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Monitoring Prescriptions for Legitimacy
Monitoring Prescriptions for Leg~timacy by Jesse C. Vivian, JD, and David B. Brushwood, JD
The pharmacists' role as provider ofprescription drugs for medicinal purposes may conflict with their legal role as monitor of the use of controlled substances. This hypothetical case looks at potential problems.
nly prescription orders for controlled substances that are for a "legitimate medical purpose" and issued in the usual course of professional practice may be dispensed by a pharmacist,l according to Drug Enforcement Agency (DEA) regulations pursuant to Title II of the Federal Comprehensive Drug Abuse Prevention and Control Act,2 commonly known as the Controlled Substances Act (CSA). This same regulation places "corresponding responsibility" on the pharmacist to ensure that the medication was properly ordered. 3 Court cases interpreting both the CSA and DEA regulations have traditionally stated that to avoid criminal, civil, or administrative liability, pharmacists must "verify" the legitimacy of controlled substance prescription orders.4
O
Handling Prescriptions for Controlled Substances The verification requirement obligates pharmacists to operate as an extension of law enforcement authorities. This is an uncomfortable thought for most pharmacists. Educated and trained as health care professionals, they do not think of 32
American Pharmacy, Vol. NS31, No.9 September 19911640
themselves as police officers. Because of their health care background, pharmacists recognize the negative health consequences of not dispensing a valid prescription and the law enforcement problems that arise if they dispense an invalid prescription. However, since they act in this dual capacity (health care provider and law enforcement facilitator), pharmacists may find themselves in a situation where concern for one area causes problems in the other. Consider the following hypothetical situation:
Alex Swanson is a pharmacist working in a chain pharmacy located in a trendy suburb of a major metropolitan area. Most of the patients Alex sees are upper-middle-class professionals. Alex received a telephone call one day from a nearby community pharmacist who is part of a "hot line" to alert area pharmacists about suspicious prescription orders. The message was that a poorly dressed man about 30 years old was attempting to pass a prescription order for Demerol. The telephoning pharmacist had just seen the order, which was very worn as if many people had handled it. The pharmacist told Alex, "The best thing to do is just say you're out of the drug. There's no sense in asking for trouble." As Alex hung up the telephone, he saw a poorly dressed man standing at the counter. He had a prescription order for Demerol 50 mg, #50, with directions to take one tablet every four hours for pain. The name of the patient on the prescription order was John Smith. The paper on which the order was written was frayed on the edges. Alex thought that the prescription order looked authentic. Issued from a major teaching hospital downtown, it was signed by a physician Alex had never heard of. Alex called the hospital, using the telephone number listed in the phone book. He was referred to the hematology department, where he finally located a resident who knew the prescriber and the patient. The prescriber could not be found, but the resident assured Alex that the prescription
order was valid. The resident said it is not unusual for patients to have trouble getting prescription orders processed at inner-city pharmacies because many have discontinued stocking controlled substances from fear of armed robberies. Alex believed the explanation and dispensed the medication. Three weeks later, two DEA officers came to Alex's pharmacy. The DEA agents contended that the person who presented the Demerol prescription order was not the patient, but a friend of the patient. Although a prescription order had been issued for Demerol, the one Alex handled was a very good duplicate of the original. Six other pharmacies also processed the prescription; approximately 30 refused. According to the agents, the Demerol tablets were then sold to students at a local high school. Alex could tell that the DEA agents thought Alex should not have processed the prescription, especially since he was warned not to dispense it, he never spoke to the prescriber, and most other pharmacists refused it. Alex expected some significant legal difficulties as a result.
Court cases deal primarily with situations where a pharmacist has deliberately closed his or her eyes to a situation that should have signaled invalid prescribing. The rules that have evolved from this body of case law dealing with pharmacist misconduct are of limited value when the facts of a situation require hairsplitting over a decision that could reasonably go either way. The most helpful judicially created standard is that the pharmacist must have acted in good faith to avoid criminal or administrative liability.7 Good faith is "that state of
Case Law Provides Few Guidelines
mind denoting honesty of purpose, freedom from intention to defraud, and generally speaking, means being faithful to one's duty or obligation."8 It is the opposite of fraud and bad faith. In some ways, the "good faith" requirement amounts to mandating a common sense approach to handling difficulties with controlled substance prescription orders.9 The traditional "good faith" defense, however, has been jeopardized in a recent federal case, United States v. Green. 10 In that case, a federal court of appeals upheld a judgment of administrative civil penalties against a pharmacist accused of controlled substances record-keeping violations. A DEA audit performed in 1986 revealed a shortage of approximately 6,000 doses of Schedule II controlled substances. The court accepted the pharmacist's argument that the violations were due to inadvertent errors and that he had acted in good faith. Nonetheless, he was held liable because, according to this
Is Alex in trouble? He certainly is if he ''knowingly'' filled an invalid prescription. On the other hand, if it can be shown that Alex did everything he could reasonably have done to prevent unlawful distribution of controlled substances, the law should forgive the fact that he undeniably processed an invalid prescription order. Unfortunately, case law does not provide clear guidelines for pharmacists. The CSA and DEA regulations do not thoroughly explain the scope of the pharmacist's duties in ''verifYing'' prescription orders for controlled substances. 5 Furthermore, guidelines provided to pharmacists by the DEA generally contemplate the presentation of several suspicious prescription orders.6 Little, if any, constructive direction is provided when a pharmacist receives a single controlled substance prescription order from an unknown prescriber.
American Pharmacy, Vol. NS31, No.9 September 19911641
The traditional 'good faith' defense has been jeopardized in a federal case that upheld penalties against a pharmacist accused of controlled substance record-keeping violations.
33
court, the controlling statute l l provides for "strict liability" (i.e., liability without fault). In coming to this conclusion, the court interpreted the legislative history of the statute and found that Congress's intent was to impose strict liability sanctions on pharmacists because they have "the greatest access to controlled substance and therefore, the greatest opportunity for diversion." The court's decision in Green should be distinguishable from consideration of Alex's case in that the facts in Green centered around record-keeping violations. Alex's problem lies in dispensing a controlled substance from what turned out to be an invalid prescription. Nevertheless, the statutory and policy considerations in Green have significant implications in the dispensing arena. If pharmacists are to be held strictly liable for dispensing controlled substances on the authority of what appears to be a valid prescription order but is determined later to be invalid, in all likelihood pharmacists will begin turning away patients presenting prescription orders with even a taint of suspicion. This chilling effect could result in any number of patients being denied access to necessary medication simply because pharmacists worry more about legal entanglement than appropriate patient care. In this context, strict liability would have a devastating effect on pharmacist-patient relationships.
Strict vs. Good Faith Liability How would these different legal standards affect Alex and the Demerol prescription? In a "strict liability" world, Alex would be liable for dispensing the medication from an invalid order. His knowledge and conduct in trying to verify the order would not be relevant. The analysis is much different, however, if a "good faith" standard is applied. It would be important to determine what Alex knew and what that should have meant to him when the prescription order for Demerol was presented. When Alex received the Demerol 34
prescription, he had advance notice that there might be something wrong with it through the hot line alert that a poorly dressed man was attempting to pass a very worn-looking prescription for Demerol. The well-meaning pharmacist even suggested how to handle the situation: "Just say you are out of the drug," and advised that processing this prescription order was 'just asking for trouble." But Alex felt a moral, if not pro-
If pharmacists are held strictly liable, in all likelihood pharmacists will begin turning away patients presenting prescriptions with even a taint of suspicion. fessional, responsibility to the patient. He did keep the medication in stock for his regular patients who have need for this type of drug therapy. Telling the customer that he was out of the drug would have been a lie. In this situation, while Alex recognized that lying would be the easy way out, deception was an unacceptable alternative. Alex believed that his primary duty was to the patient, not to law enforcement personnel. Therefore, if the prescription order was legitimate, he believed that he should dispense it; otherwise a needy patient might suffer.
Verifying Legitimacy Nonetheless, Alex knew he had a legal duty to verify the legitimacy of the prescription. In this context, Alex operated under the belief that his legal duty was satisfied by making a good faith inquiry of the prescribing physician as to whether the medication was prescribed for a legitimate medical purpose. While the suspicions of the hot line pharmacist were relevant, Alex knew he had to make his own decision whether to dispense the medication, based on what he could rea-
sonably determine about the prescriber, the patient, and the prescription order. That the prescription form was worn or a bit frayed on the edges as if many people had handled it was also relevant. Alex knew that many pharmacists do not believe, as he did, that prescription orders for controlled substances should be dispensed unless there is good reason to refuse to do so. In Alex's mind, this explained why so many other people may have handled the prescription form before it was presented to him. On visual examination the prescription order looked authentic. It contained all the information required by law and appeared to have an original signature by a physician. The fact that Alex had never heard of the physician was not surprising because the order came from the downtown teaching hospital where transient physicians are commonplace. Attempting to fulfill his legal obligations, Alex called the prescriber for verification. Using a skill he had learned from education, training, and experience, he looked up the physician's phone number in the telephone book rather than using the phone number on the prescription form. After all, Alex knew it was easy enough to have prescription blanks printed up with a bogus phone number where a "fake doctor" will verify prescriptions. Unfortunately, Alex was put in contact with a resident physician because the prescriber was nowhere to be found. The resident, however, did know the patient, the prescriber, and the circumstances surrounding the issuing of the Demerol prescription order. Alex was assured by the resident that the order was valid. Alex thought that discussing the prescription with the resident was not much different from obtaining verification from a private physician's nurse or receptionist acting as the delegated agent of the physician. Besides, the explanation provided by the resident, that patients have trouble getting controlled substance prescription orders processed in the inner city, was logical.
American Pharmacy, Vol. NS31, No.9 September 19911642
DEA Concerns With this information and knowledge, Alex decided to dispense the medication. But, according to the DEA agents, the order was an invalid copy. The DEA agents explained some other circumstances they believed were relevant and would lead any reasonable pharmacist to refuse the Demerol prescription. The individual who obtained the medication was not the patient, and when it had been presented, 30 other pharmacies had refused to dispense the prescription. Alex knows that a prescription may be dispensed to or for the ultimate user (the patient);12 the law does not require the pharmacist to physically hand a controlled substance to the patient and no one else. Alex could have determined that the person handing him the order was not the patient, but Alex decided, in hindsight, had he known this, he would still have dispensed the medication. It would have been reasonable to accept an explanation that the patient was too ill or in too much pain to come to the pharmacy for the medication. The fact that 30 other pharmacists refused to dispense the medication is a concern. Still, six other pharmacists either thought the prescription order was legitimate or just did not care and processed it anyway. In any event, Alex believed it was his own conduct and knowledge that would ultimately determine his guilt or innocence. The 30 other pharmacies may have turned away the prescription order for any number of reasons. For example, they may have legitimately been out of stock or not have carried Demerol. Alex clearly did not close his eyes to what he knew or should have known was an invalid prescription. It can be argued that he acted with all reasonable care in seeking to determine its validi ty. U sing the "good faith," as opposed to a "strict liability" standard, Alex should be exonerated from his error.
If strict liability is imposed, there would be no question that Alex could face criminal and/or administrative liability despite his best efforts. That type of policy, however, would likely have led ,Alex not to dispense the medication in the first place out of concern for legal entanglement. Such a policy is undesirable where, as here, there are no reasonable means available to the pharmacist to distinguish between valid and invalid controlled substance prescription orders.
Conclusion For now, the Green case represents a minority of one court. It is nevertheless likely that the government will seek expanded application of Green's court decision to other areas of pharmacy practice as a means of fighting drug abuse and diversion. Pharmacists should pay particular attention to the developments in this area of the law; its impact on how pharmacy is practiced could be dramatic.
Jesse C. Vivian, JD, is associate professor, College of Pharmacy and Allie~ Health Professions, Wayne State Unlversity, Detroit. David B. Brushwood, JD, is professor, College of Pharmacy, University ofFlorida, Gainesville.
References 1. 21 CFR § 1306.04(a). 2. 21 USC § 801-97l. 3.Id. 4. United States v. Lawson, 682 F2d 480 (4th Cir 1982). 5.Id. 481 n.2. 6. Pharmacists Manual: An Informational Outline of the Controlled Substances Act of 1970, US Dept of Justice (rev. April 1986) at 32. 7. United States v. Kershman, 555 F2d 198,201 (8th Cir 1977). 8. People v. Lonergan, 267 Cal Rpt 887 (1990). 9. Vermont 1l0th Medical Arts Pharmacy v. State Board of Pharmacy, 125 CA 3d 19; 117 Cal R 807, 810 (1981) cited in Nielsen, Jones R., Handbook of Federal Drug Law, Lea & Febiger (1986) at 86. 10.905 F2d 694 (3d Cir 1990), cert. denied, U.S., 111 S.Ct. 518, 112 L.Ed. 2d 530 (1991). 11. 21 USC § 842(c). 12. 21 CFR § 1306.02(f).
Another in the TARO "Signature Series" ... reaffirming our commitment to providing high quality bio-equivalent generics at competitive prices.
Research lTlakes us what we are. TARO ... a recognized leader in developing and marketing important new generics. Established by pharmacists in 1950, TARO has grown rapidly - over the past 5 years more than doubling total corporate sales. Rx Products
At Taro's research and manufacturing facilities in Toronto, more than 45 quality generic Rx and OTC products are produced: Those shown here, which are marketed in the U.S., as well as many others, which are marketed in Canada and other parts of the world. Today, wherever TARO products are marketed, the label means confidence, and consumer savings. If you're presently a TARO customer, we thank you, and look forward to serving you for years to come. If not, we invite you to learn more about our growing list of generic and OTC products by contacting your wholesaler or calling us toll-free at 800-544-1449.
o
Desoximetasone Cream, USP 0.25% Emotli«lt In on
Cr.am bole
Also available in 0.05%
Betame1hasone Valerate Cream, USP 0.1% TriamCinolone Acetonide Dental Paste, USP 0.1 %
TARO .. .founded by pharmacists. We know pharmacy, and the needs of the pharmacist. And we'd like to know you better.
TARO Pharmaceuticals U.S.A., INC. Six Skyline Drive Hawthorne, NY 10532
American Pharmacy, Vol. NS31, No.9 September 19911643
800-544-1449
Fax: 914-345-8727
35
The pharmacists' role as provider ofprescription drugs for medicinal purposes may conflict with their legal role as monitor of the use of controlled substances. This hypothetical case looks at potential problems.
nly prescription orders for controlled substances that are for a "legitimate medical purpose" and issued in the usual course of professional practice may be dispensed by a pharmacist,l according to Drug Enforcement Agency (DEA) regulations pursuant to Title II of the Federal Comprehensive Drug Abuse Prevention and Control Act,2 commonly known as the Controlled Substances Act (CSA). This same regulation places "corresponding responsibility" on the pharmacist to ensure that the medication was properly ordered. 3 Court cases interpreting both the CSA and DEA regulations have traditionally stated that to avoid criminal, civil, or administrative liability, pharmacists must "verify" the legitimacy of controlled substance prescription orders.4
O
Handling Prescriptions for Controlled Substances The verification requirement obligates pharmacists to operate as an extension of law enforcement authorities. This is an uncomfortable thought for most pharmacists. Educated and trained as health care professionals, they do not think of 32
American Pharmacy, Vol. NS31, No.9 September 19911640
themselves as police officers. Because of their health care background, pharmacists recognize the negative health consequences of not dispensing a valid prescription and the law enforcement problems that arise if they dispense an invalid prescription. However, since they act in this dual capacity (health care provider and law enforcement facilitator), pharmacists may find themselves in a situation where concern for one area causes problems in the other. Consider the following hypothetical situation:
Alex Swanson is a pharmacist working in a chain pharmacy located in a trendy suburb of a major metropolitan area. Most of the patients Alex sees are upper-middle-class professionals. Alex received a telephone call one day from a nearby community pharmacist who is part of a "hot line" to alert area pharmacists about suspicious prescription orders. The message was that a poorly dressed man about 30 years old was attempting to pass a prescription order for Demerol. The telephoning pharmacist had just seen the order, which was very worn as if many people had handled it. The pharmacist told Alex, "The best thing to do is just say you're out of the drug. There's no sense in asking for trouble." As Alex hung up the telephone, he saw a poorly dressed man standing at the counter. He had a prescription order for Demerol 50 mg, #50, with directions to take one tablet every four hours for pain. The name of the patient on the prescription order was John Smith. The paper on which the order was written was frayed on the edges. Alex thought that the prescription order looked authentic. Issued from a major teaching hospital downtown, it was signed by a physician Alex had never heard of. Alex called the hospital, using the telephone number listed in the phone book. He was referred to the hematology department, where he finally located a resident who knew the prescriber and the patient. The prescriber could not be found, but the resident assured Alex that the prescription
order was valid. The resident said it is not unusual for patients to have trouble getting prescription orders processed at inner-city pharmacies because many have discontinued stocking controlled substances from fear of armed robberies. Alex believed the explanation and dispensed the medication. Three weeks later, two DEA officers came to Alex's pharmacy. The DEA agents contended that the person who presented the Demerol prescription order was not the patient, but a friend of the patient. Although a prescription order had been issued for Demerol, the one Alex handled was a very good duplicate of the original. Six other pharmacies also processed the prescription; approximately 30 refused. According to the agents, the Demerol tablets were then sold to students at a local high school. Alex could tell that the DEA agents thought Alex should not have processed the prescription, especially since he was warned not to dispense it, he never spoke to the prescriber, and most other pharmacists refused it. Alex expected some significant legal difficulties as a result.
Court cases deal primarily with situations where a pharmacist has deliberately closed his or her eyes to a situation that should have signaled invalid prescribing. The rules that have evolved from this body of case law dealing with pharmacist misconduct are of limited value when the facts of a situation require hairsplitting over a decision that could reasonably go either way. The most helpful judicially created standard is that the pharmacist must have acted in good faith to avoid criminal or administrative liability.7 Good faith is "that state of
Case Law Provides Few Guidelines
mind denoting honesty of purpose, freedom from intention to defraud, and generally speaking, means being faithful to one's duty or obligation."8 It is the opposite of fraud and bad faith. In some ways, the "good faith" requirement amounts to mandating a common sense approach to handling difficulties with controlled substance prescription orders.9 The traditional "good faith" defense, however, has been jeopardized in a recent federal case, United States v. Green. 10 In that case, a federal court of appeals upheld a judgment of administrative civil penalties against a pharmacist accused of controlled substances record-keeping violations. A DEA audit performed in 1986 revealed a shortage of approximately 6,000 doses of Schedule II controlled substances. The court accepted the pharmacist's argument that the violations were due to inadvertent errors and that he had acted in good faith. Nonetheless, he was held liable because, according to this
Is Alex in trouble? He certainly is if he ''knowingly'' filled an invalid prescription. On the other hand, if it can be shown that Alex did everything he could reasonably have done to prevent unlawful distribution of controlled substances, the law should forgive the fact that he undeniably processed an invalid prescription order. Unfortunately, case law does not provide clear guidelines for pharmacists. The CSA and DEA regulations do not thoroughly explain the scope of the pharmacist's duties in ''verifYing'' prescription orders for controlled substances. 5 Furthermore, guidelines provided to pharmacists by the DEA generally contemplate the presentation of several suspicious prescription orders.6 Little, if any, constructive direction is provided when a pharmacist receives a single controlled substance prescription order from an unknown prescriber.
American Pharmacy, Vol. NS31, No.9 September 19911641
The traditional 'good faith' defense has been jeopardized in a federal case that upheld penalties against a pharmacist accused of controlled substance record-keeping violations.
33
court, the controlling statute l l provides for "strict liability" (i.e., liability without fault). In coming to this conclusion, the court interpreted the legislative history of the statute and found that Congress's intent was to impose strict liability sanctions on pharmacists because they have "the greatest access to controlled substance and therefore, the greatest opportunity for diversion." The court's decision in Green should be distinguishable from consideration of Alex's case in that the facts in Green centered around record-keeping violations. Alex's problem lies in dispensing a controlled substance from what turned out to be an invalid prescription. Nevertheless, the statutory and policy considerations in Green have significant implications in the dispensing arena. If pharmacists are to be held strictly liable for dispensing controlled substances on the authority of what appears to be a valid prescription order but is determined later to be invalid, in all likelihood pharmacists will begin turning away patients presenting prescription orders with even a taint of suspicion. This chilling effect could result in any number of patients being denied access to necessary medication simply because pharmacists worry more about legal entanglement than appropriate patient care. In this context, strict liability would have a devastating effect on pharmacist-patient relationships.
Strict vs. Good Faith Liability How would these different legal standards affect Alex and the Demerol prescription? In a "strict liability" world, Alex would be liable for dispensing the medication from an invalid order. His knowledge and conduct in trying to verify the order would not be relevant. The analysis is much different, however, if a "good faith" standard is applied. It would be important to determine what Alex knew and what that should have meant to him when the prescription order for Demerol was presented. When Alex received the Demerol 34
prescription, he had advance notice that there might be something wrong with it through the hot line alert that a poorly dressed man was attempting to pass a very worn-looking prescription for Demerol. The well-meaning pharmacist even suggested how to handle the situation: "Just say you are out of the drug," and advised that processing this prescription order was 'just asking for trouble." But Alex felt a moral, if not pro-
If pharmacists are held strictly liable, in all likelihood pharmacists will begin turning away patients presenting prescriptions with even a taint of suspicion. fessional, responsibility to the patient. He did keep the medication in stock for his regular patients who have need for this type of drug therapy. Telling the customer that he was out of the drug would have been a lie. In this situation, while Alex recognized that lying would be the easy way out, deception was an unacceptable alternative. Alex believed that his primary duty was to the patient, not to law enforcement personnel. Therefore, if the prescription order was legitimate, he believed that he should dispense it; otherwise a needy patient might suffer.
Verifying Legitimacy Nonetheless, Alex knew he had a legal duty to verify the legitimacy of the prescription. In this context, Alex operated under the belief that his legal duty was satisfied by making a good faith inquiry of the prescribing physician as to whether the medication was prescribed for a legitimate medical purpose. While the suspicions of the hot line pharmacist were relevant, Alex knew he had to make his own decision whether to dispense the medication, based on what he could rea-
sonably determine about the prescriber, the patient, and the prescription order. That the prescription form was worn or a bit frayed on the edges as if many people had handled it was also relevant. Alex knew that many pharmacists do not believe, as he did, that prescription orders for controlled substances should be dispensed unless there is good reason to refuse to do so. In Alex's mind, this explained why so many other people may have handled the prescription form before it was presented to him. On visual examination the prescription order looked authentic. It contained all the information required by law and appeared to have an original signature by a physician. The fact that Alex had never heard of the physician was not surprising because the order came from the downtown teaching hospital where transient physicians are commonplace. Attempting to fulfill his legal obligations, Alex called the prescriber for verification. Using a skill he had learned from education, training, and experience, he looked up the physician's phone number in the telephone book rather than using the phone number on the prescription form. After all, Alex knew it was easy enough to have prescription blanks printed up with a bogus phone number where a "fake doctor" will verify prescriptions. Unfortunately, Alex was put in contact with a resident physician because the prescriber was nowhere to be found. The resident, however, did know the patient, the prescriber, and the circumstances surrounding the issuing of the Demerol prescription order. Alex was assured by the resident that the order was valid. Alex thought that discussing the prescription with the resident was not much different from obtaining verification from a private physician's nurse or receptionist acting as the delegated agent of the physician. Besides, the explanation provided by the resident, that patients have trouble getting controlled substance prescription orders processed in the inner city, was logical.
American Pharmacy, Vol. NS31, No.9 September 19911642
DEA Concerns With this information and knowledge, Alex decided to dispense the medication. But, according to the DEA agents, the order was an invalid copy. The DEA agents explained some other circumstances they believed were relevant and would lead any reasonable pharmacist to refuse the Demerol prescription. The individual who obtained the medication was not the patient, and when it had been presented, 30 other pharmacies had refused to dispense the prescription. Alex knows that a prescription may be dispensed to or for the ultimate user (the patient);12 the law does not require the pharmacist to physically hand a controlled substance to the patient and no one else. Alex could have determined that the person handing him the order was not the patient, but Alex decided, in hindsight, had he known this, he would still have dispensed the medication. It would have been reasonable to accept an explanation that the patient was too ill or in too much pain to come to the pharmacy for the medication. The fact that 30 other pharmacists refused to dispense the medication is a concern. Still, six other pharmacists either thought the prescription order was legitimate or just did not care and processed it anyway. In any event, Alex believed it was his own conduct and knowledge that would ultimately determine his guilt or innocence. The 30 other pharmacies may have turned away the prescription order for any number of reasons. For example, they may have legitimately been out of stock or not have carried Demerol. Alex clearly did not close his eyes to what he knew or should have known was an invalid prescription. It can be argued that he acted with all reasonable care in seeking to determine its validi ty. U sing the "good faith," as opposed to a "strict liability" standard, Alex should be exonerated from his error.
If strict liability is imposed, there would be no question that Alex could face criminal and/or administrative liability despite his best efforts. That type of policy, however, would likely have led ,Alex not to dispense the medication in the first place out of concern for legal entanglement. Such a policy is undesirable where, as here, there are no reasonable means available to the pharmacist to distinguish between valid and invalid controlled substance prescription orders.
Conclusion For now, the Green case represents a minority of one court. It is nevertheless likely that the government will seek expanded application of Green's court decision to other areas of pharmacy practice as a means of fighting drug abuse and diversion. Pharmacists should pay particular attention to the developments in this area of the law; its impact on how pharmacy is practiced could be dramatic.
Jesse C. Vivian, JD, is associate professor, College of Pharmacy and Allie~ Health Professions, Wayne State Unlversity, Detroit. David B. Brushwood, JD, is professor, College of Pharmacy, University ofFlorida, Gainesville.
References 1. 21 CFR § 1306.04(a). 2. 21 USC § 801-97l. 3.Id. 4. United States v. Lawson, 682 F2d 480 (4th Cir 1982). 5.Id. 481 n.2. 6. Pharmacists Manual: An Informational Outline of the Controlled Substances Act of 1970, US Dept of Justice (rev. April 1986) at 32. 7. United States v. Kershman, 555 F2d 198,201 (8th Cir 1977). 8. People v. Lonergan, 267 Cal Rpt 887 (1990). 9. Vermont 1l0th Medical Arts Pharmacy v. State Board of Pharmacy, 125 CA 3d 19; 117 Cal R 807, 810 (1981) cited in Nielsen, Jones R., Handbook of Federal Drug Law, Lea & Febiger (1986) at 86. 10.905 F2d 694 (3d Cir 1990), cert. denied, U.S., 111 S.Ct. 518, 112 L.Ed. 2d 530 (1991). 11. 21 USC § 842(c). 12. 21 CFR § 1306.02(f).
Another in the TARO "Signature Series" ... reaffirming our commitment to providing high quality bio-equivalent generics at competitive prices.
Research lTlakes us what we are. TARO ... a recognized leader in developing and marketing important new generics. Established by pharmacists in 1950, TARO has grown rapidly - over the past 5 years more than doubling total corporate sales. Rx Products
At Taro's research and manufacturing facilities in Toronto, more than 45 quality generic Rx and OTC products are produced: Those shown here, which are marketed in the U.S., as well as many others, which are marketed in Canada and other parts of the world. Today, wherever TARO products are marketed, the label means confidence, and consumer savings. If you're presently a TARO customer, we thank you, and look forward to serving you for years to come. If not, we invite you to learn more about our growing list of generic and OTC products by contacting your wholesaler or calling us toll-free at 800-544-1449.
o
Desoximetasone Cream, USP 0.25% Emotli«lt In on
Cr.am bole
Also available in 0.05%
Betame1hasone Valerate Cream, USP 0.1% TriamCinolone Acetonide Dental Paste, USP 0.1 %
TARO .. .founded by pharmacists. We know pharmacy, and the needs of the pharmacist. And we'd like to know you better.
TARO Pharmaceuticals U.S.A., INC. Six Skyline Drive Hawthorne, NY 10532
American Pharmacy, Vol. NS31, No.9 September 19911643
800-544-1449
Fax: 914-345-8727
35