Doctors in Bangladesh continue to ignore the practice of regularly submitting Adverse Drug Reaction (ADR) reports, which is common practice in developed countries and necessary for ensuring the safe use of quality drugs.
Sources said that during the last 20 years (from 1994 to 2013), the Directorate General of Drug Administration (DGDA) authorities received only 50 ADR reports, among which only 10 reports were completed properly. Around 40 of those ADR reports were submitted in the last two years alone.
The DGDA recently revived a 16-member Adverse Drug Reaction Advisory Committee (ADRAC), headed by Director General of DGDA Major General Jahangir Hossain Mollick, while a six member ADR monitoring cell was also opened. Selim Barami, one of the directors at DGDA, heads the cell.
The lack of ADR reports has become a barrier for exporting drugs to developed countries, as clients demand to see ADR or pharmacovigilance (drug safety) reports before import. Bangladesh is yet to become a member of the Sweden-based International Drug Monitoring Centre (IDMC), set up in collaboration with the World Health Organisation, as the centre requires at least 20 valid ADR reports each month from its members.
“We had been trying to become a member of this centre for 20 years, but could not. We got only 50 reports in 17 years, so how can we send 20 valid ADR reports per month? So, Bangladesh could not get membership of IDMC,” Selim Barami told the Dhaka Tribune.
He also said authorities undertook an initiative in 1994 to encourage the practice of writing ADRs. They printed forms for ADR reporting, and around 500 doctors from nine public medical colleges were trained in preparing ADR reports. However, the reluctance of doctors to prepare ADR reports, coupled with funding and manpower crises, forced the DGDA to stop the initiative.
Meanwhile, several senior officials at DGDA said the deaths of four babies at a Tangail hospital on Friday were the result of doctors not reporting on ADR, which would have allowed them to understand the drug quality earlier. The newborn babies died after they were allegedly given out-of-date antibiotic injections. A three-member probe committee has been formed to investigate the deaths.
Prof Dr Rashid-e-Mahbub, president of Health Rights Movement National Committee and former president of Bangladesh Medical Association, told the Dhaka Tribune: “Doctors of Bangladesh are not aware of ADR reports. Most of the doctors do not know how to write valid reports or where to get the form. DGDA is not creating awareness among the doctors. Pharmaceutical industries also fail to act the right way. They offer bribes to write prescriptions for the medicine but they do not invest in creating awareness among doctors.”
Preferring not to be named, a senior professor of medicine at Bangabandhu Sheikh Mujib Medical University said sometimes there were reports of patients dying after being given the wrong injections or drugs. The practice of regular ADR reporting would allow doctors to know about the drug reaction earlier, the senior professor observed, adding that seminars and symposiums should be held to create more awareness on the issue.
DGDA director Selim Barami told the Dhaka Tribune that the authorities revived the ADRAC on April 25, with departmental heads of different medical colleges included in the committee. The ADRAC will train 20 doctors from 20 public and private medical colleges in the capital, he added.
According to Barami, the training programme had already started at several medical colleges, with technical support from USAID-backed agency System for Improved Access of Pharmaceutical and Services (SIAPS). SIAPS will provide special software to the DGDA to monitor and store ADR reports.