Saleh Karamah AL-Tamimi

The experiences of implementing generic medicine policy in eight countries: A review and recommendations for a successful promotion of generic medicine use

Generic medicines are clinically interchangeable with original brand medicines and have the same quality, efficacy and safety profiles. They are, nevertheless, much cheaper in price. Thus, while providing the same therapeutic outcomes, generic medicines lead to substantial savings for healthcare systems. Therefore, the quality use of generic medicines is promoted in many countries. In this paper, we reviewed the role of generic medicines in healthcare systems and the experiences of promoting the use of generic medicines in eight selected countries, namely the United States (US), the United Kingdom (UK), Sweden, Finland, Australia, Japan, Malaysia and Thailand. The review showed that there are different main policies adopted to promote generic medicines such as generic substitution in the US, generic prescribing in the UK and mandatory generic substitution in Sweden and Finland. To effectively and successfully implement the main policy, different complementary policies and initiatives were necessarily introduced. Barriers to generic medicine use varied between countries from negative perceptions about generic medicines to lack of a coherent generic medicine policy, while facilitators included availability of information about generic medicines to both healthcare professionals and patients, brand interchangeability guidelines, regulations that support generic substitution by pharmacists, and incentives to both healthcare professionals and patients.

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.

Is there a need for a formulary of clinically interchangeable medicines to guide generic substitution in Saudi Arabia

The escalating healthcare expenditure is a major challenge to sustainability of the healthcare systems. To confront the escalating health expenditure in general and medicines expenditure in particular, many countries promoted the use of generic medicines. To promote generic medicines, many countries have adopted a generic substitution (GS) policy and generic prescribing. To effectively implement the GS policy, it is evident in the literature that it is essential to have an evidence-based guide on therapeutic equivalence and formulary of interchangeable medicines to guide responsible GS. In Saudi Arabia, GS is permissive and pharmacists are given the right to perform GS. While the prescribers approval is not a requirement, patient consent is required when performing GS. Although there are some general drug references, such as the Saudi National Formulary (SNF) and list of registered medicines in the Saudi market, but there is currently no information available to healthcare professionals that documents the therapeutic and bioequivalence between medicines. Thus, it is essential to have a formulary of interchangeable medicines to guide appropriate GS or at least to include such vital information regarding therapeutic equivalence and brand interchangeability as part of the SNF. That, in turn, will not only make healthcare professionals more confident when providing GS, but will also enable the avoidance of situations where GS is inappropriate.

Patient knowledge, perceptions, and acceptance of generic medicines: a comprehensive review of the current literature

License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php Patient Intelligence 2014:6 1–29 Patient Intelligence Dovepress

Role of Pharmacists in Health Based Non-Governmental Organizations(NGO): Prospects and Future Directions

In this era of globalization, there are many non-government organizations (NGO) that grow in the community. Nowadays, NGOs are becoming the medium for the community to voice out or be the one who lend their hand to help the community around them. In the health care profession, NGOs play an important role to help the people in the community to have a better health in the future. In order to move the state of health of the people in the community, NGOs should acknowledge the role of the pharmacist in their organizations. However, contribution of pharmacists in NGOs is essential because inappropriate assistance or incorrect assistance can lead to death of the consumers. In fact, pharmacists as experts in medicines, they will play important role in distribution the medications and educating the medicines consumers within NGOs. Pharmacists could help in relief efforts and they also help in humanitarian aid. Besides that, they could help in the equality in social and social justice for people in need. Although all these people in the NGOs are well educated but somehow, their knowledge alone does not suffice in helping the community towards a better health. There are still some NGOs that tend to ignore the role of the pharmacist in their organization. As they tend to ignore the existence of the pharmacist, the drug that they had distributed to the community will have higher chance of producing an adverse effect towards the consumer. In this essay, the roles of pharmacist in many sectors of the NGOs will be discussed further to open the eyes of the people in the NGOs about how important and useful pharmacists could be in their organization.

‘Why I do not want to take insulin shots’: Findings from a qualitative study among diabetic patients in Malaysia

AimTo gain insight into type-2 diabetic patients’ perceptions and beliefs about the use of insulin, to explore barriers to initiation of insulin and to evaluate the impact of a short educational intervention regarding patients’ resistance to using insulin injections.Subjects and methodsThis is an exploratory qualitative study. One-to-one in-depth interviews were conducted with a purposive sample of type-2 diabetic patients. Then, a short educational intervention was conducted with the participants. After the intervention, the participants were interviewed to evaluate their acceptance of insulin initiation. The interviews were audio-taped and transcribed verbatim. Thematic content analysis was conducted and the analysis was reviewed independently by two researchers.ResultsA total of 13 diabetic patients were included in the study. Before the intervention, 11 subjects refused initiation of insulin. Resistance to initiation of insulin was influenced by misconceptions about insulin therapy, psychological barriers and fear, lack of self-efficacy and fear of adverse effects. All subjects perceived that insulin should only be initiated in very severe diabetes. Some participants demonstrated lack of belief in insulin efficacy. Psychological barriers and fears such as fear of self-injection and personal phobia about blood, needle and pain as well as perceived side effects also hindered insulin acceptance.ConclusionThe study findings revealed that misconceptions about insulin use and psychological barriers played a major role in patients’ resistance to initiation of insulin therapy. The study demonstrated, however, that a short educational intervention could dispel patients’ fears and erroneous beliefs and help them to start insulin therapy.

The Need to Cover Generic Medications and Generic Substitution Practice in the Curricula of Pharmacy Colleges in Saudi Arabia

To the Editor. Generic medications are essentially the same as their counterpart brand medications. They can provide the same therapeutic outcomes, but at a much cheaper cost.1,2 Because of this, they are promoted in many countries in order to confront the problem of escalating pharmaceutical expenditures. However, there are many challenges that hinder the promotion and use of generic medicines, including negative perceptions from healthcare professionals, misconceptions, and inadequate knowledge of the role of bioequivalence in the use of generic medications.2 In literature specifically written about pharmacy students and preregistration pharmacists, there is evidence from studies conducted in Australia and Bangladesh that highlighted the issue of negative perceptions regarding the quality, safety, and efficacy of generic medications, as well as a lack of adequate knowledge of bioequivalence.3,4 Moreover, in an American study, Holmes and Dennison reported that pharmacy students’ perceptions about effectiveness, harmful effects, and economic value can influence their recommendation of either generic medicines or brand medicines, both in general and for some specific diseases in particular.5 In Saudi Arabia, generic medications represented by value only 8.1% of the total medicine market and only 9.1% of the prescription medicines market in 2012. Moreover, it is forecasted to reach only approximately 11.5% in 2020.6 In fact, successful promotion of generic medications requires all stakeholders and involved parties including educational institutions (colleges of pharmacy and colleges of medicines) to play active roles in this regard. Therefore, as part of the national efforts, colleges of pharmacy in Saudi Arabia need to ensure that future pharmacy practitioners are empowered with adequate knowledge regarding generic medications, generic substitution, and relevant concepts, such as bioequivalence. From our experience and observations, we believe there are several important topics related to generic medications and generic substitution that need to be covered adequately in the curricula of pharmacy colleges so that following graduation, pharmacy students can play a pivotal role in the promotion of the appropriate use of generic medications. This education initiative could be done by designing a short module to include in the curricula of pharmacy colleges regarding safety, effectiveness, and quality of generic medications, generic substitution practice, and regulations related to generic substitution in Saudi Arabia. It is also important to cover issues and aspects of the use of generic medications in a systematic and comprehensive way, taking a more clinical or practical approach. Therefore, the module needs to address the clinical and non-clinical considerations that should be taken into consideration when performing generic substitution, including the factors related to the medication, the patient, the prescriber and the regulations. It is also essential to fully cover the concept and science of bioequivalence including bioequivalence study design, its clinical importance, and the correct understanding and interpretation of the regulatory bioequivalence criteria. Another important topic includes the regulations related to generic substitution by pharmacists specifically addressed in the Health Professions Act,7 including the act’s executive regulations.8 These regulations granted pharmacists the right to perform generic substitution in most cases, with the exception of NTI drugs. In this act, the permission from a prescriber is not a legal requirement for generic substitution. However, patient consent is required. Beside these scientific and legal aspects, pharmaceutical industry marketing and its potential influence on their practice need to be addressed adequately with emphasis on the professional and ethical standards that govern the relationship between the pharmacist as a healthcare professional and pharmaceutical industry. The module also needs to provide the students with more detailed information about the procedural and registration requirements of generic medications by the nation’s regulatory and registration authority, namely the Saudi Food and Drug Authority. The topics include the following: • General requirements of medication registration in Saudi Arabia. 9,10 • Registration requirements of generic medications in Saudi Arabia.11 • The concept and science of bioequivalence and bioequivalence requirements in Saudi Arabia.12 • Requirements for the renewal of marketing authorization in Saudi Arabia.13 • Current Good Manufacturing Practice (cGMP) requirements, quality assurance and quality control requirements, and inspection requirements.14 • Pharmaceutical equivalence requirements,15 and chemistry and manufacturing quality requirements.16 • Requirements and registration system of drug manufacturers and companies in Saudi Arabia.17 • Additional related issues, such as product stability requirements.18 In summary, pharmacy students are the future pharmacy practitioners and will be a source of information for their colleagues in other healthcare professions regarding medications on the market. Because of this, we believe that it is essential to ensure that they are provided with an advanced knowledge during their undergraduate training regarding the appropriate use of generic medications. We also believe that designing an instructional module and covering the topics outlined in this letter would be useful and could help to prepare pharmacy students for their important role in the appropriate use of generic medications in the Saudi healthcare system.

The need to incorporate generic medicines topic in the curriculum of Yemeni pharmacy colleges.

Generic medicines are bioequivalent versions of the original brand medicines and produce the same therapeutic effects. In addition, generic medicines can enhance medicine affordability and improve patient adherence. Moreover, wide utilization of generic medicines is effective to curb the fast growth in cost of pharmaceuticals. In Yemen, the total pharmaceutical expenditure in 2013 was approximately USD 426 million, which accounts for approximately 40% of the total health expenditure. Furthermore, in 2013, approximately 90.3% of pharmaceuticals in Yemen are imported from abroad. The sale of generic medicines represented by value were only 30% in 2010. In order to enhance the successful utilizations of generic medicines in the Yemeni market, all healthcare stakeholders need to have an excellent understanding of generic medicines issues. Therefore, promotion of generic medicines is important. However, there are negative perception and misunderstanding regarding the safety, efficacy and quality of generic medicines among healthcare professionals in Yemen. In fact, most of the studies in the literature have focused on healthcare professionals and medicine consumers to assess their knowledge and perceptions towards generic medicines. Accordingly, educational efforts and programmes have also focused on improving and correcting the knowledge of the healthcare professionals. Hence, given the lack of knowledge and negative perceptions among many healthcare professionals in several countries, Alrasheedy et al. indicated that there is a need to include more topics on generic medicines and bioequivalence in the Pharmacy curriculum. This is because introducing these topics earlier can save the time and efforts needed to fill in the gap after graduation that could be difficult. In fact, the current literature suggests that pharmacy students have inadequate knowledge of generic medicines in several countries including Malaysia, Australia, Pakistan, Bangladesh and Afghanistan. Therefore, the colleges of pharmacy in Yemen need to ensure that generic medicines are adequately covered in the pharmacy curriculum to prepare the future pharmacy practitioners with appropriate knowledge pertaining generic medicines, generic substitution, bioequivalence, bioavailability and related topics. We believe it is necessary to cover several important topics related to generic medicines in the Yemeni pharmacy curriculum as follows: • Concept of generic medicines. • Safety, efficacy and quality of generic medicines. • Generic substitution practice. • Issues related to bioequivalence and bioavailability. • General requirement of generic medicine registration in Yemen. • Medicines regulation by the Yemeni Supreme Board for Drug and Medical Appliances (drug regulatory authority). • Quality control and quality assurance requirements. In conclusion, pharmacy students are the future pharmacy practitioner, and they are the medicines experts in the healthcare system. Therefore, it is necessary to provide them withadvancedknowledgeabout theappropriateuseof generic medicines at their undergraduate study.This could save efforts in introducing these topics to them after graduation.

Pharmaceutical Policy in Saudi Arabia

Saudi Arabia has a well-developed national medicine policy as well as a well-established drug regulatory framework. Moreover, there is a well-defined pharmaceutical pricing policy, and the medicine prices are strictly controlled. The Saudi Pharmaceutical market is the largest market in the Middle East and African (MEA) region. Moreover, it is heavily dependent on imported medicines and dominated by patented and original medicines. Regarding rational use of medicines, there are several issues that need to be addressed. These include unrestricted access to medicines in the community pharmacies. Moreover, the involvement of community pharmacists in promoting rational use of medicines is currently limited. Additionally, generic medicines are still underutilized in the healthcare system. The way forward is the full implementation of these policies and the stricter enforcement of the laws governing medicines sales and dispensing.

Malaysian Cosmetic Market: Current and Future Prospects

The cosmetic industry has been expanding rapidly in both developed and developing countries. The cosmetics market in Asia seems to be one of the fastest growing markets. The market value of the Asia Pacific has increased to more than US