American Journal of Law & Medicine

The Omnibus Reconciliation Act of 1990: redefining pharmacists' legal responsibilities.

I. INTRODUCTION

Henry Fan, owner of T.I. Drugstores, one of the city's largest pharmacies, just walked into your office for legal advice. He sits down across from your desk and holds his head in his hands. With a worried look on his face, he tells you that his pharmacy has just been sued by one of its customers, Elaine Jones. A year ago, T.I. Drugstores received a prescription for Jones from Dr. Kenneth Brown for Bendectin, a prescription drug used for the treatment of nausea and vomiting during the early stages of pregnancy. After reviewing the prescription for errors, the pharmacist filled the prescription according to its directions and sold it to Jones.

Approximately eight months later, Jones gave birth to a baby girl with severe deformities as a result of the ingested Bendectin. Sadly, her child will never be able to sit or walk properly. Jones is suing T.I. Drugstores for negligently failing to advise her of the potential hazards associated with ingesting Bendectin. Additionally, Jones claims that T.I. Drugstores is strictly liable for failing to warn her of the fact that ingesting Bendectin causes birth defects in children.

Fan informs you that the pharmacist assumed that Brown had forewarned Jones of the risks associated with Bendectin. Outraged, Fan insists that neither his drugstore nor his pharmacist acted incorrectly. They simply did what they were supposed to do: fill the prescription according to its specifications.

How would you advise Fan as to when a pharmacist may be held liable for injuries resulting from prescription drugs? The law clearly provides that a pharmacist has a duty to dispense prescriptions properly.(1) However, the law becomes ambiguous when a pharmacist correctly fills a prescription which was written incorrectly by the prescribing physician. Should the courts require pharmacists to defer to the physicians' judgment and fill prescriptions as written? Alternatively, should the courts require pharmacists to contact the prescribing physicians before dispensing medicine?

This Article addresses these concerns. Part Two defines American pharmacists' traditional role and responsibilities. It also describes how the public's trust in pharmacists may be misplaced due to flaws in the pharmaceutical delivery system. Part Three explains the legal theories under which injured customers attempt to hold pharmacists liable. Part Four discusses how the Omnibus Budget Reconciliation Act of 1990 has affected and is likely to affect pharmacists' legal duties. Finally, this Article concludes by noting the trends in pharmacy education and by advocating for an expansion of pharmacists' legal duties and responsibilities.

II. PHARMACISTS' TRADITIONAL ROLE AND RESPONSIBILITIES

For the past eight years, the general public has consistently ranked pharmacists as the number one professional group for their honesty and ethical standards.(2) The public's frequent references to pharmacists as "America's most trusted professionals,"(3) reflects this respect. Interestingly, Gallup polls from the past eight years indicate that the public regards pharmacists as more honest than physicians or clergy members.(4) This evidence reflects the level of trust Americans have in their pharmicists.

In 1983, pharmacists filled approximately 1.38 billion prescriptions in the United States alone.(5) Just five years later, that number jumped to 1.63 billion,(6) and recent studies indicate a twenty percent increase in filled prescriptions between 1993 and 1997.(7) Today, the National Association of Chain Drug Stores estimates that approximately three of every five visits to physicians result in the patient's receipt of some form of prescription.(8) With U.S. retail community pharmacies dispensing more than six million prescriptions on a daily basis,(9) consumers spend approximately $30 billion annually on prescription medications alone.(10) The United States currently boasts more than 19,000 chain drugstore outlets(11) and 53,000 independent community drug stores.(12) Most Americans now live within five miles of a typical, retail community pharmacy.(13) With such pervasive numbers, pharmacists possess the ability to impact the lives of millions of people across the nation on a daily basis.

A. FLAWS IN THE CURRENT PHARMACEUTICAL SYSTEM

On November 17, 1997, the Department of Health and Human Services published the results of a survey taken by 461 nursing home pharmacists.(14) Of the 461 pharmacists, a disturbing forty-six percent reported that physicians regularly prescribed inappropriate prescription drugs for their patients.(15) This survey defined "inappropriate" drugs as "those not recommended for the elderly; those used for illnesses [that] they [are] not designed to treat; or those not given according to a prescription."(16) The report attributed the problem of prescribing inappropriate drugs to both poor communication and record keeping, stating that "[d]octors prescribe drugs without checking [and] pharmacists don't see key records and lack power to intervene...."(17) Consequently, patients experience numerous adverse reactions to the drugs, some of which require serious medical attention.(18) Although this study focused on pharmacists who serve nursing homes, it is reasonable to assume that retail pharmacists face similar problems nationwide.(19)

The American Pharmaceutical Association recently conducted a national telephone survey that indicates that only thirty-nine percent of the respondents reported that their physicians or pharmacists warn them about potential interactions resulting from taking different prescription medications simultaneously.(20) Furthermore, only forty-four percent of the respondents stated that their physicians or pharmacists warn them about the potential interactions resulting from ingesting prescription medications with over-the-counter medications.(21)

Another study revealed that seventy-two percent of pharmaceutical consumers receive insufficient information regarding their prescriptions.(22) This lack of information has resulted in approximately 100 million prescriptions not being refilled(23) and over $4.5 billion in added hospital costs.(24) Moreover, errors stemming from adverse drug reactions have reportedly caused some $76 billion in annual health care costs.(25)

B. REASONS FOR THE FLAWS IN THE CURRENT PHARMACEUTICAL DELIVERY SYSTEM

At least two factors contribute to the flaws in the current pharmaceutical delivery system. First, the sheer number of prescriptions suggests that pharmacists are overworked. Because the poisonous composition of prescription drugs may potentially lead to severe consequences, courts generally hold pharmacists to "the highest degree of care and prudence for the safety of customers known to practical men."(26) Pharmacists, however, are overworked due to the intense pressure to fill unreasonable numbers of prescriptions in limited periods of time. This means that the highest degree of care and prudence is often compromised.(27)

A decade ago, small neighborhood pharmacies filled an average of ninety-two prescriptions per day.(28) Today, that number has increased by forty-five percent to approximately 133 prescriptions per day.(29) The most troubling fact about this increase is that small pharmacies typically employ only one pharmacist,(30) leaving the individual pharmacist responsible for filling each of the 133 prescriptions by him or herself.(31) This results in pharmacists struggling to fill prescriptions at the disturbing rate of one prescription every 3.61 minutes in an average eight-hour workday without breaks. Larger pharmaceutical chains fill even greater numbers of prescriptions.(32) Although these chains typically employ two or more pharmacists, chain drugstores regularly fill approximately 165 prescriptions per day.(33) In comparison, mass merchandisers may fill as many as 450 prescriptions per day.(34)

The emergence of health maintenance organizations (HMOs) further intensifies the pressure on pharmacists to fill prescriptions. Critics claim that HMOs pay pharmacists less for dispensed drugs than insurers paid in the past.(35) Consequently, pharmacists feel pressure to maximize their hours by filling as many prescriptions as physically possible.(36) This maximization inevitably reduces the amount of time pharmacists devote to checking prescriptions for accuracy.(37) As such, customers can no longer assume that their pharmacists double-check their prescriptions for correctness prior to dispensing medication.(38)

The second possible cause of the problems is the relatively new process of employing pharmacy technicians. Although pharmacies typically hire pharmacy technicians to prepare bottle labels or stock and count pills, pharmacy technicians are also hired to ensure that two people review every prescription.(39) This allows pharmacists to focus on counseling customers.(40)

Pharmacies may save a considerable amount of money by employing technicians. While pharmacists typically earn between $30 and $39 per hour, technicians earn between $5 and $12 an hour.(41) To save costs and to capitalize upon the wage differential, at least two state legislatures are considering a departure from the general requirement of a one-to-one ratio between technicians and pharmacists.(42) These state legislatures are considering allowing up to as many as three technicians per pharmacist.(43) If such legislation passes, the quality of pharmacist supervision over pharmacy technicians will inevitably suffer, thereby exposing customers to more risk.

III. THEORIES OF PHARMACISTS' COMMON LAW LIABILITIES

Pharmacists traditionally have been held to a standard of care that is "commensurate with the degree of knowledge, skill, and diligence ordinarily exercised by other members of the profession."(44) Accordingly, injured plaintiffs have predicated their theories of liability on strict liability and negligence.

A. STRICT LIABILITY

Courts apply the strict liability doctrine in situations where a seller sold a product that was "in a defective condition unreasonably dangerous" to the ultimate user and/or consumer who was injured by that product.(45) This concept is premised upon the idea that when one presents goods to the public, he or she warrants that the goods are suitable for their intended use.(46)

However, Courts are reluctant to hold pharmacists strictly liable for any harm resulting from a drug dispensed according to a physician's prescription.(47) Courts support this position(48) with the Restatement (Second) of Torts [sections] 402A, Comment (k), which states in pertinent part:

 
   There are some products which, in the present state of human knowledge, are 
   quite incapable of being made safe for their intended and ordinary use. 
   These are especially common in the field of drugs.... Such a product, 
   properly prepared, and accompanied by proper directions and warning, is not 
   defective, nor is unreasonably dangerous.(49) 

In Murphy v. E.R. Squibb & Sons, Inc.,(50) the leading strict liability case, a woman ingested Stilbestrol(51) while pregnant.(52) As a result of ingesting the drug, the plaintiff's child developed clear cell adenocarcinoma.(53) The plaintiff sought to hold the pharmacy strictly liable for her child's injuries.(54) In thereof, the plaintiff argued that pharmacies should be strictly liable for the harm caused by their products in the same manner as retailers are strictly liable for defective products.(55)

The Supreme Court of California disagreed with the plaintiff's contentions. According to the court, pharmacists engage "in a hybrid enterprise, combining the performance of services and the sale of prescription drugs."(56) Although a pharmacist sells prescription drugs, the court noted that a pharmacist cannot offer a prescription for sale unless a physician orders its release.(57) Continuing, the court stated that a pharmacist acts essentially as an extension of the physician and provides services in the same manner as a technician who analyzes a blood sample pursuant to a doctor's order.(58) Because "those who sell their services for the guidance of others ... are not liable in the absence of negligence or intentional misconduct,"(59) the Murphy court refused to hold the pharmacy strictly liable.(60)

The Murphy court supported its holding with a number of public policy arguments. First, the court reasoned that if pharmacists were strictly liable in such situations, pharmacists may attempt to avoid liability by refusing to dispense any drugs that "pose even a potentially remote risk of harm, although such medications may be essential to the health or ... survival of patients."(61) Second, the court warned that pharmacists may feel pressure to select more expensive products from established manufacturers if he or she has the option of choosing among several brands of the same drug.(62) Finally, the court opined that imposing strict liability would unfairly burden pharmacists because pharmacists "may provide the drug only on a doctor's prescription, to which the pharmacist must strictly follow. …

Log in to your account to read this article – and millions more.