Pharmacy began 2013 under intense scrutiny after a nationwide outbreak of fungal infections caused by contaminated compounded products. Congress has given FDA new authority in that realm, and now the profession is headed back to Capitol Hill seeking something more positive: provider status. Here’s how 2013 looked through the lens of pharmacist.com.
1 Congress, FDA Act on Pharmacy Compounding: Pharmacy struggled with a compounding-quality conundrum. A few days after Pres. Obama signed what some felt was a weak Drug Quality and Safety Act, FDA issued aggressive guidances that could keep compounding in the news.
2 Pharmacists Seek Recognition as Obamacare Is Implemented: Health care is increasingly regulated and regimented, and medications are the prime mode of treatment of many diseases (especially chronic ones). To survive in the health care system now on the horizon, pharmacists need formal provider status recognition of the clinical services they can provide, and APhA is part of a coalition of 14 national pharmacy groups out to attain it. By the end of the year, Sens. Chuck Grassley (R-IA) and Tom Carper (D-DE) were ready to introduce an amendment that would have recognized pharmacists as providers in accountable care organizations (ACOs).
3 Pharmacists Excel in Clinical Roles: Nonadherence should be treated like a disease, but a polypill that addresses adherence is no solution if polypharmacy is the problem. The medication expert on the health care team can help with such problems. In 2013, pharmacist.com covered pharmacists’ impact in care transitions and medication reconciliation, on clinical care teams, and in accountable care organizations.
4 Guidelines, No Longer Official, Lead to Controversy: When the National Institutes of Health bailed out of the guideline business, an association-driven process seemed a natural answer. Within months, advice was published for lipids and obesity management, risk assessment, and lifestyle changes, and then not one but two guidelines for hypertension came out. Controversy ensued, with a risk-assessment calculator criticized and confusion among clinicians about which guidelines to adopt.
5 New Drugs, New OTCs: New drugs for chronic obstructive pulmonary disease (May 11 and December 19) and hepatitis C virus (December 9) were approved this year. Key agents made the Rx-to-OTC switch, including a court-driven Plan B One-Step and Nasacort Allergy 24 HR.
6 Misused Opioids, Other Meds: The “opioid epidemic” continues, with abuse of these drugs increasing dramatically and pharmacists helping to address these issues. Paradoxically, FDA announced one day that it wanted to move Vicodin and Lortab to Schedule II and then approved non–tamper-resistant Zohydro ER the next.
7 Genomics & Personalized Care: This may have been the year FDA approved a new drug with a companion gene-mutation test, but those hoping genomics could recharge anticoag clinics were disappointed by results presented at the American Heart Association meeting.
8 Antibiotic Stewardship: Efforts to make better use of antibiotics continued, including emphasis on treatment of methicillin-resistant Staphylococcus aureus, the need for urgent action, and community–hospital pharmacist collaboration.
9 Vitamin D Interests, Other Supplements Fade: Studies of vitamin D yielded mixed results during 2013, but uncovering of racial differences in levels, effects, and binding proteins proved fascinating. Other supplements continued to disappoint, and Americans heard an absolute recommendation to stop wasting money on vitamins.
10 Economics Paint Picture: Medicare Part D provided interesting data for evaluating the costs of pharmacotherapy as a major new CMS study affirmed pharmacist-provided medication therapy management (MTM) in Part D and showed that MTM programs that maintained or lowered drug costs were in integrated health systems that used an electronic health record.