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Frequently Asked Questions

Continuing Education Information

Pharmacy PSA


Physician, Dentist, Podiatrist, Certified Optometrist, Advanced Registered Nurse Practitioner, and Physician Assistant.

No. The “Controlled Substance Prescriber” designation found on the Department of Health’s website, is only an indicator by the prescribing practitioner that he/she prescribes controlled substances for the treatment of chronic non-malignant pain. It is for patient information only and does not affect the authority of a physician to write prescriptions for Schedule II opioids.

Yes. If a prescription for a Schedule II opioid does not meet the requirements as specified in Section 456.44, F.S., the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any deviation or change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

No. The law does not require the words “Acute Pain” to be written on a prescription, but rather the words “ACUTE PAIN EXCEPTION” for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S

A prescribing practitioner may prescribe up to a 7-day supply if the prescriber:

  1. determines it is medically necessary;
  2. indicates "acute pain exception" on the prescription; AND
  3. documents the justification for deviating from the 3-day supply limit in the patient's medical record.

 

No. The law only requires the words “ACUTE PAIN EXCEPTION” to be written for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S.

No. The law provides that for the treatment of acute pain, 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 certain conditions are met. The “3-day” and “7-day” applies to the supply of the opioid drug listed as a Schedule II controlled substance, not the number of days after the prescription is written for which it is still valid.

Yes. If the prescription is for a greater than a 7-day supply, the prescriber must indicate “Non-Acute Pain.”

Exceptions to acute pain limits:

  1. cancer,
  2. a terminal condition (a progressive disease or medical or surgical condition that causes significant functional impairment, is not considered by the treating physician to be reversible without the administration of life-sustaining procedures, and will result in death within 1 year after diagnosis if the condition runs its normal course),
  3. pain treated with palliative care (the provision of relief for symptoms related to an incurable, progressive illness or injury), and
  4. a traumatic injury with an Injury Severity Score of 9 or higher. See Trauma.org for more information.
**The law did not change prescribing of controlled substances for treatment of nonacute pain or chronic nonmalignant pain.

 

"Acute pain" is the normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness. It does not include pain related to cancer, terminal conditions, pain treated with palliative care, or traumatic injuries with an Injury Severity Score of 9 or greater.

When prescribing opioids to a patient with an Injury Severity Score of 9 or higher, the prescriber must:

  1. Prescribe an emergency opioid antagonist AND
  2. Indicate “nonacute pain” on the prescription

 

No. For example, the day supply limits do not apply to Hycodan® Cough Syrup for a patient who is being treated for an unrelenting cough or to Ritalin® for a patient being treated for ADHD. The 3-day and up to 7-day limits apply to Schedule II opioids prescribed for the treatment of acute pain.

No. The days supply limits apply to Schedule II opioids prescribed for the treatment of acute pain.

If a prescription for a Schedule II opioid does not meet the requirements as specified in the law, the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

Yes. If the “note” is transmitted with or considered to be part of the actual electronic prescription to be transmitted to the pharmacist, then the annotation of “Acute Pain Exception” or “Non-Acute Pain” would be acceptable.

The law is silent and does not reference the filling of out-of-state prescriptions (which may or may not comply with Florida’s new requirements). The law does not set forth a prohibition on filling them.

No. The legislature did not carve out an exemption for prescribers in pain management clinics who prescribe Schedule II opioid controlled substances for the treatment of acute pain. They are subject to the 3 and up to 7-day supply limits and to the labeling requirements for “ACUTE PAIN EXCEPTION” (for 4-7 day supply) and “NONACUTE PAIN” (for greater than 7-day supply).

No. This is not a requirement of the new controlled substances law. After the passing of CS/CS/HB 21, only the section numbering and title for Section 456.44, Controlled Substance Prescribing, changed to: Section 456.44(3) Standards of Practice for Treatment of Chronic Nonmalignant Pain.
The language did not change and reads:
S. 456.44(3)(d) states, in part, “The patient shall be seen by the registrant at regular intervals, not to exceed 3 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 to review the etiology of the pain….”

Continuing Education FAQs:

By January 31, 2019 and at each subsequent renewal.

All prescribing practitioners registered with the United States Drug Enforcement Agency and authorized to prescribe controlled substances must complete the continuing education course.

Unless the practitioner is already required to complete such a course under his or her practice act.

Yes. Advanced Registered Nurse Practitioners and Physician Assistants have a separate 3-hour CE requirement for controlled substances and are exempted from the new two-hour course.

Yes. Any military status practitioner who has a personal DEA registration is required to take the CE/CME course by January 31, 2019.

The course taken by January 31, 2019 will count toward the first renewal cycle. For further questions regarding your renewal period, check with your respective board.

The course must be offered by a statewide professional association of physicians in this state that is accredited to provide educational activities designated for the American Medical Association Physician's Recognition Award Category I Credit or the American Osteopathic Category 1-A continuing medical education requirement AND approved by their respective board.

Please visit www.cebroker.com to view all profession-specific board approved providers.

www.cebroker.com

Go to the course search, under "All Subjects," click the drop-down menu.

Click on "Prescribing Controlled Substances."

Once the courses are approved, then the Prescribing Controlled Substances tab will lead to registration for the available CE courses.

The course may be taken live or through distance learning from any one of the approved providers.

DOH may not renew the license of a prescriber who fails to complete this continuing education requirement.

Yes

Prescription Drug Monitoring Program FAQs:
General Questions

If you do not prescribe any controlled substances you are not required to register with or consult E-FORCSE.

You are still authorized to register. You can view your patient’s-controlled substance dispensing histories.

Prescribers, dispensers and their designees may register for access at https://florida.pmpaware.net.

Yes.

The DOH will issue a non-disciplinary citation for the initial offense.

Any subsequent offense will result in disciplinary action against the prescribing/dispensing practitioner's license. Disciplinary guidelines are individually established by the appropriate licensing board.

Yes. Information that is more than 4 years old.

Data Requesters
Prescriber Consultation

A prescriber or his or her designee must consult the PDMP to review their patient's controlled substance dispensing history prior to prescribing a controlled substance in Schedules II-V, as defined in section 893.03, F.S., for patients age 16 and older.

 

  • If the PDMP system is not operational as determined by DOH, or
  • The PDMP cannot be accessed by the prescriber practitioner due to a temporary technological or electrical failure or
  • When prescribing a nonopioid Schedule V drug or
  • The patient is less than 16 years of age

 

The prescriber must document in the patient's record the reason the PDMP was not consulted and may prescribe no more than a 3-day supply of a controlled substance.

The prescriber is not required to consult the PDMP before each refill, however, the prescriber must consult the PDMP prior to writing a new prescription for a controlled substance listed in Schedule II through V. A prescription for a controlled substance listed in Schedule II may not be refilled.

The statute does not provide any guidance on how far in advance the PDMP may be consulted. Please refer to your Board's website for further guidance.

The PDMP must be consulted each time a prescription for a controlled substance is written.

Dispenser Consultation

A dispenser or a designee of a dispenser must consult the PDMP to review a patient’s-controlled substance dispensing history prior to dispensing a controlled substance in schedules II-V, as defined in section 893.03, F.S., for patients age 16 or older for each new and refill prescription.

A dispenser or a designee of a dispenser does not have to consult the PDMP when dispensing a nonopioid controlled substance listed in Schedule V of s. 893.03, F.S. or 21 U.S.C. 812.

The duty to consult the system does not apply when the system:

  • Is determined by the department to be nonoperational; or
  • Cannot be accessed by the dispenser or a designee of the dispenser because of a temporary technological or electrical failure

 

A dispenser or designee of a dispenser who does not consult the PDMP shall document the reason he or she did not consult the system in the patient's medical record or prescription record and shall not dispense greater than a 3-day supply of a controlled substance to the patient.

A dispenser must consult the PDMP on the new prescription and on each subsequent refill.

Data Submitters

A dispenser is a dispensing health care practitioner, pharmacy, or pharmacist licensed to dispense controlled substances to the ultimate consumer or his or her agent in or into this state.

A dispensing practitioner is a practitioner authorized by law to prescribe drugs who may dispense such drugs to her or his patients in the regular course of her or his practice in compliance with s. 465.0276, F.S. Dispensing practitioners may include: physicians, dentists, certified optometrists, podiatrists, advanced registered nurse practitioners and physician assistants.

Dispensers are required to report to the PDMP each time a controlled substance is dispensed to a patient, as soon thereafter as possible, but no later than close of business the day after the prescription is dispensed unless an extension or exemption is approved by the Department of Health.

All controlled substances in schedules II through V must be reported to the system by the close of the next business day. If the dispenser does not dispense any controlled substances for that day, then a zero report must be submitted.

Yes, there are two exemptions from reporting:

  • Controlled substances administered to patients;
  • Controlled substances dispensed in the health care system of the Department of Corrections; and
  • Controlled substances dispensed to patients under the age of 16 are exempt from reporting to E-FORCSE.

 

 

  • The telephone number of the person for whom the prescription was written, in addition to the name, address, and date of birth the prescriber currently inputs;
  • Whether the prescription is an initial prescription or a refill, and the number of refills prescribed;
  • The name of the individual picking up the controlled substance prescription and the type and issuer of the identification provided; and
  • The pharmacy's DOH-issued permit number or the dispensing practitioner's DOH-issued license number

 

The Department has published a notice of rule development and will be amending Rule 64K-1.002, FAC . The PDMP will continue to accept submissions in the ASAP 2009 version 4.2 and the new 4.2a standard for one year from the effective date of the rule.

 

  • The pharmacy permit number or the dispensing health care practitioner's license number.
  • The name of the individual picking up the controlled substance prescription and type and issuer of the identification provided.

 

A person who willfully and knowingly fails to report the dispensing of a controlled substance as required by this law commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083, F.S. Further, the department shall issue a non-disciplinary citation to any prescriber or dispenser who fails to consult the system as required by this subsection for an initial offense. Each subsequent offense is subject to disciplinary action pursuant to s. 456.073, F.S.

Back
Frequently Asked Questions

Continuing Education Information

Pharmacy PSA


Physician, Dentist, Podiatrist, Certified Optometrist, Advanced Registered Nurse Practitioner, and Physician Assistant.

No. The “Controlled Substance Prescriber” designation found on the Department of Health’s website, is only an indicator by the prescribing practitioner that he/she prescribes controlled substances for the treatment of chronic non-malignant pain. It is for patient information only and does not affect the authority of a physician to write prescriptions for Schedule II opioids.

Yes. If a prescription for a Schedule II opioid does not meet the requirements as specified in Section 456.44, F.S., the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any deviation or change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

No. The law does not require the words “Acute Pain” to be written on a prescription, but rather the words “ACUTE PAIN EXCEPTION” for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S

A prescribing practitioner may prescribe up to a 7-day supply if the prescriber:

  1. determines it is medically necessary;
  2. indicates "acute pain exception" on the prescription; AND
  3. documents the justification for deviating from the 3-day supply limit in the patient's medical record.

 

No. The law only requires the words “ACUTE PAIN EXCEPTION” to be written for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S.

No. The law provides that for the treatment of acute pain, 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 certain conditions are met. The “3-day” and “7-day” applies to the supply of the opioid drug listed as a Schedule II controlled substance, not the number of days after the prescription is written for which it is still valid.

Yes. If the prescription is for a greater than a 7-day supply, the prescriber must indicate “Non-Acute Pain.”

Exceptions to acute pain limits:

  1. cancer,
  2. a terminal condition (a progressive disease or medical or surgical condition that causes significant functional impairment, is not considered by the treating physician to be reversible without the administration of life-sustaining procedures, and will result in death within 1 year after diagnosis if the condition runs its normal course),
  3. pain treated with palliative care (the provision of relief for symptoms related to an incurable, progressive illness or injury), and
  4. a traumatic injury with an Injury Severity Score of 9 or higher. See Trauma.org for more information.
**The law did not change prescribing of controlled substances for treatment of nonacute pain or chronic nonmalignant pain.

 

"Acute pain" is the normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness. It does not include pain related to cancer, terminal conditions, pain treated with palliative care, or traumatic injuries with an Injury Severity Score of 9 or greater.

When prescribing opioids to a patient with an Injury Severity Score of 9 or higher, the prescriber must:

  1. Prescribe an emergency opioid antagonist AND
  2. Indicate “nonacute pain” on the prescription

 

No. For example, the day supply limits do not apply to Hycodan® Cough Syrup for a patient who is being treated for an unrelenting cough or to Ritalin® for a patient being treated for ADHD. The 3-day and up to 7-day limits apply to Schedule II opioids prescribed for the treatment of acute pain.

No. The days supply limits apply to Schedule II opioids prescribed for the treatment of acute pain.

If a prescription for a Schedule II opioid does not meet the requirements as specified in the law, the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

Yes. If the “note” is transmitted with or considered to be part of the actual electronic prescription to be transmitted to the pharmacist, then the annotation of “Acute Pain Exception” or “Non-Acute Pain” would be acceptable.

The law is silent and does not reference the filling of out-of-state prescriptions (which may or may not comply with Florida’s new requirements). The law does not set forth a prohibition on filling them.

No. The legislature did not carve out an exemption for prescribers in pain management clinics who prescribe Schedule II opioid controlled substances for the treatment of acute pain. They are subject to the 3 and up to 7-day supply limits and to the labeling requirements for “ACUTE PAIN EXCEPTION” (for 4-7 day supply) and “NONACUTE PAIN” (for greater than 7-day supply).

No. This is not a requirement of the new controlled substances law. After the passing of CS/CS/HB 21, only the section numbering and title for Section 456.44, Controlled Substance Prescribing, changed to: Section 456.44(3) Standards of Practice for Treatment of Chronic Nonmalignant Pain.
The language did not change and reads:
S. 456.44(3)(d) states, in part, “The patient shall be seen by the registrant at regular intervals, not to exceed 3 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 to review the etiology of the pain….”

Continuing Education FAQs:

By January 31, 2019 and at each subsequent renewal.

All prescribing practitioners registered with the United States Drug Enforcement Agency and authorized to prescribe controlled substances must complete the continuing education course.

Unless the practitioner is already required to complete such a course under his or her practice act.

Yes. Advanced Registered Nurse Practitioners and Physician Assistants have a separate 3-hour CE requirement for controlled substances and are exempted from the new two-hour course.

Yes. Any military status practitioner who has a personal DEA registration is required to take the CE/CME course by January 31, 2019.

The course taken by January 31, 2019 will count toward the first renewal cycle. For further questions regarding your renewal period, check with your respective board.

The course must be offered by a statewide professional association of physicians in this state that is accredited to provide educational activities designated for the American Medical Association Physician's Recognition Award Category I Credit or the American Osteopathic Category 1-A continuing medical education requirement AND approved by their respective board.

Please visit www.cebroker.com to view all profession-specific board approved providers.

www.cebroker.com

Go to the course search, under "All Subjects," click the drop-down menu.

Click on "Prescribing Controlled Substances."

Once the courses are approved, then the Prescribing Controlled Substances tab will lead to registration for the available CE courses.

The course may be taken live or through distance learning from any one of the approved providers.

DOH may not renew the license of a prescriber who fails to complete this continuing education requirement.

Yes

Prescription Drug Monitoring Program FAQs:
General Questions

If you do not prescribe any controlled substances you are not required to register with or consult E-FORCSE.

You are still authorized to register. You can view your patient’s-controlled substance dispensing histories.

Prescribers, dispensers and their designees may register for access at https://florida.pmpaware.net.

Yes.

The DOH will issue a non-disciplinary citation for the initial offense.

Any subsequent offense will result in disciplinary action against the prescribing/dispensing practitioner's license. Disciplinary guidelines are individually established by the appropriate licensing board.

Yes. Information that is more than 4 years old.

Data Requesters
Prescriber Consultation

A prescriber or his or her designee must consult the PDMP to review their patient's controlled substance dispensing history prior to prescribing a controlled substance in Schedules II-V, as defined in section 893.03, F.S., for patients age 16 and older.

 

  • If the PDMP system is not operational as determined by DOH, or
  • The PDMP cannot be accessed by the prescriber practitioner due to a temporary technological or electrical failure or
  • When prescribing a nonopioid Schedule V drug or
  • The patient is less than 16 years of age

 

The prescriber must document in the patient's record the reason the PDMP was not consulted and may prescribe no more than a 3-day supply of a controlled substance.

The prescriber is not required to consult the PDMP before each refill, however, the prescriber must consult the PDMP prior to writing a new prescription for a controlled substance listed in Schedule II through V. A prescription for a controlled substance listed in Schedule II may not be refilled.

The statute does not provide any guidance on how far in advance the PDMP may be consulted. Please refer to your Board's website for further guidance.

The PDMP must be consulted each time a prescription for a controlled substance is written.

Dispenser Consultation

A dispenser or a designee of a dispenser must consult the PDMP to review a patient’s-controlled substance dispensing history prior to dispensing a controlled substance in schedules II-V, as defined in section 893.03, F.S., for patients age 16 or older for each new and refill prescription.

A dispenser or a designee of a dispenser does not have to consult the PDMP when dispensing a nonopioid controlled substance listed in Schedule V of s. 893.03, F.S. or 21 U.S.C. 812.

The duty to consult the system does not apply when the system:

  • Is determined by the department to be nonoperational; or
  • Cannot be accessed by the dispenser or a designee of the dispenser because of a temporary technological or electrical failure

 

A dispenser or designee of a dispenser who does not consult the PDMP shall document the reason he or she did not consult the system in the patient's medical record or prescription record and shall not dispense greater than a 3-day supply of a controlled substance to the patient.

A dispenser must consult the PDMP on the new prescription and on each subsequent refill.

Data Submitters

A dispenser is a dispensing health care practitioner, pharmacy, or pharmacist licensed to dispense controlled substances to the ultimate consumer or his or her agent in or into this state.

A dispensing practitioner is a practitioner authorized by law to prescribe drugs who may dispense such drugs to her or his patients in the regular course of her or his practice in compliance with s. 465.0276, F.S. Dispensing practitioners may include: physicians, dentists, certified optometrists, podiatrists, advanced registered nurse practitioners and physician assistants.

Dispensers are required to report to the PDMP each time a controlled substance is dispensed to a patient, as soon thereafter as possible, but no later than close of business the day after the prescription is dispensed unless an extension or exemption is approved by the Department of Health.

All controlled substances in schedules II through V must be reported to the system by the close of the next business day. If the dispenser does not dispense any controlled substances for that day, then a zero report must be submitted.

Yes, there are two exemptions from reporting:

  • Controlled substances administered to patients;
  • Controlled substances dispensed in the health care system of the Department of Corrections; and
  • Controlled substances dispensed to patients under the age of 16 are exempt from reporting to E-FORCSE.

 

 

  • The telephone number of the person for whom the prescription was written, in addition to the name, address, and date of birth the prescriber currently inputs;
  • Whether the prescription is an initial prescription or a refill, and the number of refills prescribed;
  • The name of the individual picking up the controlled substance prescription and the type and issuer of the identification provided; and
  • The pharmacy's DOH-issued permit number or the dispensing practitioner's DOH-issued license number

 

The Department has published a notice of rule development and will be amending Rule 64K-1.002, FAC . The PDMP will continue to accept submissions in the ASAP 2009 version 4.2 and the new 4.2a standard for one year from the effective date of the rule.

 

  • The pharmacy permit number or the dispensing health care practitioner's license number.
  • The name of the individual picking up the controlled substance prescription and type and issuer of the identification provided.

 

A person who willfully and knowingly fails to report the dispensing of a controlled substance as required by this law commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083, F.S. Further, the department shall issue a non-disciplinary citation to any prescriber or dispenser who fails to consult the system as required by this subsection for an initial offense. Each subsequent offense is subject to disciplinary action pursuant to s. 456.073, F.S.

Back
Frequently Asked Questions

Continuing Education Information

Pharmacy PSA


Physician, Dentist, Podiatrist, Certified Optometrist, Advanced Registered Nurse Practitioner, and Physician Assistant.

No. The “Controlled Substance Prescriber” designation found on the Department of Health’s website, is only an indicator by the prescribing practitioner that he/she prescribes controlled substances for the treatment of chronic non-malignant pain. It is for patient information only and does not affect the authority of a physician to write prescriptions for Schedule II opioids.

Yes. If a prescription for a Schedule II opioid does not meet the requirements as specified in Section 456.44, F.S., the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any deviation or change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

No. The law does not require the words “Acute Pain” to be written on a prescription, but rather the words “ACUTE PAIN EXCEPTION” for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S

A prescribing practitioner may prescribe up to a 7-day supply if the prescriber:

  1. determines it is medically necessary;
  2. indicates "acute pain exception" on the prescription; AND
  3. documents the justification for deviating from the 3-day supply limit in the patient's medical record.

 

No. The law only requires the words “ACUTE PAIN EXCEPTION” to be written for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S.

No. The law provides that for the treatment of acute pain, 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 certain conditions are met. The “3-day” and “7-day” applies to the supply of the opioid drug listed as a Schedule II controlled substance, not the number of days after the prescription is written for which it is still valid.

Yes. If the prescription is for a greater than a 7-day supply, the prescriber must indicate “Non-Acute Pain.”

Exceptions to acute pain limits:

  1. cancer,
  2. a terminal condition (a progressive disease or medical or surgical condition that causes significant functional impairment, is not considered by the treating physician to be reversible without the administration of life-sustaining procedures, and will result in death within 1 year after diagnosis if the condition runs its normal course),
  3. pain treated with palliative care (the provision of relief for symptoms related to an incurable, progressive illness or injury), and
  4. a traumatic injury with an Injury Severity Score of 9 or higher. See Trauma.org for more information.
**The law did not change prescribing of controlled substances for treatment of nonacute pain or chronic nonmalignant pain.

 

"Acute pain" is the normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness. It does not include pain related to cancer, terminal conditions, pain treated with palliative care, or traumatic injuries with an Injury Severity Score of 9 or greater.

When prescribing opioids to a patient with an Injury Severity Score of 9 or higher, the prescriber must:

  1. Prescribe an emergency opioid antagonist AND
  2. Indicate “nonacute pain” on the prescription

 

No. For example, the day supply limits do not apply to Hycodan® Cough Syrup for a patient who is being treated for an unrelenting cough or to Ritalin® for a patient being treated for ADHD. The 3-day and up to 7-day limits apply to Schedule II opioids prescribed for the treatment of acute pain.

No. The days supply limits apply to Schedule II opioids prescribed for the treatment of acute pain.

If a prescription for a Schedule II opioid does not meet the requirements as specified in the law, the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

Yes. If the “note” is transmitted with or considered to be part of the actual electronic prescription to be transmitted to the pharmacist, then the annotation of “Acute Pain Exception” or “Non-Acute Pain” would be acceptable.

The law is silent and does not reference the filling of out-of-state prescriptions (which may or may not comply with Florida’s new requirements). The law does not set forth a prohibition on filling them.

No. The legislature did not carve out an exemption for prescribers in pain management clinics who prescribe Schedule II opioid controlled substances for the treatment of acute pain. They are subject to the 3 and up to 7-day supply limits and to the labeling requirements for “ACUTE PAIN EXCEPTION” (for 4-7 day supply) and “NONACUTE PAIN” (for greater than 7-day supply).

No. This is not a requirement of the new controlled substances law. After the passing of CS/CS/HB 21, only the section numbering and title for Section 456.44, Controlled Substance Prescribing, changed to: Section 456.44(3) Standards of Practice for Treatment of Chronic Nonmalignant Pain.
The language did not change and reads:
S. 456.44(3)(d) states, in part, “The patient shall be seen by the registrant at regular intervals, not to exceed 3 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 to review the etiology of the pain….”

Continuing Education FAQs:

By January 31, 2019 and at each subsequent renewal.

All prescribing practitioners registered with the United States Drug Enforcement Agency and authorized to prescribe controlled substances must complete the continuing education course.

Unless the practitioner is already required to complete such a course under his or her practice act.

Yes. Advanced Registered Nurse Practitioners and Physician Assistants have a separate 3-hour CE requirement for controlled substances and are exempted from the new two-hour course.

Yes. Any military status practitioner who has a personal DEA registration is required to take the CE/CME course by January 31, 2019.

The course taken by January 31, 2019 will count toward the first renewal cycle. For further questions regarding your renewal period, check with your respective board.

The course must be offered by a statewide professional association of physicians in this state that is accredited to provide educational activities designated for the American Medical Association Physician's Recognition Award Category I Credit or the American Osteopathic Category 1-A continuing medical education requirement AND approved by their respective board.

Please visit www.cebroker.com to view all profession-specific board approved providers.

www.cebroker.com

Go to the course search, under "All Subjects," click the drop-down menu.

Click on "Prescribing Controlled Substances."

Once the courses are approved, then the Prescribing Controlled Substances tab will lead to registration for the available CE courses.

The course may be taken live or through distance learning from any one of the approved providers.

DOH may not renew the license of a prescriber who fails to complete this continuing education requirement.

Yes

Prescription Drug Monitoring Program FAQs:
General Questions

If you do not prescribe any controlled substances you are not required to register with or consult E-FORCSE.

You are still authorized to register. You can view your patient’s-controlled substance dispensing histories.

Prescribers, dispensers and their designees may register for access at https://florida.pmpaware.net.

Yes.

The DOH will issue a non-disciplinary citation for the initial offense.

Any subsequent offense will result in disciplinary action against the prescribing/dispensing practitioner's license. Disciplinary guidelines are individually established by the appropriate licensing board.

Yes. Information that is more than 4 years old.

Data Requesters
Prescriber Consultation

A prescriber or his or her designee must consult the PDMP to review their patient's controlled substance dispensing history prior to prescribing a controlled substance in Schedules II-V, as defined in section 893.03, F.S., for patients age 16 and older.

 

  • If the PDMP system is not operational as determined by DOH, or
  • The PDMP cannot be accessed by the prescriber practitioner due to a temporary technological or electrical failure or
  • When prescribing a nonopioid Schedule V drug or
  • The patient is less than 16 years of age

 

The prescriber must document in the patient's record the reason the PDMP was not consulted and may prescribe no more than a 3-day supply of a controlled substance.

The prescriber is not required to consult the PDMP before each refill, however, the prescriber must consult the PDMP prior to writing a new prescription for a controlled substance listed in Schedule II through V. A prescription for a controlled substance listed in Schedule II may not be refilled.

The statute does not provide any guidance on how far in advance the PDMP may be consulted. Please refer to your Board's website for further guidance.

The PDMP must be consulted each time a prescription for a controlled substance is written.

Dispenser Consultation

A dispenser or a designee of a dispenser must consult the PDMP to review a patient’s-controlled substance dispensing history prior to dispensing a controlled substance in schedules II-V, as defined in section 893.03, F.S., for patients age 16 or older for each new and refill prescription.

A dispenser or a designee of a dispenser does not have to consult the PDMP when dispensing a nonopioid controlled substance listed in Schedule V of s. 893.03, F.S. or 21 U.S.C. 812.

The duty to consult the system does not apply when the system:

  • Is determined by the department to be nonoperational; or
  • Cannot be accessed by the dispenser or a designee of the dispenser because of a temporary technological or electrical failure

 

A dispenser or designee of a dispenser who does not consult the PDMP shall document the reason he or she did not consult the system in the patient's medical record or prescription record and shall not dispense greater than a 3-day supply of a controlled substance to the patient.

A dispenser must consult the PDMP on the new prescription and on each subsequent refill.

Data Submitters

A dispenser is a dispensing health care practitioner, pharmacy, or pharmacist licensed to dispense controlled substances to the ultimate consumer or his or her agent in or into this state.

A dispensing practitioner is a practitioner authorized by law to prescribe drugs who may dispense such drugs to her or his patients in the regular course of her or his practice in compliance with s. 465.0276, F.S. Dispensing practitioners may include: physicians, dentists, certified optometrists, podiatrists, advanced registered nurse practitioners and physician assistants.

Dispensers are required to report to the PDMP each time a controlled substance is dispensed to a patient, as soon thereafter as possible, but no later than close of business the day after the prescription is dispensed unless an extension or exemption is approved by the Department of Health.

All controlled substances in schedules II through V must be reported to the system by the close of the next business day. If the dispenser does not dispense any controlled substances for that day, then a zero report must be submitted.

Yes, there are two exemptions from reporting:

  • Controlled substances administered to patients;
  • Controlled substances dispensed in the health care system of the Department of Corrections; and
  • Controlled substances dispensed to patients under the age of 16 are exempt from reporting to E-FORCSE.

 

 

  • The telephone number of the person for whom the prescription was written, in addition to the name, address, and date of birth the prescriber currently inputs;
  • Whether the prescription is an initial prescription or a refill, and the number of refills prescribed;
  • The name of the individual picking up the controlled substance prescription and the type and issuer of the identification provided; and
  • The pharmacy's DOH-issued permit number or the dispensing practitioner's DOH-issued license number

 

The Department has published a notice of rule development and will be amending Rule 64K-1.002, FAC . The PDMP will continue to accept submissions in the ASAP 2009 version 4.2 and the new 4.2a standard for one year from the effective date of the rule.

 

  • The pharmacy permit number or the dispensing health care practitioner's license number.
  • The name of the individual picking up the controlled substance prescription and type and issuer of the identification provided.

 

A person who willfully and knowingly fails to report the dispensing of a controlled substance as required by this law commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083, F.S. Further, the department shall issue a non-disciplinary citation to any prescriber or dispenser who fails to consult the system as required by this subsection for an initial offense. Each subsequent offense is subject to disciplinary action pursuant to s. 456.073, F.S.

Back
Frequently Asked Questions

Continuing Education Information

Pharmacy PSA


Physician, Dentist, Podiatrist, Certified Optometrist, Advanced Registered Nurse Practitioner, and Physician Assistant.

No. The “Controlled Substance Prescriber” designation found on the Department of Health’s website, is only an indicator by the prescribing practitioner that he/she prescribes controlled substances for the treatment of chronic non-malignant pain. It is for patient information only and does not affect the authority of a physician to write prescriptions for Schedule II opioids.

Yes. If a prescription for a Schedule II opioid does not meet the requirements as specified in Section 456.44, F.S., the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any deviation or change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

No. The law does not require the words “Acute Pain” to be written on a prescription, but rather the words “ACUTE PAIN EXCEPTION” for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S

A prescribing practitioner may prescribe up to a 7-day supply if the prescriber:

  1. determines it is medically necessary;
  2. indicates "acute pain exception" on the prescription; AND
  3. documents the justification for deviating from the 3-day supply limit in the patient's medical record.

 

No. The law only requires the words “ACUTE PAIN EXCEPTION” to be written for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S.

No. The law provides that for the treatment of acute pain, 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 certain conditions are met. The “3-day” and “7-day” applies to the supply of the opioid drug listed as a Schedule II controlled substance, not the number of days after the prescription is written for which it is still valid.

Yes. If the prescription is for a greater than a 7-day supply, the prescriber must indicate “Non-Acute Pain.”

Exceptions to acute pain limits:

  1. cancer,
  2. a terminal condition (a progressive disease or medical or surgical condition that causes significant functional impairment, is not considered by the treating physician to be reversible without the administration of life-sustaining procedures, and will result in death within 1 year after diagnosis if the condition runs its normal course),
  3. pain treated with palliative care (the provision of relief for symptoms related to an incurable, progressive illness or injury), and
  4. a traumatic injury with an Injury Severity Score of 9 or higher. See Trauma.org for more information.
**The law did not change prescribing of controlled substances for treatment of nonacute pain or chronic nonmalignant pain.

 

"Acute pain" is the normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness. It does not include pain related to cancer, terminal conditions, pain treated with palliative care, or traumatic injuries with an Injury Severity Score of 9 or greater.

When prescribing opioids to a patient with an Injury Severity Score of 9 or higher, the prescriber must:

  1. Prescribe an emergency opioid antagonist AND
  2. Indicate “nonacute pain” on the prescription

 

No. For example, the day supply limits do not apply to Hycodan® Cough Syrup for a patient who is being treated for an unrelenting cough or to Ritalin® for a patient being treated for ADHD. The 3-day and up to 7-day limits apply to Schedule II opioids prescribed for the treatment of acute pain.

No. The days supply limits apply to Schedule II opioids prescribed for the treatment of acute pain.

If a prescription for a Schedule II opioid does not meet the requirements as specified in the law, the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

Yes. If the “note” is transmitted with or considered to be part of the actual electronic prescription to be transmitted to the pharmacist, then the annotation of “Acute Pain Exception” or “Non-Acute Pain” would be acceptable.

The law is silent and does not reference the filling of out-of-state prescriptions (which may or may not comply with Florida’s new requirements). The law does not set forth a prohibition on filling them.

No. The legislature did not carve out an exemption for prescribers in pain management clinics who prescribe Schedule II opioid controlled substances for the treatment of acute pain. They are subject to the 3 and up to 7-day supply limits and to the labeling requirements for “ACUTE PAIN EXCEPTION” (for 4-7 day supply) and “NONACUTE PAIN” (for greater than 7-day supply).

No. This is not a requirement of the new controlled substances law. After the passing of CS/CS/HB 21, only the section numbering and title for Section 456.44, Controlled Substance Prescribing, changed to: Section 456.44(3) Standards of Practice for Treatment of Chronic Nonmalignant Pain.
The language did not change and reads:
S. 456.44(3)(d) states, in part, “The patient shall be seen by the registrant at regular intervals, not to exceed 3 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 to review the etiology of the pain….”

Continuing Education FAQs:

No. Only Advanced Practice Registered Nurses are required to complete 3 hours of continuing education on the topic of controlled substances.

Three hours of continuing education must be completed each biennium on the Safe and Effective Prescription of Controlled Substances. The courses must be offered by a statewide professional association of physicians in this state accredited to provide educational activities designated for the American Medical Association Physician's Recognition Award Category 1 credit, the American Nurses Credentialing Center, the American Association of Nurse Anesthetists, or the American Association of Nurse Practitioners and may be offered in a distance learning format.

Please visit www.cebroker.com to view all profession-specific board approved providers.

www.cebroker.com

Go to the course search, under "All Subjects," click the drop-down menu.

Click on "Prescribing Controlled Substances."

Once the courses are approved, then the Prescribing Controlled Substances tab will lead to registration for the available CE courses.

The course may be taken live or through distance learning from any one of the approved providers.

DOH may not renew the license of a prescriber who fails to complete this continuing education requirement.

Yes

Prescription Drug Monitoring Program FAQs:
General Questions

If you do not prescribe any controlled substances you are not required to register with or consult E-FORCSE.

You are still authorized to register. You can view your patient’s-controlled substance dispensing histories.

Prescribers, dispensers and their designees may register for access at https://florida.pmpaware.net.

Yes.

The DOH will issue a non-disciplinary citation for the initial offense.

Any subsequent offense will result in disciplinary action against the prescribing/dispensing practitioner's license. Disciplinary guidelines are individually established by the appropriate licensing board.

Yes. Information that is more than 4 years old.

Data Requesters
Prescriber Consultation

A prescriber or his or her designee must consult the PDMP to review their patient's controlled substance dispensing history prior to prescribing a controlled substance in Schedules II-V, as defined in section 893.03, F.S., for patients age 16 and older.

 

  • If the PDMP system is not operational as determined by DOH, or
  • The PDMP cannot be accessed by the prescriber practitioner due to a temporary technological or electrical failure or
  • When prescribing a nonopioid Schedule V drug or
  • The patient is less than 16 years of age

 

The prescriber must document in the patient's record the reason the PDMP was not consulted and may prescribe no more than a 3-day supply of a controlled substance.

The prescriber is not required to consult the PDMP before each refill, however, the prescriber must consult the PDMP prior to writing a new prescription for a controlled substance listed in Schedule II through V. A prescription for a controlled substance listed in Schedule II may not be refilled.

The statute does not provide any guidance on how far in advance the PDMP may be consulted. Please refer to your Board's website for further guidance.

The PDMP must be consulted each time a prescription for a controlled substance is written.

Dispenser Consultation

A dispenser or a designee of a dispenser must consult the PDMP to review a patient’s-controlled substance dispensing history prior to dispensing a controlled substance in schedules II-V, as defined in section 893.03, F.S., for patients age 16 or older for each new and refill prescription.

A dispenser or a designee of a dispenser does not have to consult the PDMP when dispensing a nonopioid controlled substance listed in Schedule V of s. 893.03, F.S. or 21 U.S.C. 812.

The duty to consult the system does not apply when the system:

  • Is determined by the department to be nonoperational; or
  • Cannot be accessed by the dispenser or a designee of the dispenser because of a temporary technological or electrical failure

 

A dispenser or designee of a dispenser who does not consult the PDMP shall document the reason he or she did not consult the system in the patient's medical record or prescription record and shall not dispense greater than a 3-day supply of a controlled substance to the patient.

A dispenser must consult the PDMP on the new prescription and on each subsequent refill.

Data Submitters

A dispenser is a dispensing health care practitioner, pharmacy, or pharmacist licensed to dispense controlled substances to the ultimate consumer or his or her agent in or into this state.

A dispensing practitioner is a practitioner authorized by law to prescribe drugs who may dispense such drugs to her or his patients in the regular course of her or his practice in compliance with s. 465.0276, F.S. Dispensing practitioners may include: physicians, dentists, certified optometrists, podiatrists, advanced registered nurse practitioners and physician assistants.

Dispensers are required to report to the PDMP each time a controlled substance is dispensed to a patient, as soon thereafter as possible, but no later than close of business the day after the prescription is dispensed unless an extension or exemption is approved by the Department of Health.

All controlled substances in schedules II through V must be reported to the system by the close of the next business day. If the dispenser does not dispense any controlled substances for that day, then a zero report must be submitted.

Yes, there are two exemptions from reporting:

  • Controlled substances administered to patients;
  • Controlled substances dispensed in the health care system of the Department of Corrections; and
  • Controlled substances dispensed to patients under the age of 16 are exempt from reporting to E-FORCSE.

 

 

  • The telephone number of the person for whom the prescription was written, in addition to the name, address, and date of birth the prescriber currently inputs;
  • Whether the prescription is an initial prescription or a refill, and the number of refills prescribed;
  • The name of the individual picking up the controlled substance prescription and the type and issuer of the identification provided; and
  • The pharmacy's DOH-issued permit number or the dispensing practitioner's DOH-issued license number

 

The Department has published a notice of rule development and will be amending Rule 64K-1.002, FAC . The PDMP will continue to accept submissions in the ASAP 2009 version 4.2 and the new 4.2a standard for one year from the effective date of the rule.

 

  • The pharmacy permit number or the dispensing health care practitioner's license number.
  • The name of the individual picking up the controlled substance prescription and type and issuer of the identification provided.

 

A person who willfully and knowingly fails to report the dispensing of a controlled substance as required by this law commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083, F.S. Further, the department shall issue a non-disciplinary citation to any prescriber or dispenser who fails to consult the system as required by this subsection for an initial offense. Each subsequent offense is subject to disciplinary action pursuant to s. 456.073, F.S.

Back
Frequently Asked Questions

Continuing Education Information

Pharmacy PSA


Physician, Dentist, Podiatrist, Certified Optometrist, Advanced Registered Nurse Practitioner, and Physician Assistant.

No. The “Controlled Substance Prescriber” designation found on the Department of Health’s website, is only an indicator by the prescribing practitioner that he/she prescribes controlled substances for the treatment of chronic non-malignant pain. It is for patient information only and does not affect the authority of a physician to write prescriptions for Schedule II opioids.

Yes. If a prescription for a Schedule II opioid does not meet the requirements as specified in Section 456.44, F.S., the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any deviation or change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

No. The law does not require the words “Acute Pain” to be written on a prescription, but rather the words “ACUTE PAIN EXCEPTION” for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S

A prescribing practitioner may prescribe up to a 7-day supply if the prescriber:

  1. determines it is medically necessary;
  2. indicates "acute pain exception" on the prescription; AND
  3. documents the justification for deviating from the 3-day supply limit in the patient's medical record.

 

No. The law only requires the words “ACUTE PAIN EXCEPTION” to be written for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S.

No. The law provides that for the treatment of acute pain, 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 certain conditions are met. The “3-day” and “7-day” applies to the supply of the opioid drug listed as a Schedule II controlled substance, not the number of days after the prescription is written for which it is still valid.

Yes. If the prescription is for a greater than a 7-day supply, the prescriber must indicate “Non-Acute Pain.”

Exceptions to acute pain limits:

  1. cancer,
  2. a terminal condition (a progressive disease or medical or surgical condition that causes significant functional impairment, is not considered by the treating physician to be reversible without the administration of life-sustaining procedures, and will result in death within 1 year after diagnosis if the condition runs its normal course),
  3. pain treated with palliative care (the provision of relief for symptoms related to an incurable, progressive illness or injury), and
  4. a traumatic injury with an Injury Severity Score of 9 or higher. See Trauma.org for more information.
**The law did not change prescribing of controlled substances for treatment of nonacute pain or chronic nonmalignant pain.

 

"Acute pain" is the normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness. It does not include pain related to cancer, terminal conditions, pain treated with palliative care, or traumatic injuries with an Injury Severity Score of 9 or greater.

When prescribing opioids to a patient with an Injury Severity Score of 9 or higher, the prescriber must:

  1. Prescribe an emergency opioid antagonist AND
  2. Indicate “nonacute pain” on the prescription

 

No. For example, the day supply limits do not apply to Hycodan® Cough Syrup for a patient who is being treated for an unrelenting cough or to Ritalin® for a patient being treated for ADHD. The 3-day and up to 7-day limits apply to Schedule II opioids prescribed for the treatment of acute pain.

No. The days supply limits apply to Schedule II opioids prescribed for the treatment of acute pain.

If a prescription for a Schedule II opioid does not meet the requirements as specified in the law, the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

Yes. If the “note” is transmitted with or considered to be part of the actual electronic prescription to be transmitted to the pharmacist, then the annotation of “Acute Pain Exception” or “Non-Acute Pain” would be acceptable.

The law is silent and does not reference the filling of out-of-state prescriptions (which may or may not comply with Florida’s new requirements). The law does not set forth a prohibition on filling them.

No. The legislature did not carve out an exemption for prescribers in pain management clinics who prescribe Schedule II opioid controlled substances for the treatment of acute pain. They are subject to the 3 and up to 7-day supply limits and to the labeling requirements for “ACUTE PAIN EXCEPTION” (for 4-7 day supply) and “NONACUTE PAIN” (for greater than 7-day supply).

No. This is not a requirement of the new controlled substances law. After the passing of CS/CS/HB 21, only the section numbering and title for Section 456.44, Controlled Substance Prescribing, changed to: Section 456.44(3) Standards of Practice for Treatment of Chronic Nonmalignant Pain.
The language did not change and reads:
S. 456.44(3)(d) states, in part, “The patient shall be seen by the registrant at regular intervals, not to exceed 3 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 to review the etiology of the pain….”

Continuing Education FAQs:

By January 31, 2019 and at each subsequent renewal.

All prescribing practitioners registered with the United States Drug Enforcement Agency and authorized to prescribe controlled substances must complete the continuing education course.

Unless the practitioner is already required to complete such a course under his or her practice act.

Yes. Advanced Registered Nurse Practitioners and Physician Assistants have a separate 3-hour CE requirement for controlled substances and are exempted from the new two-hour course.

Yes. Any military status practitioner who has a personal DEA registration is required to take the CE/CME course by January 31, 2019.

The course taken by January 31, 2019 will count toward the first renewal cycle. For further questions regarding your renewal period, check with your respective board.

The course must be offered by a statewide professional association of physicians in this state that is accredited to provide educational activities designated for the American Medical Association Physician's Recognition Award Category I Credit or the American Osteopathic Category 1-A continuing medical education requirement AND approved by their respective board.

Please visit www.cebroker.com to view all profession-specific board approved providers.

www.cebroker.com

Go to the course search, under "All Subjects," click the drop-down menu.

Click on "Prescribing Controlled Substances."

Once the courses are approved, then the Prescribing Controlled Substances tab will lead to registration for the available CE courses.

The course may be taken live or through distance learning from any one of the approved providers.

DOH may not renew the license of a prescriber who fails to complete this continuing education requirement.

Yes

Prescription Drug Monitoring Program FAQs:
General Questions

If you do not prescribe any controlled substances you are not required to register with or consult E-FORCSE.

You are still authorized to register. You can view your patient’s-controlled substance dispensing histories.

Prescribers, dispensers and their designees may register for access at https://florida.pmpaware.net.

Yes.

The DOH will issue a non-disciplinary citation for the initial offense.

Any subsequent offense will result in disciplinary action against the prescribing/dispensing practitioner's license. Disciplinary guidelines are individually established by the appropriate licensing board.

Yes. Information that is more than 4 years old.

Data Requesters
Prescriber Consultation

A prescriber or his or her designee must consult the PDMP to review their patient's controlled substance dispensing history prior to prescribing a controlled substance in Schedules II-V, as defined in section 893.03, F.S., for patients age 16 and older.

 

  • If the PDMP system is not operational as determined by DOH, or
  • The PDMP cannot be accessed by the prescriber practitioner due to a temporary technological or electrical failure or
  • When prescribing a nonopioid Schedule V drug or
  • The patient is less than 16 years of age

 

The prescriber must document in the patient's record the reason the PDMP was not consulted and may prescribe no more than a 3-day supply of a controlled substance.

The prescriber is not required to consult the PDMP before each refill, however, the prescriber must consult the PDMP prior to writing a new prescription for a controlled substance listed in Schedule II through V. A prescription for a controlled substance listed in Schedule II may not be refilled.

The statute does not provide any guidance on how far in advance the PDMP may be consulted. Please refer to your Board's website for further guidance.

The PDMP must be consulted each time a prescription for a controlled substance is written.

Dispenser Consultation

A dispenser or a designee of a dispenser must consult the PDMP to review a patient’s-controlled substance dispensing history prior to dispensing a controlled substance in schedules II-V, as defined in section 893.03, F.S., for patients age 16 or older for each new and refill prescription.

A dispenser or a designee of a dispenser does not have to consult the PDMP when dispensing a nonopioid controlled substance listed in Schedule V of s. 893.03, F.S. or 21 U.S.C. 812.

The duty to consult the system does not apply when the system:

  • Is determined by the department to be nonoperational; or
  • Cannot be accessed by the dispenser or a designee of the dispenser because of a temporary technological or electrical failure

 

A dispenser or designee of a dispenser who does not consult the PDMP shall document the reason he or she did not consult the system in the patient's medical record or prescription record and shall not dispense greater than a 3-day supply of a controlled substance to the patient.

A dispenser must consult the PDMP on the new prescription and on each subsequent refill.

Data Submitters

A dispenser is a dispensing health care practitioner, pharmacy, or pharmacist licensed to dispense controlled substances to the ultimate consumer or his or her agent in or into this state.

A dispensing practitioner is a practitioner authorized by law to prescribe drugs who may dispense such drugs to her or his patients in the regular course of her or his practice in compliance with s. 465.0276, F.S. Dispensing practitioners may include: physicians, dentists, certified optometrists, podiatrists, advanced registered nurse practitioners and physician assistants.

Dispensers are required to report to the PDMP each time a controlled substance is dispensed to a patient, as soon thereafter as possible, but no later than close of business the day after the prescription is dispensed unless an extension or exemption is approved by the Department of Health.

All controlled substances in schedules II through V must be reported to the system by the close of the next business day. If the dispenser does not dispense any controlled substances for that day, then a zero report must be submitted.

Yes, there are two exemptions from reporting:

  • Controlled substances administered to patients;
  • Controlled substances dispensed in the health care system of the Department of Corrections; and
  • Controlled substances dispensed to patients under the age of 16 are exempt from reporting to E-FORCSE.

 

 

  • The telephone number of the person for whom the prescription was written, in addition to the name, address, and date of birth the prescriber currently inputs;
  • Whether the prescription is an initial prescription or a refill, and the number of refills prescribed;
  • The name of the individual picking up the controlled substance prescription and the type and issuer of the identification provided; and
  • The pharmacy's DOH-issued permit number or the dispensing practitioner's DOH-issued license number

 

The Department has published a notice of rule development and will be amending Rule 64K-1.002, FAC . The PDMP will continue to accept submissions in the ASAP 2009 version 4.2 and the new 4.2a standard for one year from the effective date of the rule.

 

  • The pharmacy permit number or the dispensing health care practitioner's license number.
  • The name of the individual picking up the controlled substance prescription and type and issuer of the identification provided.

 

A person who willfully and knowingly fails to report the dispensing of a controlled substance as required by this law commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083, F.S. Further, the department shall issue a non-disciplinary citation to any prescriber or dispenser who fails to consult the system as required by this subsection for an initial offense. Each subsequent offense is subject to disciplinary action pursuant to s. 456.073, F.S.

Back
Frequently Asked Questions

Continuing Education Information

Pharmacy PSA


Physician, Dentist, Podiatrist, Certified Optometrist, Advanced Registered Nurse Practitioner, and Physician Assistant.

No. The “Controlled Substance Prescriber” designation found on the Department of Health’s website, is only an indicator by the prescribing practitioner that he/she prescribes controlled substances for the treatment of chronic non-malignant pain. It is for patient information only and does not affect the authority of a physician to write prescriptions for Schedule II opioids.

Yes. If a prescription for a Schedule II opioid does not meet the requirements as specified in Section 456.44, F.S., the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any deviation or change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

No. The law does not require the words “Acute Pain” to be written on a prescription, but rather the words “ACUTE PAIN EXCEPTION” for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S

A prescribing practitioner may prescribe up to a 7-day supply if the prescriber:

  1. determines it is medically necessary;
  2. indicates "acute pain exception" on the prescription; AND
  3. documents the justification for deviating from the 3-day supply limit in the patient's medical record.

 

No. The law only requires the words “ACUTE PAIN EXCEPTION” to be written for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S.

No. The law provides that for the treatment of acute pain, 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 certain conditions are met. The “3-day” and “7-day” applies to the supply of the opioid drug listed as a Schedule II controlled substance, not the number of days after the prescription is written for which it is still valid.

Yes. If the prescription is for a greater than a 7-day supply, the prescriber must indicate “Non-Acute Pain.”

Exceptions to acute pain limits:

  1. cancer,
  2. a terminal condition (a progressive disease or medical or surgical condition that causes significant functional impairment, is not considered by the treating physician to be reversible without the administration of life-sustaining procedures, and will result in death within 1 year after diagnosis if the condition runs its normal course),
  3. pain treated with palliative care (the provision of relief for symptoms related to an incurable, progressive illness or injury), and
  4. a traumatic injury with an Injury Severity Score of 9 or higher. See Trauma.org for more information.
**The law did not change prescribing of controlled substances for treatment of nonacute pain or chronic nonmalignant pain.

 

"Acute pain" is the normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness. It does not include pain related to cancer, terminal conditions, pain treated with palliative care, or traumatic injuries with an Injury Severity Score of 9 or greater.

When prescribing opioids to a patient with an Injury Severity Score of 9 or higher, the prescriber must:

  1. Prescribe an emergency opioid antagonist AND
  2. Indicate “nonacute pain” on the prescription

 

No. For example, the day supply limits do not apply to Hycodan® Cough Syrup for a patient who is being treated for an unrelenting cough or to Ritalin® for a patient being treated for ADHD. The 3-day and up to 7-day limits apply to Schedule II opioids prescribed for the treatment of acute pain.

No. The days supply limits apply to Schedule II opioids prescribed for the treatment of acute pain.

If a prescription for a Schedule II opioid does not meet the requirements as specified in the law, the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

Yes. If the “note” is transmitted with or considered to be part of the actual electronic prescription to be transmitted to the pharmacist, then the annotation of “Acute Pain Exception” or “Non-Acute Pain” would be acceptable.

The law is silent and does not reference the filling of out-of-state prescriptions (which may or may not comply with Florida’s new requirements). The law does not set forth a prohibition on filling them.

No. The legislature did not carve out an exemption for prescribers in pain management clinics who prescribe Schedule II opioid controlled substances for the treatment of acute pain. They are subject to the 3 and up to 7-day supply limits and to the labeling requirements for “ACUTE PAIN EXCEPTION” (for 4-7 day supply) and “NONACUTE PAIN” (for greater than 7-day supply).

No. This is not a requirement of the new controlled substances law. After the passing of CS/CS/HB 21, only the section numbering and title for Section 456.44, Controlled Substance Prescribing, changed to: Section 456.44(3) Standards of Practice for Treatment of Chronic Nonmalignant Pain.
The language did not change and reads:
S. 456.44(3)(d) states, in part, “The patient shall be seen by the registrant at regular intervals, not to exceed 3 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 to review the etiology of the pain….”

Continuing Education FAQs:

By January 31, 2019 and at each subsequent renewal.

All prescribing practitioners registered with the United States Drug Enforcement Agency and authorized to prescribe controlled substances must complete the continuing education course.

Unless the practitioner is already required to complete such a course under his or her practice act.

Yes. Advanced Registered Nurse Practitioners and Physician Assistants have a separate 3-hour CE requirement for controlled substances and are exempted from the new two-hour course.

Yes. Any military status practitioner who has a personal DEA registration is required to take the CE/CME course by January 31, 2019.

The course taken by January 31, 2019 will count toward the first renewal cycle. For further questions regarding your renewal period, check with your respective board.

The course must be offered by a statewide professional association of physicians in this state that is accredited to provide educational activities designated for the American Medical Association Physician's Recognition Award Category I Credit or the American Osteopathic Category 1-A continuing medical education requirement AND approved by their respective board.

Please visit www.cebroker.com to view all profession-specific board approved providers.

www.cebroker.com

Go to the course search, under "All Subjects," click the drop-down menu.

Click on "Prescribing Controlled Substances."

Once the courses are approved, then the Prescribing Controlled Substances tab will lead to registration for the available CE courses.

The course may be taken live or through distance learning from any one of the approved providers.

DOH may not renew the license of a prescriber who fails to complete this continuing education requirement.

Yes

Prescription Drug Monitoring Program FAQs:
General Questions

If you do not prescribe any controlled substances you are not required to register with or consult E-FORCSE.

You are still authorized to register. You can view your patient’s-controlled substance dispensing histories.

Prescribers, dispensers and their designees may register for access at https://florida.pmpaware.net.

Yes.

The DOH will issue a non-disciplinary citation for the initial offense.

Any subsequent offense will result in disciplinary action against the prescribing/dispensing practitioner's license. Disciplinary guidelines are individually established by the appropriate licensing board.

Yes. Information that is more than 4 years old.

Data Requesters
Prescriber Consultation

A prescriber or his or her designee must consult the PDMP to review their patient's controlled substance dispensing history prior to prescribing a controlled substance in Schedules II-V, as defined in section 893.03, F.S., for patients age 16 and older.

 

  • If the PDMP system is not operational as determined by DOH, or
  • The PDMP cannot be accessed by the prescriber practitioner due to a temporary technological or electrical failure or
  • When prescribing a nonopioid Schedule V drug or
  • The patient is less than 16 years of age

 

The prescriber must document in the patient's record the reason the PDMP was not consulted and may prescribe no more than a 3-day supply of a controlled substance.

The prescriber is not required to consult the PDMP before each refill, however, the prescriber must consult the PDMP prior to writing a new prescription for a controlled substance listed in Schedule II through V. A prescription for a controlled substance listed in Schedule II may not be refilled.

The statute does not provide any guidance on how far in advance the PDMP may be consulted. Please refer to your Board's website for further guidance.

The PDMP must be consulted each time a prescription for a controlled substance is written.

Dispenser Consultation

A dispenser or a designee of a dispenser must consult the PDMP to review a patient’s-controlled substance dispensing history prior to dispensing a controlled substance in schedules II-V, as defined in section 893.03, F.S., for patients age 16 or older for each new and refill prescription.

A dispenser or a designee of a dispenser does not have to consult the PDMP when dispensing a nonopioid controlled substance listed in Schedule V of s. 893.03, F.S. or 21 U.S.C. 812.

The duty to consult the system does not apply when the system:

  • Is determined by the department to be nonoperational; or
  • Cannot be accessed by the dispenser or a designee of the dispenser because of a temporary technological or electrical failure

 

A dispenser or designee of a dispenser who does not consult the PDMP shall document the reason he or she did not consult the system in the patient's medical record or prescription record and shall not dispense greater than a 3-day supply of a controlled substance to the patient.

A dispenser must consult the PDMP on the new prescription and on each subsequent refill.

Data Submitters

A dispenser is a dispensing health care practitioner, pharmacy, or pharmacist licensed to dispense controlled substances to the ultimate consumer or his or her agent in or into this state.

A dispensing practitioner is a practitioner authorized by law to prescribe drugs who may dispense such drugs to her or his patients in the regular course of her or his practice in compliance with s. 465.0276, F.S. Dispensing practitioners may include: physicians, dentists, certified optometrists, podiatrists, advanced registered nurse practitioners and physician assistants.

Dispensers are required to report to the PDMP each time a controlled substance is dispensed to a patient, as soon thereafter as possible, but no later than close of business the day after the prescription is dispensed unless an extension or exemption is approved by the Department of Health.

All controlled substances in schedules II through V must be reported to the system by the close of the next business day. If the dispenser does not dispense any controlled substances for that day, then a zero report must be submitted.

Yes, there are two exemptions from reporting:

  • Controlled substances administered to patients;
  • Controlled substances dispensed in the health care system of the Department of Corrections; and
  • Controlled substances dispensed to patients under the age of 16 are exempt from reporting to E-FORCSE.

 

 

  • The telephone number of the person for whom the prescription was written, in addition to the name, address, and date of birth the prescriber currently inputs;
  • Whether the prescription is an initial prescription or a refill, and the number of refills prescribed;
  • The name of the individual picking up the controlled substance prescription and the type and issuer of the identification provided; and
  • The pharmacy's DOH-issued permit number or the dispensing practitioner's DOH-issued license number

 

The Department has published a notice of rule development and will be amending Rule 64K-1.002, FAC . The PDMP will continue to accept submissions in the ASAP 2009 version 4.2 and the new 4.2a standard for one year from the effective date of the rule.

 

  • The pharmacy permit number or the dispensing health care practitioner's license number.
  • The name of the individual picking up the controlled substance prescription and type and issuer of the identification provided.

 

A person who willfully and knowingly fails to report the dispensing of a controlled substance as required by this law commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083, F.S. Further, the department shall issue a non-disciplinary citation to any prescriber or dispenser who fails to consult the system as required by this subsection for an initial offense. Each subsequent offense is subject to disciplinary action pursuant to s. 456.073, F.S.

Back
Frequently Asked Questions

Continuing Education Information

Pharmacy PSA


Physician, Dentist, Podiatrist, Certified Optometrist, Advanced Registered Nurse Practitioner, and Physician Assistant.

No. The “Controlled Substance Prescriber” designation found on the Department of Health’s website, is only an indicator by the prescribing practitioner that he/she prescribes controlled substances for the treatment of chronic non-malignant pain. It is for patient information only and does not affect the authority of a physician to write prescriptions for Schedule II opioids.

Yes. If a prescription for a Schedule II opioid does not meet the requirements as specified in Section 456.44, F.S., the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any deviation or change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

No. The law does not require the words “Acute Pain” to be written on a prescription, but rather the words “ACUTE PAIN EXCEPTION” for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S

A prescribing practitioner may prescribe up to a 7-day supply if the prescriber:

  1. determines it is medically necessary;
  2. indicates "acute pain exception" on the prescription; AND
  3. documents the justification for deviating from the 3-day supply limit in the patient's medical record.

 

No. The law only requires the words “ACUTE PAIN EXCEPTION” to be written for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S.

No. The law provides that for the treatment of acute pain, 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 certain conditions are met. The “3-day” and “7-day” applies to the supply of the opioid drug listed as a Schedule II controlled substance, not the number of days after the prescription is written for which it is still valid.

Yes. If the prescription is for a greater than a 7-day supply, the prescriber must indicate “Non-Acute Pain.”

Exceptions to acute pain limits:

  1. cancer,
  2. a terminal condition (a progressive disease or medical or surgical condition that causes significant functional impairment, is not considered by the treating physician to be reversible without the administration of life-sustaining procedures, and will result in death within 1 year after diagnosis if the condition runs its normal course),
  3. pain treated with palliative care (the provision of relief for symptoms related to an incurable, progressive illness or injury), and
  4. a traumatic injury with an Injury Severity Score of 9 or higher. See Trauma.org for more information.
**The law did not change prescribing of controlled substances for treatment of nonacute pain or chronic nonmalignant pain.

 

"Acute pain" is the normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness. It does not include pain related to cancer, terminal conditions, pain treated with palliative care, or traumatic injuries with an Injury Severity Score of 9 or greater.

When prescribing opioids to a patient with an Injury Severity Score of 9 or higher, the prescriber must:

  1. Prescribe an emergency opioid antagonist AND
  2. Indicate “nonacute pain” on the prescription

 

No. For example, the day supply limits do not apply to Hycodan® Cough Syrup for a patient who is being treated for an unrelenting cough or to Ritalin® for a patient being treated for ADHD. The 3-day and up to 7-day limits apply to Schedule II opioids prescribed for the treatment of acute pain.

No. The days supply limits apply to Schedule II opioids prescribed for the treatment of acute pain.

If a prescription for a Schedule II opioid does not meet the requirements as specified in the law, the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

Yes. If the “note” is transmitted with or considered to be part of the actual electronic prescription to be transmitted to the pharmacist, then the annotation of “Acute Pain Exception” or “Non-Acute Pain” would be acceptable.

The law is silent and does not reference the filling of out-of-state prescriptions (which may or may not comply with Florida’s new requirements). The law does not set forth a prohibition on filling them.

No. The legislature did not carve out an exemption for prescribers in pain management clinics who prescribe Schedule II opioid controlled substances for the treatment of acute pain. They are subject to the 3 and up to 7-day supply limits and to the labeling requirements for “ACUTE PAIN EXCEPTION” (for 4-7 day supply) and “NONACUTE PAIN” (for greater than 7-day supply).

No. This is not a requirement of the new controlled substances law. After the passing of CS/CS/HB 21, only the section numbering and title for Section 456.44, Controlled Substance Prescribing, changed to: Section 456.44(3) Standards of Practice for Treatment of Chronic Nonmalignant Pain.
The language did not change and reads:
S. 456.44(3)(d) states, in part, “The patient shall be seen by the registrant at regular intervals, not to exceed 3 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 to review the etiology of the pain….”

Prescription Drug Monitoring Program FAQs:
General Questions

If you do not prescribe any controlled substances you are not required to register with or consult E-FORCSE.

You are still authorized to register. You can view your patient’s-controlled substance dispensing histories.

Prescribers, dispensers and their designees may register for access at https://florida.pmpaware.net.

Yes.

The DOH will issue a non-disciplinary citation for the initial offense.

Any subsequent offense will result in disciplinary action against the prescribing/dispensing practitioner's license. Disciplinary guidelines are individually established by the appropriate licensing board.

Yes. Information that is more than 4 years old.

Data Requesters
Prescriber Consultation

A prescriber or his or her designee must consult the PDMP to review their patient's controlled substance dispensing history prior to prescribing a controlled substance in Schedules II-V, as defined in section 893.03, F.S., for patients age 16 and older.

 

  • If the PDMP system is not operational as determined by DOH, or
  • The PDMP cannot be accessed by the prescriber practitioner due to a temporary technological or electrical failure or
  • When prescribing a nonopioid Schedule V drug or
  • The patient is less than 16 years of age

 

The prescriber must document in the patient's record the reason the PDMP was not consulted and may prescribe no more than a 3-day supply of a controlled substance.

The prescriber is not required to consult the PDMP before each refill, however, the prescriber must consult the PDMP prior to writing a new prescription for a controlled substance listed in Schedule II through V. A prescription for a controlled substance listed in Schedule II may not be refilled.

The statute does not provide any guidance on how far in advance the PDMP may be consulted. Please refer to your Board's website for further guidance.

The PDMP must be consulted each time a prescription for a controlled substance is written.

Dispenser Consultation

A dispenser or a designee of a dispenser must consult the PDMP to review a patient’s-controlled substance dispensing history prior to dispensing a controlled substance in schedules II-V, as defined in section 893.03, F.S., for patients age 16 or older for each new and refill prescription.

A dispenser or a designee of a dispenser does not have to consult the PDMP when dispensing a nonopioid controlled substance listed in Schedule V of s. 893.03, F.S. or 21 U.S.C. 812.

The duty to consult the system does not apply when the system:

  • Is determined by the department to be nonoperational; or
  • Cannot be accessed by the dispenser or a designee of the dispenser because of a temporary technological or electrical failure

 

A dispenser or designee of a dispenser who does not consult the PDMP shall document the reason he or she did not consult the system in the patient's medical record or prescription record and shall not dispense greater than a 3-day supply of a controlled substance to the patient.

A dispenser must consult the PDMP on the new prescription and on each subsequent refill.

Data Submitters

A dispenser is a dispensing health care practitioner, pharmacy, or pharmacist licensed to dispense controlled substances to the ultimate consumer or his or her agent in or into this state.

A dispensing practitioner is a practitioner authorized by law to prescribe drugs who may dispense such drugs to her or his patients in the regular course of her or his practice in compliance with s. 465.0276, F.S. Dispensing practitioners may include: physicians, dentists, certified optometrists, podiatrists, advanced registered nurse practitioners and physician assistants.

Dispensers are required to report to the PDMP each time a controlled substance is dispensed to a patient, as soon thereafter as possible, but no later than close of business the day after the prescription is dispensed unless an extension or exemption is approved by the Department of Health.

All controlled substances in schedules II through V must be reported to the system by the close of the next business day. If the dispenser does not dispense any controlled substances for that day, then a zero report must be submitted.

Yes, there are two exemptions from reporting:

  • Controlled substances administered to patients;
  • Controlled substances dispensed in the health care system of the Department of Corrections; and
  • Controlled substances dispensed to patients under the age of 16 are exempt from reporting to E-FORCSE.

 

 

  • The telephone number of the person for whom the prescription was written, in addition to the name, address, and date of birth the prescriber currently inputs;
  • Whether the prescription is an initial prescription or a refill, and the number of refills prescribed;
  • The name of the individual picking up the controlled substance prescription and the type and issuer of the identification provided; and
  • The pharmacy's DOH-issued permit number or the dispensing practitioner's DOH-issued license number

 

The Department has published a notice of rule development and will be amending Rule 64K-1.002, FAC . The PDMP will continue to accept submissions in the ASAP 2009 version 4.2 and the new 4.2a standard for one year from the effective date of the rule.

 

  • The pharmacy permit number or the dispensing health care practitioner's license number.
  • The name of the individual picking up the controlled substance prescription and type and issuer of the identification provided.

 

A person who willfully and knowingly fails to report the dispensing of a controlled substance as required by this law commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083, F.S. Further, the department shall issue a non-disciplinary citation to any prescriber or dispenser who fails to consult the system as required by this subsection for an initial offense. Each subsequent offense is subject to disciplinary action pursuant to s. 456.073, F.S.

Back
Frequently Asked Questions

Continuing Education Information

Pharmacy PSA


Physician, Dentist, Podiatrist, Certified Optometrist, Advanced Registered Nurse Practitioner, and Physician Assistant.

No. The “Controlled Substance Prescriber” designation found on the Department of Health’s website, is only an indicator by the prescribing practitioner that he/she prescribes controlled substances for the treatment of chronic non-malignant pain. It is for patient information only and does not affect the authority of a physician to write prescriptions for Schedule II opioids.

Yes. If a prescription for a Schedule II opioid does not meet the requirements as specified in Section 456.44, F.S., the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any deviation or change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

No. The law does not require the words “Acute Pain” to be written on a prescription, but rather the words “ACUTE PAIN EXCEPTION” for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S

A prescribing practitioner may prescribe up to a 7-day supply if the prescriber:

  1. determines it is medically necessary;
  2. indicates "acute pain exception" on the prescription; AND
  3. documents the justification for deviating from the 3-day supply limit in the patient's medical record.

 

No. The law only requires the words “ACUTE PAIN EXCEPTION” to be written for prescriptions greater than a 3-day and up to a 7-day supply. Please see Section 456.44(5)(a)(2), F.S.

No. The law provides that for the treatment of acute pain, 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 certain conditions are met. The “3-day” and “7-day” applies to the supply of the opioid drug listed as a Schedule II controlled substance, not the number of days after the prescription is written for which it is still valid.

Yes. If the prescription is for a greater than a 7-day supply, the prescriber must indicate “Non-Acute Pain.”

Exceptions to acute pain limits:

  1. cancer,
  2. a terminal condition (a progressive disease or medical or surgical condition that causes significant functional impairment, is not considered by the treating physician to be reversible without the administration of life-sustaining procedures, and will result in death within 1 year after diagnosis if the condition runs its normal course),
  3. pain treated with palliative care (the provision of relief for symptoms related to an incurable, progressive illness or injury), and
  4. a traumatic injury with an Injury Severity Score of 9 or higher. See Trauma.org for more information.
**The law did not change prescribing of controlled substances for treatment of nonacute pain or chronic nonmalignant pain.

 

"Acute pain" is the normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness. It does not include pain related to cancer, terminal conditions, pain treated with palliative care, or traumatic injuries with an Injury Severity Score of 9 or greater.

When prescribing opioids to a patient with an Injury Severity Score of 9 or higher, the prescriber must:

  1. Prescribe an emergency opioid antagonist AND
  2. Indicate “nonacute pain” on the prescription

 

No. For example, the day supply limits do not apply to Hycodan® Cough Syrup for a patient who is being treated for an unrelenting cough or to Ritalin® for a patient being treated for ADHD. The 3-day and up to 7-day limits apply to Schedule II opioids prescribed for the treatment of acute pain.

No. The days supply limits apply to Schedule II opioids prescribed for the treatment of acute pain.

If a prescription for a Schedule II opioid does not meet the requirements as specified in the law, the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

Yes. If the “note” is transmitted with or considered to be part of the actual electronic prescription to be transmitted to the pharmacist, then the annotation of “Acute Pain Exception” or “Non-Acute Pain” would be acceptable.

The law is silent and does not reference the filling of out-of-state prescriptions (which may or may not comply with Florida’s new requirements). The law does not set forth a prohibition on filling them.

No. The legislature did not carve out an exemption for prescribers in pain management clinics who prescribe Schedule II opioid controlled substances for the treatment of acute pain. They are subject to the 3 and up to 7-day supply limits and to the labeling requirements for “ACUTE PAIN EXCEPTION” (for 4-7 day supply) and “NONACUTE PAIN” (for greater than 7-day supply).

No. This is not a requirement of the new controlled substances law. After the passing of CS/CS/HB 21, only the section numbering and title for Section 456.44, Controlled Substance Prescribing, changed to: Section 456.44(3) Standards of Practice for Treatment of Chronic Nonmalignant Pain.
The language did not change and reads:
S. 456.44(3)(d) states, in part, “The patient shall be seen by the registrant at regular intervals, not to exceed 3 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 to review the etiology of the pain….”

Continuing Education FAQs:

By January 31, 2019 and at each subsequent renewal.

All prescribing practitioners registered with the United States Drug Enforcement Agency and authorized to prescribe controlled substances must complete the continuing education course.

Unless the practitioner is already required to complete such a course under his or her practice act.

Yes. Advanced Registered Nurse Practitioners and Physician Assistants have a separate 3-hour CE requirement for controlled substances and are exempted from the new two-hour course.

Yes. Any military status practitioner who has a personal DEA registration is required to take the CE/CME course by January 31, 2019.

The course taken by January 31, 2019 will count toward the first renewal cycle. For further questions regarding your renewal period, check with your respective board.

The course must be offered by a statewide professional association of physicians in this state that is accredited to provide educational activities designated for the American Medical Association Physician's Recognition Award Category I Credit or the American Osteopathic Category 1-A continuing medical education requirement AND approved by their respective board.

Please visit www.cebroker.com to view all profession-specific board approved providers.

www.cebroker.com

Go to the course search, under "All Subjects," click the drop-down menu.

Click on "Prescribing Controlled Substances."

Once the courses are approved, then the Prescribing Controlled Substances tab will lead to registration for the available CE courses.

The course may be taken live or through distance learning from any one of the approved providers.

DOH may not renew the license of a prescriber who fails to complete this continuing education requirement.

Yes

Prescription Drug Monitoring Program FAQs:
General Questions

If you do not prescribe any controlled substances you are not required to register with or consult E-FORCSE.

You are still authorized to register. You can view your patient’s-controlled substance dispensing histories.

Prescribers, dispensers and their designees may register for access at https://florida.pmpaware.net.

Yes.

The DOH will issue a non-disciplinary citation for the initial offense.

Any subsequent offense will result in disciplinary action against the prescribing/dispensing practitioner's license. Disciplinary guidelines are individually established by the appropriate licensing board.

Yes. Information that is more than 4 years old.

Data Requesters
Prescriber Consultation

A prescriber or his or her designee must consult the PDMP to review their patient's controlled substance dispensing history prior to prescribing a controlled substance in Schedules II-V, as defined in section 893.03, F.S., for patients age 16 and older.

 

  • If the PDMP system is not operational as determined by DOH, or
  • The PDMP cannot be accessed by the prescriber practitioner due to a temporary technological or electrical failure or
  • When prescribing a nonopioid Schedule V drug or
  • The patient is less than 16 years of age

 

The prescriber must document in the patient's record the reason the PDMP was not consulted and may prescribe no more than a 3-day supply of a controlled substance.

The prescriber is not required to consult the PDMP before each refill, however, the prescriber must consult the PDMP prior to writing a new prescription for a controlled substance listed in Schedule II through V. A prescription for a controlled substance listed in Schedule II may not be refilled.

The statute does not provide any guidance on how far in advance the PDMP may be consulted. Please refer to your Board's website for further guidance.

The PDMP must be consulted each time a prescription for a controlled substance is written.

Dispenser Consultation

A dispenser or a designee of a dispenser must consult the PDMP to review a patient’s-controlled substance dispensing history prior to dispensing a controlled substance in schedules II-V, as defined in section 893.03, F.S., for patients age 16 or older for each new and refill prescription.

A dispenser or a designee of a dispenser does not have to consult the PDMP when dispensing a nonopioid controlled substance listed in Schedule V of s. 893.03, F.S. or 21 U.S.C. 812.

The duty to consult the system does not apply when the system:

  • Is determined by the department to be nonoperational; or
  • Cannot be accessed by the dispenser or a designee of the dispenser because of a temporary technological or electrical failure

 

A dispenser or designee of a dispenser who does not consult the PDMP shall document the reason he or she did not consult the system in the patient's medical record or prescription record and shall not dispense greater than a 3-day supply of a controlled substance to the patient.

A dispenser must consult the PDMP on the new prescription and on each subsequent refill.

Data Submitters

A dispenser is a dispensing health care practitioner, pharmacy, or pharmacist licensed to dispense controlled substances to the ultimate consumer or his or her agent in or into this state.

A dispensing practitioner is a practitioner authorized by law to prescribe drugs who may dispense such drugs to her or his patients in the regular course of her or his practice in compliance with s. 465.0276, F.S. Dispensing practitioners may include: physicians, dentists, certified optometrists, podiatrists, advanced registered nurse practitioners and physician assistants.

Dispensers are required to report to the PDMP each time a controlled substance is dispensed to a patient, as soon thereafter as possible, but no later than close of business the day after the prescription is dispensed unless an extension or exemption is approved by the Department of Health.

All controlled substances in schedules II through V must be reported to the system by the close of the next business day. If the dispenser does not dispense any controlled substances for that day, then a zero report must be submitted.

Yes, there are two exemptions from reporting:

  • Controlled substances administered to patients;
  • Controlled substances dispensed in the health care system of the Department of Corrections; and
  • Controlled substances dispensed to patients under the age of 16 are exempt from reporting to E-FORCSE.

 

 

  • The telephone number of the person for whom the prescription was written, in addition to the name, address, and date of birth the prescriber currently inputs;
  • Whether the prescription is an initial prescription or a refill, and the number of refills prescribed;
  • The name of the individual picking up the controlled substance prescription and the type and issuer of the identification provided; and
  • The pharmacy's DOH-issued permit number or the dispensing practitioner's DOH-issued license number

 

The Department has published a notice of rule development and will be amending Rule 64K-1.002, FAC . The PDMP will continue to accept submissions in the ASAP 2009 version 4.2 and the new 4.2a standard for one year from the effective date of the rule.

 

  • The pharmacy permit number or the dispensing health care practitioner's license number.
  • The name of the individual picking up the controlled substance prescription and type and issuer of the identification provided.

 

A person who willfully and knowingly fails to report the dispensing of a controlled substance as required by this law commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083, F.S. Further, the department shall issue a non-disciplinary citation to any prescriber or dispenser who fails to consult the system as required by this subsection for an initial offense. Each subsequent offense is subject to disciplinary action pursuant to s. 456.073, F.S.