Times Of Swaziland: 5  MORE  DRUGS FROM SWAZIPHARM REJECTED

5  MORE  DRUGS FROM SWAZIPHARM REJECTED
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Ntombi Mhlongo on 27/10/2024 16:28:00


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.