The role of pre-shipment batch testing in ensuring good medicine quality.

Background: Most donor agencies only procure drugs approved by a Stringent Regulatory Authority or the World Health Organization (WHO) Prequalification Programme in an effort to ensure high quality. However, the US President's Malaria Initiative has occasionally had to return approved drugs with quality issues to the manufacturer. This study compares the quality of artemisinin-based combination therapies (ACTs) produced by WHO-approved manufacturers with non-approved manufacturers and suggests policy changes to improve quality of donor-procured drugs.

The Medicaid expansion is not such a good deal for states or the poor.

In the wake of the Supreme Court decision, states should not rush to expand eligibility for Medicaid. They cannot be certain that the federal support promised in the Patient Protection and Affordable Care Act will remain available, and a better deal might be possible after the election. Adding millions more to Medicaid rolls will exacerbate existing problems of access to providers.

Subsidizing artemisinin-based combination therapies: a preliminary investigation of the Affordable Medicines Facility - malaria.

Background: The Affordable Medicines Facility - malaria (AMFm) is a subsidy mechanism to lower the price of, and hence increase access to, the best antimalarial medicines, artemisinin-based combination therapies (ACTs). While the AMFm stipulates that only quality-approved products are eligible for subsidy, it is not known whether those products, when actually supplied, are of good quality and comport with established pharmacopeial guidance on formulation and content of active ingredients. This study aimed to assess price and quality of AMFm ACTs, to compare AMFm ACTs with non-AMFm ACTs and artemisinin monotherapies, and to assess whether AMFm ACTs have been pilfered and diverted to a nearby country.

Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture.

Background: Some medicines for sale in developing countries are approved by a stringent regulatory authority (SRA) or the World Health Organization (WHO) prequalification program; many of these are global brands. This study ascertains whether medicines approved by SRAs or the WHO perform better in simple quality tests than those that have not been approved by either.

Methods: Over the past 4 years, 2652 essential drugs (products to treat malaria, tuberculosis, and bacterial infections) were procured by covert shoppers from eleven African cities and eight cities in a variety of mid-income nations.

Looking for better health in all the wrong places: the road to "equality" hits a dead end.

The actual evidence base for measures of health inequality among the elderly in the United States remains rather thin. Addressing the real causes of health inequalities will require measuring what matters, accounting for the time lags and non-health-care factors behind the development of future health conditions and outcomes, and setting better priorities and targets. An early intervention strategy should focus more on future generations of elderly Americans when they are young.

The AMFm and Medicine Diversion: Good intent enabling corrupt practices.

Increased donated and subsidised medicines for malaria are saving countless lives in Africa, but there is probably increasing theft and diversion of those medicines. The impact of medicine diversion is unknown but potentially dangerous and may bolster criminal networks and increase medicine stock outs (1,2). This study demonstrates that diversion is widespread; diverted subsidised medicines were found in 11 of 14 cities investigated, and in four of those, over half the pharmacies researchers visited had diverted subsidised malaria products.

Does price reveal poor-quality drugs? Evidence from 17 countries.

Focusing on 8 drug types on the WHO-approved medicine list, we constructed an original dataset of 899 drug samples from 17 low- and median-income countries and tested them for visual appearance, disintegration, and analyzed their ingredients by chromatography and spectrometry. Fifteen percent of the samples fail at least one test and can be considered substandard. After controlling for local factors, we find that failing drugs are priced 13.

Bending the curve through health reform implementation.

In September 2009, we released a set of concrete, feasible steps that could achieve the goal of significantly slowing spending growth while improving the quality of care. We stand by these recommendations, but they need to be updated in light of the new Patient Protection and Affordable Care Act (ACA). Reducing healthcare spending growth remains an urgent and unresolved issue, especially as the ACA expands insurance coverage to 32 million more Americans.

Assessing website pharmacy drug quality: safer than you think?

Background: Internet-sourced drugs are often considered suspect. The World Health Organization reports that drugs from websites that conceal their physical address are counterfeit in over 50 percent of cases; the U.S.

Anti-malarial drug quality in Lagos and Accra - a comparison of various quality assessments.

Background: Two major cities in West Africa, Accra, the capital of Ghana, and Lagos, the largest city of Nigeria, have significant problems with substandard pharmaceuticals. Both have actively combated the problem in recent years, particularly by screening products on the market using the Global Pharma Health Fund e.V.

Analysis & commentary. Health reform: only a cease-fire in a political hundred years' war.

Four dominant political forces drove the process and product of national health reform during the past two years: federal budget constraints; public concerns about the size and reach of the federal government; the time pressure of the congressional calendar; and the political parties' high-stakes, all-or-nothing bets on what became President Barack Obama's defining policy priority. Republican congressional leaders saw little advantage in offering more detailed alternatives. Congressional Democrats calculated that they had even more to lose politically by abandoning health reform legislation than by pushing it through Congress.

How can we make more progress in measuring physicians' performance to improve the value of care?

The lack of good information on providers' performance is an impediment to improving the affordability and quality of health care. Knowing that certain hospitals or physicians produce more effective and efficient care would help consumers make appropriate purchases and create incentive for improvement. Yet many physicians resist such measurement efforts, unconvinced of their accuracy.

Forbidding science: some beginning reflections.

Growing powers to manipulate human bodies and minds, not merely to heal disease but to satisfy desires, control deviant behavior, and to change human nature, make urgent questions of whether and how to regulate their use, not merely to assure safety and efficacy but also to safeguard our humanity. Oversight in democratic societies rightly belongs to the polity, not merely to self-appointed experts, scientific or ethical. Yet the task of governing the uses of dangerous knowledge is daunting, and there is little evidence that we have the will or the wisdom to do it well.

'Me-Too' Innovation in Pharmaceutical Markets.

Critics of me-too innovation often argue that follow-on drugs offer little incremental clinical value over existing pioneer products, while at the same time increasing health care costs. We examine whether consumers view follow-on and pioneer drugs as close substitutes or distinct clinical therapies. For five major classes of drugs, we find that large reductions in the price of pioneer molecules after patent expiration-which would typically lead to decreased consumption of strong substitutes-have no effect on the trend in demand for follow-on drugs.