The current study assessed preparedness among nurses about reporting adverse drug reactions in public and private hospitals. Nurses in hospitals are among health providers very close to patients and are involved in the process of administering medications especially to inpatients. A cross sectional study was conducted among nurses in public and private hospitals in Dar es Salaam city in Tanzania to compare their preparedness on reporting adverse drug reactions (ADRs). A total of 384 nurses were involved in this study, of which 50% were drawn from public hospitals and 50% from private hospitals. Majority of respondents (75.25%) in public and 84.73% in private hospitals said they have not received any training about reporting ADRs. Of the few trained nurses, 85.43% and 96.55%, in public and private hospitals, respectively, said they have been trained in a seminar only once, after they started working as nurses. Respondents in public (19.17%) and private (32.8%) hospitals reported to stock ADRS forms (Yellow cards). Less than 50% of respondents agreed to have access to reference materials such as a text books named “Good Dispensing Practice” and a “List of Registered Medicines”. Further results showed more than two third of all respondents in private (74.25%) and public (73.5%) hospitals reported that lack of training affects the process of reporting ADRs in terms of ability and tendency. In this study we found training, availability of Yellow cards and presence of a focal person are among important contributing factors to preparedness of reporting ADRs among nurses in public and private hospitals.
Drugs carry the potential ability to produce both desirable and undesirable effects. There is no drug which is absolute safe under all circumstances of use in all patients hence adverse drug reactions may occur even when the drug is correctly selected or used [
The causes of under reporting of ADRs in the health facilities include attitude, knowledge and behaviour of health care providers [
The Tanzania Food and Drug Authority (TFDA), health care providers and pharmaceutical products’ dealers in Tanzania are responsible for reporting ADRs of drugs on market through a process known as post market surveillance. In the process of strengthening and facilitating the ADRs monitoring and reporting system, TFDA provides pharmacovigilance awareness trainings to healthcare professionals, develops standard operating procedures (SOPs) for ADRs data handling and distributes the “Yellow cards” for spontaneous reporting [
A cross sectional study was carried out between December 2015 and April 2016 in seven conveniently selected public and private hospitals located in the Ilala municipality, Dar es Salaam. A total of 384 participants were involved in the study after considering the proportion of 50% due to a limited availability of data from related previous studies. The study participants were recruited so as to involve about 50% each from public and private owned hospitals [
Data were collected through self administered questionnaires (Appendix). The questionnaires were assessing contributing factors that affect preparedness of nurses on reporting (ADRs). Specific questions focused on demographic details of respondents and awareness on reporting of ADRs. Other questions aimed at gathering data on availability of in service training and seminars to nurses in public and private hospitals. The questionnaires were availed in both Swahili (a native language) and English versions. Permission from the hospitals’ administration and consent from each nurse were sought before involvement in the filling of the questionnaires. Ethical approval was obtained from the research and publication committee at the school of Pharmacy of the Muhimbili University of Health and Allied Sciences.
Questionnaires were checked and edited for any inconsistence or discrepancies. Data collected was coded, entered, cleaned and analysed using the “Statistical Package for Social Sciences” (SPSS) software version 20 (SPSS Inc., Chicago, IL, USA). Results were summarized using descriptive statistics such as frequency distribution, mean, bar charts, and cross tabulation wherever necessary and a test for Chi square was done and the significance level was set at (p ≤ 0.05).
A total of 384 respondents participated in this study from public and private hospitals. Majority of nurses were of the age between 30 to 50 years old. In public hospitals were (66.49%) nurses in this age group as compared to (55.79%) in private hospitals. The majority of respondents (39.89%) in public hospitals had 6 to 10 years of work experience while in private hospitals only (32.98%) had the same experience. The current study had revealed most experienced respondents with an experience of above 21 years, were in private hospitals (
In public hospitals (n = 194, 75.25%) nurses said have not been trained about reporting ADRs and those who were trained (85.43%) received training in a seminar once, after they started working in hospitals. In private hospitals majority of the respondents (n = 190, 84.73%) were not trained about ADRs reporting. However, of the very few trained (96.55%) received training once after their employment as nurses in hospitals. In public hospitals only 45.9% respondents knew the focal person to report to, issues concerning adverse drug reactions. However, majority (95.87%) said never received any kind of instructions about reporting ADRs from focal persons. Similarly in private hospitals only (31.1%) nurses knew the focal person and majority (98.4%) never received any lesson from their focal persons at work place. Results of this study show majority of respondents both in public (78.4%) and private (77.4%) hospitals, respectively agreed that lack of trainings and seminars had a negative impact on ability to report adverse drug reactions as well as on the tendency of reporting (
Of the reference materials used by nurses in reporting ADRs in public hospitals
Most of the respondents in public hospitals (80.8%) didn’t have access to the adverse drug reactions reporting forms (Yellow cards) and never use them for
Hospital | |||
---|---|---|---|
Private | Public | ||
Count | Count | ||
Age Groups | Below 30 | 37 (19.47%) | 57 (29.38%) |
30 to 50 | 106 (55.79%) | 129 (66.49%) | |
Above 50 | 47 (24.73%) | 8 (4.12%) | |
Gender | Male | 30 (15.70%) | 44 (22.80%) |
Female | 161 (84.30%) | 149 (77.20%) | |
Experience | 0 to 5 years | 39 (20.42%) | 53 (27.46%) |
6 to 10 years | 63 (32.98%) | 77 (39.89%) | |
11 to 20 years | 47 (24.60%) | 51 (24.42%) | |
21 and above | 42 (21.99%) | 12 (6.22%) |
Hospital | |||
---|---|---|---|
Private N (%) | Public N (%) | ||
Affect ability of reporting adverse drug reactions | Yes | 147 (77.4%) | 152 (78.4%) |
No | 43 (22.6%) | 42 (21.6%) | |
Affect tendency of reporting adverse drug reactions | Yes | 135 (71.1%) | 133 (68.6%) |
No | 55 (28.9%) | 61 (31.4%) | |
Any training over the past two years | Yes | 3 (1.6%) | 2 (1.5%) |
No | 187 (98.4%) | 192 (98.5%) |
reporting. The same trend was observed in private hospitals where (67.2%) respondents didn’t have access to the Yellow Cards. There was no significant relationship (p = 0.174 and p = 0.688) (
Results in
The need to participate in adverse drug reactions training courses is strongly perceived among nurses despite of their years of working experience in order to develop not only competencies but also preparedness in ADRs reporting. This trend has also been observed in this study both in private and public hospital findings (
Use of ADR forms in public Hospitals | Use of ADR forms in private hospitals | ||||||
---|---|---|---|---|---|---|---|
Yes N(%) | No N (%) | Total N (%) | Yes N (%) | No N (%) | Total N (%) | ||
ADR reporting form availability | Yes | 2 (8.7%) | 35 (20.6%) | 37 (19.2%) | 5 (27.8) | 57 (33.3%) | 62 (32.8%) |
No | 21 (91.3%) | 135 (79.4%) | 156 (80.8%) | 13 (72.2%) | 114 (66.7%) | 127 (67.2%) | |
X2 = 1.849, df = 1, p = 0.174 | X2 = 2.28, df = 1, p = 0.688 |
Use of ADR forms in public Hospitals | Use of ADR forms in private hospitals | ||||||
---|---|---|---|---|---|---|---|
Yes N (%) | No N (%) | Total N (%) | Yes N (%) | No N (%) | Total N (%) | ||
Nurses trained on reporting ADRs | Yes | 4 (17.4%) | 44 (25.7%) | 48 (24.7%) | 8 (44.4%) | 21 (12.2% | 29 (15.3%) |
No | 19 (82.6%) | 127 (74.3%) | 146 (75.3%) | 10 (55.6%) | 151 (87.8%) | 161 (84.7%) | |
X2 = 6.638, df = 1, p = 0.01 | X2 = 13.092, df = 1, p = 0.001 |
procedural aspects of ADRs reporting system in hospitals requires the presence of a focal person (in charge of pharmacovigilance in the hospital). This person is an instructor responsible for keeping the reporting forms, showing how to fill them, and giving directives to whom and how to send out the reporting forms [
Moreover, it’s only through filling Yellow Cards, quality information on adverse drug reactions could be obtained. The findings of this study (
Training, availability of Yellow cards and presence of a focal person are among important contributing factors in the preparedness of reporting ADRs among nurses both in public and private hospitals. More than two thirds of respondents said lack of training about ADRs affects both ability and tendency of reporting. Of the barriers to reporting ADRs unavailability of reporting forms (Yellow Cards) and lack of knowledge about reporting are among the barriers mentioned by more than 50% of all respondents. With regard to reference materials more than 50% of participants were exposed to and the mostly available was the textbook “Good Dispensing Practice”. Because of the barriers which were identified in the current study, the Tanzania Food and Drug Authority should provide continuous and regular educational training to nurses on the importance of pharmacovigilance and their roles as health professionals, in order to improve their ability to identify and report ADRs. In addition, TFDA should make use of ADRs reporting forms a regulatory requirement for nurses in public and private hospitals. This will ensure their availability and thus promote reporting.
The authors wish to acknowledge all respondents who participated in this study. Further, authors express their gratitude to the Higher Education Student’s Loans Board of Tanzania for sponsoring the current study.
The authors declare no conflict of interest
Mugoyela, V., Robert, R. and Masota, N. (2018) Investigation of Factors Affecting Preparedness of Reporting Adverse Drug Reactions among Nurses in Public and Private Hospitals in Dar Es Salaam, Tanzania. Pharmacology & Pharmacy, 9, 38-51. https://doi.org/10.4236/pp.2018.91004
QUESTIONNAIRE
MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES
B PHARM IV FINAL YEAR PROJECT
QUESTIONNAIRE TO ASSES PREPAREDNESS AMONG NURSES ABOUT REPORTING ADVERSE DRUG REACTIONS IN PUBLIC HOSPITAL AND PRIVATE HOSPITALS FOR THE AIM OF IMPROVE PATIENT CARE AND SAFETY IN RELATION TO THE USE OF MEDICINES
Code No. _________________________
1) Age (in years)_____________
2) Gender
a) Male
b) Female
3) Profession Experience
a) 0 - 5 years
b) 6 - 10 years
c) 11 - 20 years
d) 21 and above
4) Highest education
a) Certificate
b) Diploma
c) Bachelor
d) Others (mention)_____________
5) Is the hospital you are working at
a) Private hospital or
b) Public hospital
6) Have you ever being in training or attend seminar on adverse drug reaction?
a) Yes (complete question 7 and 15)
b) No (continue with question 16)
Please answer question number 7 to 15 if your answer in question 6 was “YES”
7) When was your first attended to the training/seminar, was it
a) Before or
b) After you got your job?(in service)
8) How many times have you attended seminar/training on adverse drug reactions within last two years?
a) None
b) Once
c) Twice
d) Thrice
e) More than thrice
OF THE REASON FOR TRAINING OR SEMINAR WAS GIVEN
9) Due to hospital request
a) yes
b) no
10) Due to increase of adverse drug reactions occurrence
a) yes
b) no
11) Due to increase in frequency of adverse drug reaction
a) Yes
b) No
12) Because new drugs were introduced in the market
a) Yes
b) No
13) Due to poor report (under reporting)
a) yes
b) no
14) Because government saw the need of training
a) yes
b) no
15) Order from authorized body controlling adverse reporting (TFDA)
a) yes
b) no
16) Do you know the ADRs focal person in your hospital?
a) Yes
b) No
17) Have you ever received training from him or her (focal person) regarding adverse drug reactions and reporting?
a) Yes
b) No
18) Is the lack of seminar and training affect the ability of nurses in reporting adverse drug reactions in your hospital?
a) Yes
b) No
19) Is the lack of seminar and training affect the tendency of nurses in reporting adverse drug reactions in your hospital?
a) Yes
b) No
20) Was there any adverse drug reactions training/seminar recently (for the past two year) you were asked to attend?
a) Yes
b) No
21) If there were a chance would you be willing to attend
a) Yes (complete question 22)
b) No (complete question 23)
22) If your answer was “YES” in question 21, you be willing to attend training or seminar
a) Because you were not given the chance and you need training
b) For the sake of increasing knowledge despite that you have attending it before
c) Because there is increase in number of adverse drug reactions and by getting training or seminar you would be able to report
23) If your answer was “NO” in question 21, you not be willing to attend training or seminar because
a) Reporting adverse drug reactions is not part of my job description so training/seminar is waste of time
b) There is no significance in reporting adverse drug reactions so is the training/seminar
c) There is someone already in hospital who is responsible for reporting adverse drug reactions
24) Is your experience as a nurse enough (without training/seminar) on reporting adverse drug reaction
a) Yes
b) No
25) Materials that are available in the hospital that can be used as reference during reporting
a) List of Registered Medicine
b) Guidelines for Monitoring and Reporting Adverse Drug Reactions
c) Good Dispensing Practice
26) Are there other reference material available for nurse to use during reporting adverse drug reactions
a) Yes (complete question 27)
b) No
27) If your answer in question 26 is yes then mention them
a) Books
b) Magazine
c) Brochures
d) Others
28) Are the adverse drugs reporting form available?
a) Yes
b) No
29) How do you access the reporting form for adverse drug reactions in your hospital
a) From TFDA office though post or mails
b) Download from website of TFDA
c) From zonal information center near the hospital you are working
d) From ADRs focal person in the hospital you are working
e) I real don’t know
30) Have you ever used the form for reporting adverse drug reaction?
a) Yes
b) No
31) To whom are the reports on adverse drug reactions are supposed to be send please mention
a) TFDA via post or online
b) Via zonal drug information center
c) Via ADRs focal person in the hospital am working
d) Communicate though telephone
e) I usually give to my next superior
32) Which of the above way of sending report (in question 31) do you prefer in sending Adverse Drug Reactions report?
a) ?
b) ?
c) ?
d) ?
e) ?
33) Does the availability of tools and materials affecting reporting of adverse drug reactions in your line of work?
a) Yes
b) No
34) In the following table, please respond to the statements on your left hand side by put a tick (√) on correct response at your right hand side
What do you think are barriers to ADRs reporting?
Thank you for your participation