With the death count currently at 20 and 254 sickened - and more expected - from contaminated steroid injections, a spotlight has been aimed at compounding pharmacies. It turns out states are the regulators of these entities, some of which have morphed into loosely regulated drug manufacturers. Clearly, the current crisis calls out for comprehensive federal oversight. But how many of us expect that Congress will act promptly to clarify and expand the FDA's authority? In the absence of a speedy revamping of federal authority, state legislators need to review their statutes and regulations, as well as the enforcement of those rules. While it appears that Massachusetts had some key rules in place, with complaints going back to 1999, enforcement zeal remains a question. Other states may want to look to new policies in Massachusetts including surprise inspections just announced by Governor Deval Patrick.
In addition to reviewing and beefing up their pharmacy regulations, legislators should consider a focus on best practices for prescribing and review reimbursement rules for state-funded prescription drug and insurance programs. There are a lot of steroid injections being prescribed for pain. Are they warranted given the risks? According to the Wall Street Journal, patients are going ahead with these treatments despite the risks. Just as federal policymakers are scrutinizing Medicare, state policymakers should look at Medicaid and other programs where states set the rules or pay the bills and determine if changes are warranted.
A good place for legislators to start would be to review Congressman Markey's October 29, 2012 report on federal and state oversight and note the gaps in state regulations and enforcement. Link to report: http://markey.house.gov/document/2012/compounding-pharmacies-compounding-risk-report
See Also:
| Planning a State Legislative Agenda for 2013 | more UPDATE (10-30-2012): Tragically the death count has changed to 23 confirmed deaths. |
