Noncompliance with Prescription-Writing Guidelines in an OutpatientDepartment of a Tertiary Care Hospital: A Prospective, Observational Study

Introduction

The word “prescription” refers to an order to take certain medications. The prescriptions provided by doctors to their patients contain directions for regulating their plan of care.¹ The order carried out by a pharmacist, nurse, caretaker, or therapists also can be considered as prescriptions.² As the prescriber holds accountability for the medical care of their patients, its misuse may have legal implications.³ The concept of “prescription” has broadened with time. Apart from clinical assessments, it also covers imaging studies and laboratory tests to optimize the safety and efficacy of overall medical care that the patients receive.⁴

The act of delivering the appropriate medicine to the right people at the right time is a central priority of health care. This can been assured through the effective implementation of WHO’s rational drug policies, which recommend prescribing appropriate drugs in the right dose, with correct time intervals, and for required duration.⁵ Irrational prescribing is a global problem of present-day medical practice.⁶ Some of the prototype examples of irrational use of medicines include polypharmacy, supra-/subtherapeutic dosage, use of antimicrobials for nonbacterial infections overuse of parenteral dosage form despite the availability of oral dosage forms, incorrect usage, nonadherence, and selfmedication.⁷ Its consequences are enormous, ranging from adverse effects to economic burden on both patients and society. An important method for ensuring rational prescribing among doctors is prescription auditing, which gives them accurate feedback on their prescribing patterns. It is the mainstay of quality assurance in hospitals. The audit data will be of great value to health administrators, drugs manufacturers and distributors, and health professionals’ groups for making informed decisions and drafting policies. Auditing prescriptions also plays a significant role in drug utilization studies, which are robust, experimental means to understand the role of drugs in medical practice. 

There is lack of a systematic approach for reporting medication errors in Indian hospitals.⁸ Drugs worth crores of rupees are consumed every year, but a substantial number of these drugs are not prescribed rationally. The prices of medicines in India are a matter of concern as only 0.9% of the Gross Domestic Product (GDP), i.e, INR. 200 per capita, is allocated to health.¹¹ Over 70,000 formulations are dumped into the market which are much in excess ofthe 350 drugs listed in the WHO essential drugs list.¹¹ Pharmaceutical companies entice doctors to prescribe brand-name medicines in exchange for sponsorships, incentives, and gifts.^9,10 The quantity of prescriptions of brand-name medicines is directly proportional to the cost of the drugs and therefore, the economic burden on the patients. Hence, the analysis of generic and brand-name drugs’ standards are essential.

There have been several studies on prescription audits conducted in different settings like outpatient/inpatient departments (OPDs/IPDs) in hospitals to improve the standards of medical care. As no such study has been conducted till date in our outpatient setup, this study aimed to evaluate and describe the quantitative type of prescription pattern in accordance with the core prescribing indicators proposed by WHO. It was also the objective to identify commonly prescribed drugs and to detect any irrational drug use, which could pave the way for recommendations in future.

Materials And Methods

Study Design

This was a prospective investigation conducted at the outpatient pharmacy department of a tertiary care multispecialty teaching hospital in Bengaluru, India, for six months (August 2017 to January 2018).

Selection Criteria

Inclusion criteria

• All outpatient/inpatient prescriptions presented at the outpatient pharmacy outlet.

Exclusion criteria

• Prescriptions issued by the Emergency department.

• E-prescriptions.

• Prescriptions dispensed in inpatient wards.

Source of data: Outpatient/inpatient prescriptions, pharmacy’s database, patient interviews, drug interaction report form.

Sample size: Based on the previous studies by Bhosale and Pillay, a sample size of 1000 (N=1000) randomly selected prescriptions was considered sufficient for drawing the inferences.^12,13

Study procedure

All the outpatient/inpatient prescriptions presented at the outpatient pharmacy were collected daily after obtaining approval from the institutional ethics committee. The prescriptions were screened according to WHO’s prescription-writing guidelines and recorded in a predefined data collection form. The prescription components, drug utilization behavior, and compliance of prescription to hospital formulary were noted and subjected to further analysis. Indicators used for the assessment of prescriptions were categorized as patient-related information (patient’s name, age, date of birth, gender, and address), prescriber’s information (prescription date, prescriber’s name and specialty, contact details, stamp and signature of prescriber), drug-related information (name of the drug, strength, dosage form, dose frequency, route of administration, and No. of units to be dispensed), other details (special advice), abbreviation used if any, and whether the drug was an approved one. The percentage of prescriptions containing all this information was calculated, and the prescriptions’ components that did or did not comply with the requirements were noted. The focus was on the extent of deviation from the WHO good prescriptionwriting guidelines.

According to age, gender, prescriptions’ components; the number of – drugs per prescription, drugs prescribed from the National Essential Drugs List (NEDL), fixeddose combinations (FDCs), drugs prescribed by generic name, antibiotics prescribed, and the percentage of highrisk medications in the prescription were also analyzed. The drugs interaction checker was used to check for drugs involved in potential drug-drug interactions (DDIs), which were classified based on their severity and mechanism of action, and documented in the drug interaction report form. Micromedex, Medscape, reference articles, and books were used for analyzing the prescription. The collected data was documented and kept confidential. All the prescriptions (n=1000) were analyzed based on the various objectives. The study parameters were tabulated, and the scores were analyzed with the help of Microsoft Excel software (Microsoft Office 2010).

Results

The demographic details of only 65.3% of the study population were available, as they had been poorly documented. Age was not mentioned in 34.7% of the prescriptions. The study population was categorized into four groups based on the age groups as shown in Table 1. The Table 2 provides a detailed outcome of the prescriptions analyzed. Out of the 2840 drugs prescribed in the 1000 prescriptions, 33.70% of them were generic (active ingredient) and the remainder were brand-name drugs. Only 23.45% of the drugs were written in capital letters, as shown in Table 2. A total of 13 drugs (0.45%) had no dosage forms written on the prescription, 954 drugs (33.60%) did not contain the directions for use, and 10 (0.35%) prescriptions were lacking the name and signature of the prescriber. The maximum number of prescriptions (25.6%) was noted to have two drugs in them. Prescriptions containing 3, 4, 5, 6, 7, 8, 9, and more drugs were found to be 22.9%, 17.5%, 6.2%, 4%, 3.7%, 1.1%, and 0.2%, respectively.

The most commonly prescribed dosage form was oral for 2035 drugs (85.03%) whereas topical forms were 153 (5.38%), Injectables were 87 (3.06%), and drugs to be administered via the inhalation route constituted only1.02%. The most common groups of drugs prescribed by physicians were multivitamins (25.78%), antacids (17.80%), antibiotics (15.40%), vaccines (10.53%), and analgesics (9.05%); while the least prescribed were fertility drugs (0.7%). Anticoagulants, anticancer drugs, and steroids were relatively less prescribed (<4%). Paracetamol was the maximum (27.43%) prescribed drug, and azithromycin was the least prescribed (Fig.1).

Fixed-dose combinations were 784 (27.63%) of the total drugs, and two or more fixed-dose combinations were present in 168 (16.8%) prescriptions. The commonly prescribed FDCs were rabeprazole and domperidone, amoxicillin and clavulanic acid, tramadol and paracetamol, ibuprofen and paracetamol, and aspirin and atorvastatin (Fig.2). A total of 51 drugs involved in DDIs, constituting 38 major and 13 moderate interactions, were recorded (Table 3). Most of the interactions were repetitive. The drugs commonly involved in DDIs were heparin, clopidogrel, metronidazole, aspirin, and metformin.

Drugs prescribed according to the NEDL were 86.4%, and 13.6% of the prescriptions did not comply with NEDL. The most prescribed essential drugs were pantoprazole and paracetamol. Out of the 1000 prescriptions, 7.8% contained drugs that belonged to the high-risk medications list. The commonly prescribed high-risk medications were xylometazoline hydrochloride, pentazocine, thyronorm, and insulin. A total of 99% of the prescribed drugs were listed in the hospital drug formulary, and only 10 (1%) drugs did not belong to that formulary.

Discussion

Prescription auditing is the mainstay of quality assurance in hospitals. This 6-month study gives a deep insight in to the components and the writing quality of prescriptions. A total of 1000 prescriptions were reviewed during this study. The mean number of drugs per prescription wasan essential criterion of the prescription audit. Only two drugs are recommended per prescription, which is practically difficult as most of the patients present with multiple complaints. However, the inclusion of more than two drugs per prescription carries an increased risk of DDIs.¹⁴ In our study, the mean number of drugs per prescription was 2.84, which exceeds the currently recommended limit. Other hospital-based studies in India have reported 3-5 drugs per prescription.¹⁵ Abidi et al and Pandiamunian et al have reported the average number of drugs per prescription as 4.22 and 3.31, respectively, in their studies.^16,17 However, the suggestion is to keep the average number of drugs per prescription as minimum as possible to reduce the risk of DDIs and side effects, as well as errors in prescribing and dispensing, and hospital costs.¹⁸

WHO recommends using generic drugs to facilitate education, dissemination of unbiased information about the drug, and for cost-effectiveness.¹⁹ Abidi et al reported in their study that only 3.79% medications were prescribed using their generic names,¹⁵ whereas Alagoa et al observed in a survey that 53% of the drugs prescribed were generic.²⁰ Ashish et al noted in their study that medications prescribed by generic names were 26.04%.²¹ In our study, only 33.7% of the drugs were prescribed by generic names. Despite the recommendations from various agencies, the practice of writing the generic name varies between clinicians and across hospitals.

Legibility assessment is entirely subjective and is a subject of bias in this study as well. The legibility of prescription grossly depends on the assessor’s familiarity with the handwriting of the prescriber as well as the information provided by the prescriber. According to the WHO guide to good prescribing, clarity and legibility of prescriptions are a requirement. By law, doctors are required to write the prescription in a legible manner, as badly handwritten prescriptions often lead to medication errors.¹⁸ In our study, we were unable to read 39 (1.37%) prescriptions. Karimi et al and Ni et al reported in their studies that 13.7% and 7.1% of the prescriptions were illegible, respectively.²² Following a ruling by the Chennai High Court on February 14, 2014, the Medical Council of India has issued guidelines asking physicians to write prescriptions only in capital letters.²³ In the present study, 23.45% of the drugs were written in capital letters. The WHO guide to good prescribing recommends the use of internationally accepted abbreviations to avoid misunderstanding.²⁴ A total of 17 abbreviations belonging to the Safe Medication Practices’(ISMP) error-prone abbreviations list were noted in the prescriptions, in our study.

The omission of the strength or dosage form in the prescription may not pose any problem if the prescribed drug is available only in single-strength or one dosage form. However, with the steady advancements in drug development, many drugs are increasingly available in various strengths and dosage forms, and hence, such omission errors may pose serious problems. For example, salbutamol is available in the form of 2 or 4 mg tablets, 4 mg sustained-release tablets, syrups, inhalers, inhalation powder, turbohaler, respirator solution, rotacaps, nebulizer, and injection. In a study conducted by Ni et al, 2.5% of the drugs were prescribed without strength specifications, 36.4% of the prescribed drugs lacked dosage forms in the prescription, the frequency had not been mentioned for 5.3% of the drugs, and 8.8% drugs lacked a mention of the duration in the prescription.¹⁸ However, in a study conducted by Abidi et al, 76.79% of prescriptions were perfect in terms of dose, strength, and frequency, and route and dosage forms.¹⁷ In the present study, the strength of the drug was not mentioned for 4.4% drugs. Route and frequency were not mentioned in0.73% and 0.66% of the prescriptions, respectively; 0.63% drugs did not contain the duration of treatment. A total of 0.45% drugs prescribed did not have the dosage forms written in the prescription. Most of the preparations prescribed with no indication of the dose to be used were meant for external use, such as eye or ear drops. The prescribers had probably assumed that the pharmacy staff would give the appropriate standard instructions. It should be emphasized that all preparations should be prescribed with specific doses as the prescription has limited information for the pharmacy staff to judge the prescriber’s intention. The dosage, frequency, and duration of drug therapy are the three critical parameters, which, if not neatly documented, can result in undiscerning and imprudent use of the drug.¹⁸ In the present study, 33.6% of the prescriptions did not contain the directions for use written on the prescription. This information is essential for certain types of medications such as high-risk medications, ear drops, eye drops, topical preparations, and drugs used in drug devices. In our study, 0.35% of prescriptions lacked the name and signature of the prescriber. Abidi et al and Ni et al reported 8.08% and 0.3% prescriptions without the prescriber’s signature.^17,18 The absence of the prescriber’s signature would invalidate the prescription and cause inconvenience to the patient and staff involved. 

This is especially crucial if the prescription contains psychotropic or dangerous drugs (controlled drugs).

The mean number of drugs per prescription is an essential compass for review intervention in prescribing practices. In our study, the maximum number of prescriptions (25.6%) had two drugs per prescription. This finding was in accordance with the survey by Srlshyla et al.²⁵ It is challenging to keep the mean number of medications per prescription below two; it was 2.84 in our study. Polypharmacy is a widespread practice nowadays, as confirmed by various studies. It is of concern in patients with multiple co-morbidities as it increases the chances of DDIs.²⁶ In the current study, the most common type of dosage form used was oral (71.65%), while Injectables were only 3.06%. Abidi et al reported a slightly higher percentage for both oral (93.51%) and injectable (6.19%) drugs. 

The maximum common groups of drugs prescribed to outpatients were analgesics in the studies by Abidi et al (20.67%) and Usman et al (67.2%). In our research, the most common group of drugs prescribed by physicians was multivitamins (25.78%) and antacids (17.8%). Drug classes such as anticoagulants, anticancer agents, fertility agents, and steroids were prescribed relatively less compared to the others. In a study by Karimi et al, only 4.3% multivitamins were reported to be prescribed, during the audit.²² An inconsiderate antimicrobial prescription may contribute to an increase in antimicrobial resistance. A study by Usman et al reported 57.2% of antibiotics, and a survey by Karimi et al reported 20.5% of antibiotics in prescriptions.²² In our study, we recorded 15.4% antibiotics prescribed, which reflects a better prescribing quality. The high prescription frequency of antibiotics, analgesics, drugs for gastrointestinal disorders, multivitamins, and psychotherapeutic agents may indicate the tendency of physicians towards symptomatic relief rather than curative treatment. Unnecessary prescribing of medicines such as multivitamins, minerals, enzymes, and intravenous saline, unless absolutely required by the patient, is generally discouraged. WHO and the Indian government have prepared an essential drugs list, and the prescribers are advised to adhere to it.¹⁹

The analgesics commonly prescribed were diclofenac and paracetamol, accounting for 34.8% of the total number of drugs. Yadav et al also reported diclofenac and paracetamol as the most prescribed analgesics. Amoxicillin and azithromycin were the frequently prescribed antibiotics in the present study. Pandiamunianet al reported cefixime and azithromycin as the most commonly prescribed antibiotics.¹⁶ Out of the 51 DDIs identified in the present study, 38 could be classified as potentially hazardous. However, most of the consequences of DDIs can be overcome with careful surveillance of the patients. The goal of reporting such DDIs is to promote awareness among the health care professionals so that appropriate precautions would be observed, to minimize any adverse consequences.  

In the present study, 86.4% of the prescribed drugs are mentioned in the NEML, which is higher than that reported in a study by Abidi et al (53.25%). Drugs from high-risk medication lists were 78 (7.8%) out of 1000 prescriptions in our study. It is challenging to meet the requirements for prescribing high-risk medications in outpatient pharmacy as the patient is directly handling the drugs. A hospital maintains the drugs in a pharmacy in accordance with the hospital’s formulary. Prescriptions containing medication which are not in the hospital formulary may indicate a shortage of drugs. In the present study, 99% of the prescribed drugs were from hospital formulary.

Conclusion

In our study, the maximum of the prescriptions were as per WHO’s standard norms of prescriptions, and also most of the drugs prescribed were from the essential drugs list. However, there is a lot of room for perfection in the prescription pattern. Our study demonstrates that there is a need for refining the prescription writing methods with regard to writing generic names of medications, legibility of the prescription, providing details of the prescriber and patient, etc. Overall, it was observed that the quality of the written prescriptions was low in terms of completeness. Educational sessions to encourage the prescription of drugs using generic names and correct ways of writing prescriptions, are recommended for doctors at different levels. Studies involving more number of patients and greater duration are required. This would help overcome seasonal variations and also, the utilization of drugs can be measured quantitatively. Vitamins, minerals, analgesic preparations, and FDCs should be prescribed judiciously as they could cause adverse drug reactions. Continuous education programs related to prescription writing should be conducted.