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Year : 2019  |  Volume : 5  |  Issue : 2  |  Page : 77-82

Prescription Audit, Drug Utilization Pattern and Adverse Drug Reaction Monitoring in Outpatients of Orthopedics Department of Tertiary Care Teaching Hospital: A Pilot Study

1 MBBS Student, Maulana Azad Medical College & Lok Nayak Hospital, New Delhi, India
2 Department of Pharmacology, Maulana Azad Medical College & Lok Nayak Hospital, New Delhi, India
3 Department of Orthopaedics, Maulana Azad Medical College & Lok Nayak Hospital, New Delhi, India

Date of Web Publication20-Aug-2019

Correspondence Address:
Associate Professor Bhupinder S Kalra
Department of Pharmacology, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi - 110002
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/mamcjms.mamcjms_33_19

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Background: The domain of orthopedic illnesses is grossly underrepresented in the current healthcare scenario especially due to overreliance on mortality rather than the morbidity or dysfunction. Continuous introduction of new drugs in the field of pharmacology requires holistic utilization, effectiveness, and side-effects studies. In addition, inappropriate use of drugs poses a risk of adverse drug reactions (ADRs). Our study aims to analyze the prescription pattern in outpatient department of orthopedics at a tertiary care hospital of Delhi. Methodology: The study was carried out in 210 patients who attended the orthopedics outpatient department for a period of 3 months. Patient demographic details, duration of illness, comorbid conditions, drugs prescribed, ADRs, and usage of complementary and alternative medicine were used to analyze the pattern of drug use. Results: In our study, we observed that vitamins and mineral preparations (20%) was the most commonly prescribed class of drugs followed by nonsteroidal antiinflammatory drugs (11.42%). Polypharmacy was seen in most of the prescriptions (60.95%), but 100% of the drugs were from Essential Medicine List of Government of National Capital Territory, Delhi. About 75% of the prescriptions were prescribed by generic names. ADRs were reported in 30 patients and majority of them were mild in nature (96%). Complementary and alternative medicine was used by 13.3% of the study patients. Conclusion: Majority of the drugs were prescribed by generic names and were essential medicines. Trend of polypharmacy was noted. Injudicious use of multivitamins and calcium was seen. Nonsteroidal antiinflammatory drugs were a significant part of therapy. ADRs reported were generally mild in severity and involved gastrointestinal tract. Need of the hour is to conduct frequent prescription audits to inculcate good prescribing practices.

Keywords: Drug utilization study, prescription audit, polypharmacy, rational use of medicine

How to cite this article:
Batta A, Madan N, Kalra BS, Arora S. Prescription Audit, Drug Utilization Pattern and Adverse Drug Reaction Monitoring in Outpatients of Orthopedics Department of Tertiary Care Teaching Hospital: A Pilot Study. MAMC J Med Sci 2019;5:77-82

How to cite this URL:
Batta A, Madan N, Kalra BS, Arora S. Prescription Audit, Drug Utilization Pattern and Adverse Drug Reaction Monitoring in Outpatients of Orthopedics Department of Tertiary Care Teaching Hospital: A Pilot Study. MAMC J Med Sci [serial online] 2019 [cited 2022 Jan 24];5:77-82. Available from: https://www.mamcjms.in/text.asp?2019/5/2/77/264785

  Introduction Top

Drug utilization studies have been instrumental in ascertaining the impact of drugs and prescribing patterns on healthcare. They are vital for evidence-based medicine use and healthcare decision making. Irrational use of drugs causes an increased cost of treatment, enhanced antimicrobial resistance, higher risk of adverse events, and adversely impact patient mortality.[1] Hence, in recent years, drug utilization studies have become a prominent tool to evaluate functioning of health systems.[2] Prescribing pattern monitoring can help identify the lacunae and provide feedback to prescribers to create awareness about appropriate use of drugs.[3]

Orthopedics forms an important part of tertiary-level care hospital, providing management for patients with various musculoskeletal disorders. Prevalence of musculoskeletal disorders in Delhi is about 7%.[4] The prevalence of musculoskeletal disorders is lowest in the age group of 18 to 30 years and gradually increases with age from 40 years and above.[4] As per indian council of medical research (ICMR) data, at least some functional limitation due to musculoskeletal disorders has been observed in 84.10% of patients in Delhi.[4]

Commonly prescribed drugs in the orthopedics outpatient department (OPD)-like analgesics, antiinflammatory, and antibiotics are associated with a wide range of adverse effects like gastritis, leukopenia, hepatotoxicity, stomatitis, pruritus, thrombocytopenias, and others. Earlier studies have shown that most monitored adverse drug reactions (ADRs) requiring discontinuation were seen early in therapy, with median time of onset of less than 6 months.[5]

Complementary and alternative medicine (CAM) is a broad domain of resources that encompasses health systems, modalities, and practices, and their accompanying theories and beliefs, other than those intrinsic to the dominant health system of a particular society or culture in a given historical period.[6] CAM is being used increasingly because of patients perception that these systems are safe as they are from natural sources, effective, more economical, and easily available. It is pertinent to know prevalence of usage of CAM and ADRs resulting from drug–drug interactions. The generated data and outcomes can be utilized in future for promotion of rational use of drugs.

  Methods Top

The study was conducted in the OPD of Orthopedics of Lok Nayak Hospital, New Delhi, after the approval of the Institutional Ethics committee. The study was conducted over a period of 3 months from March to June 2018. A total of 210 patients were enrolled in the study. Written informed consent was taken from patients or legal authorized representatives.

Following details were recorded from each prescription:
  1. Patients’ demographic details
  2. Details about patients’ disease
  3. Concomitant illness
  4. Treatment details

To study the prescription pattern, following prescribing indicators were used[7]:
  1. Percentage (%) of drugs prescribed by generic name
  2. Average number of drugs per encounter
  3. Percentage (%) drugs with injections prescribed
  4. Percentage (%) of drug prescribed from Essential Medicines List (EML) of Government of National
    • Capital Territory (NCT) of Delhi[8];
  5. Percentage (%) drugs with fixed-dose combinations

A predesigned proforma of Central Drug Standard Control Organization was used to record ADR.[9] The outcome parameters were types of ADR, symptomatic treatment required for ADR, requirement of dechallenge, and whether rechallenge was done, if ethically allowed. Causality assessment for the ADRs was done as per the WHO Causality assessment Uppsala Monitoring Centre scale.[10]

ADRs were graded as mild, moderate, and severe as follows. Mild: transient or mild discomfort; no limitation in activity; no medical intervention/therapy required. Moderate: limitation in activity − some assistance may be needed; no or minimal medical intervention/therapy required. Severe: marked limitation in activity; some assistance usually required; medical intervention/therapy required; hospitalization possible. Severe: life-threatening − extreme limitation in activity; significant assistance required; significant medical intervention/therapy required; hospitalization necessary.[11] Patients were also assessed on the type and duration of CAM usage.

  Statistical Analysis Top

Descriptive statistics was used for analysis. Prescription pattern of drugs along with adverse drug events and CAM usage was evaluated in terms of preferred or widely prescribed drugs for that particular disease, incidence of ADRs with those drugs, and pattern of usage of different modalities of CAM.

  Results Top

Two hundred and ten patients attending the orthopedic OPD (new or old) were enrolled in the study. Among the 210 patients, 118 (56.2%) were females and 92 (43.8%) were males. The mean age was 47.6 years. Most common patients attending the OPD were follow-up cases of fracture (28.6%) followed by backache (20.3%) and knee pain (14.3%). The demographic details and disease-related information have been represented in [Table 1] and [Table 2], respectively.
Table 1 Demographic details

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Table 2 Morbidity pattern and sex differences among different orthopedic illnesses

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Prescription analysis

In our study, we observed that total number of drugs prescribed for the treatments of the patients were 918. Average number of drugs per prescription was 4.37. Approximately 75% of drugs were prescribed by their generic name; 100% of drugs were prescribed from the EML 2016, Government of NCT of Delhi.[8] Only 13 prescriptions (6%) contained injectable drugs [[Table 3]]. Among the drugs prescribed, 35 was the actual number of drugs used. Out of which, vitamins and mineral preparations comprised 20%, nonsteroidal antiinflammatory drugs (NSAIDs) constituted 11.42%, followed by antacids and disease-modifying antirheumatic drugs (DMARDs) that constituted 8.57% [[Table 4]]. Calcium (70.95%) was prescribed in maximum number of patients followed by paracetamol (52.8%).
Table 3 Analysis of prescriptions as per WHO Core Drug use indicators

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Table 4 Various drugs used in prescriptions

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As per the core indicators of drug utilization, monotherapy was prescribed in only 17 prescriptions; rest all (91%) received combination therapy. Sixty-five (30.95%) patients received two drugs at a time. Three and more than three drugs were prescribed in 128 (60.95%) patients suggesting a trend of polypharmacy. The median duration of therapy was 4.2 days. Twenty-eight (13.33%) patients received treatment for less than 2 weeks; 34.76% patients were given for 2 to 4 weeks followed by 109 (51.90%) patients, who were prescribed drugs for more than 4 weeks.

Diagnosis was missing in 10 prescriptions and short forms of drugs were present in many prescriptions, for example, paracetamol was written as PCM, methotrexate was written as Mtx, and others. Dose, frequency, and duration of therapy was absent in few prescriptions. Majority of the prescriptions (97.62%) contained NSAIDs. The most commonly prescribed combinations in our study have been summarized in [Table 5]. Fixed-dose combinations used were Digene syrup, multivitamins, amoxycillin–clavulanic acid, etc., and were prescribed in relatively few patients.
Table 5 Commonly prescribed combination therapy

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ADRs were reported in 30 (14.28%) patients. The most common ADR was nausea and vomiting (5.71%) followed by epigastric pain (4.76%). The other common side effects included headache and constipation [[Table 6]]. Symptomatic treatment was required in five patients. During our study, no patient was hospitalized due to an ADR. In one case, drugs were discontinued due to a suspected ADR. It was with methotrexate; the patient developed derangement in liver function test. No rechallenge was performed. In terms of severity, majority (96%) of the ADRs were mild.
Table 6 Adverse drug reactions and their incidence

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CAM usage

In our study, we observed that CAM was used by 42 patients (13.3%). Twenty-nine patients used Ayurveda; 11 patients used homeopathy system of medicine [[Table 7]]. None of the patients used Unani system, whereas two patients used both homeopathy and ayurveda. Majority of these patients were using CAM since last 1 year and reported no benefit. None of these patients reported or recalled any ADR while on CAM therapy.
Table 7 Complementary and alternative medicine used by study patients

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  Discussion Top

The findings of the prescription pattern study, conducted in a tertiary care hospital, Delhi, provide information about the demographic data, prescribing patterns, and ADRs. Majority of the patients were females, and the age of onset was middle age. Our study showed a considerable female predominance that is in line with a study done by Shankar et al.[12]

In our study, the average number of drugs per prescription was found to be 4.37, which is more than the WHO recommendations. According to WHO, number of drugs prescribed per prescription should be two and justification for prescribing more than two drugs would be needed as there is an increased risk of drug interactions.[13],[14] The increase in the number of drugs per prescription also increases the cost of prescription resulting in economic burden and nonadherence to the therapy, thereby worsening the said condition and prolonging the treatment. The present study observed that 75% drugs were prescribed by their generic name. Prescribing drugs by generic name promotes rational use of drugs with regard to safety, efficacy, and cost by permitting identification of the products by its scientific names.[15],[16] Generic prescribing not only rationalizes but also decreases the cost of therapy to a great extent. However, 100% of the drugs were prescribed from the EML, NCT of Delhi. This is a relatively higher number. Essential medicines have been shown to improve the quality and cost-effectiveness of healthcare delivery when combined with proper procurement policies and good prescribing practices.[17]

Globally, NSAIDs are the most commonly prescribed drugs for the management of pain and inflammation and the same has been reflected in this study.[12] Among them, paracetamol topped the list followed by diclofenac that is in contrast with the study by Shankar et al.[12] in which diclofenac and meloxicam were the most commonly prescribed NSAIDs.[12] Despite the wide clinical use of NSAIDs, their gastrointestinal toxicity is the major limitation in clinical use. Hence, they are coprescribed with gastroprotective agents.[18] We found that most of the analgesics were coprescribed with gastroprotective agents. Our findings are in alignment with the study of Nagla et al.[19] in which proton pump inhibitors have been coprescribed with analgesics.

Calcium and vitamin D supplements were also present in a significant number of prescriptions (20%) which is in concordance with the studies done in the past in which 96% and 28.3% were calcium/multivitamins, respectively.[20],[21] These were probably given to prevent and treat osteoporosis. Folic acid was added to prevent methotrexate-associated anemia. There is a widespread deficiency of calcium and vitamin D in Indian population among all age groups.[22] However, injudicious use of these supplements without knowing the levels of these vitamins in the patient is considered inappropriate and is a matter of concern. Screening of these patients should be done before prescribing. Methotrexate was the DMARD of choice by the prescribing physician for rheumatoid arthritis. Our findings are coinciding with the study of Gawde et al.[23] in which hydroxychloroquine along with methotrexate was most commonly prescribed. Approximately 41% patients of rheumatoid arthritis were on DMARDs with three drugs. These included methotrexate, sulfasalazine, and hydroxychloroquine along with indomethacin. The variation in number of DMARDs prescribed might be due to the varied severity of disease encountered in different patients.[5] Biological agents have also been approved for the treatment of rheumatoid arthritis but have not been prescribed in our study probably because they are not included in the EML.

ADRs were reported from 14.28% of patients. However, majority of the ADRs were mild in nature and did not require any intervention. The usage of CAM was relatively low in the study population. None of the patients reported any benefit from the usage of CAM. However, no ADRs were recorded from the use of these systems of medicine. This finding is in contrast with study by Ahmed et al.[24] involving geriatric age group and reported more ADRs in patients who used CAM.

The percentage of drugs prescribed from essential medicines list and the use of the generic names were found to be satisfactory, but the average number of drugs per prescription was high. This results in huge pill burden on the patient. Polypharmacy and combination of drugs has to be discouraged to minimize ADRs and drug interactions. So monitoring the use of these drugs in the form of prescriptions audit is need of the hour. Also, rampant use of multivitamins in the orthopedics OPD is considered irrational and needs to be worked upon. Art of prescription writing should also be inculcated in the medical curriculum to avoid medication errors. Pharmacovigilance is an important tool for the clinician to develop safe medical practice. Identifying the adverse drug events and recording them meticulously and reporting them to the concerned authority is now a must in medical profession, thereby making the drug therapy safe and rational. There is a considerable scope of improvement in the prescribing practices.

  Conclusion Top

Majority of the drugs were prescribed by generic names and were essential medicines. Trend of polypharmacy was noted. Injudicious use of multivitamins and calcium was seen. NSAIDs were a significant part of therapy. ADRs reported were generally mild in severity and involved gastrointestinal tract. It is pertinent to rationalize use of medicines in patients to prevent ADRs, to ensure cost-effectiveness, and to minimize medication errors due to incomplete prescriptions. Regular prescription audits with feedback to prescribers can alter prescribing behavior toward good prescribing practices.

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Conflicts of interest

There are no conflicts of interest.

  References Top

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Central Drug Standard Control Organization − Suspected Adverse Drug Reaction Form. Available at: http://www.cdsco.nic.in/writereaddata/ADR%20form%20PvPI.pdf. [Accessed August 27, 2018].  Back to cited text no. 9
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  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]

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