Pain Management Regulations Affect More Than Pain Management Specialists January Of counsel to

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1 Pain Management Regulations Affect More Than Pain Management Specialists January 2012 LINDA A. KEEN MSN, JD, LHCRM LAW OFFICE OF LINDA A. KEEN P.A. TALLAHASSEE, FL Of counsel to

2 Pain Management Regulations Affect More Than Pain Management Specialists Controlled Substance Prescribing Requirements F.S. Section (2011) Controlled Substances Regulated by F.S. Section (2011) F.S. Section (2011)

3 Definition of Chronic Nonmalignant Pain Pain unrelated to cancer or rheumatoid arthritis which persists beyond the usual course of the disease or injury that is the cause of the pain or more than 90 days after surgery.

4 Definitional Questions What does chronic mean? What does nonmalignant mean? Not a disease or a growth What about pain related to lupus or other chronic painful disorders? Who defines the usual course of disease or injury?

5 Dictionary Definitions Chronic of long continuance, progresses slowly, distinct from acute. Nonmalignant Not malignant, as a disease Not a disease or a growth that is likely to get uncontrollably worse and lead to death Not very dangerous or harmful in influence or effect

6 Practice and Documentation Requirements for Treatment of Chronic Nonmalignant Pain A complete medical history and physical Not defined by law Minimally, must include: Nature and intensity of pain Current and past treatment for pain Underlying or coexisting diseases or conditions The effect of the pain on physical and psychological functions A review of previous medical records and diagnostic studies History of alcohol and substance abuse *these patients must be referred, or a consultation requested The presence of one or more recognized indications for use of a controlled substance

7 Documentation and Practice Requirements A written individualized treatment plan Minimally, must include: Objectives to determine treatment success Indication of further planned diagnostic evaluations or other treatments After treatment begins, adjustment of drug Rx to individual needs Consideration of other treatment, including rehab Use of an interdisciplinary approach

8 Documentation and Practice Requirements Discussion of treatment risks and benefits with the patient, persons designated by the patient or an incompetent patient s surrogate or guardian Risks of abuse and addiction Physical dependence and its consequences Although not required by law, I recommend a signed consent form documenting the above and anything else you feel is important

9 Documentation and Practice Requirements The physician must enter into a written controlled substance agreement outlining the patient s responsibilities Minimally, must include: Number and frequency of controlled substance prescriptions and refills Patient compliance expectations Reasons why drug therapy may be discontinued Controlled substances for treatment of the patient s chronic nonmalignant pain will be prescribed by a single treating physician unless that physician authorized otherwise and documents it in the medical record

10 Documentation and Practice Requirements The patient must be seen at regular intervals, at least every 3 months Assessment to: Assess treatment efficacy Ensure controlled substance therapy remains indicated Evaluate progress toward treatment objectives Consider adverse drug effects Review pain etiology Determine to continue or modify Rx, based on the evaluation and progress Reevaluate continued treatment if treatment goals aren t being met Monitor medication usage compliance, treatment plan, controlled substance agreement and indication of substance abuse or diversion

11 Documentation and Practice Requirements Office visit documentation, continued Although not required by law, I recommend a notation that the treatment plan was reviewed and updated Before writing a script for a controlled substance, ask whether the patient is being prescribed by another practitioner and document it in the medical record If you don t, and you prescribe as well, you could be found complicit in prescribing medically unnecessary medication in violation of Florida law

12 Documentation Requirements Medical records should include, at a minimum: H & P, including history of drug abuse or dependence Diagnostic, therapeutic, and laboratory results Evaluations and consultations Treatment objectives Discussion of risks and benefits Treatments Medications, including date, type, dosage, and quantity prescribed Instructions and agreements Periodic reviews Results of any drug testing A photocopy of the patient s government-issued photo ID If a written prescription of a controlled substance is given to a patient, a duplicate of the prescription The physician s LEGIBLE full name

13 Referrals Patients with signs or symptoms of substance abuse must be referred immediately to a board certified pain management specialist, an addiction medicine specialist, or a mental health addiction facility Document justification for continued use of controlled substances Incorporate the consultant s recommendations into the treatment plan

14 OTHER STUFF

15 Dispensing Controlled Substances Dispensing physicians generally may not dispense Schedule II or Schedule III controlled substances Exceptions: Drugs are complimentary or sample In the health care system of the Dept. of Corrections In approved clinical trials Methadone in a licensed treatment program For hospice patients Controlled substance is dispensed in association with a surgical procedure No greater than a 14 day supply Only one 14 day supply per procedure If you re going to do this, consult applicable laws and rules

16 Prescribers of Controlled Substances for the Treatment of Nonmalignant Pain Must Register with the Department of Health Required by F.S. Section (2011) RXReg.html

17 Controlled Substances Regulated by F.S. Section (2011) See F.S. Section (2011)

18 E-Forcse Florida s prescription drug monitoring program Collects and stores schedule II, III and IV controlled substance dispensing information Dispensers must register with E-Forcse To report within 7 days of dispensing Practitioners can access dispensing information to help make good treatment decisions Practitioners also can find approved counterfeit proof pad vendors on the website

19 To look up Florida statutes, go to Florida on Line Sunshine

20 Questions L I N D A A. K E E N M S N, J D, L H C R M L A W O F F I C E O F L I N D A A. K E E N T A L L A H A S S E E, F L ( ) Of counsel to

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