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LAHORE: The initial investigation has reportedly detected the chronic problems in repackaging (compounding) the Avastin drug and its supply and the maintenance of the cold chain that led to the outbreak of the disease in Punjab.
The official figures unveiled that the contaminated drug has severely affected the vision of 68 patients in the province since the scam surfaced.
Of the total patients, 25 were reported in Lahore, 19 in Multan, five in Bahawalpur, four each in Kasur, Rahim Yar Khan, Sadiqabad and Khanewal while three patients were reported in Mian Channu, according to the official figures.
There are reports that more cases are surfacing across the province and the health authorities are assessing them to make them a part of the government data.
Swiss company says cancer drug wasn’t approved for diabetes-related eye conditions; govt sacks 12 officials over negligence
According to senior doctors, including the eye specialists, the diabetic patients who were administered the drug may develop a life-threatening disease, endophthalmitis, an inflammation of the inner coats of the eye and the experts fear that the patients may face more severe impact in the coming days.
According to the initial inquiry, the injection was to be used within six hours of its repackaging, also called compounding.
Quoting the inquiry, an official says, the owners were repackaging (compounding) the drug/injections in a highly unsterilized environment at a laboratory situated in the basement of a private hospital in Model Town, Lahore. He says the health department teams have sent the samples of the suspected drug from the Shaukat Khanum Memorial Cancer Hospital and Saira Memorial Hospital to the Drug Testing Laboratory and added that the staff assigned with the task was neither wearing gloves, nor kits designated for manufacturing of drugs. He further lamented that the drug was being compounded in the unsterilized environment of operating theatre.
The official reveals that the drug in question needs to be strictly kept at -2ºC to -8ºC while stocking and transporting it to the destinations with caution to be used within 24 hours.
The experts in their inquiry report, however, claimed that the drug was to be administered within six hours of its drawing from the vial. Unfortunately, the employees were transporting the drug on motorbikes in ice packs to maintain cold chain in Lahore and there were also reports that the same was being sent to the distant cities, including Multan, Bahawalpur, Rahim Yar Khan, Sadiqabad and Mian Channu, probably by passenger buses.
The official says 25 injections were sent to Multan alone and other cities of south Punjab where the cases of adverse reactions to the drug surfaced. The experts have suggested to the government to ban transportation of such drugs from one city to another if the duration of the distance is more than three hours. They have recommended that the affected patients should immediately be treated with intravitreal antibiotics with and without core vitrectomy accordingly.
Meanwhile, the Punjab health department has suspended from service 12 drug inspectors, deputy drugs controllers and drugs controllers over negligence related to manufacturing, distribution and sale of injection Avastin (bevacizumab) that has led to the vision loss of patients.
The action was initiated against them a day after Chief Minister Mohsin Naqvi ordered the health authorities to initiate action against the drug inspectors and other officers concerned for not ensuring the manufacturing, supply and safe use of the drug.
According to a notification issued here on Monday, the officials placed under suspension included former drug inspector of Allama Iqbal Town Dr Danyal Elahi, present drug inspector of Allama Iqbal Town Sher Mohammad Zaman, former drug controller of Gulberg Town Rana Muhammad Shahid from Lahore, drug controller Jhang Atia Nawaz, drug controller Bahawalpur Ali Raza, deputy drug controller tehsil Bahawalpur Saddar Amjad Farooq, drug controller Rahim Yar Khan Ameer Shahid, deputy drug controller Sadiqabad Farrukh Saleem, drug controller Kasur Sanaullah, former drug controller Bahawalnagar Rao Sajid, drug controller Khanewal Rana Mohammad Akram and deputy drug controller Multan Mehmood Khan.
These officers have been directed to report to the primary and secondary healthcare department.
Reuters adds: On its website, Swiss pharmaceutical company, Roche, said its Avastin was approved in more than 130 countries, including the United States, to treat several types of cancer.
“Roche strongly condemns this criminal act of counterfeiting and is doing everything in its power to cooperate with the authorities to protect patients from counterfeits,” said Roche in a statement to Reuters.
“In Pakistan, the vision loss from Avastin has been identified by the authorities as a case of contamination by a third-party supplier,” it added.
The regulator said, in its statement, that in the cases concerned Avastin had been used off-label, meaning outside its approved use, to treat diabetes-related eye conditions.
Cancer drug Avastin, when used at much lower doses, is similar to eye drug Lucentis and is used in many countries as a low-cost option to treat certain blindness-causing conditions.
Roche added: “Avastin is not approved for any use in the eye. Counterfeit medicines pose a health risk to patients because their content may be ineffective and contain harmful ingredients.”
Alam Sher, Punjab’s deputy drug controller who filed the police complaint against the distributors, told Reuters that some companies buy Avastin and repackage it in smaller doses to make it more affordable for patients.