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The Pharmacy Technician’s Guide to Regulations Related to Controlled Substance Prescribing in Florida

INTRODUCTION

The opioid epidemic refers to the extensive overuse of opioid medications—compounds resembling opium with morphine-like effects—from medical prescriptions and illegal sources.1 The 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

This epidemic evolved in 3 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

Providing an effective response 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 (e.g., acetaminophen, ibuprofen) and non-pharmacological approaches (e.g., heat, rest, ice), opioids remain necessary 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 treat 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 laws relevant to prescribing and dispensing controlled substances in Florida, discuss the requirements of E-FORCSE (Florida’s prescription drug monitoring program), provide guidance for detecting prescription fraud, and review Florida’s standing order for naloxone. Use the SIDEBAR to identify commonly prescribed opioids and other controlled substances.

SIDEBAR: Recognizing Opioids and Scheduled Medications6-8

An important part of recognizing medication abuse and misuse is knowing which drugs to watch for in the pharmacy. Listed below are commonly prescribed opioids and examples of medications prescribed in each controlled substance Schedule. When in doubt, pharmacy technicians can identify controlled substance schedules on the manufacturer packaging, as commercial containers of controlled substances are required to contain a symbol indicating the drug’s schedule.

Opioids:

  • Buprenorphine
  • Carfentanil
  • Codeine
  • Fentanyl
  • Hydrocodone
  • Hydromorphone
  • Meperidine
  • Methadone
  • Morphine
  • Oxycodone
  • Oxymorphone
  • Tramadol

Schedule II:

  • Amphetamine
  • Codeine
  • Fentanyl
  • Hydrocodone
  • Methadone
  • Methamphetamine
  • Morphine
  • Oxycodone

Schedule III:

  • Buprenorphine
  • Chlorhexadol
  • Dronabinol
  • Ketamine
  • Testosterone

Schedule IV:

  • Alprazolam
  • Carisoprodol
  • Clonazepam
  • Diazepam
  • Lorazepam
  • Midazolam
  • Phenobarbital
  • Temazepam
  • Zaleplon
  • Zolpidem

Schedule V:

  • Atropine/diphenoxylate
  • Brivaracetam
  • Cenobamate
  • Not more than 200 mg of codeine per 100 mL of cough syrup
  • Lacosamide
  • Pregabalin

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 bill added a section related to prescribing controlled substances for acute pain to the existing section regarding managing chronic nonmalignant 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.”5 The term does not include pain related to cancer; a terminal condition; or palliative care to provide symptoms 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.5

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 (e.g., naloxone) to reverse the opioid’s effects should a patient overdose.5

House Bill 21 also redefined pain management clinic regulations. As of 2010, pain management clinics were required to register with the Florida Department of Health. In 2011, the legislation redefined these clinics as any facility that advertises any type of pain management service or where the majority of patients are prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for the management of chronic nonmalignant pain on a monthly basis.5 The following entities were granted exemption based on this legislation5,9:

  • 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

House Bill 21 also required those permitted to prescribe controlled substances to take a 2-hour board-approved continuing education course focused on controlled substances.5 These continuing education hours are now required as part of every biennial license renewal.5 Finally, House Bill 21 made significant changes to the prescription drug monitoring program, Electronic-Florida Online Reporting of Controlled Substances Evaluation Program (E-FORCSE).

FLORIDA PRESCRIPTION DRUG MONITORING PROGRAM

Florida established their prescription drug monitoring program, E-FORCSE, in 2009. The state requires pharmacists and dispensing practitioners to report to the database each time they dispense a controlled substance in an initiative to encourage safer controlled substance prescribing and reduce drug abuse and diversion.5 This electronic system is intended to deliver providers and pharmacists with real-time information about prescribing and patient behaviors to help evaluate risk factors for controlled substance abuse in an attempt to intervene sooner if abuse or diversion was suspected. The Department of Health ensures the integrity of the prescription drug monitoring program and requires every pharmacist and prescriber to register as a separate user.10 

As passed in 2009, the law did not require physicians to check the database before prescribing a controlled substance.11 The most significant change enacted with House Bill 21 was that it required prescribers and dispensers to consult the database to review dispensing history before prescribing or dispensing a controlled substance for a patient aged 16 years or older. This applies to new prescriptions and refills for existing patients.5 This mandate applies to all controlled substances, not just opioids, with the only exception being a nonopioid controlled substance listed in Schedule V .5 In the event the database is not accessible, pharmacists may dispense no more than a 3-day supply of the controlled substance with documentation as to why the database was unavailable.5

House Bill 21 also mandated that pharmacists report dispensing of a controlled substance by the close of the next business day instead of the previously established 15 day window.5 In addition, dispensers must file a zero report if they usually dispense controlled substances but have no dispensing transactions to report for the preceding 7-day period.12 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 within the required time frame commit a misdemeanor of the first degree and could face disciplinary action from their respective board.5

There are certain exemptions where practitioners are not required to report to E-FORCSE, including12

  • 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 dispensed12:

  • 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 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)

Indicators of controlled substance abuse according to rule 64K-1.007 of the Florida legislature include the following behaviors13:

  • A patient obtains a prescription for a controlled substance from more than 1 prescriber within a 90-day time period
  • A patient is dispensed a controlled substance from 5 or more pharmacies

Upon identifying a patient who exhibits this behavior, the Department of Health may provide relevant information to the identified health care practitioners who have prescribed or dispensed controlled substances for the identified patient.13 This practice was implemented with the intent being that a provider could intervene sooner if a patient is at risk of drug abuse or diversion was suspected.

REQUIREMENTS FOR CONTROLLED SUBSTANCE PRESCRIPTIONS

According to Chapter 893 of the 2020 Florida statutes, a pharmacist may dispense a controlled substance for a Schedule III or IV medication based upon a written, oral, or electronic prescription.14 A prescription for a controlled substance listed in Schedule II is only valid upon a written or electronic prescription, except in an emergency situation when an oral prescription is acceptable but limited to a 72-hour supply.14 A pharmacist may dispense a one-time emergency refill of up to a 72-hour supply of a schedule III or IV medication.14

Patients may not refill a prescription for a controlled substance in Schedule III, IV, or V more than 5 times within a period of 6 months after the date the prescription was written, and a prescription for a schedule II may never be refilled.14 Florida pharmacies must maintain records of all controlled substance prescriptions for a period of 2 years.14

A written prescription for a controlled substance must have the following items on the face of the prescription14:

  • Signature of the prescribing practitioner on the date of issue
  • The date in numerical, month/day/year format, or with the abbreviated month written out, or the month written out in full
  • The full name and address of the person for whom (or the owner of the animal for which) the controlled substance is dispensed
  • The full name and address of the prescribing practitioner
  • The 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
  • The name of the controlled substance prescribed and the strength, quantity (written and numerical), and directions for use
  • The number of the prescription, as recorded in the prescription files of the pharmacy
  • The 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.14

Prescriptions for controlled substances must be written on a counterfeit-proof pad produced by a Department of Health-approved vendor.15 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).16 Veterinarians, however, are not subject to this mandate.16 The vendor is required to pre-print the indicator “NONACUTE PAIN” or “ACUTE PAIN EXCEPTION” on the prescription face.16 The vendor’s counterfeit-proof prescription pads must also meet the following criteria17:

  • 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 preprinted name, address and category of professional licensure of the prescribing practitioner or the name and address of the health care facility
  • A space for the prescribing practitioner’s name if not preprinted and federal DEA registration number for controlled substances

The label on the vial of a controlled substance must contain the following information14:

  • Name and address of the pharmacy
  • Date filled
  • Prescription number
  • Name of the prescribing practitioner
  • Name of the patient or 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 Schedule II 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.18 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.18

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.19 The pharmacy must maintain this original copy in their records. The faxed prescription may only serve as the original copy when19

  • 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 a hospice program 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).19 The pharmacist must immediately reduce the prescription to writing, including all information required except the prescribing practitioner’s signature.19 The prescriber must provide a signed written prescription to the pharmacist within 7 calendar days that includes the terms “Authorization for Emergency Dispensing” and the date of the oral order.19 Upon receipt, the dispensing pharmacist must attach this paper prescription to the oral emergency prescription that was reduced to writing.19 The pharmacist must notify DEA if they do not receive the prescription in that timeframe.19

GUIDE TO PRESCRIPTION FRAUD

All health care professionals have an obligation to aid in averting prescription drug abuse and diversion. Prescribers who issue an invalid prescription and pharmacists who fill an invalid prescription are both 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 prescriptions are issued in the usual course of professional practice of prescribers.20

Pharmacists and pharmacy technicians should be aware of the various kinds of forged prescriptions that may be presented for dispensing. Some patients may have 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.20 Drug-seeking individuals may also call in their own prescriptions and give their own telephone number as a call-back for confirmation.20 Individuals may also steal prescription pads from practitioners’ offices and/or hospitals and write prescriptions with fictitious patient names and addresses.20 A more sophisticated method is using computer programs to create prescriptions for nonexistent prescribers or to copy legitimate prescribers’ prescriptions.20

The following criteria may indicate a prescription was not written for a legitimate medical purpose20:

  • 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 (e.g., benzodiazepines, opioids) and stimulants (e.g., amphetamines), at the same time; drug abusers often request a prescription for an “upper” and “downer” at the same time to help balance the effects of medication
  • 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 prescription20:

  • The prescriber’s handwriting is too legible
  • Quantities, directions, or dosages differ from usual usage
  • The prescription does not comply with acceptable standard abbreviations
  • The prescription appears photocopied
  • Directions are written in full with no abbreviations
  • The prescription is written in different color inks or in different handwriting

Pharmacy teams should familiarize themselves with the prescribers in the local area, including recognizing their DEA numbers, and recognize patients who frequent the pharmacy to help 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.20 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.20 Encouraging communication between prescribers and pharmacy staff within the community makes drug diversion more difficult since most drug abusers seek out areas where communication and cooperation between health professionals is minimal making abuse and diversion harder to identify.20

In addition to being aware of the above characteristics of forged prescriptions, pharmacists and pharmacy technicians 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.21 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 Letter 22
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 or 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 valid21:

  1. Check that the first 2 characters are upper case letters. The second letter should be the first letter of the prescriber’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 (x 2) = 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 (x 2) = 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 will be required to have a unique DEA number for each location in which they practice.21 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.21 Multiple individuals can use the same DEA number in specific circumstances.22 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 is required to produce the coded list at the request of any law enforcement agency.22

The Florida Board of Pharmacy issued rule 64B16-27.831 to help guide pharmacists in relation to dispensing pain medications and ensure that patients with valid prescriptions for controlled substances can access medication.23 The rule states that a pharmacist should notfear disciplinary action for dispensing controlled substances for a legitimate medical purpose in the usual course of professional practice.23 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.20,23

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 provider23 If a patient or provider refuses to cooperate with a pharmacist attempting to acquire information relevant to the prescription’s validity, the above standards for refusing to fill a prescription are not required and the pharmacist may refuse to fill the prescription.23

After appropriate inquiry, if a pharmacist believes a prescription is forged or altered, they should not dispense it and they should notify local police.20 The DEA stipulates that if pharmacists believes they have discovered a pattern of prescription abuse, they should contact the state Board of Pharmacy or the local DEA Diversion Field Office.20 In addition, the Florida Board of Pharmacy mandates that if a pharmacist has reason to believe that a prescriber is involved in the diversion of controlled substances, they must report that prescriber to the Department of Health.23 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 pharmacy staff to be watchful encourage proper controls against fraudulent prescriptions.

EMERGENCY TREATMENT FOR SUSPECTED OPIOID OVERDOSES

In the event of an opioid overdose, responders can use naloxone to reverse the effects of the opioid. Naloxone is a potent opioid antagonist (inhibitor) that displaces opioids at their receptor sites thereby reducing the effects of the opioid from potential fatal consequences and adverse effects.24 It is FDA approved for emergency treatment of known or suspected opioid overdose with respiratory depression (e.g., slow and ineffective breathing) and/or central nervous system (CNS) depression (e.g., decreased heart rate, decreased breathing, loss of consciousness).24 Naloxone administration will have no effect in people not taking opioids.25 This means it will not harm a patient who is not overdosing on opioids, and responders to the emergency should administer it without fear of harming the patient, even if they are unsure what the patient ingested. This also means naloxone is ineffective for patients overdosing on medications that are not opioids.

For the initial treatment of an opioid-associated life-threatening emergency, the American Heart Association recommends the use of naloxone along with cardiopulmonary resuscitation (CPR).24 If the patient initially responds to naloxone but then stops responding, a responder should repeat the naloxone dose and maintain CPR.24 The dose may be repeated every 2 to 3 minutes.24 Most people respond by returning to spontaneous breathing, which usually occurs within 2 to 5 minutes of naloxone administration.24  If no response is observed after 10 mg total, other causes of respiratory/CNS depression should be considered.24 The most likely explanation is that the person is not overdosing on a non-opioid substance or may be experiencing a non-overdose medical emergency.

Those administering naloxone should be aware that it may precipitate acute withdrawal or unmask pain in regular opioid users.24 Symptoms of acute withdrawal in opioid-dependent patients may include pain, tachycardia (e.g. increased heart rate), hypertension, fever, sweating, abdominal cramps, diarrhea, nausea, vomiting, agitation, and irritability.24 Recurrence of respiratory and/or CNS depression is possible if the opioid involved is long-acting; therefore, patients who receive naloxone in out-of-hospital settings should seek immediate emergency medical assistance.24 According to the American College of Obstetricians and Gynecologists, treatment should not be withheld when needed in cases of maternal opioid overdose.26 Even though naloxone may precipitate opioid withdrawal in the mother and/or fetus, the risks outweigh the benefits.

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.27 Florida’s standing order for naloxone authorizes pharmacists to dispense naloxone nasal spray to emergency responders (e.g., law enforcement, firefighters, paramedics, emergency medical technicians) for administration to persons exhibiting signs of opioid overdose.28 The signs of opioid overdose include29

  • unconsciousness or inability to awaken
  • slow or shallow breathing or breathing difficulty
  • fingernails or lips turning blue/purple

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.28 This toolkit provides steps for suspected overdose, information for health care providers to reduce the effects of opioid overdose, and safety advice for patients and family members.29 The 5 essential steps for first responders include the following29:

  • Step 1: Call the person’s name
    • If this doesn’t work, vigorously grind knuckles into the sternum or rub knuckles on the person’s upper lip; if no response, continue to step 2
    • If the person responds, assess whether he or she can maintain responsiveness and breathing; continue to monitor breathing and alertness and try to keep the person awake
  • Step 2: Call 911
  • Step 3: Administer naloxone
    • The goal should be to restore adequate spontaneous breathing, but not necessarily complete arousal
    • Provide reassurance and explain what is happening if the person becomes agitated or confused
  • Step 4: Provide rescue breathing and chest compressions if necessary
  • Step 5: Monitor for signs and symptoms of opioid toxicity for at least 4 hours from the last dose of naloxone

Table 2 lists the dos and don’ts of responding to opioid overdoses. Candidates who fit the profile for naloxone dispensing and education include the following30:

  • 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 one opioid to another (i.e., may have less tolerance to the new opioid)
    • 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
Table 2. Dos and Don’ts of Responding to Opioid Overdose29
DO DON’T

· Check the naloxone expiration date

· Stay with the person and keep them warm

· Place the person in the “recovery position” on their side if you must leave them unattended

· Attend to the person’s breathing and cardiovascular support needs by administering oxygen or performing rescue breathing and/or chest compressions

· Administer naloxone and utilize a second dose, if no response to the first dose

· Slap or forcefully try to stimulate the person; this will only cause further injury

· Put the person into a cold bath or shower; this may increase the risk of falling, drowning, or shock

· Try to make the person vomit drugs that may have been swallowed; this can lead to aspiration

· Inject the person with any substance; the only safe and appropriate treatment is naloxone

As an antidote to opioid overdose, naloxone has proven to be a valuable tool in combating overdose deaths and associated morbidity. 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.31 A trial published in 2016 found that co-prescribing naloxone rescue kits to patients treated with opioids for chronic pain in primary care resulted in reduced opioid-related emergency department visits.25 Increasing access to naloxone and helping to promote community awareness and education is a valuable area where pharmacists and pharmacy technicians can have a considerable influence in helping to reduce the number of fatal opioid overdoses.

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. Striking a balance between providing medication access for patients with legitimate pain and recognizing individuals seeking prescription opioids for illegitimate reasons is often challenging. Pharmacy technicians can be a valuable resource to pharmacists by recognizing aberrant drug-related behaviors and being knowledgeable about the legal and regulatory opioid standards in daily practice. Patients should be counseled at initiation of opioids and at every subsequent fill to ensure efficacy and safety. Instead of simply verifying that patients have no questions about the medication, pharmacy technicians can assist a pharmacist by helping to ensure that all patients receive appropriate pharmacist counseling. In addition, pharmacy technicians who are aware of the regulations surrounding naloxone dispensing for opioid overdose can aid in ensuring the appropriate dispensing of this life-saving medication. Pharmacy technicians are uniquely positioned to help pharmacists reduce the risks attributable to prescription opioids in an effort to ultimately diminish the opioid epidemic.

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. U.S. Department of Justice. Title 21 code of federal regulations: Part 1308 – Schedules of controlled substances. September 24, 1973. Accessed September 13, 2021. https://www.deadiversion.usdoj.gov/21cfr/cfr/2108cfrt.htm
  7. Johns Hopkins Medicine. What are opioids? Accessed September 13, 2021. https://www.hopkinsmedicine.org/opioids/what-are-opioids.html
  8. U.S. Food and Drug Administration. CFR – Code of federal regulations Title 21. Updated April 1, 2020. Accessed September 13, 2021. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1302&showFR=1
  9. The Florida Senate. 2020 Florida statutes: Chapter 395 hospital licensing and regulation. Accessed August 23, 2021. https://www.flsenate.gov/Laws/Statutes/2020/Chapter395
  10. Florida Department of Health. E-FORCSE home page. Updated March 12, 2021. Accessed August 27, 2021. http://www.floridahealth.gov/statistics-and-data/e-forcse/index.html
  11. 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
  12. 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
  13. Florida Administrative Code and Florida Administrative Register. Rule 64K-1.007 Prescription drug monitoring program. December 11 ,2019. Accessed August 28, 2021. https://www.flrules.org/gateway/ruleno.asp?id=64K-1.007
  14. The Florida Senate. 2020 Florida statutes: Chapter 893 drug abuse prevention and control. Accessed August 23, 2021. https://m.flsenate.gov/Statutes/893.04
  15. 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
  16. Florida Department of Health. Counterfeit proof prescription pad vendors. July 1, 2018. Accessed August 23, 2021. https://www.flhealthsource.gov/FloridaTakeControl/vendors
  17. Florida Department of Health. Frequently asked questions. Updated July 27, 2020. Accessed August 27, 2021. http://www.floridahealth.gov/licensing-and-regulation/counterfeit-proof-prescription-pad-vendors/faq.html
  18. 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
  19. 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
  20. 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
  21. 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/
  22. 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/
  23. Florida Board of Pharmacy. Validate pain medication prescriptions. December 28, 2015. Accessed August 25, 2021. https://askinglot.com/open-detail/657420
  24. Naloxone. Lexi-Drugs. Riverwoods, IL: Lexicomp, 2021. http://online.lexi.com/. Updated August 14, 2021. Accessed August 24, 2021.
  25. Kerensky T, Walley AY. Opioid overdose prevention and naloxone rescue kits: what we know and what we don't know. Addict Sci Clin Pract. 2017;12(1):4. doi:10.1186/s13722-016-0068-3
  26. The American College of Obstetricians and Gynecologists. Opioid use and opioid use disorder in pregnancy. August 2017. Accessed August 28, 2021. https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/08/opioid-use-and-opioid-use-disorder-in-pregnancy
  27. 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
  28. 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
  29. Substance Abuse and Mental Health Services Administration. Opioid overdose prevention TOOLKIT. Revised 2018. Accessed August 28, 2021. https://store.samhsa.gov/sites/default/files/d7/priv/sma18-4742.pdf
  30. 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
  31. 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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