Prescription Drug Abuse: Strategies to Reduce DiversionLawCE

Release Date:  December 1, 2009

Expiration Date: December 31, 2011

FACULTY:

Gerald Gianutsos, PhD, JD
Associate Professor of Pharmacology
University of Connecticut School of Pharmacy
Storrs, Connecticut

FACULTY DISCLOSURE STATEMENTS:

Dr. Gianutsos has no actual or potential conflict of interest in relation to this activity.

U.S. Pharmacist does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity was planned to be balanced, objective, and scientifically rigorous. Occasionally, authors may express opinions that represent their own viewpoint. Conclusions drawn by participants should be derived from objective analysis of scientific data.

ACCREDITATION STATEMENT:

Pharmacists

acpePostgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
UAN: 0430-0000-09-030-H03-P; 0430-0000-09-030-H03-T
Credits: 2.0 hours (0.20 ceu)

Type of Activity: Knowledge

TARGET AUDIENCE:

This accredited activity is targeted to pharmacists and pharmacy technicians. Estimated time to complete this activity is 120 minutes.

Exam processing and other inquiries to:
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DISCLAIMER:

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

GOAL:

To provide pharmacists with an understanding of the diversion and abuse of prescription drugs and the legal issues designed to limit diversion.

OBJECTIVES: 

After completing this activity, participants should be able to:

  1. Describe the demographics of prescription drug abuse.*
  2. Identify the dangers associated with the nonmedical use of prescription drugs.*
  3. Recognize the patient characteristics and techniques that may suggest the possibility of diversion.*
  4. Discuss the legal risks and responsibilities that arise from the diversion of drugs.*
  5. Implement strategies to reduce diversion.

*Also applies to pharmacy technicians.


Imagine a cocktail of morphine, Demerol (meperidine), codeine, chlorpheniramine, Placidyl (ethchlorvynol), and Valium (diazepam). These and other drugs were found in “significant quantities” in the tissues of Elvis Presley upon his death in 1977 from a suspected drug overdose.1

More than 30 years later, the actor Heath Ledger, who was found dead from a drug overdose, had Vicodin (hydrocodone), OxyContin (oxycodone), diazepam, and alprazolam in his bloodstream.2 What is especially noteworthy in these two high-profile cases was that none of these substances are illegal drugs, but rather medications that can be readily obtained by almost anyone through normal, legal channels with a prescription. Although the abuse of legal prescription drugs may garner headlines when well-known celebrities like these are involved, most of the lay public and many health professionals equate drug abuse with illegal street drugs. However, the problem of prescription drug abuse has become increasingly prevalent.

A number of reports have shown that the abuse of prescription drugs, especially opiates, stimulants, and sedatives, has reached alarming proportions, particularly among teenagers.3 In fact, prescription drugs have become the second most abused drug, behind only marijuana, among young people aged 12 to 17 years, and the gap is shrinking.3 Teen abuse of prescription drugs has become so pervasive that the Partnership for a Drug-Free America has introduced the term “Generation Rx” to refer to these adolescents.4 Helping to fuel the rise in this trend of drug abuse is the perception among young people and their parents that legal prescription drugs provide a safer high than street drugs. Health professionals, especially pharmacists, need to be aware of the potential for prescription drug abuse and to recognize their responsibility to limit the diversion of legitimate, beneficial medications to those who would misuse them.

This review will examine the problem of prescription drug abuse and what the pharmacist can do to recognize and minimize the problem of drug diversion. Pharmacists should also be aware that abuse of legal drugs does not end with prescription medications; OTC drugs are also widely prone to abuse, especially by adolescents, and the interested pharmacist is directed to other resources for further information.5

Patterns of Prescription Drug Abuse

Demographics: It is undeniable that the abuse of prescription medications is on the rise. Recent surveys report that the number of Americans abusing prescription drugs is approaching 7 million. From 2000 to 2006, there was an 80% increase in prescription drug abuse, and it has now become more common than the number of individuals who are abusing street drugs like cocaine, heroin, hallucinogens, Ecstasy, and inhalants combined.6 The use of illegal drugs has generally tended to show a gradual decline over the past decade, but the misuse of prescription drugs, especially sedatives, opiates, and stimulants, has grown over the same period.7

The age group most likely to abuse prescription drugs is individuals between 18 and 25 years of age, although younger groups and even the elderly are not immune.8 Among adolescents, opiates are the most popular prescription drugs.9 OxyContin use increased for all grades from 2002 to 2007. The annual prevalence of use in 2007 was 1.8%, 3.9%, and 5.2% in grades 8, 10, and 12, respectively. Vicodin abuse occurred at higher levels but remained fairly constant over the same time period, with prevalence rates of 2.7%, 7.2%, and 9.6% in grades 8, 10, and 12, respectively.9 High rates of use of prscription drugs are also noted in college students and young adults.10 Other classes of prescription drugs frequently diverted by adolescents include tranquilizers and stimulants.10,11 Among teens, 10% have abused Adderall (amphetamine and dextroamphetamine) or Ritalin (methylphenidate) compared with 9% having tried crack cocaine.11

While white males are the most common demographic among prescription abusers overall, in the younger 12 to 17-year-old age group, girls are more likely to abuse prescription drugs than boys, with stimulants and sedatives being the most popular among adolescent girls.8,9 Across all age groups, women are more likely to abuse prescription drugs than illegal drugs.12 Data suggest that prescription abuse is highest in small metropolitan areas compared with larger metropolitan or rural areas, which may be related to the availability, purity, and cost of heroin in a local region.13

A significant factor in the growth of prescription drug abuse is the ease with which these drugs can be obtained. Young people are readily able to secure prescription drugs; 40% of 12th-graders reported that painkillers are “fairly” or “very” easy to get, and more than half say the same thing for stimulants.14 The majority of teens indicate that prescription drugs are easier to obtain than illicit dugs, and more than half say they abuse prescription painkillers because they are not illegal. Teens also believe that there is less shame attached to using these drugs (33%) and that their parents would not be as concerned if they got caught (21%). This mirrors the perception among parents that prescription drug abuse is a safer alternative to street drug use.

Nearly two-thirds (64%) of teenagers who have abused prescription drugs reported receiving, buying, or stealing them from friends or relatives; almost half (46%) say they got prescription pain relievers for free from a relative or friend.14 Thus, in many cases, the procuring of prescription drugs does not entail the same risks and consequences associated with traditional drug dealing. Another 9% said they bought pain relievers from a friend or relative, while 5% took the drugs without asking. Only 4% had to resort to buying them from a drug dealer.14

Relationship to Increased Use of Prescription Drugs: Pharmacists are well aware that total prescription volume is on the rise. Could the escalating abuse of prescription drugs be a reflection of the increased prescribing of drugs in the population generally and not an unusual phenomenon? Data fail to support this view. Between 1992 and 2002, the increase in the number of prescriptions written for scheduled drugs outpaced the rate of increase in nonscheduled drugs and the growth in the population by 3 and 12-fold, respectively.13

Overall, opiates represent three-fourths of the volume of prescription drugs that are abused.8 The number of people using analgesics for nonmedical reasons increased four-fold from 1980 to 1998 and shows little sign of abating.8 Retail sales of methadone increased almost 10-fold between 1997 and 2005,11 while the number of prescriptions for hydrocodone and oxycodone increased 376% and 380%, respectively, from 1992 to 2002.15 This compares with an overall increase in prescription volume of 61% and a population growth of 12% over the same time frame.15 It is clear that the prescribing of scheduled drugs in general, and opiates in particular, has far outpaced the increase in use of most other drug classes. Part of this growth is related to an appropriate increased emphasis on and recognition of pain management, and reflects a legitimate expansion of prescription use. However, the disproportionate increase in the availability of opiate drugs in the supply chain can also lead to increased diversion into the hands of abusers.

Dangers of Prescription Drug Abuse

The increased misuse of prescription drugs has coincided with increased risks and mortality. Death from drugs is the second leading cause of accidental death in the U.S., exceeded only by motor vehicle accidents.16 According to the CDC, unintentional drug overdose deaths increased 68% between 1999 and 2004.17 In a recent study from West Virginia, 63% of deaths due to unintentional overdose of prescription drugs were associated with diversion of the drug (i.e., there was no documented prescription for the deceased person), while another 21% involved persons who had obtained prescriptions for controlled substances from five or more physicians (representing probable “doctor shopping”).18 These data indicate that the primary cause of overdose death from prescription drugs results from their nonmedical use. Prescription drug overdose associated with diversion most closely resembles the profile of traditional abusers of street drugs, being highest in unmarried men and in the 18- to 24-year-old group.17 This group was also more likely to have a history of other substance abuse and to combine prescription drugs with illicit drugs. In contrast, overdose linked to doctor shopping was highest in the group aged 35 to 44 years and was more likely to involve women.18

Nationally, the number of opioid analgesic poisonings listed on death certificates increased 91% between 1999 and 2002, while poisonings due to heroin and cocaine increased by much smaller percentages (12.4% and 22.8%, respectively).11 Emergency room admissions for prescription opioid use increased 74% from 2002 to 2006, and the misuse of opioid analgesics now results in more drug overdose deaths than cocaine and heroin combined.16 Overall, the nonmedical use of controlled prescription drugs is estimated to cost the health care system more than $72 billion annually.16

Nearly one-third of new drug abusers report that their first experience involved a prescription drug, with 19% citing opioids.16 These data highlight the risks associated with the intentional misuse of prescription drugs and are contrary to the belief among adolescents and their parents that prescription drug abuse represents a safer alternative to street drug use. Criminal activity, including thefts and robberies from pharmacies, is an additional risk.19

Methods of Prescription Drug Diversion

Surveys by the National Center on Addiction and Substance Abuse (CASA) at Columbia University asked health care professionals and the public what they perceive to be responsible for diversion of prescription drugs from legitimate uses.20 Individuals who may inappropriately acquire prescription drugs employ a variety of different means to obtain them (TABLE 1).6,20

Table 1
Methods Used to Obtain Prescription
Drugs for Purposes of Abuse
  • “Doctor shopping” (i.e., seeing more than one physician for the same prescription)
  • Traditional drug dealing
  • Theft from pharmacies or homes, including family members taking someone else’s drugs from a medicine cabinet
  • Acquiring prescription drugs via the Internet without a physician visit
  • Receiving drugs from friends or relatives
  • Buying drugs from patients leaving clinics
  • Feigning legitimate illness (e.g., sports injuries, anxiety) to obtain a prescription
Source: References 6, 20.

Physicians: Among physicians, the main reason cited for diversion (96%) is doctor shopping, followed by patient manipulation or deception of the physician, and forged or altered prescriptions.20 Clearly, physicians place the primary blame for diversion on patients who, they believe, either seek drugs from multiple sources, mislead the physician into making an inappropriate medical decision, or commit outright theft. Increased access to medical information on the Internet has facilitated the faking of apparently appropriate physical symptoms that can deceive the busy physician into issuing a prescription when it is not necessary to treat the patient. Nearly half the surveyed physicians, especially younger physicians, admitted that patients try to pressure them into prescribing a controlled drug. However, not all patients receiving prescriptions use the drugs themselves; some individuals may collect thousands of pills each year and sell them on the street, and there are also reports of patients supplementing Social Security income by selling all or part of their prescriptions.9

Physicians also admit to gaps in their medical school training that complicate their ability to detect misuse. Only 40% were trained in identifying prescription abuse and addiction.20 Almost half of primary care physicians report that they find it difficult to discuss prescription drug abuse with patients for whom they prescribe the medications; fewer than half of the surveyed physicians asked about prescription drug abuse when taking a patient history, and one-third do not regularly call or obtain records from other treating physicians before prescribing controlled drugs on a long-term basis.20

Pharmacists: Almost half (46%) of the pharmacists in one survey viewed diversion and abuse of prescription opioid analgesics as a problem in their community, and 10% of these considered the problem as serious.21

Pharmacists surveyed by CASA agreed with physicians on the three most common methods of diversion, but the order was slightly different.20 Pharmacists also felt that doctor shopping is the most common mechanism, followed by forged or altered prescriptions and patient manipulation of physicians. Less common methods were believed to be theft of prescription pads from physicians and deliberate diversion by physicians. In all, more than 60% of pharmacists believed that physicians bear the primary responsibility for preventing prescription abuse and addiction.

Only half of the surveyed pharmacists agreed that they had received training in identifying prescription drug abuse and addiction, and less than half had received instruction in preventing diversion.20 However, more than 25% of the pharmacists admitted that when a patient presents a prescription for a controlled drug, they “somewhat” or “very often” think it is for purposes of abuse or diversion. More than three-fourths of pharmacists said that they become somewhat or very concerned about abuse and diversion if a patient asks for a controlled drug by its brand name, believing that a brand name would have a higher resale value on the black market. Other circumstances that raise suspicions among pharmacists include a prescription with apparent irregularities; the patient’s lack of familiarity with the prescribing physician; a patient and/or prescribing physician from out of town; the patient’s demeanor (overly friendly, nervous, or aberrant); or the patient trying to pay in cash instead of using insurance. Some pharmacists admit to relying on their “gut instinct.”

Although pharmacists may believe that physicians bear the primary responsibility for preventing prescription abuse, pharmacists are reminded that they share the responsibility for preventing diversion. The Controlled Substance Act (CSA) mandates that only prescription orders for controlled substances that are for a “legitimate medical purpose” and issued in the “usual course of professional practice” may be dispensed by a pharmacist.22 The Drug Enforcement Agency (DEA) reminds pharmacists that while the primary responsibility for proper prescribing rests with the physician, the pharmacist who dispenses the prescription has a corresponding responsibility. A pharmacist who “knowingly” fills a prescription that is not issued in the usual course of professional treatment is subject to the penalties of the CSA.22 The pharmacist is required to exercise sound professional judgment when determining the legitimacy of a prescription for a controlled substance. The pharmacist who “looks the other way” and fills a prescription for a controlled substance that he or she knew or should have known was not for a legitimate purpose may be prosecuted. Merely contacting the physician for verification that the prescription was written by that prescriber may not be sufficient to fulfill the pharmacist’s duty, and the pharmacist should refuse to fill the prescription if there is reasonable suspicion that it is not valid. The DEA has established criteria that can serve as guidelines for a pharmacist to potential prescribing for illegitimate purposes or prescriptions that are not legitimate (TABLE 2). Of course, these are guidelines, and nothing can substitute for the pharmacist’s own experience and knowledge of the community. Recently, a major national pharmacy chain was fined $5 million by the DEA for CSA violations.23

Table 2
DEA Criteria That Indicate a
Prescription May Not Be for a
Legitimate Medical Purpose
  • A prescriber’s prescription pattern is different from that of other prescribers in the area (e.g., more prescriptions for controlled substances or prescriptions for larger quantities of controlled drugs)
  • Prescriber writes for antagonistic drugs (e.g., stimulant and depressant at the same time)
  • Patient returns to the pharmacy more frequently than expected (e.g., prescription quantities do not last as long as expected)
  • Patient presents multiple prescriptions for the same drug written for different people
  • A number of people appear within a short time period for the same controlled drug from the same physician, or a large number of previously unknown patrons show up with prescriptions from the same physician
  • The patron presents a prescription that shows evidence of possible forgery (e.g., unusual directions or quantities, no abbreviations, apparent erasures, unusual legibility, evidence of photocopying)
DEA: Drug Enforcement Agency. Source: Reference 22.

Pharmacists are also reminded that under federal and state laws, a controlled-substance prescription issued to an addict or habitual user for the purpose of keeping him or her comfortable (i.e., avoiding withdrawal) is not considered to be a valid prescription, since this is outside of the scope of legitimate medical purpose (except for patients enrolled in a licensed treatment program).22

Studies suggest that many pharmacists do not know what constitutes legitimate dispensing practices for controlled substances under federal or state policy in emergencies or for patients with terminal illnesses, especially for noncancer patients.21 Only 29% of pharmacists “strongly agreed” that their knowledge of relevant controlled-substance regulation was adequate.21 Pharmacists, like physicians, also believe that there are gaps in their education with respect to drug abuse. More than two thirds of pharmacists reported that they received 2 hours or less of addiction and substance abuse education in pharmacy school, and almost 30% received no addiction education.24 Many pharmacists are also unaware of the important distinctions among addiction, physical dependence, and tolerance. Significantly, more than half of the pharmacists said that they had never referred a patient to a drug treatment program.

Pharmacists also need to be on the lookout for fraudulent prescriptions. Patients may alter a legitimate prescription, steal prescription pads, copy prescriptions (or scan and print legitimate prescriptions), or create authentic-looking prescription blanks with a real physician’s name but a fake phone number, which would be answered if the pharmacist called to verify.22 Modern technology has made these fraudulent prescriptions even more difficult to detect.

When pharmacists were asked what they would do if they suspected a patient of abusing or diverting a controlled prescription drug, the most common responses were to call the prescribing physician (93%) or refuse to dispense the prescription (76.6%).20 Less than half would call the police. Only 1.7% said they would take no action, justifying their inaction as due to fear of reprisal by the patient or their employer.20

Patients may not obtain their drugs from a pharmacy by fraudulent means but may resort to theft. The CASA survey revealed that 29% of pharmacists had experienced a theft or robbery of prescription drugs in the preceding 5 years, most commonly involving OxyContin.20 Moreover, 21% of pharmacies would not stock certain controlled drugs, including OxyContin, Percocet, and Percodan, in an effort to reduce diversion.20

Data from the DEA reveal that in the period from 2000 through 2003, nearly 28 million dosage units of controlled substances were diverted by theft or loss from lawful channels, including pharmacies, of which 24% were opioid analgesics (primarily hydrocodone, oxycodone, morphine, methadone, meperidine, hydromorphone, and fentanyl); these figures are believed to represent underreporting of the true incident rate.25 These data provide evidence that a considerable volume of drug diversion occurs through criminal actions even before being prescribed.12,25

Approximately 6,500 pharmacy thefts occur annually in the U.S.25 Among retail pharmacies, about half the thefts are attributed to employees, with the remainder being attributed to individuals who break into pharmacies or clinics or commit armed robberies to acquire the drugs. Individuals also steal pharmaceuticals from friends or relatives who possess legitimate prescriptions.19

Role of the Internet

The Internet has brought many changes to the practice of pharmacy and medicine. Among them is the strongly held belief that it is a source of diversion for prescription drugs, especially for Schedule III and IV drugs.26 A report from CASA states that “drugs continue to be as easy to buy over the Internet as candy.”27 According to the report, 89% of sites selling controlled drugs have no prescription requirement; and of the 11% that do require a prescription, 70% only require a faxed copy that can be easily forged. Many Internet sites dispense drugs after a patient completes an online questionnaire, which may or may not have been reviewed by a physician. The most commonly sold drugs on these sites are anxiolytics like diazepam and lorazepam, followed closely by OxyContin and Vicodin.27 Of the total sites identified in 2006, slightly less than half were portal sites (acting as a conduit to a retailer) and the rest were anchor sites (which sell the drug to and receive payment from the consumer). The anchor site may or may not operate the pharmacy where the prescription is actually filled and may not even be located in the same geographic area as the dispensing pharmacy. Indeed, many sites operate beyond the borders of the U.S.

Many of the illegitimate Internet sites are run by non-DEA registrants without medical or pharmacy training.26 These sites typically work with physicians who approve the prescription, frequently targeting young graduates with significant debt or retired practitioners looking for addtional sources of income. In many cases, the prescriber reviews an online questionnaire, bypassing the accepted patient-prescriber relationship and contrary to the accepted standard of medical care. In one documented case, a Texas physician authorized over 20,000 prescriptions without ever meeting a single patient or verifying any medical information.12 Some of the rogue Internet pharmacy sites claim that a physician may contact the patient via telephone or e-mail while others attempt to distance themselves from the requirement for consultation by claiming that they are merely providing a referral service.27 The DEA also noted an absence of protection against minors obtaining potentially dangerous drugs through this process, citing an example of a 13-year-old who obtained methylphenidate after accurately filling out the form with his correct height, weight, and age.26

The Internet facilitators also recruit pharmacies, often targeting small, struggling independents.26,27 The facilitator will tell the pharmacist that all he or she has to do is prepare and ship prescriptions to customers, and provide reassurance to the pharmacist that the prescriptions are only for Schedule III or Schedule IV substances and have been “approved” by a physician. In addition to paying the pharmacy for the cost of the drug, the Internet facilitator will pay the pharmacy an agreed-upon amount that may total into the millions of dollars. The DEA has seen pharmacies close their doors completely to walk-in patients and convert their entire business to filling Internet orders. The DEA estimates that controlled substances represent 11% of prescription volume at a typical brick-and-mortar pharmacy, but may constitute as much as 95% at rogue Internet pharmacies.26 With a typically higher prescription volume, the DEA estimates that rogue Internet pharmacies may sell 20-fold more prescriptions for controlled substances each day than the normal brick-and-mortar pharmacy.26 At least one study, however, suggests that the Internet is overestimated as a direct source for illicit drug procurement.28

Warning Signs

What can a concerned parent, pharmacist, or other health professional do to prevent or stop prescription drug abuse? Individuals who are prone to abusing prescription drugs do not advertise the fact but often exhibit certain traits that can be signals to health professionals or loved ones that the person is at risk and may need monitoring or intervention. Some behavioral traits that experts believe might trigger suspicion of drug abuse are listed in TABLE 3.6,14,20,29 Patients may also employ various deceptive practices when dealing with health professionals in order to procure prescriptions or products for illicit purposes (TABLE 4).20

Table 3
Behavioral Traits That Might
Trigger Suspicion of Drug Abuse
  • Depression
  • Loss of interest in personal appearance or activities that used to bring enjoyment
  • Low self-esteem
  • Feelings that the individual does not fit in or is not popular
  • Feeling sluggish or exhibiting sleep disturbances
  • An aggressive or rebellious attitude toward authority figures
  • Difficulty paying attention
  • A shift in pattern of attending social functions
  • Vague physical complaints that the subject indicates need to be treated by drugs or exaggeration of medical problems
  • A family history of substance or alcohol abuse
  • Seeing multiple physicians for prescriptions (“doctor shopping”)
  • Frequently borrowing money or having unexpected extra cash
Source: References 6, 14, 20, 29.

Table 4
Deceptive Practices Used
to Procure Prescriptions
  • The patient must be seen right away
  • The patient is visiting friends or relatives or is passing through town and cannot see his or her regular physician
  • The individual claims to be a patient of a practitioner who is unavailable, or will not name the practitioner
  • The individual requests only specific drug brand names and is reluctant to try an alternative or claims to be “allergic” or nonresponsive to nonopiate alternatives
  • The patient shows unusual knowledge of controlled substances
  • The patient claims that his or her prescription has been lost or stolen
  • The patient pressures the practitioner by eliciting sympathy or guilt or uses direct threats
  • The patient uses a surrogate, such as a child, when seeking methylphenidate, or an elderly person when seeking opiates
Source: Reference 20.

Patients who are concerned about their own risk of abuse and are seeking guidance can be directed by the pharmacist to the CAGE questionnaire, first proposed more than 25 years ago as a screening mechanism to detect alcoholism.30 The questionnaire has been adapted for prescription drug abuse, where patients ask themselves four questions (TABLE 5).31 The patient who answers two or more questions affirmatively may be showing indications of a probable drug addiction. Even a single affirmative answer may deserve further evaluation and should be referred to a health care professional.

Table 5
CAGE Questionnaire for
Prescription Drug Abuse
  1. Have you ever felt the need to Cut down on your use of prescription drugs?
  2. Have you ever felt Annoyed by remarks your friends or loved ones made about your use of prescription drugs?
  3. Have you ever felt Guilty or remorseful about your use of prescription drugs?
  4. Have you Ever used prescription drugs as a way to “get going” or to “calm down”?
Source: Reference 31.

Prescription Drug Monitoring Programs

Regulators have taken several steps in an attempt to minimize the diversion of prescription products and the proliferation of prescription drug abuse. One measure that has grown over the past decade is the institution of national or local prescription monitoring programs that attempt to detect suspicious patterns of controlled-substance use.

Federal Programs: Nationally, the National All Schedules Prescription Electronic Reporting (NASPER) Act was signed into law in August 2005.32 The intent of NASPER was to establish a national electronic system that would monitor Schedule II, III, and IV controlled-substance prescriptions. It would be administered by the states and would enable health care providers to have timely and accurate access to prescription history information that could be used in the early identification of patients at risk for addiction or diversion and would encourage appropriate medical intervention.32,33

Under this law, each time a controlled substance was dispensed, the pharmacist would be required to report to Health and Human Services (HHS) specific information about the controlled substance, including: 1) identifying the patient; 2) name, date, and quantity of the drug dispensed; 3) number of refills ordered; 4) practitioner who signed the prescription; and 5) identity of the dispenser. Compilations of this information would be provided to practitioners (i.e., physicians, pharmacists, other licensed persons) who certify that they need this information to provide care to a current patient. HHS would also be permitted to provide compilations of this information to any local, state, or federal law enforcement, narcotics control, licensure, or disciplinary authority requesting the information as part of an ongoing drug diversion investigation.32

NASPER attempts to minimize doctor shopping, particularly by users who cross state lines, a limitation of individual state programs (discussed later). In order to receive funding under the Act, a state must collect data on Schedules II, III, and IV drugs and must meet standards that enable data sharing.34 In this way, users who try to circumvent local monitoring by presenting prescriptions in multiple locations would be subject to detection; this would be more difficult to monitor when done on a state-by-state basis. In 2007, the first pilot project was initiated for sharing of information between states (Nevada and California).34 The measure was also supported by the National Association of Chain Drug Stores (NACDS), which favored uniform standards that would apply in all states where a chain operates pharmacies. The Act authorized $60 million from 2006 to 2010 for grants to establish or improve state-run prescription drug monitoring programs; however, funding has yet to be committed.34

State Programs: Although the federal program has been slow to launch, as of November 2008, 38 states had enacted legislation that would require prescription drug monitoring programs (32 are currently in operation and 6 are in the start-up phase).34 However, the state programs vary in their design and requirements. A current summary of state programs can be found on the DEA Web site.34 All of the states track Schedule II drugs and most, but not all, also track Schedule III and IV; some also include Schedule V drugs. An additional 11 states are reportedly considering legislation; the only holdouts at this time are Wisconsin and the District of Columbia. Every state program contains safeguards to protect patient confidentiality. Only those individuals who are authorized by statute or regulation can access the controlled-substance prescription information.34 Some state programs proactively notify physicians when their patients are seeing multiple prescribers for the same class of drugs, which should assist health care professionals in managing patients.

One of the advantages noted by the DEA in an electronic information system is that it would eliminate the need for investigators to visit each location to obtain prescription information.34 Some of the expected benefits of these programs include deterrence and identification of illegal activity such as prescription forgery, indiscriminate prescribing, and doctor shopping; the agency believes that it has already been successful in thwarting diversion in a number of states.

The first state program, which many other states have used as a model, is the KASPER (Kentucky All Schedule Prescription Electronic Reporting) program, established in 1998 in Kentucky.31 KASPER is a reporting system designed to be both a source of information for practitioners and pharmacists and an investigative tool for law enforcement personnel. KASPER tracks controlled substance prescriptions dispensed within the state and shows all scheduled prescriptions for an individual over a specified time period, the prescriber, and the dispenser. KASPER specifically indicates that it is not intended to prevent people from obtaining needed drugs or to decrease the number of doses dispensed. The state also claims that access to KASPER reports are carefully controlled through identity and credential checks and secure Web access. KASPER reports are available only to prescribers and dispensers for medical treatment of a current or prospective patient; law enforcement officers for a bona fide drug-related investigation; licensure boards for an investigation of a licensee; Medicaid for utilization review on a recipient; a grand jury by subpoena; and a judge, probation, or parole officer administering a drug diversion or probation program.

Some states have approached the diversion problem in a different way. For example, a few states mandate the use of state-issued multiple-part prescription forms for Schedule II drugs that can be monitored.35 Pharmacists are cautioned to stay up to date on their state’s current requirements.

Effects on Legitimate Use for Pain

Although the abuse of prescription drugs has become a serious problem, the response by law enforcement and other concerned agencies to limit diversion has also created a therapeutic dilemma. At stake is whether the concern over diversion and the possibility of addiction impacts the legitimate treatment of pain by making prescribers reluctant to provide analgesic drugs or stigmatizing patients who receive chronic pain medications.8

In general, attitudes towards opioids in pain management have undergone cyclical changes over the past few decades. In the middle of the 20th century, irrational fear of addiction resulted in the withholding of opioids from patients until they were close to death, a position even held by the president of the American Medical Association (AMA) in the 1940s.36 In the latter part of the 20th century, the pendulum swung in the opposite direction with the emergence of the apparently erroneous belief that chronic pain patients were immune to the risks of aberrant drug-seeking behavior.36 The dilemma between appropriate pain management and the concern over the risk of addiction and diversion continues to influence the prescribing of opioid drugs today.

In 2007, the American Pain Foundation conducted a survey of health care practitioners including primary care physicians, pain specialists, nurse practitioners, and physician assistants.37 It found that more than three-fourths of the respondents felt that moderate-to-severe noncancer pain is undertreated in the U.S. The reasons for any undertreatment include many factors. Nearly 75% of surveyed physicians refrained from prescribing controlled drugs because of concern over addiction, and physicians were especially wary about prescribing controlled drugs to a patient with a history of drug or alcohol abuse.11,37 Nevertheless, 77% said that current drug control laws and policies impact their opioid-prescribing practices, and most practitioners felt that many of their patients face prejudices while filling their prescriptions for opioids.

In a survey of pharmacists, a large number of respondents did not view the chronic prescribing or dispensing of opioids for more than several months to patients with chronic pain of malignant or nonmalignant origin as a lawful and acceptable medical practice, especially when the patient had a history of opioid abuse.21

Federal and state law and policy can also influence prescribing practices. For example, DEA regulations require that all prescriptions for controlled substances “be dated as of, and signed on, the day when issued.”38 However, longstanding federal law and DEA regulations provide no express requirement that a prescription be filled within a certain time frame after it was issued. In 2007, the DEA issued a revised rule allowing practitioners to provide individual patients with multiple prescriptions to be filled sequentially for the same Schedule II controlled substance, with such multiple prescriptions having the effect of allowing a patient to receive up to a 90-day supply of the controlled substance, a benefit for the terminally ill.38

Individual states, however, can have more restrictive policies, and pharmacists need to be aware of the policies in their state. Currently, 47 states and the District of Columbia have pain management policies (i.e., from a medical or pharmacy board), the exceptions being Alaska, Delaware, Illinois, and Indiana at the time this lesson was prepared.39 For example, pain policies in eight states restrict the quantity of prescription medications that can be prescribed and dispensed at one time, stipulating either a maximum number of dosage units (100-120) or duration (30-day or 1-month supply) irrespective of patient need.39 Similarly, the number of days within which a prescription for a controlled substance must be dispensed following its issuance is not regulated by federal law or the laws of most states. However, policies in some states restrict the length of time that a Schedule II prescription is valid to less than 2 weeks; the state of Hawaii limits the period of validity to as little as 3 days. These policies are established in an apparent effort to prevent “uncashed,” although valid, prescriptions from being used as a possible source of diversion.39

Other policies that can affect pain management include statutes in 14 states and regulations in two states that classify physical dependence as synonymous with addiction, effectively making a prescription that is being used to reduce withdrawal in a terminally ill patient an invalid prescription.39 Other state policies reserve opioids as a treatment of last resort, recommend drug holidays as a part of prescribing, or limit the off-label use of certain drugs. Other polices exist that impact pharmacy practice; for example, Michigan and Oregon have legislation mandating continuing education about pain management for pharmacists.39

Summary and Conclusions

It is clear that many of the prescriptions dispensed by pharmacists each year are diverted for inappropriate use and that this problem is growing, particularly among adolescents. Patients may receive prescriptions from multiple physicians or deceive physicians into writing prescriptions for the wrong reasons. Other individuals receive or purchase unwanted drugs from family or friends, while some resort to outright theft from family or pharmacies.

The pharmacist needs to be aware of the potential for drug diversion, recognize the warning signs of possible misuse, and acknowledge a legal obligation to minimize the use of prescription drugs for improper purposes. Pharmacists also need to proactively disabuse the public of the notion that prescription drug abuse represents a safe alternative to street drugs, since statistics show that drug-induced morbidity and mortality continue to rise. In addition, pharmacists need to be aware of their state (and possible multistate or federal) prescription drug monitoring programs. By taking an active role in reducing the incidence of prescription drug abuse, the pharmacist makes a valuable contribution to society.

References

  1. Fontenot R. How and when did Elvis Presley die? http://oldies.about.com/od/elvisdeathfaq/f/elvisdeath.htm. Accessed October 23, 2009.
  2. Ledger’s death caused by accidental overdose. CNN. February 6, 2008. www.cnn.com/2008/SHOWBIZ/Movies/02/06/heath.ledger/. Accessed October 29, 2009.
  3. Prescription drug abuse prevention. Office of National Drug Control Policy. www.whitehousedrugpolicy.gov/drugfact/prescr_drg_abuse.html. Accessed October 23, 2009.
  4. Generation Rx: national study confirms abuse of prescription and over-the-counter drugs. Partnership for a Drug-Free America. May 15, 2006. www.drugfree.org/portal/drugissue/research/teens_2005/Generation_Rx_Study_Confirms_Abuse_of_Prescription. Accessed October 29, 2009.
  5. Gianutsos G. Abuse of OTC drugs. Am Pharm. 2008;130:39-48.
  6. Fact sheet: prescription drug abuse—a DEA focus. www.usdoj.gov/dea/good_medicine_bad_behavior_factsheet.doc. Accessed October 23, 2009.
  7. McCarthy M. Prescription drug abuse up sharply in the USA. Lancet. 2007;369:1505-1506.
  8. Zickler P. NIDA scientific panel reports on prescription drug misuse and abuse. NIDA Notes. 2001;16(3). www.drugabuse.gov/NIDA_notes/NNVol16N3/Scientific.html. Accessed October 23, 2009.
  9. Johnston LD, O’Malley PM, Bachman JG, Schulenberg JE. Monitoring the Future. National Results on Adolescent Drug Use: Overview of Key Findings, 2007. NIH publication 08-6418. Bethesda, MD: National Institute on Drug Abuse. www.monitoringthefuture.org/pubs/monographs/overview2007.pdf. Accessed October 23, 2009.
  10. Johnston LD, O’Malley PM, Bachman JG, Schulenberg JE. Monitoring the Future. National Survey Results on Drug Use, 1975-2007: Volume II, College Students and Adults Ages 19-45. NIH publication 08-6418B. Bethesda, MD: National Institute on Drug Abuse. www.monitoringthefuture.org/pubs/monographs/vol2_2007.pdf. Accessed October 23, 2009.
  11. Manchikanti L. National drug control policy and prescription drug abuse: facts and fallacies. Pain Physician. 2007;10:399-424.
  12. Office of the Attorney General, State of Maryland. Prescription for Disaster: The Growing Problem of Prescription Drug Abuse in Maryland. September 2005. www.oag.state.md.us/Reports/PrescriptionDrugAbuse.pdf. Accessed October 23, 2009.
  13. Comer SD, Ashworth JB. The growth of prescription opioid abuse. In: Smith HS, Passik SD, eds. Pain and Chemical Dependency. Oxford, UK: Oxford University Press; 2008:19-23.
  14. Office of National Drug Control Policy. The Abuse of Prescription and Over-the-Counter Drugs. September 2007. www.theantidrug.com/pdfs/resources/teen-rx/Prescription_Abuse_brochure.pdf. Accessed October 23, 2009.
  15. Twombly EC, Holtz KD. Teens and the misuse of prescription drugs: evidence-based recommendations to curb a growing societal problem. J Prim Prev. 2008;29:503-516.
  16. National Drug Intelligence Center. National Drug Threat Assessment 2009. December 2008. Document ID: 2008-Q0317-005. Washington, DC: U.S. Department of Justice. www.usdoj.gov/ndic/pubs31/31379/index.htm. Accessed October 23, 2009.
  17. CDC. Unintentional poisoning deaths—United States. MMWR Morb Mortal Wkly Rep. 2007;56:93-96.
  18. Hall AJ, Logan JE, Toblin RL, et al. Patterns of abuse among unintentional pharmaceutical overdose fatalities. JAMA. 2008;300:2613-2620.
  19. National Drug Intelligence Center. National Drug Threat Assessment 2005. February 2005. Washington, DC: U.S. Department of Justice. Document ID: 2005-Q0317-003. www.usdoj.gov/ndic/pubs11/12620/index.htm. Accessed October 23, 2009.
  20. National Center on Addiction and Substance Abuse at Columbia University. Under the Counter: The Diversion and Abuse of Controlled Prescription Drugs in the U.S. July 2005.www.casacolumbia.org/absolutenm/articlefiles/380-Under%20the%20Counter%20-%20Diversion.pdf. Accessed October 23, 2009.
  21. Joranson DE, Gilson AM. Pharmacists’ knowledge of and attitudes toward opioid pain medications in relation to federal and state policies. J Am Pharm Assoc (Wash). 2001;41:213-220.
  22. DEA. Pharmacist’s Manual: An Information Outline of the Controlled Substances Act of 1970. Washington, DC: DEA; April 2004. www.deadiversion.usdoj.gov/pubs/manuals/pharm2/2pharm_manual.pdf. Accessed October 23, 2009.
  23. Rite Aid Corporation and subsidiaries agree to pay $5 million in civil penalties to resolve violations in eight states of the Controlled Substances Act. DEA. January 12, 2009. http://www.usdoj.gov/dea/pubs/pressrel/pr011209.html. Accessed October 23, 2009.
  24. Lafferty L, Hunter TS, Marsh WA. Knowledge, attitudes and practices of pharmacists concerning prescription drug abuse. J Psychoactive Drug. 2006;38:229-232.
  25. Joranson DE, Gilson AM. Wanted: a public health approach to prescription opioid abuse and diversion. Pharmacoepidemiol Drug Saf. 2006;15:632-634.
  26. Rannazzisi JT. DEA congressional testimony. May 16, 2007. www.usdoj.gov/dea/pubs/cngrtest/ct051607.html. Accessed October 23, 2009.
  27. National Center on Addiction and Substance Abuse at Columbia University. “You’ve Got Drugs!” Prescription Drug Pushers on the Internet: 2006 Update. June 2006. http://static.scribd.com/docs/ed89hyvrez48g.swf?INITIAL_VIEW=width. Accessed October 23, 2009.
  28. Cicero TJ, Shores CN, Paradis AG, Ellis MS. Source of drugs for prescription opioid analgesic abusers: a role for the Internet? Pain Physician. 2008;9:718-723.
  29. Teenage prescription drug abuse. Teen Drug Abuse. June 12, 2005. www.teendrugabuse.us/prescription_drug_abuse.html. Accessed October 23, 2009.
  30. Ewing JA. Detecting alcoholism. The CAGE questionnaire. JAMA. 1984;252:1905-1907.
  31. KASPER (Kentucky All Schedule Prescription Electronic Reporting). Kentucky Cabinet for Health and Family Services. http://chfs.ky.gov/os/oig/KASPER.htm. Accessed October 23, 2009.
  32. Manchikanti L, Whitfield E, Pallone F. Evolution of the National All Schedules Prescription Electronic Reporting Act (NASPER): a public law for balancing treatment of pain and drug abuse and diversion. Pain Physician. 2005;8:335-347.
  33. Brushwood DB. Is NASPER safe and effective? Pain & the Law. October 2002. www.painandthelaw.org/mayday/brushwood_102802.php. Accessed October 23, 2009.
  34. State prescription drug monitoring programs. DEA. Updated November 2008. www.deadiversion.usdoj.gov/faq/rx_monitor.htm. Accessed October 23, 2009.
  35. Joranson DE, Carrow GM, Ryan KM, et al. Pain management and prescription monitoring. J Pain Symptom Manage. 2002;23:231-238.
  36. Kirsh KL, Vice AK, Passik SD. History of opioids and opiophobia. In: Smith HS, Passik SD, eds. Pain and Chemical Dependency. Oxford, UK: Oxford University Press; 2008:3-8.
  37. Opioid prescribing patterns and perceptions. Key survey highlights. American Pain Foundation. www.painfoundation.org/learn/publications/files/KOLSurveyHighlights.pdf. Accessed October 23, 2009.
  38. DEA. Issuance of multiple prescriptions for Schedule II controlled substances. Fed Regist. 2007;72:64921-64930. www.deadiversion.usdoj.gov/fed_regs/rules/2007/fr1119.htm. Accessed October 23, 2009.
  39. Pain & Policy Studies Group. University of Wisconsin School of Medicine and Public Health. Achieving Balance in State Pain Policy: A Progress Report Card. 4th ed. July 2008. www.painpolicy.wisc.edu/Achieving_Balan/USPExams/PRC2008.pdf. Accessed October 23, 2009.
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