Access to unauthorized hepatitis C generics: Perception and knowledge of physicians, pharmacists, patients and non-healthcare professionals
Autoři:
Amandine Garcia aff001; Sascha Moore Boffi aff002; Angèle Gayet-Ageron aff003; Nathalie Vernaz aff004
Působiště autorů:
Faculty of Medicine, University of Geneva, Geneva, Switzerland
aff001; Groupe Sida Genève, Geneva, Switzerland
aff002; Medical Directorate, Division of Clinical Epidemiology, Geneva University Hospitals, Geneva, Switzerland
aff003; Medical Directorate, Finance Directorate, Geneva University Hospitals, Geneva University, Geneva, Switzerland
aff004
Vyšlo v časopise:
PLoS ONE 14(10)
Kategorie:
Research Article
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pone.0223649
Souhrn
Objectives
Hepatitis C virus (HCV) causes both acute and chronic infection, which can potentially develop into cirrhosis and liver cancer. Healthcare systems are struggling to finance costly direct-acting antiviral agents through public funding for uninsured patients, despite the unprecedented high cure rates of these agents. Vulnerable populations are at higher risk of HCV infection. The personal importation scheme is based on the legal right to import any unauthorized generics for personal use. This study was designed to assess the knowledge and perceptions of stakeholders on unauthorized generics.
Methods
We conducted an anonymous online survey based on the fictitious situation of a patient diagnosed with HCV who lacked mandatory health insurance and personal financial resources.
Results
We obtained a sample of 781 respondents: 445 physicians, 77 pharmacists, 51 patients and 207 non-healthcare professionals. We found that only 36% and 58% of respondents believe that the quality and efficacy, respectively, of unauthorized generics are equivalent to their corresponding brand. An overwhelming majority (98%) favoured quality control upon arrival, and 31% felt they could recognize fraudulent websites. A total of 79% expressed support for financial assistance for vulnerable patients, and support among physicians was 83%.
Conclusions
Overall, the limited knowledge of the efficacy and quality of unauthorized generics, despite evidence in peer-reviewed literature, contrasts with the overwhelmingly positive attitudes toward financial assistance for personal import. This finding emphasizes the need for clearer information on imported generics and the potential safety provided by buyers’ club schemes to complete the WHO agenda of eradicating viral hepatitis by 2030 within otherwise excluded vulnerable populations.
Klíčová slova:
Physicians – Patients – Hepatitis C virus – Finance – Internet – Pharmacists – Drug screening – Quality control
Zdroje
1. WHO. Global Hepatitis Report. [cited 2019 April 22]. Availabe from http://www.who.int/hepatitis/publications/global-hepatitis-report2017/en/.
2. WHO. Combating Hepatits B and C by 2030. [cited 2017 December 12]. Availabe from: https://www.who.int/hepatitis/publications/hep-elimination-by-2030-brief/en/.
3. WHO. Global Health Sector Strategy on Viral Hepatitis 2016–2021. [cited 2019 April 22]. Availabe from: http://www.who.int/hepatitis/strategy2016-2021/ghss-hep/en/. 2016.
4. Vernaz N, Girardin F, Goossens N, Brugger U, Riguzzi M, Perrier A, et al. Drug Pricing Evolution in Hepatitis C. PLoS One. 2016;11(6):e0157098. doi: 10.1371/journal.pone.0157098 27310294
5. Vernaz N, Calmy A, Hurst S, Jackson Y, Negro F, Perrier A, et al. A buyers' club to improve access to hepatitis C treatment for vulnerable populations. Swiss Med Wkly. 2018;148:w14649. doi: smw.2018.14649 30141526
6. Chacowry Pala K, Baggio S, Tran NT, Girardin F, Wolff H, Getaz L. Blood-borne and sexually transmitted infections: a cross-sectional study in a Swiss prison. BMC Infect Dis. 2018;18(1):539. doi: 10.1186/s12879-018-3445-6 30373535
7. Negro F. Epidemiology of hepatitis C in Europe. Dig Liver Dis. 2014;46 Suppl 5:S158–64.
8. Assefa Y, Hill PS, Williams OD. Access to hepatitis C virus treatment: Lessons from implementation of strategies for increasing access to antiretroviral treatment. Int J Infect Dis. 2018;70:65–8. doi: 10.1016/j.ijid.2018.03.004 29550446
9. Beck EJ, Mandalia S, DongmoNguimfack B, Pinheiro E, t Hoen E, Boulet P, et al. Does the political will exist to bring quality-assured and affordable drugs to low- and middle-income countries? Glob Health Action. 2019;12(1):1586317. doi: 10.1080/16549716.2019.1586317 30983547
10. WTO. Intellectual Property (TRIPS)—Part II—Standards concerning the availability, scope and use of Intellectual Property Rights. [cited 2019 May 2]. Availabe from: https://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm.
11. Nicol D, Owoeye O. Using TRIPS flexibilities to facilitate access to medicines. Bull World Health Organ. 2013;91(7):533–9. doi: 10.2471/BLT.12.115865 23825881
12. Velásquez G. The Use of TRIPS Flexibilities for the Access to Hepatitis C Treatment. [cited 2018 October 24]. Availabe from: https://www.southcentre.int/wp-content/uploads/2018/10/PB54_The-Use-of-TRIPS-Flexibilities-for-the-Access-to-Hepatitis-C-Treatment_EN.pdf. South Center. October 2018;54.
13. t Hoen EF, Veraldi J, Toebes B, Hogerzeil HV. Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001–2016. Bull World Health Organ. 2018;96(3):185–93. doi: 10.2471/BLT.17.199364 29531417
14. Hoen EFMt. Practical Applications of the Flexibilities of the Agreement on Trade- Related Aspects of Intellectual Property Rights. Lessons beyond HIV for access to new essential medicines. [cited 2019 June 11] Availabe from: https://medicineslawandpolicyorg/wp- content/uploads/2018/03/EllentHoen_dissertatie_Practical_Implications_2018pdf.
15. OFSP. Médicaments Contre l’hépatite C: Forte réduction du prix et remboursement étendu. [cited 2019 April 22]. Availabe from: https://www.bag.admin.ch/bag/fr/home/das-bag/aktuell/news/news-26-06-2017.html.
16. Article 20 para. 2 a) of the Federal Act on Medicinal Products and Medical Devices (TPA) [cited 2019 September 10]. Available from: https://www.admin.ch/opc/en/classified-compilation/20002716/index.html.
17. Article 48 of the Ordinance on licensing of medicinal products (AMBV). [cited 2019 September 10]. Available from: https://www.admin.ch/opc/en/classified-compilation/20180857/index.html.
18. Swissmedic. Guideline on medicines and the Internet. [cited 2019 February 17]. Available from: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/medicinal-products-from-the-internet/leitfaden-arzneimittel-aus-dem-internet.html
19. Freeman JA, Hill A. The use of generic medications for hepatitis C. Liver Int. 2016;36(7):929–32. doi: 10.1111/liv.13157 27306303
20. Hill A, Tahat L, Mohammed MK, Tayyem RF, Khwairakpam G, Nath S, et al. Bioequivalent pharmacokinetics for generic and originator hepatitis C direct- acting antivirals. J Virus Erad. 2018;4(2):128–31. 29682307
21. Gangadhar BN, Chaturvedi SK. The brand of generic prescriptions. Indian J Med Ethics. 2018;3(1):84–5. doi: 10.20529/IJME.2018.006 29477986
22. Riner B, Bussy A, Helene-Pelage J, Moueza N, Lamy S, Carrere P. "No generics, Doctor!" The perspective of general practitioners in two French regions. BMC Health Serv Res. 2017;17(1):707. doi: 10.1186/s12913-017-2682-5 29121918
23. Fraeyman J, Peeters L, Van Hal G, Beutels P, De Meyer GR, De Loof H. Consumer choice between common generic and brand medicines in a country with a small generic market. J Manag Care Spec Pharm. 2015;21(4):288–96. doi: 10.18553/jmcp.2015.21.4.288 25803762
24. Kesselheim AS, Gagne JJ, Franklin JM, Eddings W, Fulchino LA, Campbell EG. Do patients trust the FDA?: a survey assessing how patients view the generic drug approval process. Pharmacoepidemiol Drug Saf. 2017;26(6):694–701. doi: 10.1002/pds.4205 28370652
25. Rhumorbarbe D. Acheter des médicaments sur internet: moins cher et plus risqué? [cited 2019 June 25]. Availabe from: https://www.grea.ch/sites/default/files/article_7.pdf. DÉPENDANCES.51:21–3.
26. Fédération romande des consommateurs. Achat en ligne de médicaments: méfiez-vous des faux!. [cited 2019 June 25]. Avalailable from: https://www.frc.ch/achat-en-ligne-de-medicaments/.
27. IRACM. Falsification sur internet. [cited 2019 June 25]. Availabe from: http://www.iracm.com/observatoire-thematique/falsification-sur-internet/.
28. COMPARIS. Commander ses médicaments sur internet-attention. [cited 2019 June 25]. Availabe from: https://fr.comparis.ch/krankenkassen/gesundheit-praevention/information/medikamente-ausland-bestellen.
29. Article 2 para 2 of the Federal Act on Research involving Human Beings (HRA) [cited 2019 September 10] Available from: https://wwwadminch/opc/en/classified-compilation/20061313/indexhtml.
30. Ravinetto R, Vandenbergh D, Mace C, Pouget C, Renchon B, Rigal J, et al. Fighting poor-quality medicines in low- and middle-income countries: the importance of advocacy and pedagogy. J Pharm Policy Pract. 2016;9:36. doi: 10.1186/s40545-016-0088-0 27843547
31. Dunne S, Shannon B, Dunne C, Cullen W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacol Toxicol. 2013;14:1. doi: 10.1186/2050-6511-14-1 23289757
32. Chen ML, Blume H, Beuerle G, Davit B, Mehta M, Potthast H, et al. The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference. Eur J Pharm Sci. 2018;111:153–7. doi: 10.1016/j.ejps.2017.09.047 28964950
33. Chachad S, Lulla A, Malhotra G, Purandare S. Bioequivalence study of two fixed dose combination tablet formulations of lopinavir and ritonavir in healthy volunteers. Arzneimittelforschung. 2009;59(5):263–8. doi: 10.1055/s-0031-1296395 19537528
34. Jacomet C, Allavena C, Peyrol F, Pereira B, Joubert LM, Bagheri H, et al. Perception of antiretroviral generic medicines: one-day survey of HIV-infected patients and their physicians in France. PLoS One. 2015;10(2):e0117214. doi: 10.1371/journal.pone.0117214 25658627
35. Godman B, Shrank W, Wettermark B, Andersen M, Bishop I, Burkhardt T, et al. Use of Generics-A Critical Cost Containment Measure for All Healthcare Professionals in Europe? Pharmaceuticals (Basel). 2010;3(8):2470–94.
36. Godman B, Wettermark B, Bishop I, Burkhardt T, Fürst J, Garuoliene K, et al. European payer initiatives to reduce prescribing costs through use of generics. GaBI Journal. 2012;1(1):1:22.
37. Liu CH, Huang YJ, Yang SS, Chang CH, Yang SS, Sun HY, et al. Generic sofosbuvir-based interferon-free direct acting antiviral agents for patients with chronic hepatitis C virus infection: a real-world multicenter observational study. Sci Rep. 2018;8(1):13699. doi: 10.1038/s41598-018-32060-7 30209349
38. WHO. Prequalification of Medicines by WHO. [cited 2019 May 9]. Available from:https://www.who.int/news-room/fact-sheets/detail/prequalification-of-medicines-by-who.
39. Abbreviated New Drug Application (ANDA). [cited 2019 June 25]. Available from:https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda.
40. Chahal HS, Murray JS, Shimer M, Capella P, Presto R, Valdez ML, et al. The US Food and Drug Administration's tentative approval process and the global fight against HIV. J Int AIDS Soc. 2017;20(4).
41. Chahal HS, Capella P, Presto R, Murray JS, Shimer M, Valdez ML, et al. Impact of the US Food and Drug Administration registration of antiretroviral drugs on global access to HIV treatment. BMJ Glob Health. 2018;3(3):e000651. doi: 10.1136/bmjgh-2017-000651 29862054
42. Waning B, Diedrichsen E, Moon S. A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries. J Int AIDS Soc. 2010;13:35. doi: 10.1186/1758-2652-13-35 20840741
43. Love J. The production of generic drugs in India. BMJ. 2011;342:d1694. doi: 10.1136/bmj.d1694 21427048
44. Mylan Pharma GmbH. Launch of first generics. [cited 2019 June 9]. Availabe from: https://www.mylan.ch/en-gb/news/2018/launch-of-the-first-generics.
45. Premkumar M, Grover GS, Dhiman RK. Chronic Hepatitis C: Do Generics Work as Well as Branded Drugs? J Clin Exp Hepatol. 2017;7(3):253–61. doi: 10.1016/j.jceh.2017.08.003 28970713
46. Abozeid M, Alsebaey A, Abdelsameea E, Othman W, Elhelbawy M, Rgab A, et al. High efficacy of generic and brand direct acting antivirals in treatment of chronic hepatitis C. Int J Infect Dis. 2018;75:109–14. doi: 10.1016/j.ijid.2018.07.025 30077791
47. Tang L, Kamat M, Shukla A, Vora M, Kalal C, Kottilil S, et al. Comparative Antiviral Efficacy of Generic Sofosbuvir versus Brand Name Sofosbuvir with Ribavirin for the Treatment of Hepatitis C. Interdiscip Perspect Infect Dis. 2018;2018:9124604. doi: 10.1155/2018/9124604 30364048
48. Bendas ER, Rezk MR, Badr KA. Drug Interchangeability of Generic and Brand Products of Fixed Dose Combination Tablets of Sofosbuvir and Ledipasvir (400/90 mg): Employment of Reference Scaled Average Bioequivalence Study on Healthy Egyptian Volunteers. Clin Drug Investig. 2018;38(5):439–48. doi: 10.1007/s40261-018-0622-8 29417463
49. Liu CH, Sun HY, Liu CJ, Sheng WH, Hsieh SM, Lo YC, et al. Generic velpatasvir plus sofosbuvir for hepatitis C virus infection in patients with or without human immunodeficiency virus coinfection. Aliment Pharmacol Ther. 2018;47(12):1690–8. doi: 10.1111/apt.14647 29665069
50. Hamilton WL, Doyle C, Halliwell-Ewen M, Lambert G. Public health interventions to protect against falsified medicines: a systematic review of international, national and local policies. Health Policy Plan. 2016;31(10):1448–66. doi: 10.1093/heapol/czw062 27311827
51. Swissmedic. Action « PANGEA XI »: la Suisse participe à la semaine d’actiointernationale contre le commerce illégal de produits thérapeutiques. [cited 2019 May 19]. Availabe from: https://www.swissmedic.ch/swissmedic/fr/home/medicaments-a-usage-humain/surveillance-du-marche/medicaments-par-internet/mise-en-garde-au-sujet-des-medicaments-achetes-sur-internet/aktion_pangeaxi.html.
52. Petersen A, Held N, Heide L, Difam EPNMSG. Surveillance for falsified and substandard medicines in Africa and Asia by local organizations using the low-cost GPHF Minilab. PLoS One. 2017;12(9):e0184165. doi: 10.1371/journal.pone.0184165 28877208
53. Wang X, Nutland W, Brady M, Green I, Boffito M, McClure M. Quantification of tenofovir disoproxil fumarate and emtricitabine in generic pre-exposure prophylaxis tablets obtained from the internet. Int J STD AIDS. 2019:956462419841144.
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