|Year : 2013 | Volume
| Issue : 3 | Page : 224-228
Adverse drug reactions reporting : Knowledge and opinion of general public in Penang, Malaysia
Ramadan Elkalmi1, Mohamed Azmi Hassali2, Omar Qutaiba Al-lela1, Ammar Ihsan Jawad Awadh1, Abdul Kareem Al-Shami1, Shazia Qasim Jamshed1
1 Department of Pharmacy Practice, Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan Campus, Penang, Malaysia
2 Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, University Sains Malaysia, Penang, Malaysia
|Date of Submission||13-Jan-2013|
|Date of Decision||19-Mar-2013|
|Date of Acceptance||19-Apr-2013|
|Date of Web Publication||23-Aug-2013|
Shazia Qasim Jamshed
Department of Pharmacy Practice, Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan Campus, Penang
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Objective: The objective of this study was to explore the knowledge of the general population towards ADR and their reporting system. Methods: An anonymous, self-administered questionnaire (15 items) was designed. The questionnaire was subjected to face validity and content validity. The reliability coefficient was found to be 0.71. This study recruited proportionately large convenience sample of the general public in Penang. Interviews using a structured questionnaire were conducted over a week period in August 2009. The recommended sample size was calculated to be 368. Results: Three hundred thirty-four responses were received. Slightly more than half of the respondents were in the age group of 18-25 years (53.6%; n = 179). When asked about the sources of their medication majority of them reported medical doctor (85.6%), whereas small number (34.7%) reported community pharmacists as sources of medications. Three-quarter of the respondents (77.2%) get their information about the side-effects of drugs from physicians, followed by pharmacist (44.6%). More than half of the respondents (65.6%, n = 219) reported unawareness about the existence of ADR center set up by the Ministry of Health. Conclusion: Respondents reflected inadequate knowledge on ADR reporting. This needs to be corrected as the trend of future pharmacovigilance is toward the patient. Moreover, the new trend seems to be more appropriate as the patient is the group of the people who are directly affected from the ADR of a particular drug and not the health-care providers. Furthermore, the patient will be informed about the economic implications of not reporting ADR. It is recommended that government agencies, like MADRAC needs to find ways to increase patient- reported ADR cases.
Keywords: Adverse drug reactions, general public, Malaysia, perception
|How to cite this article:|
Elkalmi R, Hassali MA, Al-lela OQ, Awadh AI, Al-Shami AK, Jamshed SQ. Adverse drug reactions reporting : Knowledge and opinion of general public in Penang, Malaysia. J Pharm Bioall Sci 2013;5:224-8
|How to cite this URL:|
Elkalmi R, Hassali MA, Al-lela OQ, Awadh AI, Al-Shami AK, Jamshed SQ. Adverse drug reactions reporting : Knowledge and opinion of general public in Penang, Malaysia. J Pharm Bioall Sci [serial online] 2013 [cited 2021 Jun 15];5:224-8. Available from: https://www.jpbsonline.org/text.asp?2013/5/3/224/116824
In recent years, lay public are progressively more and more concerned about their health-care by active involvement in decision making. The prescribers at times require giving additional information for prescribed medicines. Patients obtained medicine information through various sources, more commonly from internet because of its easy access and availability in many cultures. On the contrary, it is difficult to rely on the information obtained through internet and, therefore, validity of the internet information is questionable.
Adverse drug reactions (ADRs) have a major impact on public health by imposing a considerable economic burden on society and the already-stretched health-care systems. , Post marketing surveillance of drugs is very important in investigating and controlling the risks associated with drugs once they are accessible for the use of the general population. , The involvement of health-care professionals towards ADR reporting databases is a requirement. This supports continuous ascertainment of the benefit-risk ratio of some drugs as well as contributory toward the detection of unexpected and unusual ADRs, which were previously undetected during the initial evaluation of a drug. , Despite these merits, under-reporting remains a major draw-back of spontaneous reporting. It is estimated that only 6--10% of all ADRs are reported. ,
In Malaysia, Malaysian Adverse Drug ReactionsADR Advisory Committee (MADRAC) performs the function of monitoring safety profiles of drugs registered for use in Malaysia.  Under this monitoring program, all the received reports are screened by MADRAC before being proposed to the World Health Organization's Collaborating Center for Drug Safety Program in Uppsala, Sweden for inclusion in its ADR database.  The primary functions of MADRAC include promoting ADR reporting in Malaysia, providing information and advice to the drug control authority so that regulatory action can be taken based on the ADRs received in Malaysia and internationally, and thus render information to doctors, pharmacists and other health-care professionals on ADRs.  The challenge faced by MADRAC is, in principal, getting marketing authorization holders, health-care professionals, and consumers for reporting ADRs. 
Globally, pharmacovigilance studies are the need of the hour for invariable monitoring of undesirable effects in hospital and community settings.  The involvement of every stakeholder regarding reporting of ADR is of prime importance. Doctors, pharmacists, nurses, future practitioners and as well as lay public are all informed for reporting ADRs, which in, turn contributes to increased medication safety for the population. ,,,
In the backdrop of this, we decided to conduct a pilot study on the knowledge of the general population toward ADR and their reporting system.
| Methods|| |
A descriptive study was conducted to determine the knowledge of the general public in Penang toward ADRs identification and reporting. Interviews using a structured questionnaire were conducted over a week period in August 2009.
The study instrument was a questionnaire with 15 survey items. It was formatted as a paper-based survey and was divided into two sections; demographic characteristics and ADRs reporting knowledge.
Demographic characteristics consisted of five items; age, sex, race, educational background, and marital status. The section two comprised of 10 items with four items covered the medication and side-effect history; five items evaluate the understanding and response to ADR situation, and one item related to the history of reporting ADRs.
The questionnaire was subjected to face validity and content validity by sending to pharmacy academics who were involved in delivering the curricular contents related to pharmacovigilance. Their feedbacks were incorporated. The instrument was then administered to 10 males and females living in Penang. The data were then subjected to Statistical Package for the Social Sciences (SPSS) for reliability coefficient. A Cronbach's alpha of 0.71 was computed.
Study subjects and site
This study recruited proportionately large convenience sample of the general public in Penang. Respondents easily approachable and willing to participate from all the ethnicities of not less than 18 years old, with different marital statuses and educational background were recruited in the survey. The survey was conveniently conducted at shopping complexes, bus stations, and medical centers covering all area of Penang. The sample size was calculated by Raosoft® online sample calculator with the margin of error 5%, and confidence level of 95% and therefore, the recommended sample size was calculated to be 368. A total of 334 respondents participated in the current study.
Data collected from the questionnaire was entered into a SPSS, version 17.0. Chi-square test is generally used to see the association between the variables. If the assumption for the Chi-square test does not seem to be justified that is expected cell number was lower than five in the contingency table, than Fisher's exact test will be used to evaluate the association between dependent and independent variables. In the current study, Fisher's exact test is applied and a value of P < 0.05 is considered to be significant.
| Results|| |
The total number of the general public in Penang responded to the survey was 334. Slightly more than half of the respondents were in the age group of 18-25 years (53.6%; n = 179). Majority of the respondents were found to be either diploma holders or Sijil Tinggi Persekolahan Malaysia, which is a Malaysian Higher Secondary School Certificate. For detailed demographics please see [Table 1].
The first question inquired about the status of respondents being ever taken any medications or never takes any medications. No significant difference was observed in terms of being taken any medications (56.6%, n = 189) or never takes any medications (43.4%, n = 145).
When asked about the sources of their medication majority of them reported medical doctor (85.6%), whereas small number (34.7%) reported community pharmacists as sources of medications. Only a very few number of respondents (5.4%) reported traditional medicine practitioners as their source of medication. A high percentage of the respondents who are in the younger age group 18-25 years prefer to choose medical doctor rather than a pharmacist for their sources of medication. Respondents from the age group of 26-35 years prefer to get their medications from medical doctors, pharmacists, and traditional medicine practitioners. Interestingly, respondents from the age group of late 30 and above mostly choose traditional medicine practitioners as their source of medication). Interestingly respondents with Sijil Pelajaran Malaysia (SPM) as educational background were found to be keen in choosing traditional medicine practitioners as their sources of medication.
The respondents were also asked about the reporting of side-effects of the drugs. Two-third of the respondent (66.8%, n = 223) have reported side-effects to their medical doctors. The results were significant for comparing in between age groups and reporting to the medical doctor (P = 0.038).
Interestingly, it was noted that three-quarter of the respondents (77.2%) get their information about the side-effects of drugs from physicians, followed by pharmacist (44.6%). For detailed results please refer to [Table 2] and [Table 3].
The responses on awareness of respondents towards consumer ADR center set up by the ministry of health seem to be quite interesting. More than half of the respondents (65.6%, n = 219) reported unawareness about the existence of ADR center set up by the Ministry of Health. This showed statistical significance with respect to age (P = 0.039).
The respondents then were asked about their opinion on the safety of the marketed drugs.
Majority of the respondents believed that the drugs marketed were not safe (81.1%, n = 271). Among the respondents who felt that not all drugs that were marketed were safe, 52.4% were 18-25 years old and 39.8% hold bachelor degree. For detailed results refer to [Table 4].
| Discussion|| |
This pilot study encompasses the knowledge and opinion toward ADR reporting and its system among the general public of Penang, Malaysia. An interview-administered questionnaire was used and this is considered to be one of the best modes to reach the general population. The response rate was found to be 90.7%. However, during the survey, there is no potential for external factors such as media reports or articles regarding ADR reporting to be consulted and would not supposedly wait for the respondents' answers; therefore one can say that the results are valid and more or less reflect the understanding of the general population on ADR reporting.
In the current study, irrespective of their educational background, participants did not report any experience of side-effects due to their medications. Likewise, respondents in the senior age group did not report any side-effect from their medicines. This result seems to be very subjective and did not reflect real life situation. Generally, as the age advances, one can become more prone to develop side effects owing to decline in organ function. Moreover, this also highlights that participants might not have proper knowledge about the side-effects or either adverse effects of their prescribed medications. A study conducted in United Kingdom reported poor knowledge of the potential side- effects of their medications, but the patients were able to identify ADRs related to their medicines because of either unexpected nature of the symptom or timing  It is therefore, imperative on the part of provider, which could be either a doctor or a pharmacist to give adequate and sufficient information about their medications and to inform the patient about the reporting of any unexpected symptoms to their provider.
An interesting finding in the current study is the unawareness about consumer drug reaction center set up by the Ministry of Health. Although seems to be an expected finding, measures should be needed to well-inform the patients about how to report ADRs and committees to which these ADRs are reported. This result is in line with the previous studies in which the health-care professionals and the patients were not only unsure about the reporting, but did not have any prior information about the reporting centers in their regions. ,,
Sources of information such as internet, newspapers, televisions, and mass media campaigns seem to play a key role in reporting ADRs. In the current study, majority of the respondents receive information about their drugs and side-effects from their doctors and pharmacists. Interestingly, advices from relatives and or friends were considered unprofessional in the current study and lesser taken into account. Quite a few of the respondents categorized television as their source of information. A study from France in 2002 reported that consumers were asked to make telephone calls for registering the side- effects to pharmaceutical companies and the companies entered these reports to drug safety database.  Despite this, the personnel involved had divided opinions about the usefulness of this mode of reporting.  On the contrary vanvan Hunsel et al. (2009) reported a peak in patient reporting of ADRs at Netherlands Pharmacovigilance Center Lareb between March 2007 and August 2007.  The TV program is cited as a rational for drug discontinuation in nearly 30 reports. The study also highlighted that patients feel both lack of information and inadequate information from their health-care professionals. 
In the current study, majority of the respondents reported that they will report to doctors about any side-effects while nearly a quarter of them reported that they will report to the pharmacists. There are studies, which reported that the detection of ADRs be improved provided the pharmacists be reported rather than medical doctors as pharmacists can improve ADR reporting. ,, In a nutshell, patient reporting might have the potential to incorporate meaningful consequences to pharmacovigilance.
| Conclusion|| |
Respondents reflected inadequate knowledge on ADR reporting. This needs to be corrected as the trend of future pharmacovigilance is toward the patient. Moreover, the new trend seems to be more appropriate as the patient is the group of the people who are directly affected from the ADR of a particular drug and not the health-care providers. Therefore, it is essential for them to provide the sufficient knowledge toward reporting and reporting centers. Furthermore, specific area of the pharmacovigilance, which needs more attention includes patient understanding toward the basic concepts of ADR and how the patient will be benefited by ADR reporting and as well as what should be reported. Furthermore, the patient will be informed about the economic implications of not reporting ADR. It is recommended that government agencies, like MADRAC needs to find ways to increase patient- reported ADR cases.
The findings suggest that direct consumer education by health-care providers and the other relevant stakeholders' bodies on issues pertaining ADRs detection and reporting could accelerate the involvement of consumers in ADRs reporting process.
Limitations of the study
The sample size is not reflective of general opinion of high educational background as we were unable to recruit respondents with a post-graduate degree.
| References|| |
|1.||Feely J, Moriarty S, O'Connor P. Stimulating reporting of adverse drug reactions by using a fee. BMJ 1990;300:22-3.1. |
|2.||Smith CC, Bennett PM, Pearce HM, Harrison PI, Reynolds DJ, Aronson JK, et al. Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. Br J Clin Pharmacol 1996;42:423-9.2. |
|3.||MADRAC Malaysian Adverse Drug Reactions Advisory Committee Bulletin (2002). Malaysia: National Pharmaceutical Control Bureau, MOH; 2002. |
|4.||Aqil M. Journal of pharmacy and bioallied sciences. J Pharm Bioallied Sci 2010;2:281. |
|5.||Elkalmi RM, Ahmad Hassali MA, Al-lela QB, Jamshed SQ. The teaching of subjects related to pharmacovigilance in malaysian pharmacy undergraduate programs. J Pharmacovigilance 2013;1:106. |
|6.||Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: Predictors of under-reporting in Malaysia. Pharmacoepidemiol Drug Saf 2007;16:223-8.6. |
|7.||Elkalmi RM, Hassali MA, Ibrahim MI, Liau SY, Awaisu A. A qualitative study exploring barriers and facilitators for reporting of adverse drug reactions (ADRs) among community pharmacists in Malaysia. J Pharm Health Serv Res 2011;2:71-8. |
|8.||Jamali AN, Aqil M, Alam MS, Pillai KK, Kapur P. A pharmacovigilance study on patients of bronchial asthma in a teaching hospital. J Pharm Bioallied Sci 2010;2:333-6. |
|9.||Hughes L, Whittlesea C, Luscombe D. Patients' knowledge and perceptions of the side-effects of OTC medication. J Clin Pharm Ther 2002;27:243-8. |
|10.||Hartigan-Go K. Developing a pharmacovigilance system in the Philippines, a country of diverse culture and strong traditional medicine background. Toxicology 2002;181-182:103-7. |
|11.||Schlienger RG, Lüscher TF, Schoenenberger RA, Haefeli WE. Academic detailing improves identification and reporting of adverse drug events. Pharm World Sci 1999;21:110-5. |
|12.||Vessal G, Mardani Z, Mollai M. Knowledge, attitudes, and perceptions of pharmacists to adverse drug reaction reporting in Iran. Pharm World Sci 2009;31:183-7. |
|13.||Fleuranceau-Morel P. How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers. Pharmacoepidemiol Drug Saf 2002;11:37-44. |
|14.||van Hunsel F, Passier A, van Grootheest K. Comparing patients' and healthcare professionals' ADR reports after media attention: The broadcast of a Dutch television programme about the benefits and risks of statins as an example. Br J Clin Pharmacol 2009;67:558-64.14. |
|15.||Jarernsiripornkul N, Chaisrisawadsuk S, Chaiyakum A, Krska J. Patient self-reporting of potential adverse drug reactions to non-steroidal anti-inflammatory drugs in Thailand. Pharm World Sci 2009;31:559-64. |
|16.||Leone R, Moretti U, D'Incau P, Conforti A, Magro L, Lora R, et al. Effect of pharmacist involvement on patient reporting of adverse drug reactions: First italian study. Drug Saf 2013;36:267-76. |
[Table 1], [Table 2], [Table 3], [Table 4]
|This article has been cited by|
||Patients’ Perspectives on Adverse Drug Reaction Reporting in a Developing Country: A Case Study from Ghana
| ||George Tsey Sabblah,Delese Mimi Darko,Hudu Mogtari,Linda Härmark,Eugène van Puijenbroek |
| ||Drug Safety. 2017; |
|[Pubmed] | [DOI]|
||Factors affecting patient reporting of adverse drug reactions: a systematic review
| ||Rania Al Dweik,Dawn Stacey,Dafna Kohen,Sanni Yaya |
| ||British Journal of Clinical Pharmacology. 2016; |
|[Pubmed] | [DOI]|
||Experiences relating to adverse drug reactions in the community: a cross-sectional survey among patients and the general public in Thailand
| ||Arunrot Patsuree,Janet Krska,Narumol Jarernsiripornkul |
| ||Expert Opinion on Drug Safety. 2016; : 1 |
|[Pubmed] | [DOI]|
||Pharmacy students’ knowledge and perceptions about adverse drug reactions reporting and pharmacovigilance
| ||Kingston Rajiah,Mari Kannan Maharajan,Shashina Nair |
| ||Saudi Pharmaceutical Journal. 2015; |
|[Pubmed] | [DOI]|
||Survey of patients’ experiences and their certainty of suspected adverse drug reactions
| ||Jarernsiripornkul Narumol,Patsuree Arunrot,Janet Krska |
| ||International Journal of Clinical Pharmacy. 2015; 37(1): 168 |
|[Pubmed] | [DOI]|
||Self-Reporting of Adverse Drug Reactions in Iraqi Hospitals: Patient’s Perspectives
| ||Kadhim Ali Kadhim |
| ||Pharmacology & Pharmacy. 2015; 06(12): 566 |
|[Pubmed] | [DOI]|