The Drug Regulatory Authority Pakistan (DRAP) has launched the country’s first ever “Online National Registry for Cardiac Stent”, in a move that aims to bring greater transparency to the process of planting heart stents.
Earlier in February this year, the Supreme Court had taken suo motto notice on the alleged widespread practice of surgically implanting coronary stents into patients that suffer from cardiac diseases, even when they do not need the procedure. It also looked in to the matter of unregistered manufacturers and suppliers of stents.
A stent is a small, metal-mesh tube that expands after its placement inside a coronary artery. It is often used during or immediately after angioplasty to help prevent artery blockage and is thus, a very crucial device.
In January 2017, the Federal Investigation Agency (FIA) busted a group of doctors and investigated them for using ‘unregistered cardiac stents’, selling stents worth Rs7000 at exorbitant prices ranging from Rs125,000 to Rs140,000.
Following the FIA raid, the SC took notice of the situation, prompting DRAP to formulate a mechanism whereby stents could be verified to be legitimate.
Today, having launched the online registry for stents, a DRAP official while speaking to Dawn.com said “we have fully complied to the directives given to us by the apex court.”
What’s the need?
“The purpose of this registry is to create a system of checks and balances and to ensure patient safety and product quality,” explained the Assistant Director of Medical Devices Department at DRAP.
“Each stent would be traceable through its serial number,” he said.
How will the registry function?
Asked how exactly the registry would work, the DRAP official explained; “All catheterisation labs (cath labs) offering angioplasty to heart patients would now have to be registered. They will get a password and a login upon registration. Whenever they plant a stent into a patient, it would be binding upon them to feed the stent’s data to the registry,” he explained.
This ‘data’ would include the stent’s manufacturer profile, importer details, serial number, it’s expiry date and batch number.
“Additionally, cath labs carrying out angioplasties are required to make three copies of a video recording that shows the procedure being done. One copy of the video will go to the registry, the other to the patient and the third, they will keep for their own record,” added the DRAP official..
The problem that FIA encountered during their January raid on Mayo hospital was that unregistered stents were being used at unreasonably high prices. The climate is now changing, as only registered stent suppliers and manufacturers would be relied upon by doctors.
“We have granted registration to nearly 55 brands, and a majority of these produce latest coronary artery stents”, DRAP CEO Dr Afghani told Dawn in an interview conducted earlier this year.
“The biggest advantage of the registry will be that it will keep a check on irrational and unethical practices that are quite prevalent. It will help curb smuggling. Registered cath labs will use stents that are manufactured by registered manufacturers. In doing so, expired and substandard stents will be eliminated,” said the DRAP official.
Acknowledging that some doctors often install more stents than needed, the DRAP official informed that an international body of cardiologists would be given a certain level of kind of access which they can use to randomly oversee and monitor videos of procedures being carried out on patients.
“If the international body senses anything out of the ordinary, or in contradiction to best practices, they will report to the Pakistan Medical and Dental Association (PMDA), urging them to take action against the doctor in question,” informed the DRAP official.
The move, which is aimed at making angioplasties more transparent has been launched with much optimism, but it remains to be seen how smoothly it would be rolled out across cardiology facilities in Pakistan.