Download Controlled Substance Strategies at CVS Health

February 2016
Clinical Knowledge Management News for Clients
Controlled Substance
Strategies at CVS Health
This Issue in Brief
Controlled
Substances ...............1
Opioid Medication Uses
and Risks ..................2
Cost of Opioid
Abuse........................2
Overprescribing of
Controlled
Substances ...............2
Risk Factors for Adverse
Outcomes in Opioid
Abuse........................3
Guidelines for Opioid
Management .............3
CVS Health Controlled
Substance Management
Programs .............. 4-6
Questions and Answers
for Clients..................7
Introduction
Many controlled substances have a useful and legitimate medical purpose, such as for
treatment of pain.1,2 However, controlled substances have a potential for abuse and have
been associated with overdose deaths, emergency room visits and other adverse health
consequences.2,3 Overprescribing is a contributing factor—for instance, overprescribing
of opioids is associated with higher rates of drug overdose deaths and substance abuse
treatment admissions.4 Addressing prescribing practices is one strategy that has been
recommended to help reduce these problems.5
We recognize that patients need to receive the appropriate controlled substances to treat
their conditions, and the benefits and risks associated with these treatments must be carefully
considered. To this goal, we offer programs to help ensure safe and clinically appropriate
controlled substance medication therapy for plan members and retail customers, and to help
produce cost savings for clients through more clinically appropriate medication regimens.
This client briefing will discuss information about controlled substances, with a focus on
opioid pain medications; issues with overprescribing; and our controlled substance strategies.
Controlled Substances
The term “controlled substance” refers to a drug or other substance, or immediate
precursor (certain chemicals used to make drugs), that has been assigned to one of five
categories, called “schedules,” which are established by the Controlled Substances
Act.2,6 Each drug’s assignment is based on its potential risk of abuse and acceptable
medical use.2,6 Abuse of prescription drugs, also called “nonmedical use,” is defined by
the National Institute on Drug Abuse as “the use of a medication without a prescription, in
a way other than as prescribed, or for the experience or feelings elicited.”7 Schedule I
substances have the highest potential for abuse and are considered the most
dangerous.6 As the drug schedule changes from Schedule II, Schedule III, etc., so does
the abuse potential—Schedule V drugs represent the least potential for abuse.6 Some
types of controlled substances are opioid analgesics, benzodiazepines and stimulants.8
The Drug Enforcement Administration (DEA) ranks controlled prescription drugs as one
of the most significant drug threats to the United States because the number of deaths
attributable to controlled prescription drugs has outpaced those for cocaine and heroin
combined, and opioid use can lead to heroin use for some.9 The amount of opioids for
abuse available on the prescribed market is significant, and more than 80 percent are
oxycodone and hydrocodone products.9
The comments contained herein are the opinion of CVS Caremark Medical Affairs. This document contains proprietary information of CVS Health and
cannot be reproduced, distributed or printed without written permission from CVS Health. Saving projections based on CVS Caremark data. Individual
results will vary based on plan design, formulary status, demographic characteristics and other factors. Client-specific modeling available upon request.
CVS Caremark does not operate the websites/organizations listed here, nor is it responsible for the availability or reliability of their content. These
listings do not imply or constitute an endorsement, sponsorship or recommendation by CVS Caremark.
©2016 CVS Health. All rights reserved. 106-36743A 022216
February 2016
Clinical Knowledge Management News for Clients
Opioid Medication Uses and Risksa
Prescription opioid medications are used to treat severe acute pain, such as from surgery or injury, and chronic pain from
active cancer or at the end of life.1,10 Guidelines from the American Pain Society (APS) and American Academy of Pain
Medicine (AAPM) state that chronic opioid therapy can also be an effective therapy for carefully selected and monitored
patients with chronic noncancer pain.1 Some medications in this class include hydrocodone, oxycodone, morphine,
methadone, buprenorphine and codeine.11-13
However, opioid medications are associated with dependence, tolerance, abuse and risk of accidental overdose.14 One
study found that death rates for drug overdoses involving opioids were 7.8 per 100,000 adults aged 18 through 64 years
in 2013, an increase from 4.5 per 100,000 in 2003.15 The same study, which looked at nonmedical prescription opioid use
and use disorders, also found increases in the prevalence of opioid use disorders and frequency of use during the same
period, although the prevalence of nonmedical use of prescription opioids decreased.15 Opioids can also have side
effects, such as sleepiness and constipation.16 They can worsen pain, impair driving, and affect the immune system, and
they are associated with a number of drug interactions.16
Cost of Opioid Abuse
The cost of opioid abuse is estimated to be about $53 billion to $56 billion annually, accounting for medical and substance
abuse treatment costs, lost work productivity and criminal justice costs.17,18 According to a study that examined the costs
of opioid abuse from the employer perspective, those who abused opioids had higher average annual per-patient health
care costs than their matched comparison patients—$20,343 versus $9,716, respectively, yielding excess costs of
$10,627 (health care costs were inflated to 2012 U.S. dollars).19 The study also found that people who abused opioids had
$1,244 in excess annual per-patient indirect work-loss costs over matched comparison patients (average costs $3,773
versus $2,528, respectively).19 Based on these costs, the authors estimated that the employer burden for diagnosed
abuse was $1.71 per member per month (PMPM).19
Overprescribing of Controlled Substances
Overprescribing of controlled substances, such as opioids, is an area of concern. Health care providers wrote 258.9 million
prescriptions for painkillers in 2012, enough for every American adult to have a bottle of these pills.4,20 While those in the
United States constitute only 4.6 percent of the world’s population, they consume 80 percent of the global opioid supply and
99 percent of the global hydrocodone supply.21 According to the Centers for Disease Control and Prevention (CDC),
overprescribing of opioids is associated with higher rates of drug overdose deaths and substance abuse treatment
admissions.4
In 2014, 6.5 million people aged 12 years or older reported nonmedical use of psychotherapeutic drugs—about two-thirds
of those people were taking pain relievers nonmedically.22 National Survey on Drug Use and Health data indicate that 53
percent of nonmedical users of controlled prescription drugs (pain relievers, tranquilizers, stimulants and sedatives) aged
12 or older obtained the prescription drugs they most recently used “from a friend or relative for free,” and 21.2 percent
reported obtaining them from “one doctor,” according to a recent report from the DEA.9 More than four in five of those who
obtained prescription drugs from a friend or relative for free reported that their friend or relative had obtained the drugs
from a single doctor.9
Strategies to address overprescribing are essential. For instance, the U.S. Department of Health and Human Services
recommended looking at opioid prescribing practices to reduce opioid use disorders and overdose as one of the three
priority areas they identified in an initiative to combat opioid abuse.5
a
®
All opioids are not indicated or approved for use in all clinical situations. For example, transmucosal immediate-release fentanyl products (e.g., Actiq )
are FDA-approved and indicated in nationally recognized compendia only for the management of breakthrough pain in cancer patients who are already
receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. References: Actiq [package insert], Frazer,
®
PA, Cephalon, Inc., December 2011; Micromedex Solutions, http://www.micromedexsolutions.com, Accessed February 10, 2016.
The comments contained herein are the opinion of CVS Caremark Medical Affairs. This document contains proprietary information of CVS Health and
cannot be reproduced, distributed or printed without written permission from CVS Health. Saving projections based on CVS Caremark data. Individual
results will vary based on plan design, formulary status, demographic characteristics and other factors. Client-specific modeling available upon request.
CVS Caremark does not operate the websites/organizations listed here, nor is it responsible for the availability or reliability of their content. These
listings do not imply or constitute an endorsement, sponsorship or recommendation by CVS Caremark.
©2016 CVS Health. All rights reserved. 106-36743A 022216
February 2016
Clinical Knowledge Management News for Clients
Risk Factors for Adverse Outcomes in Opioid Abuse
A number of risk factors have been associated with adverse outcomes in opioid use, such as overdose and progression to
substance abuse.23-25 We can pursue improved clinical outcomes through positively impacting the following measures of
controlled substance use:
• Morphine equivalent dose (MED) greater than 120 mg/day, although risk also exists at lower doses.24,25
Determining MED is the process of converting from one opioid agent to an equivalent dose of another agent or
changing the route of opioid administration using morphine as the reference standard.26 It is used for determining
the dose when a patient is on one or more opioids25
• Use of opioids for greater than 90 days24
• Multiple prescribers and pharmacies23
• Combinations of central nervous system depressants (such as benzodiazepines and other sedatives—hypnotics,
antidepressants and sleep aids—along with an opioid)23
Guidelines for Opioid Management
Improving the way opioids are prescribed through clinical practice guidelines can help to ensure patients have access to
safer, more effective chronic pain treatment while reducing the number of people who misuse, abuse or overdose from
these drugs.20 CVS Health continuously reviews guidelines to help ensure CVS Health controlled substance programs
are consistent with current treatment recommendations.
Eight guidelines were reviewed by the CDC National Center for Injury Prevention and Control, the National Institute on
Drug Abuse (NIDA), the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office of the
National Coordinator for Health Information Technology (ONC) to identify common recommendations.27 These
guidelines were issued on or before January 2013 and were developed by professional societies, states or federal
agencies for general practitioners.27 Common recommendations found in all the guidelines included27:
• Conducting a physical exam, pain history, past medical history and family/social history
• Conducting urine drug testing, when appropriate
• Considering all treatment options, weighing benefits and risks of opioid therapy, and using opioids when alternative
treatments are ineffective
• Starting patients on the lowest effective dose
• Implementing pain treatment agreements
• Monitoring pain and treatment progress with documentation; using greater vigilance at high doses
• Using safe and effective methods for discontinuing opioids (e.g., tapering, making appropriate referrals to medicationassisted treatment, substance use specialists or other services)
Our Opioid Prescriber Toolkit, which is available to all Enhanced Safety/Monitoring Solutions (ESMS) clients, is used to
educate and assist physicians in providing appropriate therapy to patients with chronic noncancer pain. It is based on
CDC, SAMHSA and ONC guidelines, as well as guideline recommendations from the following authoritative
organizations—the APS/AAPM Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain, and
the American Society of Interventional Pain Physicians Guidelines for Responsible Opioid Prescribing in Chronic Non1,27,28
Cancer Pain.
The comments contained herein are the opinion of CVS Caremark Medical Affairs. This document contains proprietary information of CVS Health and
cannot be reproduced, distributed or printed without written permission from CVS Health. Saving projections based on CVS Caremark data. Individual
results will vary based on plan design, formulary status, demographic characteristics and other factors. Client-specific modeling available upon request.
CVS Caremark does not operate the websites/organizations listed here, nor is it responsible for the availability or reliability of their content. These
listings do not imply or constitute an endorsement, sponsorship or recommendation by CVS Caremark.
©2016 CVS Health. All rights reserved. 106-36743A 022216
February 2016
Clinical Knowledge Management News for Clients
CVS Health Controlled Substance Management Programs
At CVS Health, opioid analgesics is one of the top classes driving trend—it was the twelfth leading class contributing to
2014 trend. Oxycodone/acetaminophen, buprenorphine/naloxone, and hydrocodone/acetaminophen were the leading
drugs in this class, totaling 0.18 percent contribution overall.
We offer a number of programs that address management of controlled substances across CVS Caremark® and
CVS Pharmacy®—prospective controls, retrospective controls, prescriber management, and retail programs, which
include community programs. Prospective controls refer to those conducted prior to a prescription, service, or course of
treatment, while retrospective controls refer to those conducted after prescription services have been provided to the
patient.29
CVS Caremark Controlled Substance Programs
Prospective Controls
• Mail Pharmacy Review. At our mail order facilities, a group of pharmacists review prescriptions for Schedule II
opioid pain management medications to determine if they are legitimate and should be filled. These pharmacists
evaluate each prescription following our pain management protocol for appropriateness of therapy. Edits form on
prescriptions if certain criteria are met, such as an excessive number of fills, prescribers, or pharmacies, or if a
patient is receiving combination therapy that increases the risk of overdose, such as an opioid, carisoprodol, and
a benzodiazepine. These edits are reviewed by the pharmacists.
Our mail order pharmacies also validate that prescribers’ DEA numbers are valid and that they are not prescribing
for themselves or their immediate family. Prescribers with prescribing habits that may be questionable and/or
raise red flags (e.g., same diagnosis for all patients, same medications prescribed for all patients) are researched
and presented to our Prescriber Review Panel to decide if any action should be taken. Prior to making the
decision to block a prescriber, we will contact the prescriber to address our concerns. If a prescriber is blocked,
no controlled substance prescriptions written by this prescriber will be filled at our mail or retail pharmacies.
•
The Utilization Management (UM) team creates programs and tools that are designed to encourage safe and
effective drug utilization, help enhance plan members’ health outcomes and promote cost-effective drug benefit
plan designs for our clients that subcontract/delegate these services. Programs and tools are based on the latest
FDA-approved product labeling, authoritative drug compendia, journals, nationally accepted practice guidelines
and government agency guidance. They are reviewed internally and by external consultants (specialists in their
fields) to help ensure clinical integrity and compliance with regulatory agency standards. UM programs related to
controlled substances are prior authorization (PA) and quantity limits (QL).
o With PA, restrictions are based on clinical criteria, such as diagnosis, evaluation and step therapy
o With QL, criteria such as maximum daily dosing per labeling, initial dosing frequency recommendations or
dose in opioid-tolerant patients are used
•
Point of Service (POS) Drug Utilization Review (DUR) is a frontline safety review to prevent medication issues
at the point of dispensing (retail and mail). Our POS Safety Review utilizes a series of edits designed to check
members’ prescription history for possible drug conflicts and safety issues. A few of the many edits are drug-drug
interaction, drug-age alert and high-dose alert. Edits specifically addressing controlled substance issues may
include cumulative acetaminophen (cAPAP), cumulative morphine equivalent dose (cMED), multiple prescribers,
multiple pharmacies and excessive controlled substances.
The comments contained herein are the opinion of CVS Caremark Medical Affairs. This document contains proprietary information of CVS Health and
cannot be reproduced, distributed or printed without written permission from CVS Health. Saving projections based on CVS Caremark data. Individual
results will vary based on plan design, formulary status, demographic characteristics and other factors. Client-specific modeling available upon request.
CVS Caremark does not operate the websites/organizations listed here, nor is it responsible for the availability or reliability of their content. These
listings do not imply or constitute an endorsement, sponsorship or recommendation by CVS Caremark.
©2016 CVS Health. All rights reserved. 106-36743A 022216
February 2016
Clinical Knowledge Management News for Clients
Retrospective Controls
•
Safety/Monitoring Solutions (SMS) identifies members who may potentially be misusing or overusing controlled
substance medications, and notifies involved prescribers about members’ controlled substance drug utilization
patterns. In SMS, member prescription claims histories are reviewed and screened for parameters such as the
number of controlled substance prescriptions, the number of physicians and the number of pharmacies a member
is using. After potential high-risk members are identified, pharmacists perform clinical reviews of the medication
profiles to determine if they are consistent with nationally recognized guidelines or if an intervention—a letter
mailed to the prescriber requesting review of the therapy—should be made.
•
Enhanced Safety/Monitoring Solutions (ESMS) is considered the next step for cases not resolved by SMS for
clients that have implemented ESMS. Most cases referred to ESMS come from the core SMS program, but
referrals can come from other sources such as the client, the customer care area or the account team. Cases are
reviewed and investigated thoroughly, with more individual attention given and background research done on the
member, prescriber and pharmacy than in the SMS program. The ESMS team recommends to the client a variety
of actions depending on the situation, which include advanced lettering to prescribers, pharmacies and members;
pharmacy lock-ins and audits; prescriber follow-up; opioid prescriber toolkit; independent physician consultation;
medication therapy counseling; and special investigations referral.
•
Fraud, Waste and Abuse (FWA) Program. The FWA team reviews quarterly claims reports to identify high
utilizers of controlled substances, high-volume prescribers, and potential cases of FWA, such as inappropriate
billing, doctor shopping, and providing false information. Investigation and resolution can involve internal
processes or working with state and federal law enforcement.
•
CVS Caremark Retrospective Solutions is a retrospective review of patients’ prescription claims histories. The
review targets specific risk factors and at-risk member populations, for example elderly or high-risk users. Drug
safety reviews involve monitoring controlled substance prescription claims (e.g., pentazocine, meperidine,
testosterone therapy, barbiturates, muscle relaxants and benzodiazepines) for irregular use, which includes:
− Multiple prescribers of narcotics,
− Multiple prescriptions for the same controlled substance,
− Excessive dosages, or
− Drug-drug interactions.
Additionally, pregnant women on chronic opioids who are at risk for neonatal abstinence syndrome are identified.
Interventions are made by contacting prescribers.
Prescriber Management
• Retail-PBM Collaboration for Physician Overprescribing. Prescribing trends that indicate irregular prescribing
behavior are reviewed, and prescribers who warrant deeper review are discussed by a Prescriber Review Panel
composed of clinicians. We may refuse to fill prescriptions written by identified prescribers at both our retail and
mail pharmacies.
The comments contained herein are the opinion of CVS Caremark Medical Affairs. This document contains proprietary information of CVS Health and
cannot be reproduced, distributed or printed without written permission from CVS Health. Saving projections based on CVS Caremark data. Individual
results will vary based on plan design, formulary status, demographic characteristics and other factors. Client-specific modeling available upon request.
CVS Caremark does not operate the websites/organizations listed here, nor is it responsible for the availability or reliability of their content. These
listings do not imply or constitute an endorsement, sponsorship or recommendation by CVS Caremark.
©2016 CVS Health. All rights reserved. 106-36743A 022216
February 2016
Clinical Knowledge Management News for Clients
CVS Health Retail Programs
At CVS Pharmacies
Pharmacists have a legal responsibility to ensure all prescriptions dispensed have been written for a legitimate
medical purpose by prescribers practicing within the scope of their practice. Each year, we provide detailed training to
all pharmacists and support staff on how to recognize and address prescriptions of concern to help prevent the
diversion of these opioids into our communities. Specific training is provided to retail pharmacy pharmacists and
support staff centered on identifying areas of concern, such as “red flags,” when dispensing controlled substances.
Red flags can be concerns with the therapy/dosing, the prescription, the patient or the prescriber.
To ensure an opioid prescription has been written for a legitimate medical purpose, the retail pharmacy may consult
with the prescriber to validate dosage and obtain diagnosis code, review the patient’s profile for therapy duplication
and cadence of fills, and check the state’s Prescription Monitoring Program (where available) to understand whether
the patient is visiting multiple doctors and/or pharmacies. We conduct a regular review of high-risk prescribing
patterns observed within prescription data. In certain instances where concerning outlier patterns are observed, we
conduct outreach to prescribers to resolve these concerns and promote safer prescribing practices.
Additionally, from an aggregate level, all CVS Pharmacy dispensing is assessed on a regular schedule as part of a
formalized process to understand controlled substance dispensing. Any pharmacy identified with specific opioiddispensing characteristics requiring follow-up enters into a review and education program.
CVS Pharmacy Outreach to Communities
We recognize the importance of removing unwanted, unused, or expired medications from our communities in a safe
and environmentally responsible manner. Through our Medication Disposal for Safer Communities Program, we
have demonstrated our commitment to the safe disposal of this unwanted medication to help prevent prescription drug
abuse and diversion. Our Safer Communities Program has donated more than 420 medication collection units to law
enforcement departments across the country as a way to help them start a medication collection program. We raise
awareness in our communities about these sites, as well as other drop-box locations, that are available year round for
customers to dispose of their unwanted prescription medication. Currently we have more than 1,000 CVS Pharmacy
locations displaying in-store signage to direct our customers to these take-back locations. The units that we have
donated have helped facilitate the removal of more than 43,000 pounds of medications—close to 20 metric tons over
the life of the program. This is the sum total for all collections starting when the units were beginning to be delivered in
September 2014 through the end of Q3 2015.
We have a standing offer to law enforcement to use our pharmacy parking lots to host a take-back event, including
the National Drug Take-Back Day events. For the event that happened nationwide on September 26, 2015, more
than 130 CVS Pharmacy locations acted as a host site for these events.
We have also created a Community Outreach Program that discusses the dangers of prescription drug abuse and
the effects that one choice can have on individuals and their families. This presentation is geared toward high school
students, and all pharmacists at CVS Pharmacy have the opportunity to present this program to their local high school
and make a difference in the community.
The comments contained herein are the opinion of CVS Caremark Medical Affairs. This document contains proprietary information of CVS Health and
cannot be reproduced, distributed or printed without written permission from CVS Health. Saving projections based on CVS Caremark data. Individual
results will vary based on plan design, formulary status, demographic characteristics and other factors. Client-specific modeling available upon request.
CVS Caremark does not operate the websites/organizations listed here, nor is it responsible for the availability or reliability of their content. These
listings do not imply or constitute an endorsement, sponsorship or recommendation by CVS Caremark.
©2016 CVS Health. All rights reserved. 106-36743A 022216
February 2016
Clinical Knowledge Management News for Clients
Questions and Answers for Clients
Have CVS Health programs been effective?
Current programs are effective. For example, in 2014, total net pharmacy savings per member per month (PMPM) for the
SMS program was $58, and total net pharmacy savings PMPM for the ESMS program was $136.b Total gross pharmacy
savings in 2014 from SMS and ESMS combined was close to $80.1 million.b
What is being considered for the future?
We are continually reviewing current programs, determining areas for improvement and developing comprehensive
strategies. Areas identified for improvement include program enhancements, coordinated member and physician
education and more diverse treatment options. Opportunity exists to further reduce cost and create clinical outcome value
for clients. Initiatives include the following:
• Through enhanced reporting and communication, help support clients’ intervention efforts
• Continue to help ensure programs are consistent with current pain management guidelines
• Support access to and encourage use of medication-assisted treatment
• Support overdose prevention and medication disposal initiatives
• Develop a website for member, public and provider education
• Continually refine identification of and intervention with high-risk patients and prescribers
• Enhance program cost-saving documentation and reporting to clients
Where is there further information or news about opioids?
The CDC provides a number of publications and news on opioids at:
http://www.cdc.gov/drugoverdose/pubs/index.html#tabs-760094-4. Both the American Pain Society website at
http://ampainsoc.org and the American Academy of Pain Medicine website at http://www.painmed.org also feature current
news about opioids.
What does this mean for clients?
Our controlled substance management programs help to ensure safe and more clinically appropriate controlled substance
medication therapy for members and retail customers, and to produce cost savings for clients through more clinically
appropriate medication regimens. We are continually improving our programs. Please contact your Clinical Advisor to
discuss the different controlled substance management programs that would best align with your pharmacy benefit plan.
b
Total pharmacy savings are calculated by subtracting the pharmacy costs following program intervention from the pharmacy costs prior to program
intervention.
The comments contained herein are the opinion of CVS Caremark Medical Affairs. This document contains proprietary information of CVS Health and
cannot be reproduced, distributed or printed without written permission from CVS Health. Saving projections based on CVS Caremark data. Individual
results will vary based on plan design, formulary status, demographic characteristics and other factors. Client-specific modeling available upon request.
CVS Caremark does not operate the websites/organizations listed here, nor is it responsible for the availability or reliability of their content. These
listings do not imply or constitute an endorsement, sponsorship or recommendation by CVS Caremark.
©2016 CVS Health. All rights reserved. 106-36743A 022216
February 2016
Clinical Knowledge Management News for Clients
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