Kenyans have been urged to be on the lookout for a batch of fake breast cancer drug in circulation in the country.
The Pharmacy and Poisons Board in a statement on Saturday said a batch of falsified Herceptin 440mg (Trastuzumab 440mg) had been detected in the market.
According to PPB, the said product is bearing the batch number C5830083, manufacture date 12, 2021 and 11, 2024 as the expiry date.
It is claimed to have been manufactured in Germany by Roche Products Ltd, but the brand owner has since confirmed the product to be fake.
“The public is notified that this specific product batch number C5830083 is a confirmed counterfeit. It is not authorised to be in the market and is a falsified product in view of the falsified contents, packaging and labelling aspects which have been confirmed by the brand owner,” PPB CEO Fred Siyoi said.
“Consequently, the PPB cautions the public against the use, sale or distribution of the product batch number C5830083 as their safety, quality and efficacy cannot be assured,” Siyoi warned.
He said the board in collaboration with other investigative agencies has instituted legal and regulatory actions against individuals suspected to be perpetrating the illegal cancer drug activities.
“The PPB has initiated a rapid response and heightened surveillance of the market to ensure safety and public health are protected,” Siyoi said.
Herceptin is a drug that has been approved for the treatment of early-stage breast cancer and to stop its further spread.
Roche said Herceptin was the first Human Epidermal growth factor Receptor 2-positive (HER2+) targeted therapy for breast cancer.
HER2-positive breast cancer is a breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). This protein promotes the growth of cancer cells.
“It is a monoclonal antibody that binds to HER2 receptors present on the surface of HER2-positive tumour cells, blocking them from receiving growth signals and flagging them for destruction by the immune system,” Roche’s website says.
The drug is approved in several countries and is used in combination with chemotherapy for the adjuvant (post-surgery) treatment of HER2-positive early breast cancer.
It is also a first-line treatment of advanced HER2-positive breast cancer and first-line treatment of advanced HER2-positive gastric cancer, Roche says.
In the last few months, a number of falsified health products have been reported in the market.
Two weeks ago, PPB launched an assessment of 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 drugs’ 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 and depo-medroxyprogesterone 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 sectors.
Officials from PPB in collaboration with the National Pharmacovigilance and Post-marketing Surveillance (PV/PMS) technical working group conduct a national risk-based post-marketing quality survey.
The facilities surveyed 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.