Drug Product Selection: Legal Issues
Objective. To review the potential legal liability of the pharmacist in the drug product selection process.
Data Sources. Published articles identified through MEDLINE, published law reviews identified through InfoTrac, and appellate court decisions. Search terms used included pharmacist liability, drug product selection, and generic substitution. Additional articles, books, and appellate court decisions were identified from the bibliographies of retrieved articles and citations in appellate court decisions.
Data Synthesis. Pharmacists engaging in drug product selection are civilly liable under three legal theories: negligence, express or implied warranties, and strict product liability. Potential criminal liability includes prosecution for insurance fraud, deceptive business practices, and violation of state drug product selection laws and regulation.
Conclusion. Pharmacists increase their liability when engaging in drug product selection, but the increase is small. Still, the law continues to evolve as pharmacists seek expanded roles and responsibilities. When courts give closer examination to pharmacists' expanded role, it is likely that pharmacists' liability will increase.
In the early 20th century, physicians were the professionals primarily responsible for selecting the appropriate medications for patients. Pharmacists, on the other hand, were responsible for selecting the various ingredients and for compounding medications into dosage forms. Besides the active ingredients, pharmacists decided whether excipients (binders, preservatives, powder lubricants, disintegrants, solvents, or flavoring agents) were needed.
Later in the century, a standardized method of preparing drugs emerged that was not only much faster but also more economical. This development resulted in increased manufacturing of drug products in prepackaged dosage forms sold under brandnames. In addition, drug manufacturers changed their marketing strategies to promote their brandname products to physicians. This shift eventually led to physicians prescribing medication by drug brandname. While physicians retained responsibility for selecting the most appropriate drug for their patients, pharmacists' role began to erode primarily into that of repackagers of ready-to-use dosage forms.
Pharmacists' role eroded further in the early 1950s, when drug manufacturers began to use their economic power to secure market segments by encouraging the passage of antisubstitution legislation. These laws specifically prohibited a pharmacist from substituting a generic drug for a brand product prescribed by a physician. During the 1950s, almost every state passed antisubstitution laws.
Beginning in the late 1960s, the pharmacy profession began seeking ways to expand the role and professional status of pharmacists, and securing repeal of antisubstitution laws was viewed as a major step toward that goal. With advances in the pharmaceutical sciences and pharmacy education, pharmacy schools began graduating highly trained pharmacists knowledgeable in the medical sciences and pharmacology. Leaders of the pharmacy profession argued that while the physician selected the drug entity, its strength, and its dosage form, the pharmacist was most qualified to select the proper brand of drug.
It was the economic advantages, rather than the professional ones, that inspired consumer and governmental support for the repeal effort. In 1976 an extensive investigation conducted by the Federal Trade Commission (FTC) determined that antisubstitution laws imposed substantial costs on consumers by restricting price competition between large manufacturers producing the same drug. FTC reasoned that providing pharmacists with the option of choosing between a brand drug and its generic equivalent would stimulate price competition, and, presumably, pharmacists would pass on some of the resultant financial savings to their customers. The federal government would also benefit from price competition because lower drug prices would mean lower expenditures for Medicare and Medicaid programs. The potential for consumer and governmental savings led policy makers to repeal antisubstitution laws in most states by the end of the decade.
Currently, all U.S. states and territories have some form of drug product selection law allowing a pharmacist, under certain circumstances, to substitute a generic drug product when a physician has written a prescription for a brand product. Most state substitution statutes call for either explicit or implicit approval by the prescriber; a determination of therapeutic equivalence by the pharmacist, either from a formulary or through his or her professional judgment; the patient's approval of or acquiescence to the substitution; and the dispensing of a less expensive generic equivalent. A summary of differences in state drug product selection laws appears in Table 1.
Repeal of the antisubstitution laws led to questions of increased manufacturer, physician, and pharmacist liability. It appeared that drug manufacturers' and physicians' exposure to liability would remain about the same. Drug manufacturers would still be liable for injuries caused by subpotent, superpotent, or defective products, and physicians would be expected to use reasonable care in selecting appropriate drugs for their patients. Table 2 lists possible medication malpractice causes of action against a physician. However, pharmacists would be undertaking new responsibilities under the drug product selection laws. They might be exposed to additional liability if injuries were to occur when generic drugs were substituted for prescribed brand drugs.
A number of legal commentaries have described how drug product selection may result in increased pharmacist liability. To date, however, there are no reported appellate cases in which a pharmacist was found liable for damages resulting from drug product selection.This does not mean that claims are not being filed, however. Insurance companies report that claims alleging improper substitution are being filed against pharmacists. In addition, there are two reported appellate cases involving drug product selection in which the plaintiff was unsuccessful in establishing pharmacist liability. These two cases are Ullman v Grant and Bichler v Willing.
In the Ullman case, a patient presented a prescription to a pharmacy for Septra DS, the Burroughs Wellcome brand of sulfamethoxazole/trimethoprim. The physician wrote "substitution permitted" on the prescription. Instead of Septra DS, the pharmacy dispensed Bactrim DS, the Roche brand of sulfamethoxazole/ trimethoprim. When the plaintiff suffered an adverse reaction, he brought suit against the pharmacy.
In the Bichler case, a pregnant mother was prescribed diethylstilbestrol (DES). The defendant pharmacy allegedly filled the prescription with DES manufactured by Eli Lilly. Some time later, the daughter of the woman who took DES claimed severe and permanent injury due to the drug and sued the pharmacy. Although it is only mentioned in dicta, the court considered whether the pharmacist's choice of a particular brand of DES, among other available brands, would make a difference in determining liability.
The plaintiffs in the Ullman and Bichler cases advanced three possible theories under which pharmacists might be held liable for injuries sustained in drug product selection situations: negligence, express or implied warranties, and strict product liability.
Objective. To review the potential legal liability of the pharmacist in the drug product selection process.
Data Sources. Published articles identified through MEDLINE, published law reviews identified through InfoTrac, and appellate court decisions. Search terms used included pharmacist liability, drug product selection, and generic substitution. Additional articles, books, and appellate court decisions were identified from the bibliographies of retrieved articles and citations in appellate court decisions.
Data Synthesis. Pharmacists engaging in drug product selection are civilly liable under three legal theories: negligence, express or implied warranties, and strict product liability. Potential criminal liability includes prosecution for insurance fraud, deceptive business practices, and violation of state drug product selection laws and regulation.
Conclusion. Pharmacists increase their liability when engaging in drug product selection, but the increase is small. Still, the law continues to evolve as pharmacists seek expanded roles and responsibilities. When courts give closer examination to pharmacists' expanded role, it is likely that pharmacists' liability will increase.
In the early 20th century, physicians were the professionals primarily responsible for selecting the appropriate medications for patients. Pharmacists, on the other hand, were responsible for selecting the various ingredients and for compounding medications into dosage forms. Besides the active ingredients, pharmacists decided whether excipients (binders, preservatives, powder lubricants, disintegrants, solvents, or flavoring agents) were needed.
Later in the century, a standardized method of preparing drugs emerged that was not only much faster but also more economical. This development resulted in increased manufacturing of drug products in prepackaged dosage forms sold under brandnames. In addition, drug manufacturers changed their marketing strategies to promote their brandname products to physicians. This shift eventually led to physicians prescribing medication by drug brandname. While physicians retained responsibility for selecting the most appropriate drug for their patients, pharmacists' role began to erode primarily into that of repackagers of ready-to-use dosage forms.
Pharmacists' role eroded further in the early 1950s, when drug manufacturers began to use their economic power to secure market segments by encouraging the passage of antisubstitution legislation. These laws specifically prohibited a pharmacist from substituting a generic drug for a brand product prescribed by a physician. During the 1950s, almost every state passed antisubstitution laws.
Beginning in the late 1960s, the pharmacy profession began seeking ways to expand the role and professional status of pharmacists, and securing repeal of antisubstitution laws was viewed as a major step toward that goal. With advances in the pharmaceutical sciences and pharmacy education, pharmacy schools began graduating highly trained pharmacists knowledgeable in the medical sciences and pharmacology. Leaders of the pharmacy profession argued that while the physician selected the drug entity, its strength, and its dosage form, the pharmacist was most qualified to select the proper brand of drug.
It was the economic advantages, rather than the professional ones, that inspired consumer and governmental support for the repeal effort. In 1976 an extensive investigation conducted by the Federal Trade Commission (FTC) determined that antisubstitution laws imposed substantial costs on consumers by restricting price competition between large manufacturers producing the same drug. FTC reasoned that providing pharmacists with the option of choosing between a brand drug and its generic equivalent would stimulate price competition, and, presumably, pharmacists would pass on some of the resultant financial savings to their customers. The federal government would also benefit from price competition because lower drug prices would mean lower expenditures for Medicare and Medicaid programs. The potential for consumer and governmental savings led policy makers to repeal antisubstitution laws in most states by the end of the decade.
Currently, all U.S. states and territories have some form of drug product selection law allowing a pharmacist, under certain circumstances, to substitute a generic drug product when a physician has written a prescription for a brand product. Most state substitution statutes call for either explicit or implicit approval by the prescriber; a determination of therapeutic equivalence by the pharmacist, either from a formulary or through his or her professional judgment; the patient's approval of or acquiescence to the substitution; and the dispensing of a less expensive generic equivalent. A summary of differences in state drug product selection laws appears in Table 1.
Repeal of the antisubstitution laws led to questions of increased manufacturer, physician, and pharmacist liability. It appeared that drug manufacturers' and physicians' exposure to liability would remain about the same. Drug manufacturers would still be liable for injuries caused by subpotent, superpotent, or defective products, and physicians would be expected to use reasonable care in selecting appropriate drugs for their patients. Table 2 lists possible medication malpractice causes of action against a physician. However, pharmacists would be undertaking new responsibilities under the drug product selection laws. They might be exposed to additional liability if injuries were to occur when generic drugs were substituted for prescribed brand drugs.
A number of legal commentaries have described how drug product selection may result in increased pharmacist liability. To date, however, there are no reported appellate cases in which a pharmacist was found liable for damages resulting from drug product selection.This does not mean that claims are not being filed, however. Insurance companies report that claims alleging improper substitution are being filed against pharmacists. In addition, there are two reported appellate cases involving drug product selection in which the plaintiff was unsuccessful in establishing pharmacist liability. These two cases are Ullman v Grant and Bichler v Willing.
In the Ullman case, a patient presented a prescription to a pharmacy for Septra DS, the Burroughs Wellcome brand of sulfamethoxazole/trimethoprim. The physician wrote "substitution permitted" on the prescription. Instead of Septra DS, the pharmacy dispensed Bactrim DS, the Roche brand of sulfamethoxazole/ trimethoprim. When the plaintiff suffered an adverse reaction, he brought suit against the pharmacy.
In the Bichler case, a pregnant mother was prescribed diethylstilbestrol (DES). The defendant pharmacy allegedly filled the prescription with DES manufactured by Eli Lilly. Some time later, the daughter of the woman who took DES claimed severe and permanent injury due to the drug and sued the pharmacy. Although it is only mentioned in dicta, the court considered whether the pharmacist's choice of a particular brand of DES, among other available brands, would make a difference in determining liability.
The plaintiffs in the Ullman and Bichler cases advanced three possible theories under which pharmacists might be held liable for injuries sustained in drug product selection situations: negligence, express or implied warranties, and strict product liability.
Source...