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.