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1b. Policy: The Pharmaceutical Policy Process
Improving Access and Quality Use of Medicines in Palliative Care within National Drug Policy, Regulatory, and Funding Frameworks
1Drug and Therapeutics Information Service, Australia; 2Discipline, Palliative and Supportive Services, Flinders University, South Australia; 3Mater Health Services and Centre for Palliative Care Research and Education, Queensland; 4NPS: Better Choices - Better Health.
Problem statement: There is a growing need for palliative care throughout the world with an ageing world population, an increasing incidence and prevalence of cancer and HIV/AIDS, and progressive advanced chronic illness. However, improving equity of access and quality use of medicines in palliative care is impeded by the limited evidence for efficacy, cost effectiveness, and safety data for medicines commonly used for symptom control.
Objective: Improve access to affordable priority medicines to relieve suffering and symptom burden in palliative care
Methods: Australia has both a National Medicines Policy and a Palliative Care Strategy which provide a policy framework for implementing improved access to and quality use of medicines in palliative care. The work was coordinated by a government auspiced committee, the Palliative Care Medications Working Group. This committee provided a forum for medicines regulators, the pharmaceutical industry, government, policy makers, and clinicians to address the issues of access and quality use of medicines.
Results: A process to support the listing of medicines to manage symptom burden in palliative care through the national public drug reimbursement programme has been established and continues to be expanded where efficacy, safety, and cost-effectiveness criteria are met. Funding has been provided for a national multi-site collaborative clinical study network, the Palliative Care Clinical Studies Collaborative (PaCCSC), to improve the availability of evidence of clinical interventions in the palliative care setting with rigorously designed and performed phase III and IV studies to inform registration and subsidy applications. Symptoms being studied include delirium, complex pain, bowel obstruction, anorexia, breathlessness, constipation, and nausea. The improvement in access has been complemented by strategies to improve quality use through effective industry partnerships, education programs for practitioners (through NPS: Better Choices-Better Health, an independent, not-for-profit organisation), and a broader communication network for the health workforce and community. A rapid reporting pharmacovigilance programme that builds on the work of the PaCCSC has been developed and is being extended into South East Asia and New Zealand.
Conclusion: Regional and global public health programs struggle with the reality of funding disease-modifying therapies and prevention measures while trying to relieve suffering and provide optimal end of life care. This programme of work is contributing to the evidence base to inform policy decisions concerning access and quality use of medicines.
Funding source: Australian Government, Department of Health and Ageing
Use of an Indicator-Based System for Assessing, Monitoring, and Improving Pharmacy Practice
1Ministry of Health and Social Services (MoHSS); 2Management Sciences for Health/Strengthening Pharmaceutical Systems (MSH/SPS); 3Management Sciences for Health/Strengthening Pharmaceutical Systems (MSH/SPS)
Problem statement: An assessment by the Ministry of Health and Social Services (MoHSS) in 2004 identified the unavailability of routine data to monitor and improve pharmaceutical services as well as inform decision making and planning at all levels of the health system. The assessment identified a need to empower district and regional management teams to identify and address their shortcomings in the delivery of pharmaceutical services.
Objectives: To implement a Pharmacy Management Information System (PMIS) that can provide data for planning and decision making at hospital, regional, and national levels.
Setting: Following a comprehensive consultative process, the PMIS was introduced at all public hospitals in Namibia in October 2007 with the intention of rolling out at a future date to primary health care facilities.
Interventions: The main activities carried out to set up the PMIS were (1) development of the system through an all-inclusive consultative process; data collection tools, data collection and reporting schedules and systems for upward reporting and provision of feedback were established; (2) training regional pharmacists who then trained their pharmacy staff on the PMIS; (3) strengthening therapeutics committees to implement interventions to address gaps identified through PMIS; (4) implementation of the system through on-going data collection, analysis, and use at district, regional, and national levels; and (5) provision of feedback through quarterly PMIS reports at the national level.
Results: The PMIS was formally launched in July 2007; accomplishments to date include (1) all 35 hospitals in the public sector have been producing timely PMIS reports submitted through the 13 regional directorates; (2) a national database has been developed for tracking performance by all hospitals in the various areas of pharmacy service provision since October 2007; (3) PMIS data and results are discussed at district and regional therapeutic committees, and interventions aimed at improving services are designed and implemented. Notable results include development and use of a medicine list that shows brand and generic names of essential medicines has improved generic prescribing in Ohangwena region; rational medicine use trainings carried out in Kunene region to address prescribing problems identified using PMIS data (polypharmacy, inappropriate antibiotic prescribing); improved inventory management across the country as reflected by the increased percentage of stock cards with a balance that is equal to the physical stock (75.6% in December 2007 to 94.5% in April 2010); use of PMIS workload data to successfully advocate for additional pharmacy staff in the Hardap region as well as to guide allocation of dispensing equipment to hospitals.
Conclusions: Implementation of a PMIS leads to availability of critical information that can be used to guide decision making and to improve various aspects of pharmacy service provision including rational medicine use and inventory management.
Funding sources: USAID Namibia and MoHSS, Government of Republic of Namibia
The Volume Share of Generic Medicines in the Retail Market Between 1999 and 2009: a Comparison between Brazil and Mexico
1Center for Health Systems Research, National Institute of Public Health, Mexico; 2Center for Global Health and Development, Boston University, USA
Problem Statement: Most Latin American countries have implemented some pharmaceutical policies that encourage the use of generic medicines to increase access to pharmaceutical products. Mexico and Brazil are two Latin American countries that decided early on to introduce the concept of bioequivalence to increase confidence in the quality of generic medicines, and hence, promote its uptake. Little comparative analysis has been carried out to study the way policies were implemented.
Objectives: To analyze the relationship between public policies to promote the use of generic medicines and their volume share in the retail market between 1999 and 2009.
Design: Time series analysis of the retail pharmaceutical market volume and analysis of policies to promote the use of generic medicines
Setting: Brazil and Mexico retail sectors
Study Population: Innovator and generic medicines retail sales volume between 1999 and 2009
Intervention: Public policies introduced to promote the use of generic medicines
Outcome: Percentage change in volume share of generic medicines out of total retail market volume between 1999 and 2009
Results: From 1999 to 2009, the percentage volume share of generic medicines increased by more than five fold for Brazil (5% to 27.5%) and nearly four-fold for Mexico (1.8% to 8.5%). In Brazil, the annual increase in generic volume share was relatively constant over the 10 years (annual increase of 2.13%). In Mexico from 1999 to 2004, the annual increase in volume share was minimal (0.16% mean annual increase) and this changed after 2005 when the generic medicines volume increased about 1.31% per year.
Even though the policy objectives in Brazil and Mexico are similar in promoting generic medicines use, they differ largely in strategies and focus of implementation: Brazil enacted a law in 1999 which provided the framework for an explicit pharmaceutical policy largely based on WHO recommendations as well as a norm defining the requirements that generic medicines have to comply with before market authorization (among other bioequivalence tests). A key player in Brazil’s efforts to promote generic medicines was the Medicines Regulatory Agency (ANVISA). In contrast, Mexico lacked a coherent explicit pharmaceutical policy. Even though since 1998, regulations included a list of interchangeable generics, the Mexico’s Medicines Regulatory Authority (COFEPRIS) did not play an active part to promote generic medicine uptake in the private sector. In 2005, it was announced that all generic medicines will require a bioequivalence test similar to standards in Europe and the United States.
Conclusions: The Brazilian pharmaceutical policies were placed high on the political agenda, and ensured the technical, logistical, and financial preconditions for the medium- and long-term implementation since 1999. Mexican policies were targeted more effectively at the public market than the retail market.
Funding Sources: National Institute of Public Health, Mexico.
Health Litigation and New Challenges in the Management of Pharmaceutical Services
1ENSP-Fiocruz, Brazil; 2IESC- Universidade Federal do Rio de Janeiro. Brazil
Problem Statement: Health litigation spurs many challenges in the management of pharmaceutical services. Performance of health managers and decision-makers must be adjusted to new administrative and legal boundaries. Their actions must also be efficient in responding to ongoing lawsuits, as well as in avoiding additional litigation and in upholding principles and directives of the Brazilian Health System (SUS).
Objectives: This paper proposes to better understand one of the aspects of health litigation, namely the growing use of lawsuits demanding medicines, and the relationship between this phenomenon and pharmaceutical services management in SUS.
Design and Setting: A review of management and technical procedures related to health litigation of medicines in Brazil was carried out. Through the analysis of available published research on the subject the main elements of "medicines litigation" are presented and examined in light of their interference on the activities of the pharmaceutical services cycle.
Results: Three possible negative effects of judicialization were found: problems with the principles of universal access and equity, difficulties in the management of pharmaceutical services and risks to patient safety, due to misguided prescribing of listed and public-funded medicines, and also of new, innovative medicines without solid established evidence. Moreover, unregistered, unauthorized medicines as well as off label uses may be the target of demands. All technical and operational phases of the pharmaceutical services cycle may suffer disruption by judicial demands. Injunctions can press health system to select medicines in order to adjust the AF cycle to judicial demands, increase the acquisition costs and contribute to the non-rational use of medicines. It is important to develop tools to update information about lawsuits; increase ethical, legal and technical actions and stimulate future innovative actions in different fields of knowledge. A model flow for the analysis of judicial demands in light of the need for evidence-based decision-making was obtained.
Conclusions: The analysis points to possible mechanisms to be adopted by decision-makers in management and in the Judicial System, since the right to health can only be effectively established when management and Justice are predominantly aware and committed to the safety and the protection of patients and users.
Funding Source: National Council for Scientific and Technological Development (CNPq) and Carlos Chagas Filho Research Support Foundation of Rio de Janeiro (FAPERJ)