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Stock-outs: A 'shadow epidemic' of psychiatric illness looms in SA

In August, almost half of the most commonly used medications to treat mental illness in South Africa were out of stock, and many have been in short supply since March. Now, Laura Lopez Gonzalez writes in Spotlight that experts warn that amid the COVID-19 outbreak, the nation could see a “shadow epidemic” of psychiatric illness and it could prove deadly for patients.

Gonzalez writes that in most countries, the medications offered in the public sector are determined by what is included in the essential medicines list. Stock-outs of almost half of all mental health medicines on South Africa’s list were reported in August and many of these drugs had been in short supply since March, a Gauteng Health Department statement and the latest report by the civil society coalition, the Stop Stockouts Project (SSP) show. The organisation relies on healthcare workers and citizens to report medicine shortages.

Between April and June, mental health medications represented 3% of the roughly 250 reports SSP received, but by August, mental health drugs accounted for nearly a third of the almost 280 shortages they logged, says SSP coordinator Ruth Dube.

Gonzalez writes that in 2018 and 2019, it was rare that Dube’s organisation recorded more than 20 such stock-outs in the entire year. But this year, the number of times people have reported any stock-out of mental health medicines is already over 60.

She writes in Spotlight that mental health drugs are not the only medicine shortage flagged during COVID-19. When the COVID-19 lockdown shuttered pharmaceutical plants in China and India, global medicine supply chains temporarily ground to a near halt. South Africa has grappled with scarcities of not only medications to treat mental health conditions such as schizophrenia, bipolar and depression, but also HIV and tuberculosis.

The national health department oversees the tender for these drugs. The department, and some drug companies, admit that although there were problems in drug supply before COVID-19, the pandemic has exacerbated these. In response, the national health department is now working to find more suppliers.

Gonzalez writes that when disease outbreaks happen, “shadow epidemics” can follow in their wake, meaning upticks in other diseases or conditions that are in some way caused by the first. During the 2014 Ebola outbreak in West Africa, for instance, school closures – and a lack of sexual and reproductive healthcare – fuelled a rise in teenage pregnancies in some areas. Now, some psychologists and psychiatrists in South Africa say they are seeing their own shadow epidemic as mental health patients relapse because of shortages – putting them at risk of psychosis or even suicide.

Many will need to be hospitalised, experts warn, and if they are, research suggests it will only be the start of a long and costly road back to being well.

Gonzalez writes that mental health non-profit organisations contracted by the Gauteng government estimate that they have spent tens of thousands of rands out-of-pocket to cover medicine shortfalls such as these. Some, like Monroe’s, have had no choice but to shift the burden in part to families. “You can’t mess around with a person’s stability because the more up and down they go, the more they can get stuck in the wrong (mental) space,” Monroe says. “We haven’t allowed that to happen.”

In August, the Gauteng Health Department released a statement outlining medicine shortages ongoing since March. Almost half of the drugs listed were used to treat mental health conditions such as bipolar, schizophrenia and anxiety. Patients, the province assured, had been provided with alternative medications. Meanwhile, Gauteng had purchased medications from companies not on tender to make up the shortfalls – although likely at a higher price than that in national tenders.

Other provinces have done the same, according to national Health Department spokesperson Popo Maja, who added that the department is helping provinces to source quotes from new suppliers. “Because of economies of scale, the public sector contract price is, in most cases, lower than the single exit price (the price limit set by government on a medicine each year),” he is quoted in the report as saying. Gauteng has also started penalising companies for late deliveries.

But, Gonzalez writes, psychiatrist Qhama Cossie explains it can take months to get a person living with severe mental illness stabilised and doing well on a new drug. Cossie is the head of general hospital psychiatry at the University of Cape Town and works at the state psychiatric facility, Valkenberg Hospital. And options are limited.

“When there’s a stock-out, we need to reassess whether we can use a similar medication (and) more often than not in the state sector we’ve got a limited basket of medications,” he says.

In practice, changing a patient’s medication is a slow and delicate process, explains University of the Witwatersrand lecturer, Lesley Robertson. Robertson also heads the clinical unit of community psychiatry at Sedibeng District Health Services. To do it, doctors gradually decrease the dose of the older medication while slowly introducing the new medication. But when stock-outs happen, patients are forced to stop their usual medications and start new ones abruptly, which Robertson warns can lead to relapses.

“So, we try and change medications,” Cossie says, “but that change is not necessarily successful.”

Gonzalez writes that the Gauteng Health Department reported eight mental health drugs as out of stock between March and August. For two of these medications, the next best drugs were also in short supply, according to SSP data. For another drug, lamotrigine, used to treat seizures and bipolar disorder, there is no recommended alternative for women who could fall pregnant, psychiatrists are quoted in Spotlight as saying. “There’s no state psychiatrist that doesn’t believe that we’ve seen relapses because of medication shortages,” says Cossie.

Gonzalez writes that a 2017 World Health Organisation report shows China is the world’s leading supplier, by volume, of active pharmaceutical ingredients. Meanwhile, just eight Indian firms account for 80% of generic antiretrovirals used globally, UNAIDS warned in a June report. COVID-19 lockdowns led to reduced manufacturing in both countries and, in India, introduced delays of three to five weeks. Maja says factors like these are to blame for shortages of mental health medications. Sanofi, one of several pharmaceutical companies Spotlight contacted, says it was also hit by shortages in active pharmaceutical ingredients and delays in production due to load shedding.

The South African Health Products Regulatory Authority (SAHPRA), through Section 21 authorisations, has also allowed doctors to use generic medications not yet registered in the country as a way to deal with large-scale public sector stock-outs – something that has only happened in the last four or five years, according to University of KwaZulu-Natal senior pharmacy lecturer Andy Gray.

Traditionally, Section 21 approvals have been used to bring in medicines used in clinical trials or drugs needed as a last resort for individual and gravely ill patients.

In 2019 SAHPRA produced new guidance around the use of Section 21s for stock-outs that Gray says have helped to regularise how this type of approval works when it comes to the government. For instance, the document suggests the removal of some reporting requirements for doctors that make sense when experimental drugs are being tested in a clinical trial but are not needed when Section 21s have been used to procure medicines already on the market during a shortage, Gray explains.

So far, Section 21 authorisations have been used to deal with shortfalls of contraception, the Bacille Calmette-Guerin TB vaccine for infants and epilepsy medication.

“While not perfect, Section 21 has allowed for state procurement to bridge gaps in supply and ensure continued access to essential medicines,” Gray and other experts argue in a recent edition of the South African Pharmaceutical Journal. “(And), as the experience of (South Africa’s) affordable medicines directorate has demonstrated, global shortages of specific medicines are becoming more common.”

 

[link url="https://www.spotlightnsp.co.za/2020/09/23/mental-health-are-medicine-shortages-fuelling-a-shadow-epidemic/"]Full Spotlight report[/link]

 

[link url="http://www.kznhealth.gov.za/pharmacy/Tertiary-quaternary-level-essential-medicine-recommendations_January2020.pdf"]SA’s list[/link]

 

[link url="https://www.sasop.co.za/covid-19-pressure-to-weak-mental"]South African Society of Psychiatrists statement[/link]

 

[link url="https://academic.oup.com/heapol/article/34/9/706/5572608"]Health Policy and Planning study[/link]

 

[link url="https://www.who.int/phi/publications/2081China020517.pdf?ua=1"]WHO report[/link]

 

[link url="https://www.unaids.org/en/resources/documents/2020/covid19-supply-chain-availability-cost-generic-arv"]UNAIDS report[/link]

 

[link url="https://www.knowledgehub.org.za/system/files/elibdownloads/2020-08/AMD%20Connect_I18_15%20Aug%202020.pdf"]Medication Priority List[/link]

 

[link url="http://www.sapj.co.za/index.php/SAPJ/article/view/2784"]South African Pharmaceutical Journal article[/link]

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