Fighting Prescription Drug Abuse with Federal and State Law (2022)

Prescription drug abuse is an epidemic in the United States that has been the subject of ongoing legislative control since the 1970s. The pharmaceutical dispensing of opioids increased 48 percent between 2000 and 2009 [1], and prescription drugs play a significant role in unintentional death: accidental poisoning is second only to car accidents, and prescription drugs are the leading cause of it, above both cocaine and heroin [2]. Among teens, prescription drug abuse is exceeded only by marijuana use [1]. Physicians, the guardians of prescription drugs, play a key role in limiting their misuse and diversion. This article will review federal and state legislation that targets prescription drug abuse, including legislation aimed at prescribers and dispensers of controlled substances.

Federal Programs and Laws

Federal drug regulation began early in the twentieth century with opiate regulation in the 1910s [3] and the 1919 Volstead Act (prohibition of alcohol) which remained in effect into the 1930s [4]. Passage of the most comprehensive federal drug law, the Controlled Substances Act, came in 1970, putting in place a single system for regulating psychotropic and narcotic drugs [5] and establishing the legal framework that secured the 1973 creation of the Drug Enforcement Administration (DEA) [6]. Today a sizeable government program with 5,000 special agents and a budget of $2.02 billion, the DEA is the primary agency charged with policing the issuance and dispensing of controlled substances, including prescription drugs [7].

DEA regulations apply to manufacturers, dispensers, and distributors of controlled substances, but this article focuses mainly on implications for physicians and their practice. Physicians must be registered with the DEA to prescribe controlled substances (or in very rare cases, receive an exemption from registration), which is predicated on their obtaining proper state licensing [8]. Registration must be renewed every 3 years, and the physician must be registered in every state in which he or she dispenses controlled substances [8].

Regulation enforcing the Controlled Substance Act further stipulates that there be a legitimate medical purpose for prescriptions, the practitioner must be acting in the usual course of practice, and that only a pharmacist can legitimately fill a prescription [9]. All prescriptions have to be signed and dated on the day of prescribing (which makes pre-signing blank prescription pads illegal) [9]. Practitioners can prescribe up to a 90-day supply of a controlled substance, but only with certain precautions (e.g., written instructions on the prescription about the earliest date on which it can be refilled) [10]. There are limits on the number of refills for certain classes, called schedules, of highly addictive substances like opioids [11]. There are additional regulations for e-prescriptions (online prescriptions) to minimize chance of fraud or abuse [12], and registrants have to notify the DEA, in writing, of any significant loss or theft of a controlled substance [13].

Penalties for violating various aspects of the law can include jail time, fines, and loss of DEA licensure (and thus loss of ability to prescribe some or all controlled substances). Physicians may lose their DEA registration if they lose their license to practice medicine in the state, and, moreover, the DEA itself can investigate, and participate in the arrest and prosecution of, physicians who violate controlled substance laws. Example cases can be found on the DEA web site [14].

The Food and Drug Administration (FDA) has also taken measures to address the growing problem of prescription drug abuse. The Food and Drug Administration Amendments Act of 2007 granted the agency the authority to require companies to develop a risk evaluations and mitigation strategy (REMS) when the potential risks of a drug outweigh the benefits [15]. Extended-release or long-acting opioids currently have a REMS to manage the risk of accidental or intentional misuse and the risks to patients who are prescribed these drugs but do not need them. The strategy mainly requires sponsors of opioids to foot the bill for educating prescribers and patients on the risk of opioid mismanagement and proper prescribing, storage, and disposal practices [15]. At the same time, the FDA will monitor patient access to these drugs to ensure that patients receive proper pain management (and that the REMS does not dampen proper prescribing of controlled substances) [15].

President Obama has been active on this issue, launching an ongoing campaign to combat prescription drug abuse [1]. In addition to calling for a REMS for opioids, the campaign promotes youth and parent education, encourages research on patterns of abuse and successful abuse deterrents, increases tracking and monitoring of controlled substances, supports better resources for proper medication disposal, and provides increased resources to law enforcement to target improper prescribing practices and pill mills (clinics and physicians that prescribe controlled substances irresponsibly) [1].

Most recently, the Senate Finance Committee has begun investigating medical groups, physicians, and bioethicists who have advocated for increased use of narcotic and opioid painkillers to determine whether they received compensation or had inappropriate ties with drug manufacturers like Purdue Pharma and Johnson & Johnson [16].

State Regulatory Approaches

Like the federal government, states have increased regulation of prescription drug use and abuse since the 1970s, and legislation in this area continues to develop.

(Video) Prescription Drug Abuse: Red Flags for Pharmacists and Pharmacy Technicians

Most states have general prohibitions against the obtaining of drugs through fraud, deceit, or misrepresentation that date back as far as the Uniform Narcotic Drug Act of 1932 and the Controlled Substances Act of 1970 [17]. These are broad prohibitions intended to cover a range of bad actors—patients, physicians, or persons selling drugs for profit [17]. In addition to bans and penalties for fraud, at least 43 states have prescription drug monitoring programs (PDMPs), most funded by the federal government’s Department of Justice, that monitor who is writing and filling prescriptions in an effort to flag fraudulent activity [18]. There are also wide-ranging regulations that attempt to put legal limits on the amount of controlled substance prescribed, dispensed, or refilled. Examples include limits on number of refills, limits on the quantity of pills dispersed in one refill, limits on how long after a drug has been prescribed it can filled, and limits on the types of personnel who can dispense certain quantities of drugs [19].

Some state laws target abuse and diversion by restricting behaviors like intentionally withholding information from physicians and doctor shopping, in which patients seek prescriptions from different clinicians [17]. Some states require that patients show an ID to fill prescriptions [20]. A small number of states (Alaska, Maryland, New Mexico, and Washington) have some sort of immunity from prosecution or reduced sentencing for people who seek emergency help for an overdose (either for themselves or for another) [21].

Other laws apply specifically to physicians. A large majority of states require physicians to conduct a physical exam, take a patient history, or both to ensure medical need before prescribing controlled substances [22]. Some states require physicians to use tamper-resistant prescription pads with features like watermarks, serial numbers or logos, or chemically resistant paper that make it more difficult to forge or falsify prescriptions [23]. And some states, like Florida, Louisiana, and Texas, create special rules and burdens for pain clinics that may include special registration, state inspections and investigations of complaints, and requirement that the pain clinic be owned and operated by a practitioner certified in pain management who does not have a record of felonies or disciplinary action for improper prescribing [24].

State medical boards also play a key role with physician behavior. The Federation of State Medical Boards’ model policy to guide state medical boards in their review of physicians’ pain management practices recommends: proper medical evaluation of a patient including a history and physical; a written treatment plan that clearly states the objectives of treatment; a discussion of the risks and benefits of treatment with the patient, including patient responsibilities like urine drug screening, reasons why therapy might be discontinued, and limits on refills; periodic review of efficacy and consideration of other treatment modalities; clear documentation in medical records; and compliance with applicable state and federal law [25].

Regulations at the state level change frequently, and more bills are continuously being introduced to target this epidemic. A review of latest developments can be found at the National Conference of State Legislatures web site [26].

  • Mental health/Substance use,
  • Pain/Management,
  • Professionalism/Off-label prescribing and care

References

  1. Executive Office of the President of the United States.Epidemic: Responding to America’s Prescription Drug Abuse Crisis.Accessed March 21, 2013.

    (Video) Blumenthal introduces bill to combat prescription drug abuse

  2. Centers for Disease Control and Prevention. Poisoning in the United States: fact sheet.http://www.cdc.gov/homeandrecreationalsafety/poisoning/poisoning-factsheet.htm. Accessed March 21, 2013.

  3. Hohenstein K. Just what the doctor ordered: the Harrison Anti-Narcotic Act, the Supreme Court, and the federal regulation of medical practice, 1915-1919.J Supreme Ct History2001;26(3):231.

  4. Minnesota Historical Society. Prohibition & the Volstead Act.http://www.mnhs.org/library/tips/history_topics/103prohibition.html. Accessed March 21, 2013.

  5. Controlled Substances Act, 21 USC section 801 et seq (1970).

  6. Drug Enforcement Administration (DEA). 1970-1975.http://www.justice.gov/dea/about/history/1970-1975.pdf. Accessed March 21, 2013.

  7. Drug Enforcement Administration. DEA history.Accessed March 21, 2013.

  8. DEA Office of Diversion Control. Question: What does a practitioner/physician need to obtain before he/she can complete an application for a DEA registration?http://www.deadiversion.usdoj.gov/drugreg/faq.htm#1. Accessed March 21, 2013.

    (Video) Hudson Works with Local Leaders to Combat Prescription Drug Abuse

  9. Prescriptions, 21 CFR section 1306.04-06 (2013).

  10. DEA Office of Diversion Control. Practitioner’s manual: section v – valid prescription requirements.http://www.deadiversion.usdoj.gov/pubs/manuals/pract/section5.htm. Accessed March 21, 2013.

  11. Prescriptions, 21 USC section 829 (2013).http://www.deadiversion.usdoj.gov/21cfr/21usc/829.htm. Accessed March 21, 2013.

  12. Practitioner responsibilities, 21 CFR 1311.102 (2013).

  13. Other security controls for practitioners, 21 CFR 1301.76(b) (2013).

  14. DEA Office of Diversion Control. Cases against doctors.http://www.deadiversion.usdoj.gov/crim_admin_actions/doctors_criminal_cases.pdf. Updated April 3, 2012. Accessed March 21, 2013.

  15. US Food and Drug Administration. What is a risk evaluation and mitigation strategy?http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm309742.htm#Q3. Accessed March 21, 2013.

  16. Baucus, Grassley Seek answers about opioid manufacturers’ ties to medical groups [news release]. Washington, DC: US Senate Committee on Finance; March 8, 2012.http://www.finance.senate.gov/newsroom/chairman/release/?id=021c94cd-b93e-4e4e-bcf4-7f4b9fae0047. Accessed March 21, 2013.

  17. Centers for Disease Control and Prevention. Law: doctor shopping.Accessed March 21, 2013.

    (Video) New federal law will help fight Oklahoma’s opioid epidemic

  18. National Alliance for Model State Drug Laws. Status of state prescription drug monitoring programs.Accessed March 21, 2013.

  19. Centers for Disease Control and Prevention. Law: prescription limits.Accessed March 21, 2013.

  20. Centers for Disease Control and Prevention. Law: requiring patient identification before dispensing.Accessed March 21, 2013.

  21. Centers for Disease Control and Prevention. Law: providing immunity from prosecution or mitigation at sentencing for individuals seeking assistance during an overdose.Accessed March 21, 2013.

  22. Centers for Disease Control and Prevention. Law: physical exam required.Updated July 9, 2012. Accessed March 21, 2013.

  23. Centers for Disease Control and Prevention. Law: tamper-resistant forms.Accessed March 21, 2013.

  24. Centers for Disease Control and Prevention. Law: regulating pain clinics.Accessed March 21, 2013.

  25. Federation of State Medical Boards. Model policy for the use of controlled substances for the treatment of pain [revised 2004]. Accessed March 21, 2013.

  26. National Conference of State Legislatures. Prevention of prescription drug overuse and abuse.http://www.ncsl.org/issues-research/health/prevention-of-prescription-drug-overdose-and-abuse.aspx. Accessed March 21, 2013.

    (Video) Responding to Prescription Drug Abuse

FAQs

How can the abuse of prescription drugs be stopped? ›

never stopping or changing a dosing regimen without first discussing it with the doctor. never using another person's prescription and never giving their prescription medications to others. storing prescription stimulants, sedatives, and opioids safely.

Who regulates prescription drugs in the United States? ›

The Center for Drug Evaluation and Research (CDER) is the FDA Center responsible for overseeing the drug program which includes over-the-counter and prescription drugs, including biological therapeutics and generic drugs. Visit the Human Drugs Import page for more information on import requirements.

Who is responsible for drug abuse? ›

29 percent of people believed that the person addicted to the drugs were to blame for the epidemic. 19 percent believed that doctors held most of the blame for the epidemic. 18 percent didn't know or believed someone else was responsible. 15 percent believed that pharmaceutical companies were to blame.

What are the drug laws in the United States? ›

Possession, use, or distribution of illicit drugs is prohibited by federal law. Strict penalties are provided for drug convictions, including mandatory prison terms for many offenses. Penalties increase significantly where use of the illicit drugs results in death or serious bodily injury.

What are the two types of prescription drug abuse treatments? ›

The two main categories of drug use disorder treatment are behavioral treatments (such as contingency management and cognitive-behavioral therapy) and medications.

What is the role of pharmacist in drug abuse and misuse? ›

Health-system pharmacists are responsible for ensuring a safe and effective medication-use system, including legal and organizational re- sponsibilities for medication distribution and control across the continuum of practice settings within healthcare organiza- tions.

What is the difference between drug misuse and drug abuse? ›

How is drug misuse different from drug abuse? The key difference between a person who misuses drugs and a person who abuses drugs is their intent. The former takes a drug to treat a specific ailment, whereas the latter uses a drug to elicit certain feelings.

How does the FDA regulate prescription drugs? ›

The FDA will approve a drug if there is substantial evidence of effectiveness for the proposed use and if the benefits outweigh the risks and remaining uncertainties. The drug's quality and manufacturing processes must also meet rigorous standards before approval. After approval, the FDA publishes on the Drugs@FDA.

What government agency decides whether drugs may be? ›

The Food and Drug Administration (FDA), a regulatory agency within the Department of Health and Human Services, regulates the safety and effectiveness of drugs sold in the United States. FDA divides that responsibility into two phases.

Is addiction a person's fault? ›

Addiction is not your fault; whether it is to a substance such as alcohol or drugs, or a behaviour such as gambling, online gaming, or sex; addiction is a disease that can drive a person to cheat, steal and manipulate to achieve their “fix” and leaves their families and loved ones devastated by the destruction it ...

Which of the following constitutes drug abuse? ›

Drug abuse is when you use legal or illegal substances in ways you shouldn't. You might take more than the regular dose of pills or use someone else's prescription. You may abuse drugs to feel good, ease stress, or avoid reality.

What is typically the first step in the substance abuse treatment process? ›

Intensive Outpatient Rehab – The First, Second, or Third Step in Treatment. For others, the first step of drug addiction treatment is intensive outpatient rehab. Those who have a mild to a moderate issue with drugs can begin with this step while others transition to it after undergoing detox and inpatient rehab.

What does the Constitution say about drugs? ›

But we have never passed a constitutional amendment granting the federal government any power to ban marijuana, or cocaine or other drugs. The federal government's contemporary prohibition policy is an illegal and unconstitutional usurpation of a power never granted to it.

What is the mandatory minimum sentence for drugs in the US? ›

Mandatory Minimums for Drug Crimes
SubstanceMinimumMaximum
Simple possession of a controlled substance with 1 prior conviction15 days2 years
Simple possession of a controlled substance with 2 or more priors90 days3 years
Drug kingpin20 yearslife
repeat offender30 yearslife
26 more rows
Jan 11, 2018

Who are penalized by the anti drug law? ›

Any person found possessing any dangerous drug during a party, or at a social gathering or meeting, or in the proximate company of at least two (2) persons, shall suffer the maximum penalties provided for in Section 11 of this Act, regardless of the quantity and purity of such dangerous drugs.

What are 3 commonly abused prescription drugs? ›

Three types of drugs are abused most often: • Opioids—prescribed for pain relief • CNS depressants—barbiturates and benzodiazepines prescribed for anxiety or sleep problems (often referred to as sedatives or tranquilizers) • Stimulants—prescribed for attention-deficit hyperactivity disorder (ADHD), the sleep disorder ...

What are the signs of addiction to prescription drugs? ›

Common symptoms of prescription drug abuse include:
  • Drug-seeking behaviors.
  • Taking higher doses than prescribed.
  • Hostility.
  • Appearing to be intoxicated, overly energetic, or lethargic.
  • Changes in sleeping and eating patterns.
  • Increased usage of alcohol.
  • Mood swings relating to availability of prescription medications.

What happens when medication misused? ›

People who misuse drugs may present with a range of health and social problems other than dependence, which may include (particularly with opioid users): physical health problems (for example, thrombosis, abscesses, overdose, hepatitis B and C, HIV, and respiratory and cardiac problems)

What is drug abuse in pharmacy? ›

1.  Drug abuse/ Substance abuse: using chemicals for nontherapeutic effects on the body or mind  Excessive use or misuse of drugs or alcohol for intoxicating or mind altering effects.

Why pharmacists should not prescribe? ›

Negative aspects of pharmacist prescribing include (1) not all pharmacists are competent to prescribe, (2) pharmacists are not trained in diagnosis, (3) physicians oppose it, (4) it could increase patient-care costs, and (5) pharmacists' access to patient information is not adequate for competent prescribing.

Are pharmacists drug addicts? ›

It's one of many ruses used by pharmacists when they dispense drugs in order to satisfy their drug addiction. While drug addiction among pharmacists is certainly not a new phenomenon, experts report that the number of pharmacists in treatment has increased.

What are three signs of prescription abuse? ›

We can help! The following are signs of prescription drug abuse.
...
Central nervous system depressant withdrawal symptoms include:
  • Seizures.
  • Shakiness.
  • Anxiety.
  • Overactive reflexes.
  • Increased heart rate.
  • High blood pressure.
  • Fever.
  • Sweating.

What are the 6 types of drug misuse? ›

Within the above categories are six types of drug dependency: alcohol dependence, opioid dependence, hypnotics/sedative dependence, cannabis dependence, hallucinogen dependence, and cocaine abuse.

Is the FDA Federal or state? ›

The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services.

Can the FDA be trusted? ›

New FDA policies are likely to increase the epidemic of harms. This will increase costs for insurers but increase revenues for providers. This evidence indicates why we can no longer trust the FDA to carry out its historic mission to protect the public from harmful and ineffective drugs.

Why does the government regulate drugs? ›

Most governments around the world impose regulations on pharmaceutical companies, in an effort to protect their public from harmful drug effects. These regulations often prolong the process for bringing new pharmaceuticals to market.

When the FDA approves a medicine What does this tell consumers? ›

FDA Approval: What it means. FDA approval of a drug means that data on the drug's effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.

Who tests drugs for FDA approval? ›

They review each drug closely using an independent team of clinicians and scientists who evaluate safety, efficacy and labeling of the drug product. After approval, FDA follow-up continues to make sure new drugs continue to be safe and effective. The four phases of a drug approval process includes: Pre-clinical, INDA.

What medications are not FDA approved? ›

Pre-1938 Drugs Not Approved by FDA
  • Acetaminophen, Aspirin, Salicylamide, Codeine Phosphate, and Caffeine. Tablets. ...
  • Amobarbital. Tablets.
  • Amobarbital Sodium. Capsules. ...
  • Amyl Nitrate. Inhalant.
  • Antipyrine and Benzocaine. Solution, Otic.
  • Aspirin and Codeine Phosphate< Tablets.
  • Chloral Hydrate. Capsules. ...
  • Codeine and Calcium Iodide. Syrup.

How does addiction affect the brain? ›

In a person who becomes addicted, brain receptors become overwhelmed. The brain responds by producing less dopamine or eliminating dopamine receptors—an adaptation similar to turning the volume down on a loudspeaker when noise becomes too loud.

Why do people get addicted to drugs? ›

Factors such as peer pressure, physical and sexual abuse, early exposure to drugs, stress, and parental guidance can greatly affect a person's likelihood of drug use and addiction. Development. Genetic and environmental factors interact with critical developmental stages in a person's life to affect addiction risk.

What is responsible for addiction? ›

Dopamine is widely regarded as the hormone responsible for addiction, primarily due to its role in producing feelings of euphoria.

What are the 4 main effects of drugs? ›

Nausea and abdominal pain, which can also lead to changes in appetite and weight loss. Increased strain on the liver, which puts the person at risk of significant liver damage or liver failure. Seizures, stroke, mental confusion and brain damage. Lung disease.

What are the 5 types of drug abuse? ›

Types of Drug Abuse
  • Heroin. Heroin is a highly addictive opioid. ...
  • Cocaine. Cocaine, even when taken in small doses, is a very dangerous stimulant. ...
  • Crack. Crack is a potent form of cocaine that people smoke to create a short and intense euphoric sensation. ...
  • Hallucinogens. ...
  • Amphetamines. ...
  • Marijuana. ...
  • Alcohol. ...
  • Inhalants.

What are nine lifestyle diseases caused by substance abuse? ›

The Impact of Addiction Can Be Far-Reaching
  • Cardiovascular disease.
  • Stroke.
  • Cancer.
  • HIV/AIDS.
  • Hepatitis B and C.
  • Lung disease.
  • Mental disorders.
Jul 10, 2020

What are the 4 levels of addiction? ›

While there are many factors that contribute to drug and alcohol addiction, including genetic and environmental influences, socioeconomic status, and preexisting mental health conditions, most professionals within the field of addiction agree that there are four main stages of addiction: experimentation, regular use, ...

What is the most effective treatment for addiction? ›

According to American Addiction Centers, Cognitive Behavioral Therapy (CBT) is a valuable treatment tool because it can be used for many different types of addiction including, but not limited to, food addiction, alcohol addiction, and prescription drug addiction.

What are the five stages of recovery? ›

What Are the Five Stages of Change? The five stages of addiction recovery are precontemplation, contemplation, preparation, action and maintenance.

How can opioid abuse be prevented? ›

Take and Store Opioids Properly
  1. Never take prescription opioids in greater amounts or more often than prescribed.
  2. Always let your doctor know about any side effects or concerns you may have about using opioids.
  3. Avoid taking opioids with alcohol and other substances or medications.

What is prescription drug abuse? ›

Overview. Misuse of prescription drugs means taking a medication in a manner or dose other than prescribed; taking someone else's prescription, even if for a legitimate medical complaint such as pain; or taking a medication to feel euphoria (i.e., to get high).

Why is prescription drug abuse on the rise? ›

Why Is Prescription Drug Abuse on the Rise? Some experts think that more people are abusing prescription medications because there are more drugs available. Doctors report writing more prescriptions than ever before. Also, it's easy to find online pharmacies selling these drugs.

What options might you have for reducing the number of pills the patient has to take at any given time when the guidelines suggest all provided medications are necessary? ›

Reassess each medication for ongoing indication. Engage other team members in managing symptoms such as pain. Use once-daily dosing options instead of multiple daily doses. Use fixed combination tablets where possible to reduce pill burden.

Videos

1. Prescription Drug Abuse: A Growing Epidemic
(CSGovts)
2. Hearing on "Examining the Federal Government's Response to the Prescription Drug Abuse Crisis"
(Energy and Commerce Committee)
3. Prescription Drug Abuse Among Nurses A Growing Problem
(WTIU & WFIU - Indiana Public Media)
4. Prescription Drug Abuse
(The Oklahoma News Report)
5. Blackburn Passes Bill to Combat Prescription Drug Abuse
(Senator Marsha Blackburn)
6. Tom at Senate Narcotics Caucus: More Work Needed to Fight Prescription Drug Abuse
(Senator Tom Udall)

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