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Unprecedented Drug Shortages
The situation with drug shortages is possibly the worst it has ever been. This information comes from pharmacists, doctors, and nurses who are reporting that pain medications and anesthetic agents are particularly affected.
There are official lists of drug shortages produced by the FDA, and there is also the ASHP list. The ASHP's list is more comprehensive, since it includes more than just drugs considered medically necessary. Just this week, ASHP reported on the shortage of IV ibuprofen. Also included among the shortages are propofol and prefilled syringes of epinephrine.
A number of reasons account for the shortages, including the unavailability of raw ingredients, custom delays, substandard raw ingredients, FDA enforcement actions that halt production, voluntary recalls, poor inventory ordering, a change in product formulation, and even rumors of an impending shortage, which can cause hoarding.
http://blogs.wsj.com/health/2010/08/04/institute-for-safe-medication-practices-drug-shortages-unprecedented/
Recession Causing Cancer Patients to Quit Life-Extending Drugs
In 2009 and 2010, as the economic collapse shuddered across the globe, oncologists have noticed patients giving up their medications. For example, three patients who had serious tumors under control for as long as eight years reappeared in the clinic with massive cancer regrowth, which in one case required emergency surgery, after stopping their medications.
And there may be other similar cases either of patients stopping medications altogether or rationing in the hopes of making their supplies last longer. There has been some evidence to suggest that it is happening on a wider scale, as this not only happens when the economy turns down, but it may happen if Medicare programs run into budgetary problems and become restrictive or if private co-payments go up.
Gleevec costs patients close to $5,000 per month. That's out of the reach of most Americans without health insurance, and it can make Gleevec tough to afford even when insurance is available. These people previously had their drugs covered and all of a sudden the greater-than-$5,000-a-month cost became prohibitive.
If a patient has a large co-pay, or no insurance at all, the main resource to offer is connection with patient assistance programs run by pharmaceutical companies. Also, there are some foundations and charities to help people who are struggling with their cost-sharing on prescription drugs or other cost-sharing problems, and some of the pharmaceutical companies have assistance programs where they will provide drugs at lower or no cost for patients in need. There's a searchable database of patient assistance programs at RxAssist.
http://consumer.healthday.com/Article.asp?AID=641844
Senate Bill Would Bolster Drug Safety Requirements
With a recent spike in pharmaceutical recalls, Sen. Michael Bennet on Tuesday introduced legislation to bolster consumer protections governing the nation's drug supply.
His new proposal would greatly expand the FDA's enforcement powers while holding drug companies more accountable for the products they sell; the sponsor says this is vital in a globalized age when more and more drug ingredients originate overseas.
Bennet's proposal would update FDA data systems to track all global manufacturers that are feeding America's drug supply; force companies to document each contributor to their products; grant FDA subpoena authority when conducting investigations; and empower FDA officials to recall drugs when safety issues arise-a power the agency currently has over medical device makers, but not the pharmaceutical industry.
Additionally, they estimate that 80 percent of the active ingredients in the nation's pharmaceuticals are made abroad, where safety regulations are often much less stringent than U.S. guidelines.
http://thehill.com/blogs/healthwatch/prescription-drug-policy/112393-senate-bill-would-bolster-drug-safety-requirements-
FDA: Facebook Link on Novartis Drug Website is Misleading
The FDA said Novartis AG's use of a Facebook tool on the website for the cancer drug Tasigna violates regulations by presenting misleading information. The agency says that Novartis used a misleading brochure for its blood-pressure drug Exforge, and that AstraZeneca PLC used misleading promotional material for the antipsychotic Seroquel.
The FDA said the U.S. website for Tasigna has a "Facebook Share widget," or a button that users can click on to generate Novartis-created information about the drug, which visitors can share with other Facebook users. The shared content is misleading and fails to communicate any risk information associated with the use of this drug.
Drug companies have approached social media sites like Facebook and Twitter cautiously because the companies must comply with federal regulations requiring balanced presentation of risks and benefits for prescription drugs.
http://online.wsj.com/article/BT-CO-20100805-722920.html?mod=dist_smartbrief
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