Prescription pattern of fixed dose drug combination in psychiatry out-patient department

 

Rashmi Sharma^1*, Brij Mohan Gupta², Rakesh Banal³

 

 

Abstract               Background: Fixed dose combinations are one of the strategies to reduce the number of drugs prescribed and improve medical compliance. Increased requirement of drugs in patients with more than one disease justifies the use of FDCs. Aim: To examine the prescription pattern of fixed dose drug combination in psychiatry out-patient department. Material and Methods: In this cross-sectional, observational study, 700 prescriptions of psychiatric outpatients which fulfilled the inclusion criteria were evaluated. Prescription was collected by an independent person by clicking its picture with mobile phone outside the OPD without the knowledge of prescriber to avoid any bias. Results: Fixed dose combinations were prescribed in 68 (9.71%) prescriptions. Psychotropic fixed dose combinations were prescribed in 56 (8.0%) prescriptions. Combination of trifluoperazine + chlorpromazine + trihexyphenidyl was prescribed in 23.21% prescriptions, followed by pregabalin + methylcobalamin and escitalopram + clonazepam in 16.07% each. Conclusion: A sound scientific basis should be there to prescribe FDCs, these can be tailor-made according to local needs, thereby reducing adverse drug reactions and financial burden substantially.

Key words: Fixed dose combinations, prescription, rationality, psychiatry out-patient.

 

 

INTRODUCTION

Fixed dose combination (FDC) of drugs is defined as product of two or more active ingredients in a fixed ratio of doses. This is to improve adherence or to benefit from the added effects of the two medicinal products given together.¹ Fixed dose combinations are known to increase the cost of treatment. However, anti-cholinergics are sometimes required to prevent the extrapyramidal side-effects of antipsychotic drugs, but may exacerbate existing tardive dyskinesia. WHO recommends their use for short-time in selected cases.² Other aspect is that fixed dose combinations are one of the strategies to reduce the number of drugs prescribed and improve medical compliance. Increased requirement of drugs in patients with more than one disease justifies the use of FDCs.³The current study was conceived to examine the prescription pattern of fixed dose drug combination in psychiatry out-patient department.

 

MATERIAL AND METHODS

In this cross-sectional, observational study, 700 prescriptions of psychiatric outpatients which fulfilled the inclusion criteria were evaluated. Data collected from the prescriptions was entered in the predesigned proforma especially prepared from the WHO guidelines on how to investigate drug use in health facilities.³Study was conducted after necessary approval from the Institutional Ethics Committee. The present study falls under Category C, with no risk to the patient and was an observational study, all the principles of bioethics were adopted, informed verbal consent of the patient or Legally Acceptable Representative (LAR) was taken. Prescription was collected by an independent person by clicking its picture with mobile phone outside the OPD of Psychiatric Diseases Hospital without the knowledge of prescriber to avoid any bias. The name of the drug was used by generic name. Name of the prescriber and name of the patient was coded for all practical purposes to avoid any conflict of interest.

Inclusion Criteria

• Aged 18 to 60 years
• Patients of both genders
• Patient/LAR who gives consent
• No organic disorder

Exclusion Criteria

• Age group < 18 years or > 60 years
• Revisit was excluded
• Organic disorders
• Indoor psychiatric patients

Each patient’s disease classification, pharmacological class of drug prescribed, banned drug formulations, generic versus brand drugs, fixed dose combination (FDC) prescribing rate, average number of drugs per prescription was noted down. Basic indicators referred to as core indicators were used as measure of performance in three general areas related to rational use of drugs.³ To measure the tendency of prescribing psychtropic fixed dose combination, percentage was calculated by dividing the number of psychotropic fixed dose combinations by number of prescriptions studied, multiplied by 100.

Statistical Analysis: The data collected was tabulated, interpreted and analyzed as numbers and percentage and presented with the help of appropriate tables and diagrams.

 RESULTS

According to DSM IV classification, schizophrenia was diagnosed in 46.14% patients, bipolar disorder in 24% and major depressive disorder in 18.57%. Brief psychotic episode and substance related disorders were diagnosed in 2.14% patients each. Other diagnoses were panic disorder (1.57%), obsessive compulsive disorder (1.28%), adjustment disorder (1%), post-traumatic stress disorder and generalized anxiety disorder (0.71% each). There were cases of conversion disorder (0.57%), postpartum psychosis and sleep disorder (0.42% each), and schizoaffective disorder (0.28%). A total number of 1839 drugs with a range of 1 to 6 were prescribed in 700 prescriptions studied. In all prescriptions dosage form, route of administration, frequency, dose and duration of drug was mentioned. Average number of drugs prescribed was calculated to be 2.63. Total number of 1752 psychotropic drugs with a range of 1 to 5 were prescribed, average being 2.50. Drugs prescribed by generic name were 7.83%. Two per cent patients had encounter with an injection. Percentage of psychotropic drugs prescribed from EDL was 13.53% (Table 1).

 

Table 1: Prescriptions and Drugs Prescribed

Fixed dose combinations were prescribed in 68 (9.71%) prescriptions (Table 2).

Table 2: All Fixed Dose Combinations Prescribed

Psychotropic fixed dose combinations were prescribed in 56 (8.0%) prescriptions. Combination of trifluoperazine + chlorpromazine + trihexyphenidyl was prescribed in 23.21% prescriptions, followed by pregabalin + methylcobalamin and escitalopram + clonazepam in 16.07% each, gabapentin + nortriptyline in 12.50%, trihexyphenidyl + trifluoperazine in 10.71% (Table 3).

 

Table 3: Psychotropic fixed dose combinations prescribed

DISCUSSION

In the present study, fixed dose combinations were prescribed in 68 (9.71%) prescriptions. Psychotropic fixed dose combinations were prescribed in 56 (8%) prescriptions. In the study of Sarkar P et al anticholinergics and tranquilizers/hypnotics were the drugs commonly used in combination with other psychotropics.⁴Trivedi JK et alobserved in their study that 21% were prescribed a combination of two mood stabilizers, 4% patients were prescribed a combination of antipsychotic with antidepressants. Highest number of patients received a combination of mood stabilizers with antipsychotic and benzodiazepines. Second highest group was combination of mood stabilizers and benzodiazepines.⁵Thakkar KB et aland Rode SB et alreported that in their studies 22.5% and 20.58% of the respective prescriptions contained fixed dose psychotropic drug combinations.^6,7Paul PK et alwhile studying prescription pattern of anti-psychotic drugs, reported that antipsychotics in combination prescription with same groups were 14.90%, with antidepressants, sedative-hypnotics, anticholinergic were 80.76% and other agents were 10.09% which included lithium, divalproex sodium, chlordiazepoxide, sodium valproate and tiapride.⁸Sabahi A et alobserved that the combination of antidepressants with antipsychotics was the commonly prescribed combination (18.8%) in their study.⁹Yadav AK et alstudied the prescribing frequency of fixed dose combinations (FDCs) and evaluated the rationality of FDCs prescribed in psychiatric patients. Total 383 drug formulations were prescribed in 200 patients of which 107 (27.93%) were in the form of FDCs. Most frequently prescribed FDC was escitalopram + clonazepam (22.44%), followed by amitriptyline + chlordiazepoxide (13.08%). According to them, most of the FDCs were irrational and only 28.57% of the FDCs were found to be rational considering safety and efficacy as the most important criteria for rationality.¹⁰

 

 

 

CONCLUSION

In our study, over-prescription of FDCs was not seen. A sound scientific basis should be there to prescribe FDCs, these can be tailor-made according to local needs, thereby reducing adverse drug reactions and financial burden substantially.

 

REFERENCES

• WHO drug information. 2003;17(3).
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• WHO. How to Investigate Drug Use in Health Facilities: Selected Drug use Indicators, WHO/DAP/93. Volume. 1. Geneva: World Health Organisation; 1993: 1-87.
• Sarkar P, Chakraborty K, Misra A, Shukla R, Swain SP. Pattern of psychotropic prescription in a tertiary care center: A critical analysis. Indian J Pharmacol 2013; 45(3): 270-3.
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• Yadav AK, Jeenger J, Panwar D. Evaluation of rationality of fixed-dose combinations prescribed in psychatric patients. Natl J Physiol Pharm Pharmacol 2016; 6(2): 150-4.