Many mental health medicines out of stock and possibly fuelling a shadow epidemic

David Nkosi was agitated, remembers Lucy Monroe who runs a licensed non-profit home for people with mental illness and intellectual disabilities. Nkosi, not his real name, is one of the many people at the home whose care is subsidised by the Gauteng Health Department in a decades’ old arrangement with non-governmental organisations in the province.

Each month, the home’s staff collect boxes of pre-packed medication for these patients from a state hospital pharmacy.

But recently, what was in the sealed carton was not what Monroe expected.

“You’d get the box home, open it up and find there were medicines missing,” Monroe explains. Her organisation relies on health department subsidies and asked to remain anonymous for fear of compromising the centre’s funding.

Nkosi’s 15mg tablet of the antipsychotic drug olanzapine was also out of stock. Instead, the state pharmacy had sent Monroe’s staff home with a 10mg tablet for him. 

Monroe recalls Nkosi was restless and irritable, but something else was brewing with him. Finally, she knew what she had to do, Monroe tells Spotlight: She picked up the phone.

 Mental health drug stock-outs 

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. 

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, there are already over 60 stock-out reports of mental health medicines.

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 disorder 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.

Shadow epidemics

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 original disease. 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 a 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 be the start of a long and costly road to recovery.

Non-profits, families pay thousands to plug the gap

Back in Gauteng, Monroe says she rang Nkosi’s mother.

We don’t have enough medication for David, Monroe recalls telling her, asking if she could find R1,000 to buy him 5mg more of his antipsychotic medication? Monroe knows it will be a sacrifice for the family who already had to prove to the state that they were too poor to take care of Nkosi for him to qualify for a space at Monroe’s facility to begin with.

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.”

 Relapses because of medication shortages

 In August, the Gauteng health department released a statement outlining the medicine shortages since March. Almost half of the drugs listed were used to treat mental health conditions such as bipolar disorder, 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 it’s 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 the government on a medicine each year],” he told Spotlight.

Maja used the example of the anti-anxiety medication, diazepam. On state tender an injectable form of the drug costs R3,35 but this same medication goes for between R15,90 to R37,33, he says, based on quotations obtained by the national health department.

Gauteng has now started penalising companies for late deliveries.

But it can take months to get a person living with severe mental illness stabilised and doing well on a new drug, explains psychiatrist Dr Qhama Cossie. 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, Dr 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.”

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 tell Spotlight.

According to research reviews published in 2009 in the journal Reproductive Toxicology and in 2012 in the Canadian Family Physician journal, two of the suggested alternatives to lamotrigine — valproic acid and carbamazepine — have been shown to increase the risk of birth defects in babies born to women who took them during pregnancy.

SSP also reported shortages of a form of valproic acid in August.

“There’s no state psychiatrist that doesn’t believe that we’ve seen relapses because of medication shortages,” says Cossie.

Medicine and mistrust: Why mental health patients may refuse new medication

In the Eastern Cape, state clinical psychologist “Chantal Marais” remembers watching as a patient left her consulting room. Marais, who is not allowed to speak to the media directly and therefore asked to use a pseudonym, had just gone over with her several times why the medication she had been taking for years was suddenly different.

The woman’s usual drugs, Marais says she had tried to explain, were out of stock.

But Marais recalls how moments later, the door opened and the woman, who had an intellectual disability, was back insisting Marais gave her the wrong medication. She remembers the woman holding up the new medication box in one hand, and in her other hand was the packaging for her old medication. “It’s supposed to be in this box,” Marais remembers the woman saying.

 “She just didn’t understand. She needed it to be in the same box,” recalls Marais. Knowing there was no community healthcare worker or social worker to follow up with the woman — and desperate for her to get the medication she needed — Marais took the new medication out of its box and packed it in the old box.

Finally happy, the woman left.

As of mid-September, Marais says her clinic was still trying to source missing medication by borrowing from other clinics and hospitals.

Changing the colour or shape of medication can leave patients unsure they’ve received the right drugs. This may be even harder for people with severe mental illnesses who can lack what psychiatrists call “insight” or the ability to understand and solve problems.

“There may also be a sense of persecution or paranoia about the medicine changes so... they might think we [doctors] are playing tricks on them,” Robertson explains. “That’s the nature of the illnesses.”

 Factors such as these and having to prescribe different combinations of more pills can make people less likely to adhere to their medication, increasing their risk of having to be admitted into hospital.

And South Africa also has a chronic shortage of psychiatric hospital beds, the South African Society of Psychiatrists said in a statement earlier this year. 

If people are lucky enough to get a bed, research shows it will be just the start of a long and complicated journey to getting well. Almost a quarter of mental health patients who are admitted to hospital in South Africa will be readmitted within three months of being discharged, according to a 2019 study published in the journal Health Policy and Planning. 

The research also found that the country’s revolving door of psychiatric hospital care cost South Africa R1,9-billion in the 2016/17 financial year.

 Closed for business: How Covid-19 put the ‘the world’s pharmacy’ under lockdown

A 2017 World Health Organization report shows China is the world’s leading supplier, by volume, of active pharmaceutical ingredients (APIs). 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 APIs and delays in production due to power outages.

The national health department admits that many pharmaceutical companies who were contracted under the current tender, which includes more than just mental health medication and began in May 2019, have had difficulty fulfilling orders since the start of the tender. This was due to issues such as API shortages and strikes, Maja says.  

The department, he adds, works closely with provinces and companies to maximise the drugs available and identify more suppliers. Several mental health medications have also been placed on a national priority list of about 150 medications. The national health department is closely monitoring stocks of these drugs either because they are used to treat Covid-19 or because they are vulnerable to stock-outs. 

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 past 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-Guérin 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.” DM/MC 

NOTE: If you or someone you know are in crisis, please call the South African Depression and Anxiety Group on its 24-hour helpline on 0800 12 13 14. In the event of a suicide emergency, contact 0800 567 567. 

*This article was produced by Spotlight – health journalism in the public interest.

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