Why are pharmacy acquisition costs and consumer prescription drug price indices apparently diverging?

Pharmacy acquisition costs for prescription (Rx ) drugs have been trending below levels implied by the Bureau of Labor Statistics' (BLS) Consumer Price Index for Rx drugs, with the divergence higher when generic approvals are high. Dropping the first 6 months of generic sales from price indices calculated from pharmacy acquisition costs eliminates most of the difference between such indices and BLS indices.

Identical or similar brand names used in different countries for medications with different active ingredients: a descriptive analysis.

OBJECTIVE: To identify US drug brand (proprietary) names that are identical or similar to drug brand names used in other countries containing different active ingredients and name confusion medication errors associated with these drugs. METHODS: We compared a list of brand names approved by the US Food and Drug Administration from 2006 through 2018 with a list of brand names from other countries generated by Uppsala Monitoring Centre using the WHODrug Dictionary. We evaluated drug name pairs that were identical or highly similar and had different active ingredients and searched for name confusion medication errors with these drugs. RESULTS: A total of 27 US brand names were found to be identical to 38 drug brand names in other countries with different active ingredients. A total of 74 US drug brand names were highly similar to 93 brand names in other countries for drugs containing different active ingredients. We identified name confusion medication errors for one similar name pair. CONCLUSIONS: US drug brand names that are identical to or highly similar to brand names in other countries may cause confusion that can lead to medication errors such as wrong drug errors and wrong drug information being consulted. Manufacturers should consider this risk prior to submitting proposed brand names to regulatory authorities. Regulatory authorities may consider incorporating this check in their brand name reviews and work with manufacturers to eliminate the use of the same or similar brand names for products with different ingredients. Consumers filling prescriptions at foreign pharmacies should also be aware of potential name confusion.

Breastfeeding, schooling, and income: Insights from the Indonesian Family Life Survey.

Recent research has highlighted associations of breastfeeding with IQ, schooling, and income, but uncertainty about such links remains. The Indonesian Family Life Survey, representative of 83% of the Indonesian population, provides data on breastfeeding, parents' years of schooling, wealth, and other family characteristics in 1993-1994, as well as schooling and income in 2014-2015 for 5,421 children of those families. Using linear regressions and controlling for village or neighbourhood, as well as propensity score matching, we analysed breastfeeding associations for boys and girls separately, when regularly fed foods/beverages other than breast milk is significantly associated with years of schooling in 2014-2015 for girls, but not for boys, after controlling for the village or neighbourhood of residence in 1993-1994. For girls, ages 1 to 1.9, 2 to 2.9, 3 to 3.9, and >4 months, relative to ages <1 month, are associated with an additional 0.41 to 0.46 years of schooling, with p values of 0.086, 0.071, 0.043, and 0.026, respectively. No comparable estimate for boys attains statistical significance. Using propensity score matching yields similar results. Associations with annual income in 2014-2015 are not statistically significant, either for all children, or for either sex. Our finding suggests that delaying regular feeding of foods/beverages other than breast milk beyond 1 month may help girls' schooling but has no observable association with annual income, perhaps because of lower labour force participation by women. Also, the inclusion of controls for village or neighbourhood of residence reduces confounding.

Breastfeeding Duration and Adolescent Educational Outcomes: Longitudinal Evidence From India.

OBJECTIVE: There is a significant evidence gap on the long-term educational benefits of longer breastfeeding in low- and middle-income countries. We estimated the association between duration of (any) breastfeeding and educational outcomes of Indian children. METHODS: We used regression analysis to examine the association between the length of breastfeeding (in months) and future education outcomes on the basis of 2 data sets: (1) data from a follow-up survey known as the Andhra Pradesh Children and Parents Study (APCAPS, 2003-2005) of 1165 children aged 13 to 18 years from a controlled nutrition trial originally conducted in South India during the period of 1987 to 1990; and (2) nationally representative data from the India Human Development Survey (IHDS-2, 2011-2012) of 6121 children aged 6 to 12 years. RESULTS: In APCAPS, children with >36 months of breastfeeding scored 0.28 (95% confidence interval [95% CI]: 0.00-0.56; P < .05) higher on tests than those with up to 12 months of breastfeeding. In the nationally representative IHDS-2 data, above-median breastfeeding duration was associated with 0.1 year (95% CI: 0.04-0.16; P < .01) higher educational attainment. In IHDS-2, >12 to 24 months and >24 months of breastfeeding were associated with 0.12 (95% CI: 0.01-0.23; P < .05) and 0.19 years of (95% CI: 0.05-0.34; P < .05) higher educational attainment, respectively, than for those with up to 6 months of breastfeeding. In additional analyses by sex, we found that the benefits of breastfeeding accrued primarily to boys. CONCLUSION: Breastfeeding duration was associated with small gains in educational outcomes for boys but not for girls in India.

Improving weight of evidence approaches to chemical evaluations.

Federal and other regulatory agencies often use or claim to use a weight of evidence (WoE) approach in chemical evaluation. Their approaches to the use of WoE, however, differ significantly, rely heavily on subjective professional judgment, and merit improvement. We review uses of WoE approaches in key articles in the peer-reviewed scientific literature, and find significant variations. We find that a hypothesis-based WoE approach, developed by Lorenz Rhomberg et al., can provide a stronger scientific basis for chemical assessment while improving transparency and preserving the appropriate scope of professional judgment. Their approach, while still evolving, relies on the explicit specification of the hypothesized basis for using the information at hand to infer the ability of an agent to cause human health impacts or, more broadly, affect other endpoints of concern. We describe and endorse such a hypothesis-based WoE approach to chemical evaluation.

An upper-bound assessment of the benefits of reducing perchlorate in drinking water.

The Environmental Protection Agency plans to issue new federal regulations to limit drinking water concentrations of perchlorate, which occurs naturally and results from the combustion of rocket fuel. This article presents an upper-bound estimate of the potential benefits of alternative maximum contaminant levels for perchlorate in drinking water. The results suggest that the economic benefits of reducing perchlorate concentrations in drinking water are likely to be low, i.e., under $2.9 million per year nationally, for several reasons. First, the prevalence of detectable perchlorate in public drinking water systems is low. Second, the population especially sensitive to effects of perchlorate, pregnant women who are moderately iodide deficient, represents a minority of all pregnant women. Third, and perhaps most importantly, reducing exposure to perchlorate in drinking water is a relatively ineffective way of increasing iodide uptake, a crucial step linking perchlorate to health effects of concern.

Uncertain benefits estimates for reductions in fine particle concentrations.

The Environmental Protection Agency's (EPA's) estimates of the benefits of improved air quality, especially from reduced mortality associated with reductions in fine particle concentrations, constitute the largest category of benefits from all federal regulation over the last decade. EPA develops such estimates, however, using an approach little changed since a 2002 report by the National Research Council (NRC), which was critical of EPA's methods and recommended a more comprehensive uncertainty analysis incorporating probability distributions for major sources of uncertainty. Consistent with the NRC's 2002 recommendations, we explore alternative assumptions and probability distributions for the major variables used to calculate the value of mortality benefits. For metropolitan Philadelphia, we show that uncertainty in air quality improvements and in baseline mortality have only modest effects on the distribution of estimated benefits. We analyze the effects of alternative assumptions regarding the value of reducing mortality risk, whether the toxicity is above or below the average for fine particles, and whether there is a threshold in the concentration-response relationship, and show these assumptions all have large effects on the distribution of benefits.

Data disclosure for chemical evaluations.

BACKGROUND: Public disclosure of scientific data used by the government to make regulatory decisions for chemicals is a practical step that can enhance public confidence in the scientific basis of such decisions. OBJECTIVES: We reviewed the U.S. Environmental Protection Agency's (EPA) current practices regarding disclosure of data underlying regulatory and policy decisions involving chemicals, including pesticides. We sought to identify additional opportunities for the U.S. EPA to disclose data and, more generally, to promote broad access to data it uses, regardless of origin. DISCUSSION: We recommend that when the U.S. EPA proposes a regulatory determination or other policy decision that relies on scientific research, it should provide sufficient underlying raw data and information about methods to enable reanalysis and attempts to independently reproduce the work, including the sensitivity of results to alternative analyses. This recommendation applies regardless of who conducted the work. If the U.S. EPA is unable to provide such transparency, it should state whether it had full access to all underlying data and methods. A timely version of submitted data cleared of information about confidential business matters and personal privacy should fully meet the standards of transparency described below, including public access sufficient for others to undertake an independent reanalysis. CONCLUSION: Reliable chemical evaluation is essential for protecting public health and the environment and for ensuring availability of useful chemicals under appropriate conditions. Permitting qualified researchers to endeavor to independently reproduce the analyses used in regulatory determinations of pesticides and other chemicals would increase confidence in the scientific basis of such determinations.

Fetal and early childhood undernutrition, mortality, and lifelong health.

Child undernutrition is a major public health challenge, estimated to be responsible for 2.2 million annual deaths. Implementation of available interventions could prevent one-third of these deaths. Emerging evidence suggests that breast-feeding can lead to improvements in intelligence quotient in children and lower risks of noncommunicable diseases in mothers and children decades later. Nonetheless, breast-feeding and complementary feeding practices differ greatly from global recommendations. Although the World Health Organization recommends that infants receive solely breast milk for the first 6 months of life, only about one-third of infants in low-income countries meet this goal, just one-third of children 6 to 24 months old in low-income countries meet the minimum criteria for dietary diversity, and only one in five who are breast-fed receive a minimum acceptable diet. Although the potential effects of improved breast-feeding and complementary feeding appear large, funding for research and greater use of existing effective interventions seems low compared with other life-saving child health interventions.

Healthcare impact of personalized medicine using genetic testing: an exploratory analysis for warfarin.

Warfarin, an anticoagulant commonly used to prevent and control blood clots, is complicated to use because the optimal dose varies greatly among patients. If the dose is too high, the risk of serious bleeding increases; if the dose is too low, the risk of stroke increases. We estimate the potential health benefits and resulting changes in healthcare costs should it become feasible to base personalized warfarin dosing decisions on appropriate genetic testing. Using different assumptions regarding the costs and effectiveness of genetic testing, we estimate that formally integrating genetic testing into routine warfarin therapy could allow American warfarin users to avoid 4500-22,000 serious bleeding events annually. Genetic-based therapy could also reduce the incidence of strokes among patients taking warfarin. We estimate that the additional cost per patient from integrating genetic testing into warfarin therapy could range from US$300 in our pessimistic case, to substantial healthcare cost savings in the optimistic case.