ACPN seeks compensation on recalled substandard drugs

•Community pharmacists charge FG to shut down all open drug markets in Nigeria, implement new National Drug Distribution Guideline
The Association of Community Pharmacists Nigeria (ACPN) has called on the Federal Government to shut down all open drug markets, adequately compensate community pharmacists for the recalled drugs sent back to National Agency for Food and Drug Administration and Control (NAFDAC) and implement the new National Drug Distribution Guideline.

ACPN made the call during an emergency press briefing to caution and sensitise the public on the dangerous drug, ‘Dexamethasone’, which is in circulation through open drug markets.

Dexamethasone is a glucocorticoid medication used to treat rheumatic problems, a number of skin diseases, severe allergies, asthma, chronic obstructive lung disease, croup, brain swelling, eye pain following eye surgery, superior vena cava syndrome (a complication of some forms of cancer), and along with antibiotics in tuberculosis.

NAFDAC had on October 7 issued a public alert detection of substandard dexamethasone products in Nigeria.

NAFDAC notified healthcare providers and the public of the detection of substandard dexamethasone tablets purchased in Anambra State following cooperation between an academic pharmaceutical institute in Europe and a partner organisation in Africa.

Twenty-two samples of dexamethasone tablets were purchased in Anambra State and subjected to quantitative analysis using High Performance Liquid Chromatography (HPLC). The result of analysis showed that the samples were found to contain substandard amounts of dexamethasone (that is less than the amount stated on the label).

The administration of the sub-therapeutic doses of dexamethasone in the products or any substandard and falsified medical products may cause harm to patients and lead to treatment failure. They can also lead to loss of confidence in medicines, healthcare providers and health systems.

Some of the samples were also found to contain methylparaben and/or propylparaben in small amounts. NAFDAC said the use of these substances should be avoided, particularly in case of paediatric formulations.

Methylparaben and/or propylparaben is a preservative often used to give a product a longer shelf life.

National Chairman, ACPN, Adewale Aderenu, at the briefing, expressed his concerns and called on the Federal Government to sufficiently empower NAFDAC to carry out its oversight functions when it comes to commodities in the healthcare space in Nigeria. He said: “NAFDAC needs more funding to be able to carryout its oversight functions and the Federal Government must use its authority to close down all open drug markets in the country because as community pharmacists are recalling the medicines, it will be difficult to recall the ones in the open market and not only that, many people who handle medicines but do not have the requisite training do not know the implications of what they are doing.”

Oladigbolu also called on fellow community pharmacists to ensure they send those recalled drugs to the state chairmen. He said: “NAFDAC recently issued two directives; the first one was due to the type of medicine called Dexamethasone and the other on the cough syrups that has been circulating in the West African sub regions. Dexamethasone is very important medicine use for asthma, severe allergies and even kidney high disorder and because it is so important, we realise that if it is not potent then it is not good for community pharmacists to dispense it and in this case, the World Health Organisation (WHO) have found this product wanting and community pharmacists within 48 hours will recall all the ones on their shelves.”

Oladigbolu also emphasised on the need for the Federal Government to implement the New National Drug Distribution Guideline, which states that all medicines in Nigeria must be accounted for.

Oladigbolu also called on NAFDAC to partner with pharmacy schools across the country to improve surveillance of all drugs that are in circulation in Nigeria. He said: “We are calling on NAFDAC to partner with the Schools of Pharmacy in Nigeria to carry out quality surveillance for medical products in the country.”

Oladigbolu also assures the public that community pharmacists in Nigeria do not have such drugs, especially because it is not registered under NAFDAC. He said: “We want to assure the authorities that such cough syrups cannot be found on the shelve of any Nigerian pharmacists because they are not registered by NAFDAC and as such, community pharmacists in Nigeria do not stock them at all. However, we need to be careful because there are so many open drug markets. So, Nigerians have to be vigilant and careful because these cough syrups may find its way to the Nigerian market.”

He continued: “Incidentally and practically, all the brands of the Dexamethasone recalled are registered by NAFDAC and being responsible set of people, the community Pharmacists have decided to collaborate with NAFDAC to withdraw those brands and 15 brands have been listed and we are doing our best nationwide to withdraw those brands.

“When a medicine is registered by the health authority of a country, community pharmacists are at liberty to stock such medicines but when there is a defect and the health authority calls for a recall, then it is the responsibility of all pharmacists to ensure that the recall process is successful and that is exactly what we are doing right now.

“We have issued out communications to all pharmacists in Nigeria to kindly forward those medicines to the chairman of each of the states in Nigeria so that we can pull them together and send it to the appropriate authority that will take the required action.”

Oladigbolu called on the government to ensure adequate compensation to the community pharmacists for all the recalled drugs. He said: “The question now is, who pays those community pharmacists for this drugs that are being recalled? It is important that the federal government looks into this and also important to penalize and punish the companies responsible for these heinous crimes and finally repay back the money spent by pharmacists in procuring these drugs so that we can guarantee that if there happens to be a recall in the future, all responsible professionals will obey that recall.

“All over the world, once there is a recall, the government of the country ensures that the community pharmacists are adequately compensated and restored back to their original financial position without any damage or financial loss. So, we are calling on the Federal Government and the director general of NAFDAC to ensure that no stone is left unturned when it comes to this recall.“