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Special Issue "Generic Drugs"

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A special issue of Pharmaceuticals (ISSN 1424-8247).

Deadline for manuscript submissions: closed (30 April 2010)

Special Issue Editor

Guest Editor
Andrew Nathan Wilner, MD (Website)

111 Durfee Street, P.O. Box 831, Fall River, MA 02722, USA

Special Issue Information

Dear Colleagues,

The pressure to contain health care costs has propelled the prescribing of generic drugs and the practice of generic substitution. For people with epilepsy, for example, the switch from brand to generic, generic to generic, or generic to brand may come with the risks of adverse events and breakthrough seizures, although the magnitude of these risks and the vulnerable populations remain undefined. Frequent anecdotal reports from patients and physicians are echoed in survey data regarding the lack of bioeffectiveness of generic epilepsy drugs, despite FDA mandated “bioequivalence.” Claims data suggest that epilepsy patients who take generic drugs have an increased use of health care resources such as emergency room visits, hospitalizations, and other medications, challenging the argument that generic drugs are “cost effective.” The purpose of this special issue is to assess the current status of generic drugs with respect to effectiveness, tolerability, safety, and quality of life in the treatment of epilepsy and other diseases, and to help guide policy development and physicians in the care of their patients.

Dr. Andrew Nathan Wilner
Guest Editor

Keywords

  • adverse events
  • antiepileptic drugs
  • bioequivalence
  • brand
  • substitution
  • breakthrough seizures
  • cost effective
  • epilepsy
  • generic drugs
  • generic substitution
  • therapeutic range

Published Papers (2 papers)

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Review

Open AccessReview Use of Generics—A Critical Cost Containment Measure for All Healthcare Professionals in Europe?
Pharmaceuticals 2010, 3(8), 2470-2494; doi:10.3390/ph3082470
Received: 1 July 2010 / Revised: 27 July 2010 / Accepted: 4 August 2010 / Published: 5 August 2010
Cited by 41 | PDF Full-text (215 KB) | HTML Full-text | XML Full-text
Abstract
Pharmaceutical expenditures in ambulatory care rose rapidly in Europe in the 1990s and early 2000s. This was typically faster than other components of healthcare spending, leading to reforms to moderate future growth. A number of these centered on generic medicines with measures [...] Read more.
Pharmaceutical expenditures in ambulatory care rose rapidly in Europe in the 1990s and early 2000s. This was typically faster than other components of healthcare spending, leading to reforms to moderate future growth. A number of these centered on generic medicines with measures to lower reimbursed prices as well as enhance their prescribing and dispensing. The principal objective of this paper is to review additional measures that some European countries can adopt to further reduce reimbursed prices for generics. Secondly, potential approaches to address concerns with generics when they arise to maximize savings. Measures to enhance the prescribing of generics will also briefly be discussed. A narrative review of the extensive number of publications and associated references from the co-authors was conducted supplemented with known internal or web-based articles. In addition, health authority and health insurance databases, principally from 2001 to 2007, were analyzed to assess the impact of the various measures on price reductions for generic omeprazole and generic simvastatin vs. pre-patent loss prices, as well as overall efficiency in Proton Pump Inhibitor (PPI) and statin prescribing. The various initiatives generally resulted in considerable lowering of the prices of generics as well as specifically for generic omeprazole and generic simvastatin vs. pre-patent loss prices. At one stage in the UK, generic simvastatin was just 2% of the originator price. These measures also led to increased efficiency for PPI and statin prescribing with reimbursed expenditure for the PPIs and statins either falling or increasing at appreciably lower rates than increases in utilization. A number of strategies have also been introduced to address patient and physician concerns with generics to maximize savings. In conclusion, whilst recent reforms have been successful, European countries must continue learning from each other to fund increased volumes and new innovative drugs as resource pressures grow. Policies regarding generics and their subsequent impact on reimbursement and utilization of single sourced products will continue to play a key role to release valuable resources. However, there must continue to be strategies to address concerns with generics when they exist. Full article
(This article belongs to the Special Issue Generic Drugs)
Open AccessReview Generic Medicine Pricing Policies in Europe: Current Status and Impact
Pharmaceuticals 2010, 3(3), 471-481; doi:10.3390/ph3030471
Received: 8 December 2009 / Revised: 11 February 2010 / Accepted: 3 March 2010 / Published: 5 March 2010
Cited by 17 | PDF Full-text (203 KB) | HTML Full-text | XML Full-text
Abstract
Generic medicine pricing is an area of national responsibility of European Union countries. This article aims to present the current status and impact of generic medicine pricing policies in ambulatory care in Europe. The study conducts a literature review of policies relating [...] Read more.
Generic medicine pricing is an area of national responsibility of European Union countries. This article aims to present the current status and impact of generic medicine pricing policies in ambulatory care in Europe. The study conducts a literature review of policies relating to free-pricing systems, price-regulated systems, price differentiation, price competition and discounts, and tendering procedures; and a survey of European generic medicine pricing policies. Competition from Indian generic medicine manufacturers, European variation in generic medicine prices and competition between generic medicine manufacturers by discount suggest that the potential savings to health care payers and patients from generic medicines are not fully realized in Europe. One way of attaining these savings may be to move away from competition by discount to competition by price. Free-pricing systems may drive medicine prices downwards under specific conditions. In price-regulated systems, regulation may lower prices of originator and generic medicines, but may also remove incentives for additional price reductions beyond those imposed by regulation. To date, little is known about the current status and impact of tendering procedures for medicines in ambulatory care. In conclusion, the European experience suggests that there is not a single approach towards developing generic medicine pricing policies in Europe. Full article
(This article belongs to the Special Issue Generic Drugs)

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