FDCs: Community pharmacists' point of view

Community pharmacists have mixed reactions to the galore of irrational FDCs (fixed dose combinations) in the Indian market, and there is no systematic survey to assess these reactions. While Essential Medicine 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!

Different community pharmacies may see the irrational FDCs from different angles - Business angle and professional angle.

Business angle
In India pharmacy is seen mainly as a trade, the issue of rationality or irrationality of FDCs may not be viewed too seriously amongst the pharma trade community. From regular interactions and personal experiences, following could be seen as various advantages and disadvantages (positive and negative economical impacts) as seen by the trade to the increased / increasing number of FDCs in our country. The correct figure of benefit or loss is difficult to arrive at.

Possible benefits of irrational FDCs to community pharmacy
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. Companies use this opportunity to increase the cost of the product, thus giving higher profits to the pharmacy.

Heavy launching of these products then results in brisk sales of 'higher' value items, compared to the lower-value, single ingredient items. Thus, pharmacies 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.

Possible disadvantages of irrational FDCs to community pharmacy
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. Or has to resort to brand-substitution, which is considered illegal in our country.

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 pharmacies then have to be logged with extra goods dumped in their shelves!

Companies often change the drugs in an FDC, but make “almost unnoticeable” changes in the brand name. For e.g. by adding a “+”, or writing “plus” in a very tiny, indiscrete way, adding an alphabet in tiny font in front of the existing brand name, etc. This change is most often not known to the doctor, nor very often seen by the pharmacy. So, if the doctor prescribes by the old name, if the pharmacy dispenses the new formula, it amounts to substitution or dispensing a product “other than” what is prescribed. If the pharmacist is aware of the change, then he goes ahead with dispensing the “changed” product or has to keep phoning the doctors to confirm what should be done. In case of ADRs, the doctor may not take responsibility, and the blame can come on the pharmacy.

Patient reactions
Pharmacies are the ones who have to face the brunt of the public. This could be because of the rising cost of medicines, or getting an effect “other” than the usual effect, or an ADR when one or more ingredients of an FDC are changed without an obvious change in brand name.

Other disadvantages
More the products coming into the market, the more difficult it becomes for pharmacies 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 pharmacy personnel 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.


Professional angle

• Assuming that a pharmacy 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 analyze a prescription and explain to the patient about possible adverse effects and dosage regimens.
• The task of professionalizing a pharmacist in India, having to deal with about 5,000+ drugs and combinations (even the drug control authorities do not have the exact number) - piling up to more than 1 lakh brand names is much more difficult than for any pharmacist in any other country!
• 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, hospital, clinical and community pharmacy are still in infancy!  In the beginning, a pharmacist needs a simple environment of simple drugs, to absorb knowledge about drugs, their action and application of this knowledge to his practice. If he is surrounded by tens of thousands of combinations and brand names, most of them unscientific and irrational, and prescribed so freely, regularly by doctors, he is bound to give up practicing professionally, even before he begins!
• During his education, he (a D.Pharm or a B.Pharm) is not given adequate knowledge on drugs or the variety of FDCs and how to practically utilize this knowledge in the community setting.  B.Pharm does not even have the opportunity to get trained / work in a community pharmacy during his curriculum.
• The pharmacy curriculum does not even mention the concepts of EMLs (Essential Medicines Lists), RUM (Rational Use of Meidicnes), irrational medicines and combinations!
• In India, we have no reference book (Drug Information Book) which will give authentic, unbiased information on all the drugs in Indian market.
• None of the important, authorized, recognized reference books like USP DI, ASHF Drug Handbook, PDR list most of the drug combinations available in India. The BNF lists a few, but promptly adds that most of them are not recommended!
• None of the standard text books of pharmacy recommend or mention most of the drug combinations available in India.
• Internet searches for various drug combinations available in India, using different search engines generated results of products of Indian companies! It is very difficult to find most of these combinations in other countries!
• 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!
• So, where, how and who is going to give the Indian pharmacist, unbiased, reliable information about the whole range of irrational drugs and FDCs? Who will teach the pharmacists to tackle prescriptions of irrational drugs and FDCs?

For conscientious pharmacists having to dispense irrational FDCs day in and day out is very much hurting, knowing very much the ill effects or special beneficial effects of such combinations.

Another problem unique to India is that dietary supplements are more often prescribed by doctors. Since they are prescribed by doctors, public perceive them as “medicines”. Rationality of combining various dietary supplements is again a big question mark.

The community pharmacist is a silent spectator to the whole drama of approving and banning of irrational drugs and FDCs!  He has no say, and his opinion is not asked for, and if sought, I am sure not valued! He is expected to dutifully stock various drugs and combinations (including irrational FDCs), and dispense them without a bother when the doctor prescribes them. There is no written word about it, but I am sure, if a patient asks if a particular “irrational” FDC prescribed for him is good, the pharmacist is expected to say “Oh Yes!”, or no more than, “the doctor has prescribed it for you, based on your illness. Since the doctor is trained in using his clinical judgement in selecting a drug for you, he must have done his job correctly!” What a big hoax to upkeep the ethics of pharmacy and maintain a professional relationship between two health care providers (doctor & pharmacist). Morals of pharmacists who understand the concept take a crushing every time they dispense such irrational FDCs!

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 the cost of 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 pharma 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 at times 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, combinations?

The question also needs to be asked is, ‘who should be authorized to decide whether an 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 the FDC is rational, genuinely necessary in the context of our nation and its people, especially when such combinations are not approved in any part of the world? 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 advise for medications.

In cases which 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 pharmacist/s 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 pharmacist/s.

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/FDCs/ irrational prescribing, etc.
Pharmacies in which pharmacy students undergo training, may take up the task of educating trainees about irrational drugs and FDCs, about RDU, EDL etc.

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 minds of the public. Medical associations, professional pharmacy associations should take up the task of educating the public as well as the fellow professionals (doctors & 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, and improve compliance and outreach of drugs to more number of people. Use of irrational drugs, FDCs and irrational prescribing is nothing but waste of national resources, worth crores of rupees! The Health Ministry should appoint experts in the field (including international ones) 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; opinion of international experts should be taken before being granted permission for marketing! If we cannot get these things done, they are just an addition to  the 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 health care needs!