South Africa’s drug stock-out problems have worsened, according to the results of a survey by the civil society coalition Stop Stock-outs that was released at the recent SA Aids Conference 2015. And, the Mail & Guardian reports, the findings are in stark contrast with Health Minister Aaron Motsoaledi’s earlier claims in a press statement that “there is no shortage of ARVs”.
The Stop Stock-outs researchers found that one in four public health facilities in SA ran out of antiretroviral (ARV) medicines or tuberculosis (TB) medication over a three-month survey period in 2014 compared with one in five facilities that experienced stock-outs in 2013. Fixed dose combinations (three-in-one ARV pills) were however available at more facilities in 2014 than in 2013 – fixed dose combinations were introduced into the public health system in April 2013 and have been phased in over a two-year period.
The three provinces in which the situation has deteriorated the most are North West, Mpumalanga and the Eastern Cape. In North West, 10 times as many facilities (39%) experienced ARV and TB medication stock-outs in 2014 compared with 2013 (4%). In Mpumalanga, four out of 10 facilities ran out of medication in 2014 compared with 26% in 2013. In the province’s Gert Sibande district, which is a National Health Insurance pilot site, 41% ran out of ARV or TB drugs. In the Eastern Cape, at least half of the facilities in the Alfred Nzo district experienced stock-outs. The only two provinces that have shown an improvement with regards to TB and HIV drug availability is Limpopo, where 41% of facilities experienced stock-outs in 2013 and 29% in 2014, and the Western Cape where stock-outs improved slightly from 5% in 2013 to 4% in 2014.
More than 80% of public health facilities in each province, except for the Free State, were willing to participate in the telephonic survey, the report says.
In addition to HIV and TB drugs, the survey looked at the availability of three childhood vaccines – rotavirus, pentaxim (a five-in-one vaccine that protects against diphtheria, tetanus, pertussis, poliomyelitis and other invasive infections) and measles, as well as essential medicines such as asthma inhalers, epilepsy and hypertension medicines.
Nationally, one in three stock-outs lasted more than a month, which often led to patients being sent home without any medication. Researchers analysed the reasons for the stock-outs and found that facilities mostly ran out of medication because of management and logistical problems at provincial depots and clinics, and not because of supplier issues.
Motsoaledi has, meanwhile, announced that the statutory Medicines Control Council is to fast-track sourcing of active pharmaceutical ingredients pre-qualified by the World Health Organisation in order to cope with the shortage of certain medicines in the country, reports The Times. According to the minister‚ antiretroviral medicines are not affected by manufacturer supply problems.
“Most patients on ARVs are taking the fixed dose combination tablet. This FDC is fully stocked at manufacturers and provincial depots. Additionally there is a buffer stock of the FDC kept by the National Department of Health to be used in the case of emergencies. There were problems with the supply of Abacavir‚ Ritonavir/Lopinavir combination and Ritonavir however suppliers have resolved these problems and now all outstanding orders have been delivered to depots‚” Motsoaledi pointed out.
With regards to penicillins‚ particularly benzyl penicillin‚ a global supply problem was still being experienced‚ but a potential source of active pharmaceutical ingredients (API) supply had been identified in Germany. “When the stock is made available‚ it will need to be used judiciously. In the interim clinicians will be advised on how to manage infections with appropriate alternatives‚” Motsoaledi said. “In the case of vaccines there is a shortage of the BCG Vaccine due to the usual supplier withdrawing their product from the market. As a result‚ the Department of Health has imported the product from alternative international suppliers. This stock is currently in SA and awaiting quality release from the National Control Laboratory.’
On the fast tracking of active pharmaceutical ingredients‚ Motsoaledi said the MCC had resolved to allow for the sourcing of APIs from alternative manufacturing sites that had been pre-qualified by the WHO. “This will allow for expedited availability of some medicines‚ once an application for an API variation has been submitted‚ as MCC will use the WHO information to facilitate approval to ensure that any medicine that is in short supply is accessed,” he is quoted in the report as saying.
A Business Day report says South Africa’s three biggest private hospital groups are able to manage the majority of medicine shortages they currently face as there are readily available alternatives for most patients. However, they say global shortages of vaccines for tuberculosis and chicken pox are a concern.
The report notes that their position stands in sharp contrast to public sector hospitals, which face bigger challenges sourcing drugs because they have access to a smaller selection of products and are bound by state tender rules that restrict them to a limited number of manufacturers. Private hospitals also serve a smaller number of patients, and do not require the large volumes typically ordered in the state sector.
This serious shortage of ARV drugs is hindering the fight against HIV/Aids in many parts of South Africa, and resulted in angry outbursts at the Aids conference, says a Cape Argus report. Dr Karl le Roux of the Rural Doctors Association said one of the biggest frustrations rural clinicians faced was the short, yet devastating sentence: “Sorry, out of stock. It is hard to describe the helplessness and anger one feels when cheap, yet important medications, are not available to patients.”
The report says a packed auditorium at the conference heard the testimonies of several patients, mostly from rural clinics in SA, who were unable to get the drugs they needed to keep them alive. “We are suffering terribly,” cried a woman health activist. “How can we exist like this, knowing that if we can’t get the drugs, we will become resistant? We know that that is a recipe for dying. Children are not receiving vaccines, because there is no stock. People can’t get their TB meds for the same reason. How much longer can we put up with this?”
She said her daughter and other family members were HIV positive. They had tried to obtain the drugs at a rural clinic and were told to come back when these would be available. “If we have to, we will go to court to fight this, just as we did in the past. The system is allowing us to default on our medication,” the activist said.
In response, a panel of health sector leaders, including from the government, said many of the problems associated with stock-outs were due to administrative glitches. Solutions that were in the pipeline included the placement of 280 pharmacy assistants in rural clinics to ease the administration problems and improve the supply management.
However, delegates said blaming one or other department for non-delivery was not the answer. “We are saying to the Department of Health, get it right. When people are suffering unnecessarily, the time for blame is over. Action is what we need,” said one of forum facilitators.
Overburdened nurses who have to act as doctors, pharmacists, data capturers and social workers, contribute to the problem of stock outs, according to Dr Desmond Kegakilwe from the Rural Doctors Association of South Africa (RUDASA). He says in a Health-e report that nurses who were not trained to place stock orders were having to do so because of staff shortages and sometimes they ordered incorrectly. “If you ask them why they ordered incorrectly, they will tell you, ‘Doctor, I don’t know.'” Poor management has been previously highlighted as part of the stock out problem.
Healthcare practitioner and pharmacist Robert Setshedi agreed that the country was experiencing a shortage of staff, and that nurses were overburdened which was, in part, contributing to a rise in stock shortages at some clinics.
Getting drugs to clinics included a procurement process as well as a chain management process and sometimes the nurses dealing with these procedures were just not qualified to do the job, he said.
The Department of Health’s deputy director general for health regulation and compliance, Dr Anban Pillay said part of the solution lay in training pharmacy assistants to take care of drug supply management issues.
The good news is that in just four years, South Africa has seen a 40-fold increase in health facilities treating drug-resistant tuberculosis (DR-TB) as government pledges more than R130m for new medicines, reports Health-e.
In 2011, thousands of DR-TB patients could seek treatment at only 17 centres nationwide. If patients were lucky enough to secure a bed at one of these facilities, they faced a hard choice: Move away from family and home or die.
Today, almost 684 clinics and hospitals provide care for the tens of thousands of DR-TB patients started on treatment each year, according to figures announced at the SA Aids Conference.
“We have at least one (DR-TB treatment) initiation site per district,” said Dr Norbert Ndjeka, head of the Department of Health’s division on HIV, TB and drug-resistant TB. “Decentralisation is our core business.” He added that the department will now focus on rolling out treatment to sub-districts, especially in the hardest hit provinces of KwaZulu-Natal, Gauteng, and the Western and Eastern Capes.
The Department of Health also announced that more than R130m has been slated to introduce two new drugs, bedaquiline and linezolid, used to treat extensively drug-resistant TB (XDR-TB). The first new TB drug in nearly five decades, bedaquiline was approved for use in SA patients in October. This follows a clinical access programme that out that found samples from about 60% of XDR-TB patients on bedaquiline were TB-free after two months.
According to Ndjeka, the Department of Health will allocate R130m to roll out bedaquiline to at least 9,000 patients over the next three years through the ring-fenced HIV Conditional Grant. About 150 patients have already received bedaquiline in provinces like Gauteng and the Western Cape. KwaZulu-Natal, Mpumalanga, Limpopo and the Free State have yet to start patients on the drug.
Currently, only 15% of XDR-TB patients are ever cured and current treatment regimens risk leaving about 60% of patients permanently deaf due to side effects if SA studies are an indication.
To try and prevent deafness, health care workers must carefully monitor patients’ hearing. Unfortunately, the country’s 461 public sector audiologists sit mostly at large hospitals – away from patients’ clinics. SA’s Dr Dirk Koekemoer has invented the KUDUwave portable hearing test machines. More than 100 of these are currently being used around the country, according to Zerilda Claasen who works with the Department of Health