The impact of generic reference pricing interventions in the statin market

The objective of this study was to evaluate the intended and unintended impact on pharmaceutical use and sales of three public financing reforms applied to the prescription of statins: a Spanish generic reference pricing (RP) system for lovastatin and simvastatin, and two competing policies introduced by the Andalusian Public Health Service (APHS) for all statins, first a maximum consumer price (MCP) and then a so called quality prescribing incentive for general practitioners (MCP plus PI).This study is designed as an observational, retrospective, interrupted time series analysis with comparison series (APHS and the rest of Spain) of 46 monthly drug use and sales ratios from January 2001 to October 2004 for each active ingredient in the group of statins.RP has been effective at reducing the volume of sales growth of the off-patent statins, yet its overall impact on sales of all statins has been relatively modest. The quantity and volume of sales impact heavily depends on regulatory RP details such as when the system is introduced, how often it is updated, and how the reference price is calculated.

Taste acceptability of pulverized brand-name and generic drugs containing amlodipine or candesartan.

Trials with pulverized brand-name antihypertensive drugs suggest that, from the perspective of taste acceptability, crushed candesartan, chlortalidon, hydrochlorothiazide, lercanidipine and lisinopril should be preferred to pulverized amlodipine, atenolol, bisoprolol, enalapril, irbesartan, losartan, ramipril, telmisartan and valsartan. Brand-name antihypertensive drugs and the corresponding generic medicines have never been compared with respect to their taste acceptability. We therefore investigated among healthy health care workers the taste acceptability of a pulverized 1 mg-test dose of the brand-name and two generics containing either the dihydropyridine calcium-channel blocker amlodipine (Norvasc(®), Amlodipin-Mepha(®) and Amlodipin Pfizer(®)) or the angiotensin receptor antagonist candesartan (Atacand(®), Cansartan-Mepha(®) and Pemzek(®)). For this purpose, a smiley-face scale depicting four degrees of pleasure was used. Between November and December 2013, the taste test was performed among 19 nurses (15 female and 4 male subjects) and 12 physicians (5 female and 7 male subjects) aged between 25 and 49 years. Pulverized brand-names and generics containing either amlodipine or candesartan did not differ with respect to their taste acceptability.

An exploration of pharmacy-specific reasons for non-adherence to prescribed medicines in a socioeconomically deprived, ethnically diverse UK cohort

Methods - Ethical approval for the study was granted by both the local National Health Service (NHS) Research Ethics Committee (REC) and Aston University’s REC. Seven focus groups were conducted between October and December 2011 in medical or community settings within inner-city Birmingham (UK). Discussions were guided by a theme plan which was developed from key themes identified by a literature review and piloted via a Patient Consultation Group. Each focus group had between 3 and 7 participants. The groups were digitally recorded and subsequently transcribed verbatim. The transcriptions were then subjected to thematic analysis via constant comparison in order to identify emerging themes. Results - Participants recognised the pharmacist as an expert source of advice about prescribed medicines, a source they frequently felt a need to consult as a result of the inadequate supply of medicines information from the prescriber. However, an emerging theme was a perception that pharmacists had an oblique profit motive relating to the supply of generic medicines with frequent changes to the ‘brand’ of generic supplied being attributed to profit-seeking by pharmacists. Such changes had a negative impact on the patient’s perceived efficacy of the therapy which may make non-adherence more likely. Conclusions - Whilst pharmacists were recognised as medicines experts, trust in the pharmacist was undermined by frequent changes to generic medicines. Such changes have the potential to adversely impact adherence levels. Further, quantitative research is recommended to examine if such views are generalisable to the wider population of Birmingham and to establish if such views impact on adherence levels.

Análise do impacto na despesa pública com medicamentos decorrente da alteração do sistema de preços de referência

RESUMO - Com o presente trabalho pretende-se analisar o impacto na despesa pública com medicamentos decorrente da implementação do Decreto-Lei 48-A/2010, de 13 de Maio, e do Decreto-Lei 106-A/2010, de 1 de Outubro, nos anos de 2011 e 2012. Os referidos diplomas alteraram as regras de formação do preço de referência e terão contribuído para a redução da despesa do SNS com medicamentos verificada em 2011 e 2012. Crê-se que antes da implementação dos referidos diplomas, o mercado concorrencial de medicamentos genéricos não apresentava a competição necessária, não se verificando a aproximação dos preços praticados ao seu custo marginal, de acordo com o previsto na teoria económica clássica. Pretende-se identificar o mercado total dos grupos homogéneos e analisar 50% do seu valor, através da identificação do preço de referência efectivo do 1º trimestre de 2011 ao 4º trimestre de 2012 e do cálculo do preço de referência expectável, na ausência da implementação dos referidos diplomas, com base nas regras existentes antes da implementação dos referidos diplomas. A identificação o peso relativo da alteração das regras do sistema de preços de referência, na despesa do SNS com medicamentos ocorrida em 2011 e 2012, poderemos delinear com maior rigor futuras estratégicas de controlo da despesa pública com medicamentos. Um factor de especial relevância dado o contexto actual de austeridade.

Desafios da indústria farmacêutica brasileira

The paper traces a panorama of the development of new drugs and hopes to contribute for Brazil to become a player in the discovery of new drugs. Brazil is the sixth world market retail consumer of medicines prone to expansion, has a pharmaceutical industry focused on the production of generics and a very large number of undergraduate courses in Pharmacy. The national industry has grown over the last decade after the Generics Act 9787/99. Despite these positive aspects, a number of bottlenecks prevent Brazilian pharmaceutical industry to invest in the development of new drugs. There are, however, a number of initiatives to reduce the dependence on imported generic drugs. It is a very good start for the development of new pharmaceutical drugs.

América Latina y el Caribe: la propiedad intelectual después de los tratados de libre comercio

Incluye Bibliografía

Estabilidade, polimorfismo, dissolução e correlação in vivo-in vitro de Darunavir comprimidos

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Medication adherence and direct treatment cost among diabetes patients attending a tertiary healthcare facility in Ogbomosho, Nigeria

Background Diabetes mellitus (DM) is now prevalent in many countries in sub- Saharan Africa, with associated health and socioeconomic consequences. Adherence to antidiabetic medications has been shown to improve glycaemic control, which subsequently improves both the short- and longterm prognosis of the disease. The main objective of this study was to assess the level of adherence to antidiabetic drugs among outpatients in a teaching hospital in southwestern Nigeria. Methods A cross-sectional study was carried out using the eight-item Morisky Medication Adherence Scale (MMAS-8) among diabetic patients attending the medical outpatients’ diabetes clinic of Ladoke Akintola University Teaching Hospital, in Ogbomosho, Oyo State in southwestern Nigeria, during a three-month period (October to December 2013). Results A total of 129 patients participated in the study with a male-to-female ratio of 1:1.5. Seventy-eight (60.5%) patients had systemic hypertension as a comorbid condition while the remaining were being managed for diabetes mellitus alone. Only 6 (4.7%) of the patients had type 1 DM while the remaining 123 (95.3%) were diagnosed with type 2 DM. Metformin was the most prescribed oral hypoglycaemic agent (n = 111, 58.7%) followed by glibenclamide (n = 49, 25.9%). Medication adherence was classified as good, medium, and poor for 52 (40.6%), 42 (32.8%), and 34 (26.6%) patients, respectively. Medication costs accounted for 72.3% of the total direct cost of DM in this study, followed by the cost of laboratory investigations (17.6%). Conclusion Adherence of diabetes patients in the study sample to their medications was satisfactory. There is a need for the integration of generic medicines into routine care as a way of further reducing the burden of healthcare expenditure on the patients.

The right to health, the TRIPS agreement and the public health safeguards to encourage the universal access to essential medicines

The privileges arising from patent protection on pharmaceutical products often prevent the full realization of the right to health, especially in developing countries with scarce resources. This thesis first identifies the international agreements that have established the right to health in international law, obligations and violations associated with it, the problems encountered in the implementation of human rights on the field, compared with the implementation and sanctions associated with economic rights from the World Trade Organization regulatory framework. A comparative study of the legislative frameworks of both developed and developing countries will reveal to what extent Canada, the United States, the European Union, Brazil, India, and South Africa conformed with patent protection exceptions arising from international patent law to protect public health. Finally, the author identifies the crucial indicators that need to be considered in order to assess the conformity of a given approach with the right to health, before he underscores the temporary character of the relevant WTO measures, and the future stakes concerning an increased access to essential medicines.

Quality of medicines stored together in multi-compartment compliance aids

Background and Objective: Dispensing medicines into compliance aids is a common practice in pharmacy contrary to manufacturers’ advice and studies have shown the appearance of light-sensitive tablets is compromised by such storage; we previously found evidence of reduced bioavailability at elevated temperature and humidity. Our objective was to examine the physicochemical stability of two generic atenolol tablets in different compliance aids and with aspirin co-storage at room temperature and at 40 °C/75% relative humidity. Methods: The physicochemical stability of atenolol tablets was evaluated after 28 days of storage and compared with controls by examining visual appearance, weight, disintegration, dissolution, friability and hardness to accepted standards and using a previously validated HPLC method for chemical assay. Results and Discussion: The response to storage was brand-dependent and not straightforward. With one make of atenolol (Alpharma), storage in compliance aids even at room temperature impacted on physical stability, reducing tablet hardness, with storage in Dosett® exerting a greater impact than storage in Medidos® (t-test P < 0·001). Co-storage at elevated temperature and humidity also impacted on the appearance of non-coated aspirin tablets (Angette™). The chemical stability of atenolol was not affected and we did not find evidence of changes to bioavailability with either make. Certainly data for one atenolol make (CP Pharmaceuticals) co-stored with aspirin (Angette™ and Nu-Seals) in both compliance aids at room temperature provided evidence of short-term stability. But medicines are dispensed into compliance aids in multi-factorial ways so our study highlights not only the lack of evidence but also a realization that evidence to support real practice may not be accomplished through research. Conclusion: Reassuring practitioners of the continued stability of medicines in compliance aids under the countless condition in which they are dispensed in practice may requires a different approach involving medical device regulators and more definitive professional guidance.

POPREP: a generic report for population management

Genetic variation provides a basis upon which populations can be genetically improved. Management of animal genetic resources in order to minimize loss of genetic diversity both within and across breeds has recently received attention at different levels, e. g., breed, national and international levels. A major need for sustainable improvement and conservation programs is accurate estimates of population parameters, such as rate of inbreeding and effective population size. A software system (POPREP) is presented that automatically generates a typeset report. Key parameters for population management, such as age structure, generation interval, variance in family size, rate of inbreeding, and effective population size form the core part of this report. The report includes a default text that describes definition, computation and meaning of the various parameters. The report is summarized in two pdf files, named Population Structure and Pedigree Analysis Reports. In addition, results (e. g., individual inbreeding coefficients, rate of inbreeding and effective population size) are stored in comma-separate-values files that are available for further processing. Pedigree data from eight livestock breeds from different species and countries were used to describe the potential of POPREP and to highlight areas for further research.

ON GENERIC ROTATIONLESS DIFFEOMORPHISMS OF THE ANNULUS

Let f be a C(r)-diffeomorphism of the closed annulus A that preserves the orientation, the boundary components and the Lebesgue measure. Suppose that f has a lift (f) over tilde to the infinite strip (A) over tilde which has zero Lebesgue measure rotation number. If the rotation number of f restricted to both boundary components of (f) over tilde is positive, then for such a generic f (r >= 16), zero is an interior point of its rotation set. This is a partial solution to a conjecture of P. Boyland.

Generic hyperbolicity of stationary solutions for a reaction-diffusion system

In this paper, we study the generic hyperbolicity of equilibria of a reaction-diffusion system with respect to nonlinear terms in the set of C(2)-functions equipped with the Whitney Topology. To accomplish this, we combine Baire`s Lemma and the usual Transversality Theorem. (C) 2010 Elsevier Ltd. All rights reserved.

One-time signature scheme from syndrome decoding over generic error-correcting codes

We describe a one-time signature scheme based on the hardness of the syndrome decoding problem, and prove it secure in the random oracle model. Our proposal can be instantiated on general linear error correcting codes, rather than restricted families like alternant codes for which a decoding trapdoor is known to exist. (C) 2010 Elsevier Inc. All rights reserved,