Whether or not to fill a prescription is a decision made by every pharmacist.  When it comes to who acts as the final gatekeeper for the nation's drug supply, the DEA (US Drug Enforcement Administration) holds pharmacists responsible in that position.  Pharmacists fill a significant role in acute and chronic pain care and should have the necessary protocols and professional tools to fulfill their responsibility.  Beyond clinical skills to ensure that prescribed medications are therapeutically appropriate for patients, pharmacists use observational skills to ensure that medications are not diverted for illegal uses.  Preventing diversion is a clear responsibility of pharmacists.  (A diverted medication is a controlled-substance medication dispensed to a person whose intent is to use the medication in a manner other than prescribed by a physician, such as addiction.)

Is observational skill, or patient profiling, enough to enable pharmacists stop drug diversion to illegal uses?  It is time to encourage state licensing boards to provide standardized assessment protocols to pharmacies.  This type of protocol would advance a method of authorization for pharmacists to know they are properly and legally dispensing medications.  Currently acute and chronic pain patients are suffering without access to their prescribed medications because of the heavy-handed approach of the DEA to shut down high volume pharmacies and interrupt the supply chain to other pharmacies.  While the DEA’s actions are designed to drastically restrict illicit access to controlled substances, they have the unintended but foreseeable effect of also reducing access by people suffering with acute and chronic pain.

Repeatedly traveling from one pharmacy to another because pharmacists are out of stock of normally stocked medications is a large barrier to care being forced on pain patients.  Increasing barriers to care increases the cost of pain management and is ethically unacceptable on all levels.  
 
Pharmacists also have a responsibility to ensure that patients in pain receive medication that will relieve suffering.  People in pain have not always received necessary and appropriate medications because of the existing barriers for providing opioid analgesics, a controlled substance. Currently the two primary responsibilities of the pharmacist, to comply with the regulatory imperative to avoid controlled-substance diversion and the professional imperative to relieve human suffering through care and concern for individuals in pain may be in conflict.
 
Successful pharmacy practice balances between diversion-prevention activities and patient care activities.  Adding an authorization, or standardized patient assessment protocol, promises to assist pharmacists in ensuring the prevention of controlled-substance diversion while simultaneously making certain that patients in pain do not needlessly suffer.  We encourage a closer look by state medical and pharmaceutical licensing departments at the VIGIL protocol developed by David B. Brushwood, R.Ph., J.D. Professor of Pharmacy Health Care Administration, University of Florida College of Pharmacy, Gainesville.
 
 
Background:
 
Controlled Substance Regulation:
 
The federal controlled-substance law creates a closed system of drug distribution administered by the Drug Enforcement Administration (DEA).   In the closed system, drugs are classified into one of five schedules; schedules II through V are drugs that have a recognized, legitimate role in medical care.  As the number assigned to the schedule increases, the degree of regulatory oversight decreases.  The propensity for abuse also decreases as the schedule number increases.  Authorized businesses and individuals controlling the distribution of these scheduled drugs are required to register with the DEA.  By conducting an audit of a registrant within this closed system, the DEA and other regulatory agencies can know where a controlled substance is, where it has been, or where it has gone.   
 

[1] http://www.deadiversion.usdoj.gov/21cfr/cfr/index.html.  (U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion Control) accessed Mar 4 2012.

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