs respectively.

This medication is referred to as second-line ARVs which is taken when patients’ bodies have become resistant to the HIV drugs they take after starting treatment for the first time.

This is not the first time Mylan has been blamed for nationwide shortages of essential medicines. In July last year, the pharmaceutical company failed to supply the national health department with oral contraceptives such as Oralcon, Trigestrel and Famynor. Mylan was also a majority, and in some cases, the sole provider of these birth control pills that were stocked out.

According to Pillay, Mylan has continuously miscalculated the amount of second-lined ARVs needed in South African health facilities.

“The challenge relates to the capacity of the contracted supplier, Mylan, and their consistent underestimation of the demand. In numerous meetings the supplier was requested to adjust their production plan based on the average monthly demand,” he explained.  

“However, the supplier has consistently reverted to the demand based on the published tender estimates which are no longer relevant.”

Birth control shortages also plague SA

It’s not just life-saving HIV drugs that are currently in the shortfall. Pillay also confirmed there is a short supply of the injectable contraceptive Nur-Isterate because of production problems by pharmaceutical manufacturer Bayer which is the sole manufacturer.  “Bayer has been supplying stock but it may not satisfy the demand,” he explained.

Nur-Isterate has been in short supply since the new tender for contraceptives was awarded in October 2017.

Pillay said it’s the Department of Health’s policy is to ensure that women have uninterrupted access to quality safe contraceptives that allows them to choose which one best suit their personal circumstances.

“Currently, the preferred contraceptive method are intrauterine devices which are long-acting contraceptives and are freely available… Nur-Isterate has not been supplied in the ordered quantities – there have been shortages from time to time [but] not a stockout,” said Pillay.

The health department only awarded the new tender for the birth control five months later — in late February 2018, Bayer’s Head of Communications Tasniem Patel told Health-e in October last year. At the time, the stockouts were blamed on the late tender award which affected Bayer’s production capacity.

Patients left stranded

Patients who are on chronic ARV drugs and women using Nur-Isterate have been left stranded as they haven’t been receiving their medication for months.

According to the statement released by the Stop Stockouts Project (SSP) these stockouts have been unresolved since the second half of last year and the situation has now escalated into a crisis.

SSP Coordinator Kopano Klaas said the organisation has received numerous calls over the past two months from patients who were not getting their medication at clinics.

“The government has been getting the little medication that some [public] health facilities have at the moment from the private pharmacies. They know that this problem is huge but they’re not doing anything in terms of coming up with alternatives,” Klaas said.

The department helped Mylan to obtain special authorisation from the medicine regulator South African Health Products Regulatory Authority to bring stock into the country in terms of Section 21 of the Medicines Act, said Pillay. “The volumes are just sufficient to meet the demand and alternative suppliers are being engaged.”

Currently, the Treatment Action Campaign (TAC) is conducting inspections in Gauteng and Free State clinics and say the stockouts go beyond just ARVs and contraceptives. “There isn’t even flu vaccines for children. Some clinics don’t have a fix dose combination of ARVs, but it’s not as bad with Dumiva,” said Bongani Radebe, the TAC Gauteng Deputy Chairperson.

According to Radebe, some clinics are giving patients alternative ARV medication because of the Dumiva.  “As TAC we are not encouraging that because the doses of the different ARVs are not the same,” he said.

Pillay also told Health-e that there is enough stock available in the country, but it may not be evenly distributed. The department is working on redistributing excess stock across facilities so that patients don’t go without treatment.

He explained: “Mylan has been bringing in stock on a weekly basis. It is anticipated by the end of this month that all orders would be fulfilled.” – Health-e News