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On July 5, 2018, European Medicine Agency (EMA) issued notification EMA/459276/2018 which announced recall of medicines containing the active substance Valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.
The review was triggered after the company (Zhejiang Huahai) detected an impurity, N-nitrosodimethylamine (NDMA), in the active substance Valsartan which the company supplied to various manufacturers across EU and many other countries, Pakistan included. NDMA is classified as a probable human carcinogen, based on results from laboratory tests.
The presence of NDMA was unexpected and might not have been detected for long if Zhejiang Huahai had not voluntarily informed the authorities.
On July 13, 2018, US FDA issued notice for recall of medicines containing Valsartan supplied by Zhejiang Huahai, on the same grounds mentioned by EMA. FDA identified companies supplying valsartan containing products from the same source.
On July 12, 2018, Drug Regulatory Authority Pakistan DRAP issued recall notice for the same reason. DRAP identified nine companies which had imported valsartan from Zhejiang Huahai.
Following this, the regional offices of DRAP also became active and sent communications to companies and general public.
Provincial Pharmacovigilance Center Punjab and Provincial Drug Control Unit Punjab issued notices DSA-167 and 168 on July 12 and July 16 respectively.
The PPC and PDCU went a step forward. Their notices identified twelve companies which had imported valsartan from Zhejiang Huahai. In addition, they issued a list of ten brands with company names which ‘should be avoided’ and a list of thirty-two brands which ‘are doubted’. And they declared that only brands manufactured by Novartis and Getz were ‘safe’.
This information was aimed at healthcare professionals and general public. The documents were rapidly shared further on social media by everyone who somehow got it.
There is no doubt that the social media works wonders in spreading information and rallying people for any cause.
Then the news broke out like wildfire. Not everyone had access to factual information. Valsartan users were completely confused. Many stopped taking medication abruptly, whatever brand they were taking. Everyone was asking everyone what happened. There came a panic that cancer was imminent in patients who had been taking valsartan.
What Was Done Right?
The recall by EMA, FDA and DRAP was timely and well-intentioned. The communication was shared swiftly and executed quickly.
The PPC and PDCU added specific information to make healthcare professionals and general public understand more precisely and take necessary action.
EMA and FDA emphasized that the patients must not stop taking medication on their own. They must consult their physician or pharmacist to seek advice for change.
The communication of information through multiple channels helped to disseminate information at a great speed.
What Was Not Done Right
The recalls from EMA and USFDA followed their standard procedures and may not have caused panic among patients. Pakistan situation is different.
Pakistan is among high internet usage/ low internet cost countries. Millions of people access internet on their mobile devices and use social media to get and share entertainment, information etc.
Pakistan has a low literacy rate. Majority cannot access direct sources of information and they become open to be exploited and inundated by ‘shared information’. Due to lack of direct knowledge, gossip becomes the order of the day.
The PPC and PDCU Punjab communication implied that patients must stop taking certain (unsafe) medicines and start taking other (safe) medications. They went wrong on four counts.
- They became a reason for possible serious consequences caused by abrupt stoppage of blood pressure medicine. We shall never know how much damage they caused.
- Their information about the companies using valsartan from Zhejiang Huahai was not updated.
- They had no evidence to declare a list of 32 ‘doubted’ drugs. It was an act of conjecture.
- They had no justification to highlight and promote two Pharma companies and their brands, while undermining other brands without proper evidence. It was an act of favoritism which may cast doubts upon integrity of PPC and PDCU.
We wish that we don’t see an episode like this again. However, it is probable that such things may happen in future as well.
In case of valsartan, and any such event in future, the patients must not stop medication abruptly, or change on their own. They must consult their doctor for advice.
It is important that our health regulating departments act rapidly, but wisely and judiciously. It is also important that the provincial and federal departments act in unison and not try to outcompete each other for the purpose of scoring points.