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PAIN MEDICINE Volume 4 Number 2 2003 ETHICS FORUM—Edited by Michel Dubois Pain and the Pharmacist © American Academy of Pain Medicine 1526-2375/03/$15.00/190 190–194 The Case In January 2003, a major press agency published the following report: A patient with a brain tumor and pain went to a drive-up window at a major drugstore two blocks from her home to have her regular opiate prescription filled. She had been on this medica- tion for several months. The pharmacist on duty thought that she had faked her “Percocet ® ” pre- scription. The pharmacist tried to reach the prescribing physician (a surgeon), who was not immediately available. The pharmacist then called the police, failing apparently to check the patient’s past records. The patient was soon hand- cuffed by a police officer. Although her family posted bail that night, and in spite of repeated claims that she had a serious health condition and was in pain, she remained without her medicine, and, as a condition for her release, was required to attend a session at a drug treatment facility. After her physician provided confirming infor- mation to the local prosecutor’s office, the felony prescription charge was dropped. “I’ve never even had a speeding ticket,” said the patient, “this could happen to anybody.” Opinion #1: David E. Joranson, MSSW Pain Relief and War on Drugs:A Delicate Balance This case is a classic clash between the war on drugs and efforts to relieve pain. Assuming that all the necessary facts of the case are evident in the description, my comments address the rules of conduct for controlled substances established in federal and state policies. I also want to make a few recommendations. In the midst of rhetoric about the dangers of controlled substances, some forget the first prin- ciple that opioid analgesics are safe and effective for human use under medical supervision. Although opioid analgesics are federally con- trolled substances because of their potential for abuse, it is clear that the Congress never intended the controlled substances act to interfere with their medical use [1]. To prevent diversion, the pharmacist has a legal duty not to knowingly dispense prescriptions for controlled substances for other than legitimate purposes. This is a reasonable expectation if it is implemented reasonably. But research suggests that some pharmacists (like some physicians) have incorrect knowledge and inappropriate attitudes about the use of opioid analgesics that can result in failure to dispense valid prescriptions for opioid analgesics to pain patients [2]. An overly cautious pharmacist may refuse to dispense invalid as well as valid prescriptions, thus creating a conflict between pharmacists’ health care and regulatory roles [3,4]. In this particular case, the pharmacist’s action, although intended to prevent diversion, actually compromised patient care. The response was out of balance, that is, the interest in drug control outweighed the interest in patient care. Recently, the Drug Enforcement Administration and 43 organizations representing health care, including pharmacy, endorsed a consensus statement titled Promoting Pain Relief and Preventing Abuse of Pain Medications: A Critical Balancing Act. The statement says in part: “Preventing drug abuse is an important societal goal, but there is consensus, by law enforcement agencies, health care practi- tioners, and patient advocates alike, that it should not hinder patients’ ability to receive the care they need and deserve” [5]. This case stands in stark contrast to this national consensus. Practitioners can also be affected by the policies established in their own state. For example, during the late 1980s, the state of Washington medical regulators issued policy statements that discour- aged the use of opioid analgesics for chronic pain. A decade later, the state recognized that opioid analgesics can be useful [submitted]. The evolu- tion of policy probably parallels the evolution of knowledge and attitudes of practitioners. For some, the evolution takes longer. The case should be seen as a call to pharmacy organizations to improve policy, education, and practice. Here are a few suggestions: • Pharmacy organizations should become acquainted with the principle of balance, and review how this principle has been used to eval- uate state pharmacy board regulations on con- trolled substances for pain [6].

Pain and the Pharmacist: Opinion #2

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Page 1: Pain and the Pharmacist: Opinion #2

PAIN MEDICINEVolume 4 • Number 2 • 2003

ETHICS FORUM—Edited by Michel Dubois

Pain and the Pharmacist

© American Academy of Pain Medicine 1526-2375/03/$15.00/190 190–194

The Case

In January 2003, a major press agency publishedthe following report:

A patient with a brain tumor and pain wentto a drive-up window at a major drugstore twoblocks from her home to have her regular opiateprescription filled. She had been on this medica-tion for several months. The pharmacist on dutythought that she had faked her “Percocet®” pre-scription. The pharmacist tried to reach the prescribing physician (a surgeon), who was notimmediately available. The pharmacist thencalled the police, failing apparently to check thepatient’s past records. The patient was soon hand-cuffed by a police officer. Although her familyposted bail that night, and in spite of repeatedclaims that she had a serious health condition andwas in pain, she remained without her medicine,and, as a condition for her release, was requiredto attend a session at a drug treatment facility.After her physician provided confirming infor-mation to the local prosecutor’s office, the felonyprescription charge was dropped. “I’ve never evenhad a speeding ticket,” said the patient, “thiscould happen to anybody.”

Opinion #1: David E. Joranson, MSSW

Pain Relief and War on Drugs: A Delicate BalanceThis case is a classic clash between the war ondrugs and efforts to relieve pain. Assuming that allthe necessary facts of the case are evident in thedescription, my comments address the rules ofconduct for controlled substances established infederal and state policies. I also want to make a fewrecommendations.

In the midst of rhetoric about the dangers ofcontrolled substances, some forget the first prin-ciple that opioid analgesics are safe and effectivefor human use under medical supervision.Although opioid analgesics are federally con-trolled substances because of their potential forabuse, it is clear that the Congress never intendedthe controlled substances act to interfere withtheir medical use [1].

To prevent diversion, the pharmacist has a legalduty not to knowingly dispense prescriptions for

controlled substances for other than legitimatepurposes. This is a reasonable expectation if it is implemented reasonably. But research suggeststhat some pharmacists (like some physicians) haveincorrect knowledge and inappropriate attitudesabout the use of opioid analgesics that can resultin failure to dispense valid prescriptions for opioidanalgesics to pain patients [2]. An overly cautiouspharmacist may refuse to dispense invalid as wellas valid prescriptions, thus creating a conflictbetween pharmacists’ health care and regulatoryroles [3,4].

In this particular case, the pharmacist’s action,although intended to prevent diversion, actuallycompromised patient care. The response was outof balance, that is, the interest in drug control outweighed the interest in patient care. Recently,the Drug Enforcement Administration and 43organizations representing health care, includingpharmacy, endorsed a consensus statement titledPromoting Pain Relief and Preventing Abuse ofPain Medications: A Critical Balancing Act. Thestatement says in part: “Preventing drug abuse isan important societal goal, but there is consensus,by law enforcement agencies, health care practi-tioners, and patient advocates alike, that it shouldnot hinder patients’ ability to receive the care theyneed and deserve” [5]. This case stands in starkcontrast to this national consensus.

Practitioners can also be affected by the policiesestablished in their own state. For example, duringthe late 1980s, the state of Washington medicalregulators issued policy statements that discour-aged the use of opioid analgesics for chronic pain.A decade later, the state recognized that opioidanalgesics can be useful [submitted]. The evolu-tion of policy probably parallels the evolution of knowledge and attitudes of practitioners. Forsome, the evolution takes longer.

The case should be seen as a call to pharmacyorganizations to improve policy, education, andpractice. Here are a few suggestions:

• Pharmacy organizations should becomeacquainted with the principle of balance, andreview how this principle has been used to eval-uate state pharmacy board regulations on con-trolled substances for pain [6].

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Ethics Forum 191

• Pharmacy organizations should encourage statepharmacy boards to develop positive policiesabout pain management and end-of-life care.The National Association of Boards of Pharmacy has endorsed the Federation of State Medical Board’s Guidelines for the Use of Controlled Substances in the Treatment ofPain. State pharmacy boards could also adopt orendorse the Guidelines. Several pharmacyboards have led the way with statements aboutpain management and end-of-life care, includ-ing in California, Iowa, Kansas, Montana,North Carolina, Texas, and West Virginia [7].

• State pharmacy associations could sponsor edu-cational programs about pain management tohelp pharmacists manage their dual responsibil-ities at a time when they are being tested byintense media coverage about abuse of painmedications.

• Schools of pharmacy could review jurispru-dence curricula to be sure that their students arelearning not only what they cannot do under thelaw, but what they can and should do under exist-ing law.

By balancing policy, enhancing education andimproving practice we can strengthen the role ofthe pharmacist as the last critical link in the chainof distribution of pain medications to the patient.

References

1 Joranson DE, Gilson A. Controlled substances,medical practice, and the law. In: Schwartz HI, editor.Psychiatric practice under fire: The influence of gov-ernment, the media, and special interests on somatictherapies. First edition. Washington DC: AmericanPsychiatric Press, Inc.; 1994 p. 173–94. Available at: http://www.medsch.wisc.edu/painpolicy/publicat/94appcs.htm.

2 Joranson DE, Gilson AM. Pharmacists’ knowledge of and attitudes toward opioid pain medications in relation to federal and state policies. J Am PharmAssoc (Wash) 2001;41:213–20. Available at:http://www.medsch.wisc.edu/painpolicy/publicat/01japhak/index.htm.

3 Brushwood DB, Carlson JJ. The pharmacist’s respon-sibility to evaluate suspicious prescriptions. FoodDrug Cosmetic Law J 1991;46:467–85.

4 Brushwood DB. From confrontation to collabora-tion: Collegial accountability and the expanding roleof pharmacists in the management of chronic pain. J Law Med Ethics 2001;29:69–93.

5 Drug Enforcement Administration, Last Acts, Pain& Policy Studies Group, et al. Promoting pain reliefand preventing abuse of pain medications: A criticalbalancing act. Washington, DC: Last Acts; 2001.

Available at: http://www.medsch.wisc.edu/painpolicy/dea01.htm.

6 Joranson DE, Gilson AM, Ryan KM, et al. Achiev-ing balance in federal and state pain policy: A guide to evaluation. Madison, WI: Pain & PolicyStudies Group, University of Wisconsin Com-prehensive Cancer Center; 2000. Available at:http://www.medsch.wisc.edu/painpolicy/eguide2000/index.html.

7 Pain & Policy Studies Group. Matrix of state painpolicies: Full-text database; 2003. Available at:http://www.medsch.wisc.edu/painpolicy/matrix.htm.

David E. Joranson, MSSWUniversity of Wisconsin

Madison, Wisconsin

Opinion #2: Debra Elliott, MD

A Far Too Familiar Set-upSensational as this story seems, practitioners inpain management witness similar, if not quite aspunitive, occurrences in their day-to-day prac-tices. Therefore, this pharmacist’s actions,whether accurately portrayed or not, should bescrutinized.

There are many details omitted from this story,which, if they had been present, might haveexplained such outrageous behavior. We willassume for the sake of discussion that the pre-scription did not have any suspicious marks andthat the patient did not display disruptive behav-ior or have multiple physician sources for variousanalgesics. We will also assume that the pharma-cist was neither paranoid nor otherwise dysfunc-tional nor had an extraneous counteractiverelationship with the patient.

There are four major entities involved in anethical discussion of this case: The pharmacist, thepatient, the physician who wrote the prescription,and society as a whole. The law enforcement offi-cers are also involved, but I consider only howtheir involvement in this case affects society. (Howthe patient was affected by them is obvious.) Ipicture the scenario as involving the pharmacist,doctor, and patient in a triangle, with direct accessto and communication with each other. This tri-angle is within the larger sphere of society, whichalso contains the law. Each of the points in the tri-angle has an opportunity to act on behalf of thepatient and society. (It is accepted that the physi-cian and pharmacist also benefit in the form offees, which both the patient and society bear.) Theethics of the professions of medicine and phar-macy are explored not only in terms of individual

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actions, but also in terms of the respective oathsthat these professionals work under.

The pharmacist’s initial action, that of callingthe patient’s physician to clarify a question aboutthe prescription, is generally considered reason-able and a good use of the checks and balances of the triangle. Unfortunately, the doctor wasunavailable at the time, and so was removed fromthe triangle. At that point, the patient and phar-macist were in an unopposed direct relationship.The pharmacist then had an obligation to thepatient and to society. In the case presented, hemay have seen himself as protecting both thepatient and others by preventing diversion of apotentially addictive substance.

Let us look at the point of protecting the pos-sibly addicted patient from herself. The pharma-cist has power and responsibility as the dispenserof potentially dangerous substances. In this he maybe likened to a bartender, who can rather infor-mally make unilateral decisions as to whether ornot “another round” is in the customer’s and/orsociety’s best interest. But a pharmacist is not abartender. He does not sell a potentially danger-ous commodity that is used, more or less, forpleasure and nothing more. Likewise, in the phar-macy, the patient is not a tavern customer who candemand substances for her immediate ingestiondespite poor judgment. Also, the tavern-goer israrely harmed by the refusal of dispensing alcohol.But the pharmacist dispenses such substances forthe treatment of specific illnesses and symptoms,the omission of which may cause harm to thepatient. Because the consequences to the patientare greater, a second professional, the physician, isinvolved. Since the diagnosis of the illnesses andsymptoms rests on the physician, the pharmacistshould only act on his own volition in refusingmedication to protect the patient in cases ofextreme circumstances.

In the case presented here, the independentactions of the pharmacist not only potentiallycaused harm to the patient, but also to society. Incalling the police, the pharmacist not onlyremoved one or more individuals to protectsociety from criminals, but also incurred forsociety the cost of activating the legal system andthe abundant costs of the police station, court-house and lawyers, and other legal fees, whichcould be considered harmful to society as a whole.

For the purpose of this exercise, let us say hypo-thetically that instead of calling the police, thepharmacist simply refused to fill the prescriptionuntil it could be verified, acknowledging the

importance of the doctor’s role in the triangle.This is much more believable and occurs abouttwice per year in my office. From the patient’sstandpoint in this scenario, what are the ethicalimplications of delaying treatment for such a pre-caution? If the patient had enough analgesic pillsleft over to treat her pain for the time in question,there was no real difficulty. If not, she was madeto suffer pain, an extremely unpleasant and nega-tively emotional experience, for the amount oftime in question. By withholding treatment, thepharmacist thus would have been causing harm tothe patient.

Now we consider the role the pharmacist has inprotecting society from the patient, in this case,against diversion of an addicting drug. This isclearly a serious concern, which all in medicineand pharmacy continue to work against. Ethicallyspeaking, each individual professional must decidewhich counts for more: Potentially alleviating thesuffering of an individual versus potentially prop-agating the ills of society. In understanding howthe pharmacist and the physician might come to a decision as to where they stand on this issue,perhaps a look at their respective professionaloaths will be helpful.

The Hippocratic Oath, as commonly translatedfrom the Greek [1], states that the physician willstand by his teachers and treat them as family; willuse diets and medicines only for the benefit of thesick and will keep them from harm and injustice;will abstain from giving a drug for the purpose ofcausing death or abortion; will not engage in anyrelationship with a patient except as a treatingphysician; and will keep the patient’s confidencessecret. It directs attention to how the physiciantreats the individual. There is no mention of pro-tection of society as a whole. A modern version ofthe oath (commonly used by current generationsof medical graduates) adds toward the end: “I willremember that I remain a member of society, withspecial obligations to all my fellow human beings,those sound of mind and body as well as theinfirm” (Lasagna L. Tufts University; 1964). Evenwith that nod toward societal involvement,according to these oaths, physicians subscribe tothe individual first and foremost, and believe that,in doing their best for each individual, society as awhole will ultimately benefit.

The Oath of the Pharmacist [2] states: “At thistime, I vow to devote my professional life to theservice of all humankind through the profession ofpharmacy. I will consider the welfare of humanityand relief of human suffering my primary con-

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cerns. I will apply my knowledge, experience, andskills to the best of my ability to assure optimaldrug therapy outcomes for the patients I serve. Iwill keep abreast of developments and maintainprofessional competency in my profession of pharmacy. I will maintain the highest principles of moral, ethical, and legal conduct. I will embraceand advocate change in the profession of phar-macy that improves patient care. I take these vowsvoluntarily with the full realization of the respon-sibility with which I am entrusted by the public.”

It is clear that, through this oath, the pharma-cist’s first and foremost role is to serve humankind,and he considers the welfare of humanity beforethe relief of individual human suffering. There-fore, the more societal Oath of the Pharmacistmay balance the individualistic Hippocratic Oath.In general, this balance serves to keep the behav-ior of each professional within ethical bounds,which protects both the patient and society as awhole. In the case of the pharmacist discussedhere, the balance was tipped, and the pharmacistacted unethically resulting in harm to the patientand to society.

References

1 Edelstein L. The Hippocratic Oath: Text, translation,and interpretation. Baltimore: Johns Hopkins Press;1943.

2 American Pharmaceutical Association Academy ofStudents of Pharmacy/American Association of Colleges of Pharmacy Council of Deans Task Forceon Professionalism; June 1994.

Debra Elliott, MDTulane University Medical Center

New Orleans, Louisiana

Opinion #3: Arthur G. Lipman, PharmD

Communication Is KeyThis case is a tragic example of a lack of commu-nication among the health professionals fromwhom this unfortunate patient sought help. It iseasy to blame the pharmacist for his actions, thepolice officer for his aggressive response to thecall, or even the physician, if the prescription wasin any way unusual, causing the pharmacist toquestion its validity. But the problems that thiscase illustrates are due more to the system than toindividuals. It would be more useful to addresshow the system could/should be improved than totry to assign blame for any individual’s actions.

Pharmacists are legally required to report sus-

pected cases of prescription tampering to appro-priate authorities. Concurrently, they have a pro-fessional and ethical responsibility to act in thebest interests of their patients.

Physicians have an implicit responsibility tocommunicate effectively with all other health careprofessionals who participate in the care of theirpatients. In most cases, communication between aphysician and pharmacist takes place through theprocess of writing and filling prescription ordersfor drugs. Whenever those orders differ from thenorm, the prescriber should explicitly ask thepatient where the prescription will be filled andcommunicate directly with the pharmacist toassure that the prescriber’s intent is understood.Not infrequently, physicians write nontraditionalorders and do not consider the fact that the phar-macist should question those orders if the ration-ale and justification for them is not clear.

Patients also have a responsibility to assist in assuring clear communications about theirprescriptions, especially controlled-substance pre-scriptions. Any patient requiring multiple medica-tions for medical conditions, especially controlledsubstances, should be counseled both by the pre-scriber and pharmacist to use a single pharmacythat maintains patient profiles. Most states requirethat pharmacists maintain some level of recordsabout patients. Professional society-promulgatedstandards of practice require that pharmacistsmaintain a higher level of patient-specific recordsthan most state laws. Good pharmacy practicesmaintain patient profiles that document the indi-vidual and/or family prescription history, majorillnesses and other indications for drug use, aller-gies, adverse reactions, and other relevant infor-mation, such as patient-specific counseling needs.

The brief case submitted for comment leavesmany important questions unanswered. Seldomare cases as straightforward as this one appears tobe. Questions that one must ask about this casebefore reaching any conclusions or assigningblame include the following.

1. Was this patient known to the pharmacists atthis pharmacy that was just two blocks from herhome? If so, the actions that are describedwould be improbable.

2. If the patient had received her opioid at thispharmacy previously, did the pharmacistconsult her patient profile before questioningthe prescription? If not, the pharmacist wasacting outside of the standard of practice andpossibly unlawfully.

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3. Was there anything unusual about the way in which the prescription was written, forexample, format, handwriting, dose? If so, thepharmacist may have been justified in ques-tioning the prescription.

4. Did any actions by the patient raise concerns atthe pharmacy?

Education about opioid analgesia is well docu-mented to be poor in medical, pharmacy, andnursing schools. Opiophobia is a defined term, andmany health professionals are opiophobic. Thesystem within which most of us practice is far moreforgiving for a practitioner denying opioids thanproviding them liberally.

The best interests of the patient should be para-mount in most difficult decisions faced by healthprofessionals. It would be reasonable to ask whythe pharmacist did not provide a 1-day supply ofthe medication to the patient until the prescrip-tion could be verified. That is a common practice.

One also must ask why the police officerresponded in the manner described. Were thereextenuating circumstances that raised concernabout the legitimacy of the prescription?

Important questions for the pain managementcommunity arise from this case. Do we ignoreinappropriate opioid prescribing by colleagues inour communities because we “don’t want to getinvolved.” We all know that to be common. Evena small amount of inappropriate opioid prescrib-ing raises the index of suspicion about all opioidorders.

Communication is the best way to minimize therisk of such terrible circumstances being repeated.Patients should develop relationships with phar-macists in whom they have trust, just as most dowith their physicians. Education of health profes-sionals both in undergraduate curricula and incontinuing education programs on appropriateopioid use has increased, but is still badly needed.All prescriptions, especially those for controlledsubstances, should be clear and legible and shouldinclude full patient identifying information plusthe indication for the medication.

Arthur G. Lipman, PharmDUniversity of Utah Health Sciences Center

Salt Lake City, Utah