Oct 30 , 2022

A federal agency began enforcing strict measures on the quality and safety of drugs available to the public, ensuring early detection of risks caused by adverse reactions. Two medicines - whose types remain undisclosed - were reported as causing side effects after they were administered to patients, people familiar with the industry disclosed to Fortune.

Members of the public are unaware that they could report the adverse effects of drugs to the Ethiopian Food & Drug Authority (EFDA). The Authority tests reported drugs and orders recall when safety is at risk.

A committee, established six years ago, is formed anew following WHO recommendations to provide clinical decisions on adverse drug reactions. The reports are collected through mobile applications or yellow reporting cards. The Authority has developed a mobile application - Med Safety - to report adverse reactions to medicines, running for the past four years.

The Authority issued a directive to enforce the guideline already in effect, hoping to control the reporting system on drug safety. The directive was prepared by medical professionals, pharmaceutical manufacturers and importers a year ago. Reports that should have been submitted to the Authority regularly were lacking, putting the quality and safety of pharmaceuticals in question, and creating gaps in reporting patients' reactions to prescribed drugs.

"This makes reporting requirements mandatory," said Habtamu Gashaw, the Authority's clinical trials and pharmacovigilance team leader.

Health institutions and domestic pharmaceuticals are required to present drug analytics, manufacturers' profiles and safety update reports regularly.

Tesfaye Mekonen, marketing manager at Beker General Business Plc, an importer of over 200 pharmaceutical products, applauded the move.

The Chinese-owned Sansheng Pharmaceuticals began operations four years ago in Dukem Eastern Industrial Zone, 35Km east of the capital. Erected on a 160,000sqm plot, it currently operates at a five percent capacity due to foreign currency shortages. It is still waiting to secure three million dollars in letters of credit from the Commercial Bank of Ethiopia (CBE).

"The guideline requires us to report and hire a qualified professional to supervise the safety and quality of manufactured drugs," said Yared Hirpo, the deputy general manager.

According to officials of the Authority, the guideline will clarify the criteria for qualified pharmacovigilant professionals following international standards.

The state-owned Ethiopian Pharmaceuticals Supply Agency (EPSA) is the largest pharmaceutical buyer in the country. Established in 1947, the Agency distributes over a 1,000 drug types and medical equipment to more than 5,000 public health Institutions, with a 17 billion Br import bill last year.

The Agency is among the stakeholders in preparing the directive, notwithstanding the effects of the absence of quality assurance. Abdurahman Aliye, a pharmaceutical quality assurance specialist for the Agency, blames weak follow-up by compliance supervisors for failure to submit timely reports.

"We need a strong management system," said Abdurahman.

The Agency has received several complaints from pharmacies over quality and safety concerns over the past four years. The Agency's attempt to build a laboratory for drug testing was discouraged, form it has no mandate to run such a facility.

"We've requested the reporting system to be digitized since the manual system is long and arduous," said Abdurahman.

Tikur Anbessa Specialised Hospital, the largest public health Institution, has become a pharmacovigilance centre since 2020. It collects reports from health institutions to stores them in a database.

However, Demissew Gezahegne, pharmacy director, told Fortune that the reports were not submitted regularly, leaving them with little to show.

Demissew attributes reluctance to hold domestic pharmaceutical manufacturers accountable for failure to comply with the reporting requirement.

PUBLISHED ON Oct 30,2022 [ VOL 23 , NO 1174]

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