Further probe into FDA report under way: DRAP

KARACHI   -   The Drug Regulatory Authority of Pakistan (DRAP) said on Saturday it was investigating and evaluating the situation with the assistance of international bodies after FDA’s report on various medicines.

The statement comes days after the DRAP stopped several companies across the country from manufacturing medicines made with ‘Ranitidine’ — including Zantac — and recalled all such products. The US Food and Drug Administration had said these medicines could cause cancer.

Talking to reporters after addressing the conference titled “Medication Safety: Connecting Academia & Practice” which was organized by Pakistan Society of Health System Pharmacists (PSHP) at a local hotel, DRAP Chief Executive Officer Asim Rauf said that the regulatory body showed immediate reaction over reports about raw material ‘Ranitidine’ — including Zantac — and made the move in the larger interest of the industry as well as the consumers.

“Now going forward we are in close contact with the international bodies and further investigating the matter,” he said.

“There is nothing to worry about because the DRAP has made assured that not a single piece of such medicine would be available in the market after the alert was issued.


 Apart from issuing orders and directives, we have smart and vigilant teams on ground in assistance with the respective provincial government to keep checks on any wrongdoing or violations of the regulatory framework.”

Earlier, addressing the conference the Drap chief briefed the participants about the role of the regulatory body to from protecting rights of a common man to easing environment of doing business for the pharmaceutical companies. The drugs watchdog, he said, always kept the medication safety as its key priority which on one hand assured healthy environment of medication and on the other keep professionals abreast with internationally-recognized practice sharing few measures taken by the Drap on these lines.

 “Drap is already doing membership of WHO Uppsala centre for access to ‘Vigiflow’, which is global database system for pharmacovigilance reporting and this access supports regulators and medical professionals with latest safety information about the drugs,” said Mr. Rauf. “Very recently, a thorough review for valsartan containing drugs was also carried out to determine the impact of NDMA and NDEA levels on long term clinical outcomes in the patients. This effort of DRAP was acknowledged at international forums and this review was published by a prestigious international journal “Therapeutic Advances in Drug Safety.”

Marianne F. Ivey, Professor Emerita Pharmacy Practice and Administrative Sciences in her presentation touched upon several issues related to medication safety and emerging challenges amid growing technology and health issues across the world. Highlighting current issues of patient safety she referred to medication shortages, lack of regulations, transition of care, complex situation of data producing technology and intra-operative integration of technology.

 “Always use generic names where appropriate,” Ms. Ivey said while mentioning activities that could improve medication safety. “Do thorough medication histories and try your best to know the risk level of different medicines and apply precautions. Clear communication with patients is key to medication safety. And always try to engage or involve the patients. Your encouragement is this regard matters a lot.”

Abdul Latif Sheikh, president and CEO of PSHP in his opening address defined that how the medication safety had become multidimensional challenge. He referred to PSHP objective which suggested achievement of optimal health outcomes through safe medication use since its inception in 2007. Such objective, he said, could only be achieved through building with advocacy and implementing best practices while engaging members on issues related to safe medication use in public and private enterprises.

“Our vision is to make all medication usage in the country optimal, safe and effective for all people all the time. This conference and dozens of other activities during last more than ten years strengthens our argument of contributing best possible share from our side for healthy practices and medication safety,” said Sheikh.


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