Effects of Generic Exchange of Levodopa Medication in Patients With Parkinson Disease.
Journal
Journal of patient safety
ISSN: 1549-8425
Titre abrégé: J Patient Saf
Pays: United States
ID NLM: 101233393
Informations de publication
Date de publication:
01 10 2022
01 10 2022
Historique:
pubmed:
10
5
2022
medline:
1
10
2022
entrez:
9
5
2022
Statut:
ppublish
Résumé
Generic exchange is common practice in most healthcare systems. This study investigated how patients with Parkinson disease (PD) perceived a switch of their levodopa medication and the resulting effects on their PD symptoms. A questionnaire was developed, piloted, and finally distributed to 13,857 members of the national PD patient support group. It was designed to be completed by patients and their pharmacies. χ 2 tests for independence statistics with or without Monte Carlo simulation were performed. Cramér φ and Cramér V were calculated. McNemar test was used to investigate whether a generic switch of a levodopa-containing medication had an impact on PD symptoms. Analyses were done with 410 finalized respondents of 13,857 distributed questionnaires. More than half of the responders were 75 years or older and rated themselves Hoehn and Yahr stages 3 to 5. Most patients were confused by a change of their medication. A total of 54.7% of the switchers (n = 148) reported swallowing difficulties with medication, which was significantly more frequent than with nonswitchers (37.3% of 204, P = 0.001). Adverse effects related to the switch were reported by 26.6% of all switchers (switchback rate, 20.5%). The patients at higher Hoehn and Yahr stages were affected to a greater extend. Patients, who experienced any brand switch of their levodopa medication, frequently expressed distrust and confusion. Swallowing difficulties and negative effects on their symptoms were problems, which were more pronounced in advanced disease stages. It remains unclear whether the detrimental impact on therapy was caused by the brand switch or by a nocebo effect.
Identifiants
pubmed: 35532994
doi: 10.1097/PTS.0000000000001015
pii: 01209203-202210000-00010
doi:
Substances chimiques
Antiparkinson Agents
0
Levodopa
46627O600J
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
704-710Informations de copyright
Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
The authors disclose no conflict of interest.
Références
Chaudhuri KR, Healy DG, Schapira AHV. Non-motor symptoms of Parkinson’s disease: diagnosis and management. The Lancet Neurology . 2006;5:235–245.
Dorsey ER, Elbaz A, Nichols E, et al. Global, regional, and national burden of Parkinson’s disease, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol . 2018;17:939–953.
Panteli D, Arickx F, Cleemput I, et al. Pharmaceutical regulation in 15 European countries review. Health Syst Transit . 2016;18:1–122.
Pro Generika. Generika in Zahlen: Das Jahr. 2019. Available at: https://www.progenerika.de/app/uploads/2020/09/Generika-in-Zahlen-2019_DS.pdf . Accessed June 2, 2021.
Guideline Center for Drug Evaluation and Research, US Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General Considerations. Available at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm631943.pdf . Accessed January 12, 2022.
European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on the investigation on bioequivalence EMA: CPMP/EWP/QWP/1401/98. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf . Accessed March 18, 2019.
Suttrup I, Warnecke T. Dysphagia in Parkinson’s disease. Dysphagia . 2016;31:24–32.
Buhmann C, Bihler M, Emich K, et al. Pill swallowing in Parkinson’s disease: a prospective study based on flexible endoscopic evaluation of swallowing. Parkinsonism Relat Disord . 2019;62:51–56.
LeWitt PA. Levodopa therapy for Parkinson’s disease: pharmacokinetics and pharmacodynamics. Mov Disord . 2015;30:64–72.
LeWitt PA. The pharmacology of levodopa in treatment of Parkinson disease: an update. In: Calne DB, ed. Drugs for the Treatment of Parkinson’s Disease. Handbook of Experimental Pharmacology . Berlin: Springer-Verlag. 1989;88 :325–384.
Salamon A, Zádori D, Szpisjak L, et al. Fixed-dose combination therapy for Parkinson’s disease with a spotlight on entacapone in the past 20 years: a reduced pill burden and a simplified dosing regime. Expert Opin Pharmacother . 2020;21:2265–2278.
Berg MJ, Gross RA, Haskins LS, et al. Generic substitution in the treatment of epilepsy: patient and physician perceptions. Epilepsy Behav . 2008;13:693–699.
Andermann F, Duh MS, Gosselin A, et al. Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes. Epilepsia . 2007;48:464–469.
Chaluvadi S, Chiang S, Tran L, et al. Clinical experience with generic levetiracetam in people with epilepsy. Epilepsia . 2011;52:810–815.
Kesselheim AS, Misono AS, Lee JL, et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA . 2008;300:2514–2526.
Weitzel J, Erzkamp S, Langer K, et al. Effects of generic exchange of solid oral dosage forms in neurological disorders: a systematic review. Int J Clin Pharmacol . 2020;42:393–417.
Rabey JM, Klein C, Molochnikov A, et al. Comparison of the Unified Parkinson’s Disease Rating Scale and the Short Parkinson’s Evaluation Scale in patients with Parkinson’s disease after levodopa loading. Clin Neuropharmacol . 2002;25:83–88.
Kesselheim AS, Misono AS, Shrank WH, et al. Variations in pill appearance of antiepileptic drugs and the risk of nonadherence. JAMA Intern Med . 2013;173:202–208.
Håkonsen H, Eilertsen M, Borge H, et al. Generic substitution: additional challenge for adherence in hypertensive patients? Curr Med Res Opin . 2009;25:2515–2521.
Huang X, Lin J, Demner-Fushman D. Evaluation of PICO as a knowledge representation for clinical questions. AMIA Annu Symp Proc . 2006;359–363.
Moher D, Shamseer L, Clarke M, et al. Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement. Syst Rev . 2015;4:1.
Gelbe Liste Pharmindex. Available at: https://www.gelbe-liste.de/identa . Updated February 16, 2022. Accessed February 16, 2022.
Hoehn MM, Yahr MD. Parkinsonism onset, progression and mortality. Neurology . 1967;17:427–442.
McHugh ML. The chi-square test of independence. Biochem Med (Zagreb) . 2013;23:143–149.
Newman M, Barkema G. Monte Carlo Methods in Statistical Physics . New York: Oxford University Press; 1999.
Gignac GE, Szodorai ET. Effect size guidelines for individual differences researchers. Personal Individ Differ . 2016;102:74–78.
Bortz J, Schuster C. Statistik für Human- und Sozialwissenschaftler. 7. vollständig überarbeitete und erweiterte Auflage . Berlin, Heidelberg: Springer-Verlag Berlin Heidelberg; 2010. Springer-Lehrbuch. Available at: http://site.ebrary.com/lib/alltitles/docDetail.action?docID=10448295 . Accessed February 16, 2022.
Weiß C. Basiswissen Medizinische Statistik. 3. überarbeitete Auflage. Berlin, Heidelberg: Springer Medizin Verlag Heidelberg; 2005. Springer-Lehrbuch. doi: 10.1007/3-540-28549-0.
Kennedy WP. The nocebo reaction. Med World . 1961;95:203–205.
Benedetti F, Pollo A, Lopiano L, et al. Conscious expectation and unconscious conditioning in analgesic, motor, and hormonal placebo/nocebo responses. J Neurosci . 2003;23:4315–4323.
Mercado R, Constantoyannis C, Mandat T, et al. Expectation and the placebo effect in Parkinson’s disease patients with subthalamic nucleus deep brain stimulation. Mov Disord . 2006;21:1457–1461.
Chambers JA, O’Carroll RE, Dennis M, et al. “My doctor has changed my pills without telling me”: impact of generic medication switches in stroke survivors. J Behav Med . 2014;37:890–901.
Toverud E-L, Røise AK, Hogstad G, et al. Norwegian patients on generic antihypertensive drugs: a qualitative study of their own experiences. Eur J Clin Pharmacol . 2011;67:33–38.
Sarpatwari A, Gagne JJ, Lu Z, et al. A survey of patients’ perceptions of pill appearance and responses to changes in appearance for four chronic disease medications. J Gen Intern Med . 2019;34:420–428.
Barenie RE, Kesselheim AS, Gagne JJ, et al. Preferences for and experiences with pill appearance changes: national surveys of patients and pharmacists. Am J Manag Care . 2020;26:340–347.
Kieble M. Im Jahr 2020 wurden bei 234 Tsd. in Apotheken abgegebenen Packungen von Antiparkinsonmitteln pharmazeutische Bedenken geltend gemacht. Available at: https://www.dapi.de/aktuelles/zahl-des-monats/im-jahr-2020-wurden-bei-234-tsd-in-apotheken-abgegebenen-packungen-von-antiparkinsonmitteln-pharmazeutische-bedenken-geltend-gemacht . Accessed February 15, 2022.
Schröder S, Martus P, Odin P, et al. Impact of community pharmaceutical care on patient health and quality of drug treatment in Parkinson’s disease. Int J Clin Pharmacol . 2012;34:746–756.
Burgos R, Bretón I, Cereda E, et al. ESPEN guideline clinical nutrition in neurology. Clin Nutr . 2018;37:354–396.
Bird MR, Woodward MC, Gibson EM, et al. Asymptomatic swallowing disorders in elderly patients with Parkinson’s disease: a description of findings on clinical examination and videofluoroscopy in sixteen patients. Age Ageing . 1994;23:251–254.
Bushmann M, Dobmeyer SM, Leeker L, et al. Swallowing abnormalities and their response to treatment in Parkinson’s disease. Neurology . 1989;39:1309–1314.
Coelho M, Marti MJ, Tolosa E, et al. Late-stage Parkinson’s disease: the Barcelona and Lisbon cohort. J Neurol . 2010;257:1524–1532.
Go CL, Rosales RL, Schmidt P, et al. Generic versus branded pharmacotherapy in Parkinson’s disease: does it matter? A review. Parkinsonism Relat Disord . 2011;17:308–312.
Parkinson’s Foundation. Available at: https://www.parkinson.org/Understanding-Parkinsons/Treatment/Prescription-Medications/Generic-vs-Branded-Drugs . Accessed 16.02.022.
Duh MS, Paradis PE, Latrémouille-Viau D, et al. The risks and costs of multiple-generic substitution of topiramate. Neurology . 2009;72:2122–2129.
LeLorier J, Duh MS, Paradis PE, et al. Clinical consequences of generic substitution of lamotrigine for patients with epilepsy. Neurology . 2008;70(22 Pt 2):2179–2186.
Gasser UE, Fischer A, Timmermans JP, et al. Pharmaceutical quality of seven generic levodopa/benserazide products compared with original Madopar® / Prolopa®. BMC Pharmacol Toxicol . 2013;14:24.
Keller GA, Czerniuk P, Bertuola R, et al. Comparative bioavailability of 2 tablet formulations of levodopa/benserazide in healthy, fasting volunteers: a single-dose, randomized-sequence, open-label crossover study. Clin Ther . 2011;33:500–510.
Pahwa R, Marjama J, McGuire D, et al. Pharmacokinetic comparison of Sinemet and Atamet (generic carbidopa/levodopa): a single-dose study. Mov Disord . 1996;11:427–430.
Torti M, Alessandroni J, Bravi D, et al. Clinical and pharmacokinetics equivalence of multiple doses of levodopa benserazide generic formulation vs the originator (Madopar). Br J Clin Pharmacol . 2019;85:2605–2613.