MyMedR

Fulltext The need for drug and poison information--the Singapore physicians' perspective

Ponampalam R, Anantharaman V

Singapore Med J, 2003 May;44(5):231-42.

There appears to be a significant prevalence of poisoning and adverse drug reactions in Singapore. However, the resources needed by physicians to assist them in the management of such cases are limited. This study examines the information resources currently utilised by medical professionals in assisting them in the management of poisonings and adverse drug reactions. The preferred features of an ideal Drug and Poison Information Centre in the local setting were also explored.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems

Risk management from an Asian/Pacific Rim regulatory perspective

McEwen J

Drug Saf, 2004;27(8):491-7.

PMID: 15154822

This article reviews the state of adverse drug reaction monitoring in five Asian/Pacific Rim countries (Australia, Japan, Malaysia, New Zealand and Singapore). Each country has an active pharmacovigilance programme managed by a national regulatory agency. Current methods for assessing risks and current methods used for risk management and communication are compared with the 'tools' used by the US FDA. Major positive attributes of the programmes in all five countries include active involvement of independent expert clinical advisory committees in identifying and evaluating risks through the assessment of reports of serious and unusual reactions, and regular communications about risks from the national agencies to doctors and pharmacists by means of pharmacovigilance bulletins. Most components of the risk-management toolbox are currently used, in some instances without legislated support. Variations in the way risk-management tools are implemented within individual national health systems are illustrated.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems/organization & administration*

Reporting of adverse drug reactions: predictors of under-reporting in Malaysia

Aziz Z, Siang TC, Badarudin NS

Pharmacoepidemiol Drug Saf, 2007 Feb;16(2):223-8.

PMID: 16947117

Malaysia like many other countries worldwide uses spontaneous reporting systems as a mean of collecting data on suspected adverse drug reaction (ADR). However, compared to other countries, which use the system, the reporting rate in Malaysia is very low. Why some physicians do not report ADRs is not well understood.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems/statistics & numerical data*

Fulltext Pattern of potential drug-drug interactions in diabetic out-patients in a tertiary care teaching hospital in Nepal

Dinesh KU, Subish P, Pranaya M, Shankar PR, Anil SK, Durga B

Med J Malaysia, 2007 Oct;62(4):294-8.

PMID: 18551932

A prospective study was conducted at Manipal Teaching Hospital, Pokhara, Nepal to identify and analyze the pattern of the potential DDIs (drug-drug interaction) in diabetes patients. A total of 182 patients who were prescribed 685 drugs (average, 3.76 drugs per prescription) were enrolled. Patients 51 to 60 years of age had a higher risk [43 patients, or (23.6%)] of developing DDIs. It was found that 174 (92.1%) of the potential DDIs were of "moderate" severity. Cardiovascular drugs carried a risk of DDIs (187 drugs, or 49.5%). The most common potential DDI observed was between metformin and enalapril (n = 64).

Matched MeSH terms: Adverse Drug Reaction Reporting Systems*

Developing a consumer reporting program in Malaysia: a novel initiative to improve pharmacovigilance

Palaian S, Alshakka M, Mohamed Izham

Pharm World Sci, 2010 Feb;32(1):2-6.

PMID: 19894139 DOI: 10.1007/s11096-009-9342-8

The national pharmacovigilance program in Malaysia is limited to very few centers and under-reporting of adverse drug reactions (ADRs) is a major limitation. Studies from developed countries have documented the importance and usefulness of consumer reporting of ADRs. Involving consumers in ADR reporting can be very useful in improving the reporting rates in Malaysia. The present article highlights the proposed plan of initiating a consumer based pharmacovigilance program in University Wellness Center located inside the campus of the Universiti Sains Malaysia, Penang, Malaysia.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems/organization & administration*

Incidence of adverse drug reactions induced by N-acetylcysteine in patients with acetaminophen overdose

Zyoud SH, Awang R, Syed Sulaiman SA, Sweileh WM, Al-Jabi SW

Hum Exp Toxicol, 2010 Mar;29(3):153-60.

PMID: 20071472 DOI: 10.1177/0960327109359642

Intravenous N-acetylcysteine (IV-NAC) is widely recognized as the antidote of choice for acetaminophen overdose. However, its use is not without adverse drug reactions (ADR) that might affect therapeutic outcome or lead to treatment delay.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems

Community pharmacists' views on adverse drug reactions reporting in Malaysia: a pilot study

Ting KN, Stratton-Powell DM, Anderson C

Pharm World Sci, 2010 Jun;32(3):339-42.

PMID: 20336371 DOI: 10.1007/s11096-010-9382-0

OBJECTIVES: To investigate community pharmacists' knowledge, attitudes and views on adverse drug reaction (ADR) reporting. Setting Seven community pharmacies in Malaysia.

METHOD: Structured interviews with community pharmacists. Informed consent was obtained and interviews were audio-recorded and transcribed verbatim.

MAIN OUTCOME MEASURES: Content analysis of themes on awareness of ADR reporting, reporting activities, attitudes and views on patient reporting.

RESULTS: All pharmacists claimed to have some knowledge of a reporting system but only one had submitted a report directly to the regulatory authority. Despite the low level of reporting activities, all participants agreed that it was part of their professional obligation to report an ADR. Most participants were not aware of the direct patient reporting scheme and were skeptical about its success. Lack of awareness and patients' limited knowledge about their medications were viewed as barriers to patient reporting. Local attitudinal issues including pharmacists' attitude towards ADR reporting were described as possible contributing factors.

CONCLUSION: Community pharmacists have an important role in reporting ADRs. Many Malaysian patients are still perceived to be ill-informed of their medications, an important determinant to the success of patient reporting. There is a need for further training about ADRs and ADR reporting for health professionals and further education for patients.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems/standards*

Fulltext Information technology for patient safety

Huckvale C, Car J, Akiyama M, Jaafar S, Khoja T, Bin Khalid A, et al.

Qual Saf Health Care, 2010 Aug;19 Suppl 2:i25-33.

PMID: 20693213 DOI: 10.1136/qshc.2009.038497

BACKGROUND: Research on patient care has identified substantial variations in the quality and safety of healthcare and the considerable risks of iatrogenic harm as significant issues. These failings contribute to the high rates of potentially avoidable morbidity and mortality and to the rising levels of healthcare expenditure seen in many health systems. There have been substantial developments in information technology in recent decades and there is now real potential to apply these technological developments to improve the provision of healthcare universally. Of particular international interest is the use of eHealth applications. There is, however, a large gap between the theoretical and empirically demonstrated benefits of eHealth applications. While these applications typically have the technical capability to help professionals in the delivery of healthcare, inadequate attention to the socio-technical dimensions of their use can result in new avoidable risks to patients.

RESULTS AND DISCUSSION: Given the current lack of evidence on quality and safety improvements and on the cost-benefits associated with the introduction of eHealth applications, there should be a focus on implementing more mature technologies; it is also important that eHealth applications should be evaluated against a comprehensive and rigorous set of measures, ideally at all stages of their application life cycle.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems

Quality check of spontaneous adverse drug reaction reporting forms of different countries

Bandekar MS, Anwikar SR, Kshirsagar NA

Pharmacoepidemiol Drug Saf, 2010 Nov;19(11):1181-5.

PMID: 20845409 DOI: 10.1002/pds.2004

Adverse drug reactions (ADRs) are considered as one of the leading causes of death among hospitalized patients. Thus reporting of adverse drug reactions become an important phenomenon. Spontaneous adverse drug reaction reporting form is an essential component and a major tool of the pharmacovigilance system of any country. This form is a tool to collect information of ADRs which helps in establishing the causal relationship between the suspected drug and the reaction. As different countries have different forms, our aim was to study, analyze the suspected adverse drug reaction reporting form of different countries, and assess if these forms can capture all the data regarding the adverse drug reaction. For this analysis we identified 18 points which are essential to make a good adverse drug reaction report, enabling proper causality assessment of adverse reaction to generate a safety signal. Adverse drug reaction reporting forms of 10 different countries were collected from the internet and compared for 18 points like patient information, information about dechallenge-rechallenge, adequacy of space and columns to capture necessary information required for its causality assessment, etc. Of the ADR forms that we analyzed, Malaysia was the highest scorer with 16 out of 18 points. This study reveals that there is a need to harmonize the ADR reporting forms of all the countries because there is a lot of discrepancy in data captured by the existing ADR reporting forms as the design of these forms is different for different countries. These incomplete data obtained result in inappropriate causality assessment.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems/standards*

Fulltext Pharmacy students' knowledge and perceptions about pharmacovigilance in Malaysian public universities

Elkalmi RM, Hassali MA, Ibrahim MI, Widodo RT, Efan QM, Hadi MA

Am J Pharm Educ, 2011 Jun 10;75(5):96.

PMID: 21829270 DOI: 10.5688/ajpe75596

To assess senior pharmacy students' knowledge of and perceptions about pharmacovigilance and reporting of adverse drug reactions (ADRs) at 5 public universities in Malaysia.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems/organization & administration

Adverse Drug Reactions in Children--International Surveillance and Evaluation (ADVISE): a multicentre cohort study

Rashed AN, Wong IC, Cranswick N, Hefele B, Tomlin S, Jackman J, et al.

Drug Saf, 2012 Jun 1;35(6):481-94.

PMID: 22612852 DOI: 10.2165/11597920-000000000-00000

Background: A previous meta-analysis reported that 9.5% of hospitalized children suffered from an adverse drug reaction (ADR); however, reported incidences among studies varied.

Objective: To enhance the knowledge of ADRs in paediatric hospitalized patients at a global level we investigated the incidence and characteristics of ADRs in hospitalized children in European and non-European countries.

Methods: A prospective observational cohort study was conducted in academic and non-academic hospitals in five countries: Australia, Germany, Hong Kong, Malaysia and the UK. Children aged 0-18 years admitted during a 3-month period (between 1 October 2008 and 31 December 2009) were recruited. The main outcome measures were incidence, causality and outcome of ADRs.

Results: A total of 1278 patients (1340 admissions) were included [Australia n = 146 (149 admissions), Germany n = 376 (407), Hong Kong n = 143 (149), Malaysia n = 300 (314) and the UK n = 313 (321)]. The median age was 2 years (interquartile range [IQR] 0-7). Patients received a total of 5367 drugs (median 3; IQR 2-5) and median length of hospital stay was 4 days (IQR 3-7). A total of 380 ADRs were identified in 211 patients. The resultant ADR incidence of 16.5% (95% CI 14.5, 18.7) varied significantly between countries (p < 0.001). The highest incidences were observed in Malaysia and the UK. 65.3% (n = 248) of ADRs were found to be probable, and 24% of the ADRs were serious, with one being fatal.

Conclusions: By comparing data from five countries in Europe, Asia and Australia we have shown that the incidence of ADRs in hospitalized children is at least as high as incidences published in adults. However, the variation between countries was mainly due to different populations and treatment strategies. Particular attention should be given to opioid use in hospitalized children.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems/statistics & numerical data*

Use of first- and second-generation antipsychotic medications in older patients with schizophrenia in Asia (2001-2009)

Xiang YT, Kreyenbuhl J, Dickerson FB, Ungvari GS, Wang CY, Si TM, et al.

Aust N Z J Psychiatry, 2012 Dec;46(12):1159-64.

PMID: 22790175 DOI: 10.1177/0004867412453625

This study examined the prescribing patterns of several first- (FGAs) and second-generation antipsychotic (SGAs) medications administered to older Asian patients with schizophrenia during the period between 2001 and 2009.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems/statistics & numerical data*

Fulltext New pharmacovigilance course at the International Islamic University Malaysia-IIUM

Al-lela OQ, Elkalmi RM, Jamshed SQ

Am J Pharm Educ, 2013 Jun 12;77(5):106.

PMID: 23788817 DOI: 10.5688/ajpe775106

Matched MeSH terms: Adverse Drug Reaction Reporting Systems*

Fulltext Adverse drug reactions reporting : Knowledge and opinion of general public in Penang, Malaysia

Elkalmi R, Hassali MA, Al-Lela OQ, Jawad Awadh AI, Al-Shami AK, Jamshed SQ

J Pharm Bioallied Sci, 2013 Jul;5(3):224-8.

PMID: 24082699 DOI: 10.4103/0975-7406.116824

The objective of this study was to explore the knowledge of the general population towards ADR and their reporting system.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems

Characterization of Statin-Associated Myopathy Case Reports in Thailand Using the Health Product Vigilance Center Database

Boonmuang P, Nathisuwan S, Chaiyakunapruk N, Suwankesawong W, Pokhagul P, Teerawattanapong N, et al.

Drug Saf, 2013 Sep;36(9):779-87.

PMID: 23615756 DOI: 10.1007/s40264-013-0055-5

HMG-CoA reductase inhibitors [statins], a widely prescribed cholesterol-lowering therapy, are associated with muscle-related adverse events. While characteristics of such events are well documented in Western countries, little data exists for the Thai population.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems*

Fulltext Do health professionals have positive perception towards consumer reporting of adverse drug reactions?

Alshakka MA, Ibrahim MI, Hassali MA

J Clin Diagn Res, 2013 Oct;7(10):2181-5.

PMID: 24298470 DOI: 10.7860/JCDR/2013/5778.3464

The aim of this study was to evaluate the perceptions of general practitioners (GPs) and community pharmacists (CPs) in Penang, Malaysia, towards consumer reporting of Adverse Drug Reactions (ADRs).

Matched MeSH terms: Adverse Drug Reaction Reporting Systems

Community pharmacists' attitudes, perceptions, and barriers toward adverse drug reaction reporting in Malaysia: a quantitative insight

Elkalmi RM, Hassali MA, Ibrahim MI, Jamshed SQ, Al-Lela OQ

J Patient Saf, 2014 Jun;10(2):81-7.

PMID: 24618640 DOI: 10.1097/PTS.0000000000000051

This study was designed to explore awareness and attitudes of community pharmacists toward the national ADR reporting system activities in the northern states of Malaysia.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems*

Adverse drug reaction-related hospitalisations among patients with heart failure at two hospitals in the United Arab Emirates

Saheb Sharif-Askari N, Syed Sulaiman SA, Saheb Sharif-Askari F, Hussain AA

Int J Clin Pharm, 2015 Feb;37(1):105-12.

PMID: 25488317 DOI: 10.1007/s11096-014-0046-3

BACKGROUND: Little is known about the adverse drug reaction (ADR) related admissions among heart failure (HF) patients.

OBJECTIVE: The aim of this study was to determine the rate, factors, and medications associated with ADR-related hospitalisations among HF patients.

SETTING: Two government hospitals in Dubai, United Arab Emirates.

METHODS: This was a prospective, observational study. Consecutive adult HF patients who were admitted between December 2011 and November 2012 to the cardiology units were included in this study. The circumstances of their admission were analysed.

MAIN OUTCOME MEASURES: ADRs-related admissions of HF patients to cardiology units were identified and further assessed for their nature, causality, and preventability.

RESULTS: Of 511 admissions, 34 were due to ADR-related hospitalisation (6.65, 95 % confidence interval 4.8-8.5 %). Number of medications taken by HF patients was the only predictors of ADR-related hospitalisations, where higher number of medications was associated with the odd ratio of 1.11 (95 % CI, 1.03-1.20, P = 0.005). More than one-third of ADR-related hospitalisations (35 %) were preventable The most frequent drugs causing ADR-related hospitalisation were diuretics (32 %), followed by non-steroidal anti-inflammatory drugs (15 %), thiazolidinediones (9 %), anticoagulants (9 %), antiplatelets (6 %), and aldosterone blockers (6 %).

CONCLUSION: ADR-related hospitalisations account for 6.7 % of admissions of HF patients to cardiac units, one-third of which are preventable. Number of medications taken by HF patients is the only predictors of ADR-related hospitalisations. Diuretic induced volume depletion, and sodium and water retention caused by thiazolidinediones and NSAIDs medications are the major causes of ADR-related hospitalisations of HF patients.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems/trends

Sequence Symmetry Analysis as a Signal Detection Tool for Potential Heart Failure Adverse Events in an Administrative Claims Database

Wahab IA, Pratt NL, Ellett LK, Roughead EE

Drug Saf, 2016 Apr;39(4):347-54.

PMID: 26798053 DOI: 10.1007/s40264-015-0391-8

The potential for routine sequence symmetry analysis (SSA) signal detection in health claims databases to detect new safety signals of medicines is unknown.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems*

Fulltext Cross-sectional study exploring barriers to adverse drug reactions reporting in community pharmacy settings in Dhaka, Bangladesh

Amin MN, Khan TM, Dewan SM, Islam MS, Moghal MR, Ming LC

BMJ Open, 2016 08 03;6(8):e010912.

PMID: 27489151 DOI: 10.1136/bmjopen-2015-010912

OBJECTIVES: To assess community pharmacists'/pharmacy technicians' knowledge and perceptions about adverse drug reactions (ADRs) and barriers towards the reporting of such reactions in Dhaka, Bangladesh.

METHOD: A cross-sectional study was planned to approach potential respondents for the study. A self-administered questionnaire was delivered to community pharmacists/pharmacy technicians (N=292) practising in Dhaka, Bangladesh.

RESULTS: The overall response to the survey was 69.5% (n=203). The majority of the sample was comprised of pharmacy technicians (152, 74.9%) who possessed a diploma in pharmacy, followed by pharmacists (37, 18.2%) and others (12, 5.9%). Overall, 72 (35.5%) of the respondents disclosed that they had experienced an ADR at their pharmacy, yet more than half (105, 51.7%) were not familiar with the existence of an ADR reporting body in Bangladesh. Exploring the barriers to the reporting of ADRs, it was revealed that the top four barriers to ADR reporting were 'I do not know how to report (Relative Importance Index (RII)=0.998)', 'reporting forms are not available (0.996)', 'I am not motivated to report (0.997)' and 'Unavailability of professional environment to discuss about ADR (RII=0.939)'. In addition to these, a majority (141, 69.46%) were not confident about the classification of ADRs (RII=0.889) and were afraid of legal liabilities associated with reporting ADRs (RII=0.806). Moreover, a lack of knowledge about pharmacotherapy and the detection of ADRs was another major factor hindering their reporting (RII=0.731).

CONCLUSIONS: The Directorate of Drug Administration in Bangladesh needs to consider the results of this study to help it improve and simplify ADR reporting in Bangladeshi community pharmacy settings.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems/statistics & numerical data*

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