• Despite calls to publish formulary, drug regulator still relying on UK, US parameters
• Inconsistencies exist between locally available guides, foreign standards

ISLAMABAD: Knowing which drugs are available in the market to treat particular conditions is one of the basic functions that doctors are required to carry out. Having prior knowledge of which molecules are sold under what brand name in the local market is, then, a key requirement for medical practitioners, including pharmacists.

Globally, pharmaceutical directories or formularies are devised by medical boards to streamline this process and ensure that the most appropriate drug is prescribed to each patient, keeping in mind all contra-indications.

But while most developed countries, such as the UK, US, Australia, New Zealand, Japan and the Scandinavian countries have their own national formulary to help guide medical practitioners and patients, no such official directory exists in Pakistan — at least not one authorised by the Drug Regulatory Authority of Pakistan (Drap).

In the absence of an official and authoritative formulary, one of the most widely used guidelines is the PharmaGuide, a printed reference of all medicines available in Pakistan, which is also available as a mobile application.

However, there are inconsistencies and even contradictions in the way such guides represent certain medication, when compared to their foreign counterparts.

For example, a drug bearing the formula name Pizotifen, commonly sold in Pakistan under the brand name ‘Mosegor’, is frequently prescribed by local physicians to help children with their appetite. The PharmaGuide categorises medicines containing Pizotifen, such as Mosegor, Lematite and Cestonil, as ‘appetite stimulants’.

But the British National Formulary (BNF) — an authoritative resource on drug information and a mandatory reference for those practising in the UK — describes Pizotifen as meant for “prevention of vascular headache including classical migraine, common migraine and cluster headache.”

Side effects of Pizotifen listed in the BNF include “dry mouth, nausea, dizziness, drowsiness, increased appetite, weight gain, aggression, insomnia, depression…”.

A Drap official Dawn spoke to revealed that the regulator has also advised the pharmaceutical company not to market Mosegor as an appetite stimulant.

Similarly, the BNF says that Mefenamic Acid is a painkiller, but in Pakistan, medicines manufactured with this formula — such as Ponstan — are commonly prescribed for fever.

This, the Drap official said, was not out of place as painkillers can be given to patients with fever to reduce their discomfort.

But there are several serious safety hazards that come with using medicines incorrectly. Ponstan, for example, cannot be given to pregnant women after their first trimester.

However, this piece of information is never clearly mentioned in the drug’s advertisements or on the packaging. “It is correct that [Ponstan] cannot be given to pregnant women and this must be mentioned somewhere on the leaflet,” the Drap official said.

Another example is Tegaserod, which is supposed to be used only by women younger than 65 years of age for the treatment of irritable bowel syndrome with constipation. Some countries require that it be prescribed to even younger women — less than 55 years of age.

However, the Pakistan Drug Manual — another unofficial guide being used locally — simply states that it is meant for adults. There is no mention of any age limit.

“Hiding such information can be considered misbranding,” an official of the Ministry of National Health Services said, noting that in both India and Singapore, Tegaserod is clearly specified to be used only by women below 55 years of age.

Missing resource

Drap CEO Dr Asim Rauf admits the lack of an official formulary or guide prepared by the regulator, saying that most of the ones currently in use have been prepared by ‘non-profit’ organisations.

“Drap is in the process of making an online registry, after which people will be able to check or countercheck drug-related information on the internet,” he told Dawn.

However, he disagreed with the notion that drugs were being mislabeled or falsely marketed, saying: “It is possible that their claims [regarding the use of their drugs] might not be available in the British National Formulary, but they may be available in some other formulary, as the companies provide us the same details they have been providing elsewhere in the world as well”.

“That said, off-label usage is also a normal practice: if a health practitioner believes that a medicine can be useful for other diseases than it was originally intended for, he can prescribe it,” Dr Rauf said.

This refers to the practice where a physician prescribes a drug for a purpose other the approved treatments. This, in the view of many medical professionals, depends on where they have studied, i.e. UK graduates would prefer the BNF, while US graduates may follow the United States Pharmacopeia.

Noor Mahar, president of the Drug Lawyers Forum, who has also worked with the US Food and Drug Administration, noted that Section 8 of the Drug Act of 1976 clearly states that a formulary should be published. Unfortunately, one has not been published since 1981.

Mr Mahar noted that there were a number of cases in which huge fines were imposed on companies for urging off-label usage of medicines in the US and other countries. “Here, drug inspectors cannot even take action over pricing issues as there is no drug formulary with the actual prices in it,” he claimed.

Interim Punjab Health Minister Dr Javed Akram also echoed the sentiment, saying that producing a drug formulary biannually was the need of the hour.

“Provinces cannot publish formularies as it will create issues, so it should be published at the federal level. I will write to the Drap to publish formulary in a printed form and send it to all stakeholders. Drap can charge for it, as it will be in the best interest of patients,” he said.

‘No wrongdoing’

Representatives of the pharmaceutical industry, however, maintain there is no wrongdoing on their part. Pakistan Pharmaceutical Manu­facturers Association (PPMA) Chair­man Syed Farooq Bukhari said the industry follows British and Ameri­can pharmacopoeias, and quote both to Drap while applying for drug licences.

Pharma Bureau Executive Director Ayesha Tammy Haq told Dawn she was shocked to hear that medicines were being sold for indications for which they were not registered.

“Drap is responsible for checking such issues. Unfortunately, Drap only focuses on the prices of drugs rather than on quality and other issues. Pharmaceutical companies only manufacture drugs; it is Drap’s job to ensure that doctors are prescribing medicines only for the indications which are registered with the regulatory body,” she said.

Published in Dawn, February 12th, 2023