No shortage of fixed-dose combination ARVs in SA

Sunday, May 24, 2015

Pretoria – Government has strongly denied media reports that the country is experiencing extreme drug shortages, particularly fixed-dose combination (FDC) anti-retroviral drugs.

Minister of Health, Aaron Motsoaledi, said media reports began last week when a national newspaper reported that there was a drug shortage in the country and news channel eNCA broadcast a clip of an interview with a patient from the Esigodeni Clinic in KwaZulu-Natal.

In the clip, the anonymous woman reported that she did not receive her antiretroviral medicines and that many people were being turned away because of a widespread shortage of medicines at public health facilities.

He said as the Minister, he found the reports “extremely worrying” and set about trying to locate the patient to ensure she received the necessary treatment.

“Our own findings are that there were more than adequate fixed-dose combination drugs available in the facility, district, and indeed in the whole country … it must be noted that the FDCs is our flagship programme and we do everything in our power to protect it,” said the Minister.

He said measures were put in place to ensure adequate stock of the drug when it was launched in 2012.

“To make sure that there are not problems in this very important programme we even implemented the practice of a national buffer stock whereby 10% of all the FDCs provided are strategically stockpiled with a service provider in a warehouse.

“This is done in case there are unforeseen emergencies which may arise locally, nationally and even internationally,” he explained.

Also, the department made sure that it has different suppliers of the FDCs.

“So we can assure you that at no stage did we have a shortage of the FDC in the country.”

The Minister said while the department does not have any shortage of all adult treatment regimens - fixed dose or even single doses - there is a shortage of Abacavir which is used to treat children.

The shortage, he said, is due to circumstances beyond their control.

“Despite having three suppliers of Abacavir, we experienced a severe shortage because companies informed us that they had difficulty in sourcing sufficient active pharmaceutical ingredients [API] sourced internationally to produce sufficient quantities of both the syrup and the tablets.

“In addition to the problem of API availability, one supplier also suffered three batch failures which they had to investigate before the stock could be released and this took a long time.”

Minister Motsoaledi said at no stage did any company report that the shortages were related to non-payment of anti-retrovirals.

Supplies of Abacavir are expected to normalise by the middle of June, with all outstanding orders fulfilled by the end of June.

Suppliers are, however, continuously releasing stock on a weekly basis.

The Minister said the issue of drug supply was a problem across the world, as medicines were sourced from companies that whose decisions were not always based on the needs of patients but on what made business sense.

“As a country with the biggest antiretroviral programme in the world  - 30% of those on treatment globally are in South Africa - we are very vulnerable to all these production and logistical  challenges as well as business decisions that may even be made outside the borders of the country,” he said.

Changing drug suppliers

Addressing the call for a change in drug suppliers who were not able to supply drugs as per the country’s needs, the Minister explained that while the department had policies in place if a supplier failed to supply a drug, a new supplier would want a lead time of six weeks to three months to produce stock to supply.

He said this may be longer than the time the original supplier would have taken to solve the problem.

“So we are often forced to stick with the original supplier with the hope that they will soon solve the problem, as you can see in the situation with Abacavir which they started delivering on Friday, 22 May.

“If we contracted a new supplier, they would still be preparing to supply in six weeks at the earliest,” said the Minister. – SAnews.gov.za