PRIME study: Prescription review to impede medication errors

1.1. Incidence of medication errors

Medication errors occur about 1 in every 5 doses given in hospitals and it is also reported that a medication error occurs each day per patient. About 1.3 million people suffer from medication errors in the U.S. alone, of which approximately 7000 deaths occur [6].

1.2. Phases of medication process susceptible to errors

Ideal implementation of medication process requires the co-operation of various healthcare professionals such as physicians, pharmacists, and nurses [7]. Medication errors have been identified and reported during each phase of the medication use process, including prescription, transcription, dispensing, administration and monitoring [8]. It is most commonly encountered during the ordering and administration phases, occurring in up to 82% and 7% in some studies, respectively which sequentially can lead to other types of errors such as wrong drug, wrong dose prescribed or administered, known allergy, wrong time or route, or missed dose. However, dosing errors are by far the most frequent, constituting between 40% and 50% of all errors [9].

1.3. Role of clinical pharmacy in medication audit

The mission of the profession of pharmacy is to improve public health through ensuring safe, effective, and appropriate use of medications. Clinical pharmacists can play a significant role in training nurses to reduce the rate of medication errors in the hospital. One obvious solution to aid in the summons of drug related problems (DRPs) could be considering pharmacy services in intravenous (IV) product preparation by implementing a protocol prepared by clinical pharmacists and establishing reporting error systems. Pharmacists also play a role in providing expert advice on compatibility and perceptual constancy for the use of various dosage forms of drugs, update staff on new clinical practice guidelines and help interpret guidelines to treat patients with advanced illnesses [10]. Moreover, their role in evaluating patient’s medication therapy including effectiveness, side effects, toxicities, allergic drug reactions, drug interactions thereby leading to improved patient outcome makes them a necessary resource [11].

1.4. Classification of medication errors

NCCMERP index has categorized medication errors based on its severity from category A to I as listed in Fig. 1 [12].

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Fig. 1.

a. Categories of medication errors based on severity; b. proportion of medication errors encountered in the study. Category A: Circumstances or events that have the capacity to cause error; Category B: An error occurred but the error did not reach the patient; Category C: An error occurred that reached the patient but did not cause patient harm; Category D: An error occurred that reached the patient and required monitoring to confirm that it resulted in no harm to the patient and/or required intervention to preclude harm; Category E: An error occurred that may have contributed to or resulted in temporary harm to the patient and required intervention; Category F: An error occurred that may have contributed to or resulted in temporary harm to the patient and required initial or prolonged hospitalization; Category G: An error occurred that may have contributed to or resulted in permanent patient harm; Category H: An error occurred that required intervention necessary to sustain life; Category I: An error occurred that may have contributed to or resulted in the patient’s death.

While the primary objective of the study was to improve patient safety, the study also aimed to demonstrate the true worth of clinical pharmacy services to the hospital fraternity in terms of minimizing incidence of medication errors.

As per the authors’ knowledge, there is not even a single study based in India that shows the role of clinical pharmacy services. The present study was successful in showing the contribution of clinical pharmacy services in patient safety which is very important especially because clinical pharmacists are overlooked in this country. This study will clear the misconception of healthcare staff as well as general public who think that pharmacists do not play a clinical role in hospitals.

2.1. Setting and population

This was a prospective, observational study conducted at a multispecialty hospital located in one of the metropolitans of India. The protocol of the study was approved by the quality and safety department of the hospital. The study took place from December 2016 until June 2017. The study was initiated by the clinical pharmacy department in co-ordination with the consultants, nursing and hospital pharmacy staff. 1149 patients admitted to in-patient departments of the hospital were enrolled in the study and grouped through simple random enrolment. Informed consent was taken from patients before enrollment in the study. Ethics committee approval was not required for the study as patient identity was not revealed and there was no direct intervention involved from the investigators, but their recommendations were delivered to the consultants who intervened wherever necessary.

2.2. Data collection

Information related to patients’ demographics, their medical history as well as medication details were collected by the internal clinical pharmacists from case sheets and laboratory reports and recorded in a detailed data collection form. Multiple medications were prescribed in a single prescription in the hospital where this study was conducted.

2.3. Patient eligibility

Male and female patients of all ages admitted to intensive care units (ICUs) or general wards were enrolled in the study. Out-patients and in-patients with no medications prescribed were excluded from the study.

2.4. Study process

The collected data were analyzed by the clinical pharmacologist for several prescription audit parameters including prescription completeness, therapeutic duplication, drug interactions, contraindications, drug allergies, renal dose adjustment, insulin dose correctness, appropriate drug selection and inclusion of reconciliation medications.

Any type of discrepancy related to the aforesaid parameters was followed by a root cause analysis which involved identification of the phase of medication process and location of error occurrence to identify the responsible healthcare professionals. The incident was immediately reported to the concerned physician and appropriate steps were taken to rectify the malpractice. The offender was furthermore educated to prevent recurrence of similar errors in the future.

Routine checks in wards and patients’ drug storage area were performed to detect any transcription or administration errors whereas nurses were responsible to verify the indents with drugs received from the hospital pharmacy to uncover any dispensing errors.

Prescription audit was not performed in the hospital before the commencement of this study. The medication error data collected in the first week of the study was considered as the baseline control which were used to calculate the required sample size and to compare the trend of error rate with four further checkpoints assigned later at weeks 7, 14, 20 and 26. The required sample size for the study was found to be 960 according to the Cochrane formula.

2.5. Significance of the study

The study was nominated by the Federation of Indian Chambers of Commerce and Industry (FICCI) for ‘Best Patient Safety Initiative’ across the nation in the year 2017.

2.6. Data analysis

The chi-squared test for trend was used to test the severity of errors at baseline and four follow-ups whereas a two tailed t test was used to compare frequency of medication errors from the baseline with the final follow-up. Furthermore, ANOVA was used to determine the frequency of medication errors for each patient at three different time points including baseline.

3.1. Study population

A total of 1149 patients with a mean age of 49.03 years were enrolled in the study. Interestingly, mean age of patients presented with at least one error was higher than the patient group without any errors, as is depicted in Table 1. Total male patients outnumbered their female counterpart and patients with at least one error were higher than patients without any error. Overall, the average error per patient was found to be 0.608 whereas this figure was 1.395 among patients presented with at least one error.

Prescription errors accounted for the highest errors with 87.1% followed by administration, transcription and dispensing errors. Clinical documentation errors contributed the most (51.1%) to the prescription errors followed by drug name, strength and frequency. Therapeutic duplication and dose related errors contributed the same with 3.9% among other prescription related errors as seen in Table 2. While time of administration was found to be inappropriate in 4.9% of the errors, drug doses were missed in 2% of the 699 errors. In terms of transcription process, wrong drug and wrong dose together contributed for 4.2% of the errors. Intriguingly, dispensing errors were responsible for a mere 1.2% of the total errors encountered in the study.

Errors experienced in the study were distributed in different categories from A to I with A being the mildest and I being the most severe form. The majority (42.5%) of errors belonged to category A followed by category D (21%) and category E (14.4%) as represented in Fig. 1. While category H could find just one error, category C and category I were left without any error. For instance, ‘Overdose’ was reported when Allegra (Fexofenadine) 120 mg twice daily was advised as it exceeded the maximum allowed dose of 180 mg per day.

3.4. Distribution of errors in terms of location

Although the study was open to patients admitted to either ICU or general ward, patients belonging to the former could contribute a mere 7.8% to the total population. Surprisingly, ICU patients encountered a higher rate (52.8%) of medication errors than the general ward group (42.8%) (ICU, 47 of 89 patients enrolled vs general wards, 454 of 1060 patients enrolled).

3.5. Trend of medication errors during the study over 26 weeks

An average of 44.2 patients were examined each week from the third week of December 2016 to the second week of June 2017. Average error per patient at the baseline (1st week) was found to be 2.08, which gradually decreased each week. The final week of the study witnessed a dramatic drop in average error per patient of 51% from 2.08 to 1.06, as can be seen in Table 3. Furthermore, chi-squared statistic for various categories of errors at different time points was found to be highly significant with p < 0.005, as represented in Table 4. A two tailed t test was also performed at 0.05 significance level between first (control) and last week (final improvement) with frequency of medication errors in each patient. The t-value was found to be 4.37875 and the p-value was <0.0001 which was highly significant (p < 0.05).

One-way ANOVA was performed for baseline, follow-up 2 and final follow-up in terms of frequency of medication errors for each patient. The f-ratio value was found to be 15.19577 and the p-value was highly significant (p < 0.00001).

In terms of age, adults contributed the most with 72% of the total errors followed by geriatric group of patients with 18.8%, as represented in Fig. 2. Least contribution was witnessed from patients under one year of age.

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Fig. 2.

Age wise error distribution.

Chi-squared test was performed to assess the improvement of error rate from baseline to final follow-up between male and female subjects. Male and female patients affected at the baseline were 14 and 11 whereas the final week witnessed 8 and 5 cases, respectively. The chi-squared statistic was found to be 0.1076 and the p-value was 0.74 which was not significant at p < 0.05.

3.8. Intercepted and non-intercepted errors

Medication errors encountered in the study were also categorized into intercepted or non-intercepted errors, as shown in Table 5. Intercepted errors are those which either do not reach the patient or even if reached, do not cause harm whereas non-intercepted errors are those that harm the patient.

Chi-squared analysis was performed which yielded a statistic value of 10.3802 and a significant p-value (p < 0.05).

Doctors were found to be responsible for the majority (80.2%) of errors followed by nurses (17.3%) and pharmacists (1.4%). Furthermore, more than one healthcare professional was involved in a few medication errors (Fig. 3).

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Fig. 3.

Medication errors by various healthcare professionals.

Patients were enrolled from a total of 16 distinguished departments with cardiology contributing the most (33.1%) of patients followed by urology (20.2%) and general medicine (10.4%). ENT and pulmonology departments encountered a higher proportion of errors with 57.1% and 55.6%, respectively. In contrast, pediatrics encountered the least errors (16.7%) followed by general surgery, which was at a distant 36%, as depicted in Table 6.