FEDERAL & STATE LAWS RELATED TO THE PRESCRIBING OF CONTROLLED SUBSTANCES LEONARD SCHUCHMAN, DO, MPH, FAAFP PRESIDENT- ELECT, NJAOPS

Transcription

1 FEDERAL & STATE LAWS RELATED TO THE PRESCRIBING OF CONTROLLED SUBSTANCES LEONARD SCHUCHMAN, DO, MPH, FAAFP PRESIDENT- ELECT, NJAOPS

2 OBJECTIVES Review of the applicable laws and rules both Federal and for the State of Florida Standards for the Use of Controlled Substances for Pain According to the Department of Health Understand the reason for the Controlled Substances Act of 1970 Know what a proper prescription is Become familiar with EFORCSE Understand how you become a Controlled Substance Prescribing Practitioner (intentional or otherwise)

3 CONTROLLED SUBSTANCES ACT OF 1970 System for U.S. compliance with international treaties. Legal foundation of the Federal government s authority over controlled substances and listed chemicals. Consolidated over 50 laws regulating the manufacture, distribution, import / export, and dispensing of controlled substances and listed chemicals.

4 CENTRAL PRINCIPLE OF BALANCE WITH THE USE OF CONTROLLED SUBSTANCES Dual imperative of government Establish a system of controls to prevent Abuse TrafRicking Diversion Must ensure availability of controlled substances (CSs) for medical and scientiric purposes. Should be accessible to all patients who need them, including for the relief of pain

5 SCHEDULING OF CONTROLLED SUBSTANCES Schedule I - Cannot be prescribed Schedule II - High potential for abuse Schedule III - Less abuse potential than Schedule II Schedule IV - Low abuse potential relative to Schedule III Schedule V - Low abuse potential relative to Schedule IV

6 PRESCRIPTION REQUIREMENTS Don't write prescriptions for controlled substances unless you have an active DEA number and any registration required by your state.

7 PRESCRIPTION REQUIREMENTS In order for a prescription to be legal, it must: Be issued by a registered practitioner For a legitimate medical purpose In the usual course of practice DEA does not derine or regulate medical practice standards. There are no federal laws or regulations that puts limits on the quantity of controlled substances that may be prescribed. Some states or insurance providers may limit the quantities of controlled substances prescribed or dispensed. 21 CFR (a)

8 PRESCRIPTION REQUIREMENTS In order for a prescription to be legal, it must: Date of issue Patient's name and address Practitioner's name, address, and DEA registration number Drug name Drug strength 21 CFR (a)

9 PRESCRIPTION REQUIREMENTS In order for a prescription to be legal, it must: Dosage form Quantity prescribed Directions for use Number of rerills (if any) authorized Manual signature of prescriber 21 CFR (a)

10 PRESCRIPTION REQUIREMENTS A prescription must be written in ink or indelible pencil or typewritten and must be signed manually by the practitioner. Signature stamps are not legal. An individual may be designated by the practitioner to prepare the prescriptions for his/her signature, except that prescriptions for Schedule II controlled substances must be written and signed by the practitioner. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulation. 21 CFR (a)

11 PRESCRIPTION REQUIREMENTS Here is the federal regulation on how to write a prescription: "Manner of issuance of prescriptions: (a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address, and registration number of the practitioner. Where a prescription is for gamma- hydroxybutyric acid, the practitioner shall note on the face of the prescription the medical need of the patient for the prescription. A practitioner may sign a prescription in the same manner as he would sign a check or legal document (eg, J. H. Smith or John H. Smith)." 21 CFR (a)

12 PRESCRIPTION REQUIREMENTS "Where an oral order is not permitted, prescriptions shall be written with ink or indelible pencil or typewriter and shall be manually signed by the practitioner. The prescriptions may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central Rill pharmacy, who Rills a prescription not prepared in the form prescribed by DEA regulations 21 CFR (a)

13 PRESCRIPTION REQUIREMENTS If one is not residency trained in pain fellowship or anesthesia once a prescription is written for a controlled substance your care is viewed as those of a pain management expert. As a physician it is your duty to care for your patient s pain safely, however if treatment goals are not met have your patient re- evaluated by another consultant.

14 CSA AND CFR CITATIONS Prescription must be for legitimate medical purpose by a practitioner acting in usual course of professional practice. 21 CFR (a) Practitioners are not limited in their ability to prescribe, administer, or dispense narcotics to persons with intractable pain. 21 CFR (c) Corresponding responsibility rests with the pharmacist who Rills the prescription. 21 CFR (a)

15 PAIN MANAGEMENT DEA S POLICY STATEMENT Dispensing Controlled Substances for the Treatment of Pain Reiterates DEA policy to prevent abuse and diversion without adversely impacting the legitimate need of patients to have full access to pain relief prescribed by their physician. To reassure physicians that DEA does not apply a greater scrutiny to the prescribing of controlled substances to treat pain. Discussed the phrase legitimate medical purpose. Addressed requests for a guidance document on treating patients for pain.

16 FEDERAL VS. STATE REGULATIONS Healthcare professionals must comply with both federal and state laws and regulations that govern prescribing scheduled Controlled Substances. When federal laws or regulations differ from state laws or regulations, the more stringent rule applies.

17 FEDERAL REGULATIONS PRE- SIGNING DO NOT DO THIS Federal law prohibits prescribers from pre- signing prescriptions. Here is the legal language: "Manner of issuance of prescriptions. (a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address, and registration number of the practitioner." (21 CFR, Section )

18 FEDERAL REGULATIONS TIME LIMITS While states may have more restrictive rules, the federal law does not limit the amount prescribed. So, a patient could get all of a 6- month supply of a Schedule II substance at one time if the clinician writes the prescription in that way. Prescriptions for Schedule III substances expire 6 months after the date written. There may be 5 rerills within the 6- month period. ReRill authorization can be transferred from one pharmacy to another once within the 6- month period. A practitioner may issue a new prescription for the Schedule III substance within a 6- month period if necessary.

19 FEDERAL REGULATIONS PARTIAL FILLING OF PRESCRIPTIONS A pharmacist may partially Rill a prescription for controlled substances. If the remainder is not dispensed to the patient within the following 72 hours, the prescription is void and must be rewritten in order for the patient to get the remainder. Partial rerills of Schedule III, IV, and V controlled substance prescriptions are permissible under federal regulations provided that each partial Rilling is dispensed and recorded in the same manner as a rerilling (ie, date rerilled, amount dispensed, initials of dispensing pharmacist, etc), the total quantity dispensed in all partial Rillings does not exceed the total quantity prescribed, and no dispensing occurs after 6 months past the date of issue (21 CFR Section )

20 FEDERAL REGULATIONS PARTIAL FILLING OF PRESCRIPTIONS A patient with a terminal illness or in a long term care facility (LTCF) may have a prescription Rilled in partial quantities: Pharmacist must record on the prescription whether the patient is terminally ill or a LTCF patient The prescription is valid for a period not to exceed 60 days from the date of issuance unless sooner terminated by the discontinuation of the medicine (21 CFR Section )

21 FEDERAL REGULATIONS REFILLING PRESCRIPTIONS FOR CONTROLLED SUBSTANCES Prescriptions for Schedule II controlled substances cannot be rerilled. A new prescription must be issued. However, an authorized prescriber may prepare multiple prescriptions on the same day with instructions to Rill on different dates. Prescriptions for Schedule III through V controlled substances may be rerilled up to 5 times in 6 months. The prescription may be telephoned or transmitted via facsimile to the pharmacy. OfRice staff may communicate the information to the pharmacy when acting as an agent of the registered physician. (21 CFR Section )

22 FEDERAL REGULATIONS EMERGENCY SITUATIONS Emergency is derined by the Secretary of Health and Human Services as "situations in which the prescribing practitioner determines that: (1) immediate administration of a controlled substance is necessary, for proper treatment of the intended ultimate user; (2) that no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II of the Act; and (3) it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to dispensing (21 CFR Section )

23 FEDERAL REGULATIONS EMERGENCY SITUATIONS In emergency situations, a prescription for a Schedule II controlled substance may be telephoned to the pharmacy and the prescriber must follow up with a written prescription sent to the pharmacy within 7 days. (States may require that the prescription be sent to the pharmacist in a shorter time frame.) Prescriptions for Schedule III through V controlled substances may by written or transmitted orally or by fax.

24 FEDERAL REGULATIONS EMERGENCY SITUATIONS Here are some additional requirements to heed when orally transmitting prescriptions in emergency situations: "In an emergency, the prescriber may give an oral prescription for a Schedule II drug if the pharmacist makes a reasonable effort to identify the prescriber and the amount is limited to what is necessary to treat the patient during the emergency. The prescriber must cause to be delivered an original prescription to the dispensing pharmacist within 7 days. The prescriber must write 'Authorization for Emergency Dispensing' on the prescription. The prescriber must document how the situation met the criteria for emergency treatment." (21 CFR )

25 FEDERAL REGULATIONS FAXING PRESCRIPTIONS FOR CONTROLLED SUBSTANCES Prescriptions may be faxed under certain conditions. Here are the conditions, as stated in federal regulations: "A pharmacist may dispense directly a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. A prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in paragraph (e), (f), or (g) of this section. The original prescription shall be maintained in accordance with Sec (h) of this chapter (e).

26 FEDERAL REGULATIONS FAXING PRESCRIPTIONS FOR CONTROLLED SUBSTANCES "A prescription prepared in accordance with Sec written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (e) and it shall be maintained in accordance with Sec (h) of this chapter" Therefore, Schedule II prescriptions can be faxed to a pharmacist, but the copy is just an alert to the pharmacist that the patient is enroute with an original prescription. (21 CFR Section )

27 FEDERAL REGULATIONS FAXING PRESCRIPTIONS FOR CONTROLLED SUBSTANCES Schedule III and IV prescriptions may be telephoned in or faxed to the pharmacist, or the practitioner could go to the pharmacy counter and request that a drug be dispensed to a patient. In the latter case, the pharmacist would have the responsibility of reducing the verbal order to writing. Here is the legal language: "A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to either a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or the practitioner's agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in Sec , except for the signature of the practitioner." (21 CFR Section [a])

28 FEDERAL REGULATIONS FAXING PRESCRIPTIONS FOR CONTROLLED SUBSTANCES Facsimile of a Schedule II prescription may serve as the original written prescription in the following situations: Patient is a resident of a Long Term Facility Prescription faxed to dispensing pharmacy Patient enrolled in a hospice program certiried/paid for by Medicare under Title XVIII or licensed by the state Prescription faxed to dispensing pharmacy Note on script: i.e. Hospice patient (21 CFR Section [a])

29 FEDERAL REGULATIONS A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients. All prescriptions must be written for a speciric patient (21 CFR Section [b])

30 FEDERAL REGULATIONS May administer, prescribe or dispense a Schedule II controlled substance to a person with intractable pain, in which no relief or cure is possible or none has been found after a reasonable effort. This language has served as the basis to derine intractable pain in state law. To administer or dispense directly (but not prescribe) narcotic drugs to a narcotic- dependent person for detoxirication or maintenance treatment, a physician MUST have a separate registration with the DEA as an opioid treatment program (OTP). (21 CFR Section )

31 FEDERAL REGULATIONS May treat acute/chronic pain with a Schedule II controlled substance in a recovering narcotic- addicted patient Federal law or regulations do not prohibit the prescribing, dispensing or administering of a narcotic medication to a narcotic addicted patient for the purpose of alleviating pain if such prescribing is medically appropriate within standards set by the medical community One must keep good records to document the physician is treating a pain syndrome and not the disease of narcotic addiction (21 CFR Section )

32 FEDERAL REGULATIONS DEA does not impose any limitations on a physician or authorized hospital staff to administer or dispense (but not prescribe) narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction. (21 CFR Section )

33 FEDERAL REGULATIONS Issuance of multiple prescriptions for Schedule II controlled substances DEA s regulations allow practitioners to provide individual patients with multiple prescriptions for a speciric Schedule II CS, written on the same date, to be Rilled sequentially. The combined effect of such sequential multiple prescriptions is that it allows a patient to receive over time up to a 90- day supply of that controlled substance (21 CFR Section )

34 FEDERAL REGULATIONS NARCOTIC DEPENDENT PATIENT Can administer (not prescribe) a narcotic drug to relieve acute withdrawal symptoms while arranging for a referral to an opioid treatment program (OTP) In or out patient One day s medication at a time Can be done for 3 days Can not be renewed or extended (21 CFR Section )

35 FEDERAL REGULATIONS ELECTRONIC PRESCRIPTIONS Effective June 1, 2010 the CFR was revised to: Provide practitioners with the option of writing prescriptions for controlled substances electronically Addition to, not a replacement of, existing rules Permit pharmacies to receive, dispense, and archive these electronic prescriptions Provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substances prescriptions while maintaining the closed system of controls on controlled substances (21 CFR Section 75(61).16236)

36 FEDERAL REGULATIONS ELECTRONIC PRESCRIPTIONS A practitioner may sign and transmit e- prescriptions if all of the following requirements are met: Must comply with all other requirements for issuing controlled substance prescriptions Must use an application that meets speciric requirements (in Part 1311) Must comply with requirements for electronic orders and prescriptions (in Part 1311) (21 CFR Section )

37 FEDERAL REGULATIONS ELECTRONIC PRESCRIPTIONS Practitioner responsibilities Rapid reporting of identiried breaches Same responsibilities when issuing e- prescriptions for controlled substances as when issuing a paper or oral prescription Including issuing prescriptions only for a legitimate medical purpose and in the usual course of professional practice The prescription must conform in all essential respects to the law and regulation (21 CFR Section )

38 FEDERAL REGULATIONS AMENABLE ERRORS Changes a pharmacist can make to a prescription for a controlled substance May add or change patient s address upon verirication May change or add dosage form, drug strength, quantity, direction for use, or issue date Only after consultation with and agreement of the prescribing practitioner Such changes are noted on the prescription and medical records In compliance with state/local laws, regulations, or policies

39 DIFFERENTIATING BETWEEN A LEGITIMATE AND AN APPROPRIATE PRESCRIPTION Legitimate Doctor Patient Relationship Diagnosis for which the medication might be prescribed for reasonable therapeutic trial Practitioner lawfully able to prescribe the agent within the usual and customary practice Appropriate All of the above plus Careful assessment of risk (i.e. substance use disorder etc.)

40 FEDERAL REGULATIONS For additional information about controlled substances diversion and its prevention

41 FEDERAL REGULATIONS Conclusion (Federal Regulations): Healthcare practitioners can prescribe scheduled controlled substances approved by the FDA consistent with state and federal regulations to give their patients the best quality of life possible given the reality of their medical condition.

42 STATE OPIOID PRESCRIBING POLICY: FLORIDA Florida has stricter rules than Federal regulations. Florida rules supersede because The Department of Health grants you the license to practice medicine which allows them regulate and discipline.

43 STATE OPIOID PRESCRIBING POLICY: FLORIDA General Policies of the Florida Boards of Medicine and Osteopathic Medicine (Boards) The Boards recognize that "controlled substances, including opioid analgesics, may be essential in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non- cancer origins." The Boards consider "prescribing, ordering, administering, or dispensing controlled substances for pain to be for a legitimate medical purpose if based on accepted scientiric knowledge of the treatment of pain or if based on sound clinical grounds. All such prescribing must be based on clear documentation of unrelieved pain and in compliance with applicable state or federal laws."

44 STATE OPIOID PRESCRIBING POLICY: FLORIDA General Policies of the Florida Boards of Medicine and Osteopathic Medicine (Boards) The Boards will not take disciplinary action against a physician for failing to adhere strictly to the provisions of their standards for the use of controlled substances in the treatment of pain "if good cause is shown for such deviations." The Boards "will judge the validity of prescribing based on the physician's treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing."

45 STATE OPIOID PRESCRIBING POLICY: FLORIDA Deainitions According to the Boards Pain: An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. Acute pain: The normal, predicted physiologic response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, and acute illness. It is generally time- limited and is responsive to opioid therapy among other therapies. Chronic pain: A pain state which is persistent. Physical dependence: A physiologic state of neuroadaptation that is characterized by the emergence of a withdrawal syndrome if drug use is stopped or decreased abruptly or if an antagonist is administered. Physical dependence is an expected result of opioid use. Physical dependence by itself does not equate with addiction.

46 STATE OPIOID PRESCRIBING POLICY: FLORIDA Deainitions According to the Boards Tolerance: A physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce the same effect, or a reduced effect is observed with a constant dose. Addiction: A neurobehavioral syndrome with genetic and environmental inrluences 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 physiologic consequences of extended opioid therapy for pain and should not be considered addiction. Pseudoaddiction: A pattern of drug- seeking behavior of patients with pain who are receiving inadequate pain management that can be mistaken for addiction.

47 STATE OPIOID PRESCRIBING POLICY: FLORIDA Standards for the Use of Controlled Substances for Pain According to the Boards Evaluation of the patient Complete history and physical examination Documented nature and intensity of pain Underlying diseases and conditions Effect of pain on physical and psychological functioning History of substance abuse Indication for use of controlled substances

48 STATE OPIOID PRESCRIBING POLICY: FLORIDA Standards for the Use of Controlled Substances for Pain According to the Boards Treatment plan Objectives used to determine treatment success Further diagnostic evaluations or treatments planned Therapy adjusted to individual patient needs

49 STATE OPIOID PRESCRIBING POLICY: FLORIDA Standards for the Use of Controlled Substances for Pain According to the Boards Informed consent and agreement to treatment Risks and benerits discussed with patient When possible, patient should receive medications from one physician and one pharmacy Written agreement if patient is determined to be at high risk: Urine/serum drug level tests Number and frequency of rerills Reasons drug therapy may be discontinued (violation of agreement)

50 STATE OPIOID PRESCRIBING POLICY: FLORIDA Standards for the Use of Controlled Substances for Pain According to the Boards Periodic Review At reasonable intervals Reevaluate need for opioids if goals are not met Monitor compliance

51 STATE OPIOID PRESCRIBING POLICY: FLORIDA Standards for the Use of Controlled Substances for Pain According to the Boards Consultation Refer as necessary Extra care with patients having history of misuse or living arrangements conducive to misuse/diversion Addiction medicine consult for patients with a history of abuse or comorbid psychiatric disorder

52 STATE OPIOID PRESCRIBING POLICY: FLORIDA Standards for the Use of Controlled Substances for Pain According to the Boards Medical records History and physical examination History of alcohol and substance abuse Diagnostic, therapeutic, and laboratory results Evaluations and consultations Treatment objectives Discussion of risks and benerits of the use of controlled substances, including abuse and addiction

53 STATE OPIOID PRESCRIBING POLICY: FLORIDA Standards for the Use of Controlled Substances for Pain According to the Boards Medical records Medications (including date, type, dosage, and quantity prescribed) Develop a written individualized treatment plan for each patient. The treatment plan shall state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and shall indicate if any further diagnostic evaluations or other treatments are planned. Periodic reviews at regular intervals, not to exceed 3 months, to assess the efricacy of treatment, ensure that controlled substance therapy remains indicated, evaluate the patient s progress toward treatment objectives, consider adverse drug effects, and review the etiology of the pain

54 STATE OPIOID PRESCRIBING POLICY: FLORIDA Standards for the Use of Controlled Substances for Pain According to the Boards Compliance with controlled substance laws and regulations

55 STATE OPIOID PRESCRIBING POLICY: FLORIDA Federal Controlled Substance Rules That Are Enforceable in Florida General Rules All controlled substance prescriptions must be issued for a "legitimate medical purpose" and in the "usual course of professional practice" This is primarily the practitioner's responsibility Pharmacists have a corresponding responsibility to assure that this requirement has been met Under federal law, C- III and C- IV prescriptions may be authorized for rerilling up to 5 times in 6 months following issuance. Florida law imposes this requirement for C- V prescriptions also. All controlled substance prescriptions must be dated on the date of issuance. There is no maximum dose, maximum quantity, or maximum duration of therapy with controlled substance medications under federal law or Florida law.

56 STATE OPIOID PRESCRIBING POLICY: FLORIDA Speciaic rules for C- II prescriptions Under federal law there is no time limit within which a C- II prescription must be Rilled. In Florida, every prescription must be ailled within 1 year of issuance, so that basic rule covers C- II prescriptions. C- II prescriptions may not be rerilled. Period. End of story. Never use the word "rerill" with reference to the issuance of a continuing supply of C- II medication pursuant to a new prescription. Multiple C- II prescriptions may be issued on the same day for up to a 90- day continuing supply to be acquired periodically through new prescriptions that contain "do not Rill until [mo- day- year]" instructions for the pharmacist.

57 STATE OPIOID PRESCRIBING POLICY: FLORIDA Speciaic rules for C- II prescriptions Under certain circumstances, federal law permits a faxed prescription to serve as the original, and Florida law specirically defers to federal law on this matter. This applies under 3 circumstances: The prescription is for infusion treatment (narcotic C- II prescriptions only) The prescription is for a resident of a long- term care facility (LTCF) (any C- II prescription) The prescription is for a patient enrolled in hospice care (narcotic C- II prescriptions only)

58 STATE OPIOID PRESCRIBING POLICY: FLORIDA Speciaic rules for C- II prescriptions A pharmacist may partially Rill a C- II prescription if the pharmacist is unable to Rill the prescription for the full amount The balance must be dispensed within 72 hours or not at all If the balance is not dispensed within 72 hours, the prescriber must be notiried

59 STATE OPIOID PRESCRIBING POLICY: FLORIDA Speciaic rules for C- II prescriptions A pharmacist may partially Rill a C- II prescription over a period of 60 days, in periodic amounts up to the total amount prescribed, if the patient is either terminally ill or a long- term care patient. The pharmacist must write either "terminally ill or "LTCF patient" on the prescription For each partial Rilling, the date the prescription was partially Rilled, the quantity dispensed, the remaining quantify, and the identirication of the dispensing pharmacist must be documented

60 STATE OPIOID PRESCRIBING POLICY: FLORIDA Speciaic rules for C- II prescriptions In an emergency situation, a prescriber may verbally authorize a pharmacist to dispense a supply of C- II medication. Several rules apply to this process: The amount of medication dispensed is limited to that necessary to treat the patient during the emergency period The verbal order must be immediately reduced to writing by the pharmacist If the prescriber is not known to the pharmacist, the pharmacist must make a reasonable effort to verify the validity of the prescription, such as by calling the prescriber at a number listed in the telephone book Within 7 days following verbal authorization to dispense an emergency supply of C- II medication, the prescriber must furnish to the pharmacist a hard prescription that rerlects the emergency order

61 STATE OPIOID PRESCRIBING POLICY: FLORIDA Speciaic rules for C- II prescriptions No special Drug Enforcement Agency (DEA) registration is required to prescribe methadone for pain, and no special restrictions exist for the prescribing of methadone for pain. However, it is a good practice to write "for pain" on a methadone prescription issued to treat pain.

62 STATE OPIOID PRESCRIBING POLICY: FLORIDA E- FORCSE the Florida Prescription Drug Monitoring Program The Florida Prescription Drug Monitoring Program, known as E- FORCSE (Electronic- Florida Online Reporting of Controlled Substance Evaluation Program), was created by the 2009 Florida Legislature in an initiative to encourage safer prescribing of controlled substances and to reduce drug abuse and diversion within the state of Florida. E- FORCSE has selected Health Information Designs, LLC, to develop a database that collects and stores prescribing and dispensing data for controlled substances in Schedules II, III, and IV. The purpose of the PDMP is to provide the information that is collected in the database to health care practitioners to guide their decisions in prescribing and dispensing these highly abused prescription drugs.

63 STATE OPIOID PRESCRIBING POLICY: FLORIDA E- FORCSE the Florida Prescription Drug Monitoring Program Section , Florida Statutes, requires health care practitioners to report to the PDMP each time a controlled substance is dispensed to an individual. The information is reported through the electronic system as soon as possible but not more than 7 days after dispensing. This reporting timeframe ensures that health care practitioners have the most up- to- date information available. E- FORCSE complies with the Health Insurance Portability and Accountability Act (HIPAA) as it pertains to protected health information (PHI), electronic protected health information (EPHI), and all other relevant state and federal privacy and security laws and regulations. The information collected in the system will be used by the PDMP to encourage safer prescribing of controlled substances and to reduce drug abuse and diversion within the state of Florida.

64 STATE OPIOID PRESCRIBING POLICY: FLORIDA E- FORCSE the Florida Prescription Drug Monitoring Program and- data/e- forcse/

65 STATE OPIOID PRESCRIBING POLICY: FLORIDA CHRONIC PAIN Chronic nonmalignant pain - means pain, unrelated to cancer, which persists beyond the usual course of disease or the injury that is the cause of the pain or more than 90 days after surgery. REGISTRATION. Effective January 1, 2012, a physician licensed under chapter 458, chapter 459, chapter 461, or chapter 466 who prescribes any controlled substance, listed in Schedule II, Schedule III, or Schedule IV as derined in s , for the treatment of chronic nonmalignant pain, must: (a) Designate himself or herself as a controlled substance prescribing practitioner on the physician s practitioner prorile. (b) Comply with the requirements of this section and applicable board rules.

66 STATE OPIOID PRESCRIBING POLICY: FLORIDA Standards of Care Medical history & physical exam prior to beginning treatment Detailed medical records must be kept Written treatment plan for assessing and monitoring risk Controlled substance agreement Regular follow up as least every three months Referral as necessary

67 STATE OPIOID PRESCRIBING POLICY: FLORIDA Universal Precautions Utilize prescription drug monitoring program prior to writing a prescription Obtain old records from previous provider Initial urine drug testing on all patients and periodically Prescriptions for controlled substances must be written on a counterfeit- proof pad produced by an approved vendor or electronically prescribed Patient Prescriber Agreement - benerits and risks of opioids. Serves to educate, form a plan of care, counsel. Risk of harm from misuse, addiction, overdose, hyper analgesia and adverse effects discussed. %20Contract.pdf

68 STATE OPIOID PRESCRIBING POLICY: FLORIDA THINGS TO REMEMBER Don t prescribe if your gut tells you not to Co- administered diphenhydramine is for the histamine release, not the high EVERYONE GETS A STOOL SOFTENER / LAXATIVES Itch does not equal allergy True opiate allergy excludes ALL opiates Keep copies of everything (Rx, etc.) and write what every drug is for Be aware for inappropriate behavior When in doubt refer to a behavioral health specialist

69 STATE OPIOID PRESCRIBING POLICY: FLORIDA THINGS TO REMEMBER 15 is not a number on the pain scale The prescription drug monitoring program is your friend The Pharmacist is an even better friend You are a physician, not a drug dealer even though you both carry a pager The PDR is not a menu Do not prescribe opiates for anyone you are not willing to discharge from your practice. Physicians charged are NOT doing the right thing very small percentage. Do not be afraid of the meds.

70 FEDERAL & STATE LAWS RELATED TO THE PRESCRIBING OF CONTROLLED SUBSTANCES LEONARD SCHUCHMAN, DO, MPH, FAAFP PRESIDENT- ELECT, NJAOPS