Abu Dhabi Gets Strict on Adverse Drug Reactions
DUBAI - Under reporting by healthcare professionals of adverse drug reactions, often for fear of lawsuits and bad publicity, has moved health authorities in Abu Dhabi to involve the public in a system starting next year.
It will be part of a drug safety monitoring programme of the Health Authority of Abu Dhabi (HAAD). A senior health official said the programme was facing hitches because doctors failed to report medication errors and adverse reactions.
“They will have to take the time out and report these cases since it is mandatory,” said Dr Mohamed Abuelkhair, Advisor, Drugs and Medical Products, HAAD, on the sidelines of a seminar at the Gulf Medical University in Ajman.
Other reasons include the fear of documenting a wrong prescription, he said. “We are encouraging the public to become involved in the reporting process,” said Dr Abuelkhair.
The greatest challenge of the programme launched by the Abu Dhabi Pharmaco-vigilance Centre at HAAD is the low spontaneous notification rate. It is more evident in paediatric cases.
According to preliminary results, since the programme was launched in September 2008, only 35 paediatric cases were reported till mid-2009 from nine hospitals in Abu Dhabi.
“This is a new programme and we have to build a culture of reporting, which can only be done through continuous collaboration between different bodies,” he said.
Healthcare professionals are required to report serious adverse reactions regarding pharmaceutical, herbal, or blood products within 24 hours and no later than 15 days in other cases.
The programme, which will soon be expanded to the other emirates, will also see legal action against violating health establishments and professionals.
“If a hospital is not reporting cases, it means they are either not looking for them or not reporting,” said Dr Abuelkhair. “If it is found that this is being intentionally done, action will be taken.”
Follow-up includes changing the product’s safety information, adding a new side-effect caution, or warning, in addition to contacting drug manufacturers to report on the findings and perhaps even banning the drug.
The cases are also forwarded to the National Pharmaco-vigilance Committee and the World Health Organisation, which maintains a registry and advises the UAE on other pharmaco-vigilance programmes.
“All government and private hospitals and health centres under the ministry and health will be involved in the awareness programmes on pharmacovigilance,” explained Dr Amin Al Amiri, CEO Medical Practice and License at the UAE health ministry.
A healthcare professional maintained that doctors prescribed many medicines at one time. “This is an important step because medication errors and adverse reactions are rampant due to complex treatment methods,” said Dr Arun Shirwaikar, Dean of the College of Pharmacy at the Gulf Medical University.
He said that though the healthcare providers may not like the reporting system due to fear of legal action, it was for the benefit of the community. He also said that correct doctor guidance and counselling for patients could help reduce errors.
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