Malawi | Pharmacy and Medicines Regulatory Authority

PMRA employees urged to embrace professional integrity at workplace

Pharmacy and Medicines Regulatory Authority (PMRA) Director General, Mphatso Kawaye, has called on members of staff at the Authority to exemplify professional ethical behaviour and say no to corruption in discharging their duties.

Kawaye made the remarks Friday in Lilongwe when he presided over a half-day corruption awareness meeting for management and staff which was jointly facilitated by the Anti-Corruption Bureau (ACB) and PMRA’s Institutional Integrity Committee (IIC).

“Our commitment is to be a corruption free zone and each member of staff has a role to play for us to achieve this status and maintain it,” he said.

The Director General further said, by establishing an institutional integrity committee the Authority had demonstrated commitment to the fight against corruption and urged members of staff to rally behind efforts of the IIC in leading the institution in the prevention of the vice.

He then pledged the PMRA Board of Directors’ and management’s support towards activities of the IIC which he said are for the good of the organisation and the country.

among other topics, participants were taken through an overview of the NACS II and mandate of IIC, overview of corruption, and workplace ethics.

PMRA established the IIC in January this year to spearhead the Authority’s efforts in the fight against corruption in line with the National Anti-Corruption Strategy (NACs II), a government policy document in the fight against corruption.

The corruption awareness meeting was part of a series of activities which the IIC is geared to implement in the 2023/24 calendar year.

PMRA, MACRA sign MoU on herbal medicines advertising

Pharmacy and Medicines Regulatory Authority (PMRA) and Malawi Communications Regulatory Authority (MACRA) have entered into a memorandum of understanding (MoU) on regulation of broadcasting of adverts related to traditional medicines and allied substances by media houses in the country.

The MoU signed on Tuesday in Lilongwe will also see PMRA and MACRA working together in sensitizing media houses on provisions of the PMRA Act in relation to regulation of traditional medicines, allied substances and all other medicines regulated under the Act.  

PMRA Director General Mphatso Kawaye hailed the signing of the MoU as a milestone in the Authority’s efforts in ensuring that there is compliance with the law by herbal medicines traders and media houses, particularly on advertising and promotion of traditional medicines.

Section 68 (2) of the PMRA Act requires advertisers of any medicine or allied substances to seek prior screening and approval by the Authority before their advert is publicized on any media outlet.

Said Kawaye: “We have signed this MoU basically because of our public health concern over uncontrolled advertisement of traditional medicines on radios and televisions using unsubstantiated health claims.

“Although we issued guidelines to media houses about the requirement for prior screening of adverts, we have seen little compliance by media houses and that is why we reached out to Macra for collaboration in enforcing this particular legal requirement.”

On his part, MACRA Director General Daud Suleman observed that his organization has a role to play in ensuring that consumers of communication services such as radio and television content are protected from harmful and misleading information including public health messages.

“We need to start doing the right thing in as far as dissemination of information around public health is concerned,” said Suleman adding close working relationship with PMRA would benefit the nation through building well informed nation.

PMRA joins global medicines safety week social media campaign

Pharmacy and Medicines Regulatory Authority (PMRA) joins national medicines regulators from 82 countries across the globe and their stakeholders in taking part in this year’s Medicines Safety Week Social Media Campaign dubbed #MedSafetyWeek. This an international campaign led by the Uppsala Monitoring Centre (UMC), the World Health Organisation (WHO) Collaborating Centre for International Drug Monitoring. The campaign is supported by members of the International Coalition of Medicines Regulatory Authorities (ICMRA).

The seventh annual #MedSafetyWeek is running until 13 November to encourage everyone to report suspected side effects of medicines. This year’s global campaign focuses on the key role of every healthcare professional, patient, and caregiver who reports a suspected side effect hence contributes to safe use of medicines.

All medicines may cause side effects in some patients, so there are steps in place to continuously monitor their safety after they are placed on the market. The purpose of safety monitoring is to gain more information about known side effects and find out about new ones. Regulators, such as the PMRA, operate systems to detect and analyze those side effects and prevent harm to future patients.

By reporting suspected side affects you are actively participating in identifying emerging safety issues, so that PMRA can take action when necessary and protect you and others from harm. Every report made by a patient, a healthcare professional, or a caregiver plays a key role in gaining more knowledge about the benefits and risks of medicines in clinical use and allows action to be taken to minimize risks.

Anyone (patients, guardians and healthcare professionals) can report suspected side effects of medicines on Medsafe-360, a mobile phone based USSD platform accessible on Airtel and TNM networks by dialing *360#. Medsafe-360 is free of charge, works on both smart and ordinary phones and does not require internet connectivity.

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 Communications Regulatory Authority (MACRA) in the coming days in what PMRA Director General Mphatso Kawaye 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.

Kawaye 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 Kawaye.

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 warns of more action against pharmacists involved in medicine theft

Chimenya: More action is needed

Pharmacy and Medicines Regulatory Authority (PMRA) has warned it will soon start publishing names of all Pharmacy personnel and licensed business premises against whom disciplinary action has been taken for gross professional misconduct including indulging in theft of medicines in public health facilities.

In a statement issued Wednesday PMRA Acting Director General Charles Chimenya said the Authority was concerned with the rise in theft and pilferage of medicines in public health facilities, allegedly involving pharmacy personnel which the Authority regulates, adding it was even more disheartening that such malpractices are happening at a critical time when public health facilities are grappling with shortages and stockouts of medicines and medical supplies.

“PMRA joins the Pharmaceutical Society of Malawi (PHASOM) and all Malawians of goodwill in condemning the vice in its strongest terms and echoes calls for speedy prosecution of the suspected culprits.

“In continuing with its effort to stop the malpractices, PMRA will from this year start publishing names of all Pharmacy personnel and all licensed business premises against whom disciplinary action has been taken for violating dictates of the Pharmacy profession and practice,” said the Acting Director General.

Section 28 of the PMRA Act mandates the Authority to effect disciplinary action against all licensed pharmacy personnel and those operating licensed pharmacy businesses when deemed to be in gross violation of the Act. Penalties include suspension from practice and removal of offenders’ names from the appropriate register.

Similarly, stealing medicines or medical supplies from a public health facility is an offence under the PMRA Act which upon conviction attracts a fine of K20 million and imprisonment for 20 years.

The Authority has since called on potential employers to always check with the Authority the status of any pharmacy personnel before hiring them. Further to this, employers are requested to report to the Authority any pharmacy personnel suspected to be involved in theft or pilferage of medicines and medical supplies whether at a public or private facility in order for the Authority to take appropriate disciplinary action.

Added Chimenya: “Theft of medicines in public health facilities deprives innocent Malawians of access to quality health services. It is for this reason that PMRA calls for concerted efforts in ending the vice.”