The Zambia Medicines Regulatory Authority (ZAMRA) says it is not mandated to control how patients use medicines that are given to them, contrary to misconceptions advanced by the Medical for Quality Healthcare in Zambia (MQHZ).
But the Authority has expressed regret over reports of HIV-negative people accessing ARVs, a development which it hopes to minimize in collaboration with all relevant law enforcement agencies.
On Monday, MQHZ Director-General Dr Quince Mwabu accused ZAMRA of failing to control and regulate how medicines and allied substances were being made available to the general public.
Dr Mwaba had also challenged ZAMRA to inform the nation where HIV-negative people were getting ARVs in line with unspecified reports that there was widespread abuse of the drug.
But in a statement, ZAMRA public relations officer Ludovic Mwape stated that the Authority ensured that premises used for manufacture, import and export, distribute, supply and sale medicines and allied substances were registered and subjected to inspections.
“ZAMRA has noted with deep concern the above-mentioned statement attributed to Dr Quince Mwaba, Director-General of Medical for Quality Healthcare in Zambia (MQHZ), on the alleged failure by the Authority to adequately regulate the pharmaceutical industry. We take strong exception to the content of the statement as the facts, therein, were misrepresented. We wish to put it on record to the nation that in line with the Medicines and Allied Substances Act No. 3 of 2013, it is not the mandate of ZAMRA to control how patients use their medicines once they are dispensed to them. The Authority, however, ensures that premises used for manufacture, import and export, distribution, supply and sale of medicines and allied substances are registered and subject to inspections by its inspectors to ensure continued compliance with the law. Furthermore, it is also a requirement that people handling these medicines and allied substances are qualified and duly registered with their professional bodies,” Mwape stated.
But he conceded that it was regrettable to have HIV-negative people accessing ARVs.
He said the Authority would, however, work with relevant law enforcement agencies to conduct operations aimed at curbing illegal sale of medicines.
“The public may wish to know that a greater majority of our people access Anti-Retroviral drugs (ARVs) from public health facilities. The Government of the Republic of Zambia, through the Ministry of Health, ensures that suitably qualified personnel are deployed to these facilities. The Authority also registers pharmacies in both public and private hospitals. With these measures in place it is, therefore, regrettable that there are allegations of HIV-negative people accessing some types of ARVs, which they are reportedly abusing,” stated Mwape.
“The Authority is concerned that such practices expose people to high chances of experiencing adverse drug reactions (ADRs). ZAMRA will continue to work with other law enforcement agencies, such the Drug Enforcement Commission (DEC) and the Zambia Police Services to conduct operations aimed at curbing illegal sale of medicines. In addition, the Authority conducts public awareness activities aimed at equipping members of the public with information on the dangers associated with accessing medicines from unregistered outlets. We, therefore, urge our people to guard their health jealously by obtaining medicines from registered facilities where quality, safety of medicines can be assured.”
Meanwhile, in a separate statement, Pharmaceutical Society of Zambia (PSZ) president Jerome Kanyika charged that MQHZ was ignorant and that it was dangerous to issue a statement that attacked legally operating community pharmacies that provided much-needed services.
“PSZ wishes to express its displeasure on the statement issued by Medical for Quality Healthcare in Zambia (MQHZ), which we deem or describe as ignorant, uninformed and meant to flaunt laws and regulations that exist in the country. It is disheartening to note how an organization without even referring to any written laws or research could comment on important national matters. We want to advise MQHZ that medicine or drug-related issues are very sensitive and organizations should only comment on this from an informed point of view. To state that ZAMRA has totally failed to regulate the use of drugs in the country is very misleading and akin to calling for illegalities! We would want to inform the ‘good’ doctor that ZAMRA has been fulfilling its mandate as prescribed in the Medicines and Allied Substance Act (MASA) of 2013, which as PSZ, the fraternity of drug experts, commends,” stated Kanyika.
“We would want to find out which law MQHZ referred to when it commented on how legally operating retail pharmacies should be stocked and the proximity expected of such facilities to the public health facilities. If MQHZ had the courtesy to read even one section or, indeed, the preamble of the MASA it would have been guided that private pharmacies are allowed by law to operate in Zambia. The distribution and supply of drugs in Zambia is not the monopoly of public institutions and as such comparing the stocks of medicines in the independent pharmacies to public facilities reveals the sheer ignorance by the ‘good’ doctor on how drugs should be distributed and accessed in the country. It is also a dangerous stance in that such a statement is an attack on the legally operating community pharmacies, which are providing a much-needed service as close to the families as possible.”