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MBABANE – Who are the suppliers?
Perhaps this is the question most Swazis asked themselves a few days ago when they learned of the recall of certain medicines by the Ministry of Health. This publication on Friday sought answers from the Ministry of Health, led by Mduduzi Matsebula, MP for West Fokosini, to ascertain what exactly went wrong. In addition to the name of the supplier, one of the questions posed to the Ministry of Health was to ascertain how much stock had been sent to public health institutions and whether the supplier would A new batch is expected to be brought in.
Yesterday, the Ministry of Health subsequently issued a press statement informing the public that two batches of medicines (Folic Acid 5mg and Penicillin Syrup 125mg/mg) had been requested for quality checks. The Ministry of Health’s Communications Officer, Nsindiso Tsabedze, was asked if he would respond to the issues raised, to which he replied: “A statement has been issued in relation to the questionnaire you sent out”. He was then asked if he would respond to the rest of the initial questionnaire, to which he replied: “The statement currently addresses that. More details will be provided in the future.”
According to the statement, the announcement was issued after folic acid tablets with batch number 003254 were found to have black spots on them, while penicillin batch number 223131144 had different strengths on the labels. The ministry explained that it was not a matter of expired drugs as the expiry date of the folic acid tablet batch was February 2025 and the expiry date of phenoxymethyl penicillin was January 2025. “The issue is being taken very seriously and the ministry would like the public not to panic. The nationwide recall is a precautionary measure recommended by the Medicines Regulatory Unit (MRU), a unit under the ministry. The recall is in the best interest of the public and is intended to protect consumers during the investigation,” the statement read.
The statement mentioned that this is a quality control procedure to ensure that the medicines used by the public are safe and effective. The statement also mentioned that the affected medicines are batch specific, which means that only batch #003254 of folic acid and batch #223131144 of phenoxymethylpenicillin are affected, and other batches or similar products are not affected. “All public health units have been notified about the product recall and advised to remove the affected products from the shelves of pharmacies. Healthcare professionals have also been advised to immediately stop dispensing tablets and syrups from the affected batches. Public health units have also been advised to quarantine all remaining stocks of the affected medicines and return them to the Central Medical Store (CMS) through approved procedures,” the statement mentioned.
Furthermore, the Ministry of Health also shared insights about the medications at the time, explaining that folic acid is a supplement, while penicillin is an antibiotic. The Ministry of Health mentioned that customers who take folic acid tablets and penicillin syrup are advised to check the batch (lot number) of their medications and stop using them only if the medication is from an affected batch; dispose of the medication safely or return it to the nearest facility and request a replacement medication, call the Medicines Regulatory Unit (MRU) for any questions or for more information, or send a message through WhatsApp number 7655 7303.
The statement stressed: “We are conducting investigations jointly with relevant stakeholders. We will keep the public informed of any developments.” Notably, Funduzi’s forensic report on drug shortages found that there was an alleged lack of testing facilities to ensure the quality of drugs supplied. One of the recommendations in the report was that the government should develop a process to acquire drug quality testing facilities. The report recommended that the government redesign the entire drug ordering system.
Below is the questionnaire sent to the Ministry of Health last Friday;
Based on the notification issued by QC and PMS pharmacists to all public health agencies regarding the recall of Phenoxymethylpenicillin and Folic Acid Tablets BP 5mg, we request responses to the following questions:
Question 1 What or who is the name of the supplier? How much stock needs to be recalled?
Question 2 Will suppliers be asked to provide new stock? Will steps be taken to ensure this does not happen in the future?
Issue 3 The memo released indicated that a medical facility reported the incident to the Swaziland Medicines Regulator; did CMS not ensure that steps were taken to safeguard the quality of imported drugs?
Question 4 This is a health issue of national concern, why has there been no formal press statement from the Minister or the PS?
Question 5 How true are reports that one of the products was indeed supplied to schools in the country, and what about the public and patients who recently purchased the medicine in question?
About recalled drugs
Doctors told this newspaper that folic acid is suitable for Treatment of megaloblastic anemia caused by folic acid deficiencyIt is also used to prevent chronic hemolytic states, renal dialysis, and drug-induced folate deficiency. It is also used to prevent the recurrence of neural tube defects.
What is folic acid?
Doctor says folic acid is a supplement used to treat folate deficiency. It is used to treat certain types of anemia caused by folate deficiency, it is taken by pregnant women to prevent major birth defects, spina bifida and anencephaly, and it is also used with methotrexate to prevent folate deficiency caused by methotrexate. Spina bifida is a birth defect that causes the developing baby’s spinal cord to not develop properly. Folic acid is a man-made form of folate (vitamin B9). When a person takes folic acid, his body converts it into folate. Therefore, folic acid is important for making red blood cells and for making and maintaining new cells in the body. If a person’s folate level is low (as shown by a blood test), his health care professional may recommend taking folic acid tablets.
The main function of red blood cells is to carry oxygen from the lungs and deliver it throughout the body. They also carry waste products such as carbon dioxide back to the lungs to be exhaled. In short, doctors recommend folic acid tablets to treat and prevent the following diseases –
- Anemia due to folic acid deficiency in adults and children,
- Anemia during pregnancy,
- Anemia is a side effect of some medications.
- Anemia due to damage to red blood cells,
- Anemia in renal dialysis patients.
On the other hand, medical practitioners said Phenoxymethylpenicillin is a penicillin antibiotic. It is used to treat Bacterial infections, including ear, chest, throat, and skin infectionsIt is also used to prevent infection if a person has sickle cell disease, chorea (a movement disorder), rheumatic fever, or has had their spleen removed. It usually comes as a 250 mg tablet or liquid. It is said that two concentrations of liquid are available. The lower concentration is 125mg/5ml, and the higher concentration is 250mg/5ml. It is understood that these two concentrations can also be used as sugar-free liquids.
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