‘DRAP investigating further with help of world bodies after medicine recall’

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Just days after stopping tens of companies across the country from manufacturing medicines made with the raw material ‘Ranitidine’ — including Zantac — and recalling all such products already on the market over the report of United States’ Food and Drug Administration (US FDA) that the medicine could cause cancer, the Drug Regulatory Authority of Pakistan (DRAP) said on Saturday that it was further investigating and evaluating the situation with the assistance of international bodies.Talking to reporters after addressing a conference titled “Medication Safety: Connecting Academia & Practice”, which was organised by the 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 to reports about raw material ‘Ranitidine’ — including Zantac — and made a move in the larger interest of the industry and 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 DRAP has held out the assurance 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, Rauf briefed the participants about the role of the regulatory body to protect rights of the common man and ease the environment of doing business for pharmaceutical companies.The drugs watchdog, he said, always kept the medication safety as a key priority which on the one hand assured a healthy environment of medication and on the other kept professionals abreast of the internationally-recognised practice.Sharing a few measures taken by DRAP on these lines, he said: “DRAP is already doing membership of the WHO Uppsala centre for access to Vigiflow, which is a global database system for pharmacovigilance reporting and this access supports regulators and medical professionals with the latest safety information about the drugs,” said 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 Emeritus 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, a lack of regulations, transition of care, a complex situation of data-producing technology and intra-operative integration of technology.“Always use generic names where appropriate,” 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 explained how the medication safety had become a multidimensional challenge. He referred to the PSHP objective which suggested achievement of optimal health outcomes through safe medication use since its inception in 2007. Such objectives, he said, could only be achieved through building 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 the last more than ten years strengthen our argument of contributing best possible share from our side for healthy practices and medication safety,” said Sheikh.

from The News International - Karachi https://ift.tt/2lWU2VC
The News International - Karachi