McKee v. American Home Products Corp.

Callow, C.J.

The plaintiff, Elaine McKee, appeals a summary judgment dismissing her cause of action against defendant pharmacists Gerald Sidran and Leonard Mezistrano. The trial court ruled that the pharmacists, who had filled McKee's drug prescriptions for 10 years, had no duty to warn her of the adverse side effects of long-term administration of that drug. We affirm.

From 1974 through 1984 McKee received prescriptions for Plegine, an appetite suppressant, from her family physician to control an ostensible weight problem. Plegine is an amphetamine and is potentially addictive. It is a class III drug, requiring either an oral or written prescription from a physician each time it is filled. WAC 360-36-010, -020. The manufacturer's information contained in the Physicians' Desk Reference (1984) (PDR) states, among other things, that Plegine "is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) . . ."It further warns:

Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of Plegine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. . . .
Tolerance to the anorectic effect of Plegine . . . develops within a few weeks. When this occurs, its use should be discontinued . . .

The desk reference for physicians also lists various side effects from overuse, such as: extreme fatigue and mental depression after abrupt cessation, intense psychological dependence and severe social dysfunction, and at an extreme, psychosis.1

*704McKee filled nearly all her Plegine prescriptions at a pharmacy in Seward Park in Seattle. From 1974 through 1981, the prescriptions were filled by Sidran, who owned the pharmacy. In April 1981, Sidran sold the pharmacy to Mezistrano, who continued to fill McKee's prescriptions until they were discontinued by a second physician in 1984. It is undisputed that the pharmacists filled the prescriptions accurately and pursuant to either a written prescription or oral refill authorization from McKee's physician.

McKee's prescriptions were for 100 tablets each. The manufacturer packaged Plegine in 100-tablet bottles; attached to the outside of each was the manufacturer's package insert. Before giving McKee a bottle of Plegine, the pharmacists would remove the package insert and place their own label on the bottle to comply with state and federal labeling laws.2 It is undisputed that at no time did either pharmacist warn McKee of the possible side effects of extended use of Plegine or give her the manufacturer's insert.

In 1985, McKee brought this action against the prescribing physician, the drug manufacturer, and the defendant pharmacists, seeking damages for physical and psychological injuries allegedly sustained as a result of her addiction to Plegine. Only the claims against the pharmacists are at issue in this appeal.

McKee alleged the pharmacists were negligent in selling her Plegine for such an extended length of time without warning her of its adverse effects and were negligent in failing to give her the manufacturer's package insert. She also alleged strict liability and breach of express and implied warranties. The pharmacists moved for summary *705judgment and dismissal of all claims against them, contending they had no duty to warn their customers of the potential hazards of a prescription drug. The trial court granted the pharmacists' motion and dismissed McKee's claims. We granted direct review.

Initially we note that McKee did not assign error to the trial court's dismissal of her strict liability and breach of warranty claims, as required by RAP 10.3. Aside from citing the product liability act and arguing that the defendant pharmacists are "product manufacturers" thereunder, McKee provides no argument or legal authority in support of her strict liability and breach of warranty claims. We will not consider issues on appeal that are not raised by an assignment of error or are not supported by argument and citation of authority. Transamerica Ins. Group v. United Pac. Ins. Co., 92 Wn.2d 21, 28-29, 593 P.2d 156 (1979). Therefore, we will address McKee's negligence claim only.

I

A summary judgment motion may be granted under CR 56(c) only if the pleadings, affidavits, depositions, and admissions on file demonstrate there is no genuine issue concerning any material fact, and the moving party is entitled to judgment as a matter of law. Wilson v. Steinbach, 98 Wn.2d 434, 437, 656 P.2d 1030 (1982); Barrie v. Hosts of Am., Inc., 94 Wn.2d 640, 646, 618 P.2d 96 (1980). All facts submitted and all reasonable inferences from the facts must be considered by the court in the light most favorable to the nonmoving party. Wilson, at 437; Yakima Fruit & Cold Storage Co. v. Central Heating & Plumbing Co., 81 Wn.2d 528, 530, 503 P.2d 108 (1972); Barber v. Bankers Life & Cas. Co., 81 Wn.2d 140, 142, 500 P.2d 88 (1972). Motions for summary judgment should only be granted, if reasonable persons could only reach but one conclusion from all the evidence. Wilson, at 437; Morris v. McNicol, 83 Wn.2d 491, 494-95, 519 P.2d 7 (1974).

*706For purposes of CR 56(e) the affidavit must: (1) be made on personal knowledge, (2) set forth admissible evidentiary facts, and (3) affirmatively show that the affiant is competent to testify to the matters stated therein. Bernal v. American Honda Motor Co., 87 Wn.2d 406, 412, 553 P.2d 107 (1976); Meadows v. Grant's Auto Brokers, Inc., 71 Wn.2d 874, 878, 431 P.2d 216 (1967). Competency to testify can reasonably be found by the trial court. Bernal, at 413. Furthermore, "[t]he qualifications of an expert are to be judged by the trial court, and its determination will not be set aside in the absence of a showing of abuse of discretion." Bernal, at 413, quoting Nordstrom v. White Metal Rolling & Stamping Corp., 75 Wn.2d 629, 642, 453 P.2d 619 (1969).

The gravamen of this case is whether the plaintiff met her burden under RCW 7.70.040,3 of proving the defendants' failure to exercise the degree of care, skill, and learning expected of a reasonably prudent pharmacist licensed in the state of Washington at the time.

The only evidence offered by McKee concerning the standard of care of a pharmacist practicing in Washington was an affidavit of an Arizona physician. The physician was not licensed to practice medicine in Washington, nor was he a pharmacist. We recently reiterated the rule that to establish the standard of care required of professional practitioners, that standard must be established by the testimony of experts who practice in the same field. The duty of physicians must be set forth by a physician, the duty of structural engineers by a structural engineer and that of any expert must be proven by one practicing in the same field— *707by one's peer. Young v. Key Pharmaceuticals, Inc., 112 Wn.2d 216, 770 P.2d 182 (1989). So here, only a pharmacist who knew the practice and standard of care in this state could establish the standard of care for the defendants. Contrary to the requirements of RCW 7.70.040 the affidavit does not assert the standard of care of a pharmacist in this state. Therefore, for purposes of CR 56(e) the affidavit does not show that the affiant was qualified to prove the standard of care of a pharmacist in the state of Washington.

The trial court determined that no genuine issues of material fact remained. Therefore, the moving parties were entitled to judgment as a matter of law. We have thoroughly reviewed all the pleadings, affidavits, depositions and admissions on file and affirm the granting of the summary judgment by the trial court.

II

While we need go no further, it is appropriate that we discuss the merits of the primary issue raised because of the importance of the issue and the public interest therein. McKee contends the pharmacists had a duty to warn her of the harmful side effects of long-term use of Plegine, and that she should recover from the defendants under RCW 7.70.030(1). Recovery is provided under RCW 7.70.030(1) where: "[t]hat injury resulted from the failure of a health care provider to follow the accepted standard of care[.]"

Chapter 7.70 of the RCW outlines actions for injuries resulting from health care. A pharmacist is defined as a health care provider under RCW 7.70.020. RCW 7.70.030 requires that the plaintiff prove each fact essential to an award by a preponderance of the evidence.

The elements required to prove that an injury resulted from a failure to follow the accepted standard of care are stated in RCW 7.70.040. Although a pharmacist's duty to warn of potential hazards associated with a prescription drug is an issue of first impression in Washington, we choose to. join the majority of those states with statutes similar to RCW 7.70.040 which have addressed this issue *708holding that a pharmacist has no duty to warn. In Florida,4 in a case almost factually identical, the court answered two questions which are applicable here: First, does a licensed pharmacist have a duty not only to properly fill a prescription but to warn the customer of dangerous propensities of the prescription drug? Second, does a licensed pharmacist who has actual or constructive knowledge of a customer's dependency and addiction have a duty to warn the treating physician of this fact? The court answered in the negative to both questions.

[A] supplier of drugs has no duty to fail or refuse to supply a customer with drugs for which the customer has a valid and lawful prescription from a licensed physician, nor any duty to warn said customer of the fact that one using the prescribed drug for any period of time could or would become addicted to the use thereof and would become physically and psychologically dependent thereon . . .

Pysz v. Henry's Drug Store, 457 So. 2d 561, 561-62 (Fla. Dist. Ct. App. 1984). The physician has the duty to know the drug that he is prescribing and to properly monitor the patient. Here the druggist properly filled a lawful prescription.

Similarly, the Michigan Court of Appeals held that a pharmacist owes a duty to properly fill the lawful prescriptions of its customers. Adkins v. Mong, 168 Mich. App. 726, 729, 425 N.W.2d 151 (1988). "[A] pharmacist is held to a very high standard of care in performing this duty and may be held liable in tort for any breach." Adkins, at 729. However, "'a pharmacist has no duty to warn the patient of possible side effects of a prescribed medication where the *709prescription is proper on its face and neither the physician nor the manufacturer has required that any warning be given to the patient by the pharmacist."' Adkins, at 728, quoting Stebbins v. Concord Wrigley Drugs, Inc., 164 Mich. App. 204, 218, 416 N.W.2d 381 (1987). Indeed, "there exists no legal duty on the part of a pharmacist to monitor and intervene with a customer's reliance on drugs prescribed by a licensed treating physician." Adkins, at 732. It is the physician who owes the duty to the patient to monitor prescription drug usage and a pharmacist will not be found liable for lawfully filling a prescription issued by a licensed physician. Adkins, at 730.

This court has addressed a closely related issue—the manufacturer's duty to warn. Adopting the "learned intermediary" doctrine, we held in Terhune v. A.H. Robins Co., 90 Wn.2d 9, 577 P.2d 975 (1978) that a prescription drug manufacturer's duty to warn of dangers associated with its product runs only to the physician; it is the physician's duty to warn the ultimate consumer.

The reasons for this rule are apparent.

Where a product is available only on prescription or through the services of a physician, the physician acts as a "learned intermediary" between the manufacturer or seller and the patient. It is his duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or uses on his patients, and to exercise an-independent judgment, taking into account his knowledge of the patient as well as the product. The patient is expected to and, it can be presumed, does place primary reliance upon that judgment. The physician decides what facts should he told to the patient. Thus, if the product is properly labeled and carries the necessary instructions and warnings to fully apprise the physician of the proper procedures for use and the dangers involvéd, the manufacturer may reasonably assume that the physician will exercise the informed judgment thereby gained in conjunction with his own independent learning, in the best interest of the patient.

(Footnote omitted.) Terhune, at 14.

The Illinois courts have also adopted the learned intermediary doctrine. In Leesley v. West, 165 Ill. App. 3d 135, 518 N.E.2d 758 (1988), the court expanded the learned *710intermediary doctrine to apply to pharmacies. In Kirk v. Michael Reese Hosp. & Med. Ctr., 117 Ill. 2d 507, 513 N.E.2d 387, 395 (1987), cert. denied, 108 S. Ct. 1077 (1988), the court held a doctor, as a learned intermediary, decides which available drug fits the patient's needs, choosing which facts from the various warnings should be conveyed to the patient. The extent of disclosure is a matter of medical judgment. Kirk, at 523. The opinion continues:

". . . It is the physician who is in the best position to decide when to use and how and when to inform his patient regarding risks and benefits pertaining to drug therapy." (W. Prosser & W. Keeton, The Law of Torts sec. 96, at 688 (5th ed. 1984).) As such, the manufacturer is only obligated to adequately warn the physicians, who decide which drug to use and which warnings to provide. The drug companies are not required to warn hospital personnel because they do not select the proper drugs for the patient and prescribe them.

Kirk, 117 Ill. 2d at 523. Indeed "[t]he foreseeability of injury to an individual consumer in the absence of any particular warning also varies greatly depending on the medical history and condition of the individual—facts which we cannot reasonably expect the pharmacist to know." Leesley, at 142.

In North Carolina, the court held that physicians offered their professional services and skill for which they are paid by their patients. This is the basis of the relationship between the physician and his patient. Only the doctor knows the myriad of factors that went into deciding upon the proper medication, proper amount and proper frequency of ingestion. The pharmacist must fill the prescription as directed. Where there is no allegation that the product was other than what it was supposed to be, there is no negligence. Batiste v. American Home Prods. Corp., 32 N.C. App. 1, 231 S.E.2d 269, 274 (1977).5

*711The relationship between the physician-patient-manufacturer applies equally to the relationship between the physician-patient and pharmacist. In both circumstances the patient must look to the physician, for it is only the physician who can relate the propensities of the drug to the physical idiosyncrasies of the patient. "It is the physician who is in the best position to decide when to use and how and when to inform his patient regarding risks and benefits pertaining to drug therapy." W. Keeton, D. Dobbs, R. Keeton & D. Owen, Prosser and Keeton on Torts § 96, at 688 (5th ed. 1984).

In Young v. Key Pharmaceuticals, Inc., 112 Wn.2d 216, 770 P.2d 182 (1989), we stated, "proper dosages of medication is not within the scope of matters on which nonphysicians are competent ..." Young, at 230. We went on to hold that "pharmacists are not doctors and are not licensed to prescribe medication because they lack the physician's rigorous training in diagnosis and treatment." Young, at 230.

Neither manufacturer nor pharmacist has the medical education or knowledge of the medical history of the patient which would justify a judicial imposition of a duty to intrude into the physician-patient relationship. In deciding whether to use a prescription drug, the patient relies primarily on the expertise and judgment of the physician. Proper weighing of the risks and benefits of a proposed drug treatment and determining what facts to tell *712the patient about the drug requires an individualized medical judgment based on knowledge of the patient and his or her medical condition. The physician is not required to disclose all risks associated with a drug, only those that are material. Smith v. Shannon, 100 Wn.2d 26, 31, 666 P.2d 351 (1983). It is apparent that a pharmacist would not be qualified to make such a judgment as to materiality. Moreover, circumstances may exist justifying nondisclosure of even material risks. See Holt v. Nelson, 11 Wn. App. 230, 240-41, 523 P.2d 211, 69 A.L.R.3d 1235 (1974) (enumerating exceptions to the informed consent doctrine). Requiring the pharmacist to warn of potential risks associated with a drug would interject the pharmacist into the physician-patient relationship and interfere with ongoing treatment. We believe that duty, and any liability arising therefrom, is best left with the physician.

A majority of other jurisdictions that have addressed the issue have likewise refused to impose a duty to warn on the pharmacist. E.g., Jones v. Irvin, 602 F. Supp. 399 (S.D. Ill. 1985); Ramirez v. Richardson-Merrell, Inc., 628 F. Supp. 85, 88 (E.D. Pa. 1986); Eldridge v. Eli Lilly & Co., 138 Ill. App. 3d 124, 485 N.E.2d 551 (1985); Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 361 Pa. Super. 589, 597-98, 523 A.2d 374 (1987) (strict liability theory). As said in Ramirez, at 88:

To impose a duty to warn on the pharmacist, however, would be to place the pharmacist between the physician who, having prescribed the drug presumably knows the patient's present condition as well as his or her complete medical history, and the patient. Such interference in the patient-physician relationship can only do more harm than good. As the court in Batiste v. American Home Products Corp., 32 N.C.App. 1, 231 S.E.2d 269, 274 (1977) emphasized, when holding that a pharmacy could not be held liable in negligence for its failure to warn the plaintiff of the potential side effects associated with an oral contraceptive drug, defendant is not a physician and is not qualified or licensed to advise plaintiff with respect to the best medication for her use. See also Ingram v. Hook's Drugs, Inc., Ind. App., 476 N.E.2d 881 (1985).

*713McKee cites RCW 18.64.011(11) as supporting a duty to warn. RCW 18.64.011(11) defines the "practice of pharmacy." RCW 18.64.011(11) reads:

"Practice of pharmacy" includes the practice of and responsibility for: Interpreting prescription orders; the compounding, dispensing, labeling, administering, and distributing of drugs and devices; the monitoring of drug therapy and use; the initiating or modifying of drug therapy in accordance with written guidelines or protocols previously established and approved for his or her practice by a practitioner authorized to prescribe drugs; the participating in drug utilization reviews and drug product selection; the proper and safe storing and distributing of drugs and devices and maintenance of proper records thereof; the providing of information on legend drugs which may include, but is not limited to, the advising of therapeutic values, hazards, and the uses of drugs and devices.

RCW 18.64.011(11) is applicable to pharmacists. However contrary to McKee's contentions it does not require that warnings concerning the prescription be given to the patient. Initially we note this statute is definitional and does not purport to set forth duties. Further, WAC 360-12-150 states that the term "monitoring drug therapy" as used in the statute shall include duties such as measuring patient vital signs and ordering and evaluating laboratory test results. The provision is not meant to apply to the neighborhood pharmacy but only to pharmacists practicing in an institutional setting.6 Nor does the latter quoted definition create a mandatory duty on all pharmacists to warn *714customers of all dangers associated with a drug.7 That duty may be appropriate where the pharmacist has prescriptive authority, a question not presented here. See RCW 18.64-.011(11) and WAC 360-12-140.

Ill

McKee contends that although a pharmacist may not have a duty to warn of hazardous side effects in every case, here the pharmacists knew or should have known from the manufacturer's literature and frop the fact that McKee did not appear obese,8 that her physician was misprescribing Plegine, giving rise to a duty t<r warn her or to question the physician. In support of her argument, McKee relies on Hand v. Krakowski, 89 A.D.2d 650, 453 N.Y.S.2d 121 (1982) and Riff v. Morgan Pharmacy, 353 Pa. Super. 21, 508 A.2d 1247 (1986).

In Hand, a pharmacy dispensed drugs which were contraindicated with alcohol to an alcoholic, resulting in the patient's death. It was undisputed that the pharmacist had personal knowledge that the patient was an alcoholic. The court held that since the pharmacy knew the customer was *715alcoholic and knew or should have known the drugs were contraindicated for that particular customer, an issue of fact existed as to whether the pharmacy had a duty to warn the decedent and to question the prescribing physician.

Riff involved a prescription on which the doctor had failed to state the maximum safe dosage. The pharmacy took no steps to correct the error and the patient suffered an overdose. Expert testimony established that the pharmacy was negligent in failing to be aware of obvious inadequacies on the face of the prescription and to warn the patient or notify the prescribing physician.

Both of these cases involved obvious or known errors in the prescription. In Hand, the court emphasized that the drug was contraindicated, "refer[ring] to a circumstance under which the drug must never be given. It is absolute and admits of no exceptions[.]"' 89 A.D.2d at 651, citing Baker v. St. Agnes Hosp., 70 A.D.2d 400, 402, 421 N.Y.S.2d 81 (1979). We agree pharmacists should have a duty to be alert for patent errors in a prescription, for example: obvious lethal dosages, inadequacies in the instructions, known contraindications,9 or incompatible prescriptions,10 and to take corrective measures.

The alleged negligence in this case, however, involved an exercise of the physician's judgment in determining whether Plegine was an appropriate drug for McKee's condition and the length of time she could safely use it. It is *716undisputed that McKee's physician monitored her condition throughout the time she used Plegine, requiring periodic checkups during which he would check her weight and blood pressure. On at least one occasion he required her to stop using Plegine for several months. Imposing a duty such as McKee urges would, in essence, require the pharmacist to question the physician's judgment regarding the appropriateness of each customer's prescription. Sound policy reasons exist for not imposing such a duty.

As noted, without benefit of a patient's medical history, the pharmacist is not qualified to determine the propriety of a particular drug regimen. That determination certainly cannot be made from a patient's physical appearance alone. As an Illinois court observed:

The propriety of a prescription depends not only on the propensities of the drug but also on the patient's condition. A prescription which is excessive for one patient may be entirely reasonable for the treatment of another. To fulfill the duty which the plaintiff urges us to impose would require the pharmacist to learn the customer's condition ... To accomplish this, the pharmacist would have to interject himself into the doctor-patient relationship and practice medicine without a license.

Eldridge v. Eli Lilly & Co., 138 Ill. App. 3d at 127.

A physician may often have valid reasons for deviating from the drug manufacturer's recommendations based on a patient's unique condition. The duty which McKee urges would result in the pharmacist second guessing numerous prescriptions to avoid liability. This would not only place an undue burden on pharmacists, but would likely create antagonistic relations between pharmacists and physicians. As stated in Jones v. Irvin, 602 F. Supp. at 402:

It is the duty of the prescribing physician to know the characteristics of the drug he is prescribing, to know how much of the drug he can give his patient, to elicit from the patient what other drugs the patient is taking, to properly prescribe various combinations of drugs, to warn the patient of any dangers associated with taking the drug, to monitor the patient's dependence on the drug, and to tell the patient when and how to take the drug. Further, it is the duty of the patient to notify the physician of the other drugs the patient is taking. Finally, *717it is the duty of the drug manufacturer to notify the physician of any adverse effects or other precautions that must be taken in administering the drug. Placing these duties to warn on the pharmacist would only serve to compel the pharmacist to second guess every prescription a doctor orders in an attempt to escape liability.

(Citation omitted.) Moreover, unnecessary warnings to the patient could cause unfounded fear and mistrust of the physician's judgment, jeopardizing the physician-patient relationship and hindering treatment.

Pharmacists are defined as health care providers under RCW 7.70.020. The elements necessary to prove that a health care provider did not follow the accepted standard of care are found in RCW 7.70.040 previously quoted.

It is inappropriate to interpret this statute to allow any testimony regarding the practice of pharmacy as the proper standard of care. RCW 18.64 discusses pharmacists and their expected duties. The "practice of pharmacy" as defined by RCW 18.64.011(11) reads:

"Practice of pharmacy" includes the practice of and responsibility for: Interpreting prescription orders; the compounding, dispensing, labeling, administering, and distributing of drugs and devices; . . . the providing of information on legend drugs which may include, but is not limited to, the advising of therapeutic values, hazards, and the uses of drugs and devices.

(Italics ours.)

Nowhere in RCW 18.64 are pharmacists required to disclose all information when filling a prescription. RCW 18.64.011(11) provides that information may include therapeutic values, hazards and the use of the drug. Further, WAC 360-16-250 provides "the pharmacist . . . must orally explain to the patient or the patient's agent the directions for use and any additional information, in writing if necessary, to assure the proper utilization of the medication or device prescribed."

Plegine is a legend drug; it may be dispensed on prescription only. As a legend drug, the pharmacists may have given McKee information about the therapeutic values or hazards of Plegine, however, they were not required to do *718so. McKee had a prescription for every refill she received, therefore, she was constantly monitored by her physician.

Nothing in RCW 18.64 nor in WAC 360-16 requires pharmacists to disclose all contraindications or warnings. If the Legislature intended pharmacists to be liable for failure to warn, the Legislature could have so provided.

IV

McKee also contends the pharmacists were negligent in failing to provide her with the manufacturer's package insert. Prescription drugs are exempt from the package labeling requirements for drugs sold over the counter. 21 U.S.C. § 353(b)(2). Instead, the Food and Drug Administration (FDA) requires manufacturers to accompany each package of prescription drugs with a package insert describing the drug and detailing its uses, contraindications, potential harmful effects, and directions to the physician for use. 21 C.F.R. §§ 201.100(d), 201.56, 201.57. Consistent with the learned intermediary doctrine, the insert is directed to the physician or other health care provider; its contents are reprinted in the PDR. Brushwood, The Informed Intermediary Doctrine and the Pharmacist's Duty To Warn, 4 J. Legal Med. 349, 356 (1983). There is no regulatory requirement that pharmacists provide consumers with this insert. We decline to impose such a duty for several reasons.

First, such a requirement would place an unknown burden on pharmacists. As noted, manufacturers are not required to provide consumers with their warnings. Although here the amount of McKee's prescription coincided with the size of the manufacturer's package, drugs are often packaged in large units, containing only one package insert, and must be divided to fill numerous prescriptions. Thus, pharmacists would have the economic and logistic burden of copying the inserts as well as developing a storage, filing and retrieval system to ensure the current insert *719is dispensed with the proper drug. From a liability standpoint, the pharmacist may also need a system for proving the patient received the insert.

More importantly, such a duty may not be without risk. Package inserts, written for the physician, are detailed and technical, and may confuse and frighten the patient. In 1980, the FDA adopted regulations requiring patient package inserts (PPI) directed to the consumer. These were information leaflets, in lay language, to be produced by manufacturers and distributed by pharmacists at the time a prescription was filled. 40 Fed. Reg. 60,754 (1980). This program was rescinded, however, in 1982. 47 Fed. Reg. 39,147 (1982). Patient inserts are still required for oral contraceptives and several other drugs, but not Plegine. See Brushwood & Simonsmeier, Drug Information for Patients: Duties of the Manufacturer, Pharmacist, Physician, and Hospital, 7 J. Legal Med. 270, 280 n.6 (1986) (listing PPI requirements).

Some have argued that direct warnings to the consumer, once the patient has made the decision to use a drug and the physician is no longer available to counsel, may be counterproductive and are contrary to the rationale behind the learned intermediary doctrine. Brushwood & Simonsmeier, 7 J. Legal Med. at 283-84; Brushwood, 4 J. Legal Med. at 357; Makripodis, 361 Pa. Super, at 597. As one commentator stated:

The most innocuous of drugs, and those generally considered safe, effective, and best for a given problem may, nevertheless, produce serious side effects in some patients. A description of risks in a package insert drafted for the self-protection of the drug company and the FDA could disturb even the most sophisticated patient. Placing this type of information in the hands of patients after the course of treatment had been agreed on with the physician would add an uncontrollable and often unknown factor to the treatment process. The patient might make a new judgment not to take the medication as directed.

Curran, Package Inserts for Patients: Informed Consent in the 1980's, 305 New Eng. J. Med. 1564, 1565-66 (1981).

*720Moreover, a requirement that consumers receive the manufacturer's insert effectively abrogates the learned intermediary doctrine and could impact not only pharmacists' liability, but that of manufacturers and physicians as well.

While some form of written warnings to consumers may well be beneficial, in light of the potential ramifications of such a decision and the pervasive regulation in this area, if such warnings are to be required, the duty should be imposed by the Legislature. The Legislature can better assess the relative costs and benefits involved, and determine what form any warnings should take. The legislative process can better reconcile the interests of all persons concerned with the imposition of such a duty: pharmaceutical manufacturers, medical societies, retail pharmacists, health care insurers, consumer groups and patient representative groups. We find before us a single injured plaintiff and two drug store owners. Holding that the drug store owners could be negligent for failing to warn her about the drug her doctor prescribed would muddy the waters as to where responsibility lies up and down the chain of health care. We decline to do so.

Conclusion

In summary, our holding is narrow. The pharmacist still has a duty to accurately fill a prescription, see Annot. Liability of Manufacturer or Seller for Injury Caused by Drug or Medicine Sold, 79 A.L.R.2d 301 (1961), and to be alert for clear errors or mistakes in the prescription. The pharmacist does not, however, have a duty to question a judgment made by the physician as to the propriety of a prescription or to warn customers of the hazardous side effects associated with a drug, either orally or by way of the manufacturer's package insert.

Summary judgment is appropriate when "there is no genuine issue as to any material fact and . . . the moving party is entitled to a judgment as a matter of law." CR 56(c). Hontz v. State, 105 Wn.2d 302, 311, 714 P.2d 1176 *721(1986). The defendants owed no duty to the plaintiff and are entitled to judgment as a matter of law. The trial court's order is affirmed.

Dolliver, Andersen, Durham, and Smith, JJ., concur.

The Physicians' Desk Reference is supplied by drug manufacturers for the guidance of physicians, not pharmacists.

RCW 18.64.246 requires that all prescription drugs bear a label containing, inter alia, the name and address of the pharmacy, the name of the prescribing doctor and his directions, the name and strength per unit dose of the drug, the name of the patient, the date of the prescription, and the expiration date. See also WAC 360-16-255. 21 U.S.C. § 353(b)(2) contains similar federal requirements.

RCW 7.70.040 reads:

"The following shall be necessary elements of proof that injury resulted from the failure of the health care provider to follow the accepted standard of care.

"(1) The health care provider failed to exercise that degree of care, skill, and learning expected of a reasonably prudent health care provider at that time in the profession or class to which he belongs, in the state of Washington, acting in the same or similar circumstances;

"(2) Such failure was a proximate cause of the injury complained of." (Italics ours.)

Fla. Stat. § 768.45 (1985) is renumbered as 766.102 (1988) and provides for standards of recovery in medical negligence actions. Like our RCW 7.70.040, Florida provides that in an action against a health care provider:

"... the claimant shall have the burden of proving by the greater weight of evidence that the alleged actions of the health care provider represented a breach of the prevailing professional standard of care for that health care provider. The prevailing professional standard of care for a given health care provider shall be that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers."

The Batiste opinion states in part: " She alleged that she obtained a prescription from her physician and that defendant druggist filled that prescription. There is no allegation that defendant druggist added anything thereto or selected anything for plaintiff to take. Nor is this a situation where plaintiff made her choice from items selected and displayed by the druggist for sale to the general *711public. Here the drug purchased by plaintiff was not available to the general public in the sense that it was available for purchase by any customer who came in the drug store, selected it from the shelf, and paid the price therefor. It was available only to those who had previously seen their physician and obtained from the physician a prescription directing the druggist to supply the drug. Obviously the plaintiff patient did not rely on the druggist's skill or judgment in assuming that the drug would be fit for its intended purpose. This reliance had been properly placed with her physician. We are not willing to extend the applicability of implied warranties of fitness and merchantability to this situation and agree with the trial court in dismissing these two claims for relief." (Citations omitted.) Batiste, at 12.

WAC 360-12-150 reads:

Monitoring of drug therapy by pharmacists. The term “monitoring [of] drug therapy" used in RCW 18.64.011(11) shall mean a review of the drug therapy regimen of patients by a pharmacist for the purpose of evaluating and rendering advice to the prescribing practitioner regarding adjustment of the regimen. Monitoring of drug therapy shall include, but not be limited to:

(1) Collecting and reviewing patient drug use histories;

(2) Measuring and reviewing routine patient vital signs including, but not limited to, pulse, temperature, blood pressure and respiration; and

(3) Ordering and evaluating the results of laboratory tests relating to drug therapy including, but not limited to, blood chemistries and cell counts, drug levels in blood, urine, tissue or other body fluids, and culture and sensitivity tests when performed in accordance with policies and procedures or protocols *714applicable to the practice setting, which have been developed by the pharmacist and prescribing practitioners and which include appropriate mechanisms for reporting to the prescriber monitoring activities and results.

We are unaware of any practice wherein pharmacists must collect and review patient drug use histories. Such activity could intrude into the privacy of the customer and bring forth a number of issues not before us in this action. Further, we are unaware of any practice by pharmacists which includes taking the pulse, temperature, and blood pressure, and checking the respiration of a customer who enters a drug store bearing, in hand, a prescription from his doctor.

WAC 360-16-250 specifically requires the pharmacist to orally explain the directions for use and give any additional information necessary to assure-proper use of the drug. We interpret this to include nonjudgmental information, not affecting a decision to take or continue using a drug, such as: whether to take the drug on an empty or full stomach, substances to avoid while using the drug, or not to drive or use heavy machinery while taking the drug. We do not decide whether failure to give this information is actionable. See Brushwood & Simonsmeier, Drug Information for Patients: Duties of the Manufacturer, Pharmacist, Physician, and Hospital, 7 J. Legal Med. 279, 282, 308-20 (1986).

McKee is 5'4" tall and states that her maximum weight while using Plegine was 138 pounds.

Pharmacies in Washington are required to maintain a patient medication record for each patient, which may include information on ''allergies, idiosyncrasies, or chronic condition which may relate to drug utilization." WAC 360-19-030(l)(i), -040(l)(g). We recognize, however, that a pharmacist typically does not have the patient's complete medical history and there may be occasions where the pharmacist is unaware a drug is contraindicated.

WAC 360-19-050 requires a pharmacist to review a patient's medication record upon receipt of a prescription for possible drug interactions, reactions or duplications, and to contact the prescriber if needed. WAC 360-19-080(2) states: "If in the judgment of the dispenser, the prescription presented for dispensing is determined to cause a potentially harmful drug interaction or other problem due to a drug previously prescribed by another practitioner, the dispenser may communicate this information to the prescribers."