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Thursday, 29 September 2022 22:50

Morphine shortages leave South Africa's patients in pain.

By Ufrieda Ho.

The short-sightedness of relying on a single morphine powder supplier for South Africa's healthcare facilities has been pinpointed as the cause of a devastating disruption in the supply of liquid morphine that has left some terminally ill patients suffering for more than three months.

The CEO of the Independent Community Pharmacy Association (ICPA), Jackie Maimin, said Cape Town-based medicine manufacturer Barrs Pharmaceuticals Industries, which is part of the Avacare Health Group, told the ICPA a clerical slip-up had been the reason for the bottleneck and breakdown in the supply chain of morphine powder.

Morphine powder is used by pharmacists to make liquid morphine.

Stock of the powder form of the opioid in package sizes that individual pharmacists can use to make the liquid has been at critically low levels in government and private sector facilities since July.

"Barrs said it had an administrative problem and did not place an order with its bulk supplier Fine Chemical Corporation [FCC]," said Maimin.

FCC manufactures the active pharmaceutical ingredients for the commercially sold product.

Maimin added the company confirmed to her it had plenty of stock” of morphine powder at its Cape Town-based operations.

She said: Wholesalers started to show morphine as an out-of-stock item three months ago and pharmacists started to struggle to source the medicine for their patients. They had to purchase from colleagues who still had stock or contact prescribers to change medication.

Barrs' business is to repackage bulk supply of morphine powder into 5 and 10g products for pharmaceutical wholesalers.

These are in turn made up into a product called Mist Morph, a more palatable liquid pain relieving syrup for chronic pain sufferers. It is widely used for pain management for Aids and cancer patients as well as for end-of-life pain relief.

Morphine in liquid form is often the only way some patients in severe pain can receive the drug.

"There is always a risk of interruption and it's why we should not have a single supplier of morphine powder," said Maimin.

"Pharmacies also can't order directly from FCC as they only sell in bulk. Going forward, we would also like to see FCC repackage and supply morphine in package sizes that are suitable for pharmacies."

There was also a need for a better early warning system before medicine supplies hit critically low levels, Maimin said.

"If there is any interruption in supply of an essential medicine which has no alternative [like liquid morphine], both the South African Health Products Regulatory Authority and the South African Pharmaceutical Council should be notified so they can notify health professionals."

Operations restored

She added now, at the tail-end of September and after three months of disruptions, Barrs had told the ICPA its operations to repackage and supply morphine powder have been restored.

However, its current order of morphine powder is still in quarantine and awaiting release after quality assurance.

It leaves the timeframe for exactly when products will be available on dispensary shelves still uncertain and for some patients, it has already been too late.

A palliative care specialist at the Knysna Sedgefield Hospice, Dr Janet Stanford, said: "We have been facing a human rights crisis for the past three months if we go by the WHO guidelines of a patient's right to pain relief.

Severe pain has a huge impact on quality of life. It's also extremely distressing to the patient's family, carers, and healthcare professionals who have to witness people in pain and not be able to do anything for them and not have an answer for families of when the drugs will become available.

Morphine is both on the WHO's List of Essential Medicines and South Africa's Essential Drugs List.

Stanford said the public sector had been particularly hard hit since morphine was usually the only drug stocked for severe pain relief at public facilities.

Morphine is considered an inexpensive drug at an estimated R60 a gram and a package of Mist Morph syrup contains 10mg or 5ml with a typical dose of 5ml every four hours or as required.

"In the private sector there are other strong opioids that are available, but they are expensive and are not in a liquid form, so they're facing the same challenges," said Stanford.

"A liquid form of the drug is very helpful when people can't swallow because it causes them more pain and liquid morphine has a very quick onset of action compared with tablets."

'National crisis'

Dr Margie Venter of non-profit PalPrac (Association of Palliative Care Practitioners of South Africa) said the untenable situation that had unfolded needed to be called out as an "ongoing national crisis".

"It's desperate and dire. To allow this suffering to continue without alternatives is not humane," she added.

Even with Barrs Pharmaceuticals' response to IPAC that its operations have been restarted, Venter said liquid morphine remained unavailable at the end of September, adding there had also been no communication from the Department of Health on a way forward.

"We have been trying to delve through the supply network to try and find out where the hiccup is - whether it's a supply issue, whether it's an issue of non-payment from government, or even if there's a global shortage and we cannot get any communication from Barrs or the Department of Health.

We've sent enquiries through various channels, and we still don't have any clarity on what the problem is. Government has been very quiet, and it means we don't know where to focus our attention.

"We can't plan or start finding solutions, especially in the public sector where there aren't available alternatives to morphine," she added.

Venter added pain management was essential throughout the course of cancer treatment.

"With pain management, some people are able to function well, maybe even feel strong enough to work, so morphine is not just an end-of-life medication. It's needed early on as part of cancer pain management."

Letter of non-compliance

Department of Health spokesperson Foster Mohale said Barrs Pharmaceuticals had now been issued a letter of non-compliance and the department was awaiting quotations from an alternative supplier for morphine powder.

He added there was no shortage of morphine tablets in public facilities.

Several morphine tablets and injectable formulations are listed on the department's latest Master Health Product List, but there is only one powder formulation.

Mohale said shortages and stockouts of liquid morphine products were first reported in July 2022.

He added Barrs cited "problems within their packing and distribution units in Cape Town. The supplier has also been struggling on most of their line items with root causes of power outages, raw materials, and cash flow".

Mohale confirmed Barrs had as of the end of September restarted its operations.

Timeframes he provided were "15kg [of morphine powder] distributed to facilities by 26 September 2022; 20kg will be packed for distribution by 30 September 2022, and another 20kg expected in October".

*Neither Barrs Pharmaceutical Industries nor Avacare Health responded to Spotlight's questions by time of publication.