Pharmaceutical procurement among public sector procurers in CARICOM.

OBJECTIVE: To examine multiple aspects of the medicines in CARICOM procurement markets, including manufacturer headquarters location, regulatory history, and type (innovator versus generic); the proportion of World Health Organization (WHO) essential medicines; and the most expensive medicines procured. METHODS: An analysis of procurement information from selected CARICOM procurers. Four public sector procurement lists were obtained based on public availability or sharing of data from public sector procurers. Analyses were based on parameters available or deduced from these data. RESULTS: The majority of products come from manufacturers headquartered in North America and Europe (63%-67%). The percentage of medicines procured from generic companies is 60%-87%; and 25%-50% of medicines procured are on the WHO Essential Medicines List. Wide price variations exist in the most expensive medicines purchased. CONCLUSIONS: The analysis identifies vulnerabilities and opportunities in the procurement situation of CARICOM states, particularly related to quality and rational use of medicines. This analysis represents a baseline that governments and other stakeholders can use in the future.

Pharmaceutical procurement among public sector procurers in CARICOM

[ABSTRACT]. Objective. To examine multiple aspects of the medicines in CARICOM procurement markets, including manufacturer headquarters location, regulatory history, and type (innovator versus generic); the proportion of World Health Organization (WHO) essential medicines; and the most expensive medicines procured. Methods. An analysis of procurement information from selected CARICOM procurers. Four public sector procurement lists were obtained based on public availability or sharing of data from public sector procurers. Analyses were based on parameters available or deduced from these data. Results. The majority of products come from manufacturers headquartered in North America and Europe (63%–67%). The percentage of medicines procured from generic companies is 60%–87%; and 25%–50% of medicines procured are on the WHO Essential Medicines List. Wide price variations exist in the most expensive medicines purchased. Conclusions. The analysis identifies vulnerabilities and opportunities in the procurement situation of CARICOM states, particularly related to quality and rational use of medicines. This analysis represents a baseline that governments and other stakeholders can use in the future.

[RESUMEN]. Objetivo. Revisar los múltiples aspectos de los medicamentos en los mercados de compras y los proveedores de CARICOM, como la ubicación de la sede del fabricante, el historial de regulación, el tipo (patentado versus genérico); la proporción de medicamentos esenciales de la Organización Mundial de la Salud (OMS); y los medicamentos comprados más caros. Métodos. Se analizó información sobre la compra por parte de determinados organismos de CARICOM. La información procedía de cuatro listas de organismos del sector público que realizan las compras, que se consiguieron en función de su disponibilidad pública o de los datos distribuidos por los organismos del sector público que realizan las compras. Los análisis estaban basados en los parámetros disponibles o derivados de estos datos. Resultados. La mayoría de los productos proviene de fabricantes radicados en América del Norte y Europa (entre 63% y 67%). El porcentaje de medicamentos que se compra de empresas genéricas oscila entre 60% y 87%; y de 25% a 50% de los medicamentos que se compran están en la Lista de Medicamentos Esenciales de la OMS. Hay una gran divergencia de precios entre los medicamentos comprados más caros. Conclusiones. En el análisis se han encontrado vulnerabilidades y oportunidades con respecto a la situación de las compras de medicamentos de los Estados de CARICOM, especialmente en cuanto a la calidad y al uso racional de los medicamentos. Este análisis representa una línea de base que los gobiernos u otros interesados directos pueden utilizar en el futuro.

[RESUMO]. Objetivo. Examinar vários aspectos relacionados aos mercados e fornecedores de produtos farmacêuticos da CARICOM, incluindo a localização da sede do laboratório fabricante, histórico regulatório e tipo de produtos (inovadores versus genéricos); proporção de medicamentos adquiridos que constam da relação de medicamentos essenciais da Organização Mundial da Saúde (OMS); e medicamentos mais caros comprados. Métodos. Foi realizada uma análise de informação sobre compras feitas por compradores selecionados da CARICOM. Quatro listas de compras do setor público foram obtidas com informação de acesso público ou compartilhada pelos compradores. As análises foram feitas com base em parâmetros disponíveis ou inferidos a partir dos dados. Resultados. A maioria dos produtos farmacêuticos é proveniente de laboratórios com sedes na América do Norte e Europa (63%–67%). Do total, 60%–87% dos medicamentos adquiridos são de laboratórios de produtos genéricos e 25%–50% constam da relação de medicamentos essenciais da OMS. Existe uma ampla variação nos preços dos medicamentos mais caros comprados. Conclusões. Foram identificadas fragilidades e oportunidades na situação de compras dos países da CARICOM, em particular relacionadas à qualidade dos produtos e ao uso racional dos medicamentos. Esta análise serve de referência a ser usada futuramente pelos governos e outras partes interessadas.

Pharmaceutical procurement among public sector procurers in CARICOM / Compras farmacéuticas por parte de organismos del sector público de CARICOM / Aquisição de produtos farmacêuticos por compradores do setor público da CARICOM

ABSTRACT Objective. To examine multiple aspects of the medicines in CARICOM procurement markets, including manufacturer headquarters location, regulatory history, and type (innovator versus generic); the proportion of World Health Organization (WHO) essential medicines; and the most expensive medicines procured. Methods. An analysis of procurement information from selected CARICOM procurers. Four public sector procurement lists were obtained based on public availability or sharing of data from public sector procurers. Analyses were based on parameters available or deduced from these data. Results. The majority of products come from manufacturers headquartered in North America and Europe (63%-67%). The percentage of medicines procured from generic companies is 60%-87%; and 25%-50% of medicines procured are on the WHO Essential Medicines List. Wide price variations exist in the most expensive medicines purchased. Conclusions. The analysis identifies vulnerabilities and opportunities in the procurement situation of CARICOM states, particularly related to quality and rational use of medicines. This analysis represents a baseline that governments and other stakeholders can use in the future.

RESUMEN Objetivo. Revisar los múltiples aspectos de los medicamentos en los mercados de compras y los proveedores de CARICOM, como la ubicación de la sede del fabricante, el historial de regulación, el tipo (patentado versus genérico); la proporción de medicamentos esenciales de la Organización Mundial de la Salud (OMS); y los medicamentos comprados más caros. Métodos. Se analizó información sobre la compra por parte de determinados organismos de CARICOM. La información procedía de cuatro listas de organismos del sector público que realizan las compras, que se consiguieron en función de su disponibilidad pública o de los datos distribuidos por los organismos del sector público que realizan las compras. Los análisis estaban basados en los parámetros disponibles o derivados de estos datos. Resultados. La mayoría de los productos proviene de fabricantes radicados en América del Norte y Europa (entre 63% y 67%). El porcentaje de medicamentos que se compra de empresas genéricas oscila entre 60% y 87%; y de 25% a 50% de los medicamentos que se compran están en la Lista de Medicamentos Esenciales de la OMS. Hay una gran divergencia de precios entre los medicamentos comprados más caros. Conclusiones. En el análisis se han encontrado vulnerabilidades y oportunidades con respecto a la situación de las compras de medicamentos de los Estados de CARICOM, especialmente en cuanto a la calidad y al uso racional de los medicamentos. Este análisis representa una línea de base que los gobiernos u otros interesados directos pueden utilizar en el futuro.

RESUMO Objetivo. Examinar vários aspectos relacionados aos mercados e fornecedores de produtos farmacêuticos da CARICOM, incluindo a localização da sede do laboratório fabricante, histórico regulatório e tipo de produtos (inovadores versus genéricos); proporção de medicamentos adquiridos que constam da relação de medicamentos essenciais da Organização Mundial da Saúde (OMS); e medicamentos mais caros comprados. Métodos. Foi realizada uma análise de informação sobre compras feitas por compradores selecionados da CARICOM. Quatro listas de compras do setor público foram obtidas com informação de acesso público ou compartilhada pelos compradores. As análises foram feitas com base em parâmetros disponíveis ou inferidos a partir dos dados. Resultados. A maioria dos produtos farmacêuticos é proveniente de laboratórios com sedes na América do Norte e Europa (63%-67%). Do total, 60%-87% dos medicamentos adquiridos são de laboratórios de produtos genéricos e 25%-50% constam da relação de medicamentos essenciais da OMS. Existe uma ampla variação nos preços dos medicamentos mais caros comprados. Conclusões. Foram identificadas fragilidades e oportunidades na situação de compras dos países da CARICOM, em particular relacionadas à qualidade dos produtos e ao uso racional dos medicamentos. Esta análise serve de referência a ser usada futuramente pelos governos e outras partes interessadas.

An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017-2018 using the OpERA methodology.

BACKGROUND: The Caribbean Regulatory System is a centralized medicine assessment procedure established to serve the needs of the Member States of the CARICOM region. In order to better understand the effectiveness and efficiency of the processes implemented by the Caribbean Regulatory System for the regulatory assessment of medicines for the region, the system has been participating in the Optimizing Efficiencies in Regulatory Agencies (OpERA) program, a multinational endeavor to characterize the assessment procedures and the corollary metrics associated with medicine review activities in regulatory agencies and regional regulatory initiatives. METHODS: The OpERA tool was used to collect process and specific milestone data for products approved by the Caribbean Regulatory System during 2017 (n = 10) and 2018 (n = 11). RESULTS: The median total approval time was 57.5 days (25th/75th percentiles: 54, 60) in 2017 and 148 days (120, 163) in 2018. The median time to conduct the scientific assessment of the dossier was 37 days (24, 42) in 2017 and 66 (40, 132) days in 2018, within the target of 90 days for this activity. The time increases observed in 2018 were due to staff manpower limitations that reduced the ability of the system to conduct the timely assessment of applications. Based on these observations, recommendations to optimize the effectiveness and efficiency of the Caribbean Regulatory System include a commitment from Member States and partner organizations to the use of the procedure to accelerate product availability, encouraging the use of the Caribbean Regulatory System for non-generic products approved by a reference agency, ensuring the establishment of policy and legal frameworks to facilitate the rapid uptake of Caribbean Regulatory System registrations as marketing authorizations in the Member States, and maintaining the sustainability of the process through a fee-based approach. CONCLUSIONS: The observations obtained using the OpERA methodology indicate the Caribbean Regulatory System is an effective and efficient mechanism to provide recommendations to Member States for important medicines.

Patient, Physician, and Health-System Factors Influencing the Quality of Antidepressant and Sedative Prescribing for Older, Community-Dwelling Adults.

OBJECTIVE: To identify determinants of potentially inappropriate (PI) antidepressant and anxiolytic/sedative prescribing for older, community-dwelling adults. DATA SOURCES/STUDY SETTING: Office visits from the 2010 National Ambulatory Medical Care Survey. STUDY DESIGN: A cross-sectional study measuring associations between various patient and physician factors and prescribing of PI antidepressants, and PI sedatives among elderly, using Beers 2012/2015 criteria, a clinical decision model, and multivariate logistic regressions. DATA COLLECTION: Visits by older adults (≥65 years) involving medications were extracted to identify visits with antidepressants and sedatives. PRINCIPAL FINDINGS: Black race, asthma, depression, osteoporosis, payment type, consultation time, and computer systems with prescribing support were associated with reduced odds of PI antidepressant prescribing among users. Income, chronic renal failure, diabetes, and obesity were associated with reduced odds of PI sedative prescribing. Female sex, white race, depression, increasing number of medications, and physician specialty were associated with increased odds of PI sedative prescribing. CONCLUSIONS: Various patient and health-system factors influence the quality of antidepressant and sedative prescribing for older community-dwelling adults. Longer consultations and the use of computer systems with prescribing support may minimize potentially inappropriate antidepressant prescribing. As medication numbers increase, exposure to PI sedatives is more likely, requiring medication review and monitoring.