Teaching Objectives Describe the balance a that must be sought in the treatment of pain and the prevention of drug diversion. Discuss regulatory polic

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1 Preventing Controlled Substance Diversion David B. Brushwood, R.Ph.,., J.D. Professor of Pharmaceutical Outcomes & Policy The University of Florida

2 Teaching Objectives Describe the balance a that must be sought in the treatment of pain and the prevention of drug diversion. Discuss regulatory policy in the prescribing and dispensing of opioid analgesics. List the factors that correlate with regulatory problems for health care providers who use opioids in the treatment of chronic pain. Describe strategies to avoid regulatory problems in the provision of opioids to chronic pain patients.

3 The Drug Problem in America Inthe45to54agegroup to 54 group, overdose deaths from Rx drugs now surpass motor vehicle accidents as the #1 cause of accidental death. Nearly 7 million Americans abuse Rx drugs. 1i in 5t teenagers has abused dr Rx pain medications.

4 America s Other Drug Problem Undertreatment of pain is a serious problem in the United States, including pain among patients with chronic conditions and those who are critically ill or near death. Pain is undertreated in nearly half of all patients with cancer. 15% of children experience chronic pain; it can have long-lasting lasting effects on social, emotional & physical development.

5 There Is A Storm Coming Patients in pain want their medications and they don t want hassles. Abuse of Prescription Medications is Increasing. Drug Diverters Target Pharmacies. The Failure to Prevent Diversion Will Attract Regulatory Attention. Regulators May Confuse Successful Practice With Diversion. Prescribers and Pharmacists Share concerns.

6 The Structure of CS Law Controlling Substances Scheduling of drugs Registration of those who may control drugs Rules for distribution and control Record keeping from cradle to grave There is a closed system of distribution for drugs with abuse potential. Is there a closed system of distribution for drugs with abuse potential? Medications intended for use in healing are diverted to illicit purposes. Diversion and abuse cause human suffering. Drug regulators have emphasized the need to reduce diversion i and resulting abuse. How does diversion occur? Who is responsible for diversion?

7 Sources of Diversion Medical Sources Health Care Professionals Duped Dishonest Disabled Dated This is primarily a health care system problem. Nonmedical Sources Robbery Hijacking Burglary Employee Pilferage Patient Leakage Importation The Internet t This is primarily a law enforcement problem.

8 The Practitioner s Dilemma The Therapeutic Imperative: Always provide opioid analgesics, and other controlled substances, when they are appropriate for a patient. Help the patients who need help. The Regulatory Imperative: Never provide opioid analgesics when they are inappropriate for a patient. Push the pushers out of the pharmacy. To be successful, these two imperatives must be balanced with each other. Do not permit one to be emphasized over the other.

9 Good and Bad Decisions What is our Dirty Little Secret? HCP Atiit Activity Prescribed/ Dispensed State of the World Patient Is Patient NOT Legitimate Legitimate Pain Patient* Pain Patient Opioids are Good Bad Decision Opioids NOT Prescribed/ Dispensed Bad Decision Bad Decision Good Decision *Assume that opioids are appropriate therapy for the patient.

10 Bad Decisions Cannot Be Eliminated HCP Atiit Activity Prescribed/ Dispensed State of the World Patient Is Patient NOT Legitimate Legitimate Pain Patient* Pain Patient Opioids are Good Bad Decision Opioids NOT Prescribed/ Dispensed Bad Decision Bad Decision Good Decision *Assume that opioids are appropriate therapy for the patient.

11 Using Balance to Reduce Bad Decisions HCP Atiit Activity State of the World Patient Is Legitimate Pain Patient* Opioids are Good Bad Prescribed/ Dispensed Opioids NOT Prescribed/ Decision Bad Patient NOT Legitimate Pain Patient Decision Good Decision Decision Dispensed *Assume that opioids are appropriate therapy for the patient.

12 Important Distinctions Addiction is a disease state. Drug abuse is the intentional use of drugs for a purpose other than a therapeutic purpose. Aberrant behaviors Sharing drugs Unauthorized increase in dose Unauthorized route of administration Reference: Passik, Commentary. Pain Medicine, 8: (2007).

13 FSMB Pain Mgt. Guidelines Addiction - a neurobehavioral syndrome with genetic and environmental influences that results in psychological dependence on the use of substances for their psychic effects and is characterized by compulsive use despite harm. Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and should not be considered addiction.

14 FSMB Pain Mgt. Guidelines Tolerance - the need to increase the dose of opioid to achieve the same level of analgesia. does not equate with addiction Physical Dependence - physiologic state of neuro- adaptation characterized by emergence of withdrawal syndrome if drug use is stopped or decreased abruptly. does not equate with addiction. Pseudoaddiction - pattern of drug-seeking behavior of pain patients who are receiving inadequate pain management and can be mistaken for addiction

15 FSMB Pain Mgt. Guidelines Evaluation Consultation complete history and physical exam documented d Treatment Plan therapeutic goals, further evaluations Informed Consent Periodic Review reasonable intervals refer if necessary Medical Records complete and accurate Compliance with Controlled Substance Laws

16 The Ambiguity of Red Flags Flag Regulators Health Care Professionals Pts. Come from miles away Multiple symptoms treated A Candy Store Polypharmacy Specialty practice Holistic care High Doses No medical need Individualized care Lethal Pt. Asks for drugs by Addiction Pt. accepting name responsibility Returns too early Dealing Crisis

17 DEA Regulations A Setup For Forensic Challenges 21 CFR Purpose of Issue of Prescription (a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. p An order purporting p to be a prescription p issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription and the person knowingly filling such a purported prescription, as well as the person issuing i it, shall be subject to the penalties provided for violations of the law.

18 DEA Compliance Advice to Pharmacists Pharmacist s Guide to Prescription Fraud Characteristics of Forged Prescriptions 1. Prescription looks too good ; the prescriber s handwriting is too legible 2. Quantities, directions or dosages differ from usual medical usage 3. Prescription does not comply with the acceptable standard abbreviations or appears to be textbook presentations 4. Prescription appears to be photocopied 5. Directions written in full with no abbreviations

19 The VIGIL Process Verification f Unnecessary if you know a patient s need is valid. Identification Generalization Interpretation Legalization Not useful if you know a patient s need is invalid. For those in between situations, to become comfortable. The Traditional Advice As long as you practice good The Traditional Advice, As long as you practice good pharmacy and document thoroughly you ll be OK, is simply not true. Good clinical practice is necessary, but it is not sufficient. It may get you out of trouble once you are in it, but it will not keep you out of trouble to begin with.

20 The Purpose of VIGIL Restoring a policy of Balance to practice. Screening out non-patients who traffic in drugs. Reminding actual patients that they have responsibilities if medication use. Demonstrating Good Faith in prescribing and dispensing.

21 Verification Is this a responsible opioid user? Prescriber Talk with the patient openly about prior use Do not prescribe high dose C-II opioid or hydrocodone/acetaminophen as first treatment of pain without verifying prior use with previous prescriber Alternative is trusted colleague who may vouch for patient Define success with therapy Be open to verification requests of pharmacist Pharmacist Call for verification the first time a prescription is presented Document the purpose of the medication Notify the prescriber if anything unusual happens

22 Identification Do I know for sure who this person is? Prescriber and Pharmacist Require government issued photo ID of anyone being prescribed or picking up Rx for C-II opioids or hydrocodone/acetaminophen This includes patient or family member Photocopy ID or write down information Reasonable substitute is ok if circumstances warrant

23 Generalization Do we agree on mutual responsibilities Prescriber and expectations? I am your health care provider and I agree to promptly and respectfully provide medications and services if rules are met Possible rules (but you decide what fits): Keep all controlled substances under lock & key No sharing drugs with anyone If more than 20% too early, call me to explain Present Rxs for new drugs during business hours No emergency refills when there is no emergency It is your responsibility to know when you will run out. Your choice, but use only one pharmacy for CS drugs Put this in writing if necessary Pharmacist Know the rules and remind patients t of them Report infractions to the prescriber

24 Interpretation Do I now feel comfortable allowing this person to have controlled substances? Prescriber Contact another prescriber or pharmacist for support with hypothetical question Use brief questionnaire to predict misuse or abuse by yp patient Drug Abuse Screening Test (DAST) Opioid Risk Tool (ORT) Screener and Opioid Assessment for Patients t in Pain (SOAPP) Require a diary and obtain family or friend feedback regarding patient functioning Pharmacist Consult with prescriber (not the police) as needed d regarding patient behaviors Be alert for activities of concern Resolve all third party pay questions days supply, etc.

25 Legalization How can I stay squeaky clean in meeting my legal requirements? Prescriber Follow state and federal laws for CS, with NO exceptions Be familiar with State Medical Board regulations, and follow them Document what you have done but with care. Notes should be objective and avoid pejorative comments Follow up on concerns that have been documented re drug use or possible addiction Pharmacist Take a medication history Educate the patient and provide pertinent literature Physical dependence vs. addiction Tapering vs. detoxification Follow up on all Drug Use Review edits

26 Schedule II Prescriptions Must be in writing, except No Refills, but Partial filling ok emergency situation Outpatient; must fill balance verbal ok within 72 hours quantity limited to Time for verification. emergency LTCF or terminal illness pharmacist reduces to writing Must fill balance within 60 days within 7 days, prescriber sends written Rx Must record each partial facsimile ok as original if filling Narcotic & infusion therapy There is no specific time period Resident of LTCF within which a C-II prescription must be filled. (Federal Law). Narcotic & patient enrolled Texas is 7 days. NJ is 30 days. Must be in writing, except in hospice care

27 Multiple C-II Prescriptions An individual practitioner (IP) may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a C-II CS. The IP must conclude that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse. IPs must determine on their own, based on sound medical judgment, and in accordance with established medical standards,, whether it is appropriate to issue multiple prescriptions.

28 Schedule II cont. Pharmacist Changes on a CS Rx Prescribing for Maintenance or OK: dosage form, strength, Detoxification i not Legal-- --OTP only quantity, directions, date. When referring to OTP, NOT OK: Patient s name, drug to 3 days; Hospital ok when (except generic), prescriber s admitted d for other reason. signature. Buprenorphine: C-II currently in question. This /subutex_suboxone/default.htm results from a pharmacy Prescribing for addicts in pain is newsletter query. legal. Methadone for pain is perfectly If releasing a patient, prescribing fine. final supply, and verbally specify No restrictions--other than tapered dose (if no diversion). those for all C-II. Tapering opioids is not Not required, but good practice detoxification. to write for pain. administer one day at time, up

29 Forms for VIGIL Medication Use Agreement Pharmacy Responsibilities Patient Responsibilities Relative/Close Friend Patient Questionnaire Live w >2 people? >one prescriber/mo? Generics okay? Pharm Care Assessment Legal res of county? Pay cash? Male? Between 16 & 45? Non-CS in past 6 mo? Documentation Steps Rx Stickers

30 Responsibilities in VIGIL Prescriber Patient Pharmacist Clarify Practice Rules Supervise Staff Respond d to R.Ph. Queries Be Active in the Profession Prescribe Needed Meds Be Open and Honest Accept and Follow the Rules Control Access to Drugs Plan Ahead Contact Prescribers with Concerns Be Informed on Pain Management Avoid Bias Dispense Needed Meds