Regulations Related to Controlled Substance Prescribing in Florida

INTRODUCTION

The opioid epidemic refers to the extensive overuse of opioid medications, both from medical prescriptions and illegal sources.1 This epidemic began in the late 1990s in the United States (U.S.), and since 1999 the number of drug overdose deaths has quadrupled.1 Data indicates that between 1999 to 2019, nearly 500,000 people died from an opioid overdose, including both prescription and illicit sources.1

The opioid epidemic has evolved in three consecutive waves. The first wave began with increased prescribing of opioids in the 1990s. In 2010, the second wave commenced with rapid increases in overdose deaths involving heroin. The third wave started in 2013 with a significant increase in overdose deaths involving synthetic opioids, particularly illicitly manufactured fentanyl.1 Despite the number of outpatient opioid analgesic prescriptions dropping 13% nationally between 2012 and 2015, the national overdose death rate surged 38% during those years.2 In response to the opioid epidemic, the U.S. Department of Health and Human Services officially declared a public health emergency in 2017.3 In addition to the increased overdose rate, opioid abuse costs the U.S. $78.5 billion annually in the form of health care, legal programs, and lost productivity.3

Responding effectively to the opioid crisis has been difficult because of its changing nature, geographic and demographic diversity, and multiple causes.4 Even with wider use of non-opioid analgesics and non-pharmacological approaches, opioids remain a necessary option for the treatment of many patients with severe pain and are therapeutically beneficial when used properly. Initial preventive approaches in the U.S. have focused on improving prescribing practices for opioid analgesics and increasing the availability of naloxone to prevent overdose.4 Florida has already provided a standing order for naloxone to be dispensed to emergency responders for administration to persons exhibiting signs of an overdose. The state of Florida has also addressed the opioid epidemic by5

  • mandating laws related to controlled substance prescribing
  • utilizing a prescription drug monitoring program
  • issuing standards of practice for acute and chronic pain management

This activity will review the review the laws relevant to prescribing and dispensing controlled substances in Florida, discuss requirements of Florida’s prescription drug monitoring program, and provide guidance to the pharmacist for detecting prescription fraud.

PROVISIONS OF HOUSE BILL 21

House Bill 21, signed into law in March 2018, imposed several legal requirements on health care practitioners who prescribe controlled substances.5 While there were previous state regulations in place to govern controlled substance prescribing, House Bill 21 set out to amend several of the existing statutes.5 The state of Florida established their prescription drug monitoring program—Electronic-Florida Online Reporting of Controlled Substance Evaluation Program (E-FORCSE)—in 2009, which required pharmacists and dispensing practitioners to report to the database each time they dispensed a controlled substance.5

As passed in 2009 (before House Bill 21), the law required the dispensing agent (e.g., pharmacist) to report to the database within 15 days and did not require physicians to check the database before prescribing a controlled substance.6 In 2011 (Section 456.44 of Florida Statutes), the Florida legislature passed requirements that regulated controlled substance prescribers managing chronic nonmalignant pain to designate themselves as a controlled substance prescribing practitioner on their profile. This statute also mandated them to comply with the standards of practice in prescribing pain management therapy.7 Pain management clinics were also required to register with the Department of Health and adhere to a number of regulations prior to House Bill 21.5

House Bill 21 maintained the above requirements but stipulated new regulations as well. The Department of Health is still required to maintain E-FORCSE to collect and store controlled substance dispensing information, but the bill made a number of changes to the reporting, checking, and access of information.5 The most significant change is that a prescriber or dispenser must consult the database to review patients’ controlled substance history before prescribing or dispensing a controlled substance for a patient 16 years or older.5 This mandate applies to all controlled substances, not just opioids, with the only exception being a nonopioid controlled substance listed as Schedule V.5

In the event the database is not accessible, a dispenser may supply no more than a 3-day supply of the controlled substance with documentation as to why the database was unavailable.5 The database must be checked before every dispensing, including new prescriptions and refills for existing patients.5 House Bill 21 mandates that providers report controlled substance dispensing by the close of the next business day.5 If a provider does not dispense any controlled substances within 7 days, they must file a zero report through E-FORCSE to indicate this.5 The Department of Health is required to issue a non-disciplinary citation to any practitioner who fails to consult the database prior to dispensing a controlled substance.5 Those who willfully fail to report dispensing of a controlled substance within the appropriate timeframe commit a misdemeanor of the first degree and may face disciplinary action from their respective board.5

There are certain exemptions where practitioners are not required to report to E-FORCSE, including8

  • administering a controlled substance directly to a patient where the amount is adequate for treatment during that treatment session
  • administering a controlled substance to a patient at a hospital, nursing home, ambulatory surgical center, hospice, or intermediate care facility for the developmentally disabled
  • administering or dispensing a controlled substance in the health care system of the Florida Department of Corrections
  • administering a controlled substance in the emergency room of a licensed hospital
  • administering or dispensing a controlled substance to a patient younger than 16 years old
  • dispensing a one-time, 72-hour re-supply of a controlled substance

The following must be reported in the E-FORCSE system for each controlled substance dispensed:8

  • Pharmacy Drug Enforcement Administration (DEA) number
  • Patient name, address, date of birth, and gender
  • Prescription number and refill number
  • Date written and date filled
  • Drug National Drug Code (NDC) number
  • Quantity dispensed
  • Payment method
  • Prescriber’s first and last name
  • Prescriber’s National Provider Identifier (if available), DEA number, and state license number (if available)

House Bill 21 amended the existing legislation regarding controlled substance prescribing for chronic nonmalignant pain to include the treatment of acute pain.5 The statute defines acute pain as, “the normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness.”10 The term does not include pain related to cancer; a terminal condition; or palliative care to provide symptomatic relief related to an incurable, progressive illness or injury. It also does not apply to a traumatic injury with an Injury Severity Score (i.e., an established medical score to assess trauma severity) of 9 or greater.10

This bill also mandated that a prescription for a Schedule II opioid for the treatment of acute pain may not exceed a 3-day supply.5 A 7-day supply is permitted if more than a 3-day supply is needed based on the prescriber’s professional judgment.5 In this case, the prescriber is required to indicate the wording “Acute Pain Exception” on the prescription. They must also document in the medical record the acute medical condition and lack of alternative treatment options that justify deviation from the 3-day supply limit.5 If a provider prescribes a Schedule II opioid for the treatment of pain other than acute pain, they must indicate “Nonacute Pain” on the prescription.5 This bill also stipulated that if a practitioner prescribes a Schedule II controlled substance for pain related to a traumatic injury with a severity score of 9 or greater, they must concurrently prescribe an emergency opioid antagonist.5

House Bill 21 also redefined pain management clinic regulations. It defined these entities as facilities that advertise any type of pain management services or where the majority of patients are prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for chronic nonmalignant pain management on a monthly basis.5 The following entities were granted exemption5,10:

  • A clinic licensed as a facility compliant with Chapter 395 (refers to hospital licensing and regulation)
  • A clinic where the majority of physicians provide surgical services
  • A publicly owned clinic whose shares are traded on the national exchange or on the over-the-counter market and whose total assets exceed $50 million
  • A clinic affiliated with a medical school that provides training
  • A clinic that does not prescribe controlled substances for pain management
  • A clinic owned by an entity exempt from federal taxation
  • A clinic owned and operated by board-eligible or board-certified anesthesiologists, physiatrists, rheumatologists, or neurologists
  • A clinic owned and operated by a physician multispecialty practice where a board-eligible or board-certified medical specialist has completed fellowships in pain management or is board-certified in pain medicine and performs interventional pain procedures of the type routinely billed using surgical codes

Prior to House Bill 21, clinics that were exempt did not have to register or comply with legislation related to pain management permitting the facility to determine on its own if it was exempt.5 The enactment of House Bill 21 required exempted pain management clinics to register with the Department of Health for a certificate of exemption.5

The final mandate of House Bill 21 required those permitted to prescribe controlled substances to take a 2-hour board approved continuing education course focused on controlled substances.5 The continuing education hours are now required as part of every biennial license renewal.5

STANDARDS OF PRACTICE FOR CHRONIC PAIN MANAGEMENT

The Florida statute defines chronic nonmalignant pain as pain that is unrelated to cancer which persists beyond the usual course of disease or injury causing the pain or more than 90 days after surgery.9 These statutes mandate requirements for those treating patients with chronic nonmalignant pain that are applicable to all physicians, physician assistants, and advanced practice registered nurses.

According to the legislature, a complete physical exam is required before any treatment begins.9 The medical record must document the nature and intensity of the pain, current and past treatments, any coexisting diseases or conditions, and the effect of the pain on physical and psychological functioning.9 Providers must explore and document any past history of alcohol and/or substance abuse. Those with history of abuse require consultation with or referral to an addiction medicine specialist or a psychiatrist.9 Providers must review all previous medical records and diagnostic studies and document pertinent information in the current medical record.9

Providers must also document the medical indications for controlled substance use, as well as a written plan for assessing and monitoring patients’ risk of deviant drug-related behavior.9 A written individualized treatment plan is required that documents the objectives to determine treatment success and any further planned diagnostic evaluations or treatments, if any.9 Best practice encourages the use of an interprofessional team approach when possible. Finally, the medical record must also contain a photocopy of the patient’s government-issued photo identification and duplicates of all controlled substance prescriptions.9

Prescribers should discuss the risks and benefits of controlled substance use with each patient, including the risks of abuse and addiction and its consequences.9 A written controlled substance agreement must be designed that outlines patient responsibilities, including the following9:

  • Number and frequency of allowable controlled substance prescriptions and refills
  • Reasons for which drug therapy may be discontinued (e.g., violation of the agreement)
  • Agreement that all controlled substances shall be prescribed by a single treating prescriber

Prescribers are required to monitor patient compliance with medication usage, the controlled substance agreement, and watch for signs of substance abuse or diversion at a minimum of 3-month intervals.9 If the provider suspects substance abuse, they must refer the patient to a board-certified pain management physician, an addiction medicine specialist, or a mental health addiction facility unless the prescriber is a physician who is board-certified or board-eligible in pain management.9 Acting as a consultant, the specialist will give recommendations for continuing, modifying, or discontinuing controlled substance therapy.9 If the patient fails to meet the new stipulations of therapy they are to be discharged from the practice.9

The rules and regulations of chronic pain management do not apply to the following prescribers9:

  • Board-eligible or board-certified anesthesiologists, physiatrists, rheumatologists, or neurologists
  • Physicians with surgical privileges at a hospital or ambulatory surgery center who primarily provide surgical services
  • Board-eligible or board-certified medical specialists with a fellowship in pain medicine or board-eligible or board-certified in pain medicine and performs interventional pain procedures of the type routinely billed using surgical codes
  • Prescribers of medically necessary controlled substances for a patient during an inpatient stay in a hospital licensed under Chapter 395

REQUIREMENTS FOR CONTROLLED SUBSTANCE PRESCRIPTIONS

According to Chapter 893 of the 2020 Florida statutes, a pharmacist may dispense a Schedule III or IV controlled substance based upon a written, oral, or electronic prescription.11 A prescription for a Schedule II controlled substance may be dispensed only based upon a written or electronic prescription, except in an emergency situation (described in detail below). Patients may not refill a prescription for a controlled substance in Schedules III, IV, or V more than 5 times within a period of 6 months after the written date. A prescription for a Schedule II medication may never be refilled.11 A pharmacist may dispense a one-time emergency refill of up to a 72-hour supply of a Schedule III or IV medication.11 Pharmacies must maintain records of all controlled prescriptions for a period of 2 years.11

A written prescription for a controlled substance must have the following items on the face of the prescription11:

  • Prescribing practitioner’s signature
  • Written date in numerical, month/day/year format, or with the abbreviated month written out, or the month written out in full
  • Full name and address of the person for whom (or the owner of the animal for which) the controlled substance is dispensed
  • Prescribing practitioner’s full name and address
  • Prescribing practitioner’s federal controlled substance registry number
  • If the prescription is for an animal, the species of the animal for which the controlled substance is prescribed
  • Name of the controlled substance prescribed, strength, quantity (written and numerical), and directions for use
  • Number of the prescription, as recorded in the prescription files of the dispensing pharmacy
  • Initials of the pharmacist filling the prescription and the date filled

Few exceptions exist to these rules. If a prescription includes a numerical notation of the quantity of the controlled substance or date, but does not include these written out in text, the pharmacist may dispense the controlled substance without prescriber verification if the pharmacy previously dispensed another prescription for the same patient.11

Prescriptions for controlled substances must be written on a counterfeit-proof pad produced by a Department of Health-approved vendor.12 A prescription pad vendor is required to submit a monthly report to the Department of Health that documents the number of prescription pads sold and identifies the purchasers.12 Practitioners who must purchase these pads include allopathic prescribers (MD), osteopathic prescribers (OS), podiatric prescribers (PO), dentists (DMD or DDS), optometrists (DO), physician assistants (PA), and advanced practice registered nurses (APRN). Veterinarians, however, are not subject to this mandate.13 The vendor is required to pre-print the indicator “NONACUTE PAIN” or “ACUTE PAIN EXCEPTION” on the prescription face.13 The vendor’s counterfeit-proof prescription pads must also meet the following criteria14:

  • Background color must be blue or green and resist reproduction
  • Must be printed on artificial watermarked paper
  • Must be resistant to erasures and alterations
  • The word “void” or “illegal” must appear on any photocopy or other reproduction
  • A unique tracking identification number for each order must be printed on the front of the prescription pad

The label attached to the vial of a controlled substance must contain the following information11:

  • Pharmacy name and address
  • Date filled
  • Prescription number, as recorded in the prescription files of the pharmacy
  • Prescribing practitioner’s name
  • Name of the patient or of the owner and species of the animal
  • Directions for use
  • A warning that it is a crime to transfer the controlled substance to any person other than the patient for whom it was prescribed

Specific Regulations for CII Scheduled Controlled Substances

DEA initially felt that post-dating or writing instructions to fill Schedule II controlled substances at a later date was equivalent to unauthorized refills.15 However, as of December 2017, DEA allowed the issuance of separate prescriptions for Schedule II controlled substances for up to 3 months. They stipulated, however, that prescribers date them on the same day they were written and notate the earliest date to be filled.15

Providers may transmit a prescription for a Schedule II controlled substance by fax provided that the original, manually signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance.16 The pharmacy must maintain this original copy in their records. The faxed prescription may only serve as the original copy when16

  • compounding for direct patient administration by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion
  • dispensing to a resident of a long-term care facility
  • dispensing to a patient enrolled in hospice certified and/or paid for by Medicare or licensed by the state (practitioner must indicate on the prescription that it is for a patient in hospice)

In an emergency, a practitioner may call in a Schedule II prescription to the pharmacy. A pharmacist can dispense the prescription provided that the quantity is limited to an amount adequate to treat the patient only during the emergency period (i.e., no longer than 72 hours).16 The pharmacist must immediately reduce the prescription to writing, including all information required except the prescribing practitioner’s signature.16 The prescriber must provide a signed written prescription to the pharmacist within 7 calendar days that includes the terms “Authorization for Emergency Dispensing” written on it and the date of the oral order.16 Upon receipt, the dispensing pharmacist must attach this paper prescription to the oral emergency prescription that has been reduced to writing.16 The pharmacist must notify DEA if they do not receive the prescription in that timeframe.16

GUIDE TO PRESCRIPTION FRAUD

As a health care professional, pharmacists are obligated to aid in averting prescription drug abuse and diversion. Prescribers who issue invalid prescriptions and pharmacists who fills them are both be subject to penalties for violating the federal Controlled Substances Act. In addition to ensuring prescriptions are issued for a legitimate medical purpose, pharmacists must also confirm that they are issued in the usual course of prescribers’ professional practice.17

Pharmacists should be aware of the various kinds of forged prescriptions that may be presented for dispensing. Some patients may alter the practitioner’s prescription including having prescription pads printed using a legitimate prescriber’s name, but with a different call back number that is answered by an accomplice to verify the prescription.17 Drug-seeking individuals may also call in their own prescriptions and give their own telephone number as a call-back for confirmation.17 Individuals may also steal prescription pads from practitioners’ offices and/or hospitals and write prescriptions with fictitious patient names and addresses.17 A more sophisticated forgery method is using computer programs to create prescriptions for nonexistent prescribers or to copy legitimate prescribers’ prescriptions.17

The following criteria may indicate a prescription was not written for a legitimate medical purpose17:

  • The prescriber writes significantly more prescriptions (or dispenses larger quantities) compared to other practitioners in the vicinity
  • The patient appears to be returning too frequently
  • The prescriber writes prescriptions for antagonistic drugs, such as depressants and stimulants, at the same time
  • A patient presents prescriptions written in the names of other people
  • Numerous people appear simultaneously, or within a short time, all presenting similar prescriptions from the same prescriber
  • People who are not regular patrons of the pharmacy suddenly show up with prescriptions from the same prescriber

The following criteria may indicate a forged prescription17:

  • Prescriber’s handwriting is too legible
  • Quantities, directions, or dosages differ from usual usage
  • Prescription does not comply with acceptable standard abbreviations or appears to be a textbook presentation
  • Prescription appears photocopied
  • Directions are written in full with no abbreviations
  • Prescription is written in different color inks or in different handwriting

Pharmacists should familiarize themselves with the prescribers in the local area, including recognizing their DEA numbers, and recognize patients who regularly frequent the pharmacy to mitigate prescription fraud. Checking the date on the prescription to determine if it is being presented in a reasonable length of time since the prescriber wrote it is also best practice.17 Becoming familiar with which drugs are popular for abuse and resale on the streets in the local area may also help identify which drugs are likely to be prescribed inappropriately.17 Encouraging communication between prescribers and pharmacists within the community makes drug diversion more difficult since most drug abusers seek out areas where communication and cooperation between health professionals is minimal.17

In addition to being aware of the above characteristics of forged prescriptions, pharmacists must also be able to validate a DEA number. All DEA registration numbers are a combination of 2 letters followed by 7 numbers, and the first letter indicates the registrant type.18 Table 1 lists prescriber types and their corresponding first letters. The second letter is the first letter of the prescriber’s last name and the remaining characters are numbers. If a prescriber uses a business address instead of their name, the number 9 is used in place of the second letter.

Table 1. Identification of Prescriber with Corresponding DEA First Letter19
First Letter of DEA Number Prescriber Identity
A Used by older entities; last issued in 1985
B Clinics or hospitals
C Practitioner (e.g., physician, veterinarian, dentist)
D Teaching institution
E Manufacturer
F Distributor
G Researcher
H Analytical lab
J Importer
K Exporter
L Reverse distributor
M Mid-level practitioner (e.g., nurse practitioner, physician assistant)
P, R, S, T, U Narcotic treatment program
X Buprenorphine; buprenorphine/naloxone prescribing program

Many pharmacy computer systems are designed to check DEA number validity, but pharmacy teams can also use the following manual method to check that a DEA number is valid18:

  1. Check that the first 2 characters are upper case letters. The second letter should be the first letter of the practitioner’s last name.
  2. Add together the 1st, 3rd, and 5th digits in the sequence.
  3. Add together the 2nd, 4th, and 6th digits in the sequence.
  4. Double the sum from step 3 and add to the sum from step 2.
  5. If the last (7th) digit of the DEA number is the same as the last digit of the number obtained in step 4, the DEA number is considered valid.

Example 1:

John Doe, MD

AD0865937

Step 1: 0 + 6 + 9 =15

Step 2: 8 + 5 + 3 = 16 (x2) = 32

Step 3: 32 + 15 = 47

Step 4: The last digit of this sum should correspond with the last digit of the DEA registration number - AD0865937. This is a valid DEA number.

Example 2:

Sasha Sanderson, DVM

CA3456781

Step 1: 3 + 5 + 7 = 15

Step 2: 4 + 6 + 8 = 18(x2) = 36

Step 3: 36 + 15 = 51

Step 4: The last digit of this sum corresponds with the last digit of the DEA registration number, but the second letter should be an S (not an A) that corresponds with Dr. Sanderson’s last name. This is not a valid DEA number.

Prescribers who practice in multiple states are required to have a unique DEA number for each location in which they practice.18 A prescriber who only works in a clinic or hospital is allowed to use the facility’s DEA registration if that is the hospital or clinic’s policy.18 Multiple individuals can use the same DEA number in specific circumstances.19 This occurs with hospital interns or residents who administer, dispense, or prescribe controlled substances under another provider’s supervision. For accountability, the hospital or institution assigns each individual a "hospital code number" which is then appended to the DEA number of the supervising prescriber after a dash. The individual institution is responsible for creating and maintaining records of the codes and are required to produce the coded list at the request of any law enforcement agency.19

Another step to determine prescription validity in accordance with therapeutic appropriateness is for the pharmacist to perform a prospective drug use review. According to Florida Administrative Rule 64B16-27.810, in performing this review a pharmacist must identify the following20:

  • Over- or under-utilization
  • Therapeutic duplication
  • Drug-disease contraindications
  • Drug-drug interactions
  • Incorrect drug dosage or treatment duration
  • Drug-allergy interactions
  • Clinical abuse/misuse

If any of the above issues are recognized, the rule requires that pharmacists take appropriate steps to avoid or resolve the potential problems. This includes consultation with the prescriber, if necessary.20

The Florida Board of Pharmacy issued Rule 64B16-27.831 to help guide pharmacists in relation to dispensing pain medications.21 This rule states that a pharmacist should not fear disciplinary action for dispensing controlled substances for a legitimate medical purpose in the usual course of professional practice.21 The Board of Pharmacy encourages that pharmacists make every attempt to work with both the patient and the prescriber to determine the validity of a questionable prescription.

Before a pharmacist refuses to fill a prescription, the rule requires that they attempt to contact the prescriber for verification and request patient identification and other relevant information.17,21 In all circumstances the pharmacist must utilize 2 methods to identify the validity of a prescription. Pharmacists may utilize E-FORCSE in an attempt to acquire information relevant to the validity of the prescription instead of speaking to both patient and provider.21 If a patient or provider refuses to cooperate with a pharmacist attempting to acquire information relevant to the prescription’s validity, the above standards are not required and the pharmacist may refuse to fill the prescription.21

After appropriate inquiry, if a pharmacist believes a prescription is forged or altered, they should not dispense it and they should notify local police.17 DEA stipulates that if a pharmacist believes to have discovered a pattern of prescription abuse, they should contact the state Board of Pharmacy or the local DEA Diversion Field Office.17 In addition, the Florida Board of Pharmacy mandates that if a pharmacist has reason to believe that a prescriber is involved in controlled substance diversion, thy must report that prescriber to the Department of Health.21 Pharmacists should document all actions taken as a result of suspected forgery or diversion of controlled substances. Using proper dispensing procedures, upholding professional practice, and encouraging the pharmacy staff to be watchful promote proper controls against fraudulent prescriptions.

EMERGENCY TREATMENT FOR SUSPECTED OPIOID OVERDOSES

Naloxone, an opioid antagonist, is an effective therapy to reverse an opioid overdose.22 All 50 states and the District of Columbia have passed legislation increasing access to naloxone, such as allowing pharmacists to dispense naloxone without a patient-specific prescription.22 Florida’s standing order for naloxone authorizes pharmacists practicing in a pharmacy located in Florida maintaining a current active pharmacy permit to dispense naloxone to emergency responders for administration to persons exhibiting signs of opioid overdose.23 Emergency responders include law enforcement, firefighters, paramedics, and emergency medical technicians.23

The only route of administration available for dispensing by pharmacists to emergency responders includes the nasal spray, since the auto-injector has been removed from the market.23 Incorporated in this standing order for naloxone is the expectation that the Substance Abuse and Mental Health Services Administration (SAMHSA) Opioid Prevention Toolkit Five Essential Steps for First Responders be followed.23 The toolkit can be found at https://store.samhsa.gov/sites/default/files/d7/priv/sma18-4742.pdf and provides steps for first responders, information for health care providers to reduce the effects of opioid overdose, and safety advice for patients and family members.

Candidates who fit the profile for naloxone dispensing and education include the following24:

  • Receiving emergency medical care involving opioid intoxication or overdose
  • Suspected history of substance abuse or nonmedical opioid use
  • Starting methadone or buprenorphine for addiction
  • Receiving a high-dose (greater than 50 mg morphine equivalents/day) opioid prescription
  • Receiving any opioid prescription for pain plus:
    • Switched from 1 opioid to another (possible incomplete cross-tolerance)
    • Smoking, chronic obstructive pulmonary disease, emphysema, asthma, sleep apnea, respiratory infection, or other respiratory illness
    • Renal dysfunction, hepatic disease, cardiac illness, or human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)
    • Known or suspected concurrent alcohol use
    • Concurrent benzodiazepine or other sedative prescription
    • Concurrent antidepressant prescription
  • Patients who may have di­fficulty accessing emergency medical services (e.g., due to distance)
  • Voluntary request from a patient or caregiver

Counseling on the risks of overdose is a necessary part of dispensing opioids and naloxone education is an area where pharmacists can be critical advocates for the safe and effective use of pain medications. Studies have shown that community-based opioid overdose prevention programs can positively influence bystanders (mostly opioid users) to use naloxone to reverse opioid overdoses when properly trained.25 Pharmacists can play an essential role in facilitating such training programs in their communities to help combat the opioid crisis.

CONCLUSION

The abuse of prescription drugs and heroin in the U.S. has risen to epidemic levels. This has resulted in unprecedented rates of drug overdose and related fatalities, calling for all health care professionals to contribute to alleviating this public health crisis. Pharmacists can directly impact opioid misuse by educating both patients and providers, serving as members of interdisciplinary teams treating those with pain and/or dependence, and assisting with prescription drug monitoring by participating in their state’s controlled substance monitoring program. Pharmacists also have a corresponding responsibility to confirm the validity of controlled substance prescriptions by ensuring a legitimate medical utilization and verifying the prescription was dispensed within the prescriber’s appropriate scope of practice. As the ultimate dispensers of medication, pharmacists are uniquely positioned to help reduce the harms attributable to prescription opioids and to educate prescribers and patients about appropriate pain medications use and the risks of opioid addiction.

REFERENCES

  1. Centers for Disease Control and Prevention. Understanding the epidemic. Updated March 17, 2021. Accessed August 22, 2021. https://www.cdc.gov/opioids/basics/epidemic.html
  2. Dasgupta N, Beletsky L, Ciccarone D. Opioid crisis: no easy fix to its social and economic determinants. Am J Public Health. 2018;108(2):182-186. doi:10.2105/AJPH.2017.304187
  3. National Center for Drug Abuse Statistics. Opioid epidemic: Addiction statistics. Accessed August 22, 2021. https://drugabusestatistics.org/opioid-epidemic/
  4. Volkow ND, Blanco C. The changing opioid crisis: development, challenges and opportunities. Mol Psychiatry. 2021;26(1):218-233. doi:10.1038/s41380-020-0661-4
  5. Scott J. Florida’s new law on controlled substance prescribing. 2018. Accessed August 23, 2021. https://www.flmedical.org/Florida/Florida_Public/Docs/FMA-Opioid-HB21.pdf
  6. The Florida Senate. 2009 Florida statutes: 893.055 Prescription drug monitoring program. Accessed August 23, 2021. https://www.flsenate.gov/Laws/Statutes/2009/893.055
  7. The Florida Senate. 2011 Florida statutes: 456.44 Controlled substance prescribing. Accessed August 23, 2021. https://www.flsenate.gov/Laws/Statutes/2011/456.44
  8. Florida Department of Health Prescription Drug Monitoring Program. Dispenser’s Implementation Guide. November 2017. Accessed August 23, 2021. https://www.flmedical.org/florida/Florida_Public/Docs/Dispensers_Implementation_Guide.pdf
  9. The Florida Senate. 2020 Florida statutes: 456.44 Controlled substance prescribing. Accessed August 23, 2021. https://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&URL=0400-0499/0456/Sections/0456.44.html
  10. The Florida Senate. 2020 Florida statutes: Chapter 395 Hospital licensing and regulation. Accessed August 23, 2021. https://www.flsenate.gov/Laws/Statutes/2020/Chapter395
  11. The Florida Senate. 2020 Florida statutes: Chapter 893 Drug abuse prevention and control. Accessed August 23, 2021. https://m.flsenate.gov/Statutes/893.04
  12. The Florida Senate. 2020 Florida statutes: 456.42 Written prescriptions for medicinal drugs. Accessed August 23, 2021. https://www.flsenate.gov/Laws/Statutes/2019/456.42
  13. Florida Department of Health. Counterfeit proof prescription pad vendors. July 1, 2018. Accessed August 23, 2021. https://www.flhealthsource.gov/FloridaTakeControl/vendors
  14. Florida Department of Health. Frequently asked questions. Updated July 27, 2020. Accessed August 24, 2021. http://www.floridahealth.gov/licensing-and-regulation/counterfeit-proof-prescription-pad-vendors/faq.html
  15. Prescribing in Florida: Guidance provided by the Florida Department of Health. October 2010. Accessed August 24, 2021. https://www.thehealthlawfirm.com/uploads/Prescribing-in-Florida-DOH.pdf
  16. U.S. Department of Justice Drug Enforcement Administration. Controlled substances listed in Schedule II. 1306.11 Requirement of Prescription. Accessed August 24, 2021. https://deadiversion.usdoj.gov/21cfr/cfr/1306/1306_11.htm
  17. U.S. Department of Justice Drug Enforcement Administration. A pharmacist’s guide to prescription fraud. February 2000. Accessed August 25, 2021. https://www.deadiversion.usdoj.gov/pubs/brochures/pharmguide.htm
  18. NPI Lookup. How to do DEA number lookup by NPI. January 10, 2021. Accessed August 25, 2021. https://npi-lookup.org/insights/how-to-do-dea-number-lookup-by-npi/
  19. PTCB Test Prep. What are DEA numbers and what do they mean? January 24, 2020. Accessed August 25, 2021. https://ptcbtestprep.com/what-are-dea-numbers/
  20. Florida Administrative Code and Florida Administrative Register. Rule 64B16-27.810 Prospective drug use review. Updated March 10, 2020. Accessed August 25, 2021. https://www.flrules.org/gateway/ruleno.asp?id=64B16-27.810
  21. Florida Board of Pharmacy. Validate pain medication prescriptions. December 28, 2015. Accessed August 25, 2021. https://askinglot.com/open-detail/657420
  22. Chisholm-Burns MA, Spivey CA, Sherwin E, Wheeler J, Hohmeier K. The opioid crisis: origins, trends, policies, and the roles of pharmacists. Am J Health Syst Pharm. 2019;76(7):424-435. doi:10.1093/ajhp/zxy089
  23. Florida Department of Health. Declaration of public health emergency and statewide standing order for naloxone. May 3, 2017. Accessed August 25, 2021. http://www.floridahealth.gov/_documents/newsroom/press-releases/2017/08/081717-phe-opioid-re-dec-6-30-17-004.pdf
  24. Washington State Hospital Association. Instructions for healthcare professionals: Prescribing naloxone. 2012. Accessed August 26, 2021. https://www.wsha.org/wp-content/uploads/er-emergencies_prescribetoprevent_naloxone_instructions1_2.pdf
  25. Clark AK, Wilder CM, Winstanley EL. A systematic review of community opioid overdose prevention and naloxone distribution programs. J Addict Med. 2014;8(3):153-163. doi:10.1097/ADM.0000000000000034

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