scholarly journals The Impact of Modifications of the Formula for Generic Drug Prescription Rate on the Switch To New Brand-Name Drugs With Similar Therapeutic Uses

2014 ◽  
Vol 17 (7) ◽  
pp. A499
Author(s):  
S. Shimizu ◽  
S. Imai ◽  
K.B. Ishikawa ◽  
S. Ikeda ◽  
K. Fushimi
Keyword(s):  
Generic Drug ◽  
Drug Prescription ◽  
Prescription Rate ◽  
Brand Name ◽  
Therapeutic Uses ◽  
The Impact ◽  
Brand Name Drugs

Indication-Specific Generic Uptake of Imatinib Demonstrates the Impact of Skinny Labeling

2022 ◽  
Author(s):  
Bryan S. Walsh ◽  
Aaron S. Kesselheim ◽  
Ameet Sarpatwari ◽  
Benjamin N. Rome
Keyword(s):  
Patent Protection ◽  
Cross Sectional Study ◽  
Myelogenous Leukemia ◽  
Brand Name ◽  
Generic Competition ◽  
Cross Sectional ◽  
The Us ◽  
Lower Drug ◽  
The Impact ◽  
Brand Name Drugs

PURPOSE Generic competition can be delayed if brand-name manufacturers obtain additional patents on supplemental uses. The US Food and Drug Administration allows generic drug manufacturers to market versions with skinny labels that exclude patent-protected indications. This study assessed whether use of generic versions of imatinib varied between indications included and excluded from the skinny labels. METHODS In this cross-sectional study, we identified adult patients covered by commercial insurance or Medicare Advantage plans who initiated imatinib from February 2016 (first generic availability) to September 2020. Generic versions were introduced with skinny labels that included indications covering treatment of chronic myelogenous leukemia (CML) but excluded treatment of gastrointestinal stromal tumors (GISTs) because of remaining patent protections. Logistic regression was used to determine whether use of generic versus brand-name imatinib differed between patients with a diagnosis of CML or GIST, adjusting for demographics, insurance type, prior use of brand-name drugs, and calendar month. RESULTS Among 2,000 initiators, 934 (47%) had CML and 686 (34%) had GIST. Within 3 years after generics entered the market, more than 90% of initiators in both groups used generic imatinib. Initiation of generic imatinib was slightly lower among patients with GIST than among patients with CML (85% v 88%; adjusted odds ratio 0.56; 95% CI, 0.39 to 0.80; P ≤ .001). CONCLUSION Generic versions of imatinib were dispensed frequently for indications both included (CML) and excluded (GIST) from the skinny labeling, although patients with GIST were slightly less likely to receive a generic version. The skinny labeling pathway allowed generics to enter the market before patent protection for treating patients with GIST expired, facilitating lower drug prices.

Drug prescription pattern in European neonatal units

2018 ◽  
Author(s):  
Inge Mesek ◽  
Georgi Nellis ◽  
Jana Lass ◽  
Tuuli Metsvaht ◽  
Heili Varendi ◽  
...  
Keyword(s):  
Drug Use ◽  
Parenteral Nutrition ◽  
Large Scale ◽  
Alimentary Tract ◽  
Drug Prescription ◽  
Demographic Data ◽  
Geographic Region ◽  
International Studies ◽  
Prescription Rate ◽  
The Impact

ABSTRACTBackgroundHospitalized neonates receive the highest number of drugs compared to all other age groups, but consumption rates vary between studies depending on patient characteristics and local practices. There are no large scale international studies on drug use in neonatal units. We aimed to describe drug use in European neonatal units and characterize its associations with geographic region and gestational age (GA).MethodsA one-day point prevalence study (PPS) was performed as part of the European Study of Neonatal Exposure to Excipients (ESNEE) from January to June 2012. All neonatal prescriptions and demographic data were registered in a web-based database. The impact of GA and region on prescription rate were analyzed with logistic regression.ResultsIn total, 21 European countries with 89 neonatal units participated. Altogether 2173 prescriptions given to 726 neonates were registered. The 10 drugs with the highest prescription rate were multivitamins, vitamin D, caffeine, gentamicin, amino acids for parenteral nutrition, phytomenadione, ampicillin, benzylpenicillin, fat emulsion for parenteral nutrition and probiotics. The six most commonly prescribed ATC groups (alimentary tract and metabolism, blood and blood-forming organs, systemic anti-infectives, nervous, respiratory and cardiovascular system) covered 98% of prescriptions. GA significantly affected the use of all commonly used drug groups. Geographic region influenced the use of alimentary tract and metabolism, blood and blood-forming organs, systemic anti-infectives, nervous and respiratory system drugs.ConclusionsWhile GA-dependent differences in neonatal drug use were expected, regional variations (except for systemic anti-infectives) indicate a need for cooperation in developing harmonized evidence-based guidelines and suggest priorities for collaborative work.

scholarly journals Generic substitutions of antiepileptic drugs: Is it possible to put an end to the discussion?

2018 ◽  
Vol 10 (1S) ◽  
pp. 75-80
Author(s):  
E. A. Ushkalova ◽  
S. K. Zyryanov ◽  
K. E. Zatolochina
Keyword(s):  
Cost Effectiveness ◽  
Antiepileptic Drugs ◽  
Economic Benefits ◽  
Brand Name ◽  
Regulatory Requirements ◽  
The Cost ◽  
Generic Instability ◽  
The Impact ◽  
Brand Name Drugs

A policy on generic substitutions, which is aimed at reducing the cost-effectiveness of pharmacotherapy, was proposed by the WHO at the end of the 20th century; however, but the debate about their  economic benefits has continued until now. There have been the  most active discussions of whether an epileptic patient may be  switched from brand-name to generic antiepileptic drugs. The paper  gives data obtained in Russian and foreign studies of the therapeutic  efficacy and safety of anticonvulsant generics versus their brand- name drugs, as well as the impact of generic substitutions on the cost-effectiveness of  antiepileptic therapy. Emphasis is placed on the importance of the  quality of generic medicines, their dosage forms, and regulatory requirements for registration of generics. The problem of generic instability is under discussion.

The Association between Industry Payments and Brand-Name Prescriptions in Otolaryngologists

2019 ◽  
Vol 161 (4) ◽  
pp. 605-612 ◽  
Author(s):  
Elliot Morse ◽  
Jonathan Hanna ◽  
Saral Mehra
Keyword(s):  
Drug Prescription ◽  
Medicare Part D ◽  
Medicare Part ◽  
Brand Name ◽  
Part D ◽  
Individual Physician ◽  
Kendall’S Τ ◽  
The Individual ◽  
Dollar Amount ◽  
Brand Name Drugs

Objective To associate pharmaceutical industry payments to brand-name prescriptions by otolaryngologists. Study Design Retrospective cross-sectional analysis. Setting Open Payments Database and the Medicare Part D Participant User File 2013-2016. Subjects and Methods We identified otolaryngologists receiving nonresearch industry payments and prescribing to Medicare Part D recipients. Records were linked by physician name and state. The value of industry payments and the percentage of brand-name drugs prescribed per hospital referral region (HRR) were characterized as medians. Industry payments were correlated to the rate of brand-name prescription by Kendall’s τ correlation. This was repeated at the individual physician level and stratified by payment type. Results In total, 8167 otolaryngologists received a median of $434 (interquartile range, $138-$1278) in industry compensation over 11 (3-26) payments. Brand-name drugs made up a median of 12.9% (8.6%-18-4%) of each physician’s drug claims. The number (τ = 0.05, P < .001) and dollar amount (τ = 0.04, P < .001) of industry payments were correlated with the rate of brand-name drug prescription at the individual physician level. The number of industry payments was also associated with the rate of brand-name prescription by HRR (τ = 0.14, P < .001), but the dollar amount was not. By HRR, food and beverage payments received by physicians were associated with the rate of brand-name drug prescription (τ = 0.04, P < .001), but travel and lodging payments were not. Conclusions Industry financial transactions are associated with brand-name drug prescriptions in otolaryngologists, and these associations are stronger at the regional level than at the individual physician level. These correlations are of modest strength and should be interpreted cautiously by readers.

scholarly journals COMPARISON BETWEEN GENERIC DRUGS AND BRAND NAME DRUGS FROM BIOEQUIVALENCE AND THERMOEQUIVALENCE PROSPECTIVE

2017 ◽  
Vol 9 (6) ◽  
pp. 1 ◽  
Author(s):  
Mosab Arafat ◽  
Zahaa Ahmed ◽  
Osama Arafat
Keyword(s):  
Generic Drug ◽  
Active Ingredient ◽  
Generic Drugs ◽  
Pharmacokinetic Parameters ◽  
Drug Preparation ◽  
Brand Name ◽  
Drug Bioavailability ◽  
Polymer Carrier ◽  
Inactive Ingredients ◽  
Brand Name Drugs

The belief that generic drugs are inferior to brand name drugs has been always under debate. Especially since the price of generic drugs is generally far cheaper than brand-name drugs. Although, this is because of waiving the preclinical studies and clinical trials for the generic drug, the quality, and purity of materials used for generic drug preparation is still arguable. Thus, the objective of this overview was to find out the tolerable deviations between generic and brand name drugs which should not alter the pharmacology. Using inactive additives in the generic drug different than in the brand name drug, such as binders, glidants, diluents, anti-adherents, disintegrants or polymer carrier material and filler should not change the drug bioavailability and pharmacokinetic parameters as long as both products using the identical active ingredient(s) in equivalent amounts. Even if both drug products are bioequivalent to each other in terms of active ingredient, they are not in terms of inactive ingredients. Hence, the probability of unexpected adverse drug reaction and allergies from the generic formulation are possible, especially, when people react sensitive toward specific component. Therefore, the occasional negative response occurring upon the switch from brand-name drug to the generic drug can be attributed to intra-and inter-patient variations toward inactive ingredients. Variations toward inactive ingredients can be obtained experimentally by utilizing a proper thermoanalytical technique. As a result, thermoequivalence of generic drugs to brand name drugs can be determined based on thermal information obtained from both products. In conclusion, thermoequivalence study can be a useful tool to demonstrate any possible variation between the inactive ingredients of both products.

scholarly journals Continuing trends in U.S. brand-name and generic drug competition

2021 ◽  
pp. 1-1
Author(s):  
Henry Grabowski ◽  
Genia Long ◽  
Richard Mortimer ◽  
Mehmet Bilginsoy
Keyword(s):  
Generic Drug ◽  
Brand Name
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