06 Jun New Laws For Prescribing Controlled Substances in Florida
To combat the national opioid epidemic, in March 2018, the Florida Legislature passed laws creating new limits on prescriptions for pain medication. These restrictions do not apply to patients suffering pain from:
- Terminal illness;
- Provision of relief for symptoms related to an incurable, progressive illness or injury (chronic nonmalignant pain);
- Palliative care; or
- Serious traumatic injuries.
The law (Section 456.44(3)(d), F.S.) specifies requirements for prescribing practitioners seeing patients being treated with controlled substances for chronic nonmalignant pain. In proposing the 2018 legislation, lawmakers focused attention on preventing addiction through placing opioid prescription limits for patients with acute pain.
Effective July 1, 2018, the Controlled Substance Bill establishes prescribing limits, requires continuing education by prescribers on controlled substance, and expands required use of Florida’s Drug Monitoring Program (E-FORCSE®). The law also places a three-day limit on opioid prescription for acute pain. However, the practitioners may prescribe a seven-day supply if he or she determines that it is medically necessary. The law also requires that a prescribing practitioner see a patient being treated with controlled substances for chronic nonmalignant pain at least once every three months.
Requiring Continuing Education
Each prescribing practitioner who is registered with the United States Drug Enforcement Agency is required to take a 2 hour Board-approved continuing education course, unless the practitioner is already required to complete such a course under his or her practice act. The course must be completed by January 31, 2019, and at each subsequent licensure renewal.
Prescription Limitation for Acute Pain
A prescribing practitioner may prescribe or dispense up to a 3-day supply of a Schedule II opioid to alleviate acute pain. However, a prescribing practitioner may prescribe or dispense up to a 7-day supply for acute pain if the physician determines:
- more than a three-day supply is needed based on the professional judgement of the Prescriber;
- indicates “acute pain exception” on the prescription, AND
- documents the justification for deviating from the 3-day supply limit in the patient’s medical record
Prescriptions for Nonacute Pain
If the Prescriber writes a prescription for a Schedule II opioid for the treatment of pain other than acute pain, the Prescriber must indicate “Nonacute Pain” on the prescription.
Pain Management Clinics
All pain management clinics must be registered with the Department of Health as a pain management clinic or hold a certificate of exemption by January 1, 2019.
An applicant for a certificate of exemption must provide:
- The name or names under which the applicant does business;
- The address at which the pain management clinic is located;
- The specific exemption that the applicant is claiming, along with supporting documentation; AND
- Any other information DOH deems necessary.
Each certificate must be renewed biennially, be prominently displayed, and made available to the DOH or applicable board upon request.
Prescription Drug Monitoring Program
Each Prescriber and dispenser or his/her designee has a duty to consult the PDMP system to a patient’s controlled substance dispensing history each time a controlled substance is prescribed or dispensed to a patient age 16 or older unless a statutory exemption applies.
- There is required consultation of the PDMP except:
Patient is less than 16 years of age;
- Drug being prescribed is a non-opioid Schedule V;
System is not operational; or
- Requestor has technological or electrical failure.
Failure to consult the PDMP may result in a non-disciplinary citation by the regulatory board or further discipline.
PRESCRIPTION DRUG MONITORING PROGRAM (E-FORCSE®)3)
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. Controlled substance dispensing information is submitted to the database by dispensers and made available for consultation by prescribers.
Important Information for Data Submitters (Pharmacies and Dispensing Health Care Practitioners)
Dispensers of controlled substances are required to report to the PDMP each time a controlled substance in schedules II, III, IV, and V are dispensed to a patient, as soon thereafter as possible but no later than close of business the day after the prescription is dispensed.
Important Information for Data Requestors (Prescribers and Pharmacists)
Each Prescriber and dispenser or his or her designee has a duty to consult the PDMP system to review a patient’s controlled substance dispensing history each time a controlled substance is prescribed or dispensed to a patient age 16 or older unless a statutory exemption applies. Statutory exemptions include:
- If the patient is less than 16 years of age;
- Drug being prescribed is a non-opioid schedule V;
- System is not operational; or
- Requestor has technological or electrical failure.
STANDARDS OF PRACTICE4)
Although the standards of practice for Prescribers of controlled substances have not recently changed, it is important to appreciate that Florida law mandates certain documentation and treatment protocols for Prescribers.
A complete medical history and a physical examination must be conducted before beginning any treatment and must be documented in the medical record. The medical record must document:
- The nature and intensity of the pain;
- Current and past treatments for pain;
- Underlying or coexisting diseases or conditions;
- The effect of the pain on physical and psychological function;
- A review of previous medical records;
- Previous diagnostic studies;
- History of alcohol and substance abuse;
- The presence of one or more recognized medical indications for the use of a controlled substance; and
- A written plan for assessing each patient’s risk of aberrant drug-related behavior, which may include patient drug testing.
Each Prescriber must also 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.
After treatment begins, the Prescriber shall adjust drug therapy to the individual medical needs of each patient. Other treatment modalities, including a rehabilitation program, shall be considered depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment. The interdisciplinary nature of the treatment plan shall be documented.
Additionally, the Prescriber shall discuss the risks and benefits of the use of controlled substances including the risks of abuse and addiction, as well as physical dependence and its consequences, with the patient, persons designated by the patient, or the patient’s surrogate or guardian if the patient is incompetent.
Importantly, the Prescriber is required to use a written controlled substance agreement between the Prescriber and the patient outlining the patient’s responsibilities, including, but not limited to:
- Number and frequency of controlled substance prescriptions and refills;
- Patient compliance and reasons for which drug therapy may be discontinued, such as a violation of the agreement; and
- An agreement that controlled substances for the treatment of chronic nonmalignant pain shall be prescribed by a single treating Prescriber unless otherwise authorized by the treating Prescriber and documented in the medical record.
The patient shall be seen at regular intervals, not to exceed three months, to assess the efficacy 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. If treatment goals are not being achieved, despite medication adjustments, the Prescriber shall reevaluate the appropriateness of continued treatment. The Prescriber shall monitor patient compliance in medication usage, related treatment plans, controlled substance agreements, and indications of substance abuse or diversion at a minimum of three-month intervals.
The Prescriber shall refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention shall be given to those patients who are at risk for misusing their medications and to those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder requires extra care, monitoring, and documentation and requires consultation with or referral to an addiction medicine specialist or a psychiatrist.
The medical records must include, but are not limited to:
- The complete medical history and a physical examination, including history of drug abuse or dependence;
- Diagnostic, therapeutic, and laboratory results;
- Evaluations and consultations;
- Treatment objectives;
- Discussion of risks and benefits;
- 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 identification;
- If a written prescription for a controlled substance is given to the patient, a duplicate of the prescription; and
- The registrant’s full name presented in a legible manner
Prescribers shall immediately refer patients with signs or symptoms of substance abuse to a boardcertified pain management physician, an addiction medicine specialist, or a mental health addiction facility as it pertains to drug abuse or addiction unless the Prescriber is a physician who is board-certified or board-eligible in pain management.
In general, the above restrictions do not apply to a board-eligible or board-certified anesthesiologist, physiatrist, rheumatologist, or neurologist, or to a board-certified physician who has surgical privileges at a hospital or ambulatory surgery center and primarily provides surgical services.
For the treatment of acute pain only, a prescription for an opioid drug listed as a Schedule II controlled substance in s. 893.03 or 21 U.S.C. s. 812 may not exceed a 3-day supply, except that up to a 7-day supply may be prescribed if:
- The Prescriber, in his or her professional judgment, believes that more than a 3-day supply of such an opioid is medically necessary to treat the patient’s pain as an acute medical condition;
- The Prescriber indicates “ACUTE PAIN EXCEPTION” on the prescription; and
- The Prescriber adequately documents in the patient’s medical records the acute medical condition and lack of alternative treatment options that justify deviation from the 3-day supply limit established in this subsection.
For the treatment of pain other than acute pain, a prescriber must indicate “NONACUTE PAIN” on a prescription for an opioid drug listed as a Schedule II controlled substance in s. 893.03 or 21 U.S.C. s. 812.
Importantly, for the treatment of pain related to a traumatic injury with an injury – severity score of 9 or greater, a Prescriber who prescribes a Schedule II controlled substance listed in s. 893.03 or 21 U.S.C. s. 812 must concurrently prescribe an emergency opioid antagonist, as defined in s. 381.887(1).
COMPLIANCE WITH NEW AND CURRENT PRESCRIBING LAWS
Individual professional boards are required to adopt rules establishing guidelines for prescribing controlled substances for acute pain, including evaluation of the patient, creation and maintenance of a treatment plan, obtaining informed consent and agreement for treatment, periodic review of the treatment plan, consultation, medical record review, and compliance with controlled substance laws and regulations.
Importantly, failure of a Prescriber to follow such guidelines constitutes grounds for disciplinary action. As importantly, the identification of “Standards of Practice” within Florida law creates a potential haven for Plaintiffs who merely need to identify failures to comply with legislative standards in order to demonstrate claims of negligence. In October 2018, Florida will extend the scope of this legislation to include Advanced Practice Registered Nurses.
It is recommended that Prescribers not only re-evaluate their prescription and/or dispending practices but also review and possibly modify office protocols and collaborative agreements to reflect these new changes.