Irrational FDCs & community pharmacist

Weeding out irrational drugs and combinations will go a long way in reducing adverse effects as well as cost of therapy, improve compliance and outreach of drugs to more number of people, says Raj Vaidya

The large number of irrational fixed dose combinations (FDCs) in the Indian market has evoked mixed reactions from the community pharmacists. While Essential Drug Lists put down only a handful of FDCs, the Indian market is flooded with plenty of them, most of them irrational! Irrational to many NGOs and professionals in India and worldwide, but somehow ‘not irrational’ to most pharmaceutical companies who market them, and the pressures put by them on our licensing authorities.

I wonder whether to be thankful to the DTAB, and the FDA for banning a list of drugs and FDCs over the past few years, or whether to curse the fact that we are bombarded with many more newly ‘approved’ irrational FDCs....almost on a daily basis!

Unfortunately, there seems to be no uniform, worldwide, acceptable criteria to define irrational FDCs. And, it becomes very difficult to prove so, (especially in the Indian conditions) what an irrational FDC is. It is a matter of putting up a strong case, strong enough for it to be noticed, and then accepted by the DCGI, then approved by the DTAB (Drug Technical Advisory Board), and then accepted by the court of law (after a few years of postponement of hearings following ‘‘stay-orders’’ brought on by manufacturers against the ban).

The community pharmacist is expected to dutifully stock various drugs and combinations (including irrational FDCs), and dispense them without a bother when the doctor prescribes them.

Irrational FDCs have economical impacts on community pharmacy - both positive and negative. The correct figure on the balance sheet is fairly difficult to arrive at, but by rough estimates, it seems to be even.

Economic benefits of irrational FDCs

FDCs are costlier than single ingredient drugs. Many times, manufacturers add another drug (however irrational or useless) to an existing drug just to escape from DPCO. Many times another drug is added just to show that they have another “unique” combination, to promote, to the doctors.

Heavy launching of these products then results in brisk sales of ‘higher’ value items, compared to the lower-value, single ingredient items. Thus, chemists benefit from brisk sales.

Since FDCs are higher in value than single ingredient products, companies and their field force focus more on such products because they give larger turnovers in terms of value, and thus help achieve targets faster. This also facilitates chemists to have higher sales values.

Economic disadvantages of irrational FDCs

When new drugs and combinations are put in the market, the companies focus a large portion of their energies and field force in launching the new products in a big way. Unfortunately, other existing products of these and other companies remain behind in the shelves of chemists, gathering dust. Thus, this involves increasing inventories, as well as increased expiry problems.

It is very difficult for some chemists to stock the whole range of products, especially when many companies launch me-too products. This results in “bouncing of prescription” i.e. the retailer has to refuse the prescription, thus facing loss of customer and clientele.

More the combinations, line-extensions, more is the space occupied in shelves, and more is the money blocked in these goods. After brisk sales, the companies lower their promotion, shift to promoting other products, and doctors forget the earlier products. The chemists then have to be logged with extra goods dumped in his shelves!

Other disadvantages

More the products come into the market, the more difficult it becomes to remember the brand names, the generic names, and the combinations. Very often, minor cosmetic changes are done in the brand name while a change in the formulation is done. The brand name at times remains the same, but its use changes!

Multitude of FDCs makes it very difficult for the pharmacist to remember which brand contains which drugs and in what combinations and proportions. More the number, more difficult it is to remember dosage regimens, contra-indications, ADRs, drug interactions, precautions to take while taking the drugs, etc.

Assuming that a pharmacist in India does not check for drug interactions, does not tell a patient about ADRs, does not do patient counselling, etc, then irrational FDCs may not create much problems to the ‘non-professional’ pharmacist, or the salespersons. But, for pharmacists who are doing such tasks, and for pharmacists who intend to do such professional tasks, it is a horrendous job! More the number of drugs, and more varied the permutations and combinations, more difficult it is to analyse a prescription, and explain to the patient about possible adverse effects and dosage regimens.

Irrational FDCs are a big dampener to practice pharmacy in the right way, especially in a country like India, where the profession is heavily industry oriented, and hospital, clinical and community pharmacy are still in infancy!

The pharmacy curriculum does not even mention the concepts of EDLs (Essential Drug Lists), RDU (Rational Drug Use), irrational drugs and combinations. In India, we have no reference book (Drug Information Book) which will give authentic, unbiased information on drugs.

None of the important, authorized, recognized reference books like USP DI, ASHF Drug Handbook, PDR which list most of the drug combinations are available in India. The BNF lists a few, but promptly adds that most of them are not recommended!

There is no comprehensive book, or website which lists all the irrational combinations, and to tell us why they are not recommended. The only source of information about these drug combinations are the literatures provided by the manufacturers themselves. This information most of the times is biased, at times misleading, and not very scientific.

Whom to hold responsible?

This is an easy yet difficult question to answer. Are the companies who introduce and heavily promote these irrational drugs and FDCs to blame? Or is the doctor community to blame for prescribing and thus promoting such irrational products, thus permitting these drugs to be large chunks of individual therapies and budgets of hospitals? Or is it the Drug Control Department to blame for allowing/giving legal sanctions for such products to be introduced into the market? And for not taking enough stringent steps to weed out the irrational FDCs?

Or do we blame the pharmaceutical companies for going to court to bring stay orders on bans on irrational drugs and FDCs? Or the bureaucrats and politicians for interfering in the actions and deeds of the FDA and the courts? Or should we blame the retail pharmacies who push (recommend) such combinations to their customers, because they get good profit margins on some of them, especially the generic versions? Or should we blame the professional associations and the educational institutions for having remained silent spectators to this whole exercise of irrationality, and for not having educated its students and fellow professionals on the negative aspects of irrational drugs and combinations?

The moot question is, ‘Who should be authorized to decide whether a FDC is rational or not?’ Is the Drug Control Department equipped with enough expertise in deciding the rational/irrational status of these drugs?

Unfortunately, clinical trials are used more for marketing than for scientific purposes. Merely doing clinical trials of a new combination to prove safety is of no value! How do we assess and prove that the FDC is rational and genuinely necessary in the context of our nation and its people? Schedule Y needs a lot of re-thinking to do regarding this particular aspect!

What can community pharmacists do?

Community pharmacists can do something if not lots! A large portion of the public often comes directly and first to the pharmacy seeking his advice for medications.

In cases where the pharmacist can recommend medicines, from his permitted armamentarium, he should take care to recommend only those medicines which are rational (really necessary, relatively safe and cost effective). The staff in the pharmacy should be instructed to refer any patients seeking recommendation for medicines to the pharmacist.

The pharmacists should draw up a list of medicines which he can and should recommend and be well-versed with the actions, dosage, contra-indications, ADRs, etc of all these medicines.

Charts of these drugs containing prescribing details should be available at hand for quick reference by the pharmacists.

Wherever possible, pharmacists may advise clients seeking OTC medicines which are irrational, to shift to something simpler, rational, cheaper and equally effective.

If pharmacists have good contacts with doctors, they may inform/send across information to them about irrational drugs/irrational prescribing, etc.

Pharmacies in which pharmacy students undergo training may be educated about irrational drugs and FDCs, about RDU.

Conclusion

Various NGOs, and some professionals are fighting a battle against irrational drugs and FDCs, but the efforts are not enough. Education is a good way to instill negative effects of irrational drugs and FDCs into the public mind. Medical associations, professional pharmacy associations should take up the task of educating the public as well as the fellow professionals (doctors and pharmacists); and pursuing the matter with the concerned authorities.

Weeding out irrational drugs and combinations will go a long way in reducing adverse effects as well as cost of therapy, improve compliance and outreach of drugs to more number of people. Use of irrational drugs and FDCs and irrational prescribing is nothing but waste of national resources, worth crores of rupees. The Health Ministry and the FDA should appoint experts in the field and take up the task of weeding out irrational drugs and FDCs on a war-footing, shrugging off the pressures of the industry. Henceforth, any combinations should be strictly scrutinized by expert committees before being granted permission for marketing.

If we cannot get these things done, it is another of various continuing dooms to the people of our country. If we get the things done, it definitely will be a big boon to our people, a bigger boon than the newer drugs being discovered in the world. Because what little we have, if used correctly, is sufficient to take care of most of our healthcare needs. And, of course, community pharmacists like me will be pleased for obvious reasons! The writer is a community pharmacist, Hindu Pharmacy, Panaji, Goa