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Papers by Omotayo Fatokun

Research paper thumbnail of Update on Remdesivir in the Treatment of Novel Coronavirus Pneumonia

Progress In Microbes & Molecular Biology

Worldwide epidemic prevention and control remain under significant stress due to the global novel... more Worldwide epidemic prevention and control remain under significant stress due to the global novel coronavirus disease 2019 (COVID-19) pandemic and the ongoing emergence of variants like Omicron. The total confirmed COVID-19 cases globally as of now topped 620 million, while the total number of fatalities exceeded 6.6 million. The screening, drug discovery, and clinical development of novel treatments are still the hottest subjects in the treatment of COVID-19, and scientists throughout the world are dedicated to identifying prospective therapeutic agents to treat COVID-19 patients, including the new uses of old medications. Remdesivir, a COVID-19 therapeutic medication developed by Gilead Sciences, exerts antiviral effects by suppressing the RNA-dependent RNA polymerase of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Remdesivir has maintained high inhibitory activity against all existing SARS-CoV-2 variants, including the Omicron variant. We systematically retrieved...

Research paper thumbnail of Assessment of Policies, Determinants, and Characteristics of Generic Medicines Entry Into the Pharmaceutical Markets

Abstract This chapter discusses the dimensions and determinants of postpatent entry of generic me... more Abstract This chapter discusses the dimensions and determinants of postpatent entry of generic medicines into the pharmaceutical markets in developing countries. A variety of policies and regulatory measures relating to generic medicines entry are in place in developing countries. However, these policies are less robust, seem less coherent, and there are potential gaps between policy intent and implementation. The postpatent entry of generic medicines in developing countries is majorly determined by the prevailing regulatory policies and intellectual property rights, prepatent market size of the innovator products, generic firm's characteristics, and the existence and the degree of the entry-deterrence strategies by innovators, majority of which are derived from the patent system. Although the pattern of postpatent entry of generic medicines into the pharmaceutical markets in developing countries is similar to that in developed markets, the extent of generic entry and competition in developing countries appear limited.

Research paper thumbnail of Unused and expired medications disposal practices in the community: a cross-sectional survey in Cheras, Malaysia

Archives of Pharmacy Practice, Sep 1, 2011

The appropriate disposal practice of unused and expired medications has become a global challenge... more The appropriate disposal practice of unused and expired medications has become a global challenge that has caught the attention of health policymakers, pharmaceutical organizations, healthcare professionals, and the wider community. The current study aimed to evaluate the awareness, attitudes, and behaviors relating to the disposal practice of unused and expired medications and medication wastage issues among the general public in Selangor, Malaysia. The quantitative, cross-sectional study was conducted using a pre-validated structured survey form. Among the approached individuals, 426 showed their willingness to participate in the study. More than 80% of the study population reported being aware of the medication wastage issue and its impact on patients and the economy. The respondents with a higher level of education (OR = 1.85; 95% CI = 1.18-2.52; p < 0.003) were more likely to be cognizant of the detrimental consequences of inappropriate waste disposal. The female respondents were more likely to report comprehending that the availability of free healthcare resources is contributing to medication waste (OR = 1.33, 95% CI = 1.015-2.34; p < 0.005). The majority of respondents reported throwing away unused medications (202; 47.4%) and expired medications (362; 84.9%) in the garbage. The respondents believed that the provision of appropriate directions by healthcare professionals (312; 73.2%) and prescribing/dispensing medications in quantities for the duration that ensures patient adherence (114; 26.7%) could minimize medication wastage. The Ministry of Health (258; 60.5%), pharmaceutical organizations (212; 49.7%), and pharmacists (193; 45.3%) were the respondents' perceived responsible sources of information. The current findings reported that respondents were familiar that inappropriate practices of medication wastage might have harmful consequences. However, a gap exists between their awareness and practice, and the disposal approaches practiced by the respondents were generally not appropriate.

Research paper thumbnail of Assessment of generic medicines development and entry decisions by the malaysian generic pharmaceutical industries

DOAJ (DOAJ: Directory of Open Access Journals), 2012

Research paper thumbnail of PPM12 Correlates and Predictors of Acceptance of Pharmacogenetic Testing in a Malaysian General Population

Value in Health, Nov 1, 2019

Research paper thumbnail of Use of Complementary and Alternative Medicine and Adherence to Medication Therapy Among Stroke Patients: A Meta-analysis and Systematic Review

Frontiers in Pharmacology, Jun 3, 2022

Purpose: To identify the use patterns of complementary and alternative medicine (CAM) and its imp... more Purpose: To identify the use patterns of complementary and alternative medicine (CAM) and its impact on medication adherence among patients with stroke. Method: A systematic search through Science Direct, Google Scholar, and PubMed was performed to identify potential studies up to June 2021.The primary outcome was CAM use, and the secondary outcome was medication adherence among patients with stroke. Articles included in the review met the following criteria: 1) patients with stroke ≥18 years old on prescribed medications, and 2) medication adherence reported status. Metaanalyses were conducted to estimate the pooled prevalence of complementary and alternative medicine and adherence in stroke patients using a random-effects model. Results: A total of 1,330 studies were screened, of which 22 were included in the final analysis. The type of studies included were cross-sectional surveys, cohort studies, retrospective studies and prospective survey. The pooled prevalence of CAM usage was at 38% (29-48% CI) and medication non-adherence among stroke patients was at 29% (20-48% CI). The most common reason for inadequate stroke therapy and higher dependence on CAM was the patients' lack of knowledge and the regimen complexity of the medication. Other factors for medication non-adherence were forgetfulness, side effects, cost, and lack of doctor-patient communication. Conclusion: A low prevalence of CAM usage and non-adherence to medications was observed among patients with stroke. Studies investigating the association between CAM usage and medication adherence among patients with stroke are scarce and future researches are needed to explore the influence of CAM use on stroke medication adherence.

Research paper thumbnail of Risk Minimization Measures in Off-Label Drug Use: A Survey of Community Pharmacists in Malaysia

Current Drug Safety, Nov 17, 2020

Background:While off-label drug use is common and sometimes necessary, it also presents considera... more Background:While off-label drug use is common and sometimes necessary, it also presents considerable risks. Therefore, measures intended to prevent or reduce the potential exposure to off-label risks have been recommended. However, little is known about community pharmacists’ beliefs regarding these measures in Malaysia.Objectives:This study examined community pharmacists’ beliefs towards risk minimization measures in off-label drug use in Malaysia and assessed the relationship between perceived risk of off-label drug use and beliefs towards risk minimization measures.Methods:A cross-sectional survey was conducted among 154 pharmacists practicing in randomly selected community pharmacies in Kuala Lumpur and the State of Selangor, Malaysia.Results:The majority agreed or strongly agreed that adverse drug events from the off-label drug should be reported to the regulatory authority (90.9%) and the off-label drug should only be used when the benefit outweighs potential risks (88.3%). Less than half (48.1%) agreed or strongly agreed that written informed consent should be obtained before dispensing off-label drugs and a majority (63.7%) agreed or strongly agreed that the informed consent process will be burdensome to healthcare professionals. Beliefs towards risk minimization measures were significantly associated with perceived risk of off-label drug use regarding efficacy (p = 0. 033), safety (p = 0.001), adverse drug rection (p = 0.001) and medication errors (p = 0.002).Conclusion:The community pharmacists have positive beliefs towards most of the risk minimization measures. However, beliefs towards written informed consent requirements are not encouraging. Enhancing risk perception may help influence positive beliefs towards risk minimization measures.

Research paper thumbnail of Factors associated with the intention of community pharmacists to report adverse drug reactions to regulatory authority in Malaysia: application of the theory of planned behaviour

International Journal of Pharmacy Practice, Jul 9, 2021

Objectives It is known that community pharmacists in Malaysia underreport adverse drug reactions ... more Objectives It is known that community pharmacists in Malaysia underreport adverse drug reactions (ADRs). In order to improve ADR reporting, a theory-based understanding of the factors associated with the community pharmacists’ reporting behaviour is important. This study used the theory of planned behaviour (TPB) to identify the predictors of behavioural intention to report ADRs to the regulatory authority among community pharmacists in Malaysia and to assess the relative importance of the predictors. Methods A questionnaire-based study was conducted among 188 randomly selected community pharmacists in the state of Johor, Malaysia. The questionnaire included four main TPB constructs (intention, attitude, subjective norms and perceived behavioural control) and related measures, including perceived moral obligation, past reporting behaviour and sociodemographic variables. Descriptive and hierarchical regression analyses were conducted. Key findings A total of 164 questionnaires were collected. The mean score of intention to report ADRs was 15.43 (SD = 2.99). The final model of the hierarchical regression analysis showed that attitude towards ADR reporting (P = 0.004), subjective norm (P = 0.010) and perceived moral obligation (P = 0.014) were significant predictors of intention to report ADRs. Attitude was the most significant predictor, followed by subjective norm and perceived moral obligation. Conclusions Interventions targeting community pharmacists’ attitude, subjective norms and perceived moral obligations towards ADR reporting, with a specific focus on attitude would likely have a positive impact on improving ADR reporting in Malaysia.

Research paper thumbnail of Generic competition and drug prices in the Malaysian off-patent pharmaceutical market

Promoting generic competition following patent expiration of innovator product is a key policy st... more Promoting generic competition following patent expiration of innovator product is a key policy strategy in containing rising drug expenditure in both developed and developing countries. However, the effect of this measure on drug prices has not been specifically explored in Malaysia. This paper analyses the potential effect of generic competition on drug prices in the off-patent pharmaceutical market in Malaysia using retail price data of 28 off-patent multisource prescription medicines collected in a national medicines price survey in Malaysia. The relationship between number of registered brands of multisource medicines and their proportional prices was examined. The results show that the mean proportional price decreases as the number of brands increases, Pearson's r (6) =0.89, p=0.017 and the differences between the mean proportional prices among the various brands was significant, one-way ANOVA, F (5, 22) =3.68, p=0.014). However, further analysis using Tukey's post-hoc test analysis shows that the price differentials were not significant across all the brands of a given off-patent multisource product. The findings of this study revealed evidence of price lowering effect of generic competition among multisource drug products in Malaysia, though the effect was not observable across all drug brands.

Research paper thumbnail of Use of Complementary and Alternative Medicine and Adherence to Medication Therapy Among Stroke Patients: A Meta-analysis and Systematic Review

Frontiers in Pharmacology

Purpose: To identify the use patterns of complementary and alternative medicine (CAM) and its imp... more Purpose: To identify the use patterns of complementary and alternative medicine (CAM) and its impact on medication adherence among patients with stroke.Method: A systematic search through Science Direct, Google Scholar, and PubMed was performed to identify potential studies up to June 2021.The primary outcome was CAM use, and the secondary outcome was medication adherence among patients with stroke. Articles included in the review met the following criteria: 1) patients with stroke ≥18 years old on prescribed medications, and 2) medication adherence reported status. Meta-analyses were conducted to estimate the pooled prevalence of complementary and alternative medicine and adherence in stroke patients using a random-effects model.Results: A total of 1,330 studies were screened, of which 22 were included in the final analysis. The type of studies included were cross-sectional surveys, cohort studies, retrospective studies and prospective survey. The pooled prevalence of CAM usage was...

Research paper thumbnail of Assessment of generic medicines development and entry decisions by the malaysian generic pharmaceutical industries

Archives of Pharmacy Practice, 2012

Routledge is an imprint of the Taylor & Francis Group, an informa business A ll rights reserved. ... more Routledge is an imprint of the Taylor & Francis Group, an informa business A ll rights reserved. No part of this book may be reprinted or reproduced or utilized in any form or by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying and recording, or in any information storage or retrieval system, without permission in writing from the publishers. The publishers have made every effort to contact authors/copyright holders of the works reprinted in The Broadway Travellers. This has not been possible in every case, however, and we would welcome correspondence from those individuals/companies we have been unable to trace. These reprints are taken from original copies of each book. In many cases the condition of these originals is not perfect. The publisher has gone to great lengths to ensure the quality o f these reprints, but wishes to point out that certain characteristics o f the original copies will, o f necessity, be apparent in reprints thereof.

Research paper thumbnail of Barriers and facilitators to provision of written consumer medicines information among community pharmacists in Malaysia: a cross‐sectional study

Journal of Pharmaceutical Health Services Research, 2020

This study examined the barriers and facilitators to the provision of consumer medication informa... more This study examined the barriers and facilitators to the provision of consumer medication information leaflets (CMIL) by community pharmacists in Malaysia and assessed the relationship between the participants' characteristics and provision of CMIL.

Research paper thumbnail of Factors determining the post-patent entry of generic medicines in Malaysia: A survey of the Malaysian generic pharmaceutical industry

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector, 2013

Malaysia is reliant on the availability of generic medicines to contain the rising national pharm... more Malaysia is reliant on the availability of generic medicines to contain the rising national pharmaceutical expenditure. This paper assesses the factors determining the market entry of a new generic medicine following patent expiration on the innovator product in Malaysia. Data were gathered by using mail survey approach. The pre-validated Likert-scale questionnaire was mailed to all licensed members of the Malaysian Organization of Pharmaceutical Industries. A usable response rate of 53.8% (14/26) was achieved following four successive mailings. The overall internal reliability coefficients for the 5-item entry decision variables scale and 11-item entry barrier variables scale were 0.62 and 0.82 respectively. The results revealed that the major factors driving decisions to develop and introduce a new generic medicine into the Malaysian pharmaceutical market are consistent with the business model of the generic pharmaceutical industry. The pre-patent expiration market value of the in...

Research paper thumbnail of Quantification of acarbose in tablets

Attenuated total reflectance Fourier transform infrared (ATR-FTIR) spectroscopy method was develo... more Attenuated total reflectance Fourier transform infrared (ATR-FTIR) spectroscopy method was developed for the quantitative determination of acarbose in tablets. Two calibration curves were generated. The first calibration curve was based on peak height at 2928.54 cm-1 with correlation coefficient of 0.9987. The second calibration curve was based on peak area which range from 2953.39-2851.04 cm-1 with correlation coefficient of 0.9978. The FTIR method was validated according to International Conference on Harmonization (ICH) guidelines. The method was precise over a range of 40%-100% w/w with % RSD values less than 2 for intra-day and interday precision. The accuracy of the method was expressed as the percentage recovery of the spiked acarbose standards with a mean recovery of 106.9%. The limit of detection and limit of quantification values were 0.004% and 0.012 % w/w, respectively. The validated method was used for the quantification of acarbose in tablets with good results.

Research paper thumbnail of Generic competition and drug prices in the Malaysian off-patent pharmaceutical market

Promoting generic competition following patent expiration of innovator product is a key policy st... more Promoting generic competition following patent expiration of innovator product is a key policy strategy in containing rising drug expenditure in both developed and developing countries. However, the effect of this measure on drug prices has not been specifically explored in Malaysia. This paper analyses the potential effect of generic competition on drug prices in the off-patent pharmaceutical market in Malaysia using retail price data of 28 off-patent multisource prescription medicines collected in a national medicines price survey in Malaysia. The relationship between number of registered brands of multisource medicines and their proportional prices was examined. The results show that the mean proportional price decreases as the number of brands increases, Pearson’s r (6) =0.89, p=0.017 and the differences between the mean proportional prices among the various brands was significant, one-way ANOVA, F (5, 22) =3.68, p=0.014). However, further analysis using Tukey’s post-hoc test an...

Research paper thumbnail of Determination of acarbose in tablets by attenuated total reflectance Fourier transform infrared spectroscopy

Attenuated total reflectance Fourier transform infrared (ATR- FTIR) spectroscopy method was devel... more Attenuated total reflectance Fourier transform infrared (ATR- FTIR) spectroscopy method was developed for the quantitative determination of acarbose in tablets. Two calibration curves were generated. The first calibration curve was based on peak height at 2928.54 cm-1 with correlation coefficient of 0.9987. The second calibration curve was based on peak area which range from 2953.39-2851.04 cm-1 with correlation coefficient of 0.9978. The FTIR method was validated according to International Conference on Harmonization (ICH) guidelines. The method was precise over a range of 40%-100% w/w with % RSD values less than 2 for intra-day and interday precision. The accuracy of the method was expressed as the percentage recovery of the spiked acarbose standards with a mean recovery of 106.9%. The limit of detection and limit of quantification values were 0.004% and 0.012 % w/w, respectively. The validated method was used for the quantification of acarbose in tablets with good results.

Research paper thumbnail of Evaluation of Self-Medication Practice Among University Students

Current Trends in Biotechnology and Pharmacy, 2020

Research paper thumbnail of Unused and expired medications disposal practices in the community: a cross-sectional survey in Cheras, Malaysia

Research paper thumbnail of Assessment of Policies, Determinants, and Characteristics of Generic Medicines Entry Into the Pharmaceutical Markets

This chapter discusses the dimensions and determinants of postpatent entry of generic medicines i... more This chapter discusses the dimensions and determinants of postpatent entry of generic medicines into the pharmaceutical markets in developing countries. A variety of policies and regulatory measures relating to generic medicines entry are in place in developing countries. However, these policies are less robust, seem less coherent, and there are potential gaps between policy intent and implementation. The postpatent entry of generic medicines in developing countries is majorly determined by the prevailing regulatory policies and intellectual property rights, prepatent market size of the innovator products, generic firm's characteristics, and the existence and the degree of the entry-deterrence strategies by innovators, majority of which are derived from the patent system. Although the pattern of postpatent entry of generic medicines into the pharmaceutical markets in developing countries is similar to that in developed markets, the extent of generic entry and competition in deve...

Research paper thumbnail of Characterizing Pharmaceuticals on Data Exclusivity in Malaysia

This study analyses the occurrence and characteristics of pharmaceutical products containing new ... more This study analyses the occurrence and characteristics of pharmaceutical products containing new chemical entities granted data exclusivity in Malaysia since the implementation of the provision in 2011. Data for the drug products granted data exclusivity in Malaysia during March 2011 and April 2014 was obtained from the Malaysian National Pharmaceutical Control Bureau Register for granted data exclusivity. For each product, data on the type of product, the therapeutic class and the patent status in the reference country/jurisdiction and Malaysia was collected. The patent status of the drug products were sourced from international and Malaysian Patent Databases. A total of ten drug products containing new chemical entities (NCEs) were granted data exclusivity during the data period, with an average of 3.3 NCEs per year. The products were distributed among five therapeutic classes, with 50% of the products belonging to antineoplastic agents. Average effective data exclusivity period f...

Research paper thumbnail of Update on Remdesivir in the Treatment of Novel Coronavirus Pneumonia

Progress In Microbes & Molecular Biology

Worldwide epidemic prevention and control remain under significant stress due to the global novel... more Worldwide epidemic prevention and control remain under significant stress due to the global novel coronavirus disease 2019 (COVID-19) pandemic and the ongoing emergence of variants like Omicron. The total confirmed COVID-19 cases globally as of now topped 620 million, while the total number of fatalities exceeded 6.6 million. The screening, drug discovery, and clinical development of novel treatments are still the hottest subjects in the treatment of COVID-19, and scientists throughout the world are dedicated to identifying prospective therapeutic agents to treat COVID-19 patients, including the new uses of old medications. Remdesivir, a COVID-19 therapeutic medication developed by Gilead Sciences, exerts antiviral effects by suppressing the RNA-dependent RNA polymerase of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Remdesivir has maintained high inhibitory activity against all existing SARS-CoV-2 variants, including the Omicron variant. We systematically retrieved...

Research paper thumbnail of Assessment of Policies, Determinants, and Characteristics of Generic Medicines Entry Into the Pharmaceutical Markets

Abstract This chapter discusses the dimensions and determinants of postpatent entry of generic me... more Abstract This chapter discusses the dimensions and determinants of postpatent entry of generic medicines into the pharmaceutical markets in developing countries. A variety of policies and regulatory measures relating to generic medicines entry are in place in developing countries. However, these policies are less robust, seem less coherent, and there are potential gaps between policy intent and implementation. The postpatent entry of generic medicines in developing countries is majorly determined by the prevailing regulatory policies and intellectual property rights, prepatent market size of the innovator products, generic firm's characteristics, and the existence and the degree of the entry-deterrence strategies by innovators, majority of which are derived from the patent system. Although the pattern of postpatent entry of generic medicines into the pharmaceutical markets in developing countries is similar to that in developed markets, the extent of generic entry and competition in developing countries appear limited.

Research paper thumbnail of Unused and expired medications disposal practices in the community: a cross-sectional survey in Cheras, Malaysia

Archives of Pharmacy Practice, Sep 1, 2011

The appropriate disposal practice of unused and expired medications has become a global challenge... more The appropriate disposal practice of unused and expired medications has become a global challenge that has caught the attention of health policymakers, pharmaceutical organizations, healthcare professionals, and the wider community. The current study aimed to evaluate the awareness, attitudes, and behaviors relating to the disposal practice of unused and expired medications and medication wastage issues among the general public in Selangor, Malaysia. The quantitative, cross-sectional study was conducted using a pre-validated structured survey form. Among the approached individuals, 426 showed their willingness to participate in the study. More than 80% of the study population reported being aware of the medication wastage issue and its impact on patients and the economy. The respondents with a higher level of education (OR = 1.85; 95% CI = 1.18-2.52; p < 0.003) were more likely to be cognizant of the detrimental consequences of inappropriate waste disposal. The female respondents were more likely to report comprehending that the availability of free healthcare resources is contributing to medication waste (OR = 1.33, 95% CI = 1.015-2.34; p < 0.005). The majority of respondents reported throwing away unused medications (202; 47.4%) and expired medications (362; 84.9%) in the garbage. The respondents believed that the provision of appropriate directions by healthcare professionals (312; 73.2%) and prescribing/dispensing medications in quantities for the duration that ensures patient adherence (114; 26.7%) could minimize medication wastage. The Ministry of Health (258; 60.5%), pharmaceutical organizations (212; 49.7%), and pharmacists (193; 45.3%) were the respondents' perceived responsible sources of information. The current findings reported that respondents were familiar that inappropriate practices of medication wastage might have harmful consequences. However, a gap exists between their awareness and practice, and the disposal approaches practiced by the respondents were generally not appropriate.

Research paper thumbnail of Assessment of generic medicines development and entry decisions by the malaysian generic pharmaceutical industries

DOAJ (DOAJ: Directory of Open Access Journals), 2012

Research paper thumbnail of PPM12 Correlates and Predictors of Acceptance of Pharmacogenetic Testing in a Malaysian General Population

Value in Health, Nov 1, 2019

Research paper thumbnail of Use of Complementary and Alternative Medicine and Adherence to Medication Therapy Among Stroke Patients: A Meta-analysis and Systematic Review

Frontiers in Pharmacology, Jun 3, 2022

Purpose: To identify the use patterns of complementary and alternative medicine (CAM) and its imp... more Purpose: To identify the use patterns of complementary and alternative medicine (CAM) and its impact on medication adherence among patients with stroke. Method: A systematic search through Science Direct, Google Scholar, and PubMed was performed to identify potential studies up to June 2021.The primary outcome was CAM use, and the secondary outcome was medication adherence among patients with stroke. Articles included in the review met the following criteria: 1) patients with stroke ≥18 years old on prescribed medications, and 2) medication adherence reported status. Metaanalyses were conducted to estimate the pooled prevalence of complementary and alternative medicine and adherence in stroke patients using a random-effects model. Results: A total of 1,330 studies were screened, of which 22 were included in the final analysis. The type of studies included were cross-sectional surveys, cohort studies, retrospective studies and prospective survey. The pooled prevalence of CAM usage was at 38% (29-48% CI) and medication non-adherence among stroke patients was at 29% (20-48% CI). The most common reason for inadequate stroke therapy and higher dependence on CAM was the patients' lack of knowledge and the regimen complexity of the medication. Other factors for medication non-adherence were forgetfulness, side effects, cost, and lack of doctor-patient communication. Conclusion: A low prevalence of CAM usage and non-adherence to medications was observed among patients with stroke. Studies investigating the association between CAM usage and medication adherence among patients with stroke are scarce and future researches are needed to explore the influence of CAM use on stroke medication adherence.

Research paper thumbnail of Risk Minimization Measures in Off-Label Drug Use: A Survey of Community Pharmacists in Malaysia

Current Drug Safety, Nov 17, 2020

Background:While off-label drug use is common and sometimes necessary, it also presents considera... more Background:While off-label drug use is common and sometimes necessary, it also presents considerable risks. Therefore, measures intended to prevent or reduce the potential exposure to off-label risks have been recommended. However, little is known about community pharmacists’ beliefs regarding these measures in Malaysia.Objectives:This study examined community pharmacists’ beliefs towards risk minimization measures in off-label drug use in Malaysia and assessed the relationship between perceived risk of off-label drug use and beliefs towards risk minimization measures.Methods:A cross-sectional survey was conducted among 154 pharmacists practicing in randomly selected community pharmacies in Kuala Lumpur and the State of Selangor, Malaysia.Results:The majority agreed or strongly agreed that adverse drug events from the off-label drug should be reported to the regulatory authority (90.9%) and the off-label drug should only be used when the benefit outweighs potential risks (88.3%). Less than half (48.1%) agreed or strongly agreed that written informed consent should be obtained before dispensing off-label drugs and a majority (63.7%) agreed or strongly agreed that the informed consent process will be burdensome to healthcare professionals. Beliefs towards risk minimization measures were significantly associated with perceived risk of off-label drug use regarding efficacy (p = 0. 033), safety (p = 0.001), adverse drug rection (p = 0.001) and medication errors (p = 0.002).Conclusion:The community pharmacists have positive beliefs towards most of the risk minimization measures. However, beliefs towards written informed consent requirements are not encouraging. Enhancing risk perception may help influence positive beliefs towards risk minimization measures.

Research paper thumbnail of Factors associated with the intention of community pharmacists to report adverse drug reactions to regulatory authority in Malaysia: application of the theory of planned behaviour

International Journal of Pharmacy Practice, Jul 9, 2021

Objectives It is known that community pharmacists in Malaysia underreport adverse drug reactions ... more Objectives It is known that community pharmacists in Malaysia underreport adverse drug reactions (ADRs). In order to improve ADR reporting, a theory-based understanding of the factors associated with the community pharmacists’ reporting behaviour is important. This study used the theory of planned behaviour (TPB) to identify the predictors of behavioural intention to report ADRs to the regulatory authority among community pharmacists in Malaysia and to assess the relative importance of the predictors. Methods A questionnaire-based study was conducted among 188 randomly selected community pharmacists in the state of Johor, Malaysia. The questionnaire included four main TPB constructs (intention, attitude, subjective norms and perceived behavioural control) and related measures, including perceived moral obligation, past reporting behaviour and sociodemographic variables. Descriptive and hierarchical regression analyses were conducted. Key findings A total of 164 questionnaires were collected. The mean score of intention to report ADRs was 15.43 (SD = 2.99). The final model of the hierarchical regression analysis showed that attitude towards ADR reporting (P = 0.004), subjective norm (P = 0.010) and perceived moral obligation (P = 0.014) were significant predictors of intention to report ADRs. Attitude was the most significant predictor, followed by subjective norm and perceived moral obligation. Conclusions Interventions targeting community pharmacists’ attitude, subjective norms and perceived moral obligations towards ADR reporting, with a specific focus on attitude would likely have a positive impact on improving ADR reporting in Malaysia.

Research paper thumbnail of Generic competition and drug prices in the Malaysian off-patent pharmaceutical market

Promoting generic competition following patent expiration of innovator product is a key policy st... more Promoting generic competition following patent expiration of innovator product is a key policy strategy in containing rising drug expenditure in both developed and developing countries. However, the effect of this measure on drug prices has not been specifically explored in Malaysia. This paper analyses the potential effect of generic competition on drug prices in the off-patent pharmaceutical market in Malaysia using retail price data of 28 off-patent multisource prescription medicines collected in a national medicines price survey in Malaysia. The relationship between number of registered brands of multisource medicines and their proportional prices was examined. The results show that the mean proportional price decreases as the number of brands increases, Pearson's r (6) =0.89, p=0.017 and the differences between the mean proportional prices among the various brands was significant, one-way ANOVA, F (5, 22) =3.68, p=0.014). However, further analysis using Tukey's post-hoc test analysis shows that the price differentials were not significant across all the brands of a given off-patent multisource product. The findings of this study revealed evidence of price lowering effect of generic competition among multisource drug products in Malaysia, though the effect was not observable across all drug brands.

Research paper thumbnail of Use of Complementary and Alternative Medicine and Adherence to Medication Therapy Among Stroke Patients: A Meta-analysis and Systematic Review

Frontiers in Pharmacology

Purpose: To identify the use patterns of complementary and alternative medicine (CAM) and its imp... more Purpose: To identify the use patterns of complementary and alternative medicine (CAM) and its impact on medication adherence among patients with stroke.Method: A systematic search through Science Direct, Google Scholar, and PubMed was performed to identify potential studies up to June 2021.The primary outcome was CAM use, and the secondary outcome was medication adherence among patients with stroke. Articles included in the review met the following criteria: 1) patients with stroke ≥18 years old on prescribed medications, and 2) medication adherence reported status. Meta-analyses were conducted to estimate the pooled prevalence of complementary and alternative medicine and adherence in stroke patients using a random-effects model.Results: A total of 1,330 studies were screened, of which 22 were included in the final analysis. The type of studies included were cross-sectional surveys, cohort studies, retrospective studies and prospective survey. The pooled prevalence of CAM usage was...

Research paper thumbnail of Assessment of generic medicines development and entry decisions by the malaysian generic pharmaceutical industries

Archives of Pharmacy Practice, 2012

Routledge is an imprint of the Taylor & Francis Group, an informa business A ll rights reserved. ... more Routledge is an imprint of the Taylor & Francis Group, an informa business A ll rights reserved. No part of this book may be reprinted or reproduced or utilized in any form or by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying and recording, or in any information storage or retrieval system, without permission in writing from the publishers. The publishers have made every effort to contact authors/copyright holders of the works reprinted in The Broadway Travellers. This has not been possible in every case, however, and we would welcome correspondence from those individuals/companies we have been unable to trace. These reprints are taken from original copies of each book. In many cases the condition of these originals is not perfect. The publisher has gone to great lengths to ensure the quality o f these reprints, but wishes to point out that certain characteristics o f the original copies will, o f necessity, be apparent in reprints thereof.

Research paper thumbnail of Barriers and facilitators to provision of written consumer medicines information among community pharmacists in Malaysia: a cross‐sectional study

Journal of Pharmaceutical Health Services Research, 2020

This study examined the barriers and facilitators to the provision of consumer medication informa... more This study examined the barriers and facilitators to the provision of consumer medication information leaflets (CMIL) by community pharmacists in Malaysia and assessed the relationship between the participants' characteristics and provision of CMIL.

Research paper thumbnail of Factors determining the post-patent entry of generic medicines in Malaysia: A survey of the Malaysian generic pharmaceutical industry

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector, 2013

Malaysia is reliant on the availability of generic medicines to contain the rising national pharm... more Malaysia is reliant on the availability of generic medicines to contain the rising national pharmaceutical expenditure. This paper assesses the factors determining the market entry of a new generic medicine following patent expiration on the innovator product in Malaysia. Data were gathered by using mail survey approach. The pre-validated Likert-scale questionnaire was mailed to all licensed members of the Malaysian Organization of Pharmaceutical Industries. A usable response rate of 53.8% (14/26) was achieved following four successive mailings. The overall internal reliability coefficients for the 5-item entry decision variables scale and 11-item entry barrier variables scale were 0.62 and 0.82 respectively. The results revealed that the major factors driving decisions to develop and introduce a new generic medicine into the Malaysian pharmaceutical market are consistent with the business model of the generic pharmaceutical industry. The pre-patent expiration market value of the in...

Research paper thumbnail of Quantification of acarbose in tablets

Attenuated total reflectance Fourier transform infrared (ATR-FTIR) spectroscopy method was develo... more Attenuated total reflectance Fourier transform infrared (ATR-FTIR) spectroscopy method was developed for the quantitative determination of acarbose in tablets. Two calibration curves were generated. The first calibration curve was based on peak height at 2928.54 cm-1 with correlation coefficient of 0.9987. The second calibration curve was based on peak area which range from 2953.39-2851.04 cm-1 with correlation coefficient of 0.9978. The FTIR method was validated according to International Conference on Harmonization (ICH) guidelines. The method was precise over a range of 40%-100% w/w with % RSD values less than 2 for intra-day and interday precision. The accuracy of the method was expressed as the percentage recovery of the spiked acarbose standards with a mean recovery of 106.9%. The limit of detection and limit of quantification values were 0.004% and 0.012 % w/w, respectively. The validated method was used for the quantification of acarbose in tablets with good results.

Research paper thumbnail of Generic competition and drug prices in the Malaysian off-patent pharmaceutical market

Promoting generic competition following patent expiration of innovator product is a key policy st... more Promoting generic competition following patent expiration of innovator product is a key policy strategy in containing rising drug expenditure in both developed and developing countries. However, the effect of this measure on drug prices has not been specifically explored in Malaysia. This paper analyses the potential effect of generic competition on drug prices in the off-patent pharmaceutical market in Malaysia using retail price data of 28 off-patent multisource prescription medicines collected in a national medicines price survey in Malaysia. The relationship between number of registered brands of multisource medicines and their proportional prices was examined. The results show that the mean proportional price decreases as the number of brands increases, Pearson’s r (6) =0.89, p=0.017 and the differences between the mean proportional prices among the various brands was significant, one-way ANOVA, F (5, 22) =3.68, p=0.014). However, further analysis using Tukey’s post-hoc test an...

Research paper thumbnail of Determination of acarbose in tablets by attenuated total reflectance Fourier transform infrared spectroscopy

Attenuated total reflectance Fourier transform infrared (ATR- FTIR) spectroscopy method was devel... more Attenuated total reflectance Fourier transform infrared (ATR- FTIR) spectroscopy method was developed for the quantitative determination of acarbose in tablets. Two calibration curves were generated. The first calibration curve was based on peak height at 2928.54 cm-1 with correlation coefficient of 0.9987. The second calibration curve was based on peak area which range from 2953.39-2851.04 cm-1 with correlation coefficient of 0.9978. The FTIR method was validated according to International Conference on Harmonization (ICH) guidelines. The method was precise over a range of 40%-100% w/w with % RSD values less than 2 for intra-day and interday precision. The accuracy of the method was expressed as the percentage recovery of the spiked acarbose standards with a mean recovery of 106.9%. The limit of detection and limit of quantification values were 0.004% and 0.012 % w/w, respectively. The validated method was used for the quantification of acarbose in tablets with good results.

Research paper thumbnail of Evaluation of Self-Medication Practice Among University Students

Current Trends in Biotechnology and Pharmacy, 2020

Research paper thumbnail of Unused and expired medications disposal practices in the community: a cross-sectional survey in Cheras, Malaysia

Research paper thumbnail of Assessment of Policies, Determinants, and Characteristics of Generic Medicines Entry Into the Pharmaceutical Markets

This chapter discusses the dimensions and determinants of postpatent entry of generic medicines i... more This chapter discusses the dimensions and determinants of postpatent entry of generic medicines into the pharmaceutical markets in developing countries. A variety of policies and regulatory measures relating to generic medicines entry are in place in developing countries. However, these policies are less robust, seem less coherent, and there are potential gaps between policy intent and implementation. The postpatent entry of generic medicines in developing countries is majorly determined by the prevailing regulatory policies and intellectual property rights, prepatent market size of the innovator products, generic firm's characteristics, and the existence and the degree of the entry-deterrence strategies by innovators, majority of which are derived from the patent system. Although the pattern of postpatent entry of generic medicines into the pharmaceutical markets in developing countries is similar to that in developed markets, the extent of generic entry and competition in deve...

Research paper thumbnail of Characterizing Pharmaceuticals on Data Exclusivity in Malaysia

This study analyses the occurrence and characteristics of pharmaceutical products containing new ... more This study analyses the occurrence and characteristics of pharmaceutical products containing new chemical entities granted data exclusivity in Malaysia since the implementation of the provision in 2011. Data for the drug products granted data exclusivity in Malaysia during March 2011 and April 2014 was obtained from the Malaysian National Pharmaceutical Control Bureau Register for granted data exclusivity. For each product, data on the type of product, the therapeutic class and the patent status in the reference country/jurisdiction and Malaysia was collected. The patent status of the drug products were sourced from international and Malaysian Patent Databases. A total of ten drug products containing new chemical entities (NCEs) were granted data exclusivity during the data period, with an average of 3.3 NCEs per year. The products were distributed among five therapeutic classes, with 50% of the products belonging to antineoplastic agents. Average effective data exclusivity period f...