It Takes a Village : Contending With Drug Shortages During Disasters.

Critical drug shortages have been widely documented during the coronavirus disease 2019 (COVID-19) pandemic, particularly for IV sedatives used to facilitate mechanical ventilation. Surges in volume of patients requiring mechanical ventilation coupled with prolonged ventilator days and the high sedative dosing requirements observed quickly led to the depletion of "just-in-time" inventories typically maintained by institutions. This manuscript describes drug shortages in the context of global, manufacturing, regional and institutional perspectives in times of a worldwide crisis such as a pandemic. We describe etiologic factors that lead to drug shortages including issues related to supply (eg, manufacturing difficulties, supply chain breakdowns) and variables that influence demand (eg, volatile prescribing practices, anecdotal or low-level data, hoarding). In addition, we describe methods to mitigate drug shortages as well as conservation strategies for sedatives, analgesics and neuromuscular blockers that could readily be applied at the bedside. The COVID-19 pandemic has accentuated the need for a coordinated, multi-pronged approach to optimize medication availability as individual or unilateral efforts are unlikely to be successful.

Initiatives to challenge patent barriers and their relationship with the price of medicines procured by the Brazilian Unified National Health System. / Iniciativas de enfrentamento da barreira patentária e a relação com o preço de medicamentos adquiridos pelo Sistema Único de Saúde.

Since 1996, when antiretroviral (ARV) treatments started being guaranteed to people living with HIV in Brazil, the government has faced the challenge of ensuring sustainability of this policy within a context of incorporating patented medicines. This article sought to analyze the historical series of the price of lopinavir/ritonavir (LPV/r) in Brazil and in the international market also considering the initiatives to challenge patent barriers between 2001 and 2012. The methods used were mapping initiatives to challenge LPV/r patent barriers and the analysis of historical series of its price in Brazil and in the international market. Results show that, between 2001 and 2003, there were efforts to use compulsory licensing as a threat. From 2005 to 2007, initiatives by different satkeholders were identified: declaration of public interest, pre-grant opposition ("support to examination") and civil action. From 2006 to 2008, compulsory licensing initiatives in other countries resulted in a price reduction in Brazil. Between 2009 and 2012, there was a 30% reduction in the Brazilian purchasing price.

Iniciativas de enfrentamento da barreira patentária e a relação com o preço de medicamentos adquiridos pelo Sistema Único de Saúde / Iniciativas para enfrentarse a la barrera patentaria y su relación con el precio de medicamentos adquiridos por el Sistema Único de Salud / Initiatives to challenge patent barriers and their relationship with the price of medicines procured by the Brazilian Unified National Health System

Resumo: Desde 1996, com a consolidação da oferta do tratamento antirretroviral (ARV) às pessoas vivendo com HIV no Brasil, o governo tem como desafio assegurar a sustentabilidade desta oferta num contexto de incorporação de medicamentos patenteados. O artigo teve como objetivo analisar a série histórica do preço do lopinavir/ritonavir (LPV/r) no Brasil e no mercado internacional à luz de iniciativas de enfrentamento da barreira patentária no período de 2001 a 2012. A metodologia consistiu em mapeamento de iniciativas de enfrentamento da barreira patentária para o LPV/r e análise da série histórica do preço no Brasil e no mercado internacional. Os resultados encontrados apontam que, entre 2001 e 2003, identificaram-se esforços de ameaça de licença compulsória. De 2005 a 2007, identificaram-se iniciativas por diferentes atores: declaração de interesse público, subsídios ao exame e ação civil pública. De 2006 e 2008, iniciativas internacionais de licença compulsória resultaram na redução do preço no Brasil. Entre 2009 e 2012, observa-se uma redução do preço de aquisição pelo Brasil de 30%.

Resumen: Desde 1996, con la consolidación de la oferta de tratamiento antirretroviral (ARV) para las personas viviendo con VIH, el Gobierno de Brasil tiene el desafío de asegurar la sostenibilidad de dicha oferta en un contexto de incorporación de medicamentos patentados. El objetivo de este artículo es analizar la serie histórica del precio del lopinavir/ritonavir (LPV/r) en Brasil y en el mercado internacional, a la luz de iniciativas para enfrentar la barrera patentaria durante el período de 2001 a 2012. La metodología consistió en un mapeo de iniciativas para hacer frente a la barrera patentaria del LPV/r y el análisis de la serie histórica de sus precios de adquisición por el SUS y en el mercado internacional. Entre 2001 y 2003 se identificaron esfuerzos por obtener reducciones de precio de LPV/r, mediante la amenaza de expedición de licencia obligatoria. De 2005 a 2007, se identificaron varias iniciativas de diferentes actores, tales como, la expedición de declaración de interés público, preseentación de subsidios para el examen de solicitudes de patente de este medicamento y la interpesición de acción civil pública. Entre 2006 y 2008, la expedición de licencias obligatorias en el marco de iniciativas internacionales, propiciaron reducciones de precio de LPV/r en Brasil. La reducción promedio del precio de adquisición por parte SUS fue de 30% entre 2009 y 2012.

Abstract: Since 1996, when antiretroviral (ARV) treatments started being guaranteed to people living with HIV in Brazil, the government has faced the challenge of ensuring sustainability of this policy within a context of incorporating patented medicines. This article sought to analyze the historical series of the price of lopinavir/ritonavir (LPV/r) in Brazil and in the international market also considering the initiatives to challenge patent barriers between 2001 and 2012. The methods used were mapping initiatives to challenge LPV/r patent barriers and the analysis of historical series of its price in Brazil and in the international market. Results show that, between 2001 and 2003, there were efforts to use compulsory licensing as a threat. From 2005 to 2007, initiatives by different satkeholders were identified: declaration of public interest, pre-grant opposition ("support to examination") and civil action. From 2006 to 2008, compulsory licensing initiatives in other countries resulted in a price reduction in Brazil. Between 2009 and 2012, there was a 30% reduction in the Brazilian purchasing price.

Fosamprenavir (GW433908)/ritonavir in HIV-infected patients: efficacy and safety results from the Spanish Expanded Access Program.

INTRODUCTION: The use of protease inhibitors (PI) has led to a decrease in HIV-1-related mortality and morbidity. The objective of this study was to collect safety data on treatment with fosamprenavir/ritonavir (FPV/r) 700/100mg BID in HIV-infected patients through an expanded access program. PATIENTS AND METHODS: Prospective, multicenter, noncomparative study in HIV-1 infected adults, for whom a regimen containing FPV/r 700/100mg BID was appropriate. RESULTS: A total of 678 patients were included in the intention-to-treat (ITT) and safety population. The on-treatment (OT) population contained 587 patients: 76% male, 98% Caucasian, and median age 41 years. Median CD4 cell count was 351 cells/microL, HIV-RNA was 3 log copies/mL, and 49% of patients were in CDC class C. After 24 weeks of treatment, serum viral load decreased a median of 1.3 log copies/mL and 73% of patients had <400 copies/mL (P<.0001 vs. baseline); 48-week results were similar. CD4 cell count increased a median of 49 and 62 cells/microL at 24 and 48 weeks, respectively. Adverse events (AEs) associated with the study medication occurred in 21% of patients. CONCLUSIONS: Ritonavir-boosted fosamprenavir as part of antiretroviral therapy is a potent, safe treatment in real-life clinical circumstances.

Ritonavir capsule manufacturing problems will require switch to liquid formulation.

AIDS: Abbott Laboratories has halted production of Ritonavir (Norvir) capsules due to a manufacturing problem which caused the drug to crystallize, disrupting the rate with which it dissolves. Current supplies will run out in August, and patients will need to switch to the liquid formulation of the drug. The liquid formulation provides the same dosage as the capsules, but pharmacists may need to call the physician to authorize the change. The primary drawback to the liquid formulation is its bad taste, which can be masked with certain strong-tasting foods. Further information is available on Abbott's web site or directly from the company. Contact information is provided.^ieng