Legal Aspects of Counseling

Pharmacist: “Do you have any questions about your prescription?”

 

Patient’s mother: “Yes.  How long does my daughter have to take this?”

 

Pharmacist: “Until it is all gone.  Ten days.”

 

Patient’s mother: “Thank you.”

 

After getting home, mother notes the liquid is pink so she shakes it up before each dose and refrigerates it in between doses.  Her daughter gets sicker and ends up in the hospital for IV antibiotics.  It is discovered that the prescribed medication should not have been refrigerated but rather kept at room temperature.  Mother sues the pharmacy and pharmacist for not counseling her on the proper storage conditions.

 

Pharmacist responds by saying that he offered counseling and the only question presented was answered according to the applicable standard of care.

 

Who prevails in the lawsuit?

 

Every state in the US has a law of some type requiring patients presenting new prescriptions (and refills if considered practical or necessary by the pharmacist) to be either counseled or offered counseling, most states going with the latter.  If the offer is accepted counseling must be performed according to the dictates of state law.  In Kentucky, these can be found at 201 KAR 2:210 Patient Records and Patient Counseling.  The salient section of that regulation is here:

 

“ The pharmacist shall include the following elements of patient counseling that he has determined are appropriate:

(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.”

 

 

The question, as we look back over the scenario above, is whether the pharmacist has met her duty under the “determined are appropriate” doctrine.  Is merely responding to specific questions sufficient to meet the applicable standard of care?

 

A big issue here is how the pharmacist offered counseling.  “Do you have any questions about your prescription?”  “Do you have any questions for the pharmacist?”  These are the phrases most often spoken to patients.  The word “counsel” is not even used by most pharmacists, according to studies done.  Pharmacists, associations, Boards, and lawyers have argued back and forth from the beginning of counseling laws to the present day as to whether one of the above questions is actually sufficient to send the message to the uninformed public that counseling is being offered.  And while we can be amazed at how well our patients can inform themselves today as to their health conditions and treatments through current technology, their understanding quite often remains abysmally ignorant.  A clear cut concensus has not been reached.

 

One significant hint may come from legal cases with other professionals.  Both attorneys and physicians have been held liable for not meeting their full obligations (or duties) even though these people were approached and asked advice outside the office.  Even if in a social setting, such as a dinner party or at a basketball game, courts have held that if a professional responds to a question or request for advice, they must do so as thoroughly and as fully as if in the professional setting.  Liability has been attached where the duty was not fully addressed. Pharmacists should take note.

 

Based on these cases, my legal opinion is that the pharmacist in the scenario above could well be found liable for failing to take the invitation to counsel to do so fully with all the requirements.  A mere “yes” or even a question about one aspect of the medicine should be interpreted as “counsel me fully.”  In the pharmacy administrative actions I have found, to omit even one point listed in the law is often interpreted by Boards and courts to mean that the requirements of the law have not been met.  In short, once a pharmacist assumes a duty, that duty must be met 100% or it has not been met at all.

 

As a practicing pharmacist, I am one that occasionally does what most of us do: while continuing to work I raise my voice and give some counseling even if refused.  “Take that until it is all gone”  “This will make you drowsy.”  “No alcohol while on this medicine.”  We must realize that when we do this we are assuming a duty that we are only partially fulfilling.

 

A final reminder.  Failure to counsel is the Number Two reason pharmacists are sued, and the number of lawsuits is growing.

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