PMRA courts media bodies on herbal medicine adverts

Pharmacy and Medicines Regulatory Authority (PMRA) has met Media Council of Malawi (MCM) and Malawi Chapter of Media Institute of Southern Africa (MISA – Malawi) on possible collaboration to control advertisement of traditional and complementary medicines (TCM) by local media houses.

The Authority is also expected to engage Malawi Regulatory Authority (MACRA) in the coming days in what PMRA Acting Director General Charles Chimenya says is a series of stakeholder engagements aimed at ensuring that media houses are complying with legal requirements for advertisement and promotion of herbal medicines.

PMRA is mandated under the PMRA Act No. 9 of 2019 to regulate advertising of medicines and allied substances.

Section 68 (2) of the Act states that “Advertisement of any medicine or allied substance shall require prior screening and approval by the Authority.”

Traditional medicines and food supplements with medicinal value fall under allied substances.

Chimenya said despite publishing guidelines on herbal medicines adverting in the local papers and issuing communications to individual media houses on the same, the Authority still faces non-compliance by media houses.

“We have an option of invoking the law to prosecute non-compliant media houses, however, we thought it wise to first engage these media regulatory bodies for their help in engaging their members on their role in controlling allied substance adverts.

“It is the general public that continues to be deceived by unauthorized advertisements and promotions of TCM products, hence the need to act now than later,” said Chimenya.

MCM Chairperson Wisdom Chimgwede and MISA Malawi National Director Aubrey Chikungwa have both commended PMRA for taking the route of engagement on the matter saying there is need for more awareness, on the provisions of the PMRA Act, targeting media owners, editors and heads of marketing.

The Authority, through Ministry of Health, is in the process of developing applicable regulations to guide implementation of registration of TCM products and associated businesses as provided for in the Act.

PMRA is a statutory organization established by Act of Parliament No. 9 of 2019 to regulate medicines, allied substances and the practice of pharmaceutical profession in Malawi.

PMRA wants pharmacovigilance incorporated in pre-service training curriculum

Pharmacy and Medicines Regulatory Authority (PMRA) has called for introduction of pharmacovigilance (PV) in pre-service training curriculum in all Health Science Colleges in Malawi, a sharp departure from current arrangement where graduates are only trained in the program while in service.    

PMRA Acting Director General Charles Chimenya made the call Thursday in Salima when he opened a one-day consultative meeting for heads of medical training institutions on the introduction of PV in pre-service training curriculum.

Pharmacovigilance is a practice of monitoring effects of medicines to ensure safety. It involves collection, detection, assessment, monitoring and prevention of adverse effects following usage of pharmaceutical products including vaccines.

According to Chimenya, the Authority has made tremendous strides in fulfillment of its mandate under section 72 (1) of the PMRA Act No. 9 of 2019 to oversee introduction and implementation of pharmacovigilance in Malawi.

He cited, among others, setting up of national PV centre, previously based at Kamuzu University of Health Sciences (formerly College of Medicine) but now at PMRA Headquarters in Lilongwe; registration of the PV centre under World Health Organization (WHO) Program for International Drug Monitoring, having met the required standards; and institutionalization of PV in hospitals and public health programs through in-service trainings for healthcare workers.

In an effort to strengthen PV, the Authority introduced and manages Med Safe 360, a USSD based platform whereby the public is encouraged to access and report adverse drug reactions by dialing *360#, both on Airtel or Telecom Network Malawi (TNM) networks.

However, Chimenya said there was need to carefully consider issues of sustainability on in-service training hinting PV implementation through in-service training is not sustainable amid resource constraints and donor fatigue among other bottlenecks.

“Sustaining programs through in-service training has proven to be expensive elsewhere and Government cannot afford. With emerging donor fatigue in financing health services, in-service training is no exception. The best approach which has been thought to be cost-effective is to introduce the subject in pre-service training curriculum,” he explained.

Chimenya said incorporation of important subjects such as PV in pre-service training curriculum is beneficial to the Government as new recruits from colleges are already introduced to the program and are well equipped with the basics and hands-on experience by the time they start practicing.

He urged stakeholders, particularly training institutions to support the initiative, saying successful implementation of the program depends on the buy-in from all those involved.

National Pharmacovigilance Coordinator Anderson Ndalama said increased access to medicines by the public and lack of safety data from developing countries for certain medicines are some of the reasons for the country to take pharmacovigilance seriously as a tool for safeguarding the public from unnecessary drug adverse effects.

Said Ndalama: “Importance of PV cannot be overemphasized; firstly, increased access to medicines increases the chance of rare adverse drug reactions (ADR). Secondly, some medicines are specifically developed for Africa. This, therefore, means that there is no safety data from developed countries and that we have to generate the data ourselves. Thirdly, differences in co-morbidities and concomitant medicines use mean different pattern of ADR.”

He said other challenges facing the current arrangement of PV implementation through in-service training includes difficulty in reaching healthcare workers, both in public and private hospitals; and that the training itself focuses only on one scope of the program, that is, reporting of adverse effects, leaving out other aspects such as medicine use problems and product quality problems. 

The meeting drew together participants from Kamuzu University of Health Sciences (KUHeS), Malawi College of Health Sciences, Mzuzu University (MZUNI), St. John Institute of Health Sciences, Nkhoma, Daeyang and Ekwendeni colleges.

A similar interface meeting was planned for Mangochi where the Authority engaged health science colleges from the Southern Region.

PMRA is a statutory organization established by an Act of Parliament No. 9 of 2019 with a mandate to, among other functions, regulate medicines and Allied substances, training of Pharmacy personnel, the practice of pharmacy and Pharmacovigilance in Malawi.