rems and corresponding responsibility of the pharmacist 036-368-13-002-h03

7/27/2019 REMS and Corresponding Responsibility of the Pharmacist 036-368-13-002-H03

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REMS and Corresponding Responsibility of the Pharmacist

Objectives

By completing the lesson, the pharmacist will be able to:1. Identify the legal standard for dispensing medications pursuant to a valid

prescription.2. Discuss the legitimate medical purpose standard.3. Discuss the treatment of pain with controlled substances.4. Discuss the use of ICD codes in the evaluation of prescriptions.5. Discuss use of Risk Evaluation and Mitigation Strategy (REMS).6. List factors the pharmacist should consider in considering whether to dispense

medication for a legitimate medical purpose, particularly for pain.7. Discuss selected legal literature directed to the legitimate medical purpose

standard.

Introduction

Depending on the practice setting, a pharmacist may dispense hundreds of prescriptionsper month, or week, or even per day. For each of those prescriptions, the pharmacist hasa duty to ensure the prescription is valid. To be valid, the prescription must be issued fora legitimate medical purpose by an individual prescriber acting in the usual course ofhis/her professional practice typically a physician, physician assistant, nursepractitioner, veterinarian, or dentist. The FDA recently implemented a program with theintent of increasing patient safety. The so-called REMS program provides a number oftools that can assist both pharmacists and physicians working together to meet their jointresponsibilities to patients.

While the responsibility for the proper prescribing is upon the prescriber, a correspondingresponsibility rests with the pharmacist who dispenses the prescription. In other words,the pharmacist cannot fulfill all legal duties by merely accurately selecting the properpharmaceutical product and accurately labeling that product for use by the patient andcounseling the patient. This lesson will describe parameters to determine when andwhether the pharmacist is discharging the corresponding responsibility to determinewhether any given prescription is valid or invalid. A framework for mitigating strategiesfor riskier prescription drugs will be presented.

Legitimate Medical PurposeOhio Administrative Code Rule 4729-5-21 and Rule 4729-5-30

(A) A prescription, to be valid, must be issued for a legitimate medical purposeby anindividual prescriber acting in the usual course of his/her professional practice.The responsibility for the proper prescribing is upon the prescriber, but acorresponding responsibility rests with the pharmacist who dispenses the

prescription. An order purporting to be a prescription issued not in the usualcourse of bona fide treatment of a patient is not a prescription and the personknowingly dispensing such a purported prescription, as well as the person issuingit, shall be subject to the penalties of law.


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One thing to notice about the text of this rule is that there are no numerical safeharbors. In other words, the pharmacist is not always safe so long as no more thanone hundred units (or any other number) of a given medication is dispensed. Anotherthing to notice is that the statute is not limited to controlled substances or productscontaining hydrocodone (e.g. Vicodin, Lortab, Norco) or oxycodone (e.g. Percocet,

Oxycontin). Because of the addictive nature of these medications, they are perhaps moreprone to be abused, and thus not prescribed or dispensed for a legitimate medicalpurpose. It is also possible that an anabolic steroid (e.g. Testim, testosterone) or anyother type of prescription drug is not being prescribed and dispensed for a legitimatemedical purpose.

Not properly assessing the situation in dispensing prescription drugs can subject thepharmacists to penalties of law. These penalties include criminal prosecution (e.g.fines, incarceration, and probation), civil proceedings, and administrative measures bythe Ohio Board of Pharmacy (e.g. fines, suspension, and practice restriction). Criminalliability requires proof that the accused engaged in a voluntary act or omission

prohibited by law with the requisite degree of culpability for each element of theoffense the law specifies. R.C. 2901.21(A). In other words, there needs to be a guiltystate of mind.

To be subject to legal penalties, the pharmacist must act knowing in most cases. Theterm knowingly with regard to information means that a person has actual knowledgeof the information, or acts in deliberate or reckless disregard of the truth or falsity of theinformation. Thus, there are two ways for a pharmacist to knowingly fill a prescriptionfor an illegitimate purpose. The pharmacist may actually know a prescription isillegitimate (such as when a pharmacist writes a fake prescription then fills it). Thepharmacist may also recklessly disregard whether the prescription is for a legitimatemedical purpose. This lesson is primarily directed to the reckless disregard types ofdispensing instances and how to avoid them. This lesson is primarily directed to thedispensing of controlled substances used to treat pain.

Treatment of PainAs health care professionals, pharmacists have been taught to, and rightfully want to,provide needed controlled substances for their patients. Pain is described by theInternational Association for the Study of Pain (IASP) as an unpleasant sensory andemotional experience associated with actual or potential tissue damage, or described interms of such damage. Describing all the types and causes of pain is, of course, beyondthe scope of this lesson.

Untreated pain and under-treated pain are real and serious problems. The AmericanAcademy of Pain Medicine estimates that 50 million people suffer from chronic paineach year, and an additional 25 million suffer from acute pain arising from injuries orsurgery. Pain is often under-treated. Although effective treatments are available, painmanagement is adequate only 25% of the time.


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Poor pain management can produce a number of negative effects, such as impairedimmune responses and impaired movement with increased risk of thromboembolism, andcan actually contribute to the development of a chronic pain state. Unrelieved sufferingcan produce anxiety, depression, hostility, and sleep deprivation. A recent pain survey of1,500 adults in Michigan found that approximately twenty percent of adults suffer from

chronic pain and that seventy percent of patients had continued pain even with treatment,with nearly half feeling depressed about their pain. While additional statistics can bequoted, most pharmacists having day-to-day encounters with patients face real-lifeexamples of pain which are difficult to treat.

Pharmacists and patients face a number of challenges with medical conditions andprescribers. Patients may feel frustrated because there is no cure for the underlyingcause of the pain. Musculoskeletal damage and other ailments may not have a once-and-for-all complete fix even with skillful surgery. While cancer patients often have adiagnosis that is associated with legitimate pain, patients with lower back pain andother long term neuralgias that dont have such a clear cut diagnosis can prove very

frustrating to diagnose and treat. To compound the problem, there are dishonest peoplewho attempt to exaggerate injury and pain in order to obtain pain medications that can beresold illegally.

Patients themselves can also be a source of problems. They may feel reluctant to discusspain with their pharmacist and medical providers. They may feel concerned about beinglabeled as a drug abuser and may be fearful of becoming addicted when taking prescribednarcotics. Patients may also forget, minimize or exaggerate symptoms, whetherunintentionally or otherwise.

Fortunately, some treatment standards are available to guide the pharmacist. While adetailed discussion of the state of the art in treating pain is beyond the scope of thislesson, the reader may want to review standards articulated at:

Joint American Academy of Pain Medicine/American Pain Society consensusstatement on the use of opioids for the treatment of chronic pain (the AAPM/APSguidelines);

Model Guidelines for the Use of Controlled Substances for the Treatment of Pain(the Model Guidelines), which was developed by the Federation of StateMedical Boards of the United States and can be viewed athttp://www.medsch.wisc.edu/painpolicy/domestic/model.htm;

http://www.painmed.org (American Academy of Pain Medicine); and http://www.ampainsoc.org (The American Pain Society).

A number of possible risk factors for prescriptions for a non-legitimate medicalpurpose include:

Younger patients Large cash payments Scripts written for large quantities Doctors located far away Scripts presented to pharmacy late at night or weekends Missing information on script e.g. DEA number


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Patient appears to be nervous or in a hurry Early refills without a change in directions or other good reason Patient has scripts for multiple medications but only wants the controlled

substances

Something just dont look right J.D.L.R. Scripts from emergency room for a large supply. For example, a ninety day supplyof medication would typically not come from an emergency room.

No matter whom you work for or whom you work with, you do NOT have to fill everyprescription that comes across the counter. While it is true that nobody wants to turnaway business or disappoint a patient (or an employer), the pharmacist must useindependent professional judgment.

Risk Evaluation and Mitigation Strategies (REMS)

Pharmacists have a new aid in determining the appropriate use of a wide variety ofmedications, including long acting opioids such as Oxycontin. The Federal Food, Drug,

and Cosmetic Act (FDCA), as amended by the Food and Drug AdministrationAmendments Act of 2007 and the Food and Drug Administration Safety and InnovationAct of 2012, authorizes FDA to require REMS for certain drugs to assure that theirbenefits outweigh their risks. REMS are structured plans to manage specific risks ofdrugs that are effective but associated with known or potential risks (e.g., death, injury)that, without REMS, may outweigh benefits. When FDA requires a REMS, the drugmanufacturer (i.e., sponsor) must develop, implement, and assess it. FDA reviews andapproves each REMS.

FDA may deem a drug misbranded or impose civil monetary penalties on sponsors thatviolate approved REMS. Sponsors that violate REMS requirements may be subject to

civil monetary penalties of up to $250,000 per violation, up to $1 million in a singleproceeding. Civil monetary penalties may increase to $10 million for continuedviolations. Additionally, a sponsor may not introduce or deliver for introduction intointerstate commerce an approved drug if a REMS is required for the drug and thesponsor fails to maintain compliance with the requirements of the approved REMS.

The opiates REMS can be viewed online.http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.As part of the REMS, all ER/LA opioid analgesic companies must provide: Education for prescribers of these medications, which will be provided throughaccredited continuing education (CE) activities supported by independent educational

grants from ER/LA opioid analgesic companies. Information that prescribers can use when counseling patients about the risks andbenefits of ER/LA opioid analgesic use.

Pharmacists are encouraged to review these materials. The Medication Guides for ER/LAopioids are part of the ER/LA Opioid Analgesic REMS program and will be available

through the ER/LA Opioid Analgesic REMS website www.ER-LA-opioidREMS.com.Training must also be made available to healthcare providers who prescribe ER/LA opioid

analgesics.


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A Medication Guide must be dispensed with each ER/LA opioid analgesic prescriptionin accordance with 21 CFR 208.24. (e) Each authorized dispenser of a prescriptiondrug product for which a Medication Guide is required under this part shall, when theproduct is dispensed to a patient (or to a patient's agent), provide a Medication Guide

directly to each patient (or to the patient's agent) unless an exemption applies under 21CFR 208.26. See 21 CFR 208.24 (e). Under 21 CFR 208.26 (b), if a licensedpractitioner who prescribes a drug product with a REMS determines that it is not in a particular

patient's best interest to receive a Medication Guide, because of significant concerns about the

effect of a Medication Guide, the licensed practitioner may direct that the Medication Guide not

be provided to the particular patient.

However, the authorized dispenser of a prescription drug product subject to this part shall

provide a Medication Guide to any patient who requests information when the drug product is

dispensed regardless of any such direction by the licensed practitioner. In other words, a

physician may request that a medication guide not be provided to a particular patient, but the

pharmacist must provide the medication guide if asked for it by a patient.

ICD Codes

Another tool that can be helpful in reviewing prescriptions is the ICD Code. The ICDstands for International Classification of Diseases. The codes are used to maintain andreport morbidity and mortality statistics, reimbursement systems, and providedautomated decision support in a standard format. Physicians and other prescribers,clinics and hospitals use these codes very commonly.

U.S. health care organizations are working to transition from ICD-9 to ICD-10 codesets to accommodate codes for new diseases and procedures. The switch from ICD-9to ICD-10 code sets means that health care providers and insurers will have to changeout about 14,000 codes for about 69,000 codes. In August 2012, HHS released a finalrule that officially delayed the ICD-10 compliance date from Oct. 1, 2013, to Oct. 1,2014, partially to look at the incremental changes needed in reforming health care.

Currently, prescriptions may or may not include this code. As we move more toelectronic medical records, you will almost certainly see more ICD codes. Pertainingto controlled substances for pain, one ICD code that you may see is Diagnosis Code338.21 (chronic pain due to trauma.) Another example is Diagnosis Code 719.46 (Painin joint, lower leg). The full set of ICD codes can be found at numerous websites. Youwill find several by using the search term ICD codes in your favorite search engine.

The pharmacist may obtain these codes from the prescriber, or more likely, supportstaff. The codes in any given patients medical record for active problems shouldgenerally match the treatment and medications the patient is receiving. There iscurrently no specific requirement that prescriptions and pharmacy records include thesediagnosis codes. If the pharmacist is being diligent in establishing whether anyprescription is legitimate, the ICD code is one tool that can be used.


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Staff at the physicians office should be willing and able to share this information withthe pharmacist in implementing a treatment plan for each patient. Until a fuller versionof the electronic medical record is available in pharmacies, the pharmacist mightrequest the prescriber to include the ICD code on each prescription. This would savetime in calling the prescriber frequently. You should use your professional judgment

in deciding how and when to use the ICD codes.

Why the Law is Vague

The law is somewhat vague because of the difficulty in writing a law that is both veryclear, and covers all possible situations of prescribing and dispensing medications.Actually, proponents of the law would say that the law is not vague it is just a flexiblelegal standard. Pharmacists reasonably want guidance as to when they may be crossingthe line. Most of us want to do the right thing. It is difficult to innumerate each andevery instance where a prescription is or is not being provided for a legitimate medicalpurpose. A prescription for two hundred tablets of Oxycontin may be completelyappropriate for a given patient. A prescription for sixty tablets of Vicodin may be

entirely inappropriate in a different situation. The law employs a flexible standard to tryto cover both such situations.

The pharmacist's responsibility to verify a suspicious prescription should include aprofessional call to the prescriber. This is often easier said than done. Physicians arebusy, can be difficult to locate (particularly hospital residents), and often may not regardpharmacist verifications as high priority tasks. Drug diverters come in all shapes andsizes. A pharmacist can't necessarily tell from looks alone whether a person is alegitimate patient or a drug addict. Pharmacists may develop subjective feelings thatsomething about a patient just does not seem quite right. At the same time, a history ofclose interaction with a patient over several months can confirm that a prescription islegitimate despite initial concerns.

It is increasingly common for physicians to require patients to sign a Pain TreatmentAgreement as a condition of their receiving therapy for chronic pain, particularly whenprescribing opioid analgesic medications. Such agreements are often provided as take-it-or-leave-it agreements and are not generally negotiated contracts. Written agreementshave the potential to improve communication between physicians and patients, andenhance trust between physicians and patients, when they are used as tools to facilitatetreatment. The agreements may also lead to a climate of distrust and suspicion. Wheresuch agreements are involved, the pharmacist should be informed, though often thepharmacist is not informed. After all, the pharmacist is the one who is dispensing themedication. Many pharmacists would like to know when the prescriber would like to becontacted by the pharmacist and when the prescriber believes it is too early to refill aprescription.

Legal LiteratureThere are a number of sources of legal literature regarding this legal standard, such asfederal and state court decisions and the Drug Enforcement Administration (DEA).Many sources discuss the phrase legitimate medical purpose and focus primarily on


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physician prescribing. As already discussed, pharmacists also need to understand thisphrase and legal standard because of their corresponding legal duties.

On September 6, 2006, the DEA issued a Notice regarding Dispensing ControlledSubstances for the Treatment of Pain. The notice discussed a number of instances where

prescribers clearly issued prescriptions that were not for a legitimate medical purpose.The DEA noted that the following types of behaviors result in sanctions:

issuing prescriptions for controlled substances without a bona fidephysician-patient relationship;

issuing prescriptions in exchange for sex; issuing several prescriptions at once for a highly potent combination of controlled

substances;

charging fees commensurate with drug dealing rather than providing medicalservices;

issuing prescriptions using fraudulent names; and self-abuse of controlled substances by practitioners.

The pharmacist may rarely know if the prescriber is engaging in these acts. However, thepharmacist could also face sanctions for improperly dispensing controlled substances,rather than issuing prescriptions, for these same reasons.

The DEA notice also provided some sobering conclusions regarding the legitimatemedical purpose standard, including:1. Federal courts have long recognized that it is not possible to expand on the phraselegitimate medical purpose in the usual course of professional practice in a way thatwill provide definitive guidelines.2. There are no specific guidelines concerning what is required to support aconclusion that an accused acted outside the usual course of professional practice.Rather, the courts must engage in a case-by-case analysis of evidence to determinewhether a reasonable inference of guilt may be drawn from specific facts. See UnitedStates v. August, 984 F.2d 705, 713 (6th Cir. 1992).3. It is a longstanding legal principle that the government can investigate merely onsuspicion that the law is being violated, or even just because it wants assurance that it isnot. All law enforcement agencies - federal and state - have long been governed by thissame principle. See United States v. Morton Salt Co., 338 U.S. 632, 642-643 (1950).

There have been reports of an increase in prescription drug abuse. There are a variety offactors that may be contributing to the increase in prescription drug abuse. The Director

of The National Institute on Drug Abuse (NIDA) recently testified before Congress thatthe recent increase in the extent of prescription drug abuse is likely the result of acombination of factors, such as:

increases in the number of prescriptions; increases in drug availability; aggressive marketing by the pharmaceutical industry; the proliferation of illegal Internet pharmacies that dispense these medications

without proper prescriptions and surveillance; and

a greater social acceptability for medicating a growing number of conditions.


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The following recurring patterns have been identified as indicative of diversion andabuse by one court (See United States v. Rosen, 582 F.2d 1032 (5th Cir. 1978));

Inordinately large quantities of controlled substances were prescribed. Large numbers of prescriptions were issued. No physical examination was given. The physician warned the patient to fill prescriptions at different drug stores. The physician issued prescriptions knowing that the patient was delivering the

drugs to others.

The physician prescribed controlled drugs at intervals inconsistent with legitimatemedical treatment.

The physician involved used street slang rather than medical terminology for thedrugs prescribed.

There was no logical relationship between the drugs prescribed and treatment ofthe condition allegedly existing.

The physician wrote more than one prescription on occasions in order to spreadthem out.

Again, while these patterns are directed to prescribing, a similar list might be construedfor dispensing. In other words, substitute the word pharmacist in place of the wordphysician and substitute the word dispensed in place of the word prescribed.

Opinion of Counsel

One thing that practitioners can consider, to help reduce the prospects of criminalprosecution or civil liability, is to obtain an opinion from a lawyer. Remember thatcriminal acts require a criminal mind. A written opinion can be used to show apharmacist was not knowingly engaged in acts in deliberate or reckless disregard ofthe truth or falsity of the information available to the pharmacist. No lawyer can or

should guarantee a pharmacist that the pharmacist is completely immune fromprosecution if the pharmacist follows the lawyers advice. A letter from a lawyer is nota silver bullet or a license to break the law. It can show the pharmacist was legitimatelytrying to do the right thing.

Conclusion

This topic is admittedly less cut and dry than many others. The reason is that it issometimes difficult to determine when a patient is genuinely in pain and usingmedication for a legitimate medical purpose. Sometimes, its not so difficult.Relying on your professional instincts and training will go a long way in helpingyou decide when to dispense and when to not dispense.


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Questions choose the one most correct answer. A passing score is seventy percent.1. The pharmacist must determine the legitimate medical need for which of the

following before dispensing them to a patient.a. Cough preparations containing exempt narcoticsb. controlled substancesc.

antibioticsd. all of the above

2. A pharmacist may avoid all legal responsibility in dispensing controlledsubstances by claiming its hard to say no.a. trueb. false

3. A 19-year-old patient presents a written prescription from a physicians officelocated in Florida. The prescription is written by a pediatrician for two hundredtablets of methadone 10mg, to be taken every two hours. The patient offers topay cash when he drops off the prescription. In deciding whether to dispense themedication for a legitimate medical purpose, the pharmacist should consider

which of the following factors:a. the age of the patientb. offer to pay cashc. location of the physicians officed. amount of tabletse. all of the above

4. A patient may fill a prescription for a legitimate medical purpose for largeamounts of controlled substances knowing the prescribing physician neverperformed a physical examination for that patient.a. trueb. false

5. To be convicted of a crime pertaining to dispensing medication without alegitimate medical purpose, it must be shown that the pharmacist acted withwhich of the following state of mind:a. Negligentlyb. Knowinglyc. Recklesslyd. Intentionally

6. The pharmacist may want to consider ICD Codes in order to:a. guaranteed that a prescription is legitimateb. assist the physician in making a diagnosisc. properly bill for pharmacy productsd. make a decision whether dispensing is for a legitimate medical purpose

7. If a patient requests REMS materials for long acting opioids, the pharmacistshould;a. provide the materials to the patientb. provide the materials to the patient only if the prescriber says toc. refuse to provide the materials if the prescriber says tod. withhold the materials until speaking with the prescriber


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8. It is possible to explain the phrase legitimate medical purpose in a way that willprovide definitive guidelines about when to refuse to fill prescriptions in allcases.a. trueb. false

9. The recent increase in the extent of prescription drug abuse is likely the result of:a. increases in the number of prescriptionsb. increases in drug availabilityc. aggressive marketing by the pharmaceutical industryd. a greater social acceptability for medicating a growing number of conditionse. all of the above

10. Examples of activities which likely indicate diversion and abuse include:a. lack of logical relationship between the drugs prescribed and treatment of the

condition allegedly existingb. filling prescriptions at a large number of different pharmaciesc. prescribing controlled substances for childrend.

receiving treatment from a specialist, such as a rheumatologiste. a and b


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Lesson number 036-368-13-002-H03 Answer Sheet: Expires August 22, 2015Approved for one contact hour of Ohio Jurisprudence by the Ohio State Board ofPharmacy

REMS and Corresponding Responsibility of the Pharmacist

Answer Sheet circle the one correct best answer. Credit will be granted with sevencorrect answers.Question Answer Question Answe

1 A B C D 6 A B C D

2 True False 7 A B C D

3 A B C D E 8 True False

4 True False 9 A B C D E

5 A B C D 10 A B C D E

Please return by mail with check for $20 payable to James Lindon at:James Lindon, Ph.D.

35104 Saddle Creek, Cleveland (Avon), Ohio 44011-4907Phone 440-333-0011 Fax 419-710-4925You may also send payment via PayPal (account not needed) to [email protected]

You may also send credit card number, expiration and CVV to [email protected]

Please fax, e-mail, [specify one, please] my continuing education certificate to:Pharmacist Name ____________________________Street Address ____________________________City ______________ State _______ Zip _____________E-Mail ___________________________________ Phone _____________________Ohio Pharmacist License Number _____________________

NABP ID Number _____________________

Copyright 2013 James Lindon, Lindon & Lindon LLCAny views expressed are not necessarily those of the author or the law firm of Lindon &Lindon. Program Evaluation (please circle one response to each question):After completing this lesson I can achieve the lesson objectives: Yes NoThis program was an effective way for me to learn: Yes NoI liked the programs format: Yes NoThis program fostered my mental participation: Yes NoThis was a user-friendly way for me to learn: Yes NoI could sense some commercialism in this program: Yes NoIf yes, please describe: ______________________________________________

The faculty quality was: Great OK Needs to ImproveThe learning material quality was: Great OK Needs to ImproveHow long did it take to complete this program? _______________________What other topics would you like to see? ____________________________Comments welcome: ____________________________________________

rems and corresponding responsibility of the pharmacist 036-368-13-002-h03

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