When Prescribing Gets in the Way

By Scott Burris

I am not disputing the value of properly trained health professionals acting as gate-keepers to potentially dangerous drugs. And I am not taking on here the question of which health care professionals should be allowed to prescribe which drugs, though that is an important question on which the states vary quite a bit. Right now, though, there are at least three examples of important, even life-saving medicine that is being kept from people who need it because of rigid (or rigid interpretations of) state prescribing law, and the inability of the FDA to move quickly when its labeling no longer seems to meet the public interest:

1)      Epinephrine (in epi-pens) to treat severe allergic reactions.  Here’s a good story about that, highlighting a tragic case in which a child died because a school nurse would not or could not use epinephrine that had been prescribed for a different child. The story reports that 30 states now allow “undesignated” epinephrine to be used in these cases, but only four require it – and 20 still prohibit it.

2)      Naloxone to prevent death from drug overdose.  Naloxone is the standard treatment to reverse opioid overdose.  People usually suffer OD far away from a doctor, but often in the presence of someone who could administer naloxone by simple intramuscular injection or intranasal spray.  This year there has been quite a bit of legislative activity to break down this barrier to life-saving treatment, including a new bill passing both houses in California this week.  But only 16 states and the District of Columbia have acted so far.

3)      Expedited partner therapy for treatment of STDs.  It takes at least two people to get an STD, or prevent one, but often only one partner is seeing the doctor.  EPT gives the patient an extra prescription or dose for the partner.  According to the CDC, this is still illegal in six states and not clearly legal in 9, the District of Columbia and Puerto Rico.

There is evidence for the safety and effectiveness of all these practices, and has been for years. Why does it have to take so long for state prescribing rules, or FDA labels, to change?  We need a faster mechanism for keeing prescribing rules consistent with current practice and evidence. This is, after all, a matter of everyday life and death.

Temple University Center for Public Health Law Research

Temple University Center for Public Health Law Research

Based at the Temple University Beasley School of Law, the Center for Public Health Law Research supports the widespread adoption of scientific tools and methods for mapping and evaluating the impact of law on health. It works by developing and teaching public health law research and legal epidemiology methods (including legal mapping and policy surveillance); researching laws and policies that improve health, increase access to care, and create or remove barriers to health (e.g., laws or policies that create or remove inequity); and communicating and disseminating evidence to facilitate innovation.

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