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| RESEARCH ARTICLE |
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| Year : 2014 | Volume
: 46
| Issue : 5 | Page : 503-509 |
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A study of use of fixed dose combinations in Ahmedabad, India
Jayeshbhai Dineshchandra Balat1, Anuradha M Gandhi2, Prakruti P Patel2, Ram K Dikshit2
1 Department of Pharmacology, M. P. Shah Medical College, Jamnagar, Gujarat, India
2 Department of Pharmacology, B. J. Medical College, Ahmedabad Gujarat, India
| Date of Submission | 08-May-2013 |
| Date of Decision | 11-Sep-2013 |
| Date of Acceptance | 24-Jul-2014 |
| Date of Web Publication | 11-Sep-2014 |
Correspondence Address:
Jayeshbhai Dineshchandra Balat
Department of Pharmacology, M. P. Shah Medical College, Jamnagar, Gujarat
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/0253-7613.140581
Objective: The aim of this study was to evaluate the pattern of fixed dose combinations (FDCs) in Ahmedabad, a city in western part of India.
Materials and Methods: Over a period of 24 months, prescriptions were collected from 24 pharmacy stores across 6 zones of Ahmedabad city. The information was recorded in pre-formed Data Record Form after written consent from the patients (or relative (s) of the patients). The pattern of use of FDC, rationality and seasonal variation in their use were analyzed. At the end of study, results were analyzed using Chi-square test.
Results: Out of the total 1170 prescriptions, 941 (80.3%) contained 1647 FDC formulations. The average number of FDCs prescribed was 1.41 ± 1.04 (mean ± SD). The FDCs were more frequently prescribed in the age group of 31 to 40 years (23.7%) and in males (54.4%). FDCs were most commonly prescribed by oral route (92.7%). As per drug category analysis, a higher number of FDCs containing nutritional supplements (20.2%), and those for CNS (18.1%) complaints were prescribed. A seasonal analysis showed that FDCs were commonly prescribed for respiratory complaints (23.4%), central nervous system (CNS) complaints (20.3%) and as nutritional supplements (22.4%) in winter, monsoon and summer months, respectively. Only 5.8%, 9.8% and 10.9% FDCs prescribed were included in WHO (2010), National (2011) and Gujarat State (2011) Essential Medicines Lists (EML), respectively (P < 0.0001). Irrational FDCs that are banned or FDCs containing irrational active ingredients were 1343 (81.5%) and 203 (12.3%), respectively.
Conclusion: FDCs are widely prescribed with seasonal influence in their use. FDCs containing banned or controversial ingredients are prescribed widely.
Keywords: Banned FDCs, Fixed dose combinations, irrational FDCs
How to cite this article:
Balat JD, Gandhi AM, Patel PP, Dikshit RK. A study of use of fixed dose combinations in Ahmedabad, India
. Indian J Pharmacol 2014;46:503-9 |
| » Introduction | |  |
A 'Fixed Dose Combination (FDC)' is a combination of two or more active ingredients in a fixed ratio of doses. This term is used generically to mean a particular combination of active ingredients irrespective of the formulation or brand. It may be administered as a single entity product given concurrently or as a finished pharmaceutical product. [1] Use of FDCs is associated with many advantages like synergistic action and increased efficacy (e.g. cotrimoxazole), reduced adverse effects (e.g. levodopa with carbidopa, thiazides with potassium sparing diuretics), reduced pill burden and cost of therapy and hence better patient compliance (e.g. anti-tubercular drug combinations). However, certain disadvantages like incompatible pharmacokinetics, inflexible dose ratio, increased toxicity and cost, contraindication of one component of the FDC decreased their utility. Adverse effect of any one component also limits their use.
FDCs are used worldwide. Ten percent of new products in Japan are FDCs, about 56% of all drugs prescribed in European countries like Spain are FDCs, showing the higher trend of prescribing these formulations. [2] In India, there are more than 80,000 commercial formulations are available either as single drug formulations or FDCs.
Seasonal variation is a characteristic feature of many communicable diseases, such as measles, varicella, cerebro-spinal meningitis, upper respiratory tract infection malaria etc., For example, gastrointestinal infections, respiratory tract infections and malaria are more prevalent in summer, winter and monsoon, respectively. These seasonal variations may affect the prescribing pattern of FDCs. Data regarding the pattern of use of FDCs in developing countries like India are lacking. The present study was therefore carried out with the aim to study the pattern of use of FDCs in Ahmedabad, a city in Western India.
| » Materials and Methods | | |
This cross-sectional, prospective, observational study was carried out over 24 months in pharmacy stores across 6 zones of Ahmedabad city to determine the use of FDCs in the city. Permission from the Ahmedabad Chemist Association was sought before starting the study. The pharmacy stores were selected by cluster sampling method. Out of total 2376 pharmacy stores, 24 pharmacy stores (1% of the total number of pharmacy stores) were included. Prescriptions from the patients (or relatives of the patients) of all ages (except pediatric patients) and of either gender, visiting the pharmacy stores were included in the study. Patients (or their relatives) who were not willing to participate in the study or those who bought over the counter (OTC) drugs were excluded.
The pharmacy store was visited (three times a week) by the investigator at a stipulated time interval during three seasons (winter, summer and monsoon) of the year. The purpose of the study was explained and written consent was obtained from the patients or their relative before obtaining relevant information. Pre-defined number of prescriptions from patients or their relative who fulfilled the inclusion criteria, were obtained. The detailed information regarding patient, pharmacy store, prescribing doctor, diagnosis as well as drugs prescribed were recorded in the pre formed data record form (DRF). At the end of study, results were analyzed using Chi-square test. P values less than 0.05 were considered as statistically significant.
| » Results | | |
A total of 1170 prescriptions were collected from 24 pharmacy stores of Ahmedabad city during winter, summer and monsoon months (390 prescriptions during each season). Out of these, FDCs were prescribed in 941 (80.3%) prescriptions with an average of 1.41 ± 1.04 (mean ± SD) per prescription [Figure 1]. Out of the total 3252 formulations prescribed, 1647 (50.7%) were FDCs. FDCs were most commonly prescribed in the age group of 31 to 40 years (23.7%) and 41 to 50 years (23.1%). The number of FDCs prescribed in male patients (54.4%) was significantly higher than in female patients (45.6%) (P < 0.0001). FDCs were most commonly prescribed by oral route (92.7%) followed by topical (5.9%) and parenteral (1.4%) routes (P < 0.001). | Figure 1: Analysis of prescriptions of fi xed dose combinations in different seasons (n = 1170)
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A statistically significant difference was observed between FDCs among different drug categories (P < 0.0001). FDCs containing nutritional supplements were prescribed in 20.2% followed by FDCs for central nervous system (CNS) (18.1%), gastrointestinal (17.6%), respiratory complaints (15.4%), anti-infectives (13.2%), cardiovascular condition (s) (8.8%) and endocrine disorder (s) (4.3%). An analysis of seasonal influence of prescription of FDCs showed that 23.4% FDCs were prescribed for respiratory complaint (s) followed by nutritional supplements (18.2%) in winter season. Similarly, 22.4% FDCs containing nutritional supplements followed by FDCs for gastrointestinal (19.1%) disorder (s) were prescribed during summer. During monsoon, 20.3% FDCs were prescribed for CNS (20.3%) complaints followed by FDCs containing nutritional supplements (19.8%) [Figure 2]. | Figure 2: Prescribed FDCs as per drug category during different seasons (n = 1647)
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It was observed that out of the 1647 FDCs prescribed, only 95 (5.8%), 161 (9.8%) and 180 (10.9%) FDCs were included in Essential Medicines Lists (EML) of the WHO (2011), National (2011) and Gujarat state (2011), respectively [Table 1]. A statistically significant difference was observed between FDCs prescribed according to different EMLs (P < 0.0001). Multivitamins and minerals were prescribed for more than 10 times [Table 2]. Out of 1647 FDCs prescribed, 1343 (81.5%) were irrational FDCs [Table 3] while 203 (12.3%) FDCs contained either banned or controversial active ingredients [Table 4].  | Table 1: List of prescribed fixed dose combinations that were included in the different Essential Medicines Lists
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 | Table 2: Frequently prescribed fixed dose combinations in Ahmedabad, India (n=945)
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 | Table 3: Irrational fixed dose combinations prescribed in Ahmedabad, India (n=1342)
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 | Table 4: Prescribed fixed dose combinations containing banned or controversial active ingredients (n=203)
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| » Discussion | | |
The WHO Model list of Essential Medicines for adults contains 24 FDCs (17 th list, March 2011) whereas the WHO Model list of EML for children contains 12 FDCs, [3]
while 18 and 27 FDCs are included in the National list of Essential Medicines (2011) and EML of Gujarat state (2010), respectively. [4],[5] Among the commercially available FDCs, a large number of FDCs are irrational. Many FDCs available may contain banned or controversial (banned in other countries but yet available in India) active ingredient (s).
Our study was conducted at different time intervals at different zones of Ahmedabad city during different seasons to minimize the bias due to seasonal influence on use of FDCs. Out of 1170 prescriptions collected, 80% of prescriptions contained one or more than one FDC (s). These suggest a higher rate of prescribing FDCs.
The most common age group in whom FDCs were prescribed was 31-49 years, which is consistent with the observation in a study conducted in Uttaranchal. [6] Majority of FDCs 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 suggesting that oral route is the most common and preferred route for prescribing these drugs.
A seasonal variation in the incidence of diseases is known e.g. respiratory infections in winter, gastrointestinal infections in summer and water borne diseases in monsoon are usually more common. It was observed that out of total FDCs prescribed, 20.2% FDCs were nutritional supplements followed by FDCs for CNS (18.1%) and gastrointestinal (17%) complaints [Figure 2]. During winter, majority of FDCs were prescribed for respiratory complaints (23.4%), which may be due to the fact that respiratory tract infections are more common during winter. Nutritional supplements (22.4%) were commonly prescribed in summer months. This may be due to the fact that gastroenteritis (diarrohea, vomiting) is one of the common conditions reported during summer in India that may affect the nutritional status of the patient. During monsoon, FDCs were commonly prescribed for complaints of CNS (20.31%). Water borne diseases like dysentery, typhoid, jaundice, cholera, gastroenteritis etc., are common during monsoon and are associated with symptoms like fever, muscular pain, weakness. These may explain the use of FDCs containing analgesic, antipyretics and skeletal muscle relaxants for the same. A study conducted in a tertiary care teaching hospital in Nepal showed that multivitamins (31.3%) were the most frequently prescribed FDCs followed by cough and cold remedies (17.1%). [7] As we have conducted the study during different season of the year, our result reflects a seasonal variation in prescribing FDCs that is expectedly congruent with the incidence of seasonal illnesses and symptoms.
We observed that many irrational FDCs and FDCs containing banned or controversial ingredients are freely available in the Indian market and are also prescribed. Various combinations of vitamins are prescribed as nutritional supplements. However, a deficiency of these vitamins may not be present in the given patient. Also the dose of different vitamins in the FDC may not be the same as recommended therapeutic doses. Inappropriate or excessive use of FDCs may lead to several adverse reactions. Although some of these multivitamin combinations are included in National and Gujarat State EML, they should not be used unless there is a definite indication for the same. In this study, it was observed that out of the total FDCs prescribed, many FDCs are not included in any of the EML but were rational and justifiable based on the pharmacological properties of individual drug e.g. anti-hypertensives [Table 5]. [8],[9],[10],[11],[12],[13],[14],[15],[16],[17],[18],[19],[20],[21],[22]  | Table 5: Justifi able fixed dose combinations that are not included in the Essential Medicine Lists
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It was observed that non-steroidal anti-inflammatory drugs (NSAIDs) were combined with other NSAIDs, skeletal muscle relaxants and enzymes, which are irrational, as they do not provide any therapeutic advantage of the FDCs in a therapy. FDCs of proton pump inhibitor (PPI) and H 2 receptor blockers with antiemetics do not have any advantage as they have incompatible pharmacokinetics.
While the FDC of aluminum hydroxide and magnesium hydroxide are rational, it was observed that, FDCs of antacids also contained other ingredients including oxethazaine of doubtful efficacy. Similarly for probiotics that is recommended for treatment of diarrhea in the dose of 5 billion per day, it was observed that the strength of lactobacillus in the prescribed FDCs was in the range of 20 to 60 million bacilli, that is much less than the recommended doses. [23]
An irrational use of FDCs of antimicrobial was observed in this study. Clavulanic acid and sulbactam are not useful in combination with cephalosporins since β-lactamase inhibitors are not effective against class-I chromosomal β-lactamases produced by gram negative bacilli. [24] Similarly amoxicillin or ampicillin is not recommended in combination with cloxacillin as they have no synergistic or additive effect. In addition, amoxicillin is inactive against staphylococcus as most strains produce β-lactamase whereas cloxacillin has less potent antimicrobial activity against microorganisms that are sensitive to penicillin. Hence, one of the components of these combinations is not useful and only adds to the cost of therapy and increases the frequency of adverse effects. [2] Similarly, FDCs containing antiprotozoal and antimicrobials were prescribed frequently. In majority of cases of dysentery, mixed infection (bacillary and amoebic) may not occur simultaneously. The pharmacokinetic and pharmacodynamic profiles of antimicrobial and antiprotozoal groups do not match. Hence, these combinations y are not justifiable for the treatment of dysentery. [25] Allergic reactions may occur due to release of foreign proteins by the mass destruction of microfilariae and adult worms by diethylcarbamazine (DEC). There is little rationale of combining antihistaminics with DEC, since it may not be required in all patients of filariasis and eosinophilia. [26]
In this study, a total 254 FDCs were prescribed for respiratory complaints, out of which, 237 FDCs were prescribed as cough and cold remedies which were irrational. Patients suffering from respiratory infections may not require all ingredients present in the combination. Some of these cough and cold remedies also contained banned or controversial active ingredients e.g. phenylpropanolamine. We observed that FDCs of salbutamol + theophylline were frequently prescribed. This FDC may produce tachycardia and can reduce therapeutic response particularly in asthmatic children. [27] Preparation of FDCs of herbal drugs were not justifiable as sufficient data about their efficacy and safety are lacking. [2]
The Drug Controller General of India (DCGI) has banned use of FDC of vitamin B 1 , vitamin B 6 and vitamin B 12 for human use as it has no therapeutic advantage over individual drugs. FDC of centrally acting antitussives with antihistaminic drug, with atropine-like activity have also been banned. [28] Antitussives are used for the treatment of dry cough while expectorants are useful for cough with expectoration. Both the conditions do not coexist. Hence, it is irrational to use both ingredients together. In addition, a centrally active antitussive agent may antagonize the purported expectorant effect of expectorants that may lead to atelectasis and even death. [28] Although use of nimesulide is controversial, we observed that FDCs containing nimesulide were prescribed. Nimesulide has not been marketed in the USA, UK, New Zealand, Canada, Scandinavia and Australia. It can cause fatal life-threatening hepatotoxicity. Nimesulide preparation has been withdrawn from Portugal and Israel. The European Medicine Evaluation Agency (EMEA) has decided to ban the use of nimesulide in children below 12 years in all the 25 member countries and the agency has also decided to limit the use of this drug. [29] Similarly, phenylpropanolamine is banned in other countries due to the risk of stroke. The FDCs containing these controversial active ingredients, nimesulide and phenylpropanolamine are yet freely available and prescribed in India. Recently, nimesulide containing formulations in children below 12 years of age and that of phenylpropanolamine and its formulations have been banned in India. [28]
The present study showed that FDCs are commonly prescribed in India, throughout the year. Most prescriptions in our study were prescribed by private practitioners. A seasonal variation in the type and frequency of their use has been observed. A lack of awareness about FDCs included in the various EML and the drug promotional activities may explain the overuse of these drugs. Other studies have been carried out at public hospitals where guidelines for rational prescription of medicines are followed as per the standard guidelines like EML, drug formularies and Standard Treatment Guidelines (STG) that are available and the prescribers are expected to be aware of these guidelines. The results of our study and the inferences thereof are therefore expected to be different from these studies.
| » Conclusion | | |
The availability of a number of FDCs commercially coupled with a lack of awareness of their rational use, promote the overuse of FDCs in medical stores in India Various irrational use of FDCs or FDCs containing controversial or banned ingredients, are available and prescribed in India. Awareness and education about irrational FDCs, FDCs 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 FDCs.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]
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