Richard Day: Reining in reps

SHOULD we lose sleep over the influence of pharmaceutical company representatives on prescribing?

It depends if you are interested in value for money — a lot of money.

New drugs listed on the Pharmaceutical Benefits Scheme (PBS) cost a lot more than old drugs and we all pay for them through taxes that support the PBS and public hospitals, and personally through out-of-pocket spending for the copayments.

A substantial slice of the cost of the new medicine is for the promotion and education that goes with a new PBS listing.

Each visit to a prescriber by a drug rep costs hundreds of dollars that needs to be recouped in sales. The pharma companies must consider this expenditure to be money well spent; otherwise they wouldn’t do it. In fact, it is a highly effective strategy in increasing prescriptions.

But does that increase in prescribing lead to a better result for the patient and society? Do individuals and society end up paying additional costs for avoidable adverse reactions? Does “promotion and education” by pharma companies result in better-informed prescribers and healthier patients with respect to the benefits, risks and cost-effectiveness?

A recent large, well conducted study, has found, yet again, that despite different attempts at regulating this activity, there is still a substantial imbalance in communication by drug reps of the benefits of new medicines compared to “minimally adequate safety information” (mention of at least one indication, serious adverse event, common adverse event and contraindication, and no unqualified safety claims or unapproved indications).

The study examined the information provided by drug reps in France and the US, where drug promotion is directly regulated, and Canada, where promotion is self-regulated. It found that despite some medicines having a “black box” warning or even having been withdrawn in other countries (eg, rosiglitazone and cardiac failure) this did not guarantee that any harms would be mentioned by the drug reps in Canada and the US (57% of these medicines). France has the strictest product information standards.

Unlike print advertisements, it is difficult to regulate what is said when a drug rep talks with a prescriber.

Codes such as Medicines Australia Code of Conduct indicate the standards that are to be met but what assurances do we have that self-regulation is practised? What should we do as prescribers?

Only a few us, maybe around 20%, don’t see representatives at all. Many of our teaching hospitals try to limit exposure of staff to representatives.

If a prescriber is going to invest time with drug reps on behalf of their patients and also with an eye to the value for society, then a proactive approach is recommended.

This means respectful probing to have the key questions answered; namely, the risks including contraindications, the benefit relative to what you are prescribing now, and the cost to the patient and the PBS.

And it’s good to ask for the evidence behind statements and to test claims. The representative should get back to you if they cannot answer your question.

The NPS has a great service called RADAR that all prescribers can receive electronically. It provides key information about new medicines about to be listed on the PBS, in a digestible form.

One radical dream I have in moments of madness is that a pharma company will engage the NPS to promote to, and educate doctors on its new drug — in other words, to outsource the whole process. The positioning of the new drug, with alternative and older therapies, would be outlined, and its benefits and risks would be fairly put, along the lines we see already with the RADAR communications.

And if I was running the PBS, I’d pay that company more for their drug too. But I’m not holding my breath.

Professor Richard Day is the director of clinical pharmacology and toxicology at the University of NSW and St Vincent’s Hospital, Sydney. He is also the author of “How to make the most of a visit from a pharmaceutical company representative”, published in Australian Prescriber.
 

Posted 29 April 2013