Utilization of Generic Cardiovascular Drugs in Medicare’s Part D Program

Background: Generic medications cost less than brand-name medications and are similarly effective, but brand-name medications are still prescribed. We evaluated patterns in generic cardiovascular medication fills and estimated the potential cost savings with increased substitution of generic for brand-name medications. Methods: This was a cross-sectional study of cardiovascular therapies using the Medicare Part D database of prescription medications in 2017. We evaluated drug fill patterns for therapies with available brand-name and generic options. We determined the generic substitution ratio and estimated the potential savings with increased generic substitution at the national, state, and clinician level. We compared states with laws related to mandatory pharmacist generic substitution and patient consent for substitution. Results: Of ≈$22.9 billion spent on cardiovascular drugs in Medicare Part D prescription programs in 2017, ≈$11.0 billion was spent on medications with both brand-name and generic options. Although only 2.4% of medication fills were for the brand-name choice, they made up 21.2% of total spending. Accounting for estimated brand-name rebates, generic substitution for these medications would save $641 million, including $135 million in costs shouldered by patients. Furthermore, the minority of clinicians with the lowest generic utilization was responsible for a large proportion of the potential cost savings. Conclusions: There are substantial potential cost savings from substituting brand-name medications with generic medications. These savings would be primarily driven by lower use of brand-name therapies by the minority of clinicians who prescribe them at increased rates.

Knowledge, perceptions and practices of pharmacists regarding generic substitution in China: a cross-sectional study

ObjectiveTo evaluate pharmacists’ knowledge, perceptions and practices towards generic substitution in the 11 pilot locations in China.DesignAn online cross-sectional survey using questionnaires was conducted. A convenience sampling technique was implemented to recruit pharmacists.Setting and participantsThe study took place in medical institutions of 11 pilot locations that participated in the pilot national centralised procurement programme in 2019. Two thousand two hundred and ninety-one pharmacists including hospital pharmacists or community pharmacists based on health-systems or clinics participated in the study.ResultsMost of the participants had the good knowledge of requirements for evaluating the quality and efficacy of generic drugs (n=2118; 92.4%), and the definition of generic drugs (n=2078; 90.7%). In terms of perceptions, 67.3% of respondents were of the opinion that generic drugs are equally as effective as the brand-name drugs, and 69.0% of respondents were of the opinion that generic drugs are as safe as brand equivalents. A high percentage of participants supported the policy of generic substitution (n=1634; 71.4%). A significant positive correlation was demonstrated between total knowledge score and total perception score (ρ=0.267; p<0.001). Efficacy, safety and the direction of national policies and hospital regulations were the main factors affecting pharmacists’ willingness to dispense generic drugs.ConclusionsThe study identified gaps in respondents’ knowledge and perceptions of generic substitution. Pharmacists who are more knowledgeable in generic drugs tend to hold a more supportive attitude towards generic substitution. Although it appeared that pharmacists in China have largely accepted generic substitution, they still have concerns regarding the reliability and quality of generic drugs. The current issues need to be addressed for the realisation of the true value of generic drugs as part of the country’s healthcare cost-containment strategy as well as the implementation of generic substitution policy in China.

Structural Changes of Sodium Warfarin in Tablets Affecting the Dissolution Profiles and Potential Safety of Generic Substitution

At present, the risk of generic substitutions in warfarin tablets is still being discussed. The aim of this study was to assess whether API interactions with commonly used excipients may affect the safety of generic replacement of warfarin sodium tablets. These interactions were observed during an accelerated stability study, and the effect of the warfarin solid phase (crystalline/amorphous form) as well as the API particle size distribution was studied. Commercial tablets and prepared tablets containing crystalline warfarin or amorphous warfarin were used. In addition, binary mixtures of warfarin with various excipients were prepared. The structural changes before and after the stability study were monitored by dissolution test in different media, solid-state NMR spectroscopy and Raman microscopy. During the stability study, the conversion of the sodium in warfarin to its acid form was demonstrated by some excipients (e.g., calcium phosphate). This change in the solid phase of warfarin leads to significant changes in dissolution, especially with the different particle sizes of the APIs in the tablet. Thus, the choice of suitable excipients and particle sizes are critical factors influencing the safety of generic warfarin sodium tablets.

The Potential to Reduce Patient Co-Payment and the Public Payer Spending in Poland through an Optimised Implementation of the Generic Substitution: The Win-Win Scenario Suggested by the Real-World Big Data Analysis

High medication costs are one of the major barriers to patient adherence. Medication affordability might be improved by generic substitution. The aim of this study was to assess the effectiveness of the implementation of generic substitution mechanisms in Poland. This was a retrospective analysis of nationwide real-world big data corresponding to dispensation of metformin preparations in 2019 in Poland. Relevant prescription and dispensation data were compared to assess the prevalence of generic substitution and its economic consequences. Among the 1,135,863 e-prescriptions analysed, a generic substitution was found in only 4.81% of the packs dispensed, based on e-prescriptions issued for metformin under its originator version and 2.73% under generic drugs. It is estimated that if these values were applied to the total Polish drug market, patients could lose the opportunity to lower their co-payment by 15.91% and the national payer to reduce its reimbursement expenditures by 8.31%. Our results point at the suboptimal implementation of generic substitution in Poland. Therefore, relevant actions need to be taken in order to maximise the benefits provided by this mechanism. It could not only lead to the win-win scenario in which both patients and the national payer are secured substantial savings, but it could also have a positive impact on patient adherence.

Physicians’ Knowledge, Attitude and Practice of Generic Substitution in China: A Cross-Sectional Online Survey

The purpose of this study is to investigate physicians’ knowledge, attitudes and practice of generic medicine substitutions in China. We conducted a cross-sectional online questionnaire survey on physicians from secondary or tertiary hospitals in China from 2020 December to 2021 April. Descriptive statistical and ordered logistic regression were used for analysis. A total of 1225 physicians were included in the final analysis, and only 330 (26.94%) of them scored 4 or above in the knowledge part, which means that the physicians have a good knowledge of generic substitutions. Of the total, 586 (47.83%) agreed or strongly agreed that generic drugs could be substituted for originator drugs and 585 (47.75%) always or often prescribed generic medicines. The percentage of physicians with a positive attitude toward or that practice prescribing generic medicine is below 50%, which needs to be improved in China. Physicians’ knowledge, their attitude toward generic substitution, if familiar with the policy of generic substitution, and incentives for prescribing generic medicines are influencing factors for the practice of generic substitution. Our studies show that the practice of generic substitution by physicians could be improved by several measures in China. We suggested that the physicians should be taught more about the bulk-buy policy and the generic-originator equivalence evaluation policy. Moreover, government incentives to promote generic substitution should be established. Our study also suggested that physicians with less working experience and female physicians should learn more about generic substitution.

Prescription and dispensing guidelines in Lebanon: initiative of the Order of Pharmacists of Lebanon

Background In Lebanon, difficulties in accessing medications are due to two main barriers, mainly: high cost and the lack of medication safety, related to poor-quality (irrational) prescription and use. The objective of this work is to suggest guidelines to implement a unified medical prescription in Lebanon. These guidelines are expected to promote medication safety and decrease pharmaceutical expenditures in the Lebanese context. Methods The Order of Pharmacists of Lebanon (OPL) developed a comprehensive set of guidelines for physicians and pharmacists, including a detailed workflow process to improve the use of the unified medical prescription. The guidelines were presented to the Lebanese Ministry of Public Health (MOPH). Results The project covered prescription guidelines to physicians (handwritten and electronic-prescriptions), and medication dispensing and generic substitution guidelines to pharmacists. Prescription guidelines included all required information about both the prescribing physician and the patient with the maximum of details, comprehensibility, and caution regarding specific populations/co-morbidities/co-prescriptions. Dispensing guidelines included details for safe and appropriate treatment dispensing, pearls for medications’ counseling and generic substitution, as well as specific consideration for at-risk populations or those with concomitant medications and co-morbidities. Finally, a suggested workflow clarified the process for improving the unified medical prescription. Conclusions The implementation of the guidelines should now be formally evaluated, to assess if they achieve the aims to reduce prescribing and dispensing errors, to improve the quality of medicines' prescription and use, the patient care, and the interaction between all stakeholders