Download protecting your practice and patients from prescription drug

PROTECTING YOUR PRACTICE AND PATIENTS FROM
PRESCRIPTION DRUG ABUSE
RON GASBARRO, PHARM.D.
PROTECTING YOUR PRACTICE AND PATIENTS FROM PRESCRIPTION
DRUG ABUSE
ACTIVITY DESCRIPTION
ACCREDITATION
Prescription drug abuse is one of the most serious and
critical public health concerns in the country. The FDA,
DEA, state and local agencies continue to focus assets
on reducing prescription drug abuse. As a pharmacist,
it often seems that these agencies are targeting
pharmacists and pharmacies to ensure controlled
substance prescriptions are for legitimate purposes.
Since pharmacists are frontline health care providers
and the provider that actually fills the prescription, it is
imperative that they receive the education and training
to proactively work with patients and prescribers to
identify, manage, and prevent prescription drug abuse.
This knowledge based program will focus on the
enormous challenges that prescription drug abuse has
in the United States and the pivotal role that
pharmacists can play working with both prescribers and
patients to identify, reduce and prevent abuse and
misuse.
PHARMACY
PharmCon, Inc. is accredited by the
Accreditation Council for Pharmacy
Education as a provider of continuing
pharmacy education.
NURSING
PharmCon, Inc. is approved by the California Board of
Registered Nursing (Provider Number CEP 13649) and
the Florida Board of Nursing (Provider Number 503515). Activities approved by the CA BRN and the FL
BN are accepted by most State Boards of Nursing.
CE hours provided by PharmCon, Inc. meet the ANCC criteria
for formally approved continuing education hours. The ACPE
is listed by the AANP as an acceptable, accredited continuing
education organization for applicants seeking renewal
through continuing education credit. For additional
information, please visit
http://www.nursecredentialing.org/RenewalRequirements.aspx
TARGET AUDIENCE
The target audience for this activity is pharmacists,
pharmacy technicians and nurses in hospital,
community, and retail pharmacy settings.
Universal Activity No.: 0798-0000-14-146-H05-P&T
Credits: 2 contact hours (0.2 CEU)
LEARNING OBJECTIVES
Release Date: September 15, 2014
Expiration Date: September 15, 2016
After completing this activity, the pharmacist and
nurse will be able to:
 Outline the deleterious effects of
prescription opioid abuse on individuals and
society.
 Describe the signs and symptoms of
prescription opioid abuse and withdrawal.
 Identify the most common methods that
patients use to obtain prescription opioids
for purposes of abuse.
 Outline strategies pharmacists can use in
their practice to identify, manage and
prevent prescription drug abuse.
After completing this activity, the pharmacy
technician will be able to:
 List signs and symptoms of prescription
opioid abuse and withdrawal
 List ways a patient can use to obtain
prescription opioids for abuse purposes
ACTIVITY TYPE
Knowledge-Based Home Study Monograph
FINANCIAL SUPPORT BY
Purdue Pharma L.P.
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ABOUT THE AUTHOR
Ron Gasbarro is a practicing pharmacist with a strong
background as a medical/pharmaceutical writer
specializing in peer-reviewed journal articles as well as
many other aspects of medical communication. He has
long been interested in patient education. He earned
his Doctor of Pharmacy (PharmD) at the University of
Maryland at Baltimore, his MS in Science Journalism at
Boston University, and his BS in Pharmacy at SUNY
Buffalo. He has written on many topics including those
having to do with psychiatry, psychotropics,
cardiology/cardiovascular, antibiotics and infectious
disease, oncology (solid tumors; targeted therapies) as
well as a range of other subjects including
epilepsy/seizure disorders, pain management, and
HIV/AIDS.As a working pharmacist, he brings a specific
awareness to the production of educational webinars
that are meant to address the concerns and realities of
pharmaceutical work today.
Ron Gasbarro, PharmD
Rx-Press
FACULTY DISCLOSURE
It is the policy of PharmCon, Inc. to require the
disclosure of the existence of any significant financial
interest or any other relationship a faculty member or
a sponsor has with the manufacturer of any
commercial product(s) and/or service(s) discussed in
an educational activity. Ron Gasbarro reports no
actual or potential conflict of interest in relation to
this activity.
Peer review of the material in this CE activity was
conducted to assess and resolve potential conflict of
interest. Reviewers unanimously found that the
activity is fair balanced and lacks commercial bias.
Please Note: PharmCon, Inc. 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 and objective. Occasionally,
authors may express opinions that represent their own
viewpoint. 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 or pharmacy management.
Conclusions drawn by participants should be derived from
objective analysis of scientific data presented from this
monograph and other unrelated sources.
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Is it always good to be #1?
According to the IMS Institute for Healthcare Informatics, a pharmaceutical market intelligence
firm, the number one prescribed medication in the United States for 2009, 2010, 2011, 2012,
and 2013 was hydrocodone/acetaminophen [Table 1] [IMS, 2014]. That’s over 129 million
prescriptions annually. If each prescription were written for 60 tablets, then Americans would
be swallowing 7.8 billion tablets a year. To put it in perspective, if you were the only pharmacist
in the country and you had to count out 7.8 billion tablets of hydrocodone, day and night, you
would be counting for 740 years – goodbye retirement!
This exercise will discuss the pathophysiology of opioid addiction, strategies to identify and
report individuals who may be abusing opioids, and methods by which healthcare professionals,
as well as government agencies can help minimize opioid abuse in every community.
Drug dealers are no longer the primary source of illicit drugs. Your pharmacy is. As pharmacists,
you know darn well that many patients are abusing drugs, diverting them into the community,
and when they graduate to heroin, they are selling them to “narcotic newbies,” often teens,
which perpetuates the cycle of addiction. This constitutes a public health crisis. According to
the Centers for Disease Control and Prevention (CDC), overdose deaths from prescription
painkillers have skyrocketed in the past 10 years [CDC, 2012]. Approximately 16,500 people die
each year from overdoses involving these drugs—more than those who die from heroin and
cocaine combined – more than the number of deaths from both suicide and motor vehicle
crashes [Manchikanti, 2012]. This would be the equivalent to losing an airplane carrying 90 passengers
and crew every day for 6 months – clearly unacceptable from a public health and safety
standpoint. Overdoses involving prescription painkillers—a drug class that includes
hydrocodone as well as methadone, oxycodone, and oxymorphone—are almost becoming
commonplace and these medications drugs are widely misused and abused. In 2010, one in 20
people in the United States, ages 12 and older, used prescription painkillers non-medically,
without a prescription or just for the "high" they get. A recent CDC analysis discusses this
growing epidemic and suggests measures for prevention [CDC, 2012].
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Consider that [CDC, 2012a]:

Prescription painkiller overdoses in the United States have quadrupled since 1999.

Nearly half a million emergency department visits in 2009 were due to people misusing
or abusing prescription painkillers.

Nonmedical use of prescription painkillers costs health insurers up to $72.5 billion
annually in direct health care costs.
Figure 1 shows rates of opioid pain reliever (OPR) overdose death, OPR treatment admissions,
and kilograms of OPR sold in the United States during 1999-2010. Figure 2 shows rates of OPR
overdose death, OPR treatment admissions, and kilograms of OPR sold in the United States
during 1999-2010. During 1999-2008, overdose death rates, sales, and substance abuse
treatment admissions related to OPR all increased substantially.
Groups at greatest risk
Certain groups are more likely to abuse or overdose on prescription painkillers: [CDC, 201a2]

Many more men than women die of overdoses from prescription painkillers.

Middle-aged adults have the highest prescription painkiller overdose rates.

People in rural areas are about two-fold as likely to overdose on opioids as urbanites.

Whites and American Indian or Alaska Natives are more likely to overdose on opioids.

About 1 in 10 American Indian or Alaska Natives age 12 or older used opioids for
nonmedical reasons in the past year, compared to 1 in 20 whites and 1 in 30 blacks [Table 3].
Doctors and drug dealers alike
A noteworthy relationship exists between sales of opioid pain relievers and deaths. The
majority of deaths (60%) occur in patients when they are issued prescriptions based on
prescribing guidelines by medical boards, with 20% of deaths in low-dose opioid therapy of a
morphine 100 mg equivalent dose or less per day and 40% in those receiving morphine of over
100 mg per day [Manchikanti, 2012]. In comparison, the remaining 40% of deaths occur in individuals
abusing the drugs obtained through multiple prescriptions, doctor shopping, and drug
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diversion. The obstacles that must be conquered are inappropriate prescribing patterns by
physicians, which are largely based on a lack of knowledge, perceived safety, and an inaccurate
belief that pain must be treated with as much drug as possible, rather than starting low, and
increasing the doses as needed.
The highs and lows of addiction
Referring to his narcotics addiction, stand-up comic, social critic and satirist Lenny Bruce once
said, "I'll die young, but it's like kissing God." In 1966 at age 40, he did die young via a morphine
overdose. His life had been plagued by marital problems, legal woes, and a marginally
successful career. In Bruce’s case which is mirrored in countless other cases, initiation of opioid
abuse was related to familial and environmental influences such as peer pressure, disrupted
family dynamics, and history of availability of opioids in the family [Neaigus, 2001].
Comorbid psychiatric disorders such as attention-deficit/hyperactivity disorder (ADHD), bipolar
disorder, major depressive disorder (MDD), anxiety disorders, personality disorders,
posttraumatic stress disorder (PTSD), and psychosis heighten the risk of substance abuse,
including the abuse of opioids [Milby, 1996; Krausz, 1998; Callaly, 2001]. Chronic non-cancer pain syndromes
that are treated with long-term opioid therapy have also been linked to an increase in opioid
abuse in the US [Chapman, 2010; Nobel, 2010].
For drug dependence, considerable evidence suggests that genetic factors influence the risk of
these disorders, with heritability estimates of 50% to 60%; it is very possible that multiple genes
are involved [Dick, 2008]. Recent studies have indicated shared genetic influences that contribute
to the risk for substance dependence as well as comorbid psychiatric disorders [Kendler,
2003].
Association with specific genes, such as the mu opioid receptor gene, has been suggested;
however, evidence linking it to opioid use has not been fully elucidated [Gelernter, 2006]. More
recently, prescription opioid abuse has been associated with a distinct set of demographics:
younger age (20 to 29 years), white ethnicity, and better socioeconomic status with fewer
comorbid mental illnesses [Mendelson, 2008].
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You’ve got opioids on the brain.
Your body makes its own opioids when threatened by a noxious stimulus, which is an actually
or potentially tissue damaging event. A noxious stimulus can be thermal (hot water), chemical
(acid), or mechanical (a good hard pinch) [Loeser, 2008]. Opioid receptors in the brain are activated
by a family of endogenous peptides such as the endorphins (endogenous morphine), which are
released by neurons. Opioid receptors can also be activated exogenously by alkaloid opiates,
such as morphine, which still remains the most valuable painkiller in contemporary medicine.
By acting at opioid receptors, opiates such as morphine or heroin are extremely potent
painkillers, but are also highly addictive molecules.
A critical role in mediating opioid effects is the dopaminergic mesolimbic system (DMS), which
originates in the ventral tegmental nucleus (VTN) with a projection to the nucleus accumbens
[Spanagel, 1992].
The opioid receptor system includes mu, kappa, sigma, delta, and epsilon receptor
subtypes and they tend to balance one another in the brain. Opioid-induced activation of mu
and sigma receptors increases the activity of the DMS, thereby releasing dopamine into the
nucleus accumbens to produce feelings of euphoria and well-being. Stimulation of the kappa
receptors decreases activity of the DMS, which results in dysphoria, that is, the feelings of
euphoria “wear off.”
Opioid tolerance occurs when there is a decreased response by the opioid receptors in the
brain to previous doses of an opioid [Spanagel, 1992]. A higher dose of opioid is then needed to
stimulate the DMS and achieve the same release of dopamine in the nucleus accumbens.
Enzymatic inhibition occurs at the mu receptors in the locus ceruleus (an area at the base of the
brain producing norepinephrine, maintaining normal wakefulness, alertness, and hemodynamic
stability) in the presence of opioids initially, and norepinephrine production decreases [Kosten,
2002; Koob, 2001].
However, chronic use of opioids leads to increased enzymatic activity at the mu
receptors, thereby resulting in normal or higher levels of norepinephrine. Following opioid
deprivation, such as during withdrawal, there is loss of inhibitory effect on enzyme activity
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leading to an excess release of norepinephrine from these neurons, resulting in symptoms such
as muscle cramps, diarrhea, anxiety, and tremors.
Dependence on opioids is maintained by the rewarding effect of opioids mediated through the
DMS, and avoidance of the aversive opioid withdrawal symptoms mediated through the
norepinephrine pathways [Kosten, 2002]. Dysfunction in other brain areas such as the prefrontal
cortex, and neurochemicals such as cortisol, also appear to play a role.
The differences between opioid abuse, dependence, and addiction
Opioids are very important medications in that they can relieve intractable pain. Not every
person who takes opioids is a criminal or an addict. Addiction is drug seeking behavior. If you
have cancer and your physician prescribes an opioid for you, then you are controlling your pain
and improving your quality of life. True, people inadvertently get hooked on opioids in the
course of their treatment. However, as a pharmacist, you can educate your patients as to the
risks and benefits of using opioids.
Is the person who takes an opioid necessarily an addict? To some extent a continuum exists
between opioid abuse, opioid dependence, and addiction. Individuals who use narcotics to the
degree that they begin to interfere with the person's ability to do routine activities or fulfill
regular responsibilities at home, at school, or at work would be considered to be abusing
opioids [Zwanger, 2014]. Other signs that individuals are abusing opioids include maladaptive
behaviors that negatively impact relationships, worsen interpersonal problems, or involve
frequent legal problems related to opioid use. Side effects of oxycodone are illustrated in Figure
3.
Individuals who have opioid dependence often will manifest some of the following symptoms:

Ingestion of increasingly larger amounts of opioids or for longer periods of time than
intended
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
Desire or compulsion to take the drug with significant amount of time spent obtaining
opioids

Withdrawal symptoms if the drug is stopped or the amount taken is reduced

The need for increased amounts of drug to achieve the original effects (tolerance)

Social, recreational, occupational, or pleasurable activities are neglected

Persistent use of narcotics even when evidence that they are harmful to their body,
mood, thinking, or actions.
Addiction is elevated narcotic abuse that becomes a craving, with compulsive need to use
opioids and often displays self-destructive behavior.
Prescription pain killers are the new gateway drugs.
As one former addict stated, "I'd rather sell my prescriptions for better things, stronger things,
to get as high as I could." A concern exists among treatment providers, policymakers, and
others that nonmedical prescription pain reliever use can progress to heroin use [Muhuri, 2013].
Anecdotal reports and small-scale studies have suggested that some individuals who had been
abusing OxyContin® switched to heroin after the reformulation in late 2010 that made
OxyContin® more difficult to crush. Street price data from the Rocky Mountain Poison Control
Center Drug Diversion Monitoring program indicate that the demand for the new formulation
was much lower than that for the old formulation, which was more powerful, showed that the
street price of the new formulation was 20% to 30% lower than that of the original formulation,
indicating a lesser demand for the new formulation [Muhuri, 2013]. However, the reformulation may
have led potential abusers of OxyContin® to switch to heroin, which is cheaper than pills.
How is heroin linked to opioid abuse?
Damaging health consequences resulting from the abuse of prescription opioid medications
have radically increased in recent years. For example, unintentional poisoning deaths from
prescription opioids quadrupled from 1999 to 2010 and now outnumber those from heroin and
cocaine combined [Chen, 2013]. People often assume prescription analgesics are safer than illegal
drugs because they are medically prescribed; however, when these drugs are taken for reasons
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or in ways or amounts not intended by a doctor, or taken by someone other than the person
for whom they are prescribed, they can result in severe adverse health effects including
addiction, overdose, and death, especially when combined with other drugs or alcohol.
Research now suggests that abuse of these medications may actually be a gateway to heroin
use. Three recent studies have shown that almost 50% of young people who inject heroin
reported abusing prescription opioids before starting to use heroin [National Institute on Drug Abuse, 2014].
Some individuals reported switching to heroin because it is cheaper and easier to obtain than
prescription opioids.
How much is that oxy in the window?
The street value of narcotics depends on where you live, but in most cases, the street value far
exceeds the amount actually paid for the prescription. Street prices of diverted prescription
opioids can provide an indicator of drug availability, demand, and abuse potential, but these
data can be difficult to collect. Crowdsourcing is the process of obtaining needed services,
ideas, or content by soliciting contributions from a large group of people, and especially from
an online community, rather than from traditional employees or suppliers, or in this case,
people who abuse drugs. It is a rapid and cost-effective way to gather information about sales
transactions. The crowdsourcing research website, StreetRx.com, displays user-submitted
information on the latest street prices for prescription drugs. StreetRx relies on user-submitted
information and therefore data should be interpreted accordingly. All submissions are
anonymous. StreetRx is not affiliated with any government or law enforcement agency. See
Table 4.
According to one study, StreetRx revealed the mean prices per milligram were $3.29 for
hydromorphone, $2.13 for buprenorphine, $1.57 for oxymorphone, $0.97 for oxycodone, $0.96
for methadone, $0.81 for hydrocodone, $0.52 for morphine, and $0.05 for tramadol [Dasgupta,
2013].
Street prices generally followed clinical equianalgesic potency. Therefore, if your patient is
on medical assistance and has gotten 120 tablets of oxycodone 10mg for a $2 co-pay, that
prescription has a street value of $1,164 – a 58,500% mark-up and a $1,162 profit.
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Clinical scenarios
Dishonesty, violence and risk-taking are survival skills in active addiction. Certainly, most
patients who come into your pharmacy with regular prescriptions for opioids have a legitimate
medical reason for taking them. One could even argue that the person who you suspect is
addicted to opioids continues to receive the medication if that person plays by the rules, goes
to the same doctor, and does not ask for early fillings. Nevertheless, be cautious when
questioning the validity of a narcotic prescription. You can go into the back and phone the
prescriber. When informing the patient that the prescription cannot be filled, keep your
distance from the person. For example, do not go from the counter into the main part of the
pharmacy as active addicts can be desperate and therefore prone to violence. Call the police at
the first obscenity or threat. The following are scenarios in which the pharmacist is put on the
spot when a person comes in with a narcotic prescription.
Scenario 1 – No identification
A person comes into your pharmacy that you have never seen before. He presents you with a
prescription for oxycodone/acetaminophen and his insurance card. You take his birth date,
address, phone number and ask if he has any notable allergies. You ask for a picture ID and he
replies that his insurance card is his ID. You explain that there is no picture on the card and that
you would need a picture ID. He hands you his VISA card which he says confirms his identity.
What do you do next?
It depends in which state you are practicing pharmacy. According to the CDC, as of August 31,
2010, 22 states now have laws requiring an ID prior to dispensing [Figure 4] [CDC, 2012b]. Typically,
asking for ID is at the discretion of the pharmacist or in certain circumstances, e.g., the person
has similar prescriptions from multiple practitioners, the patient wants to pay in cash, the
prescription was written in another state, or the prescription was not covered at least in part by
a health plan. In some states, if a person bringing in the prescription does not have ID,
pharmacist may still dispense if the pharmacist can confirm ID and/or the validity of the
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prescription by other means, or the pharmacist determines that a detriment to the patient will
result if the prescription is not filled.
Scenario 2 – Interstate dispensing
You are working in a pharmacy in Maryland and a patient presents a prescription for
hydrocodone bitartrate/acetaminophen 5mg/500mg #30. It contains all the necessary elements
for a prescription, but you notice that the doctor’s address is Florida and the patient’s address
is Delaware. What should you consider when determining whether to dispense the
prescription?
Can you legally dispense a prescription from an out of state prescriber? Yes, a pharmacist may
dispense a controlled substance pursuant to a prescription of an out-of-state practitioner of
medicine, osteopathy, podiatry, dentistry or veterinary medicine authorized to issue such
prescription if the prescription complies with the requirements of that state. Next, is there a
valid practitioner-patient relationship? Maybe, but you may need to obtain more information
from the patient or the prescriber to determine this. Ask the patient “Was this prescription
given to you in the doctor’s office in Florida? If not, how did you obtain this prescription? Have
you ever been seen by this prescriber or one of his colleagues?”
The patient stated that the prescription was not received in the doctor’s office, but was mailed
to him, after completing an online questionnaire. Thus, the prescription lacks a bona fide
physician-patient relationship. Decline to fill the prescription. It is not acceptable for a patient
to complete an online questionnaire or to simply provide medical records to the prescriber. The
prescriber must have a record on file of the patient and must have performed an in-office
physical evaluation at some point.
Scenario 3 – The patient asks a favor
A patient presents a prescription for oxycodone/acetaminophen 5mg/325mg, 1 tab q6h prn
pain, #150. Her insurance will only cover 120 tablets. She states that she would like the
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remaining 30 tablets and that she will pay cash for them. Is this acceptable? Probably not. The
pharmacy’s official dispensing records must show only one transaction which accurately
indicates the total number of tablets dispensed pursuant to this prescription. The dispensing
record may not appear as two transactions since a Schedule II may not be refilled and this does
not comply with the provisions for allowable partial dispensing of Schedule II drugs.
Scenario 4 – The Canadian quandary
You receive a call from a pharmacist in Canada who is requesting a prescription transfer.
Additionally, you learn that the patient has been communicating with the Canadian pharmacist
and prompted him to call you for the transfer. Should you transfer the prescription to
accommodate the patient’s request?
No. It is illegal for a pharmacy located in Canada to ship prescription drugs into the United
States, therefore, this prescription cannot be legally filled or refilled in this instance.
The ABCs of starting over – Withdrawal and relapses
According to the National Institute on Drug Abuse, the severity of opioid withdrawal may be
placed into 1 of 4 categories [Trachtenberg, 2014]. Grade 0 opiate withdrawal is characterized by drug
craving, anxiety and intense drug-seeking behavior; grade 1 by yawning, sweating, lacrimation
and rhinorrhea; grade 2 by mydriasis, gooseflesh, muscle twitching and anorexia; and grade 3
by insomnia, increased pulse, respiratory rate and blood pressure, abdominal cramps, vomiting,
diarrhea and weakness.
If an opioid agonist is to be used, the preferred drug in the treatment of opiate withdrawal is
methadone [Somogyi, 2014]. Methadone is mainly used in the treatment of opioid dependence. It
has a cross-tolerance with other opioids including heroin and morphine, and offers very similar
effects but a longer duration of effect. Oral doses of methadone can stabilize patients by
mitigating opioid withdrawal syndrome or making it more tolerable. Higher doses of
methadone can block the euphoric effects of heroin, morphine, and similar drugs. As a result,
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properly dosed methadone patients can reduce or stop altogether their use of these
substances.
Some symptomatic relief may be obtained with clonidine as well [Trachtenberg, 2014]. Clonidine is a
centrally acting alpha-adrenergic agonist and usually used an antihypertensive medication. As
an agent for opiate withdrawal, clonidine suppresses restlessness, lacrimation, rhinorrhea and
sweating. Because of the ease with which clonidine tablets can be sold on the street by patients
to others seeking a self-treatment of opiate withdrawal, many physicians prefer to use
transdermal clonidine for this indication. Because clonidine does not treat some of the
symptoms associated with severe withdrawal, other non-controlled medications may be
indicated when attempting to manage opiate withdrawal without the benefit of methadone.
These include promethazine or hydroxyzine for nausea and vomiting, loperamide for diarrhea,
and methocarbamol for muscle cramps and joint pain.
Buprenorphine/naloxone (Bup/nx) is a partial μ-opioid agonist combined with the opioid
antagonist naloxone in a 4:1 ratio [Mauger, 2014]. Its abuse potential is lower, and carries less
stigma, allowing for more flexibility than methadone. Bup/nx is indicated for both inpatient and
ambulatory medically assisted withdrawal (acute detoxification) and long-term substitution
treatment (maintenance) of patients who have a mild-to-moderate physical dependence. A
stepwise long-term substitution treatment with regular monitoring and follow-up assessment is
usually preferred, as it has better outcomes in reducing illicit opioid use, minimizing
concomitant risks such as human immunodeficiency virus and hepatitis C transmission,
retaining patients in treatment and improving global functioning. A formulation of only
buprenorphine is also available. It is given during the first few days of treatment, while Bup/nx
is used during the maintenance phase of treatment.
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The potential for relapse in alcohol and drug addiction appears to persist indefinitely [Trachtenberg,
2014].
The addicted person and the physician must be aware of this enduring risk. The acute
craving may disappear after several weeks or months, but the relapse trigger may occur
spontaneously at any time. Triggers may be purely internal or may be environmental, as in
turning a corner and seeing a place or a person associated with addictive behavior in the past.
Taking great pains to address the problem
The intent of this information is not to discourage or prohibit the use of controlled substances
where medically indicated. Having stated that, people at every level of society can take steps to
help prevent overdoses involving prescription painkillers, while making sure patients have
access to safe, effective treatment. Currently, the Federal government is a) tracking overdose
trends to better understand the epidemic, b) working with stakeholder organizations to
educate health care providers and the public about prescription drug abuse and overdose, and
c) evaluating and promoting programs and policies shown to prevent prescription drug
overdose, while making sure patients have access to pain treatment [CDC, 2014]. What can other
groups do?
States can:

[CDC, 2014]
Start or improve prescription drug monitoring programs (PDMPs), which are electronic
databases that track all prescriptions for narcotics in the state.

Use PDMP, Medicaid, and workers' compensation data to identify improper prescribing of
controlled substances.

Set up programs for Medicaid, workers' compensation programs, and state-run health plans
that identify and address improper patient use of opiates.

Pass, enforce and evaluate pill mill, doctor shopping and other laws to reduce prescription
painkiller abuse.

Encourage professional licensing boards to take action against inappropriate prescribing.

Increase access to substance abuse treatment.
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Citizens can: [CDC, 2014]

Use prescription opioids only as directed by a health care provider.

Make sure the patient for whom the drug is prescribed is the only one to use that drug; not
selling or sharing them with others helps prevent misuse and abuse.

Store all prescriptions in a secure place and dispose of them properly.

Get help for substance abuse problems if needed (1-800-662-HELP).
Health insurers can: [CDC, 2014]

Set up prescription claims review programs to identify and address improper prescribing
and use of narcotics.

Increase coverage for other treatments to reduce pain, such as physical therapy, and for
substance abuse treatment.
Health care providers can: [CDC, 2014]

Follow guidelines for responsible narcotic prescribing

Screen and monitor for substance abuse and psychiatric problems.

Prescribe painkillers only when other treatments have not been effective for pain.

Write for only the quantity of pills needed, based on the expected length of pain.

Use patient-provider agreements combined with urine drug tests for people using
prescription controlled substances long term.

Talk with patients about safely using, storing and disposing of prescription opioids.

Use PDMPs to identify patients who are improperly using schedules 2 and 3 analgesics.
Pharmacists can!
As pharmacists, we have a personal responsibility to protect our practice from becoming an
easy target for drug diversion. We need to know of the potential situations where drug
diversion can occur, and establish safeguards to prevent drug diversion. In addition, the
dispensing pharmacist must maintain a constant vigilance against forged or altered
prescriptions. According to the Drug Enforcement Agency (DEA) which is under the aegis of the
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U. S. Department of Justice, the 1970 Controlled Substance Act (CSA) holds the pharmacist
responsible when he or she knowingly dispenses a prescription that was not issued in the usual
course of professional treatment [USDOJ, 2014]. Look at any of the state’s board of pharmacy
newsletters and you will see they are replete with reprimands, including fines and suspensions,
against pharmacists for not following such laws.
A controlled substance means just that
Everyone has been hit up for early refills and often we must be the objects of their wrath when
they do not get what they want. Dispensing procedures without control and professional
caution are an invitation to the drug abuser. As the pharmacist, you control the drug’s trip out
of the pharmacy.
Proper management of controlled substances can be accomplished by following common
sense, sound professional practice, and appropriate dispensing procedures. In addition,
pharmacy technicians also should have knowledge of these mechanisms, as it will help prevent
and protect the pharmacy from becoming a source of diversion [USDOJ, 2014].
Most drug abusers hunt for areas where communication and cooperation between health care
professionals are minimal [USDOJ, 2014]. This makes the work of drug abusers less complicated.
Therefore, a pharmacist should encourage other local pharmacists and physicians to develop a
working relationship which will promote teamwork and solidarity. Additionally, we should
become familiar with those controlled substances that are popular for abuse and resale on the
streets in our areas and should discuss those findings with other pharmacists and practitioners
in the community.
16
Table 1 – Top medicines by prescription count [IMS, 2014]
Dispensed prescriptions*
2009
2010
2011
2012
2013
Total US market
3,953
3,995
4,022
4,139
4,208
1. Hydrocodone/acetaminophen
12.94
13.21
13.67
13.64
12.92
2. Levothyroxine
10.02
10.30
10.47
11.22
11.52
3. Lisinopril
8.30
8.76
8.88
9.91
10.15
4. Metoprolol
7.69
7.66
7.63
8.26
8.39
5. Simvastatin
8.41
9.44
9.68
8.93
7.91
6. Amlodipine
5.21
5.78
6.25
6.91
7.40
7. Metformin
5.38
5.79
5.91
6.78
7.28
8. Omeprazole
4.56
5.35
5.94
6.66
7.07
9. Atorvastatin
5.17
4.53
4.33
5.55
6.84
10. Albuterol
5.45
5.51
5.69
6.12
6.35
(in millions)
*Prescription counts are not adjusted for length of therapy. 90-day and 30-day prescriptions
are both counted as one prescription.
17
Table 2 – Drug overdose death rates by selected characteristics - National Vital Statistics
System, United States, 2008 [Paulozzi, 2011].
Characteristic
Age-adjusted rate*
All
drugs†
Prescription
drugs§
Opioid pain
relievers¶
Illicit
drugs**
11.9
6.5
4.8
2.8
Men
14.8
7.7
5.9
4.3
Women
9.0
5.3
3.7
1.4
White
13.2
7.4
5.6
2.8
Hispanic††
6.1
3.0
2.1
2.5
Non-Hispanic
14.7
8.4
6.3
2.9
Black
8.3
3.0
1.9
4.0
Asian/Native Hawaiian or
Pacific Islander
1.8
1.0
0.5
0.6
American Indian/Alaska
Native
13.0
8.4
6.2
2.7
0-14
0.2
0.2
0.1
---§§
15-24
8.2
4.5
3.7
2.2
25-34
16.5
8.8
7.1
4.4
35-44
20.9
11.0
8.3
5.3
45-54
25.3
13.8
10.4
6.0
55-64
13.0
7.3
5.0
2.5
≥65
4.1
3.0
1.0
0.3
Unintentional
9.2
4.8
3.9
2.6
Undetermined
1.1
0.6
0.5
0.2
Suicide
1.6
1.1
0.5
0.1
Overall
Sex
Race/Ethnicity
Age group (yrs)
Intent
18
* Rate per 100,000 population age-adjusted to the 2000 U.S. standard population
using the vintage 2008 population. Because deaths might involve both prescription
and illicit drugs, some deaths are included in both categories.
† Deaths with underlying causes of unintentional drug poisoning, suicide drug
poisoning, homicide drug poisoning, or drug poisoning of undetermined intent
§ Drug overdose deaths that have prescription drugs as contributing causes.
¶ Drug overdose deaths that had other opioids, methadone, and other synthetic
narcotics as contributing causes.
** Drug overdose deaths that have heroin, cocaine, hallucinogens, or stimulants as
contributing causes.
†† Non-white Hispanics are included in the other racial groups.
§§ Rate is not presented when the estimate is unstable because the number of deaths
is less than 20.
Table 3 – Incidence of pain, as compared with other major conditions [AAPM, 2014]
Condition
Chronic pain
Number of those affected
100 million
Source
Institute of Medicine of The
National Academies [Institute,
2011]
Diabetes
Coronary heart disease
29 million (diagnosed and
American Diabetes
estimated undiagnosed)
Association [ADA, 2014]
16 million
American Heart Association
[Go, 2014]
(myocardial infarction,
angina)
Stroke
7 million
American Heart Association
[Go, 2014]
Cancer
American Cancer Society [ACS,
14 million
2014]
19
Table 4 – Street prices per unit of selected narcotics according to drug, strength and location,
according to StreetRx.com August 5, 2014.
Drug
Hydrocodone/acetaminophen
Location
Street price
Texas
$5
California
$3
Virginia
$50
Oxycodone 30 mg
Florida
$30
Oxycodone extended-release (new
Illinois
$12
South Carolina
$10
Wisconsin
$80
Ohio
$10
Pennsylvania
$10
Oxycodone/acetaminophen 5/325
New York
$5
Oxycodone/acetaminophen 5/325
Ohio
$5
Oxycodone/acetaminophen 5/325
California
$3
Oxycodone/acetaminophen 5/325
Washington
$15
Oxycodone/acetaminophen 5/325
Oregon
$4
Oxycodone/acetaminophen
Virginia
$35
10/325
Hydrocodone/acetaminophen
5/325
Hydrocodone/acetaminophen
5/325
formulation) 20 mg
Oxycodone extended-release (new
formulation) 20 mg
Oxycodone extended-release (new
formulation) 80 mg
Oxycodone/acetaminophen
10/325
Oxycodone/acetaminophen
10/650
7.5/325
20
Oxycodone/acetaminophen
Illinois
$5
7.5/500
Figure 1 – Drug overdose death rate in 2008 and rate of kilograms (kg) of opioid pain relievers
(OPR) sold in 2010 - United States [CDC, 2012a]
* Age-adjusted rates per 100,000 population for OPR deaths, crude rates per 10,000 population
for OPR abuse treatment admissions, and crude rates per 10,000 population for kilograms of
OPR sold.
21
Figure 2 – Rates* of opioid pain reliever (OPR) overdose death, OPR treatment admissions, and
kilograms of OPR sold - United States, 1999-2010* [CDC, 2012a]
*Age-adjusted rates per 100,000 population for OPR deaths, crude rates per 10,000 population
for OPR abuse treatment admissions, and crude rates per 10,000 population for kilograms of
OPR sold.
22
Figure 3 – Side effects of oxycodone
Figure 4 – States* with laws requiring patient identification before dispensing [CDC, 2012b]
*States in blue have ID laws in place
23
References
American Academy of Pain Management. AAPM Facts and Figures on Pain. Available at:
http://www.painmed.org/PatientCenter/Facts_on_Pain.aspx#overview Accessed August 11,
2014.
American Cancer Society. Cancer Prevalence: How Many People Have Cancer? Available at:
http://www.cancer.org/cancer/cancerbasics/cancer-prevalence Accessed August 11, 2014.
American Diabetes Association. Statisitics about diabetes; 2014. Available at
http://www.diabetes.org/diabetes-basics/diabetes-statistics/ Accessed August 11, 2014.
American Heart Association. Heart Disease and Stroke Statistics—2011 Update: A Report from
the American Heart Association. Circulation. 2011, 123:e18-e209, p. 20.
http://circ.ahajournals.org/content/123/4/e18.full.pdf Accessed August 11, 2014.
Callaly T, Trauer T, Munro L, et al. Prevalence of psychiatric disorder in a methadone
maintenance population. Aust N Z J Psychiatry. 2001;35:601-605.
Centers for Disease Control and Prevention (CDC). Home & Recreational Safety. Law: Requiring
patient identification before dispensing; 2012. Available at:
http://www.cdc.gov/homeandrecreationalsafety/Poisoning/laws/id_req.html Accessed
August 11, 2014. [CDC, 2012b]
Centers for Disease Control and Prevention (CDC). Prescription Painkiller Overdoses in the U.S;
2014.
Available at www.cdc.gov/Features/VitalSigns/PainkillerOverdoses/ Accessed August 11,
2014.
Centers of Disease Control and Prevention (CDC). Prescription painkiller overdoses in the U.S;
2012. Available at: http://www.cdc.gov/Features/VitalSigns/PainkillerOverdoses/ Accessed
August 11, 2014. [CDC, 2012a]
Chapman CR, Lipschitz DL, Angst MS, et al. Opioid pharmacotherapy for chronic non-cancer
pain in the United States: a research guideline for developing an evidence-base. J Pain.
2010;11:807-829.
Chen, LH, Hedegaard H, Warner M. QuickStats: Number of deaths from poisoning, drug
poisoning, and drug poisoning involving opioid analgesics - United States, 1999–2010.
MMWR. 2013;62:234.
Dasgupta N, Freifeld C, Brownstein JS, et al. Crowdsourcing black market prices for prescription
opioids. J Med Internet Res. 2013;15:e178.
24
Dick DM, Agrawal A. The genetics of alcohol and other drug dependence. Alcohol Res
Health. 2008;31:111-8.
Gelernter J, Panhuysen C, Wilcox M, et al. Genomewide linkage scan for opioid dependence and
related traits. Am J Hum Genet. 2006;78:759-769.
Go AS, Mozaffarian D, Roger VL, et al; American Heart Association Statistics Committee
and Stroke Statistics Subcommittee. Heart disease and stroke statistics – 2014 update: a report
from the American Heart Association. Circulation. 2014;129:e28-e292.
IMS Institute for Healthcare Informatics. Medicine use and shifting costs of healthcare: a review
of the use of medications in the United States in 2013; Parsippany, NJ: IMS Institute for
Healthcare Informatics; 2014.
Institute of Medicine of the National Academies: Relieving Pain in America: A Blueprint for
Transforming Prevention, Care, Education and Research. Washington DC: The National
Academies Press; 2011.
Kendler KS, Jacobson KC, Prescott CA, et al. Specificity of genetic and environmental risk factors
for use and abuse/dependence of cannabis, cocaine, hallucinogens, sedatives, stimulants, and
opiates in male twins. Am J Psychiatry. 2003;160:687-695.
Koob GF, Le Moal M. Drug addiction, dysregulation of reward, and allostasis.
Neuropsychopharmacology. 2001;24:97-129.
Kosten TR, George TP. The neurobiology of opioid dependence: implications for treatment. Sci
Pract Perspect. 2002;1:13-20.
Krausz M, Degkwitz P, Kuhne A, et al. Comorbidity of opiate dependence and mental disorders.
Addict Behav. 1998;23:767-783.
Loeser JD, Treede RD. The Kyoto protocol of IASP Basic Pain Terminology. Pain. 2008; 137: 473–
7.
Manchikanti L, Helm S 2nd, Fellows B, et al. Opioid epidemic in the United States. Pain
Physician.
2012;15(Suppl 3):ES9-38.
Mauger S, Fraser R, Gill K. Utilizing buprenorphine-naloxone to treat illicit and prescriptionopioid dependence. Neuropsychiatr Dis Treat. 2014;10:587-98.
25
Mendelson J, Flower K, Pletcher MJ, et al. Addiction to prescription opioids: characteristics of
the emerging epidemic and treatment with buprenorphine. Exp Clin Psychopharmacol.
2008;16:435-441.
Milby JB, Sims MK, Khuder S, et al. Psychiatric comorbidity: prevalence in methadone
maintenance treatment. Am J Drug Alcohol Abuse. 1996;22:95-107.
Muhuri PK, Gfroerer JC, Davies MC. Associations of Nonmedical Pain Reliever Use and Initiation
of Heroin Use in the United States. Rockville, Maryland: Substance Abuse and Mental Health
Services Administration; 2013.
National Institute on Drug Abuse. Heroin. How is heroin linked to prescription drug abuse?;
2014. Available at: http://www.drugabuse.gov/publications/research-reports/heroin/whatheroin Accessed August 11, 2014.
Neaigus A, Miller M, Friedman SR, et al. Potential risk factors for the transition to injecting
among non-injecting heroin users: a comparison of former injectors and never injectors.
Addiction. 2001;96:847-860.
Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer
pain. Cochrane Database Syst Rev. 2010;(1):CD006605.
Paulozzi LJ, Jones GM, Mack KA, Rudd RA. Vital signs: overdoses of prescription opioid pain
relievers – United States, 1999-2008. MMWR. 2011;60;1487-92.
Somogyi AA, Barratt DT, Ali RL, Coller JK. Pharmacogenomics of methadone maintenance
treatment.
Pharmacogenomics. 2014;15:1007-27.
Spanagel R, Herz A, Shippenberg TS. Opposing tonically active endogenous opioid systems
modulate the mesolimbic dopaminergic pathway. Proc Natl Acad Sci U S A. 1992;89:2046-50.
Trachtenberg AI, Fleming MF. Diagnosis and treatment of drug abuse in family practice.
Bethesda, Maryland: National Institute on Drug Abuse; 2014. Available at:
http://archives.drugabuse.gov/diagnosis-treatment/diagnosis.html Accessed August 11 2014.
U. S. Department of Justice (USDOJ). Drug Enforcement Agenecy. Office of Diversion Control.
Appendix D. Pharmacist’s Guide to Prescription Fraud; 2014. Available at:
www.deadiversion.usdoj.gov/pubs/manuals/pharm2/appendix/appdx_d.htm Accessed August
11, 2014.
Zwanger M. Narcotic abuse. eMedicinehealth.com Available at:
http://www.emedicinehealth.com/narcotic_abuse/article_em.htm Accessed August 11, 2014.
26
ACTIVITY TEST
1. According to the IMS, which opioid was the most prescribed medication for the last 5 years?
A. Hydrocodone/APAP
B. OxyContin
C. Oxycodone immediate release
D. Fentanyl transdermal
2. According to the CDC, which statement is true?
A. Prescription painkiller overdoses in the United States have tripled since 1999.
B. Nonmedical use of prescription painkillers costs health insurers up to $72.5 million annually in
direct health care costs.
C. In 2010, one in 20 people in the United States, ages 12 and older, used prescription painkillers nonmedically.
D. Nearly 50,000 ER visits in 2009 were due to people misusing or abusing prescription painkillers.
3. Which statement about the demographics of prescription drug abuse is false?
A. More men than women die of overdoses from prescription painkillers.
B. People in urban areas are about two times more likely to overdose on opioids as people in rural
areas.
C. Whites and American Indian or Alaska Natives are more likely to overdose on opioids as compared
with other demographic groups.
D. About 1 in 10 American Indian or Alaska Natives age 12 or older used opioids for nonmedical
reasons in the past year.
4. Opioid-induced activation of which 2 receptors increases the activity of the dopaminergic
mesolimbic system?
A. Mu and sigma
B. Mu and kappa
C. Mu and delta
D. Mu and epsilon
5. Elevated narcotic abuse that becomes a craving, with compulsive need to use opioids and
often displays self-destructive behavior is called:
A. Drug abuse
B. Dependence
C. Addiction
D. All of the above
27
6. Why are more drug abusers turning away from the once popular narcotic OxyContin® to
other pills?
A. The street price significantly increased.
B. OxyContin was too powerful to use recreationally.
C. Pharmacies stopped stocking it because of burglaries.
D. OxyContin’s reformulation made it more difficult to crush and snort.
7. A person comes into your pharmacy with a narcotic prescription. He is not in your system.
You ask for ID which he refuses. You tell him it is the law. Where would your pharmacy be
located for you to make that statement?
A. California
B. Pennsylvania
C. Illinois
D. Florida
8. In what case would you likely not fill a narcotics prescription?
A. A prescription from another state
B. A prescription from a podiatrist or osteopath from another state
C. A prescription presented by a new patient
D. A prescription in which there was no bona fide doctor-patient relationship
9. A patient has a prescription for oxycodone 10 mg, 1 tab q 4-6h as needed for pain, 150
tablets, but his insurance will only pay for 120 tablets with no option for a prior approval. He
wants to pay cash for the remaining tablets. How would you handle this?
A. Refuse to fill the prescription at all
B. Bill 120 tablets to insurance and sell the other 30 tablets as a cash prescription
C. Refuse to fill any more than 120 tablets
D. Give him the option of filling only the 120 tablets filed to his insurance or paying cash for all 150
tablets
10. According to the National Institute on Drug Abuse, the severity of opioid withdrawal may be
placed into 1 of 4 categories. A person with the following symptoms would be placed into
Grade 2?
A. Drug craving and anxiety
B. Yawning and sweating
C. Muscle twitching and anorexia
D. Abdominal cramps and vomiting
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11. Aside from methadone, which drug offers some symptomatic relief of narcotic withdrawal
symptoms?
A. Clonidine
B. Clonazepam
C. Citalopram
D. Captopril
12. What statement is true about the use of buprenorphine with or with naloxone?
A. They can increase the risk of HIV and hepatitis C transmission because they inhibit the immune
system
B. Unlike methadone, their use does not need to be monitored
C. Buprenorphine without naloxone is given during the first few days of treatment, while
buprenorphine/naloxone is used during the maintenance phase of treatment.
D. None of the above
13. In combating overdoses caused by narcotic abuse, individual states can do all but one of the
following:
A. Set up prescription claims review programs to identify and address improper prescribing and use
of narcotics.
B. Pass, enforce and evaluate pill mill, doctor shopping and other laws to reduce prescription
painkiller abuse.
C. Increase access to substance abuse treatment.
D. Start or improve prescription drug monitoring programs
14. In combating overdoses caused by narcotic abuse, prescribers can:
A. Prescribe painkillers at the onset of severe non-cancer pain to relieve pain more quickly
B. Encourage professional licensing boards to take action against inappropriate prescribing.
C. Write for only the quantity of pills needed, based on the expected length of pain.
D. Set up programs for Medicaid, workers' compensation programs, and state-run health plans that
identify and address improper patient use of opiates.
15. In combating overdoses caused by narcotic abuse, pharmacists:
A. Must maintain a constant vigilance against forged or altered prescriptions
B. Must not fill prescriptions that appear forged or altered
C. Have a personal responsibility to protect their practice from becoming an easy target for drug
diversion.
D. All of the above
29
16. Chronic use of opioids leads to increased enzymatic activity at the mu receptors, thereby
resulting in normal or higher levels of:
A. Dopamine
B. Norepinephrine
C. Serotonin
D. GABA
17. Which age group has the highest rate of death from opioid overdoses?
A. 15-24
B. 25-34
C. 35-44
D. 45-54
18. The incidence of chronic pain is greater than the incidence of:
A. Cancer
B. Coronary heart disease
C. Stroke
D. All of the above combined
19. In which of the following states is the drug overdose death rate and rate of kilograms of
opioid pain relievers sold the highest?
A. Nevada
B. New York
C. North Carolina
D. North Dakota
20. All but which of the following are symptoms of opioid withdrawal?
A. Increased appetite
B. Itching
C. Slow heartbeat
D. Fast heartbeat
Please submit your final responses on freeCE.com. Thank you.
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