Adverse drug reaction reporting in a large tertiary hospital in Saudi Arabia: results of an incentive strategy

Abstract

Background:

Underreporting is a common problem with spontaneous adverse drug reaction (ADR) reporting. In this study, we aim to describe the reporting of ADRs in a tertiary hospital and determine the effect of incentives to healthcare professionals on ADR reporting.

Methods:

In this interventional study, a time series analysis was used to determine the effect of incentives on ADR reporting in a tertiary hospital between 2015 and 2016. The incentive strategy included public commendation of health care providers and nomination for a monthly award.

Results:

A total of 967 ADRs were reported over a 2-year period. After the introduction of incentives in January 2016, the number of ADR reports per month increased by 40.6 (95% confidence interval: 26.1–55.1). The proportion of serious ADRs reported was significantly higher in 2016 (39/800) than 2015 (0/167) (p < 0.001). In 2016, there was a significant association between profession and serious ADR reporting (p < 0.001). A total of 14/21 ADRs (66.7%) reported by physicians in 2016 were serious compared with 20/700 (2.9%) reported by clinical pharmacists and 5/72 (6.9%) by nurses.

Conclusions:

ADR reporting was improved by providing incentives, including commendation and reward, to healthcare professionals.

Introduction

Adverse drug reactions (ADRs) are defined as “appreciably harmful or unpleasant reactions, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product.”¹ After the thalidomide disaster in 1961, the World Health Organisation (WHO) established a programme for international drug monitoring and member countries were encouraged to establish national pharmacovigilance centres.² Saudi Arabia’s National Pharmacovigilance Centre (NPC) was established in 2009 as a semiautonomous department of the Saudi Food and Drug Authority (SFDA) and the 92nd member of WHO-Uppsala Monitoring Centre.^3,4 Healthcare professionals are able to report ADRs directly to the NPC through the Saudi vigilance online reporting system, by e-mail, postal mail, fax or by phone.⁵

Despite almost a decade of the NPC’s existence, pharmacovigilance is still seen as a relatively new concept in the country, with low levels of awareness among healthcare providers.^6,7 In order to improve ADR reporting, several hospitals in the country have established Medication Safety Units (MSUs).⁸ The MSUs work under the umbrella of the pharmaceutical care services and ensure compliance with the medication safety policies and procedures within the hospitals.⁹ They collect ADR data and report them to the NPC for onward transmission to the WHO-Uppsala Monitoring Centre in Sweden.⁶ A 2013 survey showed that about 30% of the hospitals in the country have a medication safety committee, with only 9% having a medication safety officer.⁸

On account of the low ADR reporting in our hospital, an incentive strategy to enhance reporting was introduced in January 2016. This study examines the effect of the introduction of a reward system, including public commendation and award, on ADR reporting.

Methods

Design

This is an interventional study to determine the effect of incentives on ADR reporting in a tertiary hospital between 2015 and 2016. King Saud Medical City (KSMC) institutional review board approved the study (Reference number: H1RI-04-Oct17-01).

Setting

The hospital, located in Riyadh, is the largest in the kingdom of Saudi Arabia and one of the largest in the Middle East. It has 1400 ward beds and about 140 intensive-care unit beds. It has an estimated annual outpatient visit of about 300,000.¹⁰ ADRs from inpatients and outpatients are reported to the hospital’s MSU using a paper form. Two MSU pharmacists independently assess the seriousness and causality of the ADRs. Causality is assessed using the Naranjo ADR probability Scale.¹¹ Fatal, life-threatening or significantly disabling ADRs which may prolong hospitalization are considered serious.

Data source

Suspected ADR reports submitted to the MSU were reviewed and compiled by an MSU pharmacist. Information retrieved was: the name of drug, type of reporter, causality of ADRs, outcome of the ADRs, route of administration, age and sex of patients.

Intervention

In January 2016, the pharmacy leadership of the hospital through the MSU introduced incentives to encourage ADR reporting among the hospital’s pharmacy staff. A member of staff with the highest number of ADR reports, who have also excelled in other aspects of their job including, medication error reporting and participation in ongoing research projects, was nominated every month for the employee of the month award. Letters of appreciation were given to the awardees; their names were posted on the hospital’s notice board and they were entitled to a full day’s leave. Becoming the employee of the month also increased their chances of nomination for the annual performance excellence award (PEA). PEA awardees were eligible for an extra month’s salary and a certificate.

Statistical analysis

The change in the level of average monthly ADR reporting between 2015 and 2016 was determined using segmented regression analysis of an interrupted time series, with 24 observation points.¹² Serial autocorrelation was determined from the partial autocorrelation function plot of the residuals. Cochrane-Orcutt method was used to adjust the parameter estimates for first-order autocorrelation. The proportions of serious ADRs for each year were compared using Fischer’s exact test. Analyses were carried out using SPSS version 24 and GraphPad Prism 5 (IBM SPSS Statistics for Windows, Version 24.0. Armonk, NY: IBM Corp. and GraphPad Prism version 5 for Windows, GraphPad Software, La Jolla California USA).

Results

A total of 967 suspected ADRs were spontaneously reported over the 2-year period. The majority of the ADRs were reported in 2016 (n = 800, 82.7%). More ADRs involved male patients (n = 663, 68.6%). Vancomycin and furosemide were the most commonly reported causative drugs, each constituting about 5% of reported ADRs. The proportion of vancomycin- and furosemide-related ADRs declined by 77% and 92%, respectively, in 2016 compared with 2015. There was also a general decline in the proportion of reports regarding the other eight most common drug causes of ADRs in 2016 (Figure 1). About 10% (n = 93) of all the ADRs were definitely related to drug treatment, while the remaining cases were considered possibly or probably associated with the drugs. Thirty-nine ADRs (4%) were serious, requiring hospitalization, prolonged hospitalization or emergency treatment. The majority of the nonserious ADRs, 702 (88%) in 2016 and 155 (93%) in 2015, were of minor severity, some of which necessitated reduction in dosage or discontinuation of treatment. The majority of the ADRs (83.4%) reported in 2015 and 2016 were by clinical pharmacists. Nurses, physicians and the other health workers reported 100 (10.3%), 31 (3.2%) and 17 (1.3%) ADRs, respectively.

Figure 1.

Proportion of adverse drug reactions reported for specific drugs pre- and postintervention.

ADR, adverse drug reaction.

Compared with 2015, there was a seven-fold increase in reporting by clinical pharmacists in 2016. There were about two- and threefold increases in reporting by physicians and nurses, respectively, over the same period (Table 1). After the introduction of incentives in January 2016, the average number of ADR reports per month increased by 40.6 [95% confidence interval (CI): 26.1–55.1; Figure 2]. The proportion of serious ADRs was also significantly higher in 2016 than 2015 (p < 0.001). In 2016, 5% of the reported ADRs were serious compared with none in 2015. There was a significant association between the type of profession and serious ADRs reporting in 2016 (p < 0.001). A total of 14/21 ADRs (66.7%) reported by physicians in 2016 were serious compared with 20/700 (2.9%) reported by clinical pharmacists and 5/72 (6.9%) by nurses.

Table 1.

Changes in adverse drug reaction reporting between 2015 and 2016.

	2015 (n = 167)	2016 (n = 800)	% change
Clinical pharmacists	106	700	660
Physicians	10	21	210
Nurses	28	72	257
Patients	10	3	−30
Others	14	3	−21
Total	167	800	–

Figure 2.

Monthly adverse drug reaction reports before and after intervention.

ADR, adverse drug reaction.

Discussion

This study shows a significant increase in the number of ADRs reported after the introduction of the incentives. The increase in the reported ADRs was largely driven by clinical pharmacists, who were the beneficiaries of the incentives. Several studies have also described the positive effect of various intervention strategies on spontaneous ADR reporting.^13–15 Such interventions include assistance with reporting, regular reminders and feedback, modification of reporting instruments and process, provision of financial incentives and regular educational sessions. In one Spanish hospital study, a continuous multifaceted intervention, including both educational activities and financial incentives, resulted in up to six-fold increase in the average ADR reporting.¹⁴ Another study observed a significant increase in ADR reporting at a Chinese hospital after financial incentives were introduced.¹⁵ While the large increase in ADRs reported in 2016 may be attributed to the very low pre-incentive reporting level in the preceding year, the immediate sharp increase in reporting postintervention was likely a consequence of the incentives, because the relative change in reporting by clinical pharmacists in 2016 was much higher than the other healthcare professionals, despite a higher reporting baseline in 2015.

Although fewer ADRs were reported by physicians compared with clinical pharmacists and nurses, they reported more cases of serious ADRs, which is in line with the findings of a previous study.¹⁶ In addition to physicians’ preference for reporting mostly serious ADRs, they have also been shown to overlook well-known ADRs.¹⁷ Other previously documented reasons for underreporting among physicians include: lack of motivation to report, not knowing how to report, and lack of obligation to report.^18,19 Compared with another Saudi Arabian hospital study which reported 9% serious ADR rate,²⁰ we have reported serious ADR rate of 5%. This difference may be attributed to the ADR elicitation method utilized in our study. While our study relied on spontaneous reports, the previous study actively searched for the ADRs from the patients’ case notes.²⁰

This study, to our knowledge, is the first to evaluate the effect of incentives on ADR reporting in any Middle-Eastern country. We have utilized an interrupted time series analysis, which is a method infrequently used in ADR reporting studies. Only a few studies have previously utilized this approach to evaluate the role of intervention on ADR reporting.^15,21 Although financial compensation for ADR reporting can be difficult in resource-poor countries, the intervention utilized in this setting was not entirely monetized, as only the annual performance excellence awardees were eligible for financial reward. The expectation of financial reward can, however, lead to overreporting and falsification of reports. In our hospital, the MSU pharmacists regularly reviewed and verified reported ADRs to determine the veracity of reports.

A limitation of this study is the few timepoints before and after intervention, hence we were unable to evaluate the reports for seasonal variations. Furthermore, this study was carried out at a single hospital and the outcomes have not been compared with other settings. A multicentre study involving a representative sample of hospitals at a similar stage of pharmacovigilance development will provide a more generalizable outcome. Finally, the intervention was limited to clinical pharmacists and it is unclear how physicians would have been impacted if applied to them. Therefore, a future study exploring the role of these incentives on physicians’ reporting of ADRs is required.

Conclusion

ADR reporting can be improved by providing incentives to healthcare professionals. In addition to pharmacovigilance awareness and education programmes, public acknowledgement and commendation of performing health workers could encourage more ADR reporting.