Development of an adverse drug reaction bulletin in a teaching hospital
Bulletins that focus on drugs and therapeutic matters are often distributed by hospitals and other health systems that have programs for reporting adverse drug reactions.
Key Points
Abstract
A 1-page bulletin with a simple design is published monthly by the pharmacovigilance staff of Iran's Masih Daneshvari hospital and distributed to its healthcare professionals. The aim of the bulletin is to facilitate timely dissemination of information on adverse drug reaction (ADR) reports in the hospital and to provide information about safer drug therapy. A readership survey was used to seek feedback after publication of the first 24 editions; the pharmacovigilance unit received responses to 66.7% of the 60 surveys distributed. Readers indicated a high level of satisfaction with the content, format, and frequency of distribution of the bulletin. The development and implementation of a hospital-based ADR bulletin provide an opportunity to promote pharmacovigilance activities in the hospital. (Formulary. 2009; 44:333-335.)
Bulletins that focus on drugs and therapeutic matters are often distributed by hospitals and other health systems that have programs for reporting adverse drug reactions (ADRs).1,2 The primary aim of these bulletins is to educate healthcare professionals on medication-related issues, to encourage safer medication prescribing, and to increase the ADR reporting rate within the institutions by providing a feedback mechanism to potential reporters.3 Although the dissemination of this type of bulletin is widespread, few publications address these experiences with such supportive approaches at the hospital level.
At our hospital, we established an ADR reporting and monitoring center to stimulate spontaneous reporting by healthcare professionals.5 We defined ADR according to the World Health Organization definition as "a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function."
As part of our program, we developed an ADR bulletin. The development and evaluation of a routinely distributed bulletin in a teaching hospital are described here.
METHODS
Masih Daneshvari is a 466-bed, tertiary care, multidisciplinary teaching hospital. In March 2006, the hospital's pharmacovigilance unit was established to report ADRs and improve patient safety.5
The pharmacovigilance unit is an educational and academic unit concerned with the study of ADRs and other drug-related issues. The unit has a strong link with the pharmaceutical care department of the hospital.
An ADR bulletin was developed with two goals: To make it a part of the unit's activities to facilitate the dissemination of information on ADRs reported in the hospital and to provide information about safer drug therapy.
A standardized format for the bulletin was designed and approved in March 2006. The bulletin was presented as a single sheet with a simple and attractive graphic design. Topics included in the bulletin addressed severity or frequency of ADRs, interactions, usage hints, medication errors, or the most recent drug-related problems observed in our hospital. Subjects also included other matters addressed by the pharmacovigilance staff (for example, requests for drug information) and issues approved by the hospital P&T committee as being of interest to readers. The readership included healthcare professionals such as pharmacists, physicians, and nurses, and topics were chosen to meet their needs for information.
All ADRs reported in the bulletin were evaluated for causality in accordance with Naranjo's algorithm.6 Before publication, content was reviewed by at least 2 specialists: a physician specialist and either a clinical pharmacist or a pharmacologist. The specialty of the physician-reviewer was related to the topic (eg, a cardiologist reviewed the newsletter titled "Adverse drug reactions in hospitalized patients in the post-CCU ward").
Color copies of the published bulletins were distributed to the hospital's healthcare providers. After the first year, an annual bulletin comprising the first 12 editions was sent to other teaching hospitals in Tehran, in order to create awareness and encourage the initiation of similar activities that would contribute to pharmacovigilance programs throughout Iran.
The quality of the bulletin was assessed through a reader survey, a self-administered questionnaire sent to 60 recipients of the bulletin. After 1 week, the completed questionnaires were collected from individual respondents.
RESULTS
Seven topics addressed in the bulletin have been explored in greater detail and published in international journals.5,7-12
The survey included an open-ended question inviting suggestions for future topics. General suggestions from readers included requests for more detailed case reports; more practical information about ADRs, especially in connection with new drugs; considerations for nurses seeking to prevent ADRs; and information on drug-food interactions.
DISCUSSION
We developed and evaluated an ADR bulletin in order to strengthen and improve the utility of our hospital's ADR reporting program by providing information about patterns of drug use, meeting the information demands of the hospital's healthcare professionals, and reminding potential reporters of the existence of ADRs and the need to monitor them.
Although the concept and execution of this study were relatively simple, a literature review revealed only a handful of reports describing this type of study. Our bulletin showed itself to be a useful tool for improving the value of our reporting program. In addition, 7 papers were published from the bulletin.
Among survey respondents, reader satisfaction appeared to be high. Although it is difficult to evaluate the bulletin's effect on those who did not respond, interpretation of the low response rate should be made with caution. The data collection method, whereby a secretary collected written survey responses as opposed to taking oral responses by telephone or in a face-to-face interview, may explain part of the low response.
Despite the study's limitations, the results of the evaluation showed acceptance of the bulletin by our hospital's healthcare professionals. Respondents found it to be a useful and effective medium for sharing information on drug safety issues observed in the hospital.
Castel et al.3 have demonstrated that drug safety bulletins elicit a temporal increase in ADR reporting. We could not evaluate the isolated impact of the bulletin on our hospital's ADR reporting rate because development of the ADR bulletin and establishment of the ADR reporting center were simultaneous.
Although highly specialized writing, reviewing, and editing are required to publish an ADR bulletin, and although evaluation of the cultural, informative, and time-sensitive aspects of ADR bulletins may be difficult to achieve, these bulletins can be a welcome addition in strengthening hospital ADR reporting programs, especially those in the initial stages of development.3
Dr Baniasadi is assistant professor of pharmacology, TB and Lung Disease Research Center, and Virology Research Center, NRITLD, Masih Daneshvari Hospital, Shahid Beheshti University, M.C., Tehran, Iran. Dr Fahimi is assistant professor of clinical pharmacy, Pharmacy School, Shahid Beheshti University, M.C., and TB and Lung Disease Research Center, NRITLD, Masih Daneshvari Hospital, Shahid Beheshti University, M.C., Tehran, Iran. Dr Namdar is assistant professor of clinical pharmacy, School of Pharmacy, University of Colorado, Denver.
Disclosure Information: The authors report no financial disclosures as related to products discussed in this article.
REFERENCES
1. Denig P, Haaijer-Ruskamp FM, Zijsling DH. Impact of a drug bulletin on the knowledge, perception of drug utility, and prescribing behavior of physicians. DICP: Ann Pharmacother.1990;24:87–93.
2. Alderman CP. Development and evaluation of an electronic drug and therapeutics bulletin. Ann Pharmacother. 2002;36:1637–1641.
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4. Gholami K, Shalviri G, Zarbakhsh A, Daryabari N, Yousesfian S. New guideline for tramadol usage following adverse drug reactions reported to the Iranian pharmacovigilance center. Pharmacoepidemiol Drug Saf. 2007;16:229–237.
5. Baniasadi S, Fahimi F, Shalviri G. Developing an adverse drug reaction reporting system at a teaching hospital. Basic Clin Pharmacol Toxicol. 2008;102:408–411.
6. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239–245.
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8. Baniasadi S, Fahimi F, Mansouri D. Serum sickness-like reaction associated with cefuroxime and ceftriaxone. Ann Pharmacother. 2007;41:1318–1319.
9. Fahimi F, Ariapanah P, Faizi M, et al. Errors in preparation and administration of intravenous medications in the intensive care unit of a teaching hospital: An observational study. Aust Crit Care. 2008;21:110–116.
10. Fahimi F, Baniasadi S, Amini S. Adverse drug reactions in the post coronary care unit inpatients of a teaching hospital. Iranian J Pharm Res. 2008;7:223–228.
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