Perception and attitude of Korean physicians towards generic drugs

Ryu, Mikyung; Kim, Ju‐Young

doi:10.1186/s12913-017-2555-y

Cited by 7 publications

(8 citation statements)

References 10 publications

(17 reference statements)

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“…The standard for BE studies in South Korea has been comprehensively reformed since 2006 to be at par with the global standards ( Ryu and Kim, 2017 ). However, specific regulatory requirements are either absent or different from those of other countries.…”

Section: Introductionmentioning

confidence: 99%

Current Bioequivalence Study Designs in South Korea: A Comprehensive Analysis of Bioequivalence Study Reports Between 2013 and 2019

Huh

Kim²,

Lee³

et al. 2021

Front. Pharmacol.

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Demonstration of bioequivalence (BE) is mandatory while developing generic drugs. The scientific concept of BE applies equally to different regulatory agencies. However, the application of the concept may differ for each agency, which can affect the design of BE studies. To evaluate the study practices in terms of the BE concept in South Korea, we retrospectively analyzed BE study reports available from Ministry of Food and Drug Safety between 2013 and 2019. Statistical estimation of the pharmacokinetic parameters, including peak concentration and area under the concentration–time curve to the last measurable concentration, as well as study design, number of subjects in a study, study duration, fasting status, and formulation of specific drugs were obtained. The drugs were classified per World Health Organization Anatomical Therapeutic Chemical Classification and Biopharmaceutics Classification System. Post-hoc intrasubject coefficient of variation and corresponding sample sizes were calculated from the 90% confidence intervals of pharmacokinetic parameters. A total of 143 generic drugs in 588 BE studies were analyzed. The largest number of studies were performed in the area of Cardiovascular system (172 studies), followed by Nervous system (143 studies) and Alimentary tract and metabolism (92 studies). Overall, BE studies in South Korea were conducted in accordance with the global guideline despite the differences in details. BE studies were focused on the several therapeutic areas and conducted in a similar manner. The number of subjects was generally larger than that estimated with 90% power.

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Section: Introductionmentioning

confidence: 99%

Current Bioequivalence Study Designs in South Korea: A Comprehensive Analysis of Bioequivalence Study Reports Between 2013 and 2019

Huh

Kim²,

Lee³

et al. 2021

Front. Pharmacol.

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“…Since the opinions on ensuring safety measures and guaranteeing the quality of generic drugs compared to their original counterparts were also very positive, higher confidence in the processes of approval of medicinal products on the Czech market can be expected. Similarly, positive opinions have been reported in studies conducted in developed countries, where transparent, clear, and effective regulatory rules for generic substitution had been set up [27, 28]. On the other hand, healthcare professionals from countries with a less mature healthcare system appeared to have more concerned about the manufacturing sources of generics [20, 29, 30].…”

Section: Discussionmentioning

confidence: 81%

“…From the associations of socio-demographic characteristics, positive opinions on bioequivalence can be highlighted in ambulatory physicians, who are presumably more apt to prescribe drugs with higher benevolence than in physicians in the inpatient setting. The restrictions imposed by the hospital positive lists and the influence of pharmaceutical companies may also lead to lower willingness to prescribe generics [27]. However, the associations of individual results with sociodemographic characteristics should be generally considered with caution and confirmed in future research.…”

Section: Discussionmentioning

confidence: 99%

Representative sample survey on factors determining the Czech physicians’ awareness of generic drugs and substitution

Malý

Zimcikova

Babica

et al. 2019

BMC Health Serv Res

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BackgroundGeneric drugs and generic substitution belong to the tools by which healthcare costs may be reduced. However, low awareness and reluctance among healthcare professionals towards generic drugs may negatively affect the rational use of generic substitution.MethodsThe study aimed to analyze opinions and attitudes towards generic drugs and generic substitution among Czech physicians including their understanding of generic substitution legislative rules and the physicians´ previous experience in this field. Using random allocation, 1551 physicians practicing in the Czech Republic were asked to participate in the sociological representative survey conducted from November to December 2016, through face-to-face structured interviews comprising 19 items. Factor analysis as well as reliability analysis of items focused on legal rules in the context of physicians’ awareness were applied with p-value of < 0.05 as statistically significant.ResultsOf a total of 1237 (79.8%) physicians (43.7% males; mean age 47.5 ± 11.6 years, 46.3% general practitioners) 24.8% considered generic drugs to be less safe, especially those with specialized qualification (p < 0.01). However, only 4.4% of the physicians noticed any drug-related problems, including adverse drug reactions associated with generic substitution. The majority of physicians felt neutrally about performing generic substitution in pharmacies, nor they expressed any opinion on characteristics of generics, even though a better understanding of the legislation and higher need of accordance of substituted drugs were associated with more positive attitudes towards generic substitution (p < 0.05). Physicians showed low knowledge score of legislative rules (mean 3.9 ± 1.6 from maximum 9), nevertheless they overestimated the law, as they considered some rules valid, even if the law does not require them. Cronbach alpha of all legislative rules that regulate generic substitution increased from 0.318 to 0.553 if two optional rules (physician consent and strength equivalence) would be taken into account.ConclusionsThere is no sufficient awareness of generic drugs and generic substitution related issues among Czech physicians, although a deeper knowledge of legislation improves their perception about providing generic substitution.

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“…However, because generic drugs can be approved by confirming their bioequivalence without undergoing clinical trials, whether their clinical effects are equivalent to those of the original drug when administered in clinical settings remains controversial [ 6 , 7 ]. In a systematic review and meta-analysis comparing the safety and efficacy of original and generic cardiovascular drugs in 30 randomized controlled trials and 42 non-randomized clinical trials or observational studies, 60% of the studies identified no difference in effectiveness between original and generic administration, 26% found the original to be more efficacious and safer than the generic version, and 1% found the generic to be more effective than the original drug [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

Factors influencing drug switching and changes in low-density lipoprotein-cholesterol levels with atorvastatin: a real-world observational study

Lim,

Lee,

Park

2023

Lipids Health Dis

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Background Although generic drugs have been approved with the assurance of interchangeable applications with original drugs, some physicians, and patients still view their efficacy and interchangeability negatively. Using real-world data, we aimed to determine factors that impact switching between drugs that contain the same active ingredient, i.e., atorvastatin, and, in turn, whether this ‘switch’ could alter clinical outcomes. Methods Using the National Health Insurance Service senior cohort, a retrospective cohort study was conducted to assess patients who had newly started atorvastatin 10 mg and had at least two records of national health examinations from 2010 to 2014. Drug switching, which was defined as a change in the atorvastatin product administered 90 days before the first and second examinations, was assessed. Greedy propensity score matching (1:2) was performed between switchers and non-switchers to control for potential confounders. Factors influencing switching were analyzed using multivariate logistic regression to estimate odds ratios and 95% confidence intervals (CIs). Changes in low-density lipoprotein-cholesterol (LDL-C) levels attributable to drug switching were evaluated using difference-in-differences regression. Results A total of 1,588 patients were included, of whom 25.3% switched drugs (1,187 non-switchers and 401 switchers). Compared to patients taking generics before the first examination, those taking the original drugs had a lower odds ratio (0.31; 95% CI [0.21, 0.46]) for subsequent drug switching. A change in medical institution was associated with a significantly higher odds ratio (6.83; 95% CI [4.66, 10.02]). There were no significant differences in LDL-C alterations between switchers and non-switchers (0.42 mg/dL; 95% CI [-2.29, 3.13]). Conclusion The type of first-time drug administered and changes in medical institution can influence drug switching. No significant changes in LDL-C values were observed in the various switching scenarios between the original and generic drugs, suggesting their interchangeable application in real-world clinical practice.

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Perception and attitude of Korean physicians towards generic drugs

Cited by 7 publications

References 10 publications

Current Bioequivalence Study Designs in South Korea: A Comprehensive Analysis of Bioequivalence Study Reports Between 2013 and 2019

Current Bioequivalence Study Designs in South Korea: A Comprehensive Analysis of Bioequivalence Study Reports Between 2013 and 2019

Representative sample survey on factors determining the Czech physicians’ awareness of generic drugs and substitution

Factors influencing drug switching and changes in low-density lipoprotein-cholesterol levels with atorvastatin: a real-world observational study

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