Veronika J. Wirtz

Promotion of access to essential medicines for non-communicable diseases: practical implications of the UN political declaration

Access to medicines and vaccines to prevent and treat non-communicable diseases (NCDs) is unacceptably low worldwide. In the 2011 UN political declaration on the prevention and control of NCDs, heads of government made several commitments related to access to essential medicines, technologies, and vaccines for such diseases. 30 years of experience with policies for essential medicines and 10 years of scaling up of HIV treatment have provided the knowledge needed to address barriers to long-term effective treatment and prevention of NCDs. More medicines can be acquired within existing budgets with efficient selection, procurement, and use of generic medicines. Furthermore, low-income and middle-income countries need to increase mobilisation of domestic resources to cater for the many patients with NCDs who do not have access to treatment. Existing initiatives for HIV treatment offer useful lessons that can enhance access to pharmaceutical management of NCDs and improve adherence to long-term treatment of chronic illness; policy makers should also address unacceptable inequities in access to controlled opioid analgesics. In addition to off-patent medicines, governments can promote access to new and future on-patent medicinal products through coherent and equitable health and trade policies, particularly those for intellectual property. Frequent conflicts of interest need to be identified and managed, and indicators and targets for access to NCD medicines should be used to monitor progress. Only with these approaches can a difference be made to the lives of hundreds of millions of current and future patients with NCDs.

Trends in antibiotic utilization in eight Latin American countries, 1997-2007

OBJECTIVE To describe the trends in antibiotic utilization in eight Latin American countries between 1997-2007 METHODS We analyzed retail sales data of oral and injectable antibiotics (World Health Organization (WHO) Anatomic Therapeutic Chemical (ATC) code J01) between 1997 and 2007 for Argentina, Brazil, Chile, Colombia, Mexico, Peru, Uruguay, and Venezuela. Antibiotics were aggregated and utilization was calculated for all antibiotics (J01); for macrolides, lincosamindes, and streptogramins (J01 F); and for quinolones (J01 M). The kilogram sales of each antibiotic were converted into defined daily dose per 1 000 inhabitants per day (DID) according to the WHO ATC classification system. We calculated the absolute change in DID and relative change expressed in percent of DID variation, using 1997 as a reference RESULTS Total antibiotic utilization has increased in Peru, Venezuela, Uruguay, and Brazil, with the largest relative increases observed in Peru (5.58 DID, +70.6%) and Venezuela (4.81 DID, +43.0%). For Mexico (-2.43 DID; -15.5%) and Colombia (-4.10; -33.7%), utilization decreased. Argentina and Chile showed major reductions in antibiotic utilization during the middle of this period. In all countries, quinolone use increased, particularly sharply in Venezuela (1.86 DID, +282%). The increase in macrolide, lincosaminde, and streptogramin use was greatest in Peru (0.76 DID, +82.1%), followed by Brazil, Argentina, and Chile CONCLUSIONS Analyzing antibiotic utilization in Latin America presents a series of challenges. Creating policy-relevant evidence based on antimicrobial consumption patterns is needed in order to foster policies aimed at improving appropriate use of antibiotics in the region.

Policies to promote use of generic medicines in low and middle income countries: A review of published literature, 2000–2010

OBJECTIVE Review the literature on the impact of policies designed to enhance uptake of generic medicines in low and middle income countries (LMICs). METHODS We searched for publications related to generic medicines policies (January 2000-March 2010) and did a bibliometric, descriptive analysis of the dataset in addition to an analysis of studies evaluating the impact of pro-generic policies. We repeated a subset of this larger search in January 2012. RESULTS Of the 4994 articles screened, 315 (6.3%) full-text publications were related to generic medicines policies. Of these 315, 236 (75%) dealt with generic medicine policies in high-income countries, and 79 (25%) with policies in LMICs. In total, we found only 10 evaluation studies looking at the impact of competition, trade, pricing and prescribing policies on generic medicine price and/or volume. Key barriers to implementing generic medicine policies in LMICs are negative perceptions of stakeholders (e.g., generics are of lower quality) plus perverse private sector financial incentives to sell products with the highest profit margin. Other relevant barriers are legal/regulatory, such as the absence of generic substitution regulations. There also exists a general difficulty in promoting generics due to a lack of transparency in the pharmaceutical supply and distribution system, for example, a lack of price information provided by health care provider organizations to physicians. CONCLUSION There is little policy evaluation to determine which pro-generic policies increase generic medicines utilization in LMICs. Ensuring a functioning medicines regulation authority, creating a reasonably robust market of generic medicines and aligning incentives for physicians, consumers and drug sellers are necessary prerequisites for increasing the uptake and use of generic medicines.

Impact of over-the-counter restrictions on antibiotic consumption in Brazil and Mexico.

Background In Latin American countries over-the-counter (OTC) dispensing of antibiotics is common. In 2010, both Mexico and Brazil implemented policies to enforce existing laws of restricting consumption of antibiotics only to patients presenting a prescription. The objective of the present study is therefore to evaluate the impact of OTC restrictions (2010) on antibiotics consumption in Brazil and Mexico. Methods and Findings Retail quarterly sales data in kilograms of oral and injectable antibiotics between January 2007 and June 2012 for Brazil and Mexico were obtained from IMS Health. The unit of analysis for antibiotics consumption was the defined daily dose per 1,000 inhabitants per day (DDD/TID) according to the WHO ATC classification system. Interrupted time series analysis was conducted using antihypertensives as reference group to account for changes occurring independently of the OTC restrictions directed at antibiotics. To reduce the effect of (a) seasonality and (b) autocorrelation, dummy variables and Prais-Winsten regression were used respectively. Between 2007 and 2012 total antibiotic usage increased in Brazil (from 5.7 to 8.5 DDD/TID, +49.3%) and decreased in Mexico (10.5 to 7.5 DDD/TID, −29.2%). Interrupted time series analysis showed a change in level of consumption of −1.35 DDD/TID (p<0.01) for Brazil and −1.17 DDD/TID (p<0.00) for Mexico. In Brazil the penicillins, sulfonamides and macrolides consumption had a decrease in level after the intervention of 0.64 DDD/TID (p = 0.02), 0.41 (p = 0.02) and 0.47 (p = 0.01) respectively. While in Mexico it was found that only penicillins and sulfonamides had significant changes in level of −0.86 DDD/TID (p<0.00) and −0.17 DDD/TID (p = 0.07). Conclusions Despite different overall usage patterns of antibiotics in Brazil and Mexico, the effect of the OTC restrictions on antibiotics usage was similar. In Brazil the trend of increased usage of antibiotics was tempered after the OTC restrictions; in Mexico the trend of decreased usage was boosted.

Unit costs for delivery of antiretroviral treatment and prevention of mother-to-child transmission of HIV: A systematic review for low- and middle-income countries

Background As antiretroviral treatment (ART) for HIV/AIDS is scaled-up globally, information on per-person costs is critical to improve efficiency in service delivery and maximize coverage and health impact.As antiretroviral treatment (ART) for HIV/AIDS is scaled up globally, information on per-person costs is critical to improve efficiency in service delivery and to maximize coverage and health impact. The objective of this study was to review studies on unit costs for delivery of adult and paediatric ART per patient-year, and prevention of mother-to-child transmission (PMTCT) interventions per mother-infant pair screened or treated, in lowand middle-income countries. A systematic review was conducted of English, French and Spanish publications from 2001 to 2009, reporting empirical costing that accounted for at least antiretroviral (ARV) medicines, laboratory testing and personnel. Expenditures were analysed by country-income level and cost component. All costs were standardized to

Access to care for Chagas disease in the United States: a health systems analysis.

US, year 2009 values. Several sensitivity analyses were conducted.Analyses covered 29 eligible, comprehensive, costing studies. In the base case, in low-income countries (LIC), median ART cost per patient-year was

Estimating the Burden of Chagas Disease in the United States

US792 (mean: 839, range: 682–1089); for lower-middle-income countries (LMIC), the median was

Heterogeneous Effects of Health Insurance on Out-of-Pocket Expenditure on Medicines in Mexico

US932 (mean: 1246, range: 156–3904); and, for upper-middle-income countries (UMIC), the median was

Access to Medications for Cardiovascular Diseases in Low- and Middle-Income Countries

US1454 (mean: 2783, range: 1230–5667). ARV drugs were the largest component of overall ART costs in all settings (64%, 50% and 47% in LIC, LMIC and UMIC, respectively). Of 26 ART studies, 14 reported the drug regimes used, and only one study explicitly reported second-line treatment costs. The second cost driver was laboratory cost in LIC and LMIC (14% and 20%), and personnel costs in UMIC (26%). Two ART studies specified the types of laboratory tests costed, and three studies specifically included above facility-level personnel costs. Three studies reported detailed PMTCT costs, and three studies reported on paediatric ART.There is a paucity of data on the full unit costs for delivery of ART and PMTCT, particularly for LIC and middle-income countries. Heterogeneity in activities costed, and insufficient detail regarding components included in the costing, hampers standardization of unit cost measures. Evaluation of programme-level unit costs would benefit frominternational guidance on standardized costing methods, and expenditure categories and definitions. Future work should help elucidate the sources of the large variations in delivery unit costs across settings with similar income and epidemiological characteristics.

Medicines in Mexico, 1990-2004: systematic review of research on access and use

There are 300,000 estimated cases of Chagas disease in the United States but limited data on access to care. This study analyzed trends in access to care for Chagas disease in the United States and assessed the national and state barriers to access. Data on cases in blood donors and drug releases were obtained from the AABB (formerly American Association of Blood Banks) and U.S. Centers for Disease Control and Prevention (CDC), respectively. Semi-structured in-depth interviews were conducted with 30 key informants at the national level and in five states where treatment had been released. Interview responses were analyzed according to the health systems dimensions of regulation, financing, payment, organization, and persuasion. Data indicate that 1,908 cases were identified in the blood donation system from 2007 to 2013 and that CDC released 422 courses of benznidazole or nifurtimox during this period. The barriers to access at the national level include limited diagnostic and institutionalized referral and care processes, lack of financing for patient-care activities, and limited awareness and training among providers. This study demonstrates that access to treatment of Chagas disease in the United States is limited. The lack of licensing is only one of several barriers to access, highlighting the need for a health systems perspective when scaling up access to these essential medicines.