Medicamentos órfãos em Portugal no contexto internacional (séculos XX-XXI) / Orphan drugs in Portugal in the international context (XX-XXI centuries)

A consciência científica, clínica e pública da existência das doenças raras tem aumentado nos últimos anos. Os medicamentos denominados de “medicamentos órfãos” são aqueles que são apropriados para o tratamento de doenças raras. As doenças raras, comparadas com outras doenças, apresentam uma baixa incidência demográfica. Por esta razão, e em virtude das condições vigentes de comercialização, as indústrias farmacêuticas não apostam fortemente nos medicamentos órfãos. Os produtores não teriam oportunidade de recuperar o capital investido na investigação e desenvolvimento do medicamento. Neste estudo os autores fazem um historial dos medicamentos órfãos em Portugal tendo como fontes a legislação e regulamentação portuguesas no quadro da legislação e diretivas europeias, o papel das indústrias farmacêuticas em Portugal, a regulamentação e fiscalização realizada pelo INFARMED, IP, bem como o acesso dos doentes aos medicamentos órfãos e o papel fulcral das associações de doentes (AU)

Using MyDispense to simulate validation of controlled substance prescriptions in a pharmacy law course.

BACKGROUND AND PURPOSE: MyDispense is an innovative, web-based program which simulates a community pharmacy. Use of this software may assist students' comprehension of validating controlled substance prescriptions by determining if prescriptions contain errors or omissions. EDUCATIONAL ACTIVITY AND SETTING: Fourteen MyDispense practice exercises were created and implemented into a required second-year pharmacy law course. Completion of the MyDispense exercises and performance on the pharmacy law midterm exam were recorded. A questionnaire was administered to students to receive feedback on the exercises. FINDINGS: There were complete data on all 94 student pharmacists enrolled in the didactic course. Thirty-five students (37%) completed all MyDispense exercises, 15 students (16%) completed some of the exercises, and 44 (47%) did not complete any of the exercises. Linear regression results indicate that students who completed more MyDispense exercises were significantly more likely to score higher on the midterm than those who completed fewer exercises (ß = 0.28, p = 0.02). Students reported moderate to high exercise value and a willingness to use the software in preparation for future pharmacy law examinations. SUMMARY: MyDispense provided a platform for students to apply controlled substance laws to the prescription validation process in the community pharmacy setting. Completion of practice exercises in MyDispense was shown to positively impact student performance on a pharmacy law midterm. Students valued the innovative simulation tool and were willing to access the tool again to prepare for future examinations.

The Roles of Pharmacy Schools in Bridging the Gap Between Law and Practice.

Progressive pharmacy laws do not always lead to progressive pharmacy practice. Progressive laws are necessary, but not sufficient for pharmacy services to take off in practice. Pharmacy schools can play critical roles by working collaboratively with community pharmacies to close the gap between law and practice. Our experiences launching pharmacy-based point-of-care testing services in community pharmacy settings illustrate some of the roles schools can play, including: developing and providing standardized training, developing template protocols, providing workflow support, sparking collaboration across pharmacies, providing policy support, and conducting research.

The road to pharmacist prescribing in Alberta Health Services.

PURPOSE: The implementation of policy within a health organization to support a new legislative and regulatory framework of pharmacist prescribing in the Canadian province of Alberta is described. SUMMARY: The evolution of pharmacists' practice activities to encompass medication management through independent prescribing authority has occurred in many jurisdictions around the world. In 2007, Alberta pharmacists were granted the most progressive scope of practice in all of North America. Pursuant to a series of legislative and regulatory initiatives enacted since 2000, the provincial health authority, Alberta Health Services (AHS), has worked to (1) establish a policy framework that supports pharmacist prescribing, (2) provide opportunities for pharmacist prescribing in both inpatient and ambulatory care practice environments, and (3) provide motivation and resources for AHS pharmacists to acquire "additional prescribing authorization" (APA) that enables them to independently prescribe and manage patients' ongoing drug therapy. Pharmacists with APA currently are permitted to prescribe all medications requiring a prescription, with the exception of opiates and other controlled substances; efforts to expand pharmacist prescribing to include those medications are ongoing. Currently, nearly half of all AHS pharmacists have APA. The health authority plans to make APA a standard expectation for all clinical pharmacists working in collaborative practice settings. CONCLUSION: Opportunities provided to Alberta pharmacists by legislation have been embraced by the provincial health authority. The AHS leadership remains committed to ensuring that its pharmacists practice to the full extent of their scope of practice and actively encourages and supports them in their efforts to provide optimal patient care.

ASSESSMENT OF PRACTICE AT RETAIL PHARMACIES IN PAKISTAN: EXTENT OF COMPLIANCE WITH THE PREVAILING DRUG LAW OF PAKISTAN.

The main objective of this study was to assess the practice at retail pharmacies in Pakistan and to compare the same in rural and urban areas. The maintenance of pharmacy and drug inspectors' visit was also assessed. This cross sectional study was conducted in Abbottabad, Pakistan during October-November, 2012. A sample of 215 drug sellers or drug stores was selected by employing convenient sampling method. With a response rate of 91.6%, 197 drug sellers participated in this study. All the drug sellers were male. Overall, 35% (n = 197) of the drug sellers did not have any professional qualification. A majority of the drug sellers were involved in various malpractices like selling of medicines without prescription (80.7%), prescribing practice (60.9%), prescription intervention (62.4%) and selling of controlled substances (66%) without a license for selling it. These malpractices were significantly higher in rural area than that in urban area.

Emerging Developments in Pharmacists' Scope of Practice to Address Unmet Health Care Needs.

Pharmacists' comprehensive training is being leveraged in emerging patient care service opportunities that include prescriptive authority under collaborative practice agreements (CPAs) with prescribers or through state-based protocols. CPAs and state-based protocols expand pharmacists' scope of practice to allow the pharmacist to perform designated functions under the terms of the agreement or protocol. For patient-specific CPAs, this often includes initiating, modifying, or discontinuing therapy and ordering laboratory tests. For population-based CPAs and state-based protocols, pharmacists are often authorized to initiate medications to address a public health need. CPAs and state-based protocols are mechanisms to optimally use pharmacists' education and training.

The Continuum of Pharmacist Prescriptive Authority.

Recently momentum has been building behind pharmacist prescriptive authority for certain products such as oral contraceptives or naloxone. To some, prescriptive authority by pharmacists represents a departure from the traditional role of pharmacists in dispensing medications. Nearly all states, however, currently enable pharmacist prescriptive authority in some form or fashion. The variety of different state approaches makes it difficult for pharmacists to ascertain the pros and cons of different models. We leverage data available from the National Alliance of State Pharmacy Associations (NASPA), a trade association that tracks pharmacy legislation and regulations across all states, to characterize models of pharmacist prescriptive authority along a continuum from most restrictive to least restrictive. We identify 2 primary categories of current pharmacist prescriptive authority: (1) collaborative prescribing and (2) autonomous prescribing. Collaborative prescribing models provide a broad framework for the treatment of acute or chronic disease. Current autonomous prescribing models have focused on a limited range of medications for which a specific diagnosis is not needed. Approaches to pharmacist prescriptive authority are not mutually exclusive. We anticipate that more states will pursue the less-restrictive approaches in the years ahead.

Effect of legal status of pharmacy syringe sales on syringe purchases by persons who inject drugs in San Francisco and San Diego, CA.

BACKGROUND: Sharing blood-contaminated syringes is the main risk factor for acquiring and transmitting blood-borne infections among persons who inject drugs (PWID). To reduce this risk, in 2005, California enacted legislation allowing local health jurisdictions to legalize non-prescription syringe sales after approving a disease prevention demonstration project (DPDP). With San Francisco approving a DPDP immediately and San Diego never approving one, we compared PWID across cities for their use of pharmacies PWID to obtain syringes. METHODS: PWID age 18-30 years old were recruited into separate studies in San Francisco (n=243) and San Diego (n=338) between 2008 and 2011. We used multivariable logistic regression to compare the proportions of PWID who obtained syringes from pharmacies by city while controlling for sociodemographics, injection practices and other risk behaviors. RESULTS: Overall, most PWID were White (71%), male (63%), and between the ages of 18-25 years (55%). Compared to San Francisco, a smaller proportion of PWID in San Diego had bought syringes from pharmacies in the prior three months (16.9% vs. 49.8%; p<0.001), which remained statistically significant after adjusting for sociodemographic and behavioral factors (adjusted odds ratio=4.45, 95% confidence interval: 2.98, 6.65). CONCLUSIONS: Use of pharmacies to obtain syringes was greater where it was legal to do so. Public health policy can influence HIV and hepatitis C associated risk among PWID; however, implementation of these policies is crucial for the benefits to be realized.

Estudio comparado (Europa versus Estados Unidos) sobre el concepto de medicamento genérico / Comparative study (Europe vs the United States) on the concept of generic medicine

Objetivo: Determinar las similitudes y las diferencias del concepto científico de medicamento genérico en Europa y en Estados Unidos a partir de un estudio comparado de la legislación vigente en ambas regiones. Material y Método: Análisis de la legislación vigente en Europa y en Estados Unidos relativa al concepto de medicamento genérico, analizando detalladamente cada aspecto de la definición del mismo, composición (principio activo y excipientes), forma farmacéutica, características de calidad, bioequivalencia y concepto de medicamento de referencia. Estudio comparado de los resultados para concluir similitudes y diferencias en el ámbito conceptual. Resultados: Se observan similitudes y diferencias en cuanto al concepto científico de medicamento genérico en Europa y en Estados Unidos. En concreto, se observan diferencias al concepto de "mismo principio activo", "misma forma farmacéutica", al uso de excipientes con respecto al medicamento de referencia y a la elección del propio medicamento de referencia. También se observan diferencias en cuanto a cómo demostrar bioequivalencia con respecto al medicamento de referencia. Se observan similitudes en cuanto al concepto de "misma dosis", características de calidad, etiquetado e indicaciones con respecto al medicamento de referencia. Conclusiones: Estas diferencias van a tener un impacto en el desarrollo, registro y comercialización del medicamento genérico que desee comercializar una compañía farmacéutica de forma global en estas regiones

Aim: The objective is to determine the similarities and differences between Europe and the United States on the scientific concept of generic medicine. The study is based on a comparative study of the current legislation in both regions. Materials and Methods: Analysis of the current legislation in Europe and the United States in reference to the concept of generic medicine, analyzing each aspect of the definition in detail: composition (active substance and excipients), pharmaceutical form, quality characteristics, bioequivalence and the concept of reference medicinal product. Comparative study of the results obtained to conclude similarities and differences on the conceptual scope. Results: Similarities and differences are observed on the scientific concept of generic medicine between Europe and the United States. In particular, differences on the concept "same active substance" and "same pharmaceutical form", the use of excipients versus the reference medicinal product and the election of the reference medicinal product are observed. Moreover, differences on how to demonstrate bioequivalence with the reference medicinal product are also observed. Similarities on the concept of "same strength", quality characteristics, labelling and indications versus the reference medicinal product are observed. Conclusions: These differences will have an impact on the development, registration and marketing of a generic medicine by a company which decides to market a generic medicine globally in these regions