These articles are not intended as legal advice and should not be used as such. When a legal question arises, the pharmacist should consult with an attorney familiar with pharmacy law in his or her state.
Ken Baker is a pharmacist and an attorney. He tea
When pharmacies are planning their quality assurance or continuous quality improvement plans, they need to determine whether their goals are strictly conformity with state and federal requirements, or something more.
More than mechanics
In setting up your pharmacy's CQI system, begin by defining medication error. To reduce the risk of such errors, you need to know what that means.
For example, many pharmacists would argue that it is a medication error to correctly dispense a contraindicated drug. Others would cite the dispensing of a prescribed drug to a patient with a known allergy to the drug. Some would call it a medication error when a patient regularly takes more of a drug than is prescribed. These types of error I refer to as "drug-review errors."
Since the mid-1990s, drug-review errors have been the fastest growing type of professional malpractice claims against pharmacists, as shown in the Pharmacists Mutual Claims Study. The latest published version of that study shows drug-review claims totaled almost 10 percent of all professional pharmacy liability claims received by Pharmacists Mutual Insurance Company in 2008. It would seem prudent to design a CQI program to reduce this risk.
An even broader definition of a medication error might include a drug prescribed when another drug would have been a better choice. The pharmacy might have filled the prescription for the drug specified by the prescriber, but the prescriber made a mistake. It could also include a floor nurse's administration error. Pharmacists are not the only clinicians who make mistakes. As part of our CQI program, which of these should be included in our definition of medication errors?
Unless asked by the prescriber, a pharmacist is not likely to have a role in the risk-assessment decision that resulted in the inferior choice of drug. Nor would a pharmacist usually be involved in the floor nurse's mistake. A pharmacy CQI system cannot prevent all medication errors, so we do not want to expand our definition too broadly. As pharmacists we can be most effective when we look at those medication errors that we can influence. Our goal might be to reduce the risk of the medication errors we might be able to prevent. In a legal sense, then, we would include in our definition the mechanical dispensing error and go beyond that to include at least some drug-review errors.
Is there more we might want to include? From a professional pharmacy perspective, is poor patient compliance a medication error that a pharmacist might influence?
Compliance primarily involves a patient error. In designing our CQI program, we might consider reaching above the legal requirements and include ways to assist patients to overcome their own errors. From the patient's perspective, a medication error occurs when recovery is delayed because the patient took medication incorrectly, perhaps through misunderstanding what the prescriber and/or pharmacist said. A patient medication error also might be the result of the patient's attempt to save money because the prescribed drug is not on the insurance plan's formulary and the patient cannot afford it. Rather than asking to try a different drug with a lower co-payment, the patient might take one dose every third day instead of daily.
Pharmacists cannot catch all patient-caused medication errors, but we may be able to anticipate some of them and design a CQI quality system that will intervene appropriately. Usually, this would be part of the drug review, quality check, or counseling part of the program.
Legal duty defines, not our best, but our least obligation. Professional duties represent our ideals, what is done by the best of our profession. Viewed from this level, a medication error might include not just mistakes that we may be able to influence, but those of our patients that we may be able to reduce or at least influence.
This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with attorneys familiar with pharmacy law in their states.
Ken Baker is a pharmacist and an attorney with the Arizona law firm of Renaud Cook Drury Mesaros, PA. He consults in the areas of pharmacy error reduction and risk management and can be reached at email@example.com