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LetterLETTERS

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

Alian A. Alrasheedy, Mohamed Azmi Hassali, Hisham Aljadhey and Saleh Karamah Al-Tamimi
American Journal of Pharmaceutical Education June 2014, 78 (5) 108; DOI: https://doi.org/10.5688/ajpe785108
Alian A. Alrasheedy
aSchool of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia
bCollege of Pharmacy, Qassim University, Qassim, Saudi Arabia
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Mohamed Azmi Hassali
aSchool of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia
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Hisham Aljadhey
cCollege of Pharmacy, King Saud University, Riyadh, Saudi Arabia
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Saleh Karamah Al-Tamimi
aSchool of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia
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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.

  • © 2014 American Association of Colleges of Pharmacy

REFERENCES

  1. 1.↵
    1. Alrasheedy AA,
    2. Hassali MA,
    3. Aljadhey H,
    4. Ibrahim MIM,
    5. Al-Tamimi SK
    . Is there a need for a formulary of clinically interchangeable medicines to guide generic substitution in Saudi Arabia? J Young Pharm. 2013;5(2):73-75.
    OpenUrlCrossRefPubMed
  2. 2.↵
    1. Hassali MA,
    2. Alrasheedy AA,
    3. McLachlan A,
    4. et al
    . The experiences of implementing generic medicines policy in eight countries: a review and recommendations for a successful promotion of generic medicines use. Saudi Pharm J. 2014. (In press).
  3. 3.↵
    1. Hassali MA,
    2. Kong D,
    3. Stewart K
    . Knowledge and perceptions of recent pharmacy graduates about generic medicines. Pharm Educ. 2007;7(1):89-95.
    OpenUrlCrossRef
  4. 4.↵
    1. Siam MKS,
    2. Khan A,
    3. Khan TM
    . Medical and pharmacy students' knowledge and perceptions about generic medicines in Bangladesh. J Pharm Health Serv Res. 2013;4(1):57-61.
    OpenUrl
  5. 5.↵
    1. Holmes JH,
    2. Dennison KM
    . Student pharmacists' perceptions of generic and branded drugs. J Pharm Mark Manage. 1992;6(4):71-83.
    OpenUrl
  6. 6.↵
    Business Monitor International (BMI). Saudi Arabia Pharmaceuticals & Healthcare Report Q2 2013. London, UK: Business Monitor International Ltd; 2013.
  7. 7.↵
    Health Professions Practice Act 2005. Riyadh, Saudi Arabia.
  8. 8.↵
    Executive Regulations of Health Professions Practice Act 2006. Riyadh, Saudi Arabia.
  9. 9.↵
    Executive Board of the Health Ministers’ Council for GCC States. The GCC data requirements for human drugs submission: Content of the dossier (version 1.1). 2013. http://www.sfda.gov.sa/en/drug/drug_reg/Regulations/The%20GCC%20Data%20Requirements%20for%20Human%20Drugs%20Submission%20version%201%201%20GCC.pdf. Accessed March 15, 2014.
  10. 10.↵
    Saudi Food and Drug Authority, Kingdom of Saudi Arabia. Guidance for submission Version 4. March 2014. http://www.sfda.gov.sa/ar/drug/resources/DocLib2/Guidance_for_Submission_v_4%200.pdf. Accessed March 24, 2014.
  11. 11.↵
    Saudi Food and Drug Authority, Kingdom of Saudi Arabia. Regulatory framework for drug approvals Version 5. March 2014. http://www.sfda.gov.sa/ar/drug/resources/DocLib2/Regulatory_Framework_for_Drug_Approvals_v_5%200.pdf Accessed March 24, 2014.
  12. 12.↵
    Executive Board of the Health Ministers’ Council for GCC States. The GCC guidelines for bioequivalence (Version 2.2). 2013. http://www.sfda.gov.sa/ar/drug/resources/DocLib2/The%20GCC%20Guidelines%20for%20Bioequivalence%20version%202%202%20GCC.pdf. Accessed March 24, 2014.
  13. 13.↵
    Executive Board of the Health Ministers’ Council for GCC States. The GCC data requirements for the renewal of marketing authorizations Version 1.2. 2013. http://www.sfda.gov.sa/en/drug/drug_reg/Regulations/The%20GCC%20Data%20Requirments%20for%20the%20Renewal%20of%20Marketing%20Authorizations%20version%201%202%20GCC.pdf. Accessed March 24, 2014.
  14. 14.↵
    Saudi Food and Drug Authority, Kingdom of Saudi Arabia. Guide to good manufacturing practice for medicinal products Version 2.1. 2011. http://www.sfda.gov.sa/ar/drug/resources/DocLib2/SFDAGMP_2011_v21.pdf. Accessed March 24, 2014.
  15. 15.↵
    Saudi Food & Drug Authority, Kingdom of Saudi Arabia. Guidelines for pharmaceutical equivalence requirements Version 1.1 September 1, 2010. http://www.sfda.gov.sa/ar/drug/resources/DocLib2/PharmaceuticalEquivalence_v11.pdf. Accessed March 24, 2014.
  16. 16.↵
    Saudi Food and Drug Authority, Kingdom of Saudi Arabia. Quality guidelines for chemistry and manufacturing: New and generic drugs Version 2.1. August 31, 2010. http://www.sfda.gov.sa/ar/drug/resources/DocLib2/QualityGuidelinesforChemistryandManufacturingNewandGenericDrugs_v21.pdf. Accessed March 24, 2013.
  17. 17.↵
    Saudi Food and Drug Authority, Kingdom of Saudi Arabia. Registration requirements for drug companies and manufactureres. 2011. http://www.sfda.gov.sa/ar/drug/resources/DocLib2/%D8%A3%D8%B3%D8%B3%20%D9%88%D9%85%D8%AA%D8%B7%D9%84%D8%A8%D8%A7%D8%AA%20%D9%88%D8%B4%D8%B1%D9%88%D8%B7%20%D8%A7%D9%84%D8%AA%D8%B3%D8%AC%D9%8A%D9%84.pdf. Accessed March 24, 2014.
  18. 18.↵
    Executive Board of the Health Ministers’ Council for GCC States. The GCC guidelines for stability testing of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) Version 3.2. 2013. http://www.sfda.gov.sa/ar/drug/resources/DocLib2/The%20GCC%20Guidelines%20for%20Stability%20Testing%20(2013)%201%20version%203%202.pdf. Accessed March 24, 2014.
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The Need to Cover Generic Medications and Generic Substitution Practice in the Curricula of Pharmacy Colleges in Saudi Arabia
Alian A. Alrasheedy, Mohamed Azmi Hassali, Hisham Aljadhey, Saleh Karamah Al-Tamimi
American Journal of Pharmaceutical Education Jun 2014, 78 (5) 108; DOI: 10.5688/ajpe785108

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The Need to Cover Generic Medications and Generic Substitution Practice in the Curricula of Pharmacy Colleges in Saudi Arabia
Alian A. Alrasheedy, Mohamed Azmi Hassali, Hisham Aljadhey, Saleh Karamah Al-Tamimi
American Journal of Pharmaceutical Education Jun 2014, 78 (5) 108; DOI: 10.5688/ajpe785108
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