ABSTRACT
Abstracts: Background:Fixed Dose Combinations (FDCs) are combinations of two or more active drugs in a single form. Prescribing FDCs has become a routine affair in medical practice. Combination drugs increase the compliance of patient to the treatment, decrease the pill burden, but may also lead to increase in the cost of the treatment and side effects. There has been increase in the irrational FDCs in the recent past. The rationality of a fixed dose combination is the most controversial and debated issue in today’s clinical practice. The eighteenth essential medicine list (EML) of WHO includes 25 FDCs while as the 2011 national list of essential medicines (NLEM) of India includes only18 FDCs. Contrary to this Indian market is flooded with FDCs, the scientific rationale for most of these remains unknown. In India, a fixed dose combination of drugs is considered a “NEW DRUG” and has to be approved by Drugs Controller General, India (DCGI). However, the Indian laws governing the approval and marketing of FDCs are not properly defined, the pharmaceutical manufactures take advantage of these loopholes and market combination that have no pharmacological rationale.
ABSTRACT
Aims: To evaluate therapeutic rationality of combining long-acting β2-agonists (formoterol) with duration of action of 12 hours and anticholinergics (tiotropium) with 24 hours as fixed dose inhaled combination (FDC) still widely prescribed in developing countries in COPD patients. Study Design: A randomized, double-blind, placebo-controlled, parallel design study. The three regimens that were used; tiotropium 18 μg once a day in the morning along with the formoterol matched placebo in the evening, the FDC of tiotropium 18 μg plus formoterol 12 μg once a day in the morning and formoterol matched placebo in the evening and the same FDC of the two drugs once a day in the morning and once a day formoterol 12 μg in the evening in patients of COPD without any co-morbidity. Place and Duration of Study: Tertiary care pulmonary medicine university teaching government hospital of Delhi, India; 1 year. Methodology: Sixty COPD patients (Male, Avg. age 56±11 years) divided into 3 groups of 20 each without any comorbidity were admitted in the hospital for 24 hours. The spirometry, perception of dyspnea on Borg's scale and vitals such as blood pressure (BP) and pulse rate (PR) were recorded at the following interval 30 minutes, 2 hours, 12 hours after the morning dose and 30 minutes and 12 hours after the evening dose. Results: Addition of formoterol in the evening along with the FDC in the morning enhanced the peak effects in percentage predicted FEV1 (82.55+/-12.639), FEV1/FVC (0.592±0.097) that remained till the next dose (24 hours) which was statistically (P=.05) superior to the tiotropium alone group (75.55+/-17.981) as well as FDC alone group (74.55+/-12.655). Conclusion: There is no advantage of FDC once a day over tiotropium alone. However addition of evening dose of formoterol has shown therapeutic superiority over once a day FDC of the two in COPD.
ABSTRACT
Background: Irrational prescribing of drugs is of common occurrence in clinical practice. Rational drug prescribing is defined as “the use of the least number of drugs to obtain the best possible effects in the shortest period and at a reasonable cost”. The present study was designed to evaluate the practice of rational prescription in patients (cases) admitted in various wards of G.S.V.M. Medical College and associated hospitals at Kanpur. Methods: This study was carried out on patients admitted in different wards. For the study of drug prescribing patterns, each prescribed drug was counted only once for a patient, irrespective of change in dose and route of administration. WHO guidelines were taken into consideration. Both distribution of type of drug as well as drug category were evaluated in different departments thereafter. The characteristics chosen on each prescription provided the incidence of poly pharmacy and frequencies of prescribing of individual drug were analyzed. The data obtained were subsequently categorized systematically and analyzed by taking WHO guidelines into consideration. Results: The most commonly prescribed drugs were vitamins and tonics (57.5%) followed by anti-microbial agents (12.7%), non-steroidal anti-inflammatory drugs (10.5%), anti-hypertensive (5.2%), anti cough remedies and acid peptic disease drugs. Generic drug prescription was very low as most of drugs prescribed were proprietary. A low number of Fixed Dose Combinations (FDCs) were prescribed, this finding was in accordance with the WHO recommended list of FDCs. Items on the WHO model list of essential drugs were prescribed frequently. The use of drugs has been found to be in accordance with the disease, the patient had. Conclusions: Present study highlighted that there was a high incidence of irrational prescribing practice that increased with the total number of drugs per prescription.