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Adverse-drug-reaction reporting by pharmacy students in a teaching hospital

KARYN M. SULLIVAN AND LINDA M. SPOONER
dverse drug reactions (ADRs) are common causes of morbidity and mortality within the hospital setting. The American Society of Health-System Pharmacists denes an ADR as a response to a drug that is not expected, desired, or intended that requires modication of therapy (e.g., drug discontinuation, dosage modication) or necessitates additional care (e.g., hospital admission, prolonged length of stay).1 While some ADRs are unavoidable and occur without warning, others are preventable. It has been estimated that 520% of hospitalized patients have had an ADR.2,3 ADRs are the fourth to sixth leading cause of death in the United States.4 The rate of ADRs is very difcult to determine and varies among institutions by patient demographics, the number of beds, medications on formulary, and the ADR denition used.1 Appropriate documentation and tracking of ADRs allow pharmacists within a health system to identify trends and determine methods for preventing ADRs, including provider and patient education. Although identication and documentation of ADRs are hospitalwide

Purpose. Adverse-drug-reaction (ADR) reporting by pharmacy students in a teaching hospital is described. Summary. Faculty and pharmacy sta collaborated to modify the existing data collection form for suspected ADRs. During the orientation session for each new rotation, pharmacy students received an overview of ADRs, ADR trigger medications, and the hospitals ADR reporting program. Pharmacy students collected ADR data by prospectively and retrospectively reviewing inpatient charts for suspected ADRs that were identied through various means. The students were responsible for completely and accurately documenting all aspects of the suspected ADRs. At least once a week, patient charts were requested to aid students in their investigation of suspected ADRs. Data from patient cases involving allergy-related ADRs were conrmed and updated in the hospitals computer system. All documented ADRs were entered into a spreadsheet for the purpose of generating quarterly reports.

Report data were analyzed by faculty and students to identify hospitalwide trends in an eort to develop new ADR prevention strategies. Pharmacy student involvement with the ADR process began in January 2006. A total of 310 ADRs were documented for 2006, compared with 42 for 2005, when pharmacy students were not involved in data collection. ADR reports also led to allergy updates for 42 patients. With students collecting and analyzing ADR data, the hospital was able to recognize those medications that commonly caused ADRs and track hospitalwide trends in an eort to target new initiatives to prevent their occurrence. Conclusion. Pharmacy student participation in the ADR reporting program led to a signicant increase in the number of ADRs documented. Index terms: Allergies; Documentation; Drugs, adverse reactions; Hospitals; Pharmacy; Reports Am J Health-Syst Pharm. 2008; 65:1177-9

efforts, the pharmacy department is often responsible for these tasks. While effective and efcient pharmacovigilance is necessary for patient safety, it can be challenging for pharmacy departments to dedicate

the appropriate resources for these activities, thereby increasing the difculty of maintaining a program that encourages prospective and retrospective identication and recording of these events. As a result,

KARYN M. SULLIVAN, B.S.PHARM., M.P.H., is Assistant Professor of Pharmacy Practice; and LINDA M. SPOONER, PHARM.D., BCPS, is Assistant Professor of Pharmacy Practice, Massachusetts College of Pharmacy and Health Sciences, Worcester, MA. Address correspondence to Ms. Sullivan at the Massachusetts College of Pharmacy and Health Sciences, 19 Foster Street,

Worcester, MA 01608 (karyn.sullivan@mcphs.edu). Copyright 2008, American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/08/0602-1177$06.00. DOI 10.2146/ajhp070307

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many ADRs go unrecognized and are never documented, making it nearly impossible to uncover potential trends. Pharmacy students are in an ideal position to increase ADR reporting rates within health systems. ADR review can be added to the daily responsibilities of students participating in hospital and clinical rotations. This allocation of responsibility may lessen the amount of time staff and clinical pharmacists spend on documentation and allow for more time to be spent evaluating and identifying patterns and trends. This also permits pharmacists to spend time designing and implementing ADR prevention programs. Literature evaluating the role of pharmacy students in ADR reporting has focused on determining their knowledge and attitudes about the subject5,6 or has assessed their performance in comprehensive clinical intervention documentation programs.7,8 The purpose of this project was to determine the contribution of pharmacy students in ADR reporting within a hospital setting. Background In September 2005, our teaching hospital (349 beds) began a new afliation with a college of pharmacy offering an accelerated three-year doctor of pharmacy degree program. Four full-time pharmacy practice faculty who specialized in cardiology, infectious diseases, critical care, and medication safety were assigned to develop advanced experiential activities at the site. Three or four third-year students were assigned to each faculty member every six weeks, yielding a total of five advancedpractice rotations scheduled annually from August through June. During each advanced rotation, 1216 pharmacy students were onsite at the hospital. In 2005, a total of 42 suspected ADRs were documented at our hospital. However, a retrospective report
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of external cause of injury codes (Ecodes) (i.e., E-codes E8500E8589 and E9300E9499, based on International Classication of Diseases, Ninth Revision codes for identifying suspected ADRs) generated by the health information management (HIM) department showed that nearly 500 patients in 2005 had at least one ADR before or during hospital admission. This nding suggested that approximately 90% of all potential ADRs in 2005 were not documented. Lack of sufcient resources for ADR reporting and monitoring was the likely reason for inconsistent reporting and underreporting and resulted in missed opportunities for identifying prevention strategies. At that time, pharmacy staff relied primarily on occasional notication from physicians and nurses to identify ADRs. In January 2006, faculty members began following up with ADR reports. Faculty and their students began to investigate suspected ADRs reported by nurses, physicians, and pharmacists. The volume of ADRs was low, with approximately one or two ADRs reported per week. Pharmacy staff, nursing staff, and faculty members met to determine how pharmacy students could assist with ADR reporting. Description of the program Faculty and pharmacy staff collaborated to modify the existing data collection form for suspected ADRs. Additional data-entry elds were created in an effort to maximize the data collection so that trends could be identied and tracked over time. The additional data of interest included information regarding the location of the patient at the time of the ADR (i.e., outside or inside the hospital), whether the ADR was the cause of admission, the patients weight, pertinent details of the patients past medical history, the patients drug regimen at the time of the ADR, and relevant laboratory or medical test results. A retrospective E-codes re-

port from the HIM department was requested on a monthly basis. During the orientation session for each new rotation, students received an overview of ADRs, ADR trigger medications (e.g., diphenhydramine, naloxone), and the hospitals ADR reporting program. Students began prospectively and retrospectively collecting data on suspected ADRs. Prospective ADRs were identified by physicians, faculty, or students during interdisciplinary patient care rounds. The students were responsible for completely and accurately documenting all aspects of the suspected ADR. Faculty reviewed each ADR report for completeness and accuracy. At least once a week, patient charts were requested from the HIM department to aid students in their investigation of suspected ADRs. Second-year pharmacy students also became involved with ADR data collection by participating in a directed study elective on medication safety offered by two of the faculty. This class was offered during the summer months when there are no students on rotation. The elective included didactic material presented by the faculty in the classroom and handson learning at the hospital. Second- and third-year pharmacy students each retrospectively reviewed a minimum of three suspected ADR reports every week. This allowed for continuity throughout the year, with a total of 26 students involved in the review of ADR reports. Data from patient cases involving allergy-related ADRs were conrmed and updated in the hospitals computer system. All documented ADRs were electronically entered into a spreadsheet for the purpose of generating quarterly reports. Report data were analyzed by faculty and students to identify hospitalwide trends in an effort to develop new ADR prevention strategies. Experience with the program The contribution of pharmacy

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students in improving ADR reporting was determined by comparing ADR data collected for 2006 with 2005 ADR data. A total of 310 ADRs were documented for 2006, compared with 42 for 2005, an increase of almost eightfold. The data for 2006 indicated that 53% of the ADRs occurred during the patients hospital stay and that 47% of the ADRs were the cause of the hospital admission. These data were further analyzed to determine the medications most frequently causing ADRs during the hospital stay and causing ADRrelated admissions (Table 1). ADR reports also led to allergy updates in the hospitals computer system for 42 patients, information that is essential for preventing ADRs. Quarterly ADR reports are presented at meetings of the pharmacy and therapeutics (P&T) committee. The presentation of these data allows for the identification of potential areas for education and for tracking ADR trends over time. Based on data from 2006, two areas of concern (bleeding secondary to warfarin therapy and acute renal failure secondary to i.v. contrast media administration) were selected for further investigation by the P&T committee. These initiatives are invaluable for improving patient safety at our hospital and may not have been identied without student participation. Benets from the students perspective included bridging the gap between didactic curriculum and experiential education and becoming prepared for internal medicine advanced experiential rotations via patient chart review and patient data analysis. The latter was especially important to the second-year pharmacy students, as

Table 1.

Frequently Reported Adverse Drug Reactions (ADRs) During 2006

Drug or Drug Class
Antimicrobials Aspirin Atenolol Digoxin Diltiazem Enoxaparin Furosemide Heparin Hydrochlorothiazide Ibuprofen I.V. contrast media Lisinopril Lorazepam Methylprednisolone Metoprolol Morphine Naproxen Oxycodone Phenytoin Prednisone Warfarin

No. ADR-Related Inhospital Admissions

7 5 5 3 2 2 5 0 4 3 0 9 4 0 5 0 3 5 5 2 14

No. Inhospital ADR(s)

20 0 3 1 4 2 1 4 0 0 12 2 4 7 3 13 1 3 3 9 11

advanced rotations occur in the third year of the pharmacy degree program. Continued student participation in this program is planned. Conclusion Pharmacy student participation in the ADR reporting program led to a signicant increase in the number of ADRs documented.
References
1. American Society of Health-System Pharmacists. ASHP guidelines on adverse drug reaction monitoring and reporting. Am J Health-Syst Pharm. 1995; 52:417-9. 2. Lakshmanan MC, Hershey CO, Breslau D. Hospital admissions caused by iatrogenic disease. Arch Intern Med. 1986; 146:1931-4.

3. Colt HG, Shapiro AP. Drug-induced illness as a cause for admission to a community hospital. J Am Geriatr Soc. 1989; 37:323-6. 4. Lazarou J, Pomeranz BH, Corey P. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998; 279:1200-5. 5. Sears EL, Generali JA. Adverse drug reaction and medication error reporting by pharmacy students. Ann Pharmacother. 2005; 39:452-9. 6. Birdwell SW, Sullivan DL, Grauer DW et al. Pharmacy students knowledge of medication error reporting. Am J HealthSyst Pharm. 2003; 60:1054-5. 7. Slaughter RL, Erickson SR, Thomson PA. Clinical interventions provided by doctor of pharmacy students. Ann Pharmacother. 1994; 28:665-70. 8. Briceland LL, Kane MP, Hamilton RA. Evaluation of patient-care interventions by Pharm.D. clerkship students. Am J Hosp Pharm. 1992; 49:1130-2.

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