Displaying all 11 publications

Abstract:
Sort:
  1. Mansfield P
    Med J Aust, 1985 Sep 2;143(5):219-20.
    PMID: 4033497
    Matched MeSH terms: Drug Labeling*
  2. Chan HK, Hassali MA
    Int J Clin Pharm, 2014 Oct;36(5):904-13.
    PMID: 25135804 DOI: 10.1007/s11096-014-0003-1
    BACKGROUND: Inability to read instructions on drug labels has been identified among the Malaysian population since 1990's.
    OBJECTIVE: To assess the impact of font-enlarged and pictogram-incorporated labels used for long-term medications on patients' adherence, comprehension and preferences.
    SETTING: Outpatient pharmacy in one of the major general hospitals across Northern Malaysia.
    METHOD: This was a three-arm, randomized controlled trial. Outpatients with refill prescriptions of selected oral antihypertensive or antidiabetic medications were screened for eligibility. They were randomly allocated with standard (n = 35), font-enlarged (n = 40) or pictogram-incorporated (n = 35) labels. Assessment of baseline adherence scores using the 8-item Morisky Medication Adherence Scale, comprehension scores using a structured questionnaire and preferences was conducted upon recruitment. Follow-up telephone interviews were conducted after 4 weeks.
    MAIN OUTCOME MEASURE: The changes of patients' adherence and comprehension scores and their preferences.
    RESULTS: Within-group comparisons demonstrated an increase of total adherence scores after 4 weeks in all three groups (mean changes 0.35, 0.58 and 0.67; p = 0.029, 0.013 and 0.011, respectively). The repeatedly measured total comprehension score of pictogram-incorporated label group was significantly higher than baseline (mean change 0.37, p = 0.010). Two intervention groups obtained significantly higher scores for few items in both adherence and comprehension measurements after 4 weeks as compared with baselines. As indicated by F tests, three groups did not significantly differ in the changes of both total adherence and comprehension scores (p = 0.573 and 0.069, respectively) with the subjects' age adjusted. Elderlies and those with a higher number of morbidity preferred pictogram-incorporated label over font-enlarged label.
    CONCLUSION: We did not find a significant change of both adherence and comprehension levels after the introduction of modified medication labels. However, on the basis of within-group comparisons, they may have positive influences on certain aspects of patients' adherence and comprehension. Variations in preferences may reflect the unique need of different subgroups in receiving written medication instructions.
    Study site: Outpatient pharmacy, Sultanah Bahiyah Hospital, Alor Setar, Kedah, Malaysia
    Matched MeSH terms: Drug Labeling*
  3. Lee PR, Lurie P, Silverman MM, Lydecker M
    J Clin Epidemiol, 1991;44 Suppl 2:49S-55S.
    PMID: 2045842
    Recent studies of drug promotion and labeling in Third World countries since 1972 have observed important changes in the policies of multinational corporations. Earlier studies found that multinational and national drug companies often grossly exaggerated the indications for the drugs and minimized or ignored the hazards. In the latest study, initiated in 1987, considerable improvement in promotional practices of the multinational corporations has been found, but little or no improvement on the part of the national companies. As a result, physicians are still provided with grossly exaggerated claims and the hazards of prescription drugs are covered up or glossed over. A very serious problem--the marketing of fraudulent drug products--has been identified in a number of Third World countries. Drug products are shaped and colored to resemble the original multinational company product, but contain only a small percentage of the active ingredient stated on the label, or perhaps none at all. In Indonesia fraudulent drug products may represent 20-30% of all drug products in the market. Similar fraudulent products have been reported in Brazil, Thailand, Bangladesh and Malaysia.
    Matched MeSH terms: Drug Labeling*
  4. Cheah YK, Chong YW
    Glob Health Promot, 2018 Mar;25(1):63-72.
    PMID: 27406823 DOI: 10.1177/1757975916649135
    The misuse of medicine is a serious public health issue worldwide. An important factor that contributes to the misuse of medicine is the lack of medication label viewing by consumers. The objective of the present study is to examine the socio-economic, demographic and lifestyle factors associated with medication label viewing among Malaysian adults. The empirical analysis is based on a nationally representative data set of 30,992 respondents. An ordered probit model is used to examine different types of medication label viewers. The results of this study suggest that socio-economic (i.e. age, income level, education level, location of residence), demographic (i.e. gender, ethnicity, marital status) and lifestyle factors (i.e. physical activity, smoking) have significant effects on medication label viewing. It is found that age, low-income and low-education level reduce the likelihood of viewing medication label. Based on these findings, several policy implications are suggested. The present study provides policy makers with baseline information regarding which cohorts of individuals to focus on in efforts to increase the frequency of medication label viewing.
    Matched MeSH terms: Drug Labeling*
  5. Hussain A, Ibrahim MI, Baber ZU
    Int J Pharm Pract, 2012 Jun;20(3):183-90.
    PMID: 22554161 DOI: 10.1111/j.2042-7174.2011.00178.x
    The study evaluated the compliance of community pharmacies with legal requirements as laid down by the drug regulatory framework in Pakistan.
    Matched MeSH terms: Drug Labeling
  6. Chan HK, Hassali MA, Lim CJ, Saleem F, Ghani NA
    Pharm Pract (Granada), 2016 Apr-Jun;14(2):699.
    PMID: 27382422 DOI: 10.18549/PharmPract.2016.02.699
    BACKGROUND: Inadequacies of drug labeling have been frequently reported among Malaysian healthcare institutes, in which the Hospital Information System (HIS) is used.
    OBJECTIVE: To identify potential areas to improve the existing labels used for pediatric liquid medications.
    METHODS: This study was qualitative in nature, whereby focus group discussions (FGDs), face-to-face interviews (FTFIs), and onsite observation were used for data collection. Pharmacists stationed at three units (outpatient, inpatient and clinical pharmacy) of a tertiary hospital were targeted. Both FGDs and FTFIs were facilitated using a semi-structured interview guide, video-recorded and transcribed verbatim. All transcripts were thematically analyzed using content analysis approach.
    RESULTS: Thirteen pharmacists participated in FGDs, while five were approached for FTFIs. Data analysis resulted in four major themes: format of labels, presentation of medication instructions, insufficiency of information, and the need for external aids and education. Participants unanimously agreed on the need for enlarging font sizes of key information. Suggestions were made to use more specific instructions for administration times and pictograms to illustrate important directions. The absence of information about storage, stability and handling of liquid medications was also highlighted. While discussion mainly focused on improving drug labeling, participants consistently stressed the need for an instruction sheet and pharmacist-based, one-to-one education regarding medication instructions.
    CONCLUSION: This study provides important insights into critical shortcomings in current labeling practice, underlying the need for developing a new label that incorporates a new format, additional information and pictograms for pediatric liquid medications.
    KEYWORDS: Child; Drug labeling; Hospital; Hospital Information Systems; Malaysia; Medication Errors; Pharmacy Service
    Matched MeSH terms: Drug Labeling
  7. Neoh CF, Hassali MA, Shafie AA, Awaisu A, Tambyappa J
    Curr Drug Saf, 2009 Sep;4(3):199-203.
    PMID: 19534650
    Good medicine labelling practice is vital to ensure safe use of medicines. Non-compliance to labelling standards is a potential source of medication errors. This study was intended to evaluate and compare compliance towards labelling standard for dispensed medications between community pharmacists and general practitioners in Penang, Malaysia. A total of 128 community pharmacies and 26 general practitioners' clinics were visited. Using 'Simulated Client Method' (SCM), data were collected on the medications dispensed upon presentation of hypothetical common cold symptoms. The medications dispensed were evaluated for labelling adequacy. Result revealed that majority of the dispensed medications obtained were not labelled according to regulatory requirements. However, general practitioners complied better than community pharmacists in terms of labelling for: name of patient (p<0.001), details of supplier (p<0.001), dosage of medication (p=0.023), frequency to take medication (p=0.023), patient's reference number (p<0.001), date of supply (p<0.001), special instructions for medication (p=0.008), storage requirements (p=0.002), and indication for medication (p<0.001). Conversely, community pharmacists labelled dispensed medications with the words "Controlled Medicine" more often than did general practitioners (p<0.001). Although laws for labelling dispensed medicines are in place, most community pharmacists and general practitioners did not comply accordingly, thereby putting patients' safety at risks of medication errors.
    Matched MeSH terms: Drug Labeling/standards*
  8. Wang YH, Chen CB, Tassaneeyakul W, Saito Y, Aihara M, Choon SE, et al.
    Clin. Pharmacol. Ther., 2019 01;105(1):112-120.
    PMID: 29569740 DOI: 10.1002/cpt.1071
    Specific ethnic genetic backgrounds are associated with the risk of Stevens-Johnson syndrome / toxic epidermal necrolysis (SJS/TEN) especially in Asians. However, there have been no large cohort, multiple-country epidemiological studies of medication risk related to SJS/TEN in Asian populations. Thus, we analyzed the registration databases from multiple Asian countries who were treated during 1998-2017. A total 1,028 SJS/TEN cases were identified with the algorithm of drug causality for epidermal necrolysis. Furthermore, those medications labeled by the US Food and Drug Administration (FDA) as carrying a risk of SJS/TEN were also compared with the common causes of SJS/TEN in Asian countries. Oxcarbazepine, sulfasalazine, COX-II inhibitors, and strontium ranelate were identified as new potential causes. In addition to sulfa drugs and beta-lactam antibiotics, quinolones were also a common cause. Only one acetaminophen-induced SJS was identified, while several medications (e.g., oseltamivir, terbinafine, isotretinoin, and sorafenib) labeled as carrying a risk of SJS/TEN by the FDA were not found to have caused any of the cases in the Asian countries investigated in this study.
    Matched MeSH terms: Drug Labeling/standards*
  9. Hassan Y, Abd Aziz N, Sarriff A, Darwis Y, Ibrahim P
    Hosp Pharm, 1994 Jan;29(1):48-50, 53.
    PMID: 10131493
    Patients may not comply with antibiotic instructions because they do not understand them. The aim of this study was to assess outpatients' ability to comprehend their antibiotic prescription labels. Two hundred and five subjects on oral antibiotic regimens from an outpatient clinic and pharmacy of a district hospital were selected in this survey. All patients were interviewed by trained clinical pharmacy students. They were asked to read the labels and then how they would take their antibiotics. The results show that 119 (58.1%) patients could interpret the label. Forty-nine (23.9%) patients knew the name of antibiotics and interpreted the directions of use correctly. One hundred sixteen (56.6%) subjects were able to recall the auxiliary information. However, only 44 (21.4%) patients were able to comprehend complete antibiotic instruction. This study demonstrates that a significant proportion of patients could not interpret the labeling instruction. The comprehension level of patients was low and significantly associated (P < 0.05) with the ability of patient to read the label contents. These observations illustrate the need for physicians and pharmacists to provide antibiotic instructions and review these instructions with the patient.

    Study site: outpatient clinic and pharmacy of a district hospita
    Matched MeSH terms: Drug Labeling
  10. Balan S, Hassali MA, Mak VSL
    Res Social Adm Pharm, 2017 May-Jun;13(3):653-655.
    PMID: 27493130 DOI: 10.1016/j.sapharm.2016.06.014
    The pediatric population is an enormously diverse segment of population varying both in size and age. The diversity caused pharmacists face various challenges primarily related to procuring, provision as well as use of drugs in this group of patients. Pediatric dose calculation is particularly a concern for pharmacists. Another challenge faced by pharmacists is unavailability of suitable formulations for pediatric use. This has also led many pharmacists to prepare extemporaneous liquid preparations, even though stability data on such preparations are scarce. Some extemporaneous preparations contain excipients which are potentially harmful in children. Besides that, inadequate labeling and drug information for pediatric drug use had not only challenged pharmacists in recommending and optimizing drug use in children, but also inadvertently caused many drugs used outside the approved terms of the product license (off-label use). Pharmacists are striving to stay connected to overcome the common and comparable challenges faced in their day to day duties and strive to maximize the safe and effective use of medicines for children.
    Matched MeSH terms: Drug Labeling
  11. Awaisu A, Abd Rahman NS, Nik Mohamed MH, Bux Rahman Bux SH, Mohamed Nazar NI
    Am J Pharm Educ, 2010 Mar 10;74(2):34.
    PMID: 20414449
    OBJECTIVE: To implement and determine the effectiveness of an objective structured clinical examination (OSCE) to assess fourth-year pharmacy students' skills in a clinical pharmacy course.

    DESIGN: A 13-station OSCE was designed and implemented in the 2007-2008 academic year as part of the assessment methods for a clinical pharmacy course. The broad competencies tested in the OSCE included: patient counseling and communication, clinical pharmacokinetics (CPK), identification and resolution of drug-related problems (DRPs), and literature evaluation/drug information provision.

    ASSESSMENT: Immediately after all students completed the OSCE, a questionnaire containing items on the clarity of written instructions, difficulty of the tasks, perceived degree of learning gained and needed, and the suitability of the references or literature resources provided was administered. More than 70% of the students felt that a higher degree of learning was needed to accomplish the tasks at the 2 DRP stations and 2 CPK stations and the majority felt the written instructions provided at the phenytoin CPK station were difficult to understand. Although about 60% of the students rated OSCE as a difficult form of assessment, 75% said it should be used more and 81% perceived they learned a lot from it.

    CONCLUSION: Although most students felt that the OSCE accurately assessed their skills, a majority felt the tasks required in some stations required a higher degree of learning than they had achieved. This may indicate deficiencies in the students' learning abilities, the course curriculum, or the OSCE station design. Future efforts should include providing clearer instructions at OSCE stations and balancing the complexity of the competencies assessed.

    Matched MeSH terms: Drug Labeling
Related Terms
Filters
Contact Us

Please provide feedback to Administrator (afdal@afpm.org.my)

External Links