Traditionally, pharmacists have had no legal responsibility for questioning the selection of a drug by a physician. However, as pharmaceutical practice evolves and pharmacists become key resources for comprehensive medication information, some courts are beginning to take a different view of pharmacist liability.
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As pharmaceutical practice has evolved to provide the pharmacist with a vast array of comprehensive and reliable computerized medication information about a patient-information that might not be available to the prescribing physician-it is increasingly becoming the responsibility of the pharmacist to independently assess prescriptions in the context of that information. This responsibility is even beginning to be seen by some courts as a basis for liability on the part of pharmacists.
No "Duty to Warn?"
A recent article published in U.S. News & World Report made the point that pharmacists failed to warn patients about potential drug interactions. However, an article published in the June 1995 issue of For the Defense made the opposite point: that pharmacists have no duty to question or review the selection of a drug by a physician.
The reality is that the issue of pharmacist liability is evolving, for reasons that have a lot to do with the pharmacist's increasing access to a great deal more clinically relevant information on a patient's total medication picture than may be immediately available to the physician.
The physician treating a particular patient is clearly responsible for ordering the best medication for the treatment of heart disease, diabetes, cancer, allergies, infection, anxiety, or pain, and for warning of the side effects of the particular drug prescribed for that specific purpose. However, the physician may be relying solely on the patient's disclosures with regard to other drugs the patient may be taking, or on other incomplete or anecdotal information gathered during a patient counseling encounter or a chart review.
On the other hand, a drug utilization review carried out in accordance with provisions of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90), when based on a computer-generated profile that covers all the prescriptions being taken by the patient, as well as knowledge of over-the-counter drug use, forms a much more reliable information base than that available to some physicians.
The information available to a pharmacist within a pharmacy benefit plan is also considerable, and a growing number of courts are holding the pharmacist to a higher professional standard of care because of this increased access to detailed information.
Duplicated Efforts
It is understandable that pharmacists have been defended against liability in situations in which a side effect or contraindication known to accompany the administration of a particular drug was not restated by the pharmacist. These cases have been seen as holding that the pharmacist has no "duty to warn" the patient of known side effects and risks from a specific prescribed drug.
These cases support the notion that the pharmacist would simply be repeating what the physician has already told the patient about the specific drug being prescribed, and that there is therefore no duty to duplicate the informed consent and counseling session that are essential to the careful treatment of a patient by a physician.
These cases allow the pharmacist to assume that when the physician examined the patient, made the diagnosis, selected the most appropriate pharmaceutical product, and wrote the prescription, the physician communicated the necessary disclosures, warnings, and counseling information to the patient.
However, recent court decisions continue to hold that although the pharmacist is in a position to rely upon the prescribing physician in regard to the adequacy of patient counseling, the pharmacist is not in such a position when it comes to factors unknown to the physician.
The Impact of DUR Programs
It cannot be said that the pharmacist with a comprehensive body of drug utilization information that is readily available on a computer screen can rely on the fact that the same body of detailed information was available to the physician when the prescription was written and was actually considered by the physician before the medication was ordered.
In fact, computerized access to DUR information may present a pharmacist with a more accurate picture of the drugs being taken by a particular patient than can be obtained by the physician's interview of that patient or review of that patient's chart.
The information available to the pharmacist at the point at which a prescribed drug is delivered to the patient is now determinable. The data stored on an automated drug utilization or pharmacy benefit plan system is readily recorded on a time-sequence basis.
While in the past it may have been possible for a pharmacist to assert that there was no duty of inquiry and therefore no duty to evaluate a DUR profile relative to a particular patient, now it can be said that with a few key strokes, a full display of this data will become available.
In order to take the position seemingly advocated by those who advise that a physician rather than a pharmacist has the sole duty to warn patients, one must also take the position that when computerized information is thus readily available to the pharmacist, it can be ignored.
A Blind Eye
Given the extension of the drug utilization assessment of OBRA '90 to non-Medicaid patients, as recognized by some courts and most pharmacy licensure boards, taking the position that a pharmacist need not access this data seems equivalent to an assurance that a jury will excuse deliberate ignorance in cases where a few seconds on the computer could have saved a life.
Not only is this thinking unrealistic, it is contrary to the holdings of those courts that have considered pharmacy as practiced in the modern context.
It might be true that counseling a patient regarding a specific drug that has been prescribed for a particular disease or condition will remain the responsibility of the physician. However, when a catastrophic injury occurs to a patient as a result of a drug interaction, and both the physician and the pharmacist are sued for malpractice, it remains to be seen, in individual cases, whether the physician will be held soley responsible for all drug counseling.
Special Situations
There are three situations that have the potential to trigger the pharmacist's responsibility to "warn" or counsel the patient or contact the prescribing physician. These are:
The first situation is one regarding the duty to warn the patient regarding the inherent propensities of the drug, as described in the patient package insert, the Physician's Desk Reference, or the Merck Manual, such as risk factors, contraindications, potential side effects, warnings regarding use, and other effects of a single drug that are widely known in regard to that drug.
In this situation, case law currently holds that a pharmacist is not responsible for fully repeating the physician's analysis in selecting the drug for a particular disease, entity, or application, and the pharmacist need not again review all of the information about this single drug with the patient because the pharmacist can expect that a competent physician has already considered and transmitted this to the patient.
This rationale explains the many cases in which a pharmacist was broadly held to have no "duty to warn." The vast majority of those cases conclude that the pharmacist has no duty to warn the patient a second time, nor is there any responsibility to second-guess a physician's judgment in regard to the selection of a prescription drug, except in the most extraordinary circumstances.
Additional Information
The duty to warn, counsel, evaluate, and provide cognitive services appears to arise in cases in which the pharmacist acquired information that may not have been available to the physician who wrote the prescription. These cases include the following:
In the foregoing circumstances, the pharmacist has no right to assume that the physician considered the available data, made the drug selection, and provided patient counseling on a fully informed basis. Where the pharmacist knew or should have known that the physician could not have assessed a factor that would have altered the physician's judgment regarding the prescription, it is no longer possible for the pharmacist to proceed on the basis of assumptions.
Another situation arises when there is a clear problem with the prescription as written, and in circumstances in which it should be obvious that the physician has either made a mistake or was not in a position to realize the error.
Examples of this situation which have been identified in court cases are:
Computerization Brings Changes
Recent case law regarding the pharmacist's "duty to warn" does not present a monolithic body of decisions. Some cases present affirmative and some present negative judgments regarding a general duty to evaluate each prescription.
However, the availability of patient information by computer that permits the pharmacist to perform the prescription utilization assessment required by OBRA '90 has been identified in court cases as an important factor that changes the responsibility of the pharmacist.
The courts have not yet universally recognized this source of information regarding external factors not inherent in the drug itself, such as the patient's health history or the use of other prescribed drugs.
However, some courts have determined that if this information is available, it should be consulted by a reasonable, prudent pharmacist who is acting in accordance with the standard of care for pharmacists in that community.
Certain commentators have suggested that a pharmacist has no right to refuse to fill a prescription, nor does a nurse have a right simply to refuse to carry out a physician's orders. In both cases, a communication with the prescribing physician is in order. Neither the nurse nor the pharmacist in this situation is permitted to simply stand in place and do nothing. The problem needs to be worked out with the patient's attending physician.
Consultation can be difficult in these situations-physicians are notoriously hard to reach by phone, or even by pager. But the effort to communicate is required and carried out every day by nurses and pharmacists who need to confer with the physician before implementing an order.
A Fact of Technological Life
It becomes clear that although in most retail pharmacy situations there is no duty on the part of the pharmacist to take the patient aside and review the selection of the drug or to recounsel the patient regarding administration (since the pharmacist is entitled to rely on the standards of practice in the medical community that call for the physician to do this when the prescription is written), to contend that this is always the case oversimplifies the issue.
The on-line availability of comprehensive patient information by computer probably increases the number of situations that fall into the category involving drug-drug interactions or additional patient risk factors, because it significantly increases the occasions in which the pharmacist will have more information about the patient than the physician.
This is a fact of modern technology that the pharmacist cannot ignore, and that both pharmacists and physicians should welcome, since this will promote communication between prescribing physicians and pharmacists and will undoubtedly reduce the incidence of human error in the use of pharmaceutical products. But whether this increased accountability is welcomed or not, it is inevitable. In the very litigious society that the United States has become, there is not really any way to avoid the enhancement of the pharmacist's role that is taking place due to computerization, legislative and regulatory requirements, and modern pharmacy plan systems.
Edward J. Krill is an attorney specializing in health
law. He practices with the firm of Carr, Goodson & Lee in
Washington, D.C.