Handling Of Fixed Dose Combinations: A Combined Responsibility
Correspondence Address :
Arjun Poudel Discipline of Social and Administrative Pharmacy School of Pharmaceutical Sciences,Universiti Sains Malaysia, 11800 Penang,(Malaysia).Email:poudelarjaan@gmail.com
Dear Editor
A fixed dose combination (FDC) is a combination of two or more than two drugs in a single pharmaceutical formulation (1).Prescribing more than one drug to a single patient has become a common mania in medical practice (2).When two or more drugs are administered concomitantly it adds to the complexity of individualization of drug therapy since the dose of each drug should be adjusted to achieve the optimal benefit. In order to overcome this problem, many fixed dose combinations have been formulated (3).Rational combinations improve the quality of life of many people. Combination drugs such as antitubercular and antiretroviral combinations are used frequently for many diseases (4).
The safety of combination drugs has to be thoroughly evaluated. Due to many reasons the use of FDCs are common but the rational behind the FDCs are always questionable. In comparison to single- ingredient products, FDCs offer some potential advantages and disadvantages. In most countries FDCs are treated with apt seriousness. The issues of the benefit and risk of the combinations need to be addressed before the formulation or development of a fixed dose combination. The combination should be permitted only if the benefit clearly outweighs risk (5). Moreover there should be defined criteria to approve a FDC in the country (6). The fifteenth WHO model list of essential medicines (March 2007) contains 352 medicines out of which only 25 are FDCs. Similarly the fixed dose combinations account for only 7% of the total drugs in essential medicine list (7) but the Nepalese pharmaceutical market is full of irrational combinations which have flourished in the last few years.
This is a serious matter and needs to be properly highlighted in the pharmacology lectures to the undergraduates who are the future health care professionals. They should be taught about the selection and use of rational drug combinations. The fate and the rational behind the combination of each drug should be taught to them. They should be made aware of the negative consequences of several irrational combinations in market since those irrational combinations may lead to an ineffective dosage, increase adverse effects/events, may lead to abuse, increase the cost of therapy, may induce drug resistance etc (8),(9).
Pharmacy and medical schools must take the responsibility of training/encouraging students to think rationally before prescribing combination drugs. We cannot only blame or find fault onto the industry and government regulators but also the responsibility lies in the hand of the academicians of medical and pharmacy schools (10). Professional pharmacy associations, medical associations and academicians should be responsible for educating the public as well as the fellow professionals (doctors and pharmacists); and pursuing the matter with the concerned authorities. It is a high time that the resolute efforts are undertaken to address these serious issues of irrational FDCs flooding in the pharmaceutical market.
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