LAHORE: The federal government has come up with a new advisory to be followed by the medics and the public and private health institutions in the country to bring about transparency in cardiac treatment and procedures especially ‘stenting’.

The authorities concerned issued guidelines while registering new stents and balloon catheters. They contain steps for the safety of the patients undergoing critical procedures such as angiography at both public and private healthcare set-ups.

One of the major decisions the federal government has taken is that the health professionals or healthcare establishments are bound to make video recording of every cardiac procedure. “It has been declared mandatory for the healthcare establishments to hand over one video copy of the procedure to the patient or his/her attendant,” says the document.

The new advisory has come in the wake of the recent stent scam that had exposed loopholes in the heart surgery procedures and overall health system in Punjab.

According to the Federal Instigation Agency (FIA) investigations, unregistered cardiac stents are being used in the government hospitals. Initially, the scam surfaced in the Mayo Hospital, Lahore, but the FIA expanded the scope of investigation on finding ‘horrifying revelations’ about the involvement of a mafia of importers and medicine companies. The Supreme Court too had taken notice of the malpractice.

In order to facilitate the patients in the choice of medical devices for cardiac surgeries, the Drug Regulatory Authority Pakistan (DRAP) has registered 73 cardiac stents and 78 balloon catheters.

The new guidelines issued by the Ministry of National Health Services, Regulations & Coordination on March 15, state that the healthcare establishments performing heart procedures using stents shall make video recording of the whole procedure and copies and hand over one to the patient or his/her representative, one copy to the Society of Interventional Cardiologist and one for record of the Cath Lab.

“The Interventional Cardiologists Society shall prepare appropriate rules/regulations to regulate the Cath Labs to achieve the objectives of safe use of stents, fair practices and patient safety,” reads a letter of the Federal Health Ministry.

The ministry also issued advisory to check exorbitant prices of medical devices. “In order to check irrational, restrictive and exorbitant prices and huge unethical profiteering which make the devices unaffordable and beyond the reach of the most and to maintain stable prices of the cardiac stents, the federal government is pleased to direct the Policy Board and DRAP to follow the new guidelines,” the letter says.

The guidelines state that the manufacturers/importers of cardiac stents shall print maximum retail price (MRP) on the label of cardiac stents and shall widely disseminate the MRP of their brands of cardiac stents and also publicise the same on their website and in the print media while updating on a quarterly basis.

“All the manufacturers/importers of cardiac stents shall display a price list at a conspicuous place of the premises of the healthcare establishments performing cardiac procedures and healthcare institutions shall facilitate displaying the same so that it is known to all concerned including doctors doing procedures and the patients or their representatives...”

The ministry further states that the healthcare establishments performing procedures using cardiac stents shall specifically and separately maintain the price of cardiac stents along with brand names of its manufacturers and importers, batch number, serial number expiry date and other details if any in their billing to the patient or their representatives.

In addition, it also states that in order to facilitate the process and ensure quality and transparency, DRAP shall develop an IT-based national registry for cardiac stents and provide mechanism for the manufacturers/importers and Cath Labs to compulsorily enter the data of manufacturing/importation and utilisation of cardiac stents, respectively in national registry.

“All the Cath Labs shall be required to be registered with the Society of Interventional Cardiologists,” the ministry says.

Published in Dawn, March 17th, 2017

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