The Pharmaceutical Society of Ghana (PSGH) has described as “a diabolical ploy to throw dust into the public’s eye”, the Food and Drugs Board’s recent claims that some anti-malarial drugs are “fake”.

A statement by the PSGH says the FDA is only seeking to “divert attention from the recent PSGH call for investigations into the impasse between the FDA and some pharmaceutical importers”.

It said: “In fact, after the recall of the anti-malarials by the FDA, the PSGH convened a stakeholders meeting of its members in the pharmaceutical sector and took the decision to support the National Malaria Control Programme (NMCP) of the Ghana Health Service (GHS) to get Ghana on to the Global Fund’s Affordable Medicines Facility for malaria (AMFm) initiative”.

“This led to the importation into Ghana of WHO-prequalified Artemisinin Combination Therapies (ACTs) which is the main factor that led to the decrease from 36% of fake anti-malarials in 2008 to less than 5 % in 2011”.

Below is the full statement from the PSGH.

PRESS RELEASE BY THE PHARMACEUTICAL SOCIETY OF GHANA (PSGH) ON A PRESS RELEASE BY MR. SAMUEL ASANTE BOATENG OF THE FOOD AND DRUGS AUTHORITY (FDA)

The attention of the Pharmaceutical Society of Ghana ( PSGH) has been drawn to a press release widely publicized on various news websites and published on page 19 of the Daily Guide of Thursday, 17th October and on page 8 of the Ghanaian Times of Friday, 18th October, 2013.

In the said release, Mr. Samuel Asante Boateng, Acting Head, Pharmaceutical Industrial Support Department of the Food and Drugs Authority among other things said “It may be recalled that in 2009, the PSGH accused the FDA of destroying the business of pharmacists after the FDA through its post-market surveillance intelligence activities uncovered fake anti-malarials on the Ghanaian market and issued a public alert to that effect ”.

This statement by Mr. Samuel Asante Boateng is inaccurate and most unfortunate. Pharmacists by law are to supervise the process of medicines use and in line with that, the mission of the PSGH is to provide sustainable, accessible, affordable and humane quality pharmaceutical service to all through continuous professional development and collaboration with Government, international organisations and other health professionals.

It will therefore be a gross disregard of the PSGH constitution and code of ethics by members of PSGH to accuse the FDA of destroying business of any group of people in their quest to assure quality, safe and efficacious medicines for all Ghanaians since the mandate of the FDA which is to protect public health and public safety in drug regulation is very key to the provision of quality pharmaceutical care .

It must be said that members of the PSGH are pharmacists found in diverse fields of practice notably; Research and Academia; Regulation; Medical Representation, Industry; Community Practice; Hospital Practice among others.

To set the record straight, in 2009 there had been a sudden surge in issues affecting pharmacists and the issuance of several alerts by the FDA on counterfeit/fake medicines including anti-malarials. The PSGH therefore organised a meeting of its membership in Accra on a three-item agenda:

1. The baseless interdiction of the Board Chairman of the FDA who was then the President of the PSGH.

2. The Rambo-styled invasion of premises of Kinapharma Ltd and the arrest of its owner on the allegation of importation of narcotic drugs by the FDA and some security agencies.

3. The public and media misunderstanding of the recall of 22 anti-malarials by the FDA.

As a professional body whose members are bound by a constitution and code of ethics, it was only proper that the PSGH hear the side of the stories of the pharmacists involved or affected by the afore-mentioned issues and take an informed decision and position on the issues.

This is because the PSGH frowns on a member bringing the name of the profession into disrepute by engaging in illegal, unprofessional or unethical conduct. This meeting was very important because until then, it was only the side of the FDA that was in the media. After the meeting, it was established that some of the anti-malarials in question “fell short of standards” by failing tests such as dissolution and disintegration.

The PSGH never ever at anytime said or issued a press statement to the effect that the FDA was destroying the business of pharmacists in relation to the widely-publicized “banning” of the anti-malarial as Mr. Samuel Asante Boateng wants the public to believe.

The concern of the PSGH regarding the recalled anti-malarials by the FDA in 2009 was the manner in which the recall was communicated.

This culminated in most of the misunderstanding in the media where most of them labelled the affected batch numbers of anti-malarials as fake and or having been banned. Such was the confusion created by the FDA alert that the Acting Head of Laboratory Services of the FDA, Mr. Eric Karikari Boateng granted media interviews to explain to the general public that the anti-malarials were neither fake nor were they banned but specific batch numbers of the said anti-malarials had been recalled.

He said: “When you say ban, then it means the marketing authorisation, the registration of the product has been cancelled and therefore you cannot put the product on the market again. But when you say recall, normally in manufacturing the regulatory authority can allow the manufacturer to recall that product that does not meet the specifications and standards according to which the product was registered and put on the market”.

Mr. Eric Karikari Boateng went on to say categorically that the recall of the anti-malarials did not mean they were fake but rather its quality “fell short of standards”.

For Mr. Samuel Boateng Asante to now call as FAKE the recalled anti-malarials which the FDA said in 2009 were not FAKE is a DIABOLICAL ploy to throw dust into the public’s eye and divert attention from the recent PSGH call for investigations into the impasse between the FDA and some pharmaceutical importers.

In fact, after the recall of the anti-malarials by the FDA, the PSGH convened a stakeholders meeting of its members in the pharmaceutical sector and took the decision to support the National Malaria Control Programme (NMCP) of the Ghana Health Service (GHS) to get Ghana on to the Global Fund’s Affordable Medicines Facility for malaria (AMFm) initiative.

This led to the importation into Ghana of WHO-prequalified Artemisinin Combination Therapies (ACTs) which is the main factor that led to the decrease from 36% of fake anti-malarials in 2008 to less than 5 % in 2011.

Indeed, in 2010 the PSGH was the first professional body to train its members all over the country on the Revised Anti-Malaria Drug Policy. The report was submitted by the NMCP to the Global Fund to fulfil part of the conditions for the Global Fund support with the co-payment for the WHO-prequalified ACTs.

As all may recall, in 2009 the FDA, Ghana Police Service and related agencies stormed the premises of Kinapharma and its owner Pharm. Kofi Poku Nsiah on the pretext that he had in his possession narcotic drugs. This issue generated so much negative publicity for Pharm. Kofi Poku Nsiah and Kinapharma Ltd. After it was proven that the allegation was false, the PSGH issued a press statement in which it called for an independent investigation into the issue.

The PSGH stated that “ The conduct of the Police Service and related agencies; the level of media coverage and publicity gave the impression of an attempt to impugn on the hard-won professional and business niche that an illustrious pharmacist like Pharm. Kofi Nsiah-Poku had carved for himself and his company, Kinapharma over the years in Ghana, West Africa and globally “. The PSGH statement also called for a fair and transparent framework for regulating the pharmaceutical sector in Ghana.

These calls by the PSGH were not based on any public alert issued by the FDA on fake anti-malarials as was suggested by Mr. Samuel Asante Boateng.

The PSGH is a professional body that is committed to the health and well-being of Ghanaians through the provision of excellent pharmaceutical services by its members at all times.

I hope this rejoinder will be given the same prominence that was given the original article by Mr. Samuel Asante Boateng.

Thank you.

Pharm. Dennis Sena Awitty, EXECUTIVE SECRETARY CC: Hon. Minister for Health, Ministry of Health, Accra.