A survey on the use of fixed dose combination drugs (FDC), conducted prior to the union health ministry’s FDC ban of March 10, has revealed that the number of FDCs available in the medical stores in the country promote their overuse owing to lack of awareness of their rational use.
The study was conducted by a group of pharmacists representing a health organisation in Ahmadabad in Gujarat, and the aim of the survey was to evaluate the pattern of FDCs within the circle of the city.
The study signifies one fact that various irrational FDCs or FDCs containing controversial or banned ingredients are available and prescribed in India. Awareness and education about irrational FDCs, combinations containing banned or controversial ingredients will help develop a rational prescribing practice among prescribers. Monitoring of marketed FDCs and a regulation of their use is recommended to minimize the misuse of them.
According to the survey team, the study was conducted at different time intervals at different zones of Ahmadabad city during different seasons to minimize the bias due to seasonal influence on use of FDCs. Out of 1170 prescriptions collected, 80% of them contained one or more than one fixed dose combinations. This shows that there is a higher rate of prescribing FDCs in the country at present.
The most common age group in whom these combination drugs were prescribed was 31-49 years, which was consistent with the observation made in a study conducted in Uttaranchal. Majority of FDC drugs were prescribed for oral use (92.7%) and there was no significant difference in prescribing pattern of FDCs by oral route in different zones and during different seasons. This suggests that oral route is the most common and preferred route for prescribing these combination medicines.
Over a period of 24 months, prescriptions were collected from 24 pharmacy stores across 6 zones of Ahmadabad city. The information was recorded in pre-formed Data Record Form after written consent from the patients or from their relatives. The pattern of use of FDC, rationality and seasonal variation in their use were analyzed in the study. Most of the prescriptions taken for study were prescribed by private practitioners and they prescribe them throughout the year.
Out of the total 1170 prescriptions, 941 (80.3%) contained 1647 FDC formulations. As per drug category analysis, a higher number of FDCs containing nutritional supplements (20.2%) and those for central nervous system (CNS) complaints (18.1%) were prescribed. A seasonal analysis showed that FDCs were commonly prescribed for respiratory complaints (23.4%), CNS complaints (20.3%) and as nutritional supplements (22.4%) in winter, monsoon and summer months, respectively.
Only 5.8% in the FDC prescriptions were for respiratory complaints, 9.8% for CNS complaints and 10.9% for seasonal use were included in WHO (2010), National (2011) and Gujarat State (2011) Essential Medicines Lists (EML), respectively. Irrational FDCs that are banned or FDCs containing irrational active ingredients were 1343 (81.5%) and 203 (12.3%), respectively. This shows that irrational use of these combination drugs is higher in the country.
The survey also analyzed the use of combination drugs worldwide. It has been observed that ten percent of new products in Japan are FDCs and about 56% of all drugs prescribed in European countries like Spain are FDCs. This indicates the fact that there is a higher trend of prescribing these formulations in foreign countries also. In India, there are more than 80,000 commercial formulations available either as single drug formulations or as FDCs.
In the study, a total 254 FDCs were prescribed for respiratory complaints, out of which, 237 were prescribed as cough and cold remedies which were irrational. Patients suffering from respiratory infections may not require all ingredients present in the combinations. Some of these cough and cold remedies also contained banned or having controversial active ingredients like phenylpropanolamine. The study team observed that FDCs of salbutamol + theophylline were frequently prescribed. This combination may produce tachycardia and can reduce therapeutic response particularly in asthmatic children.