Cost minimization analysis of subcutaneous trastuzumab versus intravenous biosimilar trastuzumab: policy recommendations for breast cancer treatment in Malaysia.

PURPOSE: Current clinical practice recommends switching innovator intravenous trastuzumab (IV-TZMi) to subcutaneous trastuzumab (SC-TZM) to save healthcare resources. However, with the availability of biosimilar intravenous trastuzumab (IV-TZMb), there is a need to re-evaluate the recommendation. Hence, this study aims to compare the cost and resource use of SC-TZM and IV-TZMb in a Malaysian public healthcare facility. METHODS: This activity-based costing study consists of (1) a retrospective medical record abstraction to determine patient details to estimate drug costs and (2) a time-motion study to quantify personnel time, patient time, and consumables used. The total cost of both SC-TZM and IV-TZMb were then compared using a cost-minimization approach, while differences were explored using an independent t-test. A sensitivity analysis was also conducted to determine the impact of uncertainties in the analysis. RESULTS: The mean total cost of SC-TZM and IV-TZMb was USD 13,693 and USD 5,624 per patient respectively. The cost difference was primarily contributed by savings in drug cost of IV-TZMb, a reduction of USD 8,546 (SD = 134), p < 0.001 compared to SC-TZM. Interestingly, SC-TZM had a significantly lower cost than IV-TZMb for both the consumable and personnel cost, a reduction by USD 300 (SD = 17.6); p < 0.001 and USD 176 (SD = 7.3); p < 0.001 respectively. The sensitivity analysis demonstrated that the total cost difference between the formulation was mainly driven by drug costs. CONCLUSION: The study evidenced that IV-TZMb was a more economically viable option in Malaysian public healthcare currently compared to SC-TZM.

Goods and Services Tax on Pharmaceuticals in Malaysia.

In Malaysia, the goods and services tax (GST) was implemented in 2015. Within this context, medicines are subjected to GST. However, essential medicines are exempted. In fact, exempting essential medicines from tax is in line with the Malaysian National Medicines Policy which aims to promote equitable access to affordable essential medicines of good quality to improve health outcomes of the people. The implementation of GST on medicines can generate a stable source of revenue for the nation. However, there are some ways/actions that could be considered to ensure the affordability and accessibility of all medicines post-implementation of GST in Malaysia.

Knowledge and perceptions of physicians from private medical centres towards generic medicines: a nationwide survey from Malaysia.

OBJECTIVES: Generic medicine prescribing has become a common practice in public hospitals. However, the trend in private medical centres seems to be different. The objective of this study was to investigate knowledge, perceptions and behavior of physicians from private medical centres in Malaysia regarding generic medicines. METHODS: This study was a cross-sectional nationwide survey targeting physicians from private medical centres in Malaysia. The survey was conducted using questionnaire having (i) background and demographic data of the physicians, volume of prescription in a day, stock of generic medicines in their hospital pharmacy etc. (ii) their knowledge about bioequivalence (iii) prescribing behavior (iv) physicians' knowledge of quality, safety and efficacy of generic medicines, and their cost (v) perceptions of physicians towards issues pertaining to generic medicines utilization. RESULTS: A total of 263 questionnaires out of 735 were received, giving a response rate of 35.8%. Of the respondents, 214 (81.4%) were male and 49 (18.6%) were females. The majority of the participants were in the age range of 41-50 years and comprised 49.0% of the respondents. Only 2.3% of physicians were aware of the regulatory limits of bioequivalence standards in Malaysia. Of the respondents, 23.2% agreed that they 'always' write their prescriptions using originator product name whereas 50.2% do it 'usually'. A number of significant associations were found between their knowledge, perceptions about generic medicines and their demographic characteristics. CONCLUSIONS: The majority of the physicians from private medical centres in Malaysia had negative perceptions about safety, quality and the efficacy of generic medicines. These negative perceptions could be the cause of the limited use of generic medicines in the private medical centres. Therefore, in order to facilitate their use, it is recommended that the physicians need to be reassured and educated about the drug regulatory authority approval system of generic medicines with regard to their bioequivalence, quality, efficacy and safety. Apart from the policy on generic substitution, it would also be recommended to have a national medicine pricing policy, which controls drug prices, in both the public and private sector. These efforts are worthwhile to reduce the drug expenditure and improve the medicine affordability in Malaysia.

General practitioners' knowledge, attitude and prescribing of antibiotics for upper respiratory tract infections in Selangor, Malaysia: findings and implications.

BACKGROUND: Antibiotics are widely prescribed especially for upper respiratory tract infections (URTIs). Their irrational use can increase costs and resistance. AIM: Assess knowledge, attitude and prescribing of antibiotics for URTIs in Selangor, Malaysia, using a cross-sectional survey among general practitioners (GPs) working in private clinics in 2011. RESULTS: One hundred and thirty-nine physicians completed the questionnaire (response rate = 34.8%). 49.6% (n = 69) agreed antibiotics are helpful in treating URTIs, with most GPs agreeing antibiotics may reduce URTI duration and complications. The majority of GPs reported they felt patients expected antibiotics, with 36.7% (n = 51) agreeing patients would change doctors if they did not prescribe antibiotics and 21.6% (n = 30) agreeing when requested they prescribe antibiotics even if they believe them to be unnecessary. When assessed against six criteria, most GPs had a moderate level of knowledge of prescribing for URTIs. However, antibiotic prescriptions could be appreciably reduced. CONCLUSION: Further programs are needed to educate GPs and patients about antibiotics building on current initiatives.

Patients' beliefs about generic medicines in Malaysia / Creencias de los pacientes sobre los medicamentos genéricos en Malasia

Background: Acceptance of generic medicines by patients is an essential factor given that they are the end users of these medicines. In fact, adequate knowledge and positive perceptions are prerequisite to patients’ acceptance and use of generic medicines. Objective: To assess the current belief and views of patients about generic medicines in Malaysia. Method: This was a self-administered questionnairebased study. The study was conducted with patients visiting outpatient pharmacy department at a tertiary care hospital in Malaysia. The Malaysian version of Generic Medicines Scale (GMS) was used. The GMS consists of two subscales: efficacy and similarity of generic medicines to original brand medicines. The efficacy subscale consists of 10 items while the similarity subscale consists of 6 items. The responses to the items were framed as a fivepoint Likert scale (1=strongly disagree to 5=strongly agree). Results: A total of 202 out of 300 patients participated in the study, giving a response rate of 67.3%. In this study, only 49% of them (n=99) knew the term ‘generic medicine’. Moreover, only 53.5% of the respondents (n=108) believed that the efficacy of generic medicines was the same as original brand medicines. In terms of quality, only 44% of the respondents (n=89) disagreed that generic medicines were of a lower quality. About one third (n=65, 32.2%) believed that generic medicines were cheaper because they were less efficacious. In terms of side effects, 44.5% of the respondents (n=90) believed that generic medicines had the same side effect profile as original brand medicines. Conclusions: The study finding showed that almost half of the respondents had negative belief in generic medicines. Similarly, many patients were not aware of the similarities and differences between generic and original brand medicines. Therefore, there is a need to provide patients with adequate information about generic medicines (AU)

Antecedentes: La aceptación de los genéricos por los pacientes es un factor esencial dado que son los utilizadores finales de estos medicamentos. De hecho, el conocimiento adecuado y las percepciones positivas son requisitos para la aceptación y el uso de genéricos por los pacientes. Objetivo: Evaluar las creencias y la visión actuales de los pacientes sobre medicamentos genéricos en Malasia. Método: Este fue un estudio basado en un cuestionario auto-administrado. El estudio se realizó con pacientes que visitaron un departamento de farmacia ambulatoria de un hospital terciario en Malasia. Se usó la versión malaya del Generic Medicines Scale (GMS). El GMS consiste en dos escalas: eficacia y semejanza del genérico con el original de marca. La sub-escala de eficacia consiste en 10 ítems, mientras que la de semejanza consiste en 6 ítems. Las respuestas de los ítems se estipularon en una escala de Likert de 5 puntos: (1=desacuerdo fuerte a 5=acuerdo fuerte). Resultados: Un total de 202 de los 300 pacientes participaron en el estudio, lo que da una tasa de respuesta del 67,3%. En este estudio, solo el 49% de ellos (n=99) conocían el término ‘medicamento genérico’. Sólo el 53,5% de los respondentes (n=108) creían que la eficacia de los genéricos era la misma que la de los originales de marca. En términos de calidad, solo el 44% de los respondentes (n=89) estaba en desacuerdo que los genéricos eran de menor calidad. Cerca de un tercio (n=65, 32,2%) creía que los genéricos eran más baratos porque eran menos eficaces. En términos de efectos adversos, el 44,5% de los respondentes (n=90) creía que los genéricos tenían el mismo perfil de efectos adversos que los medicamentos de marca. Conclusiones: Los hallazgos del estudio demostraron que casi la mitad de los respondentes tenían creencias negativas sobre los genéricos. Del mismo modo, muchos pacientes no conocían las semejanzas y similitudes de los genéricos y los de marca. Por tanto, se necesita proporcionar a los pacientes información adecuada sobre medicamentos genéricos (AU)

Perspectives of physicians practicing in low and middle income countries towards generic medicines: a narrative review.

OBJECTIVES: This review was conducted to document published literature related to physicians' knowledge, attitudes, and perceptions of generic medicines in low- and middle-income countries (LMICs) and to compare the findings with high-income countries. METHODS: A systematic search of articles published in peer-reviewed journals from January 2001 to February 2013 was performed. The search comprised nine electronic databases. The search strategy involved using Boolean operators for combinations of the following terms: generic medicines, generic medications, generic drugs, generic, generic substitution, generic prescribing, international non-proprietary, prescribers, doctors, general practitioners, physicians, and specialists. RESULTS: Sixteen articles were included in this review. The majority (n=11) were from high income countries and five from LMICs. The main difference between high income countries and LMICs is that physicians from high income countries generally have positive views whereas those from LMICs tend to have mixed views regarding generic medicines. Few similarities were identified among different country income groups namely low level of physicians' knowledge of the basis of bioequivalence testing, cost of generic medicines as an encouraging factor for generic medicine prescribing, physicians' concerns towards safety and quality of generic medicines and effect of pharmaceutical sales representative on generic medicine prescribing. CONCLUSION: The present literature review revealed that physicians from LMICs tend to have mixed views regarding generic medicines. This may be due to differences in the health care system and pharmaceutical funding system, medicine policies, the level of educational interventions, and drug information sources in countries of different income levels.

Does educational intervention improve doctors' knowledge and perceptions of generic medicines and their generic prescribing rate? A study from Malaysia.

OBJECTIVES: To investigate the impact of an educational intervention on doctors' knowledge and perceptions towards generic medicines and their generic (international non-proprietary name) prescribing practice. METHODS: This is a single-cohort pre-/post-intervention pilot study. The study was conducted in a tertiary care hospital in Perak, Malaysia. All doctors from the internal medicine department were invited to participate in the educational intervention. The intervention consisted of an interactive lecture, an educational booklet and a drug list. Doctors' knowledge and perceptions were assessed by using a validated questionnaire, while the international non-proprietary name prescribing practice was assessed by screening the prescription before and after the intervention. RESULTS: The intervention was effective in improving doctors' knowledge towards bioequivalence, similarity of generic medicines and safety standards required for generic medicine registration (p = 0.034, p = 0.034 and p = 0.022, respectively). In terms of perceptions towards generic medicines, no significant changes were noted (p > 0.05). Similarly, no impact on international non-proprietary name prescribing practice was observed after the intervention (p > 0.05). CONCLUSION: Doctors had inadequate knowledge and misconceptions about generic medicines before the intervention. Moreover, international non-proprietary name prescribing was not a common practice. However, the educational intervention was only effective in improving doctors' knowledge of generic medicines.