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Duty to Warn With No Directions for Use

Jesse C. Vivian, RPh, JD
Professor, Department of Pharmacy Practice

College of Pharmacy and Health Sciences

Wayne State University

Detroit, Michigan 

2/17/2012

Resources


US Pharm
. 2012;37(2):60-67. 

Imagine you are the pharmacist on duty when you receive a prescription with the all-too-familiar Sig: “Use as directed” or “UAD.” The drug is a tablet that is normally dosed from one to several times per day. Federal guidelines and most state laws are fairly clear that pharmacists have a duty to counsel patients, especially when dispensing a new medication. But if the prescriber has already told the patient how to use the drug, a reasonable presumption from the “use as directed” order, is the pharmacist still required to counsel the patient on how to use it? If so, what are you supposed to say or ask when the prescription does not include any instructions? 

Imagine trying to defend a civil claim against a pharmacist for failure to counsel, with the explanation that you presumed from the order that the prescriber already went over those instructions with the patient and, hence, repetition is not legally necessary, would be redundant, or would possibly cause confusion if your directions are different from those of the prescriber. As you roll the dice with any jury hearing this evidence, you might want to hedge your liability bets because this decision could go either way. 

Let’s make this case a little more interesting. The patient has been on this drug for about 3 years, with the same number of doses prescribed every month, same prescriber, and regular refills. Each year a new prescription is called into your pharmacy, you fill it, and every month your pharmacy technician asks the patient if there are any questions. The patient always says no and scribbles a signature on one of those logs where the fine print states something like: “By signing below, the patient acknowledges refusal to be counseled by a pharmacist.” You know that  
logbook, the one no one ever reads, where most patients think they are just signing an acknowledgement that they are picking up the prescription. These additional facts would arguably tip the jury verdict in favor of the pharmacist. Since nothing changed, the argument you made that counseling is not necessary in these circumstances seems stronger. 

Let’s say that on the anniversary of calling in the prescription, the same prescriber’s agent indicates a dose of 5 mg instead of the 1-mg dose the patient has been taking for the prior 3 years. The Sig remains the same—UAD. And just to grab your attention, let’s say the drug is generic warfarin, a well-known  
narrow therapeutic index (NTI) medication. In a case like this, 1 mg of warfarin per dose might be well within the therapeutic dosage range, but a fivefold increase could be medically harmful, if not fatal. Now do you have a duty to counsel? Maybe not necessarily a duty to counsel on what the drug does, how it works, how it should be taken, or its risks, but at the very least to alert the patient there has been a significant change of dose, asking if there is a reason for the change or whether the patient even knows about it. 

A Real Case

These were the basic facts and questions posed to the Alabama Supreme Court in the recent case of Nail v. Publix Super Markets.1,2 In 2003, a surgeon performed a total knee arthroplasty on the patient. Following her surgery, she suffered from a pulmonary thromboembolism. As a result, the surgeon prescribed warfarin as an anticoagulant. From August 2003 to July 2006, her primary care physician prescribed 1 mg tablets of warfarin to be taken five times a day. Indicating only that the medication should be taken as directed, the prescription did not include the usual dosing instructions. The patient had the prescription filled at the pharmacy 15 times. 

In July 2006, the patient called her physician’s office and asked for a new prescription. The physician’s nurse called the pharmacy and communicated a prescription for warfarin 5 mg to be used as directed. The pharmacy has a computer system that tracks patient profiles and records the date, time, and dose of each prescription dispensed. When the patient went to the pharmacy to pick up her medication, she signed a form indicating that she declined counseling. At no time did a pharmacist or any other personnel tell the patient that the prescription drug strength was different from what she had been taking. 

The patient continued to take her medication five times per day as she always had. Nine days later, she was rushed to a local emergency room complaining of chest pain, back pain, coughing, and bruising on her stomach. After being admitted to the hospital, she was diagnosed with warfarin toxicity and an epidural hematoma of the cervical spinal cord. The hematoma was surgically removed. 

Lawsuit

In May 2008, the patient sued the pharmacy and her primary care physician for negligence and wanton failure to protect her best interests under the state’s tort laws. The pharmacy answered the complaint and asked for a summary judgment to dismiss the case on the grounds that neither the pharmacy nor any of its pharmacists or other employees acted negligently or with wanton disregard for her well-being. Accompanying the motion to dismiss the complaint was a copy of a Prescription Insurance Claim and Counseling Log, which provided in pertinent parts: “The signature directly below of the patient, guardian, or the authorized personal representative of the patient certifies, on behalf of the patient that this pharmacy has offered the patient counseling on the medication dispensed as may be required by state regulations, and that the prescription below was received.” 

Importantly, the court pointed out in a footnote that: “Next to the signature line where [the patient] signed her name on the form, there are two boxes indicating whether counseling was ‘accepted’ or ‘refused.’ There is [a] check mark indicating that [the patient] accepted counseling and initials next to the boxes. There was no testimony reflecting who ‘checked’ the box or whose initials were beside the check.” Of equal significance, there was no question that the patient had in fact signed the logbook below this statement. 

The pharmacy also included a statement from a pharmacist working as this location at the time of this incident to the effect that “one of her duties as a pharmacist was to counsel her patients and that it is [the pharmacy’s] policy and procedure to counsel every patient. She stated that under a pharmacist’s standard of care, she is to ask the patient if he or she has any questions and to discuss any changes in the medication, including a change in strength or dosage or a change in the drug and to make sure the patient knows the purpose of the medication and what possible side effect to look out for or any problems associated with the medication.” 

The pharmacist testified that she had counseled the patient when she picked up the warfarin prescription in July 2006, although the pharmacist admitted that she could not remember precisely what she had told the patient that day. But the pharmacist stated unequivocally that her normal practice with regard to counseling a patient taking warfarin was to “ask if the patient was being tested to ascertain the effectiveness of blood thinning and if the patient had talked with the patient’s doctor regarding the dosage and how often to take the [warfarin] if the prescription was to ‘use as directed.’” 

In defense of the request for dismissal, the patient attached an affidavit from another “expert witness” pharmacist to the effect that neither the pharmacy nor the pharmacist had complied with the applicable standards of care or laws of the state. The patient also filed an affidavit stating that “when she picked up her [warfarin] prescription from the pharmacy, she was told to sign a sheet” and that “no one at the pharmacy offered to counsel her regarding the [warfarin] and that no one informed her that the strength of the prescription had changed.” Thus, the case boiled down to what is often called a “he said–she said” factual dispute. Ordinarily, this kind of discrepancy creates a jury question that must be resolved by considering all of the facts and evidence and, most importantly, the credibility of the incompatible witnesses’ testimony. The trial court judge, however, must have been persuaded that the pharmacy had fulfilled its legal responsibilities, as the case was dismissed in August 2010. 

Appeal

The Alabama Supreme Court noted that it had adopted the “learned-intermediary doctrine” in an earlier case addressing “whether a manufacturer’s duty to warn extends beyond the prescribing physician to the physician’s patient who would ultimately use the drugs.”3 The court noted that the principle behind the doctrine is that “prescribing physicians act as learned intermediaries between a manufacturer and the consumer/patient and, therefore, the physician stands in the best position to evaluate a patient’s needs and assess the risks and benefits of a particular course of treatment.” In another case, the same court applied the doctrine to a pharmacist when it addressed the question of “whether a pharmacist has a ‘duty to warn’ of foreseeable injuries from the use of the prescription drug he/she is dispensing.”4 In a pharmacist-liability case, the court addressed a related but separate question, “where a patient alleged that a pharmacist breached a duty by providing incomplete dosing information to the patient’s physician regarding a drug prescribed to the patient. [The court] noted that the learned-intermediary doctrine addresses the question of liability in light of the relationships between the parties involved in the prescribing, distribution, and use of prescription drugs.”5 

While these cases would suggest that Alabama is a “no duty to warn” state, meaning pharmacists do not ordinarily have a duty to counsel patients on potential problems associated with the use of a particular medication, here the court distinguished those cases, finding the evidence presented is a question of fact that should be tried. It stated: “There was evidence of the standard of care applicable to a pharmacist, i.e., that a pharmacist has a duty to counsel customers on a change in dosage of any medication. The evidence submitted by both parties in support of and in opposition to the motion for a summary judgment presents a question of fact as to whether [the patient] was counseled regarding the change in her prescription for [warfarin] from a 1-mg tablet to a 5-mg tablet. Viewing the evidence in a light most favorable to [the patient], as we are required to do, the conflict in testimony supports [the patient’s] argument that there is a genuine issue of material fact as to whether [the pharmacist] counseled [the patient] regarding the change in dosage.” 

In this case, the court held that the learned-intermediary doctrine did not apply, concluding: “[The patient] is arguing that the pharmacist should have told her that there was a significant change in her dosage of a very dangerous drug, not that [the pharmacy] should have warned her against any possible harm in taking that dosage amount. Notifying a customer that there has been a change in prescription strength does not infringe upon the physician-patient relationship. Accordingly, we cannot say that the learned-intermediary doctrine bars [the patient’s] claim against [the pharmacy.]” 

By a 7 to 1 majority, the dismissal was reversed and remanded back to that court for further proceedings. The lone dissenting judge argued that the majority was mistaken in its analysis of the earlier decisions that used the learned-intermediary doctrine as a complete defense to allegations against a pharmacist for failing a “duty to warn.” This judge wrote: “I conclude that discussing information of this nature with a patient is part and parcel of the task assigned by these authorities to the physician. …The duty imposed by law on the pharmacist is to accurately fill that prescription and to notify the customer of any potential interactions between the prescribed drug and other drugs being supplied by the pharmacist to the customer.” 

Analysis

The dissent makes the point that the majority made a “distinction without a difference.” If state jurisprudence is that the learned-intermediary doctrine is a complete defense to a “failure to warn” claim against pharmacists, how is it possible to draw a reasonable line of demarcation as to what kind of counseling is needed (e.g., warnings about adverse effects and symptoms, how and when to take a dose, what to do if you miss a dose)? Or is it just, “Did you know your doctor changed the dose?” 

What the majority did was the right thing for the wrong reasons. Whether or not the learned-intermediary doctrine has any bearing on this case is beside the point. The majority’s conclusion that this is a case of who said what does raise a question of fact that a jury would normally have to decide. The real problem is that no physician should ever write and no pharmacist should ever dispense a prescription medication indicating “use as directed.” In today’s complicated environment, there is no reason to adhere to such archaic nondirections. Pharmacists and physicians should expect and demand more of each other. Leaving it up to the patient to remember exactly what the doctor said is not the best way to handle the problem. Prescription directions should always be put in writing detailed enough for a reasonable person to understand. 

Will prescribers ever abandon this ancient method of prescribing? Probably not. But pharmacists should be held to a higher understanding—just label the drug as to exactly what the prescriber directed. And if neither you nor the patient knows what those directions are, ask somebody. 

Sometimes what’s old is new again. A case with similar facts and legal considerations was reviewed in this column in 1999.6 In that case, the court held that the learned-intermediary doctrine did bar the claims against the pharmacist for labeling, as the prescription required “Use as directed” without giving further instructions to the patient.7 It is way past time for this nonsense to end. 

REFERENCES

1. Nail v. Publix Supermarkets, Inc, Slip Op No. 1091740 (May 13, 2011), 2011 Ala Lexis 69. http://caselaw.findlaw.com/al- supreme-court/1567564.html. Accessed January 15, 2012.
2. Brushwood DB. As directed prescription exposes pharmacy to liability. Pharmacy Today. 2011;17(7):24. http://apha.imirus.com/
Mpowered/book/vpt17/i7/p26. Accessed January 15, 2012.
3. Stone v. Smith, Kline & French Laboratories, 447 So. 2d 1301 (Ala 1984).
4. Walls v. Alpharma USPD, Inc, 887 So. 2d 881, 882 (Ala 2004).
5. Springhill Hospitals, Inc. v. Larrimore, 5 So. 3d 513 (Ala 2008).
6. Vivian JC. Use as directed. US Pharm. 1999;24(4):68-75. (See attached PDF).
7. Griffith v. Blatt, Or App 204, 972 P2d 385 (1999). www.publications.o jd.state.or.
us/S46476.htm. Accessed January 17, 2012. 

To comment on this article, contact rdavidson@uspharmacist.com.

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