How the US Food and Drug Administration can solve the prescription drug shortage problem.

Drug shortages are threatening care quality and cost-containment efforts. I describe the pharmaceutical marketplace changes that have caused the problem, and propose new policies to solve it, through changing incentives for producers and purchasers. I propose a grading scheme for the Food and Drug Administration when it inspects manufacturing facilities in the United States and abroad. The inspections' focus would change from closing unsafe plants to improving production process quality, reducing the likelihood that plants will be closed-the most frequent cause of drug shortages.

Prices of pharmaceuticals in poor countries are much lower than in wealthy countries.

Keeping pharmaceuticals affordable in poor countries is important for public health. Economic models suggest that manufacturers should be able to charge substantially lower prices in those markets than in industrialized countries without drastically reducing their profits. We report the results of a study of thirty drugs in twenty-nine countries, showing that many prices are already substantially discounted in middle-income and developing countries, compared to prices in the United States and other industrialized countries, and do not exceed long-run marginal costs. We also argue that the so-called peak load pricing model offers an economic foundation for fair drug pricing in the case of developing countries, and is a better solution than other pricing models to the problem of how to reduce drug prices in these countries to the level of manufacturers' marginal costs.

Issues in drug pricing, reimbursement, and access in China with references to other Asia-Pacific region.

OBJECTIVES: Pharmaceutical policies have become paramount in China and other countries of the Asia-Pacific region because of rapidly rising expenditures on drugs. The problems are especially acute in China because expenditures on drugs are typically so large. This article intends to review effects of the policy of drug expenditure containment with primary reference to China, and it proposes some measures to deal with rising pharmaceutical expenditures. METHODS: This article overviews the issues of pharmaceutical pricing, reimbursement, and access in China, and there are a number of policies or measures to control pharmaceutical expenditures. Nevertheless, the effect of those policies of containing drug expenditure is ambiguous so far, and some policies have negative impacts to the manufacturers, providers, and patients. Some underlying reasons are identified. First, the policy's focus on health-care costs is, to some extent, neglected. Second, the governance of the health sector, including pharmaceutical sector, needs to be improved by both the government and the market. RESULTS: This article proposes some suggestions to change policies in drug pricing, reimbursement, and access, and make policies more responsive to the main problem of rising health-care expenditures rather than that of pharmaceutical expenditures alone. CONCLUSIONS: The policy suggestions include those of setting the reasonable price for pharmaceuticals, instituting reasonable incentives for all health decision-makers to encourage efficient use of pharmaceuticals and other health resources, and making pharmaceutical markets more efficient, either in the demand or the supply side.

Preliminary study into the economic burden of Down syndrome in China.

BACKGROUND: To measure the economic burden of Down syndrome (DS) in China is to facilitate strategic planning development for managing and preventing DS. METHODS: The economic burden of DS was calculated from direct healthcare costs, direct non-health-care costs, and indirect costs. The incidence approach was employed to measure the lifetime economic burden of a new DS birth in China in 2003. Most parameters came from a household health services survey, which was given to caregivers of people with DS. This survey was conducted in Hebei, Shaanxi, and Shanghai in 2004. RESULTS: Caregivers of 222 people with DS were interviewed in six cities and neighboring rural areas. Average expenses and utilization rate of different services by age groups from this sample were obtained to estimate the economic burden of DS. The average lifetime economic burden of a new DS case from the family perspective and the societal perspective amounted to US$47,000 and US$55,000, respectively. Indirect (productivity) costs were responsible for most of the total economic loss. Sensitivity analysis showed that the incidence rate, survival rate, value of productivity such as GDP per capita or salary, productivity of people with DS, and utilization rate of related services were influencing factors to the economic burden of DS. CONCLUSIONS: The economic burden of DS is substantial for the family of a person with DS, as well as to society. Appropriate management and prevention of DS is needed to reduce the heavy burden for people with DS and their families. Birth Defects Research (Part A) 2008.

Cost-effectiveness analysis of prenatal diagnosis intervention for Down's syndrome in China.

OBJECTIVES: The cost-effectiveness of prenatal diagnosis intervention for Down's syndrome (DS) in China was assessed and evidence-based information for policy makers and providers is presented. METHODS: Based on field surveys in four selected cities in China and a literature review, the economic evaluation of prenatal diagnosis for DS from a societal perspective is conducted by cost-effectiveness analysis. RESULTS: In current clinical practice, for a cohort of 10,000 pregnant women, the strategy that delivers karyotyping by chorionic villus sampling (CVS) or amniocentesis (AC) only to those pregnant women 35 years of age and older (maternal age screening strategy) can detect .67 DS births. The strategy that offers the diagnostic test after maternal serum screening with alpha-fetoprotein and human chorionic gonadotrophin (maternal serum screening strategy) can detect 1.41 DS births. The cost per prevented DS birth by the maternal age screening strategy and maternal serum screening strategy is US$ 13,091 and US$ 56,048, respectively. Sensitivity analysis shows that the maternal serum screening strategy can be cost-effective if uptake rate of CVS or AC for patients with positive serum tests increase while the cost of serum screening decreases. CONCLUSIONS: Although, in general, serum screening has been found to be more cost-effective than maternal age screening, this appears not to be the case in China. The reasons appear to be low uptake rate of the maternal serum strategy, low uptake rate of CVS or AC, and the high price of serum screening. Our findings are that health system factors concerning technology utilization are important determinants of the technology's efficiency.

Direct-to-consumer advertising of COX-2 inhibitors: effect on appropriateness of prescribing.

Spending on direct-to-consumer advertising (DTCA) of prescription drugs has increased dramatically in the past several years. An unresolved question is whether such advertising leads to inappropriate prescribing. In this study, the authors use survey and administrative data to determine the association of DTCA with the appropriate prescribing of cyclooxygenase-2 (COX-2) inhibitors for 1,382 patients. Treatment with either a COX-2 or a traditional nonsteroidal anti-inflammatory drug (NSAID) was defined as appropriate or not according to three different definitions of gastrointestinal risk. Patients who saw or heard a COX-2 advertisement and asked their physician about the advertised drug were significantly more likely to be prescribed a COX-2 (versus a NSAID, as recommended by evidence-based guidelines) than all other patients. Findings also suggest that some patients may benefit from DTCA. The authors discuss the need for balanced drug information for consumers, increased physician vigilance in prescribing appropriately, and further study of DTCA.