VALIDATION AND COUNSELING OF PRESCRIPTIONS FOR
CONTROLLED SUBSTANCES AND OPIOIDS
Faculty:
Steven Malen, PharmD, MBA
Steven Malen graduated with a dual degree in Doctor of Pharmacy (PharmD) and Master of Business Administration (MBA) from the University of Rhode Island. Steven Malen has worked as a clinical pharmacist in the retail, specialty, and compounding sectors.
Pamela Sardo, PharmD, BS
Pamela Sardo, PharmD, BS, is a freelance medical writer and licensed pharmacist. She is the founder and principal at Sardo Solutions in Texas. Pam received her BS from the University of Connecticut and her PharmD from the University of Rhode Island. Pam’s career spans many years in retail, clinics, hospitals, long-term care, Veterans Affairs, and managed health care responsibilities across a broad range of therapeutic classes and disease states.
Abstract
Controlled substances may be prescribed to patients for legitimate medical purposes. However, controlled substances, such as opioids, may be misused. Patients must be assessed for the appropriate therapeutic use of controlled substances so that misuse, addiction, or dependence does not occur. To protect patients from the inappropriate use of controlled substances, clinicians must know the laws and rules related to the prescribing and dispensing of controlled substances. Clinicians in Florida must use the prescription drug monitoring program database and implement protocols to address and resolve problems identified during a drug utilization review, as required by Florida law. Pharmacists are particularly situated to counsel patients with opioid prescriptions on the proper storage and disposal of controlled substances, standing orders for reversal agents, such as naloxone, and treatment resources for opioid physical dependence, addiction, or misuse.
Accreditation Statements
In support of improving patient care, RxCe.com LLC is jointly accredited by the Accreditation CouncilTM for Continuing Medical Education (ACCME®), the Accreditation Council for Pharmacy Education (ACPE®), and the American Nurses Credentialing Center (ANCC®), to provide continuing education for the healthcare team.
Joint Universal Activity Number: The Joint Accreditation Universal Activity Numbers assigned to this activity are as follows:
Pharmacists: JA4008424-0000-26-103-H08-P
Pharmacy Technicians: JA4008424-0000-26-103-H08-T
Credits: 2 contact hour(s) (0.2 CEU(s)) of continuing education credit.
Credit Types:
Pharmacy - 2 Credit(s)
Type of Activity: Knowledge
Media: Computer-Based Training (i.e., online courses)
Estimated time to complete activity: 2 contact hour(s) (0.2 CEU(s)), including Activity Pre-Test, Post-Test, and Activity Evaluation.
Release Date: July 1, 2026 Expiration Date: July 1, 2027
Target Audience: This educational activity is for Pharmacists and Pharmacy Technicians
How to Earn Credit: From July 1, 2026, through July 1, 2027, participants must:
Read the “learning objectives” and “author and planning team disclosures;”
Take the “Educational Activity Pre-Test;”
Study the section entitled “Educational Activity;” and
Complete the Educational Activity Post-Test and Activity Evaluation. The Educational Activity Post-Test will be graded automatically. Following successful completion of the Educational Activity Post-Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)
CE Credits: Credits for this course will be uploaded to CPE Monitor® for pharmacists and pharmacy technicians.
Statement of Need
Pharmacists and pharmacy staff do not consistently validate controlled substances. They sometimes fail to perform a thorough investigation of the prescriber’s credentials or conduct a full patient history. Pharmacists and pharmacy staff need to ensure that controlled substance prescriptions are for legitimate medical purposes.
Learning Objectives: Upon completion of this educational activity, participants should be able to:
Describe the laws and rules related to the prescribing and dispensing of controlled substances, including the Standards of Practice for the Filling of Controlled Substance Prescriptions and Electronic Prescribing in Florida (Fla. Admin. Code, Rule 64B16-27.831)
Identify How to Ensure that access to controlled substances for all patients with a valid prescription includes assessment of prescriptions for appropriate therapeutic value, and pharmacist-initiated counseling of patients with opioid prescriptions
Describe the use of the Prescription Drug Monitoring Program’s Database
Identify the risk for controlled substance misuse, addiction, or dependence, and detection of prescriptions not based on a legitimate medical purpose
Describe available treatment resources for opioid physical dependence, addiction, misuse, or abuse.
Counsel patients about the proper storage and disposal of controlled substances and the available treatment resources for opioid physical dependence, addiction, or misuse
Describe how to treat an opioid overdose, which includes reversal agents or standing orders for naloxone, including the Florida State laws and Surgeon General’s Statewide Standing Order for Naloxone
Describe protocols for addressing and resolving problems recognized during the drug utilization review, including but not limited to drug/drug interactions, side effects, and high-dose/low-dose guidelines
Disclosures
The following individuals were involved in planning, developing, and/or authoring this activity: Steven Malen, PharmD, MBA; and Pamela Sardo, PharmD, BS. None of the individuals involved in developing this activity has a conflict of interest or financial relationships related to the subject matter. There are no financial relationships or commercial or financial support relevant to this activity to report or disclose by RxCe.com or any of the individuals involved in the development of this activity.
© RxCe.com LLC 2026: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.
Educational Activity Pre-Test
A patient presents with a Schedule II opioid prescription from an out-of-state prescriber. What is the pharmacist’s responsibility regarding E-FORCSE in Florida?
No action needed if it looks legitimate.
Consult E-FORCSE prior to dispensing (for patients ≥ 16) and report the dispense.
Only check if it’s a refill.
Refer to the prescriber only.
According to the 2022 CDC Guideline, what is the preferred approach for many patients with subacute or chronic pain?
Start with opioids as first-line.
Limit to 3 days regardless of condition.
Always use high-dose MME.
Maximize nonopioid and nonpharmacologic therapies; use opioids only when benefits outweigh risks.
Under Florida law, can a pharmacist dispense naloxone to a caregiver without a patient-specific prescription?
No, a pharmacist should always require a prescription
Yes, a pharmacist can dispense naloxone to a caregiver under Florida statute
Yes, a pharmacist can dispense naloxone to a caregiver, but only in a 911 emergency situation.
No, because a pharmacist can only dispense naloxone directly to the patient.
Educational Activity
Validation and Counseling of Prescriptions for Controlled Substances and Opioids
Highlights
|
|---|
Introduction
Patients may be prescribed controlled substances for legitimate medical purposes. These controlled substances include prescription opioids. Because of the risk for opioid misuse, addiction, and dependence, patients must be assessed for the appropriate therapeutic use of controlled substances, which, by definition, involves detecting when a prescription is not based on a legitimate medical purpose. To protect patients from the inappropriate use of controlled substances, clinicians must know the laws and regulations governing the prescribing and dispensing of controlled substances, the use of the Prescription Drug Monitoring Program database, and the protocols for addressing and resolving problems identified during a drug utilization review. Patients must be educated on the proper storage and disposal of controlled substances. In the event of a suspected overdose, clinicians and patients must know how to treat an opioid overdose, which includes reversal agents or standing orders for naloxone. Pharmacists are ideally situated to counsel patients with opioid prescriptions on appropriate use and guide them toward available treatment resources for opioid physical dependence, addiction, or misuse.
Controlled Substances Act and Other Regulations
The Controlled Substances Act (CSA), enacted in 1970, regulates drugs, medications, or chemicals on their potential for misuse, as outlined in 21 U.S.C. § 811. Controlled substances are classified into five schedules, but not all narcotics; for example, opioids, stimulants, and muscle relaxants are often mislabeled as “narcotics” by the public, despite distinct classifications.
The CSA is enforced by the Drug Enforcement Administration (DEA).2,3 When the CSA was passed, it consolidated several laws that already regulated the manufacture and distribution of certain substances. States have also passed laws pertaining to controlled substances. It is important to understand not only federal DEA laws but also state-controlled-substance regulations, and to follow whichever law is more stringent. Drugs regulated by the CSA all have a potential for misuse. While opioid analgesics make up a substantial number of controlled substances, other classes of drugs are included, such as anabolic steroids, stimulants, hallucinogens, and depressants.4
Schedules of Controlled Substances
Drugs, substances, and certain chemicals used to make drugs are classified into five distinct categories or, more specifically, “schedules.” A substance’s placement within a schedule depends on several factors, most notably the drug’s acceptable medical use and potential for misuse.3,4 Each schedule has a specific set of parameters for the potential for misuse, currently accepted medical use, and safety when used under medical supervision:
Schedule I: No medical use, high misuse potential (e.g., heroin, LSD)
Schedule II/IIN: High misuse potential, accepted medical use (e.g., oxycodone, methylphenidate)
Schedule III/IIIN: Moderate misuse potential (e.g., codeine, ketamine)
Schedule IV: Lower misuse potential (e.g., alprazolam, tramadol)
Schedule V: Lowest misuse potential (e.g., pregabalin)
Schedule I Drugs
Schedule I drugs are those that have the highest potential for misuse or the highest potential for leading to substance use disorder. They are drugs that have no recognized medical use within the healthcare community and lack acceptable safety, even when used under medical supervision.4
Schedule I substances are not available by prescription since they have no accepted medical use and would not normally be found in healthcare institutions except in specific research situations.4 Examples of Schedule I drugs include methylenedioxymethamphetamine (Ecstasy), heroin, lysergic acid diethylamide (LSD), or methaqualone.
Cannabis or marijuana, legal for use in some states, remains classified as a Schedule I drug at the national level for unlicensed or recreational use. However, as of April 2026, the DEA has placed certain FDA-approved cannabis-derived products and state-regulated medical cannabis products into Schedule III pursuant to an order implementing President Trump’s December 2025 Executive Order. Broader rescheduling proceedings for cannabis are ongoing.5
Electronic Prescriptions for Schedules II Through V
Prescriptions for Schedules II through V drugs cannot be phoned or faxed to pharmacies (they must be prescribed via hard copy or electronically), except in a few special cases (namely, for long-term care residents, hospice patients, or emergencies).6-8 Florida mandates electronic transmission for prescribers with EHR systems.9
Schedule II and IIN Drugs (“CIIs”)
Schedule II and IIN drugs have less potential for misuse than Schedule I drugs, but still have a high potential to lead to substance use disorder.4 Misuse of these drugs can lead to strong physical and psychological dependence. Unlike Schedule I drugs, Schedule II drugs have accepted medical uses and can be prescribed. They are the most tightly regulated scheduled drugs available by prescription. In practice, Schedule II and IIN drugs are often referred to as “CII” medications, named for the symbol required on the manufacturer's label.4
Schedule II (but not IIN) drugs are sometimes classified as narcotics and are often prescribed for pain control. Examples of Schedule II drugs include hydrocodone combinations, methadone, hydromorphone (Dilaudid®), oxycodone (Oxycontin® and others), morphine, cocaine, meperidine (Demerol®), and fentanyl (DuragesicⓇ). Notably, single-ingredient codeine products fall under Schedule II.4
Schedule IIN drugs have the same potential for misuse as other Schedule II drugs but are not considered narcotics.4 They are often prescribed as stimulants to promote wakefulness, prescribed for attention-deficit/hyperactivity disorder (ADHD), or to induce sleep. Examples of Schedule IIN drugs include methamphetamine, methylphenidate (Ritalin®), dextroamphetamine/amphetamine (Adderall®), pentobarbital (Nembutal®), and secobarbital (Seconal®).4
No refills are allowed for Schedule II drugs.10 Each fill requires a new prescription, although prescribers can issue multiple prescriptions at a time (up to a 90-day supply total) within certain guidelines.10 Individual states are beginning to legalize dispensing one prescription of a 90-day supply at one time in limited instances.11
Partial filling of a CII drug is allowed if the pharmacist is unable to supply the full quantity called for in the prescription.12 The filled quantity must be noted. The remainder of the prescription may be filled within 72 hours if the medication is out of stock.12 If the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall notify the prescribing practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.12
If the patient, parent, caregiver, or prescriber request a partial refill, the remaining portions must generally be filled within 30 days based on updated federal flexibility.13 The pharmacist must notify the prescriber if the prescription cannot be filled within this time frame.13 If the patient is in a long-term care facility, the pharmacist may partially fill and complete the quantity like a non-scheduled prescription. Still, the pharmacist must document “LTCF patient” on the prescription. The same applies to a terminally ill patient, in which case, the pharmacist must record “terminally ill” on the prescription.14
Schedule III and IIIN Drugs (“CIIIs”)
The drugs classified as a Schedule III or IIIN have less potential for misuse than those in Schedules I and II. Although Schedule III/IIIN drugs can cause physical dependence, they more commonly cause psychological dependence.4 Prescriptions may be transmitted by phone, fax, hard copy, or electronic prescribing.6-8,15 Prescriptions may be written with refills, but may not be filled or refilled more than six months after the date the prescription was issued. These prescriptions are limited to five refills within a six-month time frame.16
A partial filling of a prescription for a Schedule III or IIIN drug is allowed in some circumstances.17 When a partial filling takes place, it is treated in the same manner and with the same rules as a refill of the drug. As with refills, partial prescription filling of Schedule III or IIIN drugs cannot occur more than six months after the date of issue.17
Some drugs in Schedule III are opioids used for pain control, such as codeine/acetaminophen combinations (note: codeine-containing medications can fall under other schedules, depending on strength and other active ingredients present). Another example in this drug category is buprenorphine/naloxone (Suboxone®).4 Non-narcotic (non-opioid) Schedule III drugs (Schedule IIIN) are prescribed for various other health conditions. Examples of Schedule IIIN drugs include ketamine, anabolic steroids, or those products containing testosterone, phendimetrazine (Bontril®), and benzphetamine (Didrex®).4
Schedule IV Drugs (“CIVs”)
Schedule IV drugs are more commonly prescribed and used within healthcare and have a lower propensity for leading to a substance use disorder when compared to drugs in Schedules I, II, or III.4 These drugs may risk causing physical or psychological dependence. As with Schedule III drugs, prescriptions may be transmitted by phone, fax, hard copy, or electronic prescribing,6-8 and may be written with refills (limited to 5 within a 6-month timeframe).16
Examples of Schedule IV drugs include alprazolam (Xanax®), diazepam (Valium®), midazolam (Versed®), temazepam (Restoril®), tramadol (Ultram®), carisoprodol (Soma®), triazolam (Halcion®), and clonazepam (Klonopin®).4
Schedule V Drugs (“CVs”)
Schedule V drugs are the least likely of all controlled substances to be misused.3,4 They are less likely to be prescribed for pain control and instead are often prescribed for conditions such as diarrhea, seizures, or cough.
Prescriptions for Schedule V drugs can be transmitted by phone, fax, hard copy, or electronic prescription.6-8 Examples of drugs that are classified as Schedule V medications include Robitussin AC, atropine/diphenoxylate (Lomotil®), pregabalin (Lyrica®), and ezogabine (Potiga®).4 Notably, there are some Schedule V controlled substance compounds, mixtures, or preparations (i.e., codeine-containing cough preparations) that can be sold over the counter in some states, including Florida, though sold only in limited quantities, only to individuals over the age of 18, and only by a registered pharmacist.18
Stock Ordering of Controlled Substances
Schedule CII drugs must be ordered for pharmacy or facility use by using a DEA Form 222 or the electronic Controlled Substance Ordering System (CSOS).19 Only staff with a power of attorney authority (established by a signed power of attorney form that must be kept on premises) can sign a DEA Form 222 or CSOS orders electronically.19 There are separate intake and recordkeeping requirements for each, depending on whether paper DEA Form 222s or CSOS ordering is used.19
Schedule CIII through CV drugs can be ordered through normal ordering channels; however, wholesalers and distributors will require certain registration documentation before initially shipping any controlled substance to a pharmacy or facility.
Storage, Recordkeeping, and Disposal of Controlled Substances
Per the CSA, Schedule II through V controlled substances can be stored in one of the following manners:20
In a “securely locked, substantially constructed cabinet;”
Dispersed in with non-controlled stock in such a way as to obstruct theft/diversion (in general, this is interpreted to mean organized in alphabetical order intermixed with non-controls, rather than by schedule or some other grouping);
Other means: provided the manner of storage has received prior approval from the DEA.
Specific recordkeeping and inventory management requirements (at the federal and sometimes state levels) must be followed, but these are beyond the scope of this course. Each pharmacy personnel, but ultimately, the pharmacist-in-charge, is responsible for ensuring that all laws (including inventory requirements) are followed.
Pharmacies and facilities often face the dilemma of how to dispose of expired, broken, spilled, or otherwise unusable controlled substances that remain in inventory. Note that this type of disposal is distinct from “wastage” (which is the disposal of an unused portion of a drug that has been removed from inventory for immediate administration to a patient and which has not been entirely administered to the patient, such as with vial overfill).
According to the CSA, there are two methods of disposal:21-23
Destroy on-site using a method that makes the controlled substances completely irretrievable
Preferred method: Transfer to a “reverse distributor” for off-site disposal
Both disposal methods are commonly used. Note that methods such as dissolving in water or flushing down the toilet are not considered to fulfill the “irretrievable” requirement. Small and affordable options (such as Rx DestroyerTM) are methods for irretrievably destroying controlled substances. Additional requirements apply for drugs that are also hazardous substances.
The DEA Form 41, “REGISTRANT RECORD OF CONTROLLED SUBSTANCES DESTROYED,” must be witnessed by two employees, and it is kept on-site.23 The DEA Form 41 is not submitted to the DEA, and it must be available in the case of audit or inspection. DEA Form 41 should not be used to document wastage.24 The current Form 41 expires on April 30, 2027.23 Each pharmacy or facility should have established policies for adjusting inventories to account for destruction (and safeguards to prevent inventory adjustments from being used to mask diversion).
When transferring to a reverse distributor, the pharmacy must receive a DEA Form 222 for recordkeeping since it is technically acting as the supplier for the reverse distributor in this transaction.2
Resource for Pharmacy Staff: The Department of Justice and DEA provide a Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act.2 Following is the link to this resource: https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EO-DEA154R1)_Pharmacist's_Manual_DEA.pdf |
|---|
State-Level Scheduling and Regulations
States can schedule drugs differently from the CSA; however, state-level leniency does not override federal law. For instance, gabapentin is not a controlled substance under the CSA, but it is a controlled substance under some state laws.25 Some states require monitoring of gabapentin in the Prescription Drug Monitoring Program (PDMP). Gabapentin is not a controlled substance in Florida; however, a study in South Florida found misuse of gabapentin through sharing, trading or purchasing the drug through dealers or on the informal market.26 Pharmacists should remain vigilant for misuse patterns with gabapentin, especially when combined with opioids.26
Additionally, states may enact restrictions regarding other aspects relating to controlled substances, such as collaborative prescriptive authority, ordering by the pharmacist for purchase by the patient, prescription requirements (especially in the area of limits for prescriptions for opioid-naive patients), patient identification requirements, and registration of prescribers and dispensers at the state level. Florida has a three-day limit on opioid prescriptions for acute pain unless a practitioner judges that a seven-day supply is medically necessary.27 Exemptions apply for cancer, terminal illness, etc., and pharmacists should verify documentation of medical necessity for longer supplies. Under this law, a practitioner must see a patient who is being treated for chronic, non-cancer pain every three months, at minimum.28
Staying Up to Date
It is each practitioner’s responsibility to be aware of any changes in laws and rules that may affect their practice. This is especially true for areas of practice affected by technological advancements, such as electronic prescribing and ordering of controlled substances.
Drug Enforcement Administration (DEA)
The Drug Enforcement Administration was created in 1973 as the primary organization dedicated to the control of drug use at the federal level. Prior to its implementation, multiple organizations controlled different aspects of drug enforcement. The DEA was established to combine these duties.29
The DEA operates under the Department of Justice and enforces controlled substance laws and regulations. Among many other tasks, the DEA investigates and prosecutes those who violate the CSA and works to track and act against those involved with illicit drug trafficking.29
Prescribing providers must register with the DEA. This registration also applies to dispensing pharmacies (but not to individual pharmacists).29 The DEA requires the registrant to track and monitor providers who prescribe and dispense controlled substances, thereby limiting access to these drugs to the public and maintaining accountability.
Prescription Drug Misuse
Published studies describe that women are more likely to misuse prescription drugs (compared to illicit drugs) than men, especially drugs such as sedatives and tranquilizers, likely due to their perceived safety and social acceptability.30
Those who use controlled substances alongside other substances, such as alcohol or tobacco, are at greater risk of using them inappropriately and are more likely to become impaired with their use.29 Co-ingestion of other substances, such as alcohol, or with sedatives or tranquilizers, also contributes to overdose deaths.30
Mortality rates from the misuse of opioids have risen dramatically over the years, beginning with the first wave of the opioid crisis in the 1990s.31 The Centers for Disease Control and Prevention (CDC) reports that prescription and illicit opioids led to nearly 450,000 overdose deaths in the U.S., during the period 1999–2018.31
From 2017 to 2018, overall opioid-involved death rates declined by 4.1%.32 However, during that same time, there was a 10% increase in overdose deaths involving synthetic opioids (excluding methadone).33 Illicitly manufactured fentanyl is a synthetic opioid that is of particular concern due to its extreme potency. The rise in fentanyl misuse reportedly drives the increase in overdose deaths due to synthetic opioids.32,33
Prevention of Prescription Drug Misuse
Prescription drug use remains prevalent across age groups and among various social backgrounds. Healthcare providers must take steps to reduce the risk of prescription drug misuse among the patients they serve. Motivational interviewing can help raise awareness and unlock possible reasons for substance misuse.34 Healthcare providers can minimize misuse of controlled substances and reduce the risk of a substance use disorder by following established guidelines and best practices; however, this must be done within the context of ensuring that patients may still access medications being prescribed for appropriate purposes.35-38
Motivational Interviewing (MI) Techniques
Motivational Interviewing (MI) is a patient-centered counseling style that enhances motivation for change by helping patients explore and resolve ambivalence or issues affecting substance use. Research has shown that MI is effective in reducing substance misuse and improving adherence to treatment plans, making it a valuable tool for healthcare providers managing patients with controlled substance prescriptions. Incorporating MI into routine practice can foster nonjudgmental dialog, encouraging patients to be more open about their substance use, which can lead to better treatment outcomes and reduced risk of misuse.33
Ensuring Appropriate Access
A foundation of discussion on the prevention of overprescribing prescription drugs is ensuring appropriate medication access.34,35 Regulations and policies may inadvertently cause harm to people who genuinely need certain medications.334,35 Regulations and policies should not discriminate against patients in need of controlled substances, nor should they create unreasonable barriers to access. In furtherance of this, the Florida Administrative Code, Rule 64B16-27.831, provides that pharmacists should not allow fear of disciplinary action to interfere with dispensing controlled substances that are for a legitimate medical purpose and which are dispensed in the usual course of the pharmacist’s practice.36 Florida law recognizes that each patient’s medical status is unique and must be reviewed on a case-by-case basis when dispensing controlled substances.36 The valid use of controlled substances involves collaborative decision-making with the prescriber, pharmacist, and patient.36 Under Florida law, a valid prescription is prescribed and dispensed within a practitioner-patient relationship and is issued for a legitimate medical purpose.36
Legitimate Concerns or “Red Flags”
Under federal law, pharmacy staff must seek additional information to validate a prescription before dispensing it if there is a legitimate concern about the appropriateness, safety, or legitimacy of a controlled-substance prescription.37 According to Florida law, a valid prescription is one issued within a practitioner-patient relationship for a legitimate medical purpose, while an invalid prescription is one that the pharmacist knows or has reason to believe lacks such a purpose. Pharmacists must exercise independent professional judgment to validate prescriptions, seeking further information if concerns arise regarding their appropriateness, safety, or legitimacy, and ensuring patient privacy throughout the process.36 Florida Rule 64B16-27.831 emphasizes not letting fear interfere with legitimate dispensing but requires validation.36
If a pharmacist reasonably suspects that a prescription is not legitimate, the pharmacist must take action to determine that it was issued for a legitimate medical purpose.35 Options include contacting the prescriber, discussing the situation with the patient, and checking the state PDMP or another registry. States such as California, Florida, and Texas have laws that allow a pharmacist to refuse to fill a prescription if the pharmacist has reasonable concerns about the prescription's validity or the potential for patient harm.35-38
Prescription validation should always be done discreetly with patient privacy in mind.35 A common practice is to have a staff member phone the prescriber from a back room, which serves the additional purpose of avoiding alerting the patient (which may be wise in cases where a referral to law enforcement may be appropriate).
Pharmacy Case:
In January, a patient came to the pharmacy with a Schedule CIV prescription from an out-of-state physician. The pharmacist called the physician’s office, and the prescription was verified and filled.
The same patient came to the pharmacy in February with a Schedule CIII prescription from the same out-of-state physician. The pharmacist called the physician’s office again, and it was verified and filled.
In March, the same patient came to the pharmacy with a CII prescription from the same out-of-state physician.
|
|---|
The pharmacist was concerned about the increasing medication schedule and the physician's out-of-state location for ongoing care, so they called the Board of Pharmacy to discuss the case. The Board investigator asked for the physician’s DEA number.
The Board investigator discovered the DEA number on these prescriptions belonged to a deceased physician in a third state. The Board investigator collaborated with the out-of-state Board of Pharmacy to conduct further investigation. The physician’s office was found to have a legitimate DEA number from the state where it was located and had been using a deliberately improper DEA number for some patients. The out-of-state Board took immediate action, and the physician’s office was closed.
Basic Prescribing Best Practices
When writing a prescription, the provider should write legibly to reduce the risk of forgery. Illegible writing can result in a patient or another person altering the prescription without the pharmacy or the prescriber noticing.39-41 Protection of the actual prescription pad is essential to prevent theft.39-41 In general, electronic prescribing is preferred over paper prescriptions to reduce the risk of forgery and falsification. Prescribers should safeguard their electronic prescribing credentials or digital keys.
Some states, including Florida, require prescribers to check the state PDMP when prescribing controlled substances.42 Even if a practitioner’s state does not require this, doing so is an advisable best practice.
Basic Dispensing Best Practices
Pharmacists have a “corresponding responsibility” (along with prescribers) to ensure that controlled substances are prescribed and dispensed appropriately.43 In addition to following all applicable regulations, pharmacists may want to consider the following best practices to ensure appropriate dispensing of controlled substances. Best practices include the following:
Check the state’s PDMP with every controlled substance prescription
Monitor transactions involving insured patients who prefer to pay in cash for controlled substances.
Maintain good working relationships and open lines of communication with other healthcare providers in the community (including prescribers, their staff, and other pharmacies).
Take the time to understand the standard pain management agreements commonly used in your geography.
Monitor for possible conflicting treatments, such as stimulants prescribed together with opioids or benzodiazepines.
Investigate any suspicious prescriptions, such as those with inappropriately high dosages or quantities, misspellings, questionable signatures, or any other signals that the prescription may have been forged, altered, or prescribed for an illegitimate purpose.
Double-count controlled substances, especially CIIs, when processing each prescription.
Know when to call the doctor, when to have an open and honest or difficult conversation with the patient, and when to call the police.
Implementation and Use of PDMPs
Most states within the U.S., have developed prescription drug monitoring programs to track the prescribing and dispensing of controlled substances through online databases. Although state laws vary, access is generally limited to healthcare providers and, under specific circumstances, to law enforcement.
There is sustained interest in developing these monitoring programs and incorporating telehealth to possibly reduce substance misuse.42-43 Ultimately, provider participation in these programs is a step toward preventing the misuse of controlled substances.
Good communication among the patient, prescriber, pharmacist, and other interdisciplinary health team members, after reviewing the PDMP, helps ensure that controlled substances are prescribed and used appropriately and safely.41,44,45 Communication also helps ensure that medications are effective in achieving the patient's intended healthcare outcomes.
When Healthcare Providers Access PDMPs
Some states require providers to check the state PDMP before prescribing or dispensing controlled substances, but many states leave that decision up to provider discretion. Florida is one of the states that requires providers to check the PDMP. Healthcare providers are influenced by several factors when deciding whether to use their state PDMP.46 Witry, et al. (2020) reported that a patient’s age, diagnosis, payment method, and the type of drug prescribed were important to a healthcare provider’s decision whether to consult a state database or not.45
Healthcare providers have reported the importance of checking a PDMP for younger patients.46 Literature shows a higher risk for opioid misuse for patients between ages 18 and 25, as compared to other age groups.46 There are also reports that prescription opioid use by older adults (persons aged ≥65 years) is on the rise.32,46
Providers may be more likely to concur with the importance of reviewing the PDMP data in patients requesting opioids for the treatment of symptoms such as headaches, especially since guidelines state that opioids should not be routinely prescribed to patients as a headache treatment.45 Healthcare providers might consider PDMP as less important for postoperative pain management. Witry, et al., point out, however, that this leniency could cause providers to miss potential use problems.45
Cash transactions involving controlled substances are reportedly a serious indicator that a patient may be at high risk for opioid misuse.45 Cash payments are used by patients to evade insurance rejections, which may draw a pharmacist’s attention to potential misuse.45
Impact of PDMPs
PDMPs are critical tools in the fight against prescription drug misuse and overdose. These databases track prescribing and dispensing of controlled substances, enabling detection of controlled substance use from multiple physicians. It is important to remember that the controlled substance is appropriate in treating terminal cancer pain, for example. PDMPs also may reveal doctor shopping or inappropriate prescriptions. Recent data from the CDC indicates that PDMPs have been instrumental in reducing opioid prescription rates and preventing overdose deaths. PDMP data can help inform point-of-care clinical decision-making to improve patient care and safety.47
Florida State Prescription Drug Monitoring
PDMPs have undergone evaluation and some criticism in recent years. Some have suggested that patient privacy and the potential for adverse outcomes for those who live with pain require a more in-depth review of these regulatory programs.42
In Florida, epidemic levels of prescription drug misuse led to the enactment of a law in 2009 that created a PDMP under the Florida Department of Health.42 This online system is known as E-FORCSE (Electronic-Florida Online Reporting of Controlled Substance Evaluation Program).42 Florida law requires healthcare providers to check the registry before prescribing or dispensing controlled substances (with certain limited exceptions).48 The statutory exemptions include:48
If the patient is less than 16 years of age
The drug being prescribed is a non-opioid Schedule V
The system is not operational
Requestor has a technological or electrical failure
Failure to consult E-FORCSE may result in a citation by the regulatory board
Impact of E-FORCSE
The Florida PDMP annual report (2023-2024) of E-FORCSE included the following statistics:42
Prescriber registrations: 6.7% increase
Dispenser registrations: 4.7% increase
Prescriber and dispenser queries: 230.2 million
Average morphine milligram equivalents prescribed: 2.3% decrease
People who visited 5 or more prescribers and 5 or more pharmacies within 90 days (doctor shoppers): 3.4% decrease
Opioid prescriptions: 2.3% decrease
Drug overdose deaths: 24% decrease
Accidental drug overdoses: 30% decrease
Opioid-related overdoses: 37% decrease (87% from fentanyl)
In addition, Florida reported that 3,298 entities with electronic health record systems from across the state have integrated PDMP information into the clinician’s workflow and that they have shared data with 38 other states, Puerto Rico, and the Military Health System. Additionally, overdoses involving prescription opioids showed a reduced incidence trend.42
Drug Diversion and Doctor Shopping
People who use controlled substances for non-medical purposes are increasingly interested in obtaining prescription drugs as their choice of drug, often resorting to various methods of obtaining prescription drugs, such as diversion, doctor shopping, and doctor hopping.
Drug diversion describes the process of transferring prescription drugs to a person for whom they were not intended or prescribed for illicit use.49 One drug diversion example is when a patient who genuinely needs pain control medications may sell their extra medications to make money. Some people divert drugs because they have a substance use disorder and may sell a prescription drug and use the money to buy a different drug that they crave. Also, people may divert drugs from others, such as friends or partners. Diversion also occurs at the healthcare provider level.49
Those who misuse controlled substances that are prescription drugs may also practice “doctor shopping” or “doctor hopping.”49 Doctor shopping occurs when a patient seeks out multiple prescribers in order to obtain a larger amount of opioids or other controlled substances. Patients who doctor shop may travel great distances to obtain their drugs. They will even cross state lines to obtain the prescription they seek.50 Some clinicians refer to this behavior as doctor hopping.49 Doctor hopping is “characterized by above average patient‐to‐prescriber travel distances and patients bypassing nearby prescribers in favor of more distant ones.”49 Doctor hopping is a clear indication of high‐risk opioid use and is distinct from doctor shopping. Prescription Drug Monitoring Programs may reveal a patient’s travel patterns as an indicator of potential misuse.49
In addition to doctor-hopping or doctor-shopping, patients often use multiple pharmacies to mask their misuse.49 Additionally, it is common for patients to seek out a new pharmacy if they feel their current pharmacy is suspicious of misuse or is restricting or refusing to fill their prescriptions. When transferring controlled-substance prescriptions between pharmacies, pharmacists may share drug-seeking concerns about a patient with one another due to continuity-of-care allowances. Patients may try to avoid this situation by obtaining a new prescription at a new pharmacy (rather than having an old prescription transferred from another pharmacy).49
Safe Prescribing of Opioids
Pain management is a treatment intended to reduce pain and maintain or improve a patient’s ability to function.51 Acute pain is defined as lasting less than 4 weeks, subacute pain lasts 4 to 12 weeks, and chronic pain lasts more than 12 weeks.52,53
As is the case for patients taking any medication, patients taking opioids should be monitored for side effects, drug interactions, and other similar problems; however, they should also be monitored for substance use disorder due to the risk of misuse.51 A substance use disorder is of particular concern during pain management of chronic pain.54,55
Indications for Opioid Pain Treatment
There are many medical scenarios where opioids are considered an appropriate treatment option. Common indications for opioid pain treatment include the following:
Acute or subacute pain management52,53
Cancer pain or end-of-life care with correspondent pain56
Chronic pain not due to a malignancy57,58
Acute Pain Management
Current guidelines for acute pain management focus on the type of drug used (versus dosage or duration of use).52 Guidelines typically suggest opioid use only when non-opioid alternatives are considered inappropriate.
A study by del Portal, et al. (2016) reported that opioid prescribing has decreased significantly in an acute care setting, from 52.7 percent (before guidelines for the appropriate management of acute pain were issued) to 33.8 percent 12 to 18 months later, based on retrospective chart review.52 Current postoperative opioid prescribing recommendations (2016) state that drug administration should “be based on the specific surgical procedure, type of anesthesia used, patient age, and other variables.”52
Back pain treatment guidelines released in 2017 by the American College of Physicians indicated that nonpharmacologic approaches should be used for acute and subacute back pain, as such pain can resolve on its own over time.53 If a pharmacological approach is desired for acute and subacute back pain, nonsteroidal anti-inflammatory drugs (NSAIDs) or skeletal muscle relaxants are often recommended.53
Cancer Pain and End-of-Life Care
Opioid use for cancer pain and end-of-life care is a widely accepted practice.56 Monotherapy analgesia, such as opioids (morphine, oxycodone, and others), can often reduce pain due to malignancy.44 The World Health Organization's (WHO's) analgesic ladder outlines an approach to the use of opioids for end-of-life care.50
However, the WHO analgesic ladder has been described as simplistic and inappropriate for people with chronic non-cancer end-of-life pain.50 Moreover, a greater number of people now survive cancer treatment than was the case during the development of the WHO guidelines. Yang, et al. (2020) proposed modifications to the analgesic ladder to align them better with the current pain management.50
Chronic Pain (Non-Malignant)
The use of opioids to treat chronic pain has been described as controversial, especially in recent years.54,55,59 Treatment guidelines have been developed by professional societies, state medical boards, and federal agencies. Standard guidelines for safe and appropriate prescribing and dispensing of opioids typically focus on key topic areas, such as:
Determining whether to initiate opioids for pain;
Selecting opioids and determining opioid dosages;
Deciding the duration of the initial opioid prescription and conducting follow-up; and,
Assessing risk and addressing potential harms of opioid use
The CDC has developed prescribing guidelines for chronic pain, emphasizing using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology to rate pain quality and the strength of the recommendations.58
This CDC clinical practice guideline provides evidence-based recommendations for clinicians who provide pain care to adults and children. The recommendations on the use of opioids for acute pain and on tapering opioids for patients already receiving opioid therapy were substantially expanded in these updated guidelines.58 These recommendations do not apply to patients experiencing pain associated with sickle cell disease, cancer-related pain treatment, palliative care, and end-of-life care.58 These recommendations apply to pain management for patients, mainly in outpatient settings or long-term residential facilities.58 Guidelines employing the use of morphine milligram equivalent (MME) are common.58
The CDC 2022 guidelines recommend that patients with pain receive appropriate pain treatment using the following principles:58
Nonopioid therapies are at least as effective as opioids for many common types of acute pain. Clinicians should maximize use of nonpharmacologic and nonopioid pharmacologic therapies as appropriate for the specific condition and patient and only consider opioid therapy for acute pain if benefits are anticipated to outweigh risks to the patient.
Nonopioid therapies are preferred for subacute and chronic pain.
Clinicians should maximize use of nonpharmacologic and nonopioid pharmacologic therapies as appropriate for the specific condition and patient.
Only consider initiating opioid therapy if expected benefits for pain and function are anticipated to outweigh risks to the patient.
The benefits and risks of all treatment options in the context of the patient’s circumstances must be carefully considered.
The recommendations should not be used as inflexible standards of care across patient populations.
The CDC recommendations are intended to improve communication between clinicians and patients about the benefits and risks of pain treatments, including opioid therapy.58 They are also intended to improve the effectiveness and safety of pain treatment, mitigate pain, and improve function and quality of life for patients with pain. Finally, the goal of these recommendations is to reduce risks associated with opioid pain therapy, including opioid use disorder (OUD), overdose, and death. 58
Common features of treatment recommendations or guidelines include patient follow-up, monitoring, and screening tools for OUD.60 They also discuss when to discontinue opioid treatment or taper dosage. Some recommendations describe when a patient should be referred to a pain specialist.60
Federal agencies and organizations such as the National Institute of Drug Abuse, Food and Drug Administration, U.S. Department of Veterans Affairs, U.S. Department of Defense, and SAMHSA have also published treatment strategies for chronic pain.61
Special Considerations for Opioid Dispensing
Although pharmacy staff may focus on a few critical opioid dispensing considerations (such as logging prescriptions into perpetual inventories and checking registries), they might not always be equally aware of additional, more clinical considerations, especially regarding drug utilization review and patient counseling. Florida law requires that pharmacists initiate counseling with patients receiving opioid prescriptions, covering topics such as therapeutic appropriateness, misuse risks, naloxone access, and proper storage/disposal.
Drug Utilization Review
Pharmacists must perform a drug utilization review before dispensing a drug to a patient.62 The review is not limited to controlled substances. It involves screening for prescription accuracy, allergies, medication appropriateness, dosage, and length of therapy, drug interactions, drug-disease contraindications, drug-food interactions, therapeutic duplication, appropriate use, adverse effects, and misuse.56 Due to the potentially dangerous nature of opioids, special attention must be paid during a drug utilization review to recognize and resolve potential problems or notify the prescriber to discuss the concerns.
Issues that should be reviewed involve the following:62-64
Adverse reactions (often, adverse reactions can be spotted by reviewing the patient’s medication list, especially if other medications have been prescribed to address side effects)
Dosage problems, especially high dosages for opioid-naive patients (although dosages that are too low to be effective should also be addressed)
Duration problems, especially for opioid-naive patients
Drug interactions, the most significant of which generally fall into the following categories for opioids:
Additive central nervous system depression interactions
CYP interactions
QT-prolongation interactions (for certain opioids)
Serotonin syndrome interactions (for certain opioids)
Agonist-antagonist interactions
Counseling
A few additional counseling minutes can go a long way to prevent controlled substance misuse or errors. In addition to standard counseling, pharmacists should address safe storage and disposal and options for treating opioid overdose, including reversal agents such as nalmefene or naloxone.
Pharmacists should ensure patients understand the need to keep their medication in a safe place (out of children's reach and not easily accessible to theft). This discussion can serve as an excellent segue to gently help patients understand that these drugs can be misused.
Counseling should include a discussion regarding safe disposal.65 “Take-back” programs are a great resource, and personal medication destroyer products and strategies are increasingly available.66 Patients can mix the products with cat litter or coffee grounds and water in a sealable bag and dispose of the bag in the trash.66,67 Do not accept any return of a controlled substance into a pharmacy for any reason (except through DEA-approved take-back programs).66,67
Pharmacists may want to consider shared decision-making discussions regarding nalmefene or naloxone.68 Patients filling opioid prescriptions can benefit from learning about reversal agents in states with standing orders or within a collaborative practice agreement. Awkwardness can be prevented by approaching the subject from a safety perspective. Remind patients that accidental overdoses happen easily, and having reversal agents, such as naloxone, available could save the life of a household member or child who might unpredictably overdose. Use empathetic, nonjudgmental language to discuss overdose risks, emphasizing that naloxone can protect household members, and provide resources like SAMHSA’s hotline (1-800-662-HELP).
Naloxone Standing Orders
Most states, including Florida, have naloxone standing orders (per Section 381.887 F.S.) that allow pharmacists and other providers to dispense naloxone without obtaining a patient-specific prescription from a prescriber, as well as laws that provide liability protection for healthcare providers or caregivers involved in the provision of naloxone.68-70 These laws generally allow pharmacists to dispense naloxone to a person who may not be the intended ultimate user but may be a caregiver or other individual who may come in contact with opioid overdoses. By 2017, all the states and the District of Columbia had passed legislation to improve public access to naloxone.71 Some states authorized naloxone prescriptive authority for pharmacists or similar workarounds by legislation, while others used statewide standing orders.71
State laws vary, and some states encourage or require special training (usually provided free of charge) for healthcare providers using the naloxone standing order, while others require specialized counseling (such as providing patients with specific printed materials). States typically restrict which naloxone products are available by standing order (most states allow nasal spray products or automatic injectors).68-70
Florida Statutes, Chapter 381, Section 887 outlines the emergency treatment for suspected opioid overdose patients.68 The stated purpose of section 887 “is to provide for the prescribing, ordering, and dispensing of emergency opioid antagonists to patients and caregivers and to encourage the prescribing, ordering, and dispensing of emergency opioid antagonists by authorized health care practitioners.”71 Caregivers in this section are broadly defined as “a family member, friend, or person in a position to have contact with a person at risk of experiencing an opioid overdose.”72 A patient or caregiver may store and possess approved emergency opioid antagonists. In an emergency where a physician is not immediately available, a patient or caregiver may “administer the emergency opioid antagonist to a person believed in good faith to be experiencing an opioid overdose, regardless of whether that person has a prescription for an emergency opioid antagonist.”73
Under this statute, healthcare practitioners may prescribe and dispense emergency opioid antagonists to a caregiver or patient.74 In addition, pharmacists “may order an emergency opioid antagonist with an auto-injection delivery system, a prefilled injection device delivery system, or an intranasal application delivery system for a patient or caregiver for use” in an emergency opioid overdose.74 “Emergency opioid antagonist” means naloxone hydrochloride or any similarly acting drug that blocks the effects of opioids administered from outside the body and that is approved by the United States Food and Drug Administration for treating an opioid overdose.75 The Florida Surgeon General issued a statewide Standing Order for the Administration of Naloxone as authorized by Section 381.887 of the Florida Statutes.69 The Standing Order states that the “pharmacy must maintain a copy of the Standing Order for Naloxone if dispensing naloxone pursuant to the order Incorporated in this Standing Order for Naloxone is the expectation that the SAMHSA Opioid Overdose Prevention Toolkit, Five Essential Steps for First Responders, be followed. Approved Options for Intranasal or Auto-Injector Administration: lists the emergency opioid antagonists.”69 Florida law also provides liability protection for providers and caregivers who prescribe, dispense, or administer naloxone. The full text of the standing order, which includes a list of emergency opioid agonists that can be used in the event of an opioid overdose, may be found at the Florida Department of Health website at the following link:69
https://www.floridahealth.gov/licensing-and-regulation/ems-system/_documents/standing-order-naloxone.pdf
Opioid Use Disorder and Pain Management
In recent years, deaths from opioid overdoses related to pain management and heroin combined have reached alarming rates. The 2016 National Survey of Drug Use and Health indicated that 1.8 million people had a prescription pain medication use disorder, and 626,000 had a heroin use disorder.76,77
First-line treatment for an OUD involves medication management with methadone, intramuscular naltrexone, or buprenorphine-naloxone (Suboxone). The medication management of OUDs reportedly corresponds with decreased illicit opioid use and relapse, increased treatment engagement, and decreased mortality.
A multisite randomized study sponsored by the National Institute of Drug Abuse provided the following statistics related to OUD treatment:77
Illicit opioid relapse rates were over 90% when Suboxone was tapered off after 12 weeks of treatment. Continuing medication treatment is important, and prematurely stopping medication treatment should be avoided.
Following inpatient detoxification, relapse rates and risk of opioid-related overdose are high unless medication treatment after discharge is continued.
Many patients likely to benefit from medication management of OUDs are not offered such treatment. Identified barriers to treatment include a lack of trained clinicians, a poor understanding of the effectiveness of medication treatments, stigma against individuals with substance use disorders, and poor insurance coverage.
Listening to the patient, providing reassurance, and maintaining transparency are fundamental clinical skills and values that will help to improve patient engagement in treatment outcomes. All interdisciplinary health team members need to continuously communicate strategies for the safe prescribing of opioids for a patient known to have an OUD.77
All healthcare providers who prescribe or dispense opioids should be familiar with the particular OUD treatment resources in their communities, which can range from dedicated inpatient treatment (“rehab”) facilities to Nar-Anon groups, licensed addiction counselors, and other behavioral treatment providers, and specialized hotlines, such as SAMHSA’s confidential free hotline (1-800-662-HELP).78
New FDA Class Label Change
The FDA is requiring an updated class-wide label change to provide additional opioid long-term use risk information.79 The terms “extended treatment period” will be removed from the Indications and Usage section of the prescribing information. The label changes will provide clearer risk information, stronger warnings for higher doses, and treatment guidance, including guidance on reinforcing other treatments. The FDA is also requiring enhanced drug interaction warnings, including gabapentinoids, and requires new information about opioid esophageal issues and toxic leukoencephalopathy that may occur after an overdose.
Summary
Controlled substances are defined as drugs, medications, or chemicals that are regulated by the CSA or state law.
A substance’s placement within a schedule depends on several factors, most notably the drug’s acceptable medical use and potential for misuse.
There are specific recordkeeping and inventory management requirements (federal and state) that must be followed.
Healthcare providers can minimize the misuse of controlled substances and reduce the risk of a substance use disorder by following established guidelines, recommendations, and best practices.
Ensure patients can access medications being prescribed for valid purposes.
States have developed prescription drug monitoring programs to track the prescribing and dispensing of controlled substances through online databases. In Florida, the PDMP, under the Florida Department of Health, is known as E-FORCSE (Electronic-Florida Online Reporting of Controlled Substance Evaluation Program).
Florida Statutes, Chapter 381, Section 887 outlines the emergency treatment for suspected opioid overdose patients. The Florida Surgeon General issued a statewide Standing Order for the Administration of Naloxone as authorized by Section 381.887 of the Florida Statutes. The Florida Surgeon General’s Standing Order may be found at:
https://www.floridahealth.gov/%5C/licensing-and-regulation/ems-system/_documents/standing-order-naloxone.pdf
References
Wallace LS. Terminology matters: patient understanding of "opioids" and "narcotics". Pain Pract. 2013;13(2):104-8.
Department of Justice. Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act. DOJ-DEA. 2022. Accessed September 8, 2025. https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EO-DEA154R1)_Pharmacist's_Manual_DEA.pdf
21 U.S.C. § 811
21 C.F.R. § 1308.11-15. last amended 8/18/2023.
U.S. Department of Justice. Justice Department Places FDA-Approved Marijuana Products and Products Containing Marijuana Subject to a Qualifying State-issued License in Schedule III, Strengthening Medical Research While Maintaining Strict Federal Controls. DOJ. April 23, 2026. Accessed June 22, 2026. https://www.justice.gov/opa/pr/justice-department-places-fda-approved-marijuana-products-and-products-containing-marijuana
21 C.F.R. § 1306.11
21 C.F.R. § 1311.100
21 C.F.R. § 1306.08
Section 456.42(3), Fla. Stat. Ann. 2025.
21 C.F.R. § 1306.12
State of Rhode Island General Assembly An Act relating to Food and Drugs Uniform Controlled Substances Act. 2025-H5866 Substitute B. 119th Congress. June 23, 2025. Accessed July 31, 2025. https://legiscan.com/RI/text/H5866/2025
21 C.F.R. § 1306.13(a)
21 C.F.R. § 1306.13(b)
21 C.F.R. § 1306.13(c)
21 C.F.R. § 1306.21
21 C.F.R. § 1306.22
21 C.F.R. § 1306.23(c)
Section 893.08, Fla. Stat. Ann. 2025.
21 C.F.R. § 1305, et seq.
21 C.F.R. § 1301.72
21 C.F.R. § 1317.90
21 C.F.R. § 1317.95
US Department of Justice Drug Enforcement Administration Division of Diversion Control. Registrant Record of Controlled Substances Destroyed. Form Expires April 30, 2027. Accessed July 31, 2025. https://www.deadiversion.usdoj.gov/21cfr_reports/surrend/41_form.pdf
79 Fed.Reg. 53520. Disposal of Controlled Substances. September 9, 2014. Accessed on June 22, 2026. https://www.federalregister.gov/documents/2014/09/09/2014-20926/disposal-of-controlled-substances
Grauer JS, Cramer JD. Association of State-Imposed Restrictions on Gabapentin with Changes in Prescribing in Medicare. J Gen Intern Med. 2022;37(14):3630-3637. doi: 10.1007/s11606-021-07314-2
Buttram ME, Kurtz SP. Descriptions of Gabapentin Misuse and Associated Behaviors among a Sample of Opioid (Mis)users in South Florida. J Psychoactive Drugs. 2021;53(1):47-54. doi:10.1080/02791072.2020.1802087
Section 456.44(5), Fla. Stat. Ann. 2025.
Section 456.44(3), Fla. Stat. Ann. 2025.
US Department of Justice Drug Enforcement Administration. DEA history (n.d.). Accessed September 8, 2025. https://www.dea.gov/about/history
McHugh RK, Votaw VR, Sugarman DE, Greenfield SF. Sex and gender differences in substance use disorders. Clin Psychol Rev. 2018;66:12-23. doi:10.1016/j.cpr.2017.10.012.
Centers for Disease Control and Prevention. Understanding the Opioid Overdose Epidemic. CDC. June 9, 2025. Accessed September 10, 2025. https://www.cdc.gov/overdose-prevention/about/understanding-the-opioid-overdose-epidemic.html
Wilson N, Kariisa M, Seth P, Smith H 4th, Davis NL. Drug and Opioid-Involved Overdose Deaths - United States, 2017-2018. MMWR Morb Mortal Wkly Rep. 2020;69(11):290-297. Published 2020 Mar 20. doi:10.15585/mmwr.mm6911a4.; CDC “Drug Overdose Deaths, 2001-2021. NCHS Data Brief No. 457, December 2022
Hedegaard H, Minino A, Warner M. Drug overdose deaths in the United States, 1999-2018. NCHS Data Brief. No. 356. Centers for Disease Control and Prevention. January 2020. Accessed July 31, 2025. https://www.cdc.gov/nchs/products/databriefs/db356.htm
Using Motivational Interviewing in Substance Use Disorder Treatment. 2021. SAMHSA. Accessed September 8, 2025. https://store.samhsa.gov/sites/default/files/PEP20-02-02-014.pdf.
Burke-Shyne N, Csete J, Wilson D, Fox E, Wolfe D, Rasanathan JJK. How drug control policy and practice undermine access to controlled medicines. Health Hum Rights. 2017;19(1):237-252.
Fla. Admin. Code, Rule 64B16-27.831. Effective: 04/05/2023.
21 C.F.R. § 1306.04(a).
O'Brien CP. Managing patients with a history of substance abuse. Can Fam Physician. 2014;60(3):248-250.
Perrone J, Nelson L. Medication reconciliation for controlled substances – an “ideal” prescription drug monitoring program. N Engl J Med. 2012;366:2341-2343; “Impact of Illegible Prescriptions on Dispensing Practice,” 2022 Oct 12. doi: 10.3390/pharmacy10050132
Centers for Medicare and Medicaid Services. Partners in integrity. What is a prescriber’s role in preventing the diversion of prescription drugs? CMS. 2015. Accessed September 8, 2025. https://www.cms.gov/files/document/prescriber-role-drugdiversion-033115pdf
21 C.F.R § 1306.04
Section 893.055, Fla. Stat. Ann. 2025.
Fleddermann K, Molfenter T, Jacobson N, et al. Clinician Perspectives on Barriers and Facilitators to Implementing e-Health Technology in Substance Use Disorder (SUD) Treatment Facilities. Subst Abuse. 2021;15:11782218211053360. Published 2021 Oct 26. doi:10.1177/11782218211053360
Brummond, P. ASHP guidelines on preventing diversion of controlled substances. Am J Health-Syst Pharm. 2017;74:325-48.
Witry MJ, St Marie BJ, Viyyuri BR, Windschitl PD. Factors influencing judgments to consult prescription monitoring programs: a factorial survey experiment. Pain Manag Nurs. 2020;21(1):48-56.
Florida Department of Health. Division of Medical Quality Assurance. Prescription Drug Monitoring Program Annual Report 2022-2023. https://www.floridahealth.gov/statistics-and-data/e-forcse/news-reports/2023-pdmp-annual-report.pdf.pdf. Accessed September 8, 2024.
Centers for Disease Control and Prevention. Overdose Prevention. Prescription Drug Monitoring Programs (PDMPs). CDC. May 6, 2024. Accessed September 9, 2025. https://www.cdc.gov/overdose-prevention/hcp/clinical-guidance/prescription-drug-monitoring-programs.html
Pellegrini CA. Joint Commission focuses on strategies to detect, prevent drug diversion. American College of Surgeons. 2019. Accessed September 8, 2025. https://www.jointcommission.org/en-us/knowledge-library/newsletters/quick-safety/issue-48
Young SG, Hayes CJ, Aram J, Tait MA. Doctor hopping and doctor shopping for prescription opioids associated with increased odds of high-risk use. Pharmacoepidemiol Drug Saf. 2019;28(8):1117-1124.
Yang J, Bauer BA, Wahner-Roedler DL, Chon TY, Xiao L. The Modified WHO Analgesic Ladder: Is It Appropriate for Chronic Non-Cancer Pain?. J Pain Res. 2020;13:411-417. Published 2020 Feb 17. doi:10.2147/JPR.S244173
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Phillips JK, Ford MA, Bonnie RJ, et al., eds. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington (DC): National Academies Press (US); July 13, 2017.
del Portal DA, Healy ME, Satz WA, McNamara RM. Impact of an Opioid Prescribing Guideline in the Acute Care Setting. J Emerg Med. 2016;50(1):21-27. doi:10.1016/j.jemermed.2015.06.014.
Qaseem A, Wilt TJ, McLean RM, et al. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017;166(7):514-530. doi:10.7326/M16-2367
Rosenblum A, Marsch LA, Joseph H, Portenoy RK. Opioids and the treatment of chronic pain: controversies, current status, and future directions. Exp Clin Psychopharmacol. 2008;16(5):405–416. doi: 10.1037/a0013628
Severino AL, Shadfar A, Hakimian JK, et al. Pain Therapy Guided by Purpose and Perspective in Light of the Opioid Epidemic. Front Psychiatry. 2018;9:119. Published 2018 Apr 23. doi:10.3389/fpsyt.2018.00119
Merlin JS, Khodyakov D, Arnold R, et al. Expert Panel Consensus on Management of Advanced Cancer-Related Pain in Individuals With Opioid Use Disorder. JAMA Netw Open. 2021;4(12):e2139968. Published 2021 Dec 1. doi:10.1001/jamanetworkopen.2021.39968
El-Tallawy SN, Nalamasu R, Pergolizzi JV, Gharibo C. Pain Management During the COVID-19 Pandemic. Pain Ther. 2020;9(2):453-466. doi:10.1007/s40122-020-00190-4
Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain - United States, 2022. MMWR Recomm Rep. 2022;71(3):1-95. Published 2022 Nov 4. doi:10.15585/mmwrScholz SM, Thalmann NF, Müller D, Trippolini MA, Wertli MM. Factors influencing pain medication and opioid use in patients with musculoskeletal injuries: a retrospective insurance claims database study. Sci Rep. 2024;14(1):1978. Published 2024 Jan 23. doi:10.1038/s41598-024-52477-7
Engineering, and Medicine. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. 2017. doi.org/10.17226/24781
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse; Phillips JK, Ford MA, Bonnie RJ, editors. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington (DC): National Academies Press (US); 2017 Jul 13. 2, Pain Management and the Intersection of Pain and Opioid Use Disorder. Accessed September 9, 2025. https://www.ncbi.nlm.nih.gov/books/NBK458655/
Castillo S, Begley K, Hoie E, Elsasser G, Augustine S. "Brown bag" simulations to teach drug utilization review. Am J Pharm Educ. 2014;78(2):40. doi:10.5688/ajpe78240
McCance-Katz EF, Sullivan LE, Nallani S. Drug interactions of clinical importance among the opioids, methadone and buprenorphine, and other frequently prescribed medications: a review. Am J Addict. 2010;19(1):4-16. doi:10.1111/j.1521-0391.2009.00005.x
Kotlinska-Lemieszek A, Klepstad P, Haugen DF. Clinically significant drug-drug interactions involving opioid analgesics used for pain treatment in patients with cancer: a systematic review. Drug Des Devel Ther. 2015;9:5255-5267.
Potru S, Tang YL. Chronic Pain, Opioid Use Disorder, and Management Among Older Adults. Focus (Am Psychiatr Publ). 2021;19(3):294-302. doi:10.1176/appi.focus.20210002
Buffington DE, Lozicki A, Alfieri T, Bond TC. Understanding factors that contribute to the disposal of unused opioid medication. J Pain Res. 2019;12:725-732. Published 2019 Feb 19. doi:10.2147/JPR.S171742
Environmental Protection Agency. How to Dispose of Medicines Properly. EPA. 2011. Accessed September 4, 2025. https://www.epa.gov/sites/default/files/2015-06/documents/how-to-dispose-medicines.pdf
Naloxone Access Rules and Resources. SAFE Project. Accessed September 9, 2025. https://www.safeproject.us/naloxone-awareness-project/state-rules/
Section 381.887, Fla. Stat. Ann. 2025.
Ladapo JA. Office of the State Surgeon General. State of Florida Department of Health Statewide Standing Order for Naloxone. Florida Health. Updated September 2022; Accessed September 9, 2025. https://www.floridahealth.gov/licensing-and-regulation/ems-system/_documents/standing-order-naloxone.pdf
The Network for Public Health Law. Harm Reduction and Overdose Prevention. 50-State Survey. Legal Interventions to Reduce Overdose Mortality: Naloxone Access Laws. Updated August 2023. Accessed September 9, 2025. https://www.networkforphl.org/wp-content/uploads/2023/11/Naloxone-Access-Laws-50-State-Survey-2023.pdf
Section 381.887(2), Fla. Stat. Ann. 2025.
Section 381.887(1)(c), Fla. Stat. Ann. 2025.
Section 381.887(3)(c), Fla. Stat. Ann. 2025.
Section 381.887(3)(a), (b) and (c), Fla. Stat. Ann. 2025.
Section 381.887(1)(d), Fla. Stat. Ann. 2025.
Ward, EN, Naa-Afoley Quaye, A, Wilens, T. Opioid use disorders: perioperative management of a special population. Anesth Analg. 2018;127(2): 539-547.
Substance Abuse and Mental Health Services Administration, National Survey of Substance Abuse. Treatment Services (N-SSATS): 2019. Data on Substance Abuse Treatment Facilities. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2020. Accessed September 9, 2025. https://www.samhsa.gov/data/sites/default/files/reports/rpt29389/NSSATS-2019.pdf
Substance Abuse and Mental Health Services Administration. National Helpline. Updated: 06/09/2023. SAMHSA. Accessed September 9, 2025. https://www.samhsa.gov/find-help/national-helpline
FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks. US Food and Drug Administration. July 31, 2025. Accessed August 4, 2025. https://www.fda.gov/news-events/press-announcements/fda-requires-major-changes-opioid-pain-medication-labeling-emphasize-risks
DISCLAIMER
The information provided in this course is general in nature, and it is designed solely to provide participants with continuing education credit(s). This course and materials are not meant to substitute for the independent, professional judgment of any participant regarding that participant’s professional practice, including but not limited to patient assessment, diagnosis, treatment, and/or health management. Medical and pharmacy practices, rules, and laws vary from state to state, and this course does not cover the laws of each state; therefore, participants must consult the laws of their state as they relate to their professional practice.
Healthcare professionals must consult their employer, healthcare facility, hospital, or other organization for guidelines, protocols, and procedures to follow. The information provided in this course does not replace those guidelines, protocols, and procedures, but is for academic purposes only, and this course’s limited purpose is for the completion of continuing education credits.
Participants are advised and acknowledge that information related to medications, their administration, dosing, contraindications, adverse reactions, interactions, warnings, precautions, or accepted uses is constantly changing. Any person taking this course understands that such a person must make an independent review of medication information before any patient assessment, diagnosis, treatment and/or health management. Any discussion of off-label use of any medication, device, or procedure is informational only, and such uses are not endorsed hereby.
Nothing contained in this course represents the opinions, views, judgments, or conclusions of RxCe.com LLC. RxCe.com LLC is not liable or responsible to any person for any inaccuracy, error, or omission with respect to this course or course material.
© RxCe.com LLC 2026: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.
RxCe.com
© RxCe.com LLC 2025: All rights reserved.