HEALTH MINISTER REVEALS: RECALLED DRUGS SUPPLIED BY SWAZIPHARM

MBABANE – It was reported last year that there is a company that supplied medical drugs for public use, which the Ministry of Health later recalled.

The Times SUNDAY can reveal that one of these companies is SwaziPharm Wholesalers (Pty) Ltd, the long-time serving supplier of drugs in the country. While the country grapples with the shortage of medical drugs, it has since emerged that SwaziPharm’s drugs have been recalled three times this year.

The Ministry of Health recalled the drugs for various reasons, but this newspaper can disclose that government removed them from shelves so that they could not be dispensed to the public. Other companies whose drugs were recalled include IT Solutions and Artemis. Collectively, government had placed an order for 59 514 units of drugs from these companies. However, when the recall notice was issued, only 17 513 were available.

This information is contained in the Ministry of Health’s report tabled in Parliament. Matsanjeni South MP Sabelo Ndlangamandla moved a private motion, which was seconded by Somntongo MP Sandile Nxumalo, seeking clarity on the recalled drugs. The report was delivered to Parliament by Mduduzi Matsebula, the Minister of Health. SwaziPharm is one of the suppliers that was summoned by the Public Accounts Committee (PAC). The PAC is  a special parliamentary committee that holds public entities to account for public finance expenditure.

The report is yet to be debated. According to the report, the recalled drugs were class 3, meaning they were not likely to cause any adverse health reaction, but violates regulatory agency labelling or manufacturing laws. “There is no recorded harm to our clients,” reads the report. The ministry said the Medicine Regulatory Unit (MRU) relies on reports from EPR and health facilities for any signs of symptoms and adverse reaction resulting from taking the medication. The minister said the public is encouraged to report any adverse reaction resulting from the cited medication. Patients who consumed these medications were cautioned that the risk of future well-being is unknown, considering that no specific research was undertaken in other countries regarding effects of similar recalled products.

Enforcing

The ministry said the MRU is expected to continue enforcing quality control activities and post-marketing surveillance in order to reduce the occurrence of such incidents. According to the report, there was no intention by the suppliers to supply the recalled products.  The report states that the recalled drugs had dark and black spots. Another drug line had two different strengths while another one had a controlled release. Some of the drugs that were supplied by SwaziPharm include the following -

• Folic acid tablets, supplied under batch number: 003254;
• Penicillin suspension 100mls delivered under the batch number 223131144.
• Other drugs that were found to be faulty from this supplier include the carbamazepine 200mg tablet and the drug was also recalled in June 2024. In July 2022, it is reported that government also recalled the Cold and Flu syrup 100ml from the same supplier.

According to the report, government ordered and received 40 000 units of the phenoxymethyl drug and 13 741 units were received on recall; the others had been used up. The phenexymethyl suspension drug or penicillin 125mg/5ml, 100ml, is a drug used to treat bacterial infections, including ear, chest, throat and skin infections.
It was recalled because its labelling had two different strengths. “The recall continued due to the fact that antimicrobial resistance can be caused by continued use of either low or high doses of antibiotics as misuse.”

Epilepsy

Another drug that the company supplied, but found to have issues is the carbamazepine 200mg, a drug used to manage and treat epilepsy, trigeminal neuralgia, and acute manic and mixed episodes in bipolar disorder. The company, IT Solutions, supplied the drug, Delamanide 50mg tablet. These drugs were recalled because they were wrongly stored and exposed to high temperature conditions. Meanwhile, artemis supplied the drug Chlorpheniramine drug. These drugs were declared to have Erythrosine colour. They were found to have more than one colour. On another note, the ministry of health said patients who consumed the drugs should not fear. This is because there were no adverse effects of the consumed drugs that were reported before the drugs were recalled. “There is no recorded harm to our clients.”

However, the ministry encouraged patients to report adverse events and provide their disposing history. “This includes the consumption of the product similar to the one recalled,” reads the report. According to the report, there were also no identified patients who reported adverse events due to consumption. Patients who suspect to have undesirable effects after consuming the product may call the ministry of health’s emergency line 977 or visit the nearest health facility for assessment. Worth noting is that in June this year, this publication reported how the Ministry of Health became evasive when asked about the name of a supplier after certain drugs were recalled. This happened after the ministry had issued a press statement informing the nation that certain medication has been recalled.

Besides the name of the supplier, this publication sought to ascertain how much of the stock had been dispatched to the public health facilities and whether the supplier was expected to bring in a new batch. The press statement issued by the ministry advised the public that two batches of the medication, folic acid 5mg and Penicillin Syrup 125mg/mg had been called for quality purposes. According to the statement, the statement followed the discovery of black spots on folic acid tablets from batch #003254, while the penicillin had different strengths in labelling for batch #223131144.

The ministry explained that this was not an issue of expired drugs as the batch of folic acid tablets was to expire in February 2025, and the phenoxy methyl penicillin in January 2025.
“The matter is being handled with high priority, and the ministry wishes to inform the public not to panic. The national recall is a precautionary measure recommended by the Medicines Regulatory Unit (MRU), a unit under the Ministry of Health. The recall is in the best interest of the public and is meant to protect the consumers while an investigation is ongoing,” read part of the statement.

It was mentioned that this was done as a process of quality control to ensure that medication used by the public is safe and efficacious. Also mentioned was that it was batch specific, meaning that only folic acid from batch #003254 and phenoxy methyl penicillin from batch #223131144 were affected and that other batches or similar products are not affected. “All public health facilities already have been contacted and informed of the recall of the products, and they have been advised to remove the affected products from the shelves in pharmacies.

Advised

“Healthcare professionals also have been informed to stop dispensing the tablets and syrup of the affected batches, immediately. The public health facilities have also been advised to quarantine all remaining stock of the affected medicine and return it to the Central Medical Stores (CMS) through the approved processes,” it was mentioned in the statement.
Also, the ministry shared insight regarding the medication by explaining that folic acid is a supplement and penicillin is an antibiotic.

It was mentioned that clients taking folic acid tablets and the penicillin syrup were advised to check their batch of medication (the batch number) and only discontinue use if the medication is from the affected batches; safely dispose of the medication or return it to the nearest facility and ask for another medication, call the MRU about any concerns or to get more information, or send a message via WhatsApp number 7655 7303.

It should be noted that the Funduzi forensic report into the shortage of drugs has a finding that there was allegedly a lack of testing facility for quality assurance of supplied drugs.
A recommendation contained in the report was that government should institute a process towards the acquisition of a drug testing facility for quality. It was recommended that government should redesign the entire system for drugs ordering system to supply.

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