Displaying publications 1 - 20 of 45 in total

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  1. Magdalene Andrew-Munot, Abdullah Yassin, Syed Tarmizi Syed Shazali, Marini Sawawi
    MyJurnal
    Remanufacturing of used-products is becoming an important activity in many production companies. This paper reviews key remanufacturing process, highlights eight unique characteristics of remanufacturing process environment and proposes a generic conceptual remanufacturing process model that considers the presence and interactions of these eight features. The generic conceptual model could be modified to suit remanufacturing process of any given used products to be remanufactured. Future research can modify the generic remanufacturing model to suit used automotive parts remanufacturing with unique characteristics and apply simulation technique to model and analyse the corresponding remanufacturing process.
    Matched MeSH terms: Drugs, Generic
  2. Rajendran MAP, Allada R, Sajid SS
    Recent Adv Drug Deliv Formul, 2021;15(1):15-36.
    PMID: 34602030 DOI: 10.2174/2667387815666210203151209
    Co-crystal is an attractive alternative and a new class of solid forms because that can be engineered to have desired physicochemical properties. Co-crystals have gained considerable attention from the generic pharmaceutical industry after the USFDA released its finalized guidlines in the year 2018 on the regulatory classification of co-crystals. In this review, we discussed how co-crystals could be explored as a potential alternative solid form for the development of a generic product that meets the legal, regulatory, and bioequivalence requirements. In the contents, we discussed in detail concepts such as the selection of coformers, various ways of making co-crystals, the strategy of characterization to discriminate between co-crystal and salt, polymorphism in co-crystals, the aspects of intellectual property and, finally, the regulatory aspects of co-crystals.
    Matched MeSH terms: Drugs, Generic*
  3. Hassali MA, Wong ZY, Alrasheedy AA, Saleem F, Mohamad Yahaya AH, Aljadhey H
    SAGE Open Med, 2014;2:2050312114555722.
    PMID: 26770747 DOI: 10.1177/2050312114555722
    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.
    Matched MeSH terms: Drugs, Generic
  4. Albadr Y, Khan TM
    Saudi Pharm J, 2015 Apr;23(2):143-6.
    PMID: 25972733 DOI: 10.1016/j.jsps.2014.07.002
    Rising costs of medicines have increased the interest of policy makers in generic medicines. However, consumers' and health care providers' perception and attitude towards generic medicine act as a main barrier to the promotion of generic medicines.
    Matched MeSH terms: Drugs, Generic
  5. Godman B, Fadare J, Kwon HY, Dias CZ, Kurdi A, Dias Godói IP, et al.
    J Comp Eff Res, 2021 Aug;10(12):1019-1052.
    PMID: 34241546 DOI: 10.2217/cer-2020-0273
    Aim: Global expenditure on medicines is rising up to 6% per year driven by increasing prevalence of non-communicable diseases (NCDs) and new premium priced medicines for cancer, orphan diseases and other complex areas. This is difficult to sustain without reforms. Methods: Extensive narrative review of published papers and contextualizing the findings to provide future guidance. Results: New models are being introduced to improve the managed entry of new medicines including managed entry agreements, fair pricing approaches and monitoring prescribing against agreed guidance. Multiple measures have also successfully been introduced to improve the prescribing of established medicines. This includes encouraging greater prescribing of generics and biosimilars versus originators and patented medicines in a class to conserve resources without compromising care. In addition, reducing inappropriate antibiotic utilization. Typically, multiple measures are the most effective. Conclusion: Multiple measures will be needed to attain and retain universal healthcare.
    Matched MeSH terms: Drugs, Generic
  6. Alrasheedy AA, Hassali MA, Aljadhey H, Al-Tamimi SK
    Am J Pharm Educ, 2014 Jun 17;78(5):108.
    PMID: 24954948 DOI: 10.5688/ajpe785108
    Matched MeSH terms: Drugs, Generic/therapeutic use
  7. Shankar PR, Herz BL, Dubey AK, Hassali MA
    Indian J Pharmacol, 2016 Oct;48(Suppl 1):S29-S32.
    PMID: 28031604 DOI: 10.4103/0253-7613.193309
    OBJECTIVE: Use of generic medicines is important to reduce rising health-care costs. Proper knowledge and perception of medical students and doctors toward generic medicines are important. Xavier University School of Medicine in Aruba admits students from the United States, Canada, and other countries to the undergraduate medical (MD) program. The present study was conducted to study the knowledge and perception about generic medicines among basic science MD students.

    MATERIALS AND METHODS: The cross-sectional study was conducted among first to fifth semester students during February 2015. A previously developed instrument was used. Basic demographic information was collected. Respondent's agreement with a set of statements was noted using a Likert-type scale. The calculated total score was compared among subgroups of respondents. One sample Kolmogorov-Smirnov test was used to study the normality of distribution, Independent samples t-test to compare the total score for dichotomous variables, and analysis of variance for others were used for statistical analysis.

    RESULTS: Fifty-six of the 85 students (65.8%) participated. Around 55% of respondents were between 20 and 25 years of age and of American nationality. Only three respondents (5.3%) provided the correct value of the regulatory bioequivalence limits. The mean total score was 43.41 (maximum 60). There was no significant difference in scores among subgroups.

    CONCLUSIONS: There was a significant knowledge gap with regard to the regulatory bioequivalence limits for generic medicines. Respondents' level of knowledge about other aspects of generic medicines was good but could be improved. Studies among clinical students in the institution and in other Caribbean medical schools are required. Deficiencies were noted and we have strengthened learning about generic medicines during the basic science years.

    Matched MeSH terms: Drugs, Generic*
  8. Md Hamzah N, See KF
    BMC Health Serv Res, 2021 Oct 19;21(1):1119.
    PMID: 34663311 DOI: 10.1186/s12913-021-06786-6
    BACKGROUND: Policymakers are faced with the challenge of balancing patient's access for effective and affordable medicines to sustain the rising healthcare costs. In a mixed healthcare market such as Malaysia, coverage decisions of new medicines are different: public funded health system has a formulary listing process whereas for private sector, which is a market-based economy, depends on patient's willingness to pay and insurance coverage. There is little overlap between public and private healthcare service delivery with access to new innovative medicines, as differentiated by sources of funding. The objectives of this study were to examine the diffusion of New Chemical Entities (NCEs) into the public and private healthcare market between 2010 and 2014, and determine the factors explaining the diffusion.

    METHODS: We matched medicines from the product registration database by medicine formulation to medicines in IQVIA National Pharmaceutical Audit database for each year. The price per Defined Daily Dose (DDD), market concentration and generic utilization share variables were calculated. A panel fixed effect model was performed to measure diffusion of NCEs for each year and test possible determinants of diffusion of NCEs for overall market and sector specifics.

    RESULTS: The utilization of NCEs was larger in the private sector compared to the public sector but the speed of diffusion over time was higher in the public sector. Price per DDD was negatively associated with diffusion of NCEs, while generic utilization share was significantly regressive in the public sector. Market concentration was negatively associated with utilization of NCEs, however result tends to be mixed according to sector and Anatomical Therapeutic Chemical (ATC) category.

    CONCLUSIONS: Understanding key aspects of sectoral variation in diffusion of NCEs are crucial to reduce the differences of access to new medicines within a country and ensure resources are used on cost effective treatments.

    Matched MeSH terms: Drugs, Generic
  9. Jain D, Darrow JJ
    Health Matrix Clevel, 2013;23(2):425-57.
    PMID: 24341078
    Access to affordable drugs for the treatment of HIV/AIDS and other diseases is increasingly challenging in many developing countries such as Brazil, South Africa, and India. These challenges are in part the result of strengthened patent laws mandated by the 1994 Trade-Related Aspects of Intellectual Property Rights (TRIPS) treaty. However, there are underutilized instruments within TRIPS that governments can use to limit the adverse effects of patent protection and thereby ensure a supply of affordable generic drugs to their people. One such instrument is compulsory licensing, which allows generic manufacturers to produce pharmaceutical products that are currently subject to patent protection. Compulsory licensing has been used by a number of countries in the last few years, including the United States, Canada, Indonesia, Malaysia, Brazil, and Thailand, and is particularly significant for countries such as India, where large numbers of people are infected with HIV. This Article explores the feasibility of compulsory licensing as a tool to facilitate access to essential medicines within the current patent regime in India, drawing on the experiences of other countries.
    Matched MeSH terms: Drugs, Generic/economics; Drugs, Generic/supply & distribution*
  10. Taylor PW, Arnet I, Fischer A, Simpson IN
    Obes Facts, 2010 Aug;3(4):231-7.
    PMID: 20823686 DOI: 10.1159/000319450
    OBJECTIVE: To compare the pharmaceutical quality of Xenical (chemically produced orlistat) with nine generic products, each produced by fermentation processes.

    METHODS: Xenical 120 mg capsules (Roche, Basel, Switzerland) were used as reference material. Generic products were from India, Malaysia, Argentina, Philippines, Uruguay, and Taiwan. Colour, melting temperature, crystalline form, particle size, capsule fill mass, active pharmaceutical ingredient content, amount of impurities, and dissolution were compared. Standard physical and chemical laboratory tests were those developed by Roche for Xenical.

    RESULTS: All nine generic products failed the Xenical specifications in four or more tests, and two generic products failed in seven tests. A failure common to all generic products was the amount of impurities present, mostly due to different by-products, including side-chain homologues not present in Xenical. Some impurities were unidentified. Two generic products tested failed the dissolution test, one product formed a capsule-shaped agglomerate on storage and resulted in poor (=15%) dissolution. Six generic products were powder formulations.

    CONCLUSIONS: All tested generic orlistat products were pharmaceutically inferior to Xenical. The high levels of impurities in generic orlistat products are a major safety and tolerability concern.

    Matched MeSH terms: Drugs, Generic/standards*; Drugs, Generic/chemistry
  11. Hassali MA, Shafie AA, Jamshed S, Ibrahim MI, Awaisu A
    Int J Pharm Pract, 2009 Apr;17(2):79-88.
    PMID: 20214255
    OBJECTIVES: To review the literature on consumers' knowledge, attitudes and opinions of the use of generic medicines.
    METHOD: A narrative review of studies conducted from 1970 to 2008 on consumers perceptions and views towards generic medicines was performed. An extensive literature search was undertaken using indexing services available at the authors' institution library. The following keywords were used for the search: brand, generic, multisource, medications, medicines, drugs, pharmaceuticals and consumers, customers, and patients. Electronic databases searched were Medline, Inside Web, ISI Web of Knowledge, Science Direct, Springer Link, JSTOR, Proquest, Ebsco Host and Google Scholar. These electronic databases were searched for full text papers published in English from 1970 to October 2008.
    KEY FINDINGS: Twenty studies were identified. Eleven were from the USA, four were from Europe, two were from Canada and one each was from Australia, Brazil and Malaysia. In general, consumers showed mixed reactions towards the use of generic medicines. This was evident from the divergence of views observed by country development level, consumers' socioeconomic characteristics, drug product characteristics, pharmaceutical reimbursement system, policy environment, contact with health care professionals, past experience with medications, and knowledge of the seriousness of a medical condition.
    CONCLUSIONS: Patient confidence and knowledge pertaining to generic medicines use have increased over the past four decades, especially in developed countries. Mass educational efforts, financial incentives, and greater communication among patients and health care professionals were seen as major drivers to the uptake of generic medicines among consumers.
    Matched MeSH terms: Drugs, Generic/economics; Drugs, Generic/therapeutic use*
  12. Al-Tamimi SK, Hassali MA, Shafie AA, ALrasheedy AA
    Int J Pharm Pract, 2016 Feb;24(1):72-3.
    PMID: 26764227 DOI: 10.1111/ijpp.12204
    Matched MeSH terms: Drugs, Generic/economics; Drugs, Generic/therapeutic use*
  13. Sharrad AK, Hassali MA
    Res Social Adm Pharm, 2011 Mar;7(1):108-12.
    PMID: 21397885 DOI: 10.1016/j.sapharm.2009.12.003
    BACKGROUND: The use of generic medicines has been increasing steadily internationally, primarily because of cost concerns. Knowledge and use patterns of generic medicines in Iraq have not yet been measured.
    OBJECTIVE: This study aimed to explore consumers' perception and knowledge on issues relating to generic medicine use in Basrah, Iraq.
    METHODS: A qualitative approach was used to gather information from consumers in Basrah, Iraq. A purposive sample of 14 consumers in Basrah was interviewed face-to-face using a semistructured interview guide.
    RESULTS: Thematic analysis of the interviews identified 5 major themes: understanding of the term "generic medicine," preference for generic medicine, refusal of generic medicine, generic substitution, and education on the use of generic medicines. Not all the consumers were familiar with the term "generic medicine;" they were familiar with the term "commercial medicine." Most of the participants understood that generics cost less compared with their branded counterparts. Most of the consumers said that their physicians and pharmacists had given them information on generics.
    CONCLUSION: Knowledge of generic medicines may be lacking among consumers in Iraq. Development of consumer education on generics by health care providers is required to support the implementation of the policy on generic medicines in Iraq.
    Matched MeSH terms: Drugs, Generic/economics; Drugs, Generic/therapeutic use*
  14. Ping CC, Bahari MB, Hassali MA
    Pharmacoepidemiol Drug Saf, 2008 Jan;17(1):82-9.
    PMID: 17879323
    The purpose of this study was to evaluate the generic substitution (GS) practices undertaken by community pharmacists in the State of Penang, Malaysia with a focus on the extent of communication between pharmacists and prescribers on issues related to GS, consumer's acceptance on the GS and estimation of cost saving achieved for patients opted for GS.
    Matched MeSH terms: Drugs, Generic/economics*; Drugs, Generic/supply & distribution*
  15. Al-Gedadi NA, Hassali MA, Shafie AA
    Pharm Pract (Granada), 2008 Apr;6(2):93-7.
    PMID: 25157287
    OBJECTIVE: To explore the consumers' perceptions and knowledge towards issues surrounding generic medicines utilization in Penang, Malaysia.

    METHODS: A cross sectional survey was conducted with consumers who attended the annual University open day. Using convenience sampling, survey forms were distributed to the respective consumers via the help of a group of trained 1st year pharmacy students. For a period of 5 days, 400 respondents had participated in the survey. Analysis of the response from the collected forms yielded in 396 usable forms.

    RESULTS: Only 28.3% (n=112) of the respondents were familiar with the term "generic medicines". More than 70% of the respondents do not know that generic medicines can be marketed under different names. About 34% (n=38) of consumers stated that they had been given information regarding generics by their pharmacists. In terms of side effects, about 32% (n=127) of the respondents felt that generic medicines may cause more side effects than branded medicines. Majority of the consumers surveyed (64%) understand that generic cost less compared to their branded counterparts.

    CONCLUSION: This survey showed that there is a gap in consumers' knowledge and understanding about generic medicines. The findings also suggest that direct patient education by the healthcare providers on issues relating to safety and efficacy of generic medicines could further enhance their uptake.

    Matched MeSH terms: Drugs, Generic
  16. Wong ZY, Alrasheedy AA, Hassali MA, Saleem F
    Res Social Adm Pharm, 2016 04 20;12(5):807-10.
    PMID: 27157864 DOI: 10.1016/j.sapharm.2016.04.002
    Matched MeSH terms: Drugs, Generic/adverse effects; Drugs, Generic/economics; Drugs, Generic/therapeutic use*
  17. Hassali MA, Wong ZY, Alrasheedy AA, Saleem F, Mohamad Yahaya AH, Aljadhey H
    Health Policy, 2014 Sep;117(3):297-310.
    PMID: 25129135 DOI: 10.1016/j.healthpol.2014.07.014
    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.
    Matched MeSH terms: Drugs, Generic
  18. Das AK, Okita T, Enzo A, Asai A
    Asian Bioeth Rev, 2020 Jun;12(2):103-116.
    PMID: 33717332 DOI: 10.1007/s41649-020-00114-6
    The use of single-use items (SUDs) is now ubiquitous in medical practice. Because of the high costs of these items, the practice of reusing them after sterilisation is also widespread especially in resource-poor economies. However, the ethics of reusing disposable items remain unclear. There are several analogous conditions, which could shed light on the ethics of reuse of disposables. These include the use of restored kidney transplantation and the use of generic drugs etc. The ethical issues include the question of patient safety and the possibility of infection. It is also important to understand the role (or otherwise) of informed consent before reuse of disposables. The widespread practice of reuse may bring down high healthcare costs and also reduce the huge amount of hospital waste that is generated. The reuse of disposables can be justified on various grounds including the safety and the cost effectiveness of this practice.
    Matched MeSH terms: Drugs, Generic
  19. Binh NH, Anh PN, Phuong NM
    Pharm Pat Anal, 2016 Jul;5(4):261-70.
    PMID: 27346326 DOI: 10.4155/ppa-2016-0008
    Ratification of the Trans-Pacific Partnership (TPP) will attract a large number of foreign drug companies in the coming years to Vietnam. It is anticipated to bring investment to Vietnam's pharmaceutical industries, lead to increased infrastructure and enable the use of more sophisticated technologies for the discovery, development and manufacture of drugs. However, with respect to pharmaceutical companies, which are producing generic drugs primarily, the availability of biologic will be reduced. Thus, the consequence is, an increase in drug cost resulting in difficulties for patients wishing to procure these drugs. This will be particularly detrimental for developing countries, such as Vietnam and Malaysia.
    Matched MeSH terms: Drugs, Generic
  20. Chan HK, Lim YM
    Asian Pac J Cancer Prev, 2016 11 01;17(11):4951-4957.
    PMID: 28032722
    Background: Apart from reducing occupational exposure to cytotoxic hazards, the PhaSeal® closed-system transfer device (CSTD) can extend the beyond-use dates (BUDs) of unfinished vials of antineoplastic drugs for up to 168 hours (seven days). In this study, the total material cost incurred by its use in a Malaysian government-funded hospital was calculated. Methods: A list of vial stability following initial needle punctures of 29 commonly-used antineoplastic drugs was compiled. The amount of the materials used, including drugs, infusion bottles, the PhaSeal® CSTD and other consumables, was recorded on a daily basis for three months in 2015. The total cost was calculated based on the actual acquisition costs, and was compared with that of a hypothetical scenario, whereby conventional syringe-needle sets were used for the same amounts of preparations. Results: The use of the PhaSeal® CSTD incurred a cost of MYR 383,634.52 (USD 92,072.28) in three months, representing an average of MYR 170.5 (USD 40.92) per preparation or an estimated annual cost of MYR 1,534,538.08 (USD 368,289.14). Compared with conventional syringe-needle approach, it is estimated to lead to an additional spending of MYR 148,627.68 (USD 35,670.64) yearly. Conclusion: Although there was a reduction of drug wastage achieved by extending BUDs of unfinished vials using the PhaSeal® CSTD, cost saving was not observed, likely attributable to the wide use of lower-priced generic drugs in Malaysia. Future studies should further evaluate the possibility of cost saving, especially in health settings where branded and high-cost antineoplastic drugs are more commonly used.
    Matched MeSH terms: Drugs, Generic
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