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Generic medicines utilizations and generic prescribing in Nepal: A reflection of current scenario and possible solutions
Research in Social and Administrative Pharmacy xxx (2017) 1e2
Contents lists available at ScienceDirect
Research in Social and Administrative Pharmacy journal homepage: www.rsap.org
Generic medicines utilizations and generic prescribing in Nepal: A reflection of current scenario and possible solutions The World Health Organization (WHO) defines generic medicine as a ‘pharmaceutical product usually intended to be interchangeable with the originator brand product, manufactured without a license from the originator manufacturer and marketed after the expiry of patent or other exclusivity rights’. Generally, generic medicines are produced and marketed in the form of nonproprietary name (INN), e.g. paracetamol; however, they can also be marketed under brand names, often called ‘branded generics’.1 Generic medicines are not inferior to branded medicines.2 Furthermore, generic medicines are cost effective and particularly needed in developing nations like Nepal where the majority of people are poor, reside in rural areas and cannot afford medicines. Other advantages of generic medicines and generic prescribing include but not limited to: ) Less chances of medication errors especially in context to sound a-like medicines ) No need to remember different brand names ) Generic name provides a guide to the drug's pharmacology and chemical class ) Cost effective and affordable. Despite these advantages, there are, however, certain categories of medicines that can better be prescribed by brand names. These medicines include drugs with narrow therapeutic index (e.g. theophylline, digoxin, warfarin, phenytoin, and lithium), antiarrhythmic agents, modified release preparations and medicines with different delivery systems. Nepal signed the Trade Related Intellectual Property Rights (TRIPS) agreement on March 11th, 2016 and it does not need to provide patent protection till December 31st, 2017.3 This privilege for Nepal being among the Least Developed Countries (LDCs) is an opportunity to promote generic medicines. Nepal has been susceptible to natural disasters such as massive earthquakes and severe flooding. On April 25th, 2015, the massive earthquake caused huge devastations and thousands of people lost their lives. The post-effects of the jolts are still miserable.4 There has been a huge shortage of basic commodities including food, shelter, and medicine supplies in most of the affected areas.5 The shopkeepers and suppliers took advantage of such situation through raising the prices of commodities including medicines multiple times.6 Although the 2015 National Health Policy states that the physician should prescribe in generic names with clear hand writing, the practice of prescribing in genetic names has not been recognized yet.7 However, a limited number of generic medicines can be seen in the market which include injectable adrenaline, atropine, heparin and metronidazole.8 In Nepal, medicine production and prescribing are exclusively in the form of brand names and the scenario is similar among other developing nations of Asia. The major driving forces toward
promoting the practice of branded medicines are unethical promotional strategies of pharmaceutical manufacturers, lack of regulation on the promotion of pharmaceutical products, prescribers and dispensers. The pharmaceutical companies provide a variety of incentives to the prescribers. Heavy incentives, bonuses and profit margins offered to the private retail pharmacies for a given brands of medicines results in unwarranted substitution by dispensing staffs.2 Furthermore, consumers or patients are mostly illiterate and lack proper knowledge and awareness about generic medicines. Dispensing staff members may substitute brands for generics.8 There is a huge competition among medical representatives (also called pharmaceutical company's marketing representatives) to bargain with prescribers and dispensers about the incentives to lure them to prescribe and dispense their specific brands and the process is two way.9 The matter does not stop here and even some more expensive imported brands (e.g. Calcium) and others are prescribed and sold which have no added advantages over the locally available brands. Furthermore, review of literature shows that physicians of developed nations are more in favor of generic medicines than of developing nations.10 Despite the challenges, there is no alternative than adopting and encouraging generic medicine use to ensure safe and effective use of medicines. Awareness and education among the stakeholders are required toward promoting the practice of generic medicine in the country. Healthcare professionals who are involved in prescribing (e.g. physicians) and dispensing (e.g. pharmacists) can play an important role in ‘the promotion of generic medicines and in patients’ acceptance of generic medicines and generic substitution’.11 The new national health policy statement regarding generic prescribing should strictly be implemented. In larger facilities especially teaching hospitals, the Medicine and Therapeutics Committee (MTC) can play a key role in promoting the use of generic medicines through providing a forum in bringing various stakeholders together. MTC membership includes physicians, pharmacists, nurses and others. Thus, MTC should carefully select only certain generics and or brands of medicines which would be cost effective. The Government of Nepal and the concerned regulatory authorities should play their role to promote the utilization of generic medications in the nation. The authors would like to acknowledge Dr. Subish Palaian, Associate Professor of Pharmacy Practice, Gulf Medical University, Ajman, UAE and Dr. Daya Ram Gaudel, Lecturer, English Language Center, University of Hail, Saudi Arabia for reviewing the initial version of the manuscript and suggesting modifications. This project has not received any funding from any funding agency and we declare no competing interest.
http://dx.doi.org/10.1016/j.sapharm.2017.01.004 1551-7411/© 2017 Elsevier Inc. All rights reserved.
Please cite this article in press as: Ansari M, et al.Generic medicines utilizations and generic prescribing in Nepal: A reflection of current scenario and possible solutions, Research in Social and Administrative Pharmacy (2017), http://dx.doi.org/10.1016/j.sapharm.2017.01.004
2
M. Ansari et al. / Research in Social and Administrative Pharmacy xxx (2017) 1e2
References 1. GaBi. WHO Definitions of Generics; 24 February 2012. ed 2012 http://gabionline. net/Generics/General/WHO-definitions-of-generics. 2. Hassali MA, Alrasheedy AA, McLachlan A, et al. The experiences of implementing generic medicine policy in eight countries: a review and recommendations for a successful promotion of generic medicine use. Saudi Pharm J. 2014;22: 491e503. 3. WTO. Nepal, Tanzania and Ukraine accept protocol amending the TRIPS Agreement. https://www.wto.org/english/news_e/news16_e/trip_18mar16_e. htm2016. 4. Wolfson E. One year after a devastating earthquake, Nepal is still in ruins. 5. UNICEF. Serious Shortage of Essential Supplies Threatens Millions of Children This Winter. Nepal: UNICEF; 30 November 2015. 6. BMJ. Abhishek Yadav: Nepal struggles to cope with the aftermath of the earthquake. 7. MoH. National Health Policy. Government of Nepal: Ministry of Health; 2015. 8. Shankar PR, Hassali MA, Subish P, Piryani RM, Thapa BB, Mishra N. GenMed 010: a one day workshop on generic medicines. Australas Med J. 2011;4: 133e135. 9. Giri BR, Shankar PR. Learning how drug companies promote medicines in Nepal. PLoS Med. 2005;2:e256. 10. Hassali MA, Wong ZY, Alrasheedy AA, Saleem F, Mohamad Yahaya AH, Aljadhey H. Perspectives of physicians practicing in low and middle income countries towards generic medicines: a narrative review. Health Policy. 2014;117:297e310.
11. Alrasheedy AA, Hassali MA, Stewart K, et al. Patient knowledge, perceptions, and acceptance of generic medicines: a comprehensive review of the current literature. Patient Intell. 2014;6:1e29.
Mukhtar Ansari* Department of Clinical Pharmacy, College of Pharmacy, University of Hail, Saudi Arabia Baburam Humagain Department of Pharmacy, Cist College, Pokhara University, Kathmandu, Nepal Mohamed Azmi Hassali Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Malaysia * Corresponding author. E-mail address: [email protected] (M. Ansari).
7 January 2017
Please cite this article in press as: Ansari M, et al.Generic medicines utilizations and generic prescribing in Nepal: A reflection of current scenario and possible solutions, Research in Social and Administrative Pharmacy (2017), http://dx.doi.org/10.1016/j.sapharm.2017.01.004
Contents lists available at ScienceDirect
Research in Social and Administrative Pharmacy journal homepage: www.rsap.org
Generic medicines utilizations and generic prescribing in Nepal: A reflection of current scenario and possible solutions The World Health Organization (WHO) defines generic medicine as a ‘pharmaceutical product usually intended to be interchangeable with the originator brand product, manufactured without a license from the originator manufacturer and marketed after the expiry of patent or other exclusivity rights’. Generally, generic medicines are produced and marketed in the form of nonproprietary name (INN), e.g. paracetamol; however, they can also be marketed under brand names, often called ‘branded generics’.1 Generic medicines are not inferior to branded medicines.2 Furthermore, generic medicines are cost effective and particularly needed in developing nations like Nepal where the majority of people are poor, reside in rural areas and cannot afford medicines. Other advantages of generic medicines and generic prescribing include but not limited to: ) Less chances of medication errors especially in context to sound a-like medicines ) No need to remember different brand names ) Generic name provides a guide to the drug's pharmacology and chemical class ) Cost effective and affordable. Despite these advantages, there are, however, certain categories of medicines that can better be prescribed by brand names. These medicines include drugs with narrow therapeutic index (e.g. theophylline, digoxin, warfarin, phenytoin, and lithium), antiarrhythmic agents, modified release preparations and medicines with different delivery systems. Nepal signed the Trade Related Intellectual Property Rights (TRIPS) agreement on March 11th, 2016 and it does not need to provide patent protection till December 31st, 2017.3 This privilege for Nepal being among the Least Developed Countries (LDCs) is an opportunity to promote generic medicines. Nepal has been susceptible to natural disasters such as massive earthquakes and severe flooding. On April 25th, 2015, the massive earthquake caused huge devastations and thousands of people lost their lives. The post-effects of the jolts are still miserable.4 There has been a huge shortage of basic commodities including food, shelter, and medicine supplies in most of the affected areas.5 The shopkeepers and suppliers took advantage of such situation through raising the prices of commodities including medicines multiple times.6 Although the 2015 National Health Policy states that the physician should prescribe in generic names with clear hand writing, the practice of prescribing in genetic names has not been recognized yet.7 However, a limited number of generic medicines can be seen in the market which include injectable adrenaline, atropine, heparin and metronidazole.8 In Nepal, medicine production and prescribing are exclusively in the form of brand names and the scenario is similar among other developing nations of Asia. The major driving forces toward
promoting the practice of branded medicines are unethical promotional strategies of pharmaceutical manufacturers, lack of regulation on the promotion of pharmaceutical products, prescribers and dispensers. The pharmaceutical companies provide a variety of incentives to the prescribers. Heavy incentives, bonuses and profit margins offered to the private retail pharmacies for a given brands of medicines results in unwarranted substitution by dispensing staffs.2 Furthermore, consumers or patients are mostly illiterate and lack proper knowledge and awareness about generic medicines. Dispensing staff members may substitute brands for generics.8 There is a huge competition among medical representatives (also called pharmaceutical company's marketing representatives) to bargain with prescribers and dispensers about the incentives to lure them to prescribe and dispense their specific brands and the process is two way.9 The matter does not stop here and even some more expensive imported brands (e.g. Calcium) and others are prescribed and sold which have no added advantages over the locally available brands. Furthermore, review of literature shows that physicians of developed nations are more in favor of generic medicines than of developing nations.10 Despite the challenges, there is no alternative than adopting and encouraging generic medicine use to ensure safe and effective use of medicines. Awareness and education among the stakeholders are required toward promoting the practice of generic medicine in the country. Healthcare professionals who are involved in prescribing (e.g. physicians) and dispensing (e.g. pharmacists) can play an important role in ‘the promotion of generic medicines and in patients’ acceptance of generic medicines and generic substitution’.11 The new national health policy statement regarding generic prescribing should strictly be implemented. In larger facilities especially teaching hospitals, the Medicine and Therapeutics Committee (MTC) can play a key role in promoting the use of generic medicines through providing a forum in bringing various stakeholders together. MTC membership includes physicians, pharmacists, nurses and others. Thus, MTC should carefully select only certain generics and or brands of medicines which would be cost effective. The Government of Nepal and the concerned regulatory authorities should play their role to promote the utilization of generic medications in the nation. The authors would like to acknowledge Dr. Subish Palaian, Associate Professor of Pharmacy Practice, Gulf Medical University, Ajman, UAE and Dr. Daya Ram Gaudel, Lecturer, English Language Center, University of Hail, Saudi Arabia for reviewing the initial version of the manuscript and suggesting modifications. This project has not received any funding from any funding agency and we declare no competing interest.
http://dx.doi.org/10.1016/j.sapharm.2017.01.004 1551-7411/© 2017 Elsevier Inc. All rights reserved.
Please cite this article in press as: Ansari M, et al.Generic medicines utilizations and generic prescribing in Nepal: A reflection of current scenario and possible solutions, Research in Social and Administrative Pharmacy (2017), http://dx.doi.org/10.1016/j.sapharm.2017.01.004
2
M. Ansari et al. / Research in Social and Administrative Pharmacy xxx (2017) 1e2
References 1. GaBi. WHO Definitions of Generics; 24 February 2012. ed 2012 http://gabionline. net/Generics/General/WHO-definitions-of-generics. 2. Hassali MA, Alrasheedy AA, McLachlan A, et al. The experiences of implementing generic medicine policy in eight countries: a review and recommendations for a successful promotion of generic medicine use. Saudi Pharm J. 2014;22: 491e503. 3. WTO. Nepal, Tanzania and Ukraine accept protocol amending the TRIPS Agreement. https://www.wto.org/english/news_e/news16_e/trip_18mar16_e. htm2016. 4. Wolfson E. One year after a devastating earthquake, Nepal is still in ruins. 5. UNICEF. Serious Shortage of Essential Supplies Threatens Millions of Children This Winter. Nepal: UNICEF; 30 November 2015. 6. BMJ. Abhishek Yadav: Nepal struggles to cope with the aftermath of the earthquake. 7. MoH. National Health Policy. Government of Nepal: Ministry of Health; 2015. 8. Shankar PR, Hassali MA, Subish P, Piryani RM, Thapa BB, Mishra N. GenMed 010: a one day workshop on generic medicines. Australas Med J. 2011;4: 133e135. 9. Giri BR, Shankar PR. Learning how drug companies promote medicines in Nepal. PLoS Med. 2005;2:e256. 10. Hassali MA, Wong ZY, Alrasheedy AA, Saleem F, Mohamad Yahaya AH, Aljadhey H. Perspectives of physicians practicing in low and middle income countries towards generic medicines: a narrative review. Health Policy. 2014;117:297e310.
11. Alrasheedy AA, Hassali MA, Stewart K, et al. Patient knowledge, perceptions, and acceptance of generic medicines: a comprehensive review of the current literature. Patient Intell. 2014;6:1e29.
Mukhtar Ansari* Department of Clinical Pharmacy, College of Pharmacy, University of Hail, Saudi Arabia Baburam Humagain Department of Pharmacy, Cist College, Pokhara University, Kathmandu, Nepal Mohamed Azmi Hassali Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Malaysia * Corresponding author. E-mail address: [email protected] (M. Ansari).
7 January 2017
Please cite this article in press as: Ansari M, et al.Generic medicines utilizations and generic prescribing in Nepal: A reflection of current scenario and possible solutions, Research in Social and Administrative Pharmacy (2017), http://dx.doi.org/10.1016/j.sapharm.2017.01.004