Kenyans urged to report adverse drug reactions for action

Healthcare workers and the general public have been urged to report any cases of adverse drug reactions for further action.

An adverse drug reaction is a reaction from the drug that is undesirable and unintended.

The Pharmacy and Poisons Board (PPB) has noted that despite improvement in reporting such reactions, poor reporting culture amongst healthcare providers and the public still slows down the process. 

According to the data by the board, the National Pharmacovigilance Centre received 1,244 Suspected Adverse Drug Reactions (SADR) reports between July 2023 and June 2024.

A total of 315 Adverse events following Immunization (AEFIs) reports, 562 Medication Error (ME) and 94 Public Adverse Drug Reaction (PADR) reports were received from the public during the same time interval.

“This was a slight decrease from the total number of reports received in the year 2022/2023 when the board conducted a Cohort Event Monitoring Study for the Covid-19 vaccine,” the board said in a statement.

“In addition, a total of 49 serious AEFIs and 13 serious SADRs were investigated and submitted to the expert committees for causality assessment, from which feedback was issued to relevant stakeholders.”

The World Health Organisation says that unintended, harmful reactions to medicines are among the leading causes of death in many countries.

It further notes that even though no medicine is risk-free, vigilant assessment of the risks and benefits of medicines promotes patient safety.

“The effects of any treatment with a medicine cannot be predicted with absolute certainty. All medicines have both benefits and the potential for harm,” the WHO says.

It adds: “The risk of harm can be minimised by ensuring the quality of prescription medications, and that they are medically appropriate, effective and safe for patient use.”

Preventing and detecting adverse effects from medicines is termed pharmacovigilance.

The board through the Pharmacy and Poisons Rules, 2022, established the office of the County Pharmacovigilance Focal Person.

The mandate is to help coordinate the implementation of the pharmacovigilance and post-market surveillance activities within counties ultimately improving patient safety. 

The vigilance focal persons serve as a critical link between the Board and the county governments on matters of patient safety as well as conducting and implementing pharmacovigilance and post-marketing surveillance activities within their respective counties and facilities.

They report and investigate adverse events, train and sensitise healthcare providers and the public, and disseminate feedback from the Board to the relevant stakeholders within their respective counties.

Started in May 2023, every county through the Council of Governors (CoG), nominated a County Vigilance Focal Person.

Additionally, two national referral hospitals; Kenyatta National Hospital (KNH) and Moi Teaching and Referral Hospital (MTRH), also designated vigilance focal persons.

Consultative meetings were held on May 16 and July 29 to reflect on the impacts of the appointment of the vigilance focal persons and to chart the way forward based on the feedback provided.

During the meeting, key findings indicated a notable improvement in training of healthcare providers to identify, report and investigate adverse events.

A significant increase in the number of investigations of serious adverse events carried out by the County and Subcounty Health Management teams was also reported.