Back in the 1990s when OBRA ’90 became law, I predicted that lawsuits about failure to counsel or failing to fully counsel would soon be the source of many lawyers’ income. I was right. Except for the word “soon.” The 90s became the 2000s and then we aged into the 2010s before my prediction finally came true. Today, and for the past few years, failure to counsel is the number two reason for lawsuits against pharmacists and pharmacies (number one remains misfiling a prescription). Indeed, in California recently all three of the Big Three chains received six figure fines from the federal government for failing to counsel.
Let us start off by reviewing Kentucky law (pharmacists in other states can still rely on this for the most part as most states laws on this subject are very similar). 201 KAR 2:210 if you want to follow along with the actual regulation.
Counseling is not required in Kentucky. What is required is an OFFER to counsel on all new prescriptions and on refills where professional judgment dictates. Only by an acceptance of the offer does the duty to counsel arise.
Before we look at what counseling requires, what about if counseling is refused? Kentucky requires documentation of the refusal. There is no requirement to obtain an acknowledgement that counseling was done. If such documentation is not present, a legal presumption exists that states counseling was offered, the offer was accepted, and reasonable counseling was provided.
Once counseling is accepted, the regulation provides the areas that must be covered
(a)The name and description of the drug;
(b) The dosage form, dose, route of administration, and duration of therapy;
(c) Special directions and precautions;
(d) Common and clinically significant adverse effects, interactions, or contraindications that may be encountered, including their avoidance and the action required should they occur;
(e) Techniques for self-monitoring of drug therapy;
(f) Proper storage;
(g) Refill information;
(h) Action to be taken in event of a missed dose;
(i) His comments relevant to the individual’s therapy; and
(j) Any other information peculiar to the specific patient or drug.
Legal issues arise from several areas. First and foremost are a failure to offer to counsel and providing insufficient counseling. With the failure to offer, it is most often an absolute failure to make any kind of inquiry to the patient about counseling. Most states, including Kentucky, permit the phrase “Do you have any questions about your prescription?” even though the word “counseling” is not part of the question. Plaintiffs’ lawyers have been battling that for a long time, arguing that this does not connote a true offer but only a desire to have the patient ask questions.
Insufficient counseling is providing counseling but failing to reasonably cover any of the above required criteria. Talking about all of the above except for “action to be taken in the event of a missed dose” is not acceptable to state boards of pharmacy. Omitting any provision, deliberately or inadvertently, in required counseling points does not mean that a patient was partially counseled—the patient was not counseled. Period.
Example: Patient presents a prescription for acetaminophen with codeine and accepts the offer to counsel. All the points are covered but the pharmacist fails to warn against mixing the medication with alcohol. Patient does so and falls down a staircase. Pharmacist is liable for failing to counsel on a common and clinically significant adverse effect.
The common and clinically significant adverse effect provision has been the basis for several lawsuits (in other states, not KY). However, most of these lawsuits have resulted in no pharmacist liability as the patients were found to have counseled reasonably. In one matter, the family sued because the patient was not warned of the possibility of developing Stevens-Johnson syndrome. In another, the male plaintiff contended he should have been warned of the possibility of priapism from trazodone. Both courts, through the use of expert witnesses, found for the pharmacist as these adverse effects, though clinically significant, were uncommon to the point that they would not be found in reasonable counseling.
Special directions is another leading factor in lawsuits. These are pretty clear cut where a pharmacist fails to tell the patient to refrigerate or not refrigerate, shake well or shake gently, etc. A note here. The KY regulation states that things like patient instruction sheets and auxiliary labels are supplemental to counseling and are not counseling in and of themselves. The presence of these where there was a failure to counsel is not going to be very helpful in your defense.
Example: At a dinner party, patient approaches Joe Pharmacist and asks if she can get a little advice on her medication, as she did not speak to her pharmacist when she first picked it up. Pharmacist agrees though she is not really desirable of doing so, and her responses are short and abrupt. Relying on the “advice,” patient ends up injured.
The example above is more often seen where a patient does a “corner consult” with a physician and is injured relying on that advice, but it has happened to a couple of pharmacists. Yes, the pharmacist is liable here. The place of the counseling is not important; neither is the fact that this is not at the pharmacy but at a dinner party. The law holds that when a professional accepts a duty, no matter where, the duty must be fulfilled as if the pharmacist were behind the prescription counter.
Example: Patient presents a prescription for acetaminophen with codeine and accepts the offer to counsel. Patient is warned not to mix the medication with alcohol but does so anyway and is injured. At trial pharmacist shows that he warned against mixing the two but patient is able to prove the pharmacist did not cover other provisions of the counseling criteria.
I bring this example up to show you a twist on the situation. Here, the pharmacist is not liable. The court would hold that the failure to fully counsel is “no harm, no foul” as the lack to fully counsel has no effect on the issue before the court. However, a complaint to the board of pharmacy could still see the pharmacist sanctioned for failing to fulfill a duty, the court’s holding notwithstanding.
Some states are playing with the concept of pre-emptive counseling, where a pharmacist would relate an important fact about a drug and then offer counseling. “Sir, you will be taking metronidazole. You should avoid all forms of alcohol while taking this. Now, do you have any questions about your medication?” “Your prescription today is for amoxicillin. Make sure to take it until it is all gone. Now, do you have any questions about your medication?” Pre-emptive counseling is not in KY and most states. Phrased as above, this meets the legal requirement, as the pre-emptive statement is followed by the offer to counsel. However, if there is no offer included, the pharmacist has pre-emptively assumed the duty to counsel and must do so fully, covering all the required criteria.
Counseling on prescriptions is an important duty for pharmacists, and this importance has not shrunk even though many pharmacists today have problems finding the time to adequately counsel those patients who request such. Pharmacists should keep in mind that boards do not consider being busy as an excuse for failing to offer or to counsel. There are as many pitfalls to this duty as there are rewards.