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First Script Prescription Benefit News
for Workers’ Compensation
April 2017
Drug of the
Month
Suboxone®
Suboxone® is a Schedule III Controlled Substance containing the long-acting partial opioid agonist
buprenorphine in combination with the opioid antagonist naloxone. Suboxone® is FDA-approved
for maintenance treatment of opioid dependence as part of a complete treatment plan that incorporates counseling and psychosocial support. It is important to remember that buprenorphine is an opioid, therefore, it does
carry the risk of addiction and chronic use can lead to physical dependence. However, when used properly as part of an overall
treatment program, addiction risk is minimized. Buprenorphine may be dispensed from an opioid-dependence treatment
facility or prescribed for at-home use by doctors who have obtained a special waiver under the Drug Addiction Treatment Act
(DATA 2000). A “Buprenorphine Treatment Physician Locator” can be found online at www.samsha.gov.
In general, agonists bind to and activate various receptors in the body to produce a response (e.g., analgesia). Antagonists
bind to receptors and block and/or reverse a response. In the case of naloxone, administration of this agent alone can produce
opioid withdrawal signs and symptoms in individuals who are physically dependent on opioid agonists. Buprenorphine is
a partial agonist, meaning it does not exhibit as maximal a response as that of a full agonist such as morphine. This partial
agonist effect makes buprenorphine clinically desirable to many prescribers who are looking for a drug with lower abuse
potential, a lower level of physical dependence (potentially less discomfort from withdrawal), a “ceiling effect” at higher doses
(meaning that at a certain point, taking higher doses of the drug does not create any additional analgesia or euphoria), and
comparatively greater safety in overdose situations vs. full opioid agonists.
Suboxone® was originally approved in October of 2002 as a
sublingual (under the tongue) tablet that has since been discontinued, and the sublingual film formulation available today was
approved August 30, 2010. The formulation is such that naloxone
(the opioid antagonist component) is only active and will block
and reverse the effects of the opioid if the oral formulation is
tampered with for administration through a different route such
as injection, for example, as might be attempted for abuse of the
opioid ingredient. Suboxone® is intended to be taken sublingually
as a single daily dose, and is available in the following strengths:
buprenorphine 2 mg with naloxone 0.5 mg and buprenorphine
8 mg with naloxone 2 mg. The most commonly reported side
effects associated with the use of Suboxone® include numbness
or a reduced sense of touch or sensation, a burning or painful
sensation in the tongue, redness and swelling of the inside of
the mouth, headache, nausea, vomiting, sweating, constipation,
withdrawal signs and symptoms, insomnia, pain, and swelling of
the lower limbs (i.e., legs).
Suboxone® sublingual film is not intended for use as an analgesic. Similar available products containing buprenorphine with
naloxone for maintenance treatment of opioid dependence
are Bunavail® (buccal film) and Zubsolv® (sublingual tablet).
State Fee Schedule Changes Q1, 2017
Nevada had a change in fee schedule with an
implementation date of 2/1/17:
• Brand: AWP + $10.94 (was AWP + $10.54)
• Generic: AWP + $10.94 (was AWP + $10.54)
Oregon and Alaska both had fee schedule changes with an
implementation date of 4/1/17. Pricing did not change.
Oregon has now added information to their rules
regarding over-the-counter (OTC) medications and
compounds with an implementation date of 4/1/17:
• AWP - 16.5% for each individual ingredient plus a
single compounding fee of $10.00 (the compounding
fee includes the dispensing fee)
• For dispensed OTC medications, the insurer must pay
the retail-based fee
New Jersey rule change with an implementation date of
5/15/17:
• Initial opioid prescriptions cannot exceed a 5-day
supply and must be for lowest effective dose of
immediate-release opioid drug
Reference: www.accessdata.fda.gov/scripts/cder/daf/
First Script Prescription Benefit News for Workers’ Compensation
April 2017 | 1
Ask The
Pharmacist
What is the difference between drug dependence
and addiction?
In order to better understand the concepts of opioid addiction and physical dependence, it can
be helpful to review basic opioid pharmacodynamics, or how opioids exert their effects in the
body. Opioids bind to and activate various opioid receptors in the body to produce a response,
and these receptors are present on the surface of cells found in several places in the body. The analgesic, euphoric, and addictive
effects associated with opioids are exerted primarily through receptors found in the brain and spinal cord (Central Nervous System
[CNS]), and the receptor most studied and relevant to opioid abuse and treatment is the mu receptor. “Full opioid agonists” are those
that bind to and activate receptors to produce increasing effects until that receptor is fully activated or a maximum effect is achieved.
Full mu opioid agonists are also the types of opioids that have the greatest abuse potential, and these include the street drug heroin
as well as morphine, hydrocodone, oxycodone, hydromorphone, oxymorphone, fentanyl, codeine, and methadone. In this context,
physical dependence on a substance is not the same as drug dependence or addiction, although it may be a component of each.
To suggest a topic, send an email to:
[email protected]
Physical Dependence
Definitions vary depending on the referenced source, but in general, physical dependence related to opioids describes the state where
the body is used to seeing that opioid introduced and has adapted accordingly. In other words, the opioid receptors have adapted to
being activated repeatedly by the opioid agonist. This can occur after an opioid is used on a daily basis and can manifest in as little as
one week; however, physical dependence is more likely to result in individuals who have taken opioids on a continuous basis for two
weeks or more. Tolerance may also develop after repeated administration of an opioid where ever-increasing doses of the same agonist
are required over time to achieve the same desired effect or level of pain relief. The hallmark of physical dependence is that signs and
symptoms of withdrawal will result in response to a reduction of dose, discontinuation of opioid therapy, or the loss of opioid agonist
activity at receptors. Essentially, when the body has adapted to regular exposure to a substance (such as an opioid drug) and the drug is
taken away, the body goes through a period of adjusting to the loss of that substance. Withdrawal may also be precipitated in a person
physically dependent upon opioids through administration of an opioid antagonist like naloxone. Antagonists bind to opioid receptors
and produce no effect while also preventing any agonists from binding to and activating the receptor. Signs and symptoms of opioid
withdrawal syndrome include diarrhea, fever, yawning, insomnia, muscle cramps and aches, watery eyes, runny nose, dilated pupils,
sweating, and goose bumps.
Addiction
Addiction is also defined many ways. The American Society of Addiction Medicine (ASAM) defines addiction as a primary, chronic,
neurobiologic disease of brain motivation, reward, and memory with genetic, psychosocial, and environmental factors influencing its
development and manifestations. The American Psychiatric Association (APA) does not classify addiction within their Diagnostic and
Statistical Manual of Mental Disorders (DSM-5). Instead, the DSM was updated in 2013 and replaced two separate disorders (substance
abuse and substance dependence) with one category of “substance use disorder.” This is the diagnosis that would likely be seen on a
patient’s chart today if he or she were struggling with addiction but may also cover those who demonstrate risky use of a substance
or physical drug-related manifestations such as tolerance or withdrawal. This is where it can get tricky in that “dependence” on a drug
may be different from “physical dependence” as described above. Generally, the terms “drug dependence” and “addiction” fall under
substance use disorders and may include a component of physical dependence as part of their characteristics but also meet additional criteria.
The National Institute on Drug Abuse (NIDA) uses a definition that aligns closely with the DSM definition of substance use disorder.
NIDA considers addiction to be related to impaired control over drug use or the impulse to use a drug despite negative consequences.
NIDA also recognizes a change in brain function along with behavioral changes similar to ASAM’s assertion that addiction is a chronic
neurobiologic disease. Many rely on the less scientific rule of thumb known as the “5 C’s of addiction” to help determine when a
condition has crossed the line into addiction: chronicity, impaired control over drug use, compulsive use, continued use despite harm,
and craving. The disease of addiction is also often characterized by cycles of relapse and remission.
Regardless of the definition used, both dependence and addiction can represent very complex treatment challenges, and a multimodal
approach is often required. In order to achieve positive outcomes, the physical component of opioid dependence must be addressed
along with behavior modifications and any psychological components of substance use disorder. Over the years, the stigma of addiction
and drug dependence has shifted from that of an individual struggling to make good life choices to that of an individual suffering
from a disease that should be treated as we would any other medical condition: with appropriate resources and support. Today, the
“biopsychosocial model” is often applied where the approach often includes consideration beyond physical treatment, and instead
focuses on biological, psychological, and social factors that may impact health and recovery. Whatever the approach, patients suffering
from addiction or dependence should be addressed and guided toward appropriate care. The Official Disability Guidelines (ODG) have
several recommendations related to handling opioid misuse, abuse, and addiction and there are several additional national resources
available on this subject as well. For more information, please contact your account manager. You may also send your questions to our
team of clinical pharmacists at [email protected].
The information which is provided herein is offered as a courtesy to our clients. All material is intended for information, communication and educational purposes only and is
in no manner an endorsement, recommendation or approval of any information. Coventry Workers’ Comp Services accepts no liability for the content of this distribution, or
for the consequences of any actions taken on the basis of the information provided.
First Script Prescription Benefit News for Workers’ Compensation
April 2017 | 2