International Journal of Risk & Safety in Medicine 26 (2014) 139–145 DOI 10.3233/JRS-140620 IOS Press



Adverse drug reactions reporting: Pharmacists’ knowledge, attitude and practice in Shiraz, Iran Saba Afifia , Najmeh Maharlouia,∗ , Payam Peymania , Soha Namazib , Alireza Gholami Gharaeic , Pegah Jahanid and Kamran B. Lankarania a

Health Policy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran Clinical Pharmacy Department, Faculty of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran c Student Research Committee, Fasa University of Medical Sciences, Fasa, Iran d Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran b

Received 10 March 2014 Accepted 8 June 2014 Abstract. BACKGROUND: While yellow card reporting system has started in 1998 in Iran, the ADR reporting rate is very low. OBJECTIVE: In order to explore whether the Iranian Pharmacovigilance system could be modified, and to determine reasons for under-reporting, a study to investigate the role of pharmacists in ADR reporting was done in Shiraz. METHODS: A cross-sectional study was conducted between January and June 2013 in Shiraz, Iran. After describing the study and its goal for each participant, oral consent was taken. RESULTS: 100 out of 120 pharmacists (83.3%) agreed to participate in the interview. 79 out of 100 respondents were working in private pharmacies, 7% in governmental pharmacies, and 3% in pharmacies located in hospitals. Although level of knowledge regarding ADR was low among pharmacists, all of them admitted that paying attention to ADRs and timely reporting is very important. While 6 (6%) pharmacists thought that they had been taught too much about ADR in the university, 30% believed that it was enough, 41 % claimed that it was not satisfactory and23% admitted that it was little. CONCLUSIONS: Our pharmacists have little knowledge about the process, goal, and importance of ADR spontaneous reporting system. Otherwise, education and training courses will be important in maintaining, improving and enhancing ADR reports by pharmacists. Keywords: Pharmacists, knowledge, attitude, practice adverse drug reaction reporting, Iran

1. Introduction Adverse drug reactions (ADRs) are an important public health issue, causing considerable harmful responses for patients and increase health systems costs. ADRs are a major cause of morbidity and mortality among patients [1]. It is reported that ADRs have been responsible for about 6% of all hospital ∗

Address for correspondence: Najmeh Maharloui, Health Policy Research Center, Shiraz University of Medical Sciences, Building No 2, Eighth Floor, School of Medicine, Zand Avenue, Postal code 7134853185, Shiraz, Iran. Tel./Fax: +98 07112309615; E-mail: [email protected] 0924-6479/14/$27.50 © 2014 – IOS Press and the authors. All rights reserved


S. Afifi et al. / Adverse drug reactions reporting

admissions to medical wards [2], and it is the fourth to sixth leading cause of mortality in the United States of America [3, 4]. The economic burden of ADRs is also considerable: a total cost of $47.4 billion annually for 8.7 million drug-related admissions was reported in the United States [5]. Therefore, safe use of medicines is a critical concern for all healthcare professionals, including prescribers, pharmacists, and nurses, as well as public and pharmaceutical companies. After the thalidomide disaster in 1960s, most countries developed their national Pharmacovigilance centers in which spontaneous reporting or other Pharmacoepidemiological methods were used to collect data, analyze ADRs and identify signals [6–8]. WHO defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems”). Spontaneous ADR reporting is the basic component of Pharmacovigilance system. However, it strongly depends on actual reports by health care professionals to detect the broad spectrum of complications related to pharmaceutical treatment, under-reporting is the main intrinsic disadvantage [7, 9]. Reporting in various countries is different. Although Australia is a country with a small population, the ADRs reporting rate is 12000 per year [10]. In France, this rate is 21000 annually [11]. In china, the ADRs reporting rate increased from 500 in 1998 [12] to 547000 in 2007 [13]. According to studies less than 10 percent of all adverse drug reactions are reported worldwide [14, 15]. The Iranian Pharmacovigilance center (IPC) was established in 1997. While yellow card reporting system has started in 1998 in Iran [16], the ADR reporting rate is very low [17]. However, voluntary ADRs reporting must be a major responsibility for all health care professionals, pharmacists have a critical role to improve the quality of pharmacotherapy and reduce the incidence of adverse drug reactions. So, there are several reports of other countries which show the role and attitudes of pharmacists in and toward ADR reporting [7, 18–22]. In order to improve ADR reporting and determine reasons of under-reporting, this study was performed to investigate the level of knowledge, attitude and practice of pharmacists about spontaneous reporting system in Shiraz, the capital of Fars province. 2. Subjects and methods A cross-sectional study was conducted between January and June 2013 in Shiraz, Iran. 240 pharmacists were working in private and/or governmental pharmacies in Shiraz. After describing the study and its goal for each participant, oral consent was taken. Three trained interviewers distributed the questionnaires among the pharmacists. Each Participant him/herself filled the questionnaire while the interviewer was there and answered the participant’s questions (if any). 3. Data collection form A semi-structured questionnaire which included the following three parts was used: demographic information, knowledge of ADRs and Pharmacovigilance and attitude and practice regarding ADRs reporting. The questionnaire has 33 questions and consists of 19 knowledge, 6 attitude and practices 8 questions. Our team design questions by themselves and use expert opinion. Fourteen questions of knowledge section were yes-no question, others were short answer. 3 questions of attitude section were yes-no question, one of them was short answer and 2 questions were multiple choice question. Three questions of practice section

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were yes-no question, others questions were multiple choice questions. Experts’ opinions were used for checking its validity, while reliability was examined in a pilot study which included 30 pharmacists (␣ Chronbach = 0.82). The first part, demographic information, contained respondents’ sex, age, the university from which they were graduated, and their working place and duration of pharmacy practice. Working places were private, public, and/or hospital pharmacies, while the respondents could choose more than one option. The second part was assessing respondent’s knowledge regarding ADRs and ADR reporting. In the first question respondents claimed if they knew about ADRs concept, while in the second question they were asked to describe ADR in one or two sentences. The third question asked the respondents to define some expressions in ADRs; such as, “very rare ADR”, “rare ADR”, “occasional ADR” and “common ADR”. Responses to these open ended questions were evaluated based on the WHO’s definition [6], however the concept was more important than the defined words. Also the respondents answered the questions regarding their knowledge about pharmacovigilance, yellow card and reporting indications. Then we divided the respondents into two groups, A and B, according to their claims regarding their knowledge of ADR’s meaning and compared other items in these two groups. For scoring the answers, one point was given to each correct answer; therefore, the respondents’ knowledge score ranged from 0–16, while those who got 12 or more points were labeled to have an acceptable knowledge regarding ADRs. The third part, practice, was consisted of 8 questions designed to evaluate the respondents’ reaction when encountering ADRs. In this part pharmacists were asked if they had reminded ADRs to patients and otherwise to explain the reason (multiple choices). We also asked the respondents about encountering patients referred with ADRs, whether they had reported ADRs; otherwise they were asked about the reasons for not having reported the case (multiple choices). 4. Statistical analysis SPSS version 16 was used for statistical analysis. Student t-test was used to examine the statistical differences in knowledge scores between group A and group B. Furthermore, we used Chi-square test to examine the relationship between binary variables. A P-value less than 0.05 was considered to be significant. 5. Results One hundred out of 120 pharmacists (83.3%) agreed to participate in the study. Sixty-seven out of 100 respondents were male (67%). Ninety-four percent were graduated from Iranian universities and 6% from foreign universities. Seventy-nine percent of the respondents were working in private pharmacies, 7% in governmental pharmacies, and 3% in hospital pharmacies. Besides, 4% of respondents were working in all of these three places, 6% in private and hospital pharmacies and only one percent of participants were working in private and governmental pharmacies. As mentioned in methods, responders were categorized into two groups; group A (71%) and group B (29%). 9 (12.7%) pharmacists in group A and no one in group B described ADR correctly. Asking some expressions regarding ADR, we found out that in group A, the rate of correct answers to “very rare ADR” was 4 out of 71 (5.6%), to “rare ADR” was 0%, while 2 out of 71 pharmacies (2.8%) answered “occasional ADR” correctly and 3 (4.2%) described “common ADR” appropriately. No statistical significance was found between groups A and B in replying the questions (Table 1). As a whole, 3 (4.2%) pharmacists in group A got an acceptable knowledge score comparing with group B in which no one gave a correct answer.


S. Afifi et al. / Adverse drug reactions reporting Table 1 Pharmacists’ claims on their knowledge regarding the ADRs reporting chain

Pharmacists’ claims on their knowledge about (N = 100)

Positive claims

Negative claims

Frequency (%)

Frequency (%)

32 (32%) 24 (24%) 12 (12%) 39 (39%) 37 (37%) 46 (46%) 30 (30%) 90 (90%) 95 (95%)

68 (68%) 76 (76%) 88 (88%) 61 (61%) 63 (63%) 54 (54%) 70 (70%) 10 (10%) 5 (5%)

The presence of Pharmacovigilance Center The Pharmacovigilance Center’ performance The Pharmacovigilance Center’ criteria The yellow card system How to work with yellow card system The reporting of ADR Their responsibility regarding reporting ADR The references including ADR The access to pharmacological information

Table 2 Comparing knowledge of pharmacists who claimed that they knew ADR completely with the rest of the study population Answers

Describing ADR Very rare ADR Rare ADR Occasional ADR Common ADR Describing phamaco- vigilance Acceptable level of knowledge

Correct Incorrect Correct Incorrect Correct Incorrect Correct Incorrect Correct Incorrect Correct Incorrect Achieved Did not achieved

Pharmacists who claimed they knew ADR well (n = 71)

Pharmacists who claimed they did not know ADR well (n = 29)

Frequency (%)

Frequency (%)

62 (87.3%) 9 (12.7%) 4 (5.6%) 67 (94.4%) 0 71 (100%) 2 (2.8%) 69 (97.2%) 3 (4.2%) 68 (95.8%) 16 (22.5%) 55 (77.5%) 3 (4.2%) 68 (95.8%)

0 29 (100%) 0 29 (100%) 0 29 (100%) 0 29 (100%) 0 29 (100%) 1 (3.4%) 28 (96.6%) 0 29 (100%)

P value

Adverse drug reactions reporting: pharmacists' knowledge, attitude and practice in Shiraz, Iran.

While yellow card reporting system has started in 1998 in Iran, the ADR reporting rate is very low...
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