PPB survey to determine quality of e-pills, other drugs in market

Samples collected will undergo triage using MiniLabs and compendial analysis at the quality control laboratory

In Summary

•Others include analgesics, antipsychotics, medicines used in maternal, neonatal, and child diseases, non-communicable diseases and cancer medications.

•The field exercise includes data and sample collection from pre-identified sampling facilities across public, private, and faith-based organisation (FBO) sectors.

Officials from PPB in collaboration with the National Pharmacovigilance and Post-marketing Surveillance (PV/PMS) technical working group conduct a a national risk-based post-marketing quality survey
Officials from PPB in collaboration with the National Pharmacovigilance and Post-marketing Surveillance (PV/PMS) technical working group conduct a a national risk-based post-marketing quality survey
Image: HANDOUT

A team from the Pharmacy and Poisons Board (PPB) has begun assessing the quality of medicines and other Health Products and Technologies (HPTs) in the country.

The exercise is being conducted in collaboration with the National Pharmacovigilance and Post-marketing Surveillance (PV/PMS) technical working group.

The aim is to conduct a national risk-based post-marketing quality survey to assess their compliance with quality specifications and standards.

The survey, according to PPB, focuses on specific product categories, including cough syrups, herbal medicines for erectile dysfunction (ED products) and emergency oral contraceptives, depo-medroxyprogesterone (DMPA) injections.

Others include analgesics, antipsychotics, medicines used in maternal, neonatal, and child diseases, non-communicable diseases and cancer medications.

The field exercise includes data and sample collection from pre-identified sampling facilities across public, private, and faith-based organisation (FBO) sectors.

Officials from PPB in collaboration with the National Pharmacovigilance and Post-marketing Surveillance (PV/PMS) technical working group conduct a a national risk-based post-marketing quality survey
Officials from PPB in collaboration with the National Pharmacovigilance and Post-marketing Surveillance (PV/PMS) technical working group conduct a a national risk-based post-marketing quality survey
Image: HANDOUT

The facilities include various tiers, such as central procurement agencies like the Kenya Medical Supplies Authority (KEMSA) and Mission for Essential Drugs and Supplies (MEDS), public and private hospitals, health centres, dispensaries and pharmaceutical outlets.

“Samples collected will undergo triage using MiniLabs and compendial analysis at the quality control laboratory, following the survey protocol provisions,” PPB said in a statement.

“The findings will guide regulatory actions by the PPB, with results and recommendations disseminated to relevant stakeholders through established knowledge management platforms,” it added.

Compendial testing comprises all of the analytical testing required to prove the identity, efficacy, and safety of drug products before they are packaged or distributed.

The board’s regional offices have minilabs for random sampling and testing of medicines in the market to ensure that medicines in the Kenyan market are of good quality, safe and efficacious.

The board has stepped up its fight against substandard, falsely labelled and falsified drugs to protect consumers.

It has an elaborate drug registration system that ensures that only safe, quality and efficacious products are registered.

The drugs are analysed by laboratories to ensure they comply with the label claims.

Officials from PPB in collaboration with the National Pharmacovigilance and Post-marketing Surveillance (PV/PMS) technical working group conduct a a national risk-based post-marketing quality survey
Officials from PPB in collaboration with the National Pharmacovigilance and Post-marketing Surveillance (PV/PMS) technical working group conduct a a national risk-based post-marketing quality survey
Image: HANDOUT

Currently, the agency randomly collects samples from all over the country and analyses them at the National Quality Control Laboratory to test for quality, safety and efficacy.

A system reporting suspected poor-quality medicines and adverse drug reactions has also been established to monitor medicines.

“PPB urges the public to remain vigilant and report any suspected poor-quality medicines or adverse drug reactions to the nearest healthcare facility and the Pharmacy and Poisons Board,” it said.

This can be done through various channels, including the official website, mobile application (mPvERS for both Android and iOS), USSD code (*271#), email ([email protected]) and telephone number 0795743049.

The PPB is the national medicines regulatory authority whose mandate is to protect the health of the public by regulating pharmacy and ensuring the quality, safety and efficacy of medical products and health technologies.

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