Udt pdmp cme 2015

1. Administration, Management
and Control for Pain
Management Drugs and
Therapy
Alberto Rivera Sanchez, MD FAAPMR, DABPM
Pain Management Subspecialist
Diplomate of the American Board of Pain Medicine
February 22, 2015

2. “Physicians prescribe drug of which they know little for diseases they know
even less, to people of which they know nothing…”
Voltaire, 16th century

3. Learning Objectives
 Key facts and statistics on the pain management epidemic – illicit drugs,
prescription drugs and drug abuse
 Better understanding of chronic pain and the impact on the patient and your
practice
 Best practices for prescribing opioid therapy

4. Facts & Stats on the Pain Management
Epidemic
 Many physicians do not understand the risks and management of addictive
disease.
 Physicians traditionally receive little or no education about pain management
or the treatment of addiction.
 OxyContin, methadone and Percocet availability have increased dramatically
in recent years because of over-prescribing practices by physicians and the
internet.
 Puerto Rico Health and Anti-Addiction Services Administration
 4 million Americans used a prescription drug last year for non-medicinal
purposes

5. Facts & Stats on the Pain Management
Epidemic
 Overall, health-care providers wrote 259M prescriptions for painkillers in
2012, based on prescription data gathered from retail pharmacies by a commercial
vendor
 Centers for Disease Control
 New federal data show the rate of deaths involving prescription painkillers have
like Oxycontin and Vicodin more than tripled between 1999 and 2012.
 Centers for Disease Control Report, December 2014
 Heroin and pharmaceutical drugs are among the most abused substances in
Puerto Rico
 The National Drug Intelligence Center

6. Facts & Stats on the Pain Management
Epidemic
 8% of the national population receive chronic opioid therapy
 U.S. Department of Veterans Affairs, Monday, November 17, 2014
 Americans constitute less than 5% of the world population, but consume
80% of the opiates
 Substance abuse is one of Puerto Rico’s most compelling socio-medical problems
 Mental Health and Anti-Addiction Services Administration
 DEA Diversion Drug Trend Report identifies hydrocodone as the most commonly
diverted and abused controlled pharmaceutical in the U.S.
 Every day 46 people die from an overdose of prescription painkillers
 HealthDay News, Wednesday, July 2, 2014, Dr. Tom Frieden, Director of CDC

7. Trend in Prescription Drug Abuse
 52 Million people in the U.S. over the age of 12 have used prescription non-
medically in their lifetime
 6.1 Million have used them non-medically in the past month
 25% of the U.S. consumes 75% of the world’s prescription drugs
 In 2010, enough prescription painkillers were prescribed to medicate every
American adult every 4 hours for 1 month
 National Institute on Drug Abuse
 The U.S. spends $200 Billion each year on medical care stemming from improper
or unnecessary use of prescription drugs
 Medscape, 2014

8. The Pain Dilemma
Chronic Pain Opioid Abuse

9. The Scales of Opioid Therapy Have Tipped
Liberal use of
opioids for
chronic non-
malignant pain
Restricted use of
opioids for chronic
non-malignant pain.
Use for cancer pain.

10. Pain epidemiology
 Pain is undertreated
 Fear of patient harm
 Fear of regulatory, legal or licensing penalties
 Addictive disorder or risk for addiction
 Divert or misuse of medications

11. Definitions
 Chronic nonmalignant pain
 Unrelated to cancer
 Pain greater than 90 days after surgery.
 Pain that persists beyond the usual course of the disease and beyond the
expected time for healing from injury or trauma.
 Pain which is associated with long term incurable or intractable medical illness or
disease. i.e. Chronic pain from abdominal adhesions post-operative.

12. Initial Patient Assessment
Trial of Opioid Therapy
Alternatives
to Opioid
Therapy
Patient Reassessment
Implement Exit Strategy
Comprehensive Pain Management Plan
Continue Opioid Therapy
Patient Selection
Prescribing Opioid Therapy

13. Prescribing Opioid Therapy
 Informed Consent
 Pain Contract
 Risks of the Opioid Therapy
 Addiction, Abuse
 Cognitive Changes
 Hormonal Changes
 Withdrawal
 State Short-Term Use (6 months)
 Prescription Monitoring Program
 Addiction Screening Assessment
 Urine Toxicology
 Pain medication is a PRIVILEGE not a RIGHT!

14. Prescribing Opioid Therapy
 ABCDPQRS for Opioid Risk Assessment (ICSI 2014)
 Alcohol Use
 BDZ
 Clearance and Metabolism (GFR <60 Morphine & Meperidine are toxic, GFR <30
cause delay elimination of oxycodone and hydrocodone) (Hepatic impairment use low
dose or no APAP opioid combinations)
 Delirium, Dementia and Falls Risk
 Psychiatric Comorbidities
 Opioids are powerful anxiolytics
 Depression and Anxiety Dz
 Chilhood Sex trauma and/or ADHD history
 OCD, PTSD

15. Prescribing Opioid Therapy
 Query the Prescription Drug Monitoring Program
 Respiratory Insufficiency and Sleep Apnea
 Safety
 Safe driving
 Safe work
 Safe storage
 Safe disposal

16. Prescribing Opioid Therapy & Challenges
Associated with Opioids
 High dose pain medication almost never improves function
 Opioid Induced Hyperalgesia is a real and common consequence of chronic
opioid therapy
 Prescription opioid pain medications such as OxyContin and Vicodin can have
effects similar to heroin when taken in doses or in ways other than prescribed.
Research now suggests that abuse of these drugs may actually open the
door to heroin abuse
 www.drugabuse.gov/publicaitions/drugfacts

17. Addiction
 Using a drug in a compulsive fashion not for its intended medical effects but for its
pleasant, psychic effects.
 World Health Organization
 The abuse results in physical, psychological or social harm to the abuser who
continues the use despite the harm.

18. Addiction and Abuse Behaviors
 Drug hoarding during periods of
reduced symptoms
 Requesting specific drugs
 Acquisition of similar drugs from
other sources
 Multiple unsanctioned “self” dose
escalations
 Unapproved use of the drug to
treat another symptom
 Reporting psychic effects
 Aggressive complaining about
need for higher doses
 Recurrent prescription losses
 Stealing or Borrowing another
patient’s medications
 Injecting/snorting oral formulation
 Heating fentanyl patches
 Obtaining prescription drugs from
non-medical sources
 Concurrent abuse of related
illicit drugs or alcohol/tobacco

19. Identify Addiction Risks
 History and Physical Examination must be performed and documented for every
patient for every visit
 Treatment Plan with goals
 Evaluate Opioid Requirements
 Risk Assessment
 Opioid Risk Tool
 (http://www.partnersagainstpain.com/printouts/Opioid_Risk_Tool.pdf)
 Pain Assessment and Documentation Tool
 (http://healthinsight.org/Internal/assets/SMART/PADT.pdf)
Screener and Opioid Assessment for Patients with Pain
(http://nationalpaincentre.mcmaster.ca/documents/soap
p_r_sample_watermark.pdf)

20. Diversion
 Narcotic pain medication is extremely valuable
 Do not replace stolen/lost medication
 No sharing medication
 No early refills
 Random Urine Drug Testing
 Random Pill Counts

21. What can we do about it
 Practice appropriate controlled substance prescribing
 Opiates are a means to an end not an end by itself
 Learn about the patient? Why is he asking me for these drugs?
 Refer to pain management specialists

22. Legislation for Puerto Rico
 Currently, Puerto Rico does not have adequate legislation to address these issues.
 A local law firm has developed a project of law based on similar legislation in
Florida and other states.
 Local legislation seeks to include a combination of both the electronic monitoring
system and the UDT.
 The electronic monitoring system, based on Florida’s NASPER system, will be
administered by the Puerto Rico Department of Health.

23. Project of Law Stakeholder Meetings
 The project of law is championed by the President of the Senate’s Health Committee,
the Honorable Senator José Luis Dalmau.
 The Senator has formally filed a petition in the Senate requesting all of the health related
agencies to provide information related to these issues and their costs.
 Puerto Rico Board of Physicians (CMPR).
 Puerto Rico Board of Pharmacists (CFPR)
 Presentation during their national convention (August 2014).

24. Project of Law Stakeholder Meetings
 Puerto Rico State Insurance Fund Corporation (CFSE).
 Currently under review by the Drug Enforcement Agency (DEA) and the Puerto
Rico Health Administration (ASES).
 The content of the project of law has received general approval except for:
 The proposed penalties.
 Requests for a more comprehensive costs-benefits analysis.

25. Controlled Substance Agreement
 Written Agreement, Explaining
 Risks/Benefits
 Addiction/Dependence
 Number and frequency of prescriptions and refills
 Compliance rules and violation with reasons for termination of therapy
 CS by a single MD, unless authorized and documented
 Evaluated every 3 months
Monitor efficacy, indications, progress to objectives, adverse effects,
review of etiology, modifications, appropriateness of treatment, monitor
compliance.

26. Summary of Prescription Drug
Monitoring Program (PDMP)
 Prohibits donations of pharmaceutical manufacturers.
 Not mandatory for a prescriber or dispenser to review PDMP prior
to prescribing or dispensing.
 Data submission -- 7 days for pharmacies and dispensing
physicians that dispense CS.
 The following are exempt from reporting in the PDMP for that
specific act of dispensing or administration.
 When administering a CS directly to a patient if the amount of the
CS is adequate to treat the patient during that particular treatment
session.
 A pharmacist or health care practitioner when administering a CS
to a patient or resident receiving care as a patient at a hospital,
nursing home, ambulatory surgical center, hospice, or intermediate
care facility for the developmentally disabled which is licensed in
this state.

27. PDMP - Goals
The PDMP will allow health care practitioners to view all of their patient’s dispensed
prescription history that is seven (7) days or later. The practitioner will then be able
to check the following to:
• Determine
• the potential for adverse drug reactions
• the best possible therapeutic therapy
• patient compliance with practitioner’s guidance
• if there are duplicative prescriptions during the same time period
• if their patient is “doctor shopping” i.e. seeing multiple physicians within the past thirty
(30) days and not telling them they already have a prescription for the same controlled
substance(s)
• potential for drug to drug or drug to allergy interactions

28. URINE DRUG TESTING (UDT)
 Centers for Medicare and Medicaid (CMS) policy
 Medical Necessity
 Who, When, Why
 Best Practice Protocols

29. Urine Toxicology
 We may be surprised with what we find!

30. CMS Policy on Urine Drug Testing (UDT)
 According to CMS policy – UDT provides objective information to assist clinicians
in identifying the presence or absence of drugs or drug classes in the body and
assist in making treatment decisions
 Details of the policy include:
 Appropriate indications and expected frequency of testing for safe medication
management of prescribed substances in risk stratified pain management patients
and/or in identifying and treating substance abuse;
 Designates documentation, by clinicians in the patient’s medical record, or medical
necessity for, and testing ordered on an individual patient basis;
 Provides an overview of presumptive (screening) UDT and definitive UDT testing by
various methodologies
 CMS Policy Number DL35654

31. AMA DEFINITION OF MEDICAL
NECESSITY
 Health care services or products that a prudent physician would provide to a
patient for the purpose of preventing, diagnosing or treating an illness, injury,
disease or its symptoms in a manner that is:
• (a) In accordance with generally accepted standards of medical practice;
• (b) Clinically appropriate in terms of type, frequency, extent, site, and duration; and
• (c) Not primarily for the economic benefit of the health plans and purchasers or for the
convenience of the patient, treating physician, or other health care provider.

32. ACCORDING TO CMS
 Services are Reasonable and Necessary if the contractor determines that
the service is:
 Safe and effective;
 Not experimental or investigational;
 At least as beneficial as an existing and available medically appropriate alternative;
and
 Meeting, but not exceeding the patient’s need and furnished
(a) In accordance with accepted standards of medical practice for the diagnosis or
treatment of the patient's condition or to improve the function of a malformed
body member;
(b) In a setting appropriate to the patient's medical needs and condition;
(c) And ordered by qualified personnel.

33. Urine Toxicology
 Random urine testing provides a wealth of information
 Identifies Illicit Drugs
 Marijuana
 Cocaine
 Heroin
 Identifies the PRESENCE and CONCENTRATION of medication
 One of the only ways to combat DIVERSION

34. Urine Drug Testing Study
 In a study investigating urine drug toxicology results in 122 patients receiving
chronic opioids over a three year period, aberrant drug-related behaviors were
discordant with urine toxicology.
 27% of patients with no behavioral issues had an illicit or non-prescribed
controlled substance in their urine (Katz & Fanciullo, 2002).
 Michna (2007) reported on 470 patients where 45% were found to have an illicit
drug, a non-prescribed controlled substance, or the absence of the
prescribed medication.
 No clear predictors of abnormal drug screens were identified based on the
variables of gender, pain site, type of opioid, opioid dose, number of opioids
prescribed, or prescribing physician.

35. Who to test:
 Patients who are:
 New to your practice and already taking a controlled substance
 May want you to prescribe a controlled substance
 Request specific drugs
 Frequently request refills
 Display aberrant behavior or frequently report loss of medications

36. American
Clinical
Solutions
When to test
 Test patients when:
 A patient is newly prescribed a controlled substance
 There is a major change in the patient’s treatment plan
 There is observation of aberrant, drug-related behavior
 Reports from a third-party of drug-related behavior

37. Why Test?
 Influence positive health behaviors after discharge from a hospital or during
treatment
 Deplete clinical variance in rehabilitation
 Use as a standard of care when prescribing an opioid
 Decrease hospital visits and re-hospitalization
 Prevent toxicity / overdose
 Identify diversion, abuse and addiction
 Classify risk behaviors (Low, Moderate, High)
 Decrease medical malpractice of wrongful death from overdose in my practice

38. Urine Drug Test Protocols for Prescription
Management
 Test upon initial evaluation if the diagnosis indicates a need to prescribe a
pain/psych medication
 Test all patients on a narcotic as medically necessary for compliance, diversion,
suspicion of abuse
 Test patients who ask for a specific medication other than what physician
prescribed them
 Test patients who have had a lapsed time in visiting your practice for treatment

39. Urine Drug Test Protocols for Prescription
Management
 If a patient tests positive for an undisclosed drug/medication, retest and
council them at each visit until you can justify improved compliance
 Test patients who complain of an exacerbation in pain, which might require
increase of dosage
 Test newly discharged hospital patients who have been prescribed a narcotic
medication
 Test your patient prior to a procedure that requires anesthesia to identify
harmful substances
 Utilize an Opioid Treatment Agreement for all patients who present chronic pain
and verify they will be coming only to you for treatment and to be prescribed these
medications

40. Immunoassay
 Immunoassay - use antibodies to detect the presence of specific drugs or
metabolites and are the most common method used for the initial screening
process.
 Advantages - relatively low cost, small sample sizes, and rapid
turnaround
 Disadvantage - relatively low specificity and the potential for receiving
false-positive results

41. Immunoassay
 Results of immunoassays are always considered presumptive until confirmed by a
laboratory-based test for the specific drug
 According to CMS policy, LC-MS/MS “is roughly 100 times more sensitive
and selective, involves less human steps, provides quicker turn-around time, uses
less specimen volume and can test for a larger number of substances
simultaneously when compared to GC-MS.”
 UHPLC-MS/MS (ultra high performance) lab services provide highly sensitive and
specific lab-guided medication management that can provide an advanced level of
detection in both urine and oral samples to give the support and confidence
physicians need for practice, patient and clinical outcome success.

42. ICSI, Acute Pain Assessment and
Opioid Prescribing Protocol 2014

43. Drug Duration in Urine
Alcohol (EGT) 3-5 days
BDZ 1-6 weeks
Cocaine 2-30 days
Buprenorphine 1-3 days
Codeine, Tramadol and Most
Opioids
2-4 days
Cotinine (Tobacco) 1-3 days
Demerol 6-12 days
Heroin 2-4 days
Diazepam 7-10 days or up to 6 weeks
Ectasy 1-5 days
Fentanyl patch 8-24 hours
Methylphenidate 1-2 days
Morphine 3-4 days
Oxycodone/Oxycontin 3-4 days
Tylenol #3 Min Use 8-24hrs

44. In Conclusion
 Understand the principles of pain management
 Best practice Opioid Therapy Management
 Controlled Substance Agreement with Patient
 Urine Drug Testing
 Drug Monitoring Program
 Identify opioid abuse and diversion tactics
 Know your patient
 Documentation to support Medical Necessity for services provided