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      Factors influencing the use of the “not for generic substitution” mention for prescriptions in primary care: a survey with general practitioners

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          Abstract

          Background

          Generic drug substitution is a public health policy challenge with high economic potential. Generic drugs are generally cheaper than brand-name drugs. Drugs are a significant part of the total health expenditure, especially in ambulatory care. We conducted a cross-sectional study with general practitioners in the Champagne-Ardenne region to determine physician-related factors and beliefs causing doctors to use the Not for Generic Substitution (NGS) mention.

          Methods

          Questionnaires were sent to General Practitioners (GPs) practicing in Champagne-Ardenne via 3 shipments, from January 2015 to May 2015. Prescriber characteristics and beliefs influencing the use of the NGS mention were assessed for frequent (≥ 5%) and less frequent (< 5%) users of the NGS mention.

          Results

          Factors associated with above average NGS mention use in bivariate analysis included patient comorbidity, polypharmacy, a concern that generic and brand-name drugs are not bioequivalent and belief in higher efficacy of the brand name drug. The use of an e-prescribing system (EPS) and medical practice in rural areas appeared to be associated with lower use of NGS mention in bivariate analysis but not in multivariable analysis. In multivariable analysis, patient request was associated with a higher use of the NGS mention (NGS ≥ 5%, adjusted Odds Ratio (aOR) = 2.52; 95% CI = [1.46–4.35]; p = 0.001), which was also linked to patient age over 65 (NGS ≥ 5%, aOR = 2.33; 95% CI = [1.03–5.30]; p = 0.04). The NGS mention was often used for drugs where substitution is debated in the literature (thyroid hormones, antiepileptic drugs).

          Conclusion

          This work highlights the involvement of the doctor-patient pair for the use of the NGS mention. Patient request was the major reason for using the NGS mention, even though it was not always endorsed by prescribers. Further studies are needed to assess patient views on generic drugs and drug substitution, accounting for their health status and socio-economic condition, to help improve the relevance of the information available to them.

          Electronic supplementary material

          The online version of this article (10.1186/s12913-018-3652-2) contains supplementary material, which is available to authorized users.

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          Most cited references20

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          Patients' perceptions of generic medications.

          Insurers and policymakers encourage the use of generic drugs to reduce costs, but generics remain underused. We conducted a national survey of commercially insured adults to evaluate their perceptions about generic drugs. Patients agreed that generics are less expensive and a better value than brand-name drugs, and are just as safe. However, although 56 percent reported that Americans should use more generics, only 37.6 percent prefer to take generics. We discuss perceptions about communicating with practitioners about generics, generic substitution, and policymakers' role in influencing generic use. These findings underscore the challenge that providers, insurers, and policymakers face in stimulating the cost-effective use of medications.
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            Bioequivalence and other unresolved issues in generic drug substitution.

            Substitution of generic drugs for brand-name products is highly controversial and often is met with suspicion by health care providers and patients. Historically, the debate has focused on the issue of bioequivalence, and clinical practice has identified a number of drug classes for which generic substitution should be approached with caution. Current bioequivalence requirements are based on a measure of average bioequivalence; however, there are fears that use of this measure may be inappropriate in the case of a drug with a narrow or wide therapeutic range or high intrasubject or intersubject variability. Under these circumstances, measures of individual and population bioequivalence are proposed to be more accurate than measures of average bioequivalence. This paper addresses issues of bioequivalence and other concerns with generic drug substitution. I conducted a MEDLINE search of the English-language literature containing the key terms generic, multisource, quality, and brand and published between 1973 and 2003. The names of branded pharmaceuticals whose patents had recently expired (eg, Ventolin HFA, Adalat, Capoten, Tagamet HB 200, and Valium) also were used to search for articles on generic substitution. Reference lists of relevant articles also were searched. Bioequivalence issues are presented together with more general concerns over generic drug substitution, such as consumer perception of risk, differences in product and packaging appearance, and differences in excipients. The literature reviewed act to highlight a number of different drug categories and patient subpopulations for which generic substitution can still prove to be problematic. I recommend that health care providers continue to exercise caution in the consideration of generic drug substitution under certain circumstances.
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              Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes.

              Compulsory generic substitution of antiepileptic drugs (AEDs) may lead to adverse effects in epilepsy patients because of seizure recurrence or increased toxicity. The study objectives were (a) to quantify and compare the switchback rates from generic to brand-name AEDs versus non-AEDs, and (b) to assess clinical implications of switching from branded Lamictal to generic lamotrigine (LTG) and whether signals exist suggesting outcome worsening. By using a public-payer pharmacy-claims database from Ontario, Canada, switchback rates from generic to branded AEDs [Lamictal, Frisium (clobazam; CLB), and Depakene (VPA; divalproex)] were calculated and compared with non-AED long-term therapies, antihyperlipidemics and antidepressants, in January 2002 through March 2006. We then assessed pharmacy utilization and AED dosage among LTG patients switching back to branded Lamictal compared with those staying on generic formulation. The 1,354 patients (403 monotherapy, 951 polytherapy) were prescribed generic LTG, of whom 12.9% switched back to Lamictal (11.7% monotherapy, 13.4% polytherapy). Switchback rates of other AEDs were approximately 20% for CLB and VPA. The switchback rates for AEDs were substantially higher than for non-AEDs (1.5-2.9%). Significant increases in LTG doses were observed after generic substitution for those who did not switch back (6.2%; p<0.0001). The average number of codispensed AEDs and non-AED drugs significantly increased (p<0.0001) after LTG generic entry, especially in the generic group. These results reflect poor acceptance of switching AEDs to generic compounds. They may also indicate increased toxicity and/or loss of seizure control associated with generic AED use.
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                Author and article information

                Contributors
                virgil.beauvais@ch-troyes.fr
                annabelle.marque@ch-troyes.fr
                g.ferte@wanadoo.fr
                jan.chrusciel@ch-troyes.fr
                jsouille@chu-reims.fr
                pnazeyrollas@chu-reims.fr
                0625036892 , Stephane.sanchez@ch-troyes.fr
                Journal
                BMC Health Serv Res
                BMC Health Serv Res
                BMC Health Services Research
                BioMed Central (London )
                1472-6963
                12 November 2018
                12 November 2018
                2018
                : 18
                : 850
                Affiliations
                [1 ]General Practice, 10000 Troyes, France
                [2 ]GRID grid.440376.2, Emergency Department, , Centre Hospitalier de Troyes, ; 10000 Troyes, France
                [3 ]ISNI 0000 0004 0472 3476, GRID grid.139510.f, Emergency Department, , Centre Hospitalier Universitaire de Reims, ; 51092 Reims, France
                [4 ]ISNI 0000 0004 0472 3476, GRID grid.139510.f, Cardiology Department, , Centre Hospitalier Universitaire de Reims, ; 51092 Reims, France
                [5 ]GRID grid.440376.2, Medical Information Department, , Centre Hospitalier de Troyes, ; 10000 Troyes, France
                [6 ]Troyes, France
                Author information
                http://orcid.org/0000-0002-0925-6948
                Article
                3652
                10.1186/s12913-018-3652-2
                6233580
                30419890
                1bed43f4-7db2-468b-8f3a-ec818b408e21
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 30 January 2018
                : 26 October 2018
                Funding
                Funded by: Hôpitaux Champagne Sud
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2018

                Health & Social care
                generic drugs,prescribing,not for generic substitution
                Health & Social care
                generic drugs, prescribing, not for generic substitution

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