Kathryn Foxhall

If the Washington, D.C.-based Patient-Centered Primary Care Collaborative has anything to say about it, MTM will help shift pharmacists' roles from dispensing to direct clinical practice.

What has staved off even higher levels of ongoing shortages is that drugmakers are reporting potential shortages much more often and FDA is using various tactics to prevent them from becoming reality.

Republicans in the House of Representatives have published a report blaming the current increase in drug shortages mostly on FDA under the current administrator.

The National Institute for Occupational Safety and Health (NIOSH) may recommend that healthcare workers, including pharmacists and pharmacy technicians, be transferred from positions where they handle hazardous drugs if the workers are trying to conceive, are pregnant, and/or breastfeeding.

In coming years, nearly half of all newly approved drugs could come from biotechnology. With stakes so high, Congress is working to create a more direct pathway for the FDA to approve "biosimilars", the generic or "follow-on" versions of biologics. Two bills before Congress approach the issues differently.

Deaths from C. difficile increase yearly

Biomarkers may be on the verge of changing medicine, but they need a push.

Some pharmacists feel that record-keeping is unduly burdensome and the process has not reduced the production of methamphetamines.

FDA is considering how to deal with the phaseout of chlorofluorocarbons from inhalers, which is only a year away.

Pharmacists' organizations were out in force at a recent FDA hearing on the possibility of creating a third category of drugs that would be placed "behind-the-counter" and pharmacist-assisted.

A survey commissioned by pharmacist groups indicates once again that patients are often not adhering to directions for prescription medications.

Last June the Food & Drug Administration approved a new vaccine, Gardasil (Merck & Co.), which studies show to be highly effective against major types of human papillomavirus (HPV). Now comes the hard part: actually getting it to girls and women.

Medicare Part D is still not for wimps, be they health professionals or consumers, any more than it was in early 2006, according to a Kaiser Family Foundation (KFF) analyst. Indeed, there is high risk that many beneficiaries are getting into plans, both for 2006 and 2007, that are not good for covering their medications and there could be health consequences, said Patricia Neuman, Sc.D., director of the foundation's Medicare Policy Project.

While the nation waits for the electronic health record (EHR) to become an everyday reality, the Department of Health & Human Services (HHS) is pushing for widespread use of personal health records (PHRs), which are controlled by the consumer and include a medication history. HHS Secretary Mike Leavitt recently accepted the first set of interoperability standards for PHR, hammered out over many months by the Health Information Technology Standards Panel (HITSP).

Several dozen neuropsychiatrists and others, at a recent meeting in Washington, D.C., emphasized the need for a national postmarketing surveillance system for drugs. But how will the country move to such a system?

In an extension of cooperation begun earlier this year, health insurance plans and pharmacist groups have created a booklet and a Web site to guide Medicare beneficiaries through choosing a 2007 Part D plan, just as open enrollment is set to begin on Nov. 15.

A late September hearing saw patients and advocates telling the government that people are dying due to lack of access to intravenous immune globulin therapy (IVIG). It also recorded allegations about suspected artificial shortages, federal foot-dragging, and supplies directed to less-deserving patients. The "town hall" meeting, held recently in Arlington, Va., took five-minute statements from about three dozen witnesses as part of an independent study the Department of Health & Human Services (HHS) contracted for. Patients have been unable to get IVIG, get it in the best setting, or get the brand that works for them.

A public interest law firm has sued the government over the restrictions placed on pharmacists and other healthcare providers in helping Medicare beneficiaries choose a Part D plan. The suit claims that the rules in the marketing guidelines are a violation of free speech.

Can society countenance paying $161,000 a year for treating one cancer patient, as was estimated for one new drug? And again and again for many patients? If newer agents cost 500 times the older ones, can we cover them? What if, due to new agents, some cancers become more like other chronic diseases, where expensive treatment continues for a lifetime?