Monitoring controlled substances

Key Points

A controlled substance prescription is not a legal prescription unless it is written for a "legitimate medical purpose" in the "usual course of professional treatment." The rules say:

How is a pharmacist supposed to know which prescriptions are for a "legitimate medical purpose?" Thirty-nine states now have a tool to help pharmacists identify at least some questionable prescriptions and suggest when a patient may be doctor-shopping or pharmacy-shopping in order to obtain controlled substances. That tool is the state prescription monitoring program (PMP).

The purpose of these programs, according to the Arizona Board of Pharmacy, which administers that state's program, is to "track the use of controlled substances, assist law enforcement in identifying illegal activity, and provide information to help avoid their inappropriate use." With the PMP, pharmacists can see all controlled-substance prescription records of all other pharmacies in the state where the patient has received drugs.

Now that pharmacists have this tool, what happens if they don't use it? Because PMPs are still relatively new, it may be too early to know. Much will depend on how state legislation is written and how courts interpret it. Without question, in coming years there will be cases in which patients who allege that they became addicted to controlled substances will sue their pharmacies, citing pharmacy failure to monitor their medication use through the PMP.

PMP in court

To date, at least one case [Sanchez ex rel. Sanchez v. Wal-Mart Stores, Inc., 221 P.3d 1276 (2009)] has been filed against a group of pharmacies for not using their state's PMP. The case, which was decided by the Nevada Supreme Court, was different because it was filed, not by a patient of the pharmacies, but by the widow and minor children of a deceased motorist who was killed by a patient of the pharmacies.

It was noteworthy that each of the pharmacies had received a letter from the PMP administrator alerting them to the patient's drug use a year before the accident. The letter informed the pharmacies that between May 2002 and May 2003, the patient who later killed a husband and father "had obtained approximately 4,500 hydrocodone pills at 13 different pharmacies." The lawsuit alleged that the pharmacies did not properly respond to the information and did not properly use the PMP. That failure, the plaintiffs said, led to the accident and death.

In that case, the court ruled that the defendant pharmacies do not have a duty to prevent a patient from injuring an unidentified third party with whom the pharmacies had no relationship. Explaining their ruling, the court majority said that the law was not intended for that purpose but to "enhance recordkeeping" for drug enforcement and regulation, and to provide information to physicians, pharmacies, and others.

Minority opinion

There was, however, a minority opinion written by 2 of the 7 justices. Disagreeing from the majority, these judges felt that pharmacists had the tools, skill, and knowledge to either investigate the patient's medication use or refuse to fill the prescriptions. These 2 justices would have held the pharmacies liable to the third parties.

Today, in most states at least, pharmacists have access to information that can suggest cases of doctor- and pharmacy-shopping. How pharmacists will use these tools and whether courts will hold pharmacies liable for failing to use the information, time will tell. For now, each pharmacist must decide how best to fulfill his or her "corresponding responsibility."

These articles are not intended as legal advice and should not be used as such. When a legal or risk management question arises, the pharmacist should consult an attorney familiar with pharmacy law in his or her state.

KEN BAKER is a pharmacist and an attorney with the Phoenix, Arizona, law firm of Renaud Cook Drury Mesaros, PA. His practice includes pharmacy malpractice defense; he also consults in the areas of pharmacy error reduction, communication, and risk management. Contact him at Ken@kenbakerconsulting.com