The Continued Importance of Controlled Substance Management by Health Care Professionals
Success with the use of controlled substances in the management of chronic pain requires the acceptance of shared
responsibilities among all health care professionals in a partnership with patients and family caregivers. The so-called
“Goldilocks Principle” of “not too much; not too little; but just
right” is more important in the use of controlled substances for
the treatment of pain than it is in virtually any other health care
activity. The provision of controlled substances can lead to diversion, abuse, and addiction.
The failure to provide necessary controlled substances can
lead to suffering and the aggravation of disease among the most
vulnerable members of society. Working together, health care professionals, patients, and family caregivers can establish realistic
expectations of each other, and these expectations can be met.
DRUG ABUSE AND DIVERSION
One of the saddest commentaries on contemporary American
society is that safe, effective, and unadulterated pharmaceutical
products, made available as an essential modality to treat disease,
are instead diverted from their intended purpose for illicit use.
The diversion of medications for illicit use ruins individual lives
and threatens the public health.
Although drugs do not cause drug abuse, when factors such
as genetic predisposition, personality, and social circumstances
coalesce to produce a predisposition to abuse, access to substances
that may be abused can change lives. The changes affect not only
the abuser, but also the abuser’s family and community.
Furthermore, each dose of diverted and abused controlled substance is no longer available to treat those patients who legitimately need it.
The data on substance abuse are staggering. Results from the
2006 National Survey on Drug Use and Health disclose that 20.4
million Americans 12 years or older currently use illicit drugs.1 The survey asked respondents to identify drugs used for other
than medical purposes within the previous month. The most
common illicitly used drugs are marijuana, cocaine, heroin, hallucinogens, and prescription pharmaceuticals. Marijuana is the
most frequently used illicit drug, with 14.8 million reported users
in the past month. Nearly seven million respondents indicated
that they had used pharmaceutical controlled substances non-medically in the previous month, with 5.2 million indicating that
the controlled substances used were opioid analgesics.
In a separate study, the researchers discovered that in the 45-to-54 age group, overdose deaths from prescription drugs now
surpass motor vehicle accidents as the most frequent cause of
accidental death.2 Perhaps of even greater concern is the trend
among teenagers to abuse pharmaceutical controlled substances.
Data show that 20% of teenagers have abused controlled substances.3 Pharmaceuticals are often seen as preferred drugs of
abuse because they are regulated, are of high quality, and are
freely available in family medicine chests. Teenagers view them as
being less risky than street drugs (Table 1).
Table 1.
Facts About Drug Diversion
Over a four-year period (2000 to 2003) among 22 states, 12,894
theft/loss incidents regarding administration of controlled substances
were reported. These losses were primarily from pharmacies (89.3%).
Almost 28 million dosage units of all controlled susbtances were
diverted.1 According to a report on prescription drug monitoring programs, of
24 states listed, 17 allow law enforcement personnel to use data to
support investigations of prescription drug abuse and 8 allow law
enforcement personnel to employ data to initiate investigations.2
Drug diversion drains health insurers of up to $72.5 billion a year,
including up to $24.9 billion annually for private insurers. The losses
include insurance schemes, plus the larger hidden costs of treating
patients who develop serious medical problems from abusing the
addictive narcotics they obtained.3 The addiction and withdrawal associated with the abuse of many prescription drugs may be more harmful than that associated with illegal
drugs.4
1Joranson DE, Gilson AM. Drug crime is a source of abuse of pain medications in the U.S. J Pain Symp Manage. 2005;30:299.
2Prescription Monitoring Programs: Current Practices and Consideration of
Their Effectiveness. Presented at the National Institute of Justice Annual Conference on Criminal Justice Research & Evaluation, Washington DC, July 2005.
3Coalition Against Insurance Fraud. Prescription for Peril. Available at:
www.insurancefraud.org/drugDiversion.htm. Accessed: February 17, 2009.
4Geier P. The dark side of prescription drugs. Prescription Drug Abuse, 2003.
Available at www.prescription-drug-abuse.org. Accessed: February 17, 2009. |
SOURCES OF PHARMACEUTICAL DIVERSION
The federal Controlled Substance Act establishes a “closed system” of distribution for those pharmaceutical controlled substances classified into one of five schedules.4 For schedules II
through V, distribution is permitted for medical purposes, but
authority to control distribution is granted only to those who are
registered with the Drug Enforcement Administration (DEA) or
to those who are employees of a DEA registrant. Within the
closed system, lifelong record keeping is required. If scheduled
drugs are found outside the control of a registrant or a patient for
whom the drug has been prescribed, or if required records have
not been maintained, then the drugs are considered to have been
diverted from the closed system of distribution.
The existence of a high level of prescription drug abuse
necessarily leads to the conclusion that there are “leaks” in the
supposedly closed system of controlled substance distribution.
The leaks in the system of distribution have not been adequately documented and at this point are the subject of speculation.
Law enforcement personnel and health care professionals have
attempted to discover how prescription drugs are leaving the
closed system, because the problem of diversion can be best
addressed if the sources of diversion are accurately identified. It
is clear that at least some volume of controlled substances are
diverted through theft or loss early in the chain of distribution,
prior to the issuance and processing of a prescription.5 No amount of oversight by health care professionals or patients can
prevent this sort of preprescribing/dispensing loss from the
system (Table 2).
Table 2. Sources of Drug Diversion
Doctor shopping
Drug theft
Illegal Internet pharmacies
Illicit prescribing by health care professionals
Prescription forgery |
On the other hand, recent federal data suggest that prescribed and dispensed pharmaceuticals may be a significant
source of diversion.6 In the federal study, survey respondents who admitted abusing prescription drugs were asked how they had
acquired them. Of those who responded, 19.1% indicated they
had acquired the drugs from a single doctor and 55.7% indicated
they had acquired the drugs from a friend or relative for free. Of
this group, 80.7% indicated that their source had acquired the
drugs from a single doctor.
The previously mentioned survey results suggest that over
half of all diverted controlled substances come from the orders of
a single prescriber and not from doctor shopping or other illicit
activities. The message postulated from these results may be that
prescribers and dispensers of opioids for pain do not exercise sufficient oversight, and that they should be considered culpable for
at least half of the drug diversion events that occur.
The aforementioned data have been subject to significant criticism. Note that only one half of one percent of respondents indicate that the Internet is the source of their supply. Other
researchers have concluded that the Internet serves as a far greater
source of controlled substances that are used nonmedically.7 That
the federal government believes Internet sales to be a significant
source of diverted controlled substances is evidenced by the recent
passage of new legislation aimed at curbing the activities of rogue
online pharmacies.8 Nevertheless, lack of oversight by health care
professionals does appear to cause leaks from the closed system of
controlled substance distribution. The reality of these leaks serves
as an incentive for health care professionals to better organize their
practices to prevent controlled substance diversion.
THE PROBLEM OF
UNDERTREATED AND UNTREATED PAIN
Plugging leaks in the system of drug distribution would be relatively easy were it not for the reality that overly aggressive limits
on access to controlled substances contribute to the problems of
undertreated and untreated pain. Limiting access for those who
would abuse controlled substances also limits access for those
who legitimately need the drugs, and the problem of uncontrolled pain is aggravated.
According to the National Center for Health Statistics,
approximately 75 million Americans suffer from pain.9 Although
patients with cancer tend to have better access to pain medications, even they have trouble acquiring the medications they
need. Pain is undertreated in nearly half of all patients with cancer. In addition, 15% of children, perhaps the most sympathetic
patients of all, experience chronic pain, causing long-lasting
effects on social, emotional, and physical development. The
denial of access to pain medication disproportionately affects certain populations. African Americans are less likely to have their
pain managed than are Caucasians,10 and women are less likely to
have their pain managed than are men.11
Opioid analgesics are approved as safe and effective drugs to
treat pain, yet they are not consistently prescribed when they are
indicated. Numerous barriers have been suggested as reasons for
the reluctance of patients and health care providers to use opioids
for pain. These barriers include fear of addiction, inadequate education and training, the threat of regulatory oversight, and poor
communication.12
Overcoming these barriers is a significant challenge for those
who advocate more effective management of pain. However,
some barriers to access are appropriate to prevent the acquisition
of unnecessary drugs by those who have no medical need for
them. The health care professional’s challenge is to implement
controls in practice that effectively screen patients to filter out
those with no legitimate need while continuing to supply necessary medications to those who will use them responsibly and benefit from them. Achieving this objective requires a balanced
approach to drug policy and patient care.
BALANCING ACCESS TO
CONTROLLED SUBSTANCES
Balance is important in health care because it minimizes human
suffering. The health care practice that disproportionately emphasizes the denial of medications to those who would abuse
them will inevitably deny access to large numbers of patients who
truly need medications. The practice that overly emphasizes the
availability of medications to those who need them will end up
inadvertently supplying them to those who do not need them. In
either case, people suffer from the effects of poor pain management or from substance abuse.
The most successful health care practices are those that balance the need to provide controlled substances when appropriate with the need to deny them when inappropriate. It is more
difficult to achieve this balance than to simply take one
approach as opposed to the other, but it is necessary to promote
the public health. What this means is that in a conscientious
practice there will be some small number of people who need
drugs but do not receive them and a small number who do not
need them but get them. To reduce either small number to zero
increases the correlative error to an unacceptable level. The law
does not require health care professionals to be perfect. It does
require that they exercise good faith in their practice.13
Balance has been recognized as the most appropriate
approach to the dual problems of substance abuse and
undertreated and untreated pain. The Pain and Policy
Studies Group at the University of Wisconsin has described
the Central Principle of Balance in this way: “The Central
Principle of ‘Balance’ represents a dual imperative of governments to establish a system of controls to prevent abuse,
trafficking, and diversion of narcotic drugs while, at the
same time, ensuring their medical availability.”14
The federal Drug Enforcement Administration (DEA) has
supported balance as the appropriate foundation of controlled
substance use in health care, joining in 2001 with 21 health care
organizations in support of a joint statement that recognizes the
value of opioids in the treatment of pain, the need for these
drugs to be accessible to all patients for whom they are medically indicated, and the importance of having regulations that do
not hinder legitimate medical practice.15
A MODEL POLICY TO ACHIEVE BALANCE
The Federation of State Medical Boards (FSMB) provides guidance for health care professionals on the level of oversight and
clinical review that is adequate to represent a balance in practice
between providing access to those who need medications and
denying access to those who do not need them.16 The FSMB
Model Policy for the Use of Controlled Substances for the
Treatment of Pain has been adopted into law in a majority of
states and it serves as instructive authority even in the states that
have not yet adopted it (Table 3).
|
Table 3. Steps for the Treatment of Pain
with Controlled Substances
Evaluation of the patient
Development of treatment plan
Informed consent and agreement for treatment
Periodic review
Consultation as necessary
Complete and accurate medical records
Source: Federation of State Medical Boards
|
The following are the criteria the FSMB recommends for
evaluating and managing pain, including the use of controlled
substances.
Evaluation of the Patient
A medical history and physical examination must be obtained,
evaluated, and documented in the medical record. The medical
record should document the nature and intensity of the pain,
current and past treatments for pain, underlying or coexisting
diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical
record also should document the presence of one or more recognized medical indications for the use of a controlled substance.
Treatment Plan
The written treatment plan should state objectives that will be
used to determine treatment success, such as pain relief and
improved physical and psychosocial function, and should indicate
if any further diagnostic evaluations or other treatments are
planned. After treatment begins, the clinician should adjust drug
therapy to the individual medical needs of each patient. Other
treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to
which the pain is associated with physical and psychosocial
impairment.
Informed Consent and Agreement for Treatment
The clinician should discuss the risks and benefits of the use of
controlled substances with the patient, with persons designated
by the patient, or with the patient’s surrogate or guardian if the
patient is incapable of making medical decisions. The patient
should receive prescriptions from one clinician and one pharmacy
whenever possible. If the patient is at high risk for medication
abuse or has a history of substance abuse, the clinician should
consider the use of a written agreement between clinician and
patient outlining patient responsibilities, including urine/serum
medication level screening when requested, number and frequency of all prescription refills, and reasons for why drug therapy
may be discontinued (eg, violation of agreement).
Periodic Review
The clinician should periodically review the course of pain treatment
and any new information about the etiology of the pain or the
patient’s state of health. Continuation or modification of controlled
substances for pain management therapy depends on the clinician’s
evaluation of progress toward treatment objectives. Satisfactory
response to treatment may be indicated by the patient’s decreased
pain, increased level of function, or improved quality of life. Objective evidence of improved or diminished function
should be monitored and information from family members or
other caregivers should be considered in determining the patient’s
response to treatment. If the patient’s progress is unsatisfactory,
the clinician should assess the appropriateness of continued use
of the current treatment plan and consider the use of other therapeutic modalities.
Consultation
The clinician should be willing to refer the patient as necessary
for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those
patients with pain who are at risk for medication misuse, abuse,
or diversion.
The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require
extra care, monitoring, documentation, and consultation with or
referral to an expert in the management of such patients.
Medical Records
The clinician should keep accurate and complete records. They
should include the items listed in Table 4. Records should
remain current and be maintained in an accessible manner and
readily available for review.
|
Table 4. Items To Be Included in Medical Records
The medical history and physical examination
Diagnostic, therapeutic, and laboratory results
Evaluations and consultations
Treatment objectives
Discussion of risks and benefits
Informed consent forms
Documentation of treatments
Medications (including date, type, dosage, and quantity prescribed)
Instructions and agreements
Periodic reviews |
Compliance With Controlled
Substances Laws and Regulations
To prescribe, dispense, or administer controlled substances,
the clinician must be licensed in the state and comply with
applicable federal and state regulations. The FSMB’s seven
steps for compliance with medical requirements and legal
requirements are not unduly burdensome. In fact, they represent standard procedures in a health care practice. The FSMB
policy should be considered a strong recommendation for the
development of an approach to practice that will balance the
need of patients to receive medications and the importance of
restricting availability for those who would divert controlled
substances.
CONCEPTS AND TERMINOLOGY
The FSMB has also defined terms that are commonly used in
pain management practice. Note that the definition of “pain”
does not require the identification of actual or even potential tissue damage. The source of the pain need not be known for the
pain to be considered real. It is the patient’s self-report of the
pain that defines the existence of pain.
Pain
Pain is defined as an unpleasant sensory and emotional experience associated with atual or potential tissue damage or
described in terms of such damage.
Acute pain is the normal, predicted physiological response to
a noxious chemical, thermal or mechanical stimulus and typically
is associated with invasive procedures, trauma and disease. It is
generally time-limited.
Chronic pain is a state in which pain persists beyond the
usual course of an acute disease or healing of an injury, or that
may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over
months or years.
Addiction, Physical Dependence,
Tolerance, and Pseudoaddiction
The FSMB policy goes to great lengths to distinguish clearly
among addiction, physical dependence, tolerance and pseudoad-diction. Although addiction is a disease warranting treatment, the
other three terms describe relatively common occurrences that
often accompany pain management. They present challenges for
the health care professional, but they do not require treatment as
a disease and they do not raise legal issues.
Addiction is a primary, chronic, neurobiologic disease, with
genetic, psychosocial, and environmental factors influencing its
development and manifestations. It is characterized by behaviors
that include the following: impaired control over drug use, craving, compulsive use, and continued use despite harm.
Physical dependence and tolerance are normal physiological
consequences of extended opioid therapy for pain and are not the
same as addiction.
Physical dependence is a state of adaptation that is manifested by drug class- specific signs and symptoms that can be produced by abrupt cessation, rapid dose reduction, decreasing
blood level of the drug, and/or administration of an antagonist.
Physical dependence, by itself, does not equate with addiction.
Pseudoaddiction is an iatrogenic syndrome resulting from
the misinterpretation of relief-seeking behaviors as though they
are drug-seeking behaviors that are commonly seen with addiction. The relief-seeking behaviors resolve upon institution of
effective analgesic therapy.
Tolerance is a physiologic state resulting from regular use of
a drug in which an increased dosage is needed to produce a specific effect, or a reduced effect is observed with a constant dose
over time. Tolerance may or may not be evident during opioid
treatment and does not equate with addiction.
It is quite clear from these definitions that some traditional
beliefs about the use of opioids may be misguided. For example,
a health care professional may express concern that a patient
whose need for opioids is gradually increasing is becoming
addicted to opioids. Such a concern is not well founded. The
patient is experiencing tolerance, and the condition does not
meet the definition of addiction. Or, a patient may become worried because she or he has experienced withdrawal symptoms
after deciding to abruptly stop using a prescribed medication.
The patient may conclude that this is evidence of addiction to
the prescribed medication, and the health care provider can
counsel the patient that this is a symptom of physical dependence
and is no cause for alarm.
ASSESSING THE RISK OF DIVERSION
Health care professionals who provide access to controlled substances for the treatment of pain must assess each situation individually to determine whether a patient is at low, medium, or
high risk for diversion and abuse.17 No patient who receives controlled substances is considered at “no risk” for diversion. The
vast majority of patients in a primary care setting will be low risk.
In the absence of any warning signs, these patients can be carefully monitored and educated about the appropriate use of controlled substances, but there is no need for special limitations or
risk-management techniques.
However, there will be a significant minority of patients who
fall into the medium-risk category. These are patients who have a
past history of a substance abuse disorder, who have a family history of the disease of addiction, or who live in a setting that
exposes them to others who openly abuse controlled substances.
For these patients, consultation with a professional who has experience in the treatment of addiction should be strongly considered. These patients should be required to accept a medication-management agreement, and it may be necessary to authorize frequent access to small amounts of medication, rather than monthly dispensing of a large quantity.
For high-risk patients, who have active addiction issues,
referral to a pain and addiction medicine professional is essential.
These are patients whose issues exceed the level of expertise that
will be available within a primary care practice.
To facilitate the assessment of the risk of drug diversion in a
primary care setting, several validated and self-administered brief
survey instruments have been developed. These are questionnaires that can be used to predict the likelihood that a patient
falls into the low-, medium-, or high-risk category.18 Each one of
these screening tools is available through an Internet search and
can be administered with ease. These tools include CAGE-AID,
the Trauma Test, the Opioid Risk Tool, and the Screener and
Opioid Assessment for Patients with Pain (SOAPP). An investment of less than an hour in the location of these tools and
review of the methodology for using them can save many hours
over the long term.
A significant problem in the assessment of diversion risk is
that legitimate patients frequently say and do things that appear
similar to the things drug diverters would say and do. In fact, the
drug diverters have often rehearsed the behaviors they believe are
appropriate for a patient with pain, and their “performance” in a
health care setting may seem more valid that that of the legitimate patient who is suffering, confused, and frightened. Drug
diverters can dupe health care providers into allowing access to
unnecessary medications, whereas patients with real pain can
raise red flags that result in the denial of necessary medications.
To assist in the distinction between those behaviors that can be
classified as “red flags” of aberrant behaviors and those behaviors
that could be considered “red herrings” that do not indicate aberrant behaviors, researchers have identified factors that are more
and less predictive of inappropriate drug use.19 These are listed in Table 5.19
| Table 5. Factors To Assess Drug-Related Behaviors |
|
Factors Identified As More Predictive of Aberrant
Drug-Related Behaviors
|
|
Selling controlled substances
Forging controlled substance prescriptions
Stealing or borrowing drugs
Injecting oral formulations
Obtaining prescription drugs from non-medical sources
Concurrent alcohol or illicit drug abuse
Multiple unauthorized dose escalations
Multiple losses of controlled substances
Secretive acquisition of controlled substances from multiple health
care professionals after being warned not to do so
Deterioration of functionality
Repeated resistance to treatment change despite adverse effects
|
| Factors Identified As Less Predictive of Aberrant
Drug-Related Behaviors |
|
Aggressive complaining about pain and the need for
drugs to relieve pain
Hoarding drugs during periods of reduced symptoms
Requesting specific drugs that are perceived as effective
Openly acquiring controlled substances from other
health care professionals
Unauthorized dose escalation once or twice
Unauthorized use of drug to treat other symptom
Reporting psychic effects unfamiliar to the health care professional
Anxiety about treatment changes necessitated by adverse effects |
Patients whose activities fall into the more predictive category should be classified as a medium- or high-risk candidate
for diversion. Patients whose activities fall into the less predictive category can continue to be classified as low-risk candidates, but they must be counseled that their behaviors place
themselves and the health care professional at some level of risk.
Working together, health care professionals, patients, and family caregivers can manage that risk, but they cannot eliminate the risk of diversion.
THE DRUG ENFORCEMENT
ADMINISTRATION PERSPECTIVE
Under DEA regulations, health care professionals must assure
that the purpose of issuance of a prescription is legitimate. The
pertinent FDA rule emphasizes that for a prescription for a controlled substance to be effective, it must be issued for a legitimate medical purpose by an individual practitioner acting in the
usual course of his or her professional practice (Table 6). The
responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the
prescription. An order purporting to be a prescription issued not
in the usual course of professional treatment or in legitimate and
authorized research is not a prescription and the person knowingly filling such a purported prescription, as well as the person
issuing it, shall be subject to the penalties provided for violations
of the law.20
Table 6. Controlled Substances by CSA Schedule
I: High potential for abuse; not currently acceptable for medical use;
not considered safe
II: High potential for abuse; accepted for medical use; abuse may lead
to severe dependence
III: Potential for abuse less than for Schedules I & 11; accepted for
medical use; abuse may lead to moderate or low physical or high psychological dependence
IV: Low potential for abuse relative to Schedule III; accepted for medical use; abuse may lead to limited dependence relative to Schedule III
V: Low potential for abuse relative to Schedule IV; accepted for
medical use; abuse may lead to limited dependence relative to
Schedule IV |
Compliance with this rule requires that health care professionals collaborate with each other. The DEA has offered guidance on how health care professionals can identify drug
diverters.21 These signs of drug-seeking behavior are listed in Table 7. However, the DEA cautions that any of these behaviors
can be associated with legitimate patients with pain. These are
not behaviors that rule out the need for controlled substances,
but they rule in the need for caution in the provision of access to
controlled substances.
Table 7. Signs of Drug-Seeking Behavior
Requesting an appointment at the end of office hours
Arriving without an appointment
Arriving late for an appointment when office staff are anxious to leave
Reluctance to undergo thorough physical or diagnostic tests
Failure to keep follow-up appointments
Unwilling to provide medical records or identify previous
health care professionals
Unusual stories that cannot be corroborated |
THE FIVE-STEP VIGIL PROCESS
Many excellent sources have suggested factors to consider in
order to reduce the risk of diversion and abuse in the management of drug therapy with patients who need controlled substances. Taking this information and organizing it into a cohesive
protocol for the primary care setting may seem daunting. It need
not be. A five-step process called VIGIL incorporates the available advice and makes it practical for patient care (Table 8).22
|
Table 8. Responsibilities in the VIGIL Process |
| Step |
Prescriber |
Pharmacist |
Patient |
| Verification |
Confer with previous
prescriber
|
Contact prescriber
on first Rx |
Provide accurate
information |
| Identification |
Check ID |
Check ID |
Provide ID |
| Generalization |
Specify expectations
of patient verbally
or in writing |
Participate in
agreement if
asked |
Meet expectations
as specified |
| Interpretation |
Use screening tool |
Report patient
behavior to
prescriber |
Keep diary if asked |
| Legalization |
Physical exam and
documentation |
Patient education
and drug
use review |
Keep controlled
substances secure |
The VIGIL process
need not be used with every
patient for whom controlled substances are prescribed. A patient who
receives a seven-day supply
or less for acute pain does
not need to be put through
the VIGIL process. In fact,
any patient with whom a
health care professional feels
completely comfortable
providing access to controlled substances is not a
candidate for VIGIL.
However, for any patient
who makes the health care
professional feel uncomfortable, VIGIL provides the comfort level necessary to allow access to controlled substances, with firm but fair oversight of medication use. Obviously, if a health care professional knows that a person’s need for controlled substances is not legitimate, the VIGIL process is of no use.
The purposes of VIGIL are fourfold:
(1) to establish a policy
of balance in health care practice;
(2) to screen out non-patients
who traffic in controlled substances;
(3) to remind legitimate
patients that they have significant responsibilities in medication
use; and
(4) to demonstrate good faith in health care practice to
anyone who questions a health care professional’s activities and
motivations.
No approach to health care practice will completely eliminate drug diversion and abuse. VIGIL is one of several techniques that can be used to manage the risk of drug diversion and
abuse while continuing to maintain ready access to medications
for those who need them.
The five steps of VIGIL are: Verification, Identification,
Generalization, Interpretation, and Legalization.
Step One: Verification
This step answers the question: “Is this a responsible opioid
user?” Prescriber responsibilities in the verification step are to talk
openly with the patient about prior use of drugs, including illicit
drug use. On the first visit, a patient may be able to refer the
clinician to a previous clinician who can vouch for the patient’s
responsible use of opioids. If this is not possible, the clinician
should strongly consider starting drug therapy with a non-controlled substance and moving on to a controlled substance only
after having sufficient experience with the patient to warrant an
expectation of responsible future opioid use.
Pharmacists’ responsibilities in this step require calling the
prescriber for verification the first time a Schedule II opioid prescription is presented by a patient, documenting the purpose of
the medication, and notifying the prescriber of anything that
seems unusual about the patient’s medication use.
Step Two: Identification
This step answers the question: “Do I know for sure who this
person is?” Prescribers and pharmacists have every right to know
the identity of the person to whom controlled substances are
being given. This includes the patient as well as any relative or
friend who is picking up a prescription for the patient. Each person to whom a prescription is given should be asked to present a
government issued photo identification card, and this card
should be photocopied. For those people who can reasonably
explain why they do not possess government issued identification, an alternative form of identification may be sufficient.
Health care professionals need to be able to identify to law
enforcement agents who picked up a prescription medication if
later an issue arises over the illicit use of that medication.
Step Three: Generalization
This step answers the question: “Do we agree on mutual responsibilities and expectations?” In this step, clinicians will need to
explain to each patient that the patient has a right to expect
respectful health care services, and that the clinician has expectations of the patient as well. These expectations should be spelled
out and this may require a written medication-use agreement.
Patients should be told, for example, that they may not share
medications, that they must keep medications secure from theft,
and that they must plan ahead to assure an available supply.
Pharmacists may be included in the agreement between prescribers and patients. Medication-use agreements may limit a
patient to a specific pharmacy chosen by the patient. It is the
pharmacist’s responsibility to be familiar with the expectations of
each patient and to report to the prescriber circumstances in
which expectations are not met.
Step Four: Interpretation
This step answers the question: “Do I now feel comfortable
allowing this person to have controlled substances?” Even after
verifying responsible use, identifying the patient, and establishing
mutual expectations with the patient, a health care professional
may continue to feel uncomfortable about providing controlled
substances to the patient.
This is the step where it may be necessary to use one of the
screening tools previously described. In addition, the clinician
may require the patient to complete a diary that describes functionality at work, with family, and in social situations. In this
step, the pharmacist will want to consult with the prescriber if
there are any lingering concerns regarding patient behaviors. In
particular, if patients request that they pay cash for some medications while having insurance pay for others, prescribers should be
made aware of this request.
Step Five: Legalization
This step answers the question: “How can I stay squeaky clean in
meeting my legal requirements?” Sometimes in health care the
technical requirements of the law seem picky and unnecessary.
There is a temptation to creatively interpret the law, when to do
otherwise creates an inconvenience for patients. This is a temptation to firmly resist when using controlled substances for the
treatment of pain.
Anyone who prescribes or dispenses controlled substances should become familiar with the federal rules found
on the DEA website: www.deadiversion.usdoj.gov. Some
states have laws that are stricter than the federal laws; to find
these laws the state board of medicine or pharmacy should be
contacted. Federal and state laws should be followed with no
exceptions.
CONCLUSION
Several technologies are becoming available to assist health care
professionals in managing the risk of controlled substance diversion and abuse. State electronic prescription monitoring programs can provide a history of controlled substance acquisition
through a report requested on a patient, but these reports are
not always available in real time and the identification of a
patient is not always accurate. Security prescription pads and verified electronic orders are being made available, but they are
not foolproof either. Tamper-resistant products may reduce abuse
by those who alter the dosage form as a method of abuse, but
they will have little effect on patients who abuse by swallowing
oral dosage forms whole. The FDA’s new REMS (Risk
Evaluation and Mitigation Strategies) program can require
patients, prescribers, and pharmacies to be on a registry and,
thus increase assurance of appropriate controlled-substance
acquisition and use.
None of these technologies, as useful as they may be, can
replace the vigilance of health care professionals who control
access to medications. Working together with patients and family
caregivers, those in health care who are committed to meeting the
needs of patients in pain will continue to use low-tech methods
of managing the risks of diversion and abuse. These low-tech
methods are far from perfect, but they do protect the integrity of
the system of drug distribution while providing a measure of
relief for those who are living and dying in pain.
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