Drug Shortages, PhRMA, FDA, and the world

What are the causes of drug shortages? Can we predict and prepare for shortages? 
-some links for background reports

FDADrug Shortages - Review and Discussion of Key Issues

Summary of the Jan. 6, 2012 Meeting of the Science Board to the FDA

IMS Health IncorporatedDrug Shortages: A Closer Look at Products, Suppliers and Volume Volatility
The drug shortages problem is of increasing concern for patients, clinicians and policymakers. Using IMS Health’s comprehensive, proprietary data on the drug supply chain, we examine the issue from an entirely new point of view, offering insights and recommendations to help the FDA, pharmacists and other healthcare stakeholders monitor and respond to this important issue.

The Pew Charitible Trust
After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs
Pharmaceutical manufacturers and distributors work together in a robust system to deliver high-quality products, but drug manufacturing and distribution have become increasingly complex in recent years. Prescription and over-the-counter (OTC) medications originate in factories all over the world, moving into the American marketplace through supply chains that can involve numerous processing plants, manufacturers, suppliers, brokers, packagers and distributors.

Obamacare’s Effect on Drug Spending

Published by Angie Drakulich on April 6, 2012 08:10 am under Trends

This blog post was written by Ben Comer.

Provisions in the Affordable Care Act (ACA) drove out-of-pocket costs down, while increasing drug spending among 19 to 25-year-olds in 2011, according to research published on Wednesday. The decline observed in overall out-of-pocket spending last year was the “first on record,” and was “largely related to the introduction of the ‘donut-hole’ subsidy for Medicare Part D beneficiaries,” a highly-touted element of the ACA, according to the IMS Institute for Healthcare Informatics. While copays for commercial providers and Medicaid were flat (average commercial plan copays increased by $1.14, to $26.10 in 2011), seniors covered by Medicare Part D got the largest break, with average copays decreasing by $2.66 – from $25.97 in 2010, to $23.31 in 2011 – according to the report.

The dip in copay costs for seniors didn’t translate into an increase in volume for chronic or acute medications, however; in fact, patients 65-years and older reduced their drug usage by 3.1%. Prescription use among the same group declined in 2010 as well, by 2.7%, but the last two years represent an inflection from prior years, when “seniors’ usage of medicines grew on average at 4%,” the report found. College-aged patients (19-24 years old), on the other hand, were the only age group to increase their drug usage, by a modest 2%. That increase “coincides with the first full year of implementation of the provision of the ACA allowing under-26-year-olds to stay on their parents’ health insurance,” according to the report.

Michael Kleinrock, director of research development at the institute, said on a call with reporters that patients over 65 years old are foregoing the medications they use the most. Drug usage for hypertension, the most common disease among this population, decreased more than any other class of drugs. “This correlates strongly with the economy…seniors are on a fixed income, and costs [of living] are rising,” said Kleinrock on the call. Kleinrock called the development a “tipping point,” adding that seniors are resetting their expectations around how often, and under what circumstances, they will visit a doctor.

Per capita figures adjusted for currency changes showed a 0.5% growth in total drug spending in 2011 – to $320 billion. Other fun facts from the report include:

more...
http://blog.pharmtech.com/2012/04/06/obamacares-effect-on-drug-spending/

Orphan drug launches reach 10-year high in 2011

Orphan drug launches for rare diseases reached a 10-year high in 2011, underscored by new breakthroughs in personalized medicine, according to a report by IMS Institute for Healthcare Informatics in New Jersey.

Orphan drugs carry a higher price tag than other drugs because they are intended for a patient population of no more than 200,000.

Among the 12 orphan drugs launched last year was Pfizer’s (NYSE:PFE) drug critzotinib, branded Xalkori, to treat nonsmall cell lung cancer. The drug targets a specific biomarker — the anaplastic lymphoma kinase fusion gene. The therapy is for 3 percent to 7 percent of patients with tumors that carry a unique mutation and can improve survival by nine months. Roche-owned Genentech drug, sumotropin, a human growth hormone, was launched to alleviate the short stature associated with Turner syndrome, a disorder that affects women in which they lack or have a malfunctioning sex chromosome.

http://www.medcitynews.com/2012/04/orphan-drug-launches-reach-10-year-high-in-2011/?edition=pharmaceuticals

Breakthrough Treatments, Fewer Doctor Office Visits, Reduced Use of Medicines Impact U.S. Healthcare in 2011, According to IMS Study

PARSIPPANY, N.J. -- The most medicines launched in a decade brought new, transformative treatment options to more than 20 million Americans in 2011, even as patients visited their physicians and used prescription drugs less often, according to a new report from the IMS Institute for Healthcare Informatics.

The report, The Use of Medicines in the United States: Review of 2011, found that there were important variations across the country and by patient age in the use of healthcare services. Young people, age 19-25, increased their use of prescription drugs as many for the first time were able to remain on their parents’ health insurance, while seniors age 65 and over reduced their volume of prescriptions.
Additionally, the availability of new generic drugs in a number of chronic therapies contributed to a minimal increase in drug expenditures overall. Total healthcare system spending on medicines reached $320 billion in 2011, up 0.5 percent on a real per capita basis.

for more: http://www.sunherald.com/2012/04/04/3862336/breakthrough-treatments-fewer.html

Read more here: http://www.sunherald.com/2012/04/04/3862336/breakthrough-treatments-fewer.html#storylink=cpy