5 MORE DRUGS FROM SWAZIPHARM REJECTED

MBABANE – The question of whether medical drugs consumed by patients in the country do meet applicable standards of safety and quality has come to the fore again.

In the latest development, about five types of medical supplies delivered at the Central Medical Stores (CMS) have been found to be not meeting the required safety standards.These drugs were supplied by Swazipharm Wholesalers and another company known as MVJ Surgical Medical Supplies. This has happened barely five months after the Ministry of Health recalled two batches of medication for quality purposes.

It comes at a time when government, through the ministry, shared good news to the effect that there has been an improvement in health products availability and improved rates of meeting needs of facilities from 39 per cent in January to 61 per cent in August 2024.Also, it comes at a time when the Minister of Health, Mduduzi Matsebula, told Parliament last week that he visited some of the public health facilities to ascertain the shortage of medical drugs.During his visit, the minister said he discovered that some of the drugs were available at the CMS.

Engaged other suppliers

He also said the ministry engaged other suppliers and discovered that they did have some of the drugs that were needed and that most of the stock is coming this month until June next year. The Times SUNDAY has uncovered that the ministry has acted with vigilance and wrote letters to the two suppliers, notifying them of a decision to reject the drugs.One of the letters seen by this publication and directed to Swazipharm Wholesalers dated October 10, 2024, is referenced ‘Rejection of Beclomethasone Spray 100mcg/dose Complete’. In terms of description, health experts describe Beclomethasone as a product used to help control the symptoms of asthma and improve breathing.

It is used when a patient’s asthma has not been controlled sufficiently by other asthma medicines, or when a patient’s condition is so severe that more than one medicine is needed every day. It is reflected that the drug was supplied through Purchase Order No.EG24104517, delivered under Tender for Pharmaceuticals and Vaccines Tender No.9 of 2023/24.“The Ministry of Health would like to bring to your attention that the product cited above is not accepted by the ministry,” reads part of the letter. It was mentioned that according to the purchase order, Beclomethasone Spray 100mcg/dose Complete was ordered by the CMS.

However, the letter states, when the quality team conducted an assessment, the name of the product on the primary label was Beclomethasone Nasal Spray 100ug and the instruction for use on the secondary level referred to two types of Beclomethasone Spray and Drop. “However, further investigation of the same product showed that the label instruction on the secondary packaging was misleading, as the actual product was Beclomethasone nasal drops,” the letter reads.It is stated in the letter that the affected supplier was notified that product information, which includes labelling, is important for the safe use of the product by healthcare professionals as well as the patients.

Substandard and falsified

It was mentioned that product information is also important for detecting substandard and falsified medical products. The letter said product information is part of the regulatory notification or approval, is legally binding and a responsibility of the manufacturer and any party that places a product on the market in any country. “The supply of an inappropriately labelled product is, therefore, not acceptable. Presently, you are advised to replace the stock with a contractually good quality stock with the sameness of information on the labels that you will be allowed to invoice,” it was stated in the letter.

Another letter reflects that the ministry rejected the same type of drug (Beclomethasone Spray), but this one was labelled 50mcg and purchased from the same supplier.Again, the ministry stated in the letter that it is not accepting the product. As with the first one, the ministry noted that a 50mcg/dose Complete was ordered by CMS. It said however, when the quality team conducted an assessment, the name on the primary label was Beclomethasone Nasal Spray 50ug and the instruction for use on the side of the secondary label referred to two types of the product (spray and drop). “However, further investigation of the same product showed that the label instructions on the secondary packaging was misleading as the actual product was nasal drops,” the ministry mentioned.

The ministry also wrote a letter to another supplier to give a notification that it was rejecting a product known as Oxymetazoline Nasal Spray 0.25%, which was received through Purchase Order No.EG24107471 and delivered under Tender for Pharmaceuticals and Vaccines Tender No.9 of 2023/24. Again, the ministry said it will not accept the product as it had an almost similar problem as the aforementioned first two in that its labelling information was found to be conflicting as it was referring to a nasal spray, whereas it was nasal drops.

Health experts describe Oxymetazoline nasal spray as a product that is used to relieve nasal discomfort caused by colds, allergies and hay fever. It is also used to relieve sinus congestion and pressure. Another product rejected by the ministry is known as the Fluticasone 50ug and again, the reason, as reflected in the letter, is that the instruction for use on primary label at the back indicated that the product is a spray.

Secondary packaging

However, further investigation showed that the secondary packaging indicated that it was nasal drops. In terms of description, Fluticasone is a product used to relieve seasonal and year-round allergic and non-allergic nasal symptoms, such as stuffy/runny nose, itching and sneezing.  It can also help relieve allergy eye symptoms such as itchy, watery eyes. This medication belongs to a class of drugs known as corticosteroids. As if that was not enough, this publication got hold of another letter which reflects that the ministry also rejected a product known as a Cloxacillin Suspension USP 125/5ML, which supplied through purchase order No.EG24104568 and delivered under Tender for Pharmaceuticals and Vaccines Tender No.9 of 2023/2024.

“The Medicine Regulatory Unit has received a product complaint from facility. The complaint was that the Cloxacillin Suspension USP 125/5ML does not dissolve and has multiple colours. The CMS warehouse also corroborated it and noted that the same batch in the warehouse was not homogenous in colour, but also had a clumpy consistency,” reads part of the letter. It was mentioned that poorly soluble drugs can have significant implications for their effectiveness and safety.

“Undissolved medication can irritate the lining of the stomach or intestines to cause more severe side effects. Following these findings, you are informed that the current affected batch be destroyed at your cost and be replaced with a good quality one that you will be allowed to invoice. The Destruction Certificate should be submitted to the Medicines Regulatory Unit,” it was mentioned in the letter. In terms of description, Cloxacillin is used to treat a wide variety of bacterial infections.

Growth of bacteria

This medication is a type of penicillin antibiotic and works by stopping the growth of bacteria. Meanwhile, the drugs that were recalled in June this year were two batches of the medication, Folic acid 5mg and Penicillin Syrup 125mg/mg.Through a press statement, the ministry said the drugs had been recalled for quality purposes.According to the statement, the decision 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.
It also emphasised that the public did not have to panic and that the national recall is a precautionary measure recommended by the Medicines Regulatory Unit (MRU). The recall, according to what the ministry said, was in the best interest of the public and meant to protect the consumers while an investigation was ongoing.

Also mentioned was that this was done as a process of quality control to ensure that medication used by the public is safe and efficacious. The ministry also had to provide answers in Parliament after a motion was moved by Matsanjeni South Member of Parliament (MP) Sabelo Ndlangamandla, who was seconded by Somntongo MP Sandile Nxumalo, seeking clarity on the recalled drugs.

Quality and safety

In a report containing the answers, the minister stated that the ministry does have proper structures aimed at ensuring quality and safety of medical supplies. The minister said despite these structures and stringent regulations, drug recalls still happen all over the world, some for minor issues and others can cause serious harm. He said medicines are recalled for reasons such as contamination, mislabelling, defective products, adverse reactions, incorrect potency and discolourations to name but a few.

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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