Adverse drug reactions (ADRs) are global problems of major concern. They affect both children and adults with varying magnitudes, causing both morbidity and mortality [
The information collected during the premarketing phase is incomplete with regard to adverse drug reactions and this is mainly because (1) patients used in clinical trials are limited in number and are not representative to the public at large. In addition, the conditions of use of medicines differ from those in clinical practice and the duration is limited. (2) Information about rare but serious adverse reactions, chronic toxicity, and use in special groups (such as children, the elderly, or pregnant women) or drug interactions is often incomplete. Therefore, postmarketing surveillance is important to permit detection of less common but sometimes very serious ADRs. Thus, postmarketing surveillance is important to permit detection of less common, but sometimes very serious ADRs. Therefore health professionals worldwide should report on ADRs as it can save lives of their patients and others [
Different studies have documented that new adverse reaction are discovered efficiently from spontaneous reporting than from other methods, including large postmarketing studies [
In Ethiopia, a report by Drug Administration and Control Authority (DACA), showed that out of the total of ADRs encountered (413) only 22 are reported to DACA making the total reported to be 5% only [
This study was aimed at investigating the knowledge, attitude, and practice of HCPs on spontaneous ADR reporting and factors affecting the reporting process in Nekemte town and also to suggest possible ways of improving method of reporting.
Nekemte town is situated on a flat, hilly landscape. It is located at a distance of 331 km west of Addis Ababa, 110 km North East of Gimbi, the principal town of West Wollega Zone, and 250 km North West of Jima Zone in Oromia Regional state. According to the central statistical Agency of 2007, the population size of Nekemte is 75,219 [
Descriptive cross-sectional study design was conducted by using structure questionnaires.
All the nurses, medical doctors, health officers, and pharmacists who are available during the study period and willing to participate in the study with equal chance were included.
Sample size was calculated using single proportion of size less than 10,000 assuming the KAP of ADR-report to be 50%; to get maximum possible size the following equation was used:
The total number of HCPs (nurses, medical doctors, health officers, and pharmacists) working in Nekemte town private and governmental health centers and clinics as well as in Nekemte hospital is found to be 176.
Since this figure is below 10,000 we use the following adjustment for the sample size:
Assuming variation among the different HCPs KAP towards ADR reporting, study subjects were recruited using stratified random sampling technique with proportional allocation: medical doctors (MDs) = 25; then the sample taken was = 25/176 nurses = 93; then the sample taken was = 93/176 health officers (HOs) = 33; then the sample taken was = 33/176 pharmacists = 25; then the sample taken was = 25/176
Data were collected by the researcher assistants under the supervision of principal investigators using structural questionnaires on the sociodemographic status, the knowledge, attitude, and practice of health professional towards ADR reporting, and influencing factors.
After data collection, data were entered into the Statistical Package for the Social Sciences (SPSS) version 20 for analysis. Checking, clearing, and coding of data were done before the analysis activities. Data collection from interviewee was analyzed, summarized, and represented in tables. By the analyzing data the KAP of HCPs towards ADR reporting and factors affecting the reporting process was assessed.
Ethical clearance was obtained from the Ethical Review Committee of Wollega University, College of Medical and Health Sciences. A participant’s written informed consent was obtained after explaining about the purpose and procedures of the study. In addition all the responses were kept confidential.
This study was conducted on 133 health professionals comprising medical doctors, pharmacists, health officers, and nurses.
Of the total 133 HCPs, 90 (67.6%) were males and 43 (32.3%) were females. The majority of participants 98 (73.6%) were below 36 years. The majority of HCPs 50 (37.6%) have 3–5 years of service. The study included 70 (52.6%) nurses, 19 (14.3%) MDs, 19 (14.3%) pharmacists, and 25 (18.8%) HOs (Table
The sociodemographic status of respondents in Nekemte town from January 2015 to June 2015.
Variable | Category | Frequency | % |
---|---|---|---|
Age | <26 | 51 | 38.3 |
26–35 | 47 | 35.3 | |
36–45 | 27 | 20.3 | |
>45 | 8 | 6.0 | |
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Sex | Male | 90 | 67.6 |
Female | 43 | 32.3 | |
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Profession | MD | 19 | 14.3 |
Pharmacist | 19 | 14.3 | |
Nurse | 70 | 52.6 | |
Health officer | 25 | 18.8 | |
| |||
Year of service | <3 | 42 | 31.6 |
3–5 | 50 | 37.6 | |
6–8 | 21 | 15.8 | |
>8 | 20 | 15.0 |
Regarding the knowledge of HCPs, 83 (62.4%) had heard about ADR reporting. Out of 83 HCPs who heard about ADR reporting, 37 (44.5%) get information about ADR reporting from formal teaching. Only 31 (37.4%) HCPs had heard about the existence of yellow card. Only 20 (24.0%) HCPs said that ADR had to be reported to Food, Medicine and Healthcare Administration and Control Authority of Ethiopia (FMHACA) (Table
The knowledge status data of HCPs on ADR reporting in Nekemte town from January 2015 to June 2015.
Variable | Category | Frequency | % |
---|---|---|---|
Heard about ADR-reporting | Yes | 83 | 62.4 |
No | 50 | 37.6 | |
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Information source | In-service training | 24 | 27.6 |
Mass media | 6 | 7.2 | |
Journals or publication | 9 | 10.8 | |
Formal teaching | 37 | 44.5 | |
Peer group | 7 | 8.4 | |
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ADRs can be reported on | Drugs | 43 | 51.8 |
Medical devices | 12 | 14.4 | |
Both | 28 | 33.7 | |
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Know about existence of yellow card | Yes | 31 | 37.4 |
No | 52 | 62.6 | |
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Agents to which ADR is to be reported | I do not know | 28 | 33.7 |
FMHACA | 20 | 24.0 | |
Health center | 14 | 16.8 | |
DTC/local drug monitor | 9 | 10.7 | |
MD/physician | 6 | 7.2 | |
Manufacturer | 3 | 3.6 | |
Department of Pharmacy | 3 | 3.6 | |
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Know responsible body | Yes | 41 | 30.8 |
No | 92 | 69.1 | |
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To which drug do you expect more unexpected ADRs? | Newly marketed drugs | 87 | 65.4 |
Established drugs | 14 | 10.5 | |
I do not know | 32 | 24.0 | |
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ADRs that should be reported | All suspected reactions | 20 | 15.0 |
Unknown/unexpected | 33 | 24.8 | |
Serious | 40 | 30.1 | |
Unexpected therapeutic effects | 21 | 15.7 | |
All | 19 | 13.2 | |
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Mostly expected to be reported | Expected/labeled | 45 | 33.8 |
Unexpected/unlabeled | 54 | 40.6 | |
I do not know | 34 | 25.5 |
Regarding attitude of the HCPs, the majority of them (103 (77.4%)) agree that ADR reporting is essential and out of 103 HCPs 58 (43.6%) suggested that ADR reporting is encouraged when reaction is serious. Of the respondents 63 (47.5%) responded that premarket drug evaluation is not enough for detecting ADR. Most of the HCPs (77 (57.9%)) said that ADR reporting must be compulsory (Table
Attitude of HCPs towards ADR-reporting in Nekemte town from January 2015 to June 2015.
Variable | Category | Frequency | % |
---|---|---|---|
ADR-reporting essential | Agree | 103 | 77.4 |
Disagree | 6 | 4.5 | |
Neutral | 24 | 18.1 | |
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Reporting encouraged when | Reaction is serious | 58 | 43.6 |
Unusual reaction | 33 | 24.8 | |
You are certain | 31 | 23.3 | |
Every one of each | 11 | 8.3 | |
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Premarket drug evaluation enough | Yes | 21 | 15.7 |
No | 63 | 47.5 | |
Neutral | 49 | 36.8 | |
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Yellow card reporting cost effective | Yes | 46 | 34.8 |
No | 13 | 9.8 | |
Neutral | 74 | 55.6 | |
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ADR reporting | Compulsory | 77 | 57.9 |
Voluntary | 38 | 28.6 | |
Neutral | 18 | 13.5 |
Regarding practice of HCPs, only 36 (27%) HCPs had faced patients with ADR. From those 36 HCPs who have noticed ADRs from their clients, 14 (38.8%) have reported ADR; 11 (78.5%) had reported 1 to 3 times; and 3 (21.4%) did more than 3 times. On the reasons why HCPs did not report ADRs (i.e., from those 22), 10 (45.5%) were not aware whether to report them, 9 (40.9%) because there was no report available at the work places, and 2 (9%) do not know the system responsible for receiving their reports. Types of ADRs which were reported by 14 respondents are unexpected (5, 35.7%), serious (6, 42.8%), reactions to recently marketed (within five years) pharmaceuticals (2, 14.4%), and all of the three types (1, 7.1%). ADRs were reported mainly to the responsible bodies in the respective health center/hospital 7 (50.0%), to DTC 5 (35.7%), and FMHACA 2 (14.3%) (Table
Practice of HCPs on ADR-reporting in Nekemte town from January 2015 to June 2015.
Variable | Category | Frequency | % |
---|---|---|---|
Faced ADR from patient/s/ | Yes | 36 | 27.0 |
No | 97 | 73.0 | |
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Reported | Yes | 14 | 38.8 |
No | 22 | 61.1 | |
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Number of ADR-reports done | 1–3 times | 11 | 78.5 |
More than 3 times | 3 | 21.4 | |
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Reason not to report | I did not know | 10 | 45.5 |
No report form | 9 | 40.9 | |
No system responsible | 2 | 9.1 | |
Not usual to report | 1 | 4.5 | |
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Types of ADRs-reported | Unexpected | 5 | 35.7 |
Serious | 6 | 42.7 | |
Reaction to recently marketed | 2 | 14.2 | |
All of the above | 1 | 7.1 | |
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Agents to whom ADRs were reported | FMHACA | 2 | 14.3 |
DTC | 5 | 35.7 | |
Other responsible bodies | 7 | 50.0 |
When we see the comparison of the KAP status of HCPs in the four professions, from the total of 20 KAP based questions interviewed, 9 (45%) were knowledge based, 5 (25%) attitudinal, and the remaining 6 (30%) practice oriented. Of the total respondents, only 64 (48.2%), 56 (42.1%), and 13 (9.8%) health care professionals have correctly answered the knowledge, attitude, and practice assessment questions, respectively (Table
Comparison of the KAP of HCPs in each health profession in Nekemte town from January 2015 to June 2015.
Profession | Number of professionals | Correctly answered | |||||
---|---|---|---|---|---|---|---|
Knowledge | Attitude | Practice | |||||
Frequency | % | Frequency | % | Frequency | % | ||
Nurse | 70 | 18 | 25.7 | 14 | 20.0 | 7 | 10.0 |
Doctor | 19 | 16 | 84.2 | 14 | 73.6 | 2 | 10.5 |
Health officer | 25 | 14 | 56.0 | 11 | 44.0 | 1 | 4.0 |
Pharmacist | 19 | 16 | 84.2 | 17 | 89.5 | 3 | 15.8 |
Total | 133 | 64 | 48.2 | 56 | 42.1 | 13 | 9.8 |
General assessment | Low knowledge | Low attitude | Low practice |
As shown in Table
Factors that affect spontaneous ADR-reporting in Nekemte town from January 2015 to June 2015.
Variables | Frequency | % |
---|---|---|
| ||
Lack of awareness and knowledge on what, when, and to whom to report | 41 | 30.8 |
Unavailable format | 22 | 16.5 |
Not knowing or absence of responsible body | 18 | 13.5 |
Lack of commitment of HCPs | 34 | 25.5 |
Low patient follow-up/contact | 12 | 9.0 |
I cannot suggest | 6 | 4.5 |
| ||
Awareness creation on what, when, how, & to whom to report and increasing awareness at all levels of education | 56 | 42.1 |
In-service training | 35 | 26.3 |
Make availability of the reports format | 14 | 10.5 |
Announcing ADR report as it is a professional obligation of HCPs | 8 | 6.0 |
Follow-up of patients | 9 | 6.7 |
Direct supervision of patients by pharmacist | 15 | 8.3 |
Factors responded by HCPs to improve ADR reporting as shown in Table
The result of our finding showed that the knowledge of HCPs about ADR reporting is low with only 64 (48.2%) of the HCPs having answered correctly to the knowledge based questions. This result is consistent with different studies; only 34.2% of the respondents had sufficient knowledge on the ADR reporting system in a study conducted in Amhara Region of Ethiopia [
When we compare the knowledge of HCPs among themselves medical doctors (84.2%) and pharmacists (84.2%) were more knowledgeable than health officers (56%) and nurses (25.7%). This finding is consistent with a study reported from Nepal [
Concerning the attitude of HCPs, only 56 (42.1%) HCPs have correctly answered the attitude based questions. The finding of this study showed that there is low attitude towards reporting ADR as compared to the previously done studies which showed high attitude towards ADR reporting: 75% in Southwest Ethiopia [
When we compare the attitude of HCPs among themselves pharmacists (89.5%) have good attitude towards ADR reporting followed by medical doctors (73.6%). Nurses have the poorest attitude in which only 20% have good attitude. This finding is consistent with a study reported from Southwest Ethiopia [
Regarding the practice of HCPs, this study revealed that the practice of HCPs towards ADR reporting is poor with only 13 (9.8%) of HCPs having answered correctly to the practice based questions. The practice of HCPs in this study is lower than other studies: 16.2% in Amhara Region of Ethiopia [
This study identified the factors that discourage the spontaneous ADR reporting of the HCPs; accordingly lack of awareness and knowledge on what, when, and to whom to report ADRs is the common factor followed by lack of commitments of HCPs and unavailable format. To overcome these discouraging factors HCPs have suggested some factors to improve ADR reporting; these are awareness creation on what, when, and to whom to report ADRs, in-service training, direct supervision of patients by pharmacist, and making report formats available are the main encouraging factors.
Strength of our study was that we have used a detailed structured questionnaire on KAP towards ADR reporting and the study subjects were recruited by using stratified random sampling technique with proportional allocation. The limitation of this study was that this study did not show the KAP difference of health care professionals within the same profession with different level of education.
The finding of this study showed that the knowledge, attitude, and practice of the HCPs working in Nekemte town towards spontaneous ADR reporting were low. Thus, we would like to recommend the concerned bodies to strive on the improvement of the knowledge, attitude, and practice status of health care professionals.
The authors declare that they have no competing interests.
The authors are thankful to Wollega University for their unreserved cooperation in making this study a fruitful work. They are also thankful for data collectors and the study participants.