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| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 8
| Issue : 2 | Page : 168-175 |
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Prescription analysis of rheumatology and endocrinology departments of a teaching hospital in Western India
Vikas Yadav, Sanjay Jaiswal, Sharan Shyam
Department of Pharmacology, Armed Forces Medical College, Pune, Maharashtra, India
| Date of Submission | 01-Apr-2022 |
| Date of Decision | 30-Sep-2022 |
| Date of Acceptance | 02-Oct-2022 |
| Date of Web Publication | 23-Dec-2022 |
Correspondence Address:
Sharan Shyam
Department of Pharmacology, Armed Forces Medical College, Pune - 411 040, Maharashtra
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/jcrsm.jcrsm_26_22
Background: Prescription analysis is the simplest method to observe the current treatment practice in any health-care setting. Biopharmaceuticals are a class of drugs that hold great promise in treating diseases. In recent years, there has been an increase in their consumption. The present analysis was carried out to obtain data on the prescribing patterns and the prevalence of the use of biologics in two departments of a tertiary care hospital through a cross-sectional study.
Methodology: The study was conducted as an observational study in the departments of rheumatology and endocrinology of a tertiary care hospital in western India. Data were collected from the prescription notebooks or medical case sheets of patients on treatment in the outpatient departments (OPDs) or wards by the rheumatologists or endocrinologists of the hospital. The World Health Organization core drug use indicators for drug prescription analysis were calculated.
Results: A total of 4684 drugs had been prescribed in the 874 patient encounters analyzed with the average number of drugs per prescription being 5.36. While 13.3% of prescriptions in the rheumatology department contained a biologic, more than 55% of prescriptions in the endocrinology department contained a biologic. The commonly used biologics were infliximab and etanercept in the rheumatology department and insulin analogs in the endocrinology department.
Conclusion: The use of eight types of biologics in rheumatoid arthritis patients in this study is an indicator of active monitoring of the disease and early intervention. The present study has brought out the rational use of biologics such as infliximab and etanercept in rheumatology and insulin analogs in the endocrinology departments of the hospital.
Keywords: Antirheumatic agents, biological products, endocrinology, observational study, prescriptions, rheumatology
How to cite this article:
Yadav V, Jaiswal S, Shyam S. Prescription analysis of rheumatology and endocrinology departments of a teaching hospital in Western India. J Curr Res Sci Med 2022;8:168-75 |
How to cite this URL:
Yadav V, Jaiswal S, Shyam S. Prescription analysis of rheumatology and endocrinology departments of a teaching hospital in Western India. J Curr Res Sci Med [serial online] 2022 [cited 2023 Mar 21];8:168-75. Available from: https://www.jcrsmed.org/text.asp?2022/8/2/168/364496 |
| Introduction | |  |
Drug utilization research is defined by the World Health Organization (WHO) as “the marketing, distribution, prescription and use of drugs in a society with special emphasis on the resulting medical, social and economic consequences.”[1]
Biopharmaceuticals hold tremendous promise in the treatment of diseases. It is important to carry out their prescription analysis periodically, especially in developing nations to ensure that the benefits outweigh the demerits of their use.
Biopharmaceuticals are products of high-molecular mass polymers of nucleotides (RNA or DNA) or amino acids (peptides and proteins).[2] Human insulin was the first recombinant protein approved by the United States Food and Drug Administration in 1982.[3] More than 100 protein-based therapeutics are approved for clinical use.[4] The global market for biopharmaceuticals is over $275 billion, and it continues to grow at 12%–13% annually.[5]
Rheumatoid arthritis (RA) and diabetes are the most common diseases treated with biologicals. Hence, we planned to carry out a prescription analysis of drugs prescribed by the departments of rheumatology and endocrinology of a teaching hospital.
Most specialists monitor the therapy of RA patients through monthly C-reactive protein levels and disease activity scores of 28 joints (composite scores).[6] Often, monotherapy treatment is started as soon as possible with first-line conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). DMARDs inhibit damage to cartilage and bone and are, therefore, started early. csDMARDs include methotrexate (MTX), leflunomide (LEF), or sulfasalazine (SSZ). Hydroxychloroquine (HCQ) is considered an alternative to oral MTX, LEF, or SSZ for mild or palindromic disease. Short-term bridging therapy is considered with oral glucocorticoids or intramuscular/intra-articular injections when starting a new csDMARD. Targeted synthetic DMARDs (tsDMARDs) recommended are baricitinib, tofacitinib, and upadacitinib.[7],[8] Biological original DMARDs are tumor necrosis factor inhibitors – adalimumab, certolizumab, etanercept, golimumab, and infliximab; interleukin-6 receptor inhibitors – sarilumab and tocilizumab (TCZ); costimulation inhibitor – abatacept; and anti-B-cell (CD20) – rituximab. Biosimilar DMARDs (bsDMARDs) are currently available for adalimumab, etanercept, infliximab, and rituximab.[7],[9]
Metformin is started in all patients of T2DM, and other medications are added stepwise to achieve the target HbA1c. Diabetic patients whose blood glucose is not controlled with dual therapy can be given triple therapy or insulin injections.[10] Noninsulin glucose-lowering agents approved for use in diabetes include biguanides, second-generation sulfonylureas, thiazolidinediones, α-glucosidase inhibitors, meglitinides, dipeptidyl peptidase-4 inhibitors (DPP-4i), sodium-glucose transporter-2 inhibitors (SGLT-2i), and glucagon-like peptide-1 receptor agonists. Insulin products available are human insulins and analogs such as lispro, glulisine, aspart, glargine, detemir, and degludec.[11]
We, therefore, planned the present analysis to obtain data on the prescribing pattern and prevalence of the use of biologicals in two departments of a tertiary care hospital. This study would, therefore, add to the knowledge of current treatment practices, with the emergence of biopharmaceuticals as effective therapeutic agents.
| Materials and Methods | | |
This study protocol was prepared as per the technical document “Introduction to drug utilization research” and “how to investigate drug use in health facilities-selected drug use indicators.”[12] The study protocol was approved by the Institutional Ethics Committee vide approval number IEC/12/OCT/2018 date October 22, 2018. Waiver of written informed consent was obtained from the Institutional Ethics Committee since the study involved observation of anonymized prescriptions recorded without linked identifiers.
This drug utilization research was conducted as a cross-sectional observational study in the departments of rheumatology and endocrinology of a tertiary care hospital in western India.
The WHO guideline on drug use indicators recommends a sample size of at least 600 encounters to be included in a cross-sectional survey. We, therefore, chose a sample size of 800 encounters inclusive of outpatient and inpatient treatment.[12]
Data were collected from the prescription notebooks or medical case sheets of patients as they were treated in the OPDs or wards by the rheumatologists and endocrinologists of the hospital. All sequential prescriptions and medical case sheets were chosen to be analyzed for the prescribing indicators.
Inclusion criteria
- All patients attending OPDs of a tertiary care hospital and treated by a rheumatologist or endocrinologist
- All patients admitted to wards under the rheumatology and endocrinology departments of the hospital
- All patients admitted to the day-care facility who had received biopharmaceuticals from the rheumatology or endocrinology department of the hospital
Exclusion criteria
- Patients who were primarily treated by other departments of the hospital and given rheumatology/endocrinology consultation only.
Each entry in the prescription notebook or medical case sheet was regarded as a single-patient encounter for the calculation of the required parameters. Data were collected on the demographic details of age, gender, clinical diagnosis, and the treatment prescribed.
Prescribing indicators
Following “WHO core drug use indicators” for drug prescription analysis, the following prescribing indicators were calculated:
- The average number of drugs per encounter
- Percentage of drugs prescribed by the generic name
- Percentage of encounters with an antibiotic prescribed
- Percentage of encounters with an injection prescribed
- Percentage of drugs prescribed from the National List of Essential Medicines of India (NLEM 2015).[13]
In addition to the above indicators, the percentage of encounters with a biologic prescription was also calculated.
Statistics and data analysis
Data were entered in Microsoft Excel software version 2007 and descriptive statistics were applied. Continuous variables were presented as mean values ± standard deviation, and categorical variables were expressed as percentages or proportions.
| Results | | |
Demographic data
A total of 874 prescriptions from the departments of rheumatology and endocrinology of a tertiary care hospital were included in the study. The study was carried out over 9 months from January to September 2019.
Out of the total prescriptions analyzed, 793 prescriptions were from outpatient departments and 81 prescriptions were from inpatients admitted to the hospital. The share of endocrinology was 447 OPD prescriptions and 21 inpatient case sheets and that of rheumatology was 346 OPD prescriptions and 60 inpatient case sheets.
The total prescriptions of 874 consisted of 498 female patients and 376 male patients. The mean age of patients in the rheumatology department was 46 years while that of the endocrinology department was 53 years. The maximum of patients attended to in this analysis were in the age group of 46–65 years.
Prescription analysis
A total of 4684 drugs had been prescribed in the 874 patient encounters analyzed. Hence, the average number of drugs per prescription was 5.36 in the hospital. In the rheumatology department, a total of 2319 drugs had been prescribed in the 406 prescription encounters. Similarly, in the endocrinology department, a total of 2365 drugs had been prescribed in the 468 prescription encounters.
The results are depicted in [Table 1], [Table 2], [Table 3] and [Figure 1] and [Figure 2]. | Figure 1: Drug prescribing trends in a) Rheumatology and b) Endocrinology departments
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 | Figure 2: Prescribing trends of biologicals in a tertiary care hospital a) Rheumatology (54 biologicals) and b) Endocrinology (352 biologicals)
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World Health Organization core drug use indicators (prescribing indicators) assessing drug prescriptions
All 874 prescription encounters were analyzed as per the WHO core drug use indicators (prescribing indicators), results represented in [Table 1] for rheumatology and endocrinology, respectively, along with optimal levels as defined by the WHO.[14]
Prescription analysis of biologics
Fifty-four out of 406 prescriptions (13.3%) in rheumatology and 260 out of 468 (55.6%) in endocrinology departments contained a biologic. The most commonly prescribed biopharmaceutical in the rheumatology department was injection infliximab, and in endocrinology, it was injection insulin glargine. The least commonly prescribed biopharmaceuticals in the above departments were injection secukinumab and injection insulin aspart, respectively.
| Discussion | | |
Drug utilization study forms an important pillar of rational pharmacotherapy. It describes the prescription preferences and trends in any health-care institution, which allows analysis by experts on the adherence to regulatory and/or position statements of management of diseases. A cross-sectional study provides the prescribing trend.[12] Health care has now transformed into the practice of evidence-based medicine. Hence, there is a constant revision in drug therapy of diseases with emerging clinical research. The status of existing drugs in the management of diseases changes with time as more efficacious and safer agents are made available. Prescription analysis with a focus on the prevalence of the use of newer agents in the pharmacotherapy of diseases helps pick up the change in medical practices and their adherence to current treatment guidelines.
More than 90% of prescriptions analyzed in our study pertained to OPDs. The male: female ratio of patients attended to in the rheumatology department was 1.63:1, which is expected due to the 2.5 times higher prevalence of RA in females than males.[15] In the endocrinology department, the gender ratio was 1.12:1, since gender distribution of diabetes in India has shown mixed results.[16] In our study, the mean age of patients attending the endocrinology department was 53 years, in conformity with the younger age profile of diabetics in India.[10]
We observed, in our study for both the departments, an average of more than five drugs per prescription, over 75% of the drugs prescribed were in their generic names, and less than 1% of prescriptions contained an antibiotic. Studies carried out by other workers in India found the average number of drugs per prescription in the range of 2 to 13.[17],[18] The WHO has recommended the optimal level of the “average number of drugs per prescription” to be <2.[14] However, this may not be possible in the treatment of many chronic diseases, where drug synergism and step-up therapy are recommended. However, polypharmacy is discouraged because it increases the risk of drug interactions and the cost of therapy and lowers patient compliance.[14],[19]
In India, it is a regulatory requirement to prescribe medicines in their generic names, to reduce the financial burden on the patient.[20] Our study has shown a high use of generic drug prescriptions. We found the antibiotic prescriptions to be minimally low in our survey, as infections were well controlled in the patients with chronic diseases. The major reason for this observation was that our prescription analysis was done in a public hospital providing free treatment and medicines to most of its patients.
Traditionally, prescribing injections on an OPD basis has been discouraged due to the high cost. However, with the advent of day-care procedures in arthritis patients and self-administration of subcutaneous insulin, the use of injections is presently recommended on an OPD basis. Hence, injections forming more than 27% of rheumatology and more than 50% of endocrinology prescriptions are logical.
More than 80% of drugs prescribed in the rheumatology department of the hospital surveyed are enlisted in NLEM 2015. This indicates a high adherence to the national formulary and list of essential medicines. In endocrinology, adherence to the national list was more than 64% which is still high. Perhaps, newer well-established antidiabetic drugs are on the market, such as DPP-4i and SGLT-2i, which did not figure in the NLEM 2015 but are being used popularly.
RA (40% approximately) and T2DM (76% approximately) were the most common diseases being treated in the two super-specialty departments surveyed. Methotrexate was the most common DMARD used, followed by HCQ, while prednisolone was the most common corticosteroid used in RA. Insulin glargine followed by injection lispro was the most common insulin analog used while metformin was the most common oral antidiabetic agent and atorvastatin was the highest prescribed cardiovascular system drug in endocrinology prescriptions.
In a study in Delhi (India), the average number of drugs per prescription was 8.06. Forty-one percent of the drugs were prescribed by their generic names, approximately 76.3% were from the WHO Essential Medicines List 2013, and 35.4% of all drugs comprised DMARDs with no prescription containing a biologic.[15] A study in Mumbai (India), on T2DM patients' prescriptions, observed that 61.74% of drugs prescribed were from NLEM. Of these, 84% contained metformin, 41% contained glimepiride followed by DPP-4i, and only 8% contained insulin, mainly lispro.[18]
In a study on newly detected diabetes in Nepal, the mean number of drugs per prescription was 1.83 with 24.5% receiving metformin, 19.9% receiving sulfonylureas (glimepiride or glipizide), and only 2.5% receiving insulin.[21]
In a study on RA patients in Mumbai, the most frequently prescribed agents were MTX and HCQ, the average number of drugs per prescription was 6.17 with 35% of prescriptions being in generic names, and 67% of patients were found to be on a combination of two DMARDs.[19] An audit of prescriptions of more than 20-year duration diabetics revealed insulin use in 46% of patients, after metformin, sulfonylureas, and DPP-4i drug consumption.[22]
A cross-sectional study in Spain of drug therapy for RA patients found MTX as the highest-used csDMARD together with corticosteroids. Among biologicals, etanercept/TCZ/adalimumab was the preferred biological used in combination with DMARDs.[23] A 50% decline in HCQ use has been reported in recent times.[24] A study on RA veteran patients found 20.6% use of biologic therapy within 2 years of starting MTX.[25]
The use of eight types of biologics in the present prescription analysis of RA patients is an indicator of active monitoring of the disease and early intervention. Infliximab was the most commonly prescribed biological DMARD in our study. Infliximab is approved for RA, ankylosing spondylitis, and psoriatic arthritis. The present survey demonstrates the emerging popularity of biopharmaceuticals in the treatment of arthritis patients even in a public hospital providing free medical treatment.
The present study has revealed the use of ten antidiabetic agents, other than insulin, and five types of insulin preparations in the effective control of blood glucose in diabetics. The insulin analogs were prescribed either alone or add-on to oral ADA to achieve the treatment target. Insulin glargine (28.48%) was the most common form, which was prescribed as basal-bolus and add-on therapy to oral ADA.
Limitations of the present study
This study has been carried out at only one center in the region. A better analysis could have been obtained if it was compared with other tertiary care centers in the region or in the country.
Strengths of the study
The present analysis could be compared with data from earlier years at the same center to elicit the change in prescribing patterns. A comparison of similar prescriptions from private hospitals could also elicit differences in the drugs prescribed by the government super-specialist doctors and those in private practice.
| Conclusion | | |
The WHO core drug use indicators (prescribing indicators) have been used in the present study to analyze 874 prescriptions of rheumatologists and endocrinologists in a tertiary care public hospital. In addition, the prevalence of drugs prescribed from the NLEM 2015 and the WHO-EML 2019 has also been analyzed. Biopharmaceuticals in particular have been the drugs of special interest in the present study to analyze their prevalence and pattern of use. The study has brought out the rational use of biologics such as infliximab and etanercept in arthritis patients and insulin analogs in the diabetics treated by this hospital.
Ethical approval
The study was approved by the Institutional Ethics Committee (Approval No. IEC/12/OCT/2018 dated October 22, 2018).
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| References | | |
| 1. | World Health Organization (WHO). Introduction to Drug Utilization Research/WHO International Working Group for Drug Statistics Methodology, WHO Collaborating Centre for Drug Statistics Methodology, WHO Collaborating Centre for Drug Utilization Research, and Clinical Pharmacological services. Geneva: WHO Press, World Health Organization; 2003.  |
| 2. | Crommelin DJ, Storm G, Verrijk R, de Leede L, Jiskoot W, Hennink WE. Shifting paradigms: Biopharmaceuticals versus low molecular weight drugs. Int J Pharm 2003;266:3-16. |
| 3. | Leader B, Baca QJ, Golan DE. Protein therapeutics: A summary and pharmacological classification. Nat Rev Drug Discov 2008;7:21-39. |
| 4. | Dimitrov DS. Therapeutic proteins. Methods mol biol 2012;899:1-26. |
| 5. | Morrow KJ Jr., Langer ES. A Biopharma Year in Review – And a Look Ahead to 2020. Available from: www.biosimilardevelopment.com/doc/a-biopharma-year-in-review – and a look ahead to 2020. [[Last updated on 2019 Dec 16, Last accessed on 2020 Nov 10]. |
| 6. | Hawkins T. Rheumatoid arthritis and osteoarthritis. In: Whittlesea C, Hodson K, editors. Clinical Pharmacy and Therapeutics. 6 th ed. Beijing: Elsevier; 2019. p. 923-48. |
| 7. | Smolen JS, Landewé RB, Bijlsma JW, Burmester GR, Dougados M, Kerschbaumer A, et al. Eular recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis 2020;79:685-99. |
| 8. | Ritter JM, Flower R, Henderson G, Loke YK, Macewan D, Rang HP. Rang and Dale's Pharmacology. 9 th ed. Beijing: Elsevier; 2020. |
| 9. | Brezinski EA, Klickstein LB, Armstrong AW. Pharmacology of immunosuppression. In: Golan DE, Armstrong EJ, Armstrong AW, editors. Principles of Pharmacology the pathophysiologic basis of drug therapy. 4 th ed. New Delhi: Wolters Kluwer; 2017. p. 844-63. |
| 10. | Government of India. Ministry of Health & Family Welfare. ICMR Guidelines for Management of type 2 diabetes 2018. ICMR, Ansari Nagar; 2018. p. 73. |
| 11. | American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of medical care in diabetes-2020. Diabetes Care 2020;43:S98-110. |
| 12. | World Health Organization (WHO). How to investigate drug use in health facilities, Selected drug use indicators. Geneva: WHO/DAP/93.1 World Health Organization; 1993. |
| 13. | |
| 14. | Dumoulin J, Kaddar M, Velásquez G. Guide to Drug Financing Mechanisms. Geneva: World Health Organization; 1998. |
| 15. | Dahiya A, Kalra BS, Saini A, Tekur U. Prescription pattern in patients with rheumatoid arthritis in a teaching tertiary care hospital. MAMC J Med Sci 2016;2:33. [Full text] |
| 16. | Gutch M, Razi SM, Kumar S, Gupta KK. Diabetes mellitus: Trends in Northern India. Indian J Endocrinol Metab 2014;18:731-4. |
| 17. | Hazra A, Tripathi Sk, Alam MS. Prescribing and dispensing activities at the health facilities of a non-governmental organization. Natl Med J India 2000;13:177-82. |
| 18. | Kakade A, Mohanty IR, Rai S. Assessment of prescription pattern of antidiabetic drugs in the outpatient department of a tertiary care hospital. Int J Clin Endocrinol Metab 2017;3:1-7. |
| 19. | Gawde SR, Shetty YC, Merchant S, Kulkarni UJ, Nadkar MY. Drug utilization pattern and cost analysis in rheumatoid arthritis patients-a cross-sectional study in tertiary care hospital, Mumbai. British J Pharm Res 2013;3:37. |
| 20. | Andrade C, Rao TS. prescription writing: Generic or brand? Indian J Psychiatry 2017;59:133-7. [ PUBMED] [Full text] |
| 21. | Das P, Das BP, Rauniar GP, Roy RK, Sharma SK. Drug utilization pattern and effectiveness analysis in diabetes mellitus at a tertiary care centre in Eastern Nepal. Indian J Physiol Pharmacol 2011;55:272-80. |
| 22. | Singla R, Bindra J, Singla A, Gupta Y, Kalra S. Drug prescription patterns and cost analysis of diabetes therapy in India: Audit of an endocrine practice. Indian J Endocrinol Metab 2019;23:40-5. |
| 23. | Cruz BH, Garnica IU, Parera RS, Romero ER, Gutiérrez JC, Sánchez AG, et al. Disease-modifying antirheumatic drug prescription patterns in adult rheumatoid arthritis patients in routine clinical practice in Spain. Eur J Rheumatol 2020;7:149. [doi 10.5152/eurjrheum. 2020.19053]. |
| 24. | Melles RB, Jorge AM, Marmor MF, Zhang Y, Choi Hk. Sharp decline in hydroxychloroquine dosing-analysis of 17,797 initiators from 2007 to 2016. Clin Rheumatol 2018;37:1853-9. |
| 25. | George MD, Sauer BC, Teng CC, Cannon GW, England BR, Kerr GS, et al. Biologic and glucocorticoid use after methotrexate initiation in patients with rheumatoid arthritis. J Rheumatol 2019;46:343-50. |
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]
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