CMST recalls drug
Central Medical Stores Trust (CMST) has ordered hospitals to stop administering an antibiotic, cefotaxime, as a precautionary measure to allow further quality assessment.
CMST public relations officer Herbert Chandilanga confirmed the development in an interview last week, saying it was a precautionary measure following a report from Mchinji District Hospital, one of the six hospitals that had the drug in stock, that the antibiotic showed a yellowish colour instead of white after being diluted.
He said: “Our recalling it from all other facilities is a precautionary measure pending PMPB [Pharmacy, Medicines and Poisons Board] investigation of the matter.
“[Nonetheless] the product passed quality control tests by the Pharmacy, Medicines and Poisons Board before being dispatched to facilities.”
Chandilanga further said out of the five hospitals that had the drug in stock, only Mchinji District Hospital reported having a problem with the drug as it would discolour after diluting.
However, communication The Nation has seen from CMST pharmacist in Southern Region, Cosmas Sawamba, read: “Take note that CMST is recalling the product mentioned above with the following details for further quality assessment.
“We are, therefore, requested to immediately withdraw the product from our stock and send it back to CMST. Cefotaxime injection 500ng PFR, manufacturer: Intermed India, batch no. P14002, date of manufacture: 6/2014, date of expire: 5/2016.”
In response to the communication, Mangochi district medical officer Jeffrey Jooma said: “I believe this is the stand for all the DHOs [district health offices] regarding what Dr Kabwere and Dr Chise have highlighted. I suggest CMST gives us an answer on this in a timely manner so [that] we can map the way forward.
“In the meantime, those who have the particular batch of cefotaxime in stock shall stop dispensing it. Therefore, CMST should supply us with other I.V. antibiotics to fill the gap this will leave considering the supply rate for I.V. antibiotics in the last order ranged from poor to non-existent.”
Responding to Jooma’s e-mail, Sawamba said: “All issues raised by the DHOs are well noted. I will take the matter to the relevant authorities and surely feedback will follow. In the meantime, let us stop administering the said item. Thank you for your understanding.”
In another e-mail communication seen by The Nation, PMPB registrar Godfrey Kadewere said the drug had not yet been administered to any patient because the discolouring was noticed earlier on before it was administered.
He said: “Nothing was missed by way of laboratory assessment to inform product release by CMST. The product passed quality tests and after that, it was released by CMST. However, quality of a product can change while in storage depending on many factors such as storage conditions. That is why it is always important to have suitable storage facilities.
“On the findings of the PMPB, Mchinji District Hospital pharmacy at the moment has unsuitable storage conditions for cefotaxime injection. The injection requires conditions of temperature not exceeding 25 degrees Celsius or preferably refrigeration and protection from light.”
Chandilanga said cefotaxime is a tertiary level drug administered in central hospitals or, where there is need, district hospitals. He said the batch in question was dispatched five months ago to Queen Elizabeth Central Hospital (QECH) in Blantyre, Kamuzu Central Hospital (KCH) in Lilongwe as well as Salima, Mchinji and Ntcheu district hospitals.
A CMST source agreed with Kadewere’s observation that there could be storage challenges at Mchinji District Hospital to warrant the discolouring of the drug.
Cefotaxime is an antibiotic used to treat a wide variety of bacterial infections. It works by stopping the growth of bacteria, according to a medical doctor.
