Times Of Swaziland: MINISTRY  EVASIVE OVER RECALLED  DRUGS

MINISTRY  EVASIVE OVER RECALLED  DRUGS
================================================================================
Ntombi Mhlongo on 30/06/2024 08:32:00


MBABANE-Who is the supplier?
Perhaps this is the question that most emaSwati asked themselves when they
learnt of the news that certain medication has been recalled by the Ministry of
Health a few days ago. This publication sought answers from the ministry, headed
by Siphocosini Member of Parliament Mduduzi Matsebula on Friday to ascertain
what really went wrong. Besides the name of the supplier, one of the questions
posed to the ministry was meant to ascertain how much of the stock had been
dispatched to the public health facilities and whether the supplier will be 
expected to bring in a new batch.
Yesterday, the ministry then issued a press statement advising the public that
two batches of the medication, Folic acid 5mg and Penicillin Syrup 125mg/mg had
been called for quality purposes. A question was posed to the ministry’s
Communications Officer Nsindiso Tsabedze on whether there would be responses to
the questions posed and he responded by saying, “In relation to the matter of
which you sent a questionnaire, a statement has been issued”. A follow-up
question was posed on whether there were responses coming to address the rest of
the initial questionnaire to which he responded by saying, “The statement
addresses this matter at the moment. Further details will be provided in
future".
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,” reads part of the statement.
It was mentioned that this was done as a process of quality control done 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. 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 then medication by explaining that
Folic acid was a supplement, and penicillin is an anti-biotic. 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 batch; safely dispose of the medication or
return it to the nearest facility and ask for another medication, call the
Medicines Regulatory Unit (MRU) about any concerns or to get more information,
or send a message via WhatsApp number 7655 7303.
“An investigation is being conducted in conjunction with the relevant.
stakeholders. The public will be informed of any developments in due course,”
it was emphasized in the statement. 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 advised that
government should redesign the entire system for drugs ordering system to
supply.
Below is the questionnaire that was sent to the Ministry of Health last Friday;
Following a minute issued by the QC and PMS Pharmacist to all public health
facilities recalling the Phenoxy methyl penicillin and Folic acid tablet BP 5mg,
we request responses to the questions below:
Question 1 What or who is the name of the supplier and how much of the stock is
being recalled?
Question 2 Will the supplier be made to supply new stock? Will there be action
taken to ensure that such is avoided in future?
Question 3 The minute issued reflects that the incident was reported to the
Eswatini Medicine and Regulatory Unit by one health facility; doesn’t the CMS
ensure that there are measures to safeguard the quality of imported drugs?
Question 4 This being a health issue of national concern, why has there been no
formal press statement issued by the minister or PS?
Question 5 How true are reports that one of the products has actually been
supplied to schools in the country? What about members of the public and
patients who recently purchased the meds in question?
About the recalled drugs
Medical practitioners told this newspaper that Folic acid is indicated for the
treatment of megaloblastic anaemia due to folic acid deficiency. It is also used
for prophylaxis in chronic haemolytic states, in renal dialysis, and in drug
induced folate deficiency. It can also be used for the prevention of recurrence
of neural tube defects.
What is Folic acid?
Medical practitioners say Folic acid is a supplement used to treat folate
deficiency. It is used to treat certain types of anemia caused by folic acid
deficiency and it is taken by pregnant women to prevent the major birth defects,
spina bifida and anencephaly, and it is also prescribed with methotrexate to
prevent methotrexate-induced folate deficiency.  Spina bifida is a birth defect
in which a developing baby’s spinal cord fails to develop properly. Folic acid
is the man-made form of folate (vitamin B9). When one takes folic acid, his or
her body turns it into folate. Therefore, folate is important for making red
blood cells and also for making and maintaining new cells in one’s body. If
one’s folate levels are low, as shown by a blood test, his healthcare
professional may recommend taking folic acid tablets.
The red blood cell's main function is to carry oxygen from the lungs and deliver
it throughout the body. They also transport waste such as carbon dioxide back to
lungs to be exhaled. In a nutshell, medical practitioners advised that Folic
acid tablets are used in the treatment and prevention of the following -
*Anaemia due to a lack of folic acid in adults and children, 	*Anaemia in
pregnancy, 	*Anaemia, as a side effect from treatment with certain medicines,
	*Anaemia due to damaged red blood cells, 	*Anaemia in patients on kidney
dialysis.
On the other hand, medical practitioners say Phenoxymethylpenicillin is a type
of penicillin antibiotic. It's used to treat bacterial infections, including
ear, chest, throat and skin infections. It can also be used to prevent
infections if one had sickle cell disease, or if he has had chorea (a movement
disorder), rheumatic fever, or a person’s spleen removed. It usually comes as
250mg tablets and as a liquid. It is said that there are two strengths of liquid
available. The lower strength is 125mg/5ml and the higher strength is 250mg/5ml.
It is understood that both strengths can also come as a sugar free liquid.