Download fsSolutions - Coventry Workers` Comp Services

Winter 2010
fsSolutions
Prescribed solutions to restore health and productivity.
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INSIDE THIS ISSUE:
Monitoring Opioid Use and Abuse
Page 4
A Coventry Workers’
Comp Services Solution
The Changing Landscape of Repackaged Medications
Page 21
Drug Utilization Assessment and Physician
Peer Discussions Improve Claim Outcomes
Page 24
Containing Out-of-Network Prescription Costs
Page 26
Table of Contents
Welcome Letter
1
2009 Top Drugs
2
Monitoring Opiod Use and Abuse
4
DMEplus Spotlight - Catastrophic Care
9
Fall Prevention and Home Safety
10
New Labels for Morphine Sulfate Oral Solution
12
City-Dwelling, Middle-Aged Women at Highest Risk for Drug Overdose 13
Adverse Drug Effects
14
Texas “Houston Cocktail” Gains in Popularity
16
Retail Pharmacy Safety
18
Genzyme Takes First Bold Step Towards Medication Tracking
20
The Changing Landscape of Repackaged Medications
21
fsAlert Triggers
22
Drug Utilization Assessment and Physician Peer Discussions
Improve Claim Outcomes
24
Containing Out-of-Network Prescription Costs
26
Upcoming Patent Expirations
27
Drug Delivery Methods
28
2010 Pipeline Drugs
29
fsSolutions is published by First Script, a national Pharmacy Benefit Management and Durable
Medical Equipment & Ancillary Services provider.
© 2010 First Script. All rights reserved.
155 N. Rosemont Blvd., Suite 201, Tucson, Arizona 85711
www.coventrywcs.com
Please send comments to [email protected]
W
elcome to the winter edition of fsSolutions, a publication created specifically to provide
timely information related to Pharmacy Benefit Management (PBM) and Durable Medical Equipment
(DME) programs. We hope you find this edition a valuable resource filled with information that will
assist you in managing your workers’ compensation programs.
This has been an exciting year for First Script, and we have incorporated a great deal of new innovation
into our product lines. We continue to lead in the workers’ compensation industry through several key
strategies which focus on clinical cost containment, and our goal remains to provide programs that
address the overall claims outcomes and service(s) impacting our clients.
Earlier this year, First Script introduced real-time pharmacist intervention using client agreed upon
protocols to drive better outcomes, limit claims examiner interruption and place clinical decisions
where they belong, with a pharmacist. We continue to expand our risk assessment tools to enable an
ease of understanding for the claims examiner where clinical intervention might be required. We are
also focusing on how to better integrate our tools into client platforms, such as integrating clinical tools
into client platforms in order to pass clinical notes, create data feeds into the client platform, and
enhancement of our on-line reporting tools.
The First Script clinical platform has also been enhanced to greatly expand our fsAlerts to incorporate
various guidelines for drug utilization management. Using primary injury diagnostic codes, First Script
is able to interpret a vast amount of data in order to understand the standards of care for a given injury.
By using this data, we can provide the statistical relevance of how each claim is being managed. In
partnership with our clients, we are then able to assist claims examiners in developing clinical decision
trees that may involve all forms of care.
First Script believes drug utilization is the primary indicator of claim management that can drive appropriate intervention by case management, pharmacists, examiners and physicians. Our Drug Utilization
Assessment (DUA) and Peer-to-Peer (P2P) tools give First Script the ability to provide a closed-loop
process by taking physician agreed upon treatment plans and integrating them into our point-of-sale
application. We also continue to stay strategically focused on cost drivers, such as repackaging, compound drugs and specialty pharmacy/biologicals.
Our latest initiative for DMEplus includes further development and enhancements to our proprietary DME
application platform to enhance our current workflows, processes, and service delivery. We are also
making enhancements to provide an out-of-network solution to our clients that redirect bills into DMEplus to take advantage of greater network discounts. Through our closed-loop process, we can pull and
update bills to reduce out-of-network utilization, increase penetration and increase savings for our clients.
The components of our business are evolving daily and our clients demand that we stay focused and
“ahead of the curve” allowing them to maintain a competitive position in the marketplace. In this
edition of fsSolutions, you will find articles that address current issues impacting your workers’ compensation program. With dedicated resources, focused daily on market changes, regulatory and legal
updates, and the evolving treatment and prescribing patterns of physicians, First Script provides information that enables our clients to stay ahead of the ever changing issues they face in the workers’ compensation industry. We feel confident that you will find this publication useful, and welcome your
suggestions for future editions.
Sincerely,
Alan Madison
Vice President, First Script Operations
Michael Patterson
Vice President, DMEplus Operations
1
2009 Top Drugs
The Top Drugs for 2009 for First Script clients
are listed in Table 1. We compared the top 25
medications by retail billed amount for First
Script (in the left column) with the top 25
medications billed under national group
health plans (in the right column).
business for 2009, whereas in group health,
OxyContin® ranked eighth. Only two drugs in
the First Script top 25, Nexium® (used for
stomach ulcers) and Ambien® (used as a
sleep aid), are not directly related to pain
control.
In July 2010, Intercontinental Marketing
Services (IMS) Health released “The Top 15
Global Therapeutic Classes of 2009”, which
listed narcotics and non-narcotics in the top
fifteen, being thirteenth and fourteenth
respectively (see Table 2).
Table 1. Medications
Rank
Top 25
First Script
Top 25
National TrendGroup Health
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
OxyContin*
Lidoderm
Vicodin*
Lyrica
Percocet*
Duragesic*
Celebrex
Neurontin*
Cymbalta*
MS Contin*
Actiq
Skelaxin
Topamax*
Zanaflex
Opana ER
Ultram*
Ambien CR
Ultram ER
Flexeril*
Mobic*
Nexium
Ambien*
Soma*
Flector
Avinza
Lipitor
Nexium
Plavix
Advair Diskus
Seroquel
Abilify
Singulair
OxyContin
Actos
Prevacid
Cymabalta
Effexor XR
Lexapro
Crestor
Zyprexa
Hydrocodone/APAP
Valtrex
Flomax
Lantus
Lyrica
Celebrex
Levaquin
Aricept
Spiriva
Diovan
Table 2.
Top 15 Global Therapeutic Classes of 2009
* Includes both brand name and generic products
The majority of First Script’s top 25 medications are utilized for pain for a variety of
symptoms ranging from neurological,
muscle, joint and internal organ pain.
OxyContin® ranked number one within the
First Script workers’ compensation book of
Drug Class
2009 Sales Annual
(Billions)
Growth
Oncologics
$52.37
8.8%
Lipid Regulators
$35.28
4.9%
Respiratory Agents
$33.59
11.0%
Antidiabetics
$30.40
13.4%
Anti-ulcerants
$29.61
0.6%
Angiotensin II Antagonists
$25.20
11.4%
Antipsychotics
$23.24
4.6%
Antidepressants
$19.41
-1.3%
Autoimmune Agents
$17.96
18.0%
Platelet Aggr. Inhibitors
$14.60
9.0%
HIV Antivirals
$13.75
14.9%
Anti-epileptics
$12.99
-19.8%
Narcotic Analgesics
$11.23
8.6%
Non-narcotic Analgesics
$11.17
7.3%
Erthropoietins
$10.80
-4.1%
Data courtesy of IMS Health
FierceBiotech 7/15/10
2
IMS Health further showed the fastest growing therapeutic classes (by sales) in the last
five years in which narcotics and nonnarcotics ranked ninth and tenth respectively. Utilization and price changes by the
manufacturer are the two main factors that
influence the annual increase in drug spend.
in 2009: Flector®, a topical pain patch, and
Avinza®, a once-a-day morphine sulfate
capsule.
Prescribing trends in the workers’ compensation Industry appear to follow the release
and popularity of certain drugs. Most injuries,
from onset to end of life of a claim, require
relief from mild to moderate or severe pain.
In 2009, generic OxyContin® experienced a
decrease in supply with a concurrent
increased AWP of 9% for the brand, which
then generated inflation among all oxycodone products. In April 2010, the Food and
Drug Administration (FDA) approved a new
formulation of OxyContin® designed to minimize illicit use. This will replace all previous
supplies of the product, thus giving the
manufacturer exclusive control over pricing.
The group health trend consists of several
different therapeutic categories. Lipitor® is a
cholesterol reducing drug, Singulair®
prevents and treats asthma and allergies and
Plavix® prevents blood clotting in patients
prone to heart attacks and stroke.
Average Wholesale Price (AWP) is a reflection
of pricing by the manufacturer. Increases
occur in both brand name drugs and generic
medications, but because brands generally
cost significantly more than generics, any
increase in AWP of a brand medication has a
greater impact on drug spend. Many of First
Script’s top medications are not available in
generic form. Examples are Lidoderm® which
is ranked second and Lyrica® which is ranked
fourth. Additionally, two newer brand medications are included in First Script’s top 25 list
Given the narrower scope of medications
used in the workers’ compensation industry,
the introduction of new brands or generics
and the resulting pricing effects have a much
greater impact than in group health. The
broader range of therapeutic categories in
the group health industry enables it to more
readily absorb any cost effects that result
from drug class trends.
First Script has several resources and
processes in place through our drug utilization management tools, and is committed to
effectively managing costs for our clients and
coordinating quality healthcare throughout
the life of the claim for the injured worker.
References:
FierceBiotech
http://www.fiercebiotech.com/pages/top-15-globaltherapeutic-classes-2009#ixzz0tlc51rIa
Subscribe:
http://www.fiercebiotech.com/signup?sourceform=Vi
ral-Tynt-FierceBiotech-FierceBiotech
Drugtopics.com
3
www.coventrywcs.com
agesic l Actiq l Fentora l Vicodin l Lortab l Methadose l Dolophine l MS Contin l Avinza l Kadian l OxyContin l
e l Darvon l Darvocet l Ultram ER l Duragesic l Actiq l Fentora l Vicodin l Lortab l Methadose l Dolophine l M
tin l Avinza l Kadian l OxyContin l Roxicodone l Darvon l Darvocet l Ultram ER l Duragesic l Actiq l Fentora l
tab l Methadose l Dolophine l MS Contin l Avinza l Kadian l OxyContin l Roxicodone l Darvon l Darvocet l U
Monitoring Opioid Use and Abuse
Opioids are the most widely prescribed class of medication in the United States. They are highly
addictive and illicitly abused substances as well. Providers are finding themselves in compromising situations as the legal consequences for both the over and under utilization of narcotics
become more common. In what circumstances is an opioid indicated, and furthermore, when
should an opioid be discontinued? With very little information about maximum dosages in
prescribing guidelines, at what point is a dose considered too high? How does a prescriber
determine if the patient is diverting and selling his or her chronic pain medications? Data compiled from the Drug Enforcement Administration (DEA), Boards of Medicine, and the Official
Disabilities Guidelines (ODG) can provide insight to these issues. The workers’ compensation
industry must remain cognizant of these concerns since they are such a prevalent component
of the business. Just as providers, pharmacists and insurance companies have the responsibility
to provide proper medical care, they must do their part to prevent prescription drug abuse and
diversion as well.
Background
Opiates are addictive due to their euphoric effects and also because of the uncomfortable withdrawal symptoms that result from the physical dependence associated with them. Because
these prescription pain relievers have the potential for diversion and abuse, prescribers find
they must meet requirements by many different agencies that regulate their prescribing. The
DEA, state licensing boards, law enforcement, and heath care benefit plans oversee and regulate the utilization of these medications. However, as the potential legal implications increase,
a separate, opposite issue has recently emerged: undertreated pain. Although rare, some
prescribers concerned with prescribing high doses of opioids have been accused of undertreating patients, mainly those with terminal conditions. As a result, many prescribers find
themselves balancing more aspects than ever before when considering opiate therapy for their
patients.
Some Common Opioid Medications*
FENTANYL – Duragesic, Actiq, Fentora
HYDROCODONE – Vicodin, Lortab
METHADONE – Methadose, Dolophine
MORPHINE – MS Contin, Avinza, Kadian
OXYCODONE – OxyContin, Roxicodone
PROPOXYPHENE – Darvon, Darvocet
TRAMADOL – Ultram ER
* Not all-inclusive
4
Legal Circumstances
Most opioids are controlled substances, as classified by the DEA. An exception to this is tramadol (Ultram®, Ultram® ER). According to federal law, physicians may prescribe controlled
substances for legitimate medical purposes in the usual course of professional practice. The
terms within this statement have been analyzed and interpreted differently since the inception
of the Controlled Substances Act in 1970. Court cases have resulted in disciplinary action
towards prescribers for both under and over treating chronic pain, though more cases involve
the latter.
One case involved the death of a young high school student. A nurse practitioner prescribed
OxyContin® to an adult who then sold the pills to high school students. The students used the
medications at a party resulting in one fatality due to an overdose. The same prescriber also
prescribed extremely high doses of opioids for nine other patients with chronic non-cancer
pain. The pain complaints included back pain, knee pain, soft-tissue injuries, fibromyalgia, and
major depressive disorder. The state board of nursing charged the nurse practitioner with inappropriate assessments and lack of routine monitoring, as well as unprofessional conduct,
incompetence, negligence, and malpractice.
A second case involved a Nevada physician who was charged with contributing to a patient’s
death. A 69 year old woman, who was prescribed narcotics by the physician for four years, died
of an infection. The woman complained frequently of constipation and abdominal pain,
common side effects of opioids; however, her family states that the doctor did not address the
problem. The woman died from a bowel rupture, thereby causing a blood infection which
claimed her life. The physician was charged with failing to monitor the effects of the medications prescribed, keeping inadequate records, and failing to address her abdominal pain. All
three of these factors were considered by the court to be contributing factors to her death.
Another case involves the under treatment of pain. A cancer patient moved into a hospice for
pain management care. While in the hospital, he received injections of Demerol®, a schedule II
opioid, but upon discharge received oral Vicodin® tablets, a schedule III opioid in combination
with acetaminophen. The patient’s family felt his pain relief was not adequate and requested
liquid morphine for him, but the provider instead prescribed a fentanyl patch and another dose
of Demerol®. The patient received liquid morphine from a different prescriber on his final day of
life, after which the family declared he finally felt relief of pain. After the ensuing court case, the
hospital paid $1.5 million to the patient’s family and also began a training program in pain management to hospital staff.
esic l Actiq l Fentora l Vicodin l Lortab l Methadose l Dolophine l MS Contin l Avinza l Kadian l OxyContin l R
Darvon l Darvocet l Ultram ER l Duragesic l Actiq l Fentora l Vicodin l Lortab l Methadose l Dolophine l MS
n l Avinza l Kadian l OxyContin l Roxicodone l Darvon l Darvocet l Ultram ER l Duragesic l Actiq l Fentora l V
b l Methadose l Dolophine l MS Contin l Avinza l Kadian l OxyContin l Roxicodone l Darvon l Darvocet l Ult
5
agesic l Actiq l Fentora l Vicodin l Lortab l Methadose l Dolophine l MS Contin l Avinza l Kadian l OxyContin l
e l Darvon l Darvocet l Ultram ER l Duragesic l Actiq l Fentora l Vicodin l Lortab l Methadose l Dolophine l M
tin l Avinza l Kadian l OxyContin l Roxicodone l Darvon l Darvocet l Ultram ER l Duragesic l Actiq l Fentora l
tab l Methadose l Dolophine l MS Contin l Avinza l Kadian l OxyContin l Roxicodone l Darvon l Darvocet l U
Drug Enforcement Administration
The DEA, a federal agency, is responsible for both the oversight of controlled substance use
(legal and illegal), as well as the enforcement of the laws governing their distribution. In their
policy statement, they explain that their oversight is “not intended to interfere with the legitimate practice of medicine or cause any physician to be reluctant to provide legitimate pain
treatment.” The DEA also wishes to dispel the notion that the agency has embarked on a campaign to “target” physicians who prescribe controlled substances for the treatment of pain (or
that physicians must curb their legitimate prescribing to avoid legal liability).
The DEA does have the legal authority to take action against an individual who violates the
controlled substance laws. This may include revocation of a prescriber or pharmacy’s DEA
license and possible prosecution. To assist clinicians in complying with controlled substance
laws, they offer the following guidelines:
Behaviors That May Suggest Inappropriate Prescribing*
 An inordinately large quantity of controlled substances were prescribed
 A large number of prescriptions issued compared to other clinicians within a geographic area
 No physical examination was given
 Clinician told the patient to fill prescriptions at different drug stores
 Clinician was aware the patient is delivering drugs to others
 Clinician prescribed medications in return for favors or money
 Controlled medications prescribed at intervals inconsistent with legitimate medical treatment
 No logical relationship exists between the drug prescribed and the treatment of the condition
*Not all-inclusive
The DEA does not supply more specific guidelines, nor further defines such terms as “inordinately large quantity” or “large number of prescriptions.” This is because the DEA does not
determine the manner in which physicians practice, but instead enforces controlled substance
laws.
The DEA also provides the list on the following page of behaviors that might indicate that a
patient is seeking drugs for the purpose of diversion or abuse:
6
Patient Behaviors That May Indicate Abuse or Diversion Intent
 Demanding to be seen immediately
 Appearing to fake symptoms in an effort to obtain narcotics
 Indicating that non-narcotics do not work for him or her
 Requesting a particular narcotic drug
 Complaining that a prescription has been lost or stolen and needs replacing
 Requesting more refills than originally prescribed
 Using pressure tactics or threatening behavior to obtain a prescription
 Showing visible signs of drugs use, such as track marks
State Boards
Many licensing boards exist within each state. The boards of Medicine, Nursing, and Pharmacy
in each state are responsible for licensing and disciplining their respective medical providers.
Their primary purpose is to serve the state with safe, qualified healthcare professionals. They
investigate complaints reported by consumers and resolve the situations as needed.
Each state has adopted a set of guidelines for opioid prescribing to which medical providers
should adhere. While the specific guidelines vary by state, they are similar in overall content and
provide a standard by which to compare a prescriber’s behavior. For example, below is the state
of Montana’s requirements for providers when prescribing opioids:
State of Montana: Opioid Prescribing
 Provide a thorough history and physical examination, including an assessment of the
cause of pain, substance abuse history, other therapies, underlying diseases or conditions,
and statements by other treating physicians that the patient’s pain is intractable and
cannot be controlled by medications other than opioid analgesics.
 Document a treatment plan that includes how treatment success will be evaluated. Use
several treatment modalities concurrently with opiates.
 Discuss the risks for, and benefits of, the controlled substances with the patient and/or
guardian in an ongoing manner.
 If treatment objectives are not being met or if the patient is at risk for misuse of medications
refer to an appropriate specialist, including a specialist in addiction and chronic pain
management .
 Record all of the above recommendations in the patient’s medical record.
esic l Actiq l Fentora l Vicodin l Lortab l Methadose l Dolophine l MS Contin l Avinza l Kadian l OxyContin l R
Darvon l Darvocet l Ultram ER l Duragesic l Actiq l Fentora l Vicodin l Lortab l Methadose l Dolophine l MS
n l Avinza l Kadian l OxyContin l Roxicodone l Darvon l Darvocet l Ultram ER l Duragesic l Actiq l Fentora l V
b l Methadose l Dolophine l MS Contin l Avinza l Kadian l OxyContin l Roxicodone l Darvon l Darvocet l Ult
7
agesic l Actiq l Fentora l Vicodin l Lortab l Methadose l Dolophine l MS Contin l Avinza l Kadian l OxyContin l
e l Darvon l Darvocet l Ultram ER l Duragesic l Actiq l Fentora l Vicodin l Lortab l Methadose l Dolophine l M
tin l Avinza l Kadian l OxyContin l Roxicodone l Darvon l Darvocet l Ultram ER l Duragesic l Actiq l Fentora l
tab l Methadose l Dolophine l MS Contin l Avinza l Kadian l OxyContin l Roxicodone l Darvon l Darvocet l U
Official Disability Guidelines
The Official Disabilities Guidelines (ODG), a publication produced by the Work Loss Data
Institute, is a set of evidence-based standards to which the workers’ compensation industry
can refer. Medical conditions and the appropriate treatments are outlined in great detail, and
references to associated studies are provided.
Since opioids comprise such a large component of workers’ compensation prescriptions, these
medications are addressed in the ODG treatment regimens. One section entitled, “Criteria for
Use of Opioids” gives a general overview of the use of narcotics for injuries. It is summarized
below.
1) Establishing a Treatment Plan
 Gather history of opioid use and results
 Have alternatives been tried?
 Will the patient improve with opioid use?
5) On-Going Management
 Prescriptions should be written by one
provider and filled at one pharmacy
 Satisfactory response to treatment may
be indicated by the patient’s decreased
pain, increased level of function, or
improved quality of life.
 Use drug-screening processes with issues
of abuse, addiction, or poor pain control
 Refer to a pain control clinic if pain does not
improve within three months
2) Steps to take before an opioid trial
 Determine pain origin
 Patient should set goals
 Record baseline pain and function levels
 Consider creating a written pain treatment
contract with the patient
3) Initiating Therapy
6) When to discontinue opioids
 If there is no overall improvement in
function
 Continuing pain
 Decrease in function
 Resolution of pain
 If serious non-adherence occurs
 Discontinuation should follow a slow
taper protocol to avoid adverse effects
 Start with a short-acting opioid or extendedrelease in cases of continuous pain
 Change only one drug at a time
 If pain relief is not obtained, discontinue
opioids
4) Recommended frequency of visits
 Every two weeks for the first two to four
months
What can we do?
Narcotics are and will continue to be a mainstay of treatment in the workers’ compensation
industry. As claimants are initiated and maintained on these powerful substances, claims
management has a unique opportunity to assist in reducing opioid abuse. Claimants that use
multiple providers or pharmacies, or receive extraordinarily high quantities of opioids, may be
using the drugs for other than their intended purpose. Carefull monitoring of prescription
transaction histories can help injured workers use the medications available for the best
outcomes possible.
8
DMEplus Spotlight - Catastrophic Care
The DMEplus program has been extremely successful in coordinating all the arrangements for
catastrophic products and services that improve the long-term or permanent health of an
injured worker. DMEplus provides a single source for all referrals that is highly
efficient and reduces the potential for mistakes. We also monitor these
cases to ensure appropriate supplies and services are provided while
reducing overall claim costs.
The ability of DMEplus to provide specialized services, such as home
healthcare, rehabilitation equipment, and home and vehicle modification
further improve the injured worker’s quality of life. We contract with
a broad range of cost-effective, catastrophic care professionals covering
many specialties, including trauma, rehabilitation, and spine and brain
injuries. This extensive local and national network ensures that we
meet the needs of virtually any type of severe or long-term workers’
compensation case.
DMEplus also integrates with Coventry services to provide a single
claims management source for all aspects of an injured worker’s
claim, including ordering care management services (such as
Telephone Case Management, Field Case Management or
Independent Medical Examination), First Script pharmacy
benefits, and bill review.
Catastrophic Care Examples
 Quadriplegic
 Paraplegic
 Burn victims
 Multiple gun shot wounds
 Amputees
 Spinal cord injury
 Traumatic brain injury
 Crush injury
9
 Fall Prevention and Home Safety 
Post-accident and post-operative patients often experience a higher incidence of falls and injuries in the
home because they do not properly prepare the environment to accommodate their new condition.
Common everyday items can easily become a tripping hazard or increase the chance of injury for
patients compromised by ambulatory or medication related limitations. A simple assessment of the
home environment can help alleviate the risk of further injury. Depending upon the level of severity,
this could be a self-guided appraisal, or a family member could assist. In addition, many First
Script/DMEplus home healthcare agencies will offer this as a free evaluation during their care planning
visits. Here is a home safety checklist for injured workers:
Reduce the Risk of Falls on Stairs
 Are the stairs well lit (especially at the top and bottoms)?
 Are there stair treads on the steps? Beware of loose or bunched carpet.
 Are there handrails along the steps? Both sides are preferred.


If no stair railing, place a hand on the wall while going up and down the stairs.
Never carry any package that will obstruct view of the next step.
Carpeting and Area Rug Tips
 Avoid patterned or deep pile carpeting; solid colors show edges of steps more clearly.
 Be careful walking from a carpeted room to a tile floor and back.
 Keep flashlights handy in the event of a power outage, and keep spare batteries.
 Use 100-watt bulbs if they do not exceed warnings on lamps/fixtures (to avoid fire hazard).
Bathroom Safety
 Use bathroom grab bars to help with balance while sitting or rising.
 Never grab a towel rack, shampoo holder or soap tray for support in the shower.
 Clean up puddles immediately and use a slip-resistant rug next to the bathtub/shower.
 Non-skid strips on the bathtub/shower floor can help reduce the risk of slipping.
 A shower chair in a tub/shower can provide a steady platform for washing/rinsing.
 A raised toilet seat may help with balance getting on or off the toilet and assist with
low toilets or where there is difficulty with bending.
 Sit when shaving, brushing teeth, fixing hair or putting on make-up.
 Let soap suds go down the drain before moving around in the shower. Do not turn suddenly.
 Do not lock the bathroom door. This will delay help from reaching you in a timely manner.
Bedroom Safety
 Have a clear path to the bathroom to avoid stumbling in the dark.
 Have a lamp, flashlight and telephone near the bed.
 Place night lights along the path from the bedroom to the bathroom.
 Can the injured worker get in and out of bed easily? If not, consider raising the mattress.
 Arrange clothes in the closet so they are easy to reach.
 Replace satiny sheets/comforters with products made of non-slippery material, such as cotton.
10
Living Area Safety
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
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


Create clear paths between rooms.
Consider removing low coffee tables, magazine racks, footrests, plants, glass topped furniture
or glass knick knacks from pathways in the rooms used.
Look for easy access light switches at entrances to rooms to avoid walking into the dark.
Look for loose rugs on non-carpeted floors, and secure them with double-faced tape or slip
resistant backing.
Make sure carpet is secure and there are no bumps or raised areas.
Make sure that cords are out of the way, however do not put cords under a rug.
Identify wobbly chairs and tables – a person could lean on them and fall.
Try to sit on furniture that is firm, high and has armrests to help when standing.
Make sure there is access to a telephone that can be reached to call for help if needed.
Consider cordless phones that can be kept close to avoid hurrying to reach the phone.
Kitchen Safety




Remove throw rugs from the kitchen.
Clean up all liquids, grease or spilled food immediately. Depending on the need, seek
assistance with bending or kneeling to clean up spills.
Store food, dishes and cooking equipment at an easy-to-reach, waist high level.
Do not stand on chairs or boxes to reach upper cabinets. Ensure all step stools are in good
working condition.
General Safety Recommendations



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

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

Have eye exams regularly and update your prescription glasses or contacts.
Wear glasses if needed, but remove reading glasses before walking.
Feeling weak or dizzy can be a possible side effect of many medications and can
increase the risk of falls. Talk to a doctor or pharmacist about side effects caused by
medications, and read the information about side effects that comes with each prescription.
Never take more medication than was prescribed. Medicine dosage instructions are provided
to protect from overdose or adverse reactions.
High heels, floppy slippers and shoes with slick soles can cause stumbles and falls.
Walking in stockings or socks can also cause falls.
When first waking up, sit on the bed edge and evaluate dizziness before you get out of bed.
Eat breakfast every morning. Skipping a meal may cause weakness or dizziness.
Be careful around pets—they can get in front of your feet or jump on you.
If using a cane or walker, replace any worn rubber tips.
If additional assistance is needed, a home healthcare provider can assist with continued in-home care that
allows an injured worker to remain independent and recover at home. Our DMEplus home healthcare
program can coordinate all the arrangements for care givers, equipment, and any medical supplies needed for
treatment to promote faster recovery and return-to-work. Home healthcare providers work closely with the
injured worker, healthcare provider, and employer to facilitate timely and appropriate medical care and
coordinate a safe and timely return-to-work. Other services such as home modification, rehabilitation equipment, and patient lifts can also be requested to support an injured worker‘s home healthcare rehabilitation.
11
Safety Update
NEW LABELS FOR MORPHINE SULFATE ORAL SOLUTION
The Food and Drug Administration (FDA) reviewed and approved a morphine sulfate oral solution in
January of 2010. The product had been made by Roxane Laboratories since before the FDA began their
drug-approval process in 1962, and was approved for re-manufacture by the same company. The reason for
the recent FDA review was to ensure that the medication’s safety, effectiveness, quality, and labeling met
FDA standards. The major change to the product was in its labeling.
In previous years, there were numerous reports of medication mix-ups that resulted in serious adverse
effects. The design of Roxane’s old label was very similar to other products they manufacture, including
other strengths of morphine. New labeling and packaging features are intended to reduce the risk of these
medication errors.
Here is the old packaging. Notice how similar these two products are; however, the box with the red stripe
contains a solution five times more potent than the other.
New labeling has been changed to the following:
Packaging continues to be a very significant factor in medication errors, especially as more and more medications enter the marketplace. The influence of the FDA and other medication-safety organizations on drug
manufacturers is essential to reduce unnecessary medication errors.
Reference: http://www.ismp.org/Newsletters/acutecare/articles/20100211.asp
Image Source: Photo used with permission of the Institute of Safe Medicine Practices
12
Clinical News
City-Dwelling, Middle-Aged Women at Highest Risk for Drug Overdose
A recently published study in the American Journal of Preventative Medicine found urban women
to be at high risk for poisoning by prescription drugs. A database of records, the U.S. Nationwide
Inpatient Sample, was reviewed for the study, which may help to spur healthcare workers, government regulators, and law enforcement to push attention toward this rising epidemic. The category
of U.S. citizens most likely to be hospitalized due to prescription drug poisoning was found to be
women between the ages of 35 and 54 who were living in cities. Additionally, the reasons for
ingestion were largely unintentional. Study researchers note that the reasons for ingestion in “a
large number of cases was undetermined.” The report also outlined the following overall results:
 1999 to 2006: Hospital admissions due to opioid prescription overdoses rose from
43,000 to 71,000
 1999 to 2006: Intentional prescription drug poisonings rose from 10,000 to 24,000
 Accidental poisonings by prescription drugs are now the second leading cause of unintentional
injury death in the U.S.
 2005: Accidental poisoning was the leading cause of unintentional injury death and surpassed
motor vehicle crashes among 35 to 54 year olds
With the statistics provided by this research study, the healthcare community gains further insight
into the prescription drug abuse epidemic in the United States. Dr. Coben, MD, lead researcher of
the study states, “A multifaceted approach is needed. Doctors need to perhaps rethink the types
and quantities of medications they are prescribing. And, we need to get better messages out to
the public in terms of the dangers associated with these medications and combinations of these
medications that are being used.”
References:
1) Coben, MD et al. “Hospitalizations for Poisoning by Prescription Opioids, Sedatives, and Tranquilizers,” American Journal of Preventative Medicine; Vol.38, Issue 5, May 2010.
2) www.msnbc.msn.com/id/36191349/ns/health-womens_health
13
Adverse Drug Effects
Adverse drug effects are results that are unwanted, unpleasant and potentially harmful. Some
of the more common adverse drug effects seen in the workers’ compensation industry are
listed and explained below.
Constipation - A common condition in the human body. The main symptoms are:
Hard stools  Difficulty passing stools  Abdominal pain and cramping
Many causes of constipation exist, including medications, diet, and bowel obstructions or
tumors. In workers‘ compensation, medication-related constipation is often seen in connection
with the following classes of medications:



Narcotic pain medications: OxyContin®, morphine, hydrocodone
Some antidepressants: Amitriptyline, nortriptyline, imipramine
Some anticonvulsants: Neurontin®, Lyrica®, carbamazepine
The standard treatment for constipation may include changes in diet and increased fluid intake;
however, the use of stool softeners, such as Colace®, are often used in conjunction. If stool softeners are not effective, a laxative such as Dulcolax® or Miralax® may be prescribed or a combination drug including a laxative plus a stool softener such as Senokot-S® can be prescribed.
Nausea - One of the most common medication side effects. It is the sensation of uneasiness of
the stomach and can often precede vomiting. Nausea that prolongs for more than 24 hours can
lead to dehydration.
Medication – related nausea in workers’ compensation is commonly seen with:



Narcotic pain medications: OxyContin®, morphine, hydrocodone
Non-steroidal anti-inflammatories (NSAIDs): Ibuprofen, naproxen
Antibiotics: Erythromycin, Bactrim DS®, doxycycline
The treatment of nausea may include taking the medication with or before meals and, in severe
cases, Phenergan® tablets or suppositories may be prescribed.
Peptic Ulcers - Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) often results in upper
gastrointestinal (GI) tract irritation that can result in stomach ulcers or bleeding. Recent studies
of NSAID ulcer prevention in the Gastro Intestinal (GI) tract have defined them as any lesion
three millimeters or greater with or without apparent depth. Symptoms of peptic ulcers are:
Heartburn  Gastro Esophageal Reflux Disease (GERD)  Nausea
Vomiting of blood  Loss of appetite and weight loss
14
Other drugs that increase the risk of gastrointestinal bleeding are Selective Serotonin Reuptake Inhibitors (SSRIs) such as Prozac® or Cymbalta®.
Treatment, healing and prevention of ulcers are managed by the following:



Lowering doses of the NSAIDs
Switching to a COX-2 Selective NSAID, such as Celebrex®
Adding a Proton Pump Inhibitor (PPI), such as Nexium®
Liver Failure - Certain medications can cause debilitating liver failure. This is defined as the liver
becoming damaged and failing to function. Initial symptoms include the following:
Nausea  Fatigue  Loss of appetite  Diarrhea
Certain types of liver failure occur rapidly (in as little as 48 hours). Tylenol® (acetaminophen) is
an example of a medication that may cause liver failure if excessive doses are taken. Some
examples of medications that contain acetaminophen are Vicodin®, Percocet®, and Ultracet®.
The maximum daily dosage of acetaminophen is 4,000 milligrams per day or eight tablets of
the 500-milligram strength. This dosage can vary depending upon the patient’s other disease
states or medications. There is a small difference between the maximum and lethal dose.
Ingestion of 7,500 milligrams daily can result in liver failure in fewer than seven days. Treatment
of overdose involves the administration of an anti-dote, acetylcysteine.
Other causes of liver failure include the following:



Viruses, such as Hepatitis A, B, and C
Malnutrition
Long-term alcohol consumption
Strategies to prevent or treat adverse drug effects can range in cost. For example, to prevent GI
upset, switching from a generic NSAID to a brand name medication like Celebrex® can increase
the cost of treatment. Nexium®, also a brand-name medication, added to a regimen to prevent
gastric ulcers, is also an expensive addition. In some cases, options can be fairly inexpensive,
such as adding fiber and fluids to the diet to prevent constipation: however, the cost of ignoring the adverse effects can be exponentially higher. A patient taking a very high dose of
Percocet®, plus an over-the-counter sleep aid and a cough and cold product may inadvertently
overdose on acetaminophen and end up with a lengthy, expensive hospital stay.
First Script is committed to providing information about all issues within the realm of pharmacy to our clients for the safety of the injured worker.
15
Texas “Houston Cocktail” Gains in Popularity
A combination of three highly addictive medications, dubbed the “Houston Cocktail” or “Holy
Trinity,” has become a recent target of U.S. Drug Enforcement Administration (DEA) scrutiny. The
medications prescribed include hydrocodone-containing products (Vicodin®, Lortab®) used for
the treatment of pain, carisoprodol (Soma®), a muscle relaxant, and alprazolam (Xanax®), an
anti-anxiety medication. Houston, Texas has become a national hub for the sale of the combination, which is being sold at small pain clinics dispersed throughout the area.
The three-drug combination has gained popularity and reputation for its heroin-like high. In a
world where OxyContin® has been under intense watch by federal and state agencies, abusers
are turning to new substances. According to the DEA, “Hydrocodone, alprazolam, and [other]
benzodiazepine products continue to comprise the majority of prescription controlled drugs
abused in North Texas.”
The DEA classifies controlled substances into five schedules, with schedule one (C-I) being the
most addictive (see chart below). Within the cocktail in question, only two medications are
federally controlled substances, hydrocodone and alprazolam. While none of the substances
alone are classified to be as addictive as OxyContin®, the claim is that the combination provides
euphoric effects close to that of a C-I medication. As of June 22, 2009, the State of Texas made
legislative changes to categorize carisoprodol as a C-IV controlled substance.
Schedule
Level
Description
Examples
C-l
High potential for abuse, no accepted medical use in the
U.S., lack of safety data available
C - ll
High potential for abuse, has an accepted medical use
with or without severe restrictions, abuse may lead to high
psychological or physical dependence
Morphine, Oxycodone
C - lll
Lower potential of abuse than those in schedule 1 or 2,
has accepted medical use, abuse may lead to
moderate/low physical dependence, or high psychological
or physical dependence
Hydrocodone, Tylenol ®
with codeine
C - lV
Lower potential of abuse than those in schedule 3, has
accepted medical use, abuse may lead to limited
psychological or physical dependence
Alprazolam, Carisoprodol
(state-specific)
C-V
Lower potential of abuse than those in schedule 4, has
accepted medical use, abuse may lead to limited
psychological or physical dependence
Lyrica ® , codeine cough
syrups
16
Heroin, Marijuana
Because the addictive effects of each medication in the combination are lower than
OxyContin®, the assumption is that they are less likely to receive attention by regulatory
bodies. However, according to Dr. C. M. Schade, past president of the Texas Pain Society, “doctors have no justifiable medical reason to prescribe patients all three drugs.”
The Texas Department of Public Safety (DPS) began a prescription monitoring program for
controlled substances in September 2008 which has played a fundamental role in detecting
and tracking illegitimate narcotic utilization. According to the Texas DPS, prescription monitoring programs are among the most effective tools available to identify and prevent drug diversion at the prescriber, pharmacy, and patient levels. Other neighboring states began tracking
narcotics several years earlier, which resulted in a decreased number of illegitimate pain clinics
and prescription drug abuse in those states. For example, DEA spokesman Wendell Campbell
said of Louisiana’s 2006 Prescription Monitoring Program Act that after its enactment, “… Louisiana customers, many times by the van load, started coming into Texas for the drugs.”
With the help of law enforcement agencies, the DEA, and the Texas DPS prescription monitoring program, Texas hopes to crack down on this health and public safety issue. A new state law
effective in September 2010 will require the following:
 Clinics in which 50% or more of patients are prescribed controlled substances will require
certification by the Texas Medical Board.
 Clinics must be under ownership by a Texas doctor. That doctor will also be required to be
on the premises of the facility for at least one-third of the clinic’s operating hours.
 Additional requirements for the owning doctors are to complete ten (10) continuing
education credits per year regarding pain management; provide a written drug screening
policy and compliance plan for patients receiving chronic opioids; and maintain all billing
records.
References:
1) Drug Enforcement Administration, 2008 Texas Factsheet. Accessed at www.DEA.gov on July 15, 2010.
2) Texas DPS, Updates and Notices. Accessed at www.txdps.state.texas.us on July 28, 2010.
3) Justice News Flash, Press Release. Houston TX Drug News: Potentially Lethal Drug Cocktail excessively Prescribed. June 3,
2010. Accessed at www.justicenewsflash.com on July 15, 2010.
4) Texas DPS Narcotics Service, The Goals of Prescription Monitoring. 2009. Accessed at www.txdps.state.texas.us on July 15, 2010.
5) Texas Administrative Code, Title 22, Part 9, Chapter 195. Pain Management Clinics, §§ 195.1-195.4. Accessed at
www.tmb.state.tx.us/rules/rules/bdrules.php on July 28, 2010.
17
Retail Pharmacy Safety
As the prevalence of illicit drug abuse increases,
so does the risk that retail pharmacies become
unwilling suppliers. A 2005 study reports that
40% of U.S. citizens believe prescription medicines are “much safer” to use than illegal drugs.
Additionally, 31% believe there is “nothing
wrong” with using prescription medicines without a prescription “once in a while.” Pharmacy
robberies of OxyContin® and Vicodin® are commonly reported across the country, often times
placing the lives of pharmacy employees at risk.
Drugs are typically stocked in 100-count bottles
and easily accessible by the pharmacist on open
shelves or locked drawers. The ease of access, as
well as the street value of many narcotics, makes
pharmaceuticals a profitable and relatively easy
theft for criminals. While individual states have
some programs in place to monitor robberies,
there is currently no national database to record
or analyze the frequency of these occurrences,
nor their financial and emotional impact.
Department of Justice and the Attorney
General. Eleven other agencies contribute to
their resources, including the Federal Bureau
of Investigations (FBI), the U.S. Coast Guard,
the Internal Revenue Service, as well as state
and local law enforcement agencies. In 2006,
the OCDETF created a Fusion Center, which is a
tracking system used to document all activities by the OCDETF and its affiliates. This enormous database is continually updated with
drug-related data and intelligence analysis
from the DEA.
Safety Improvements
A second significant advancement in the
ability of the United States to trend, predict,
and prevent retail pharmacy crimes was
created in 2009. The National Institute for
Occupational Safety and Health (NIOSH)
entered into a partnership with Statistical
Analysis Centers (SACs) to create a database of
homicides, robberies, and assaults on healthcare workers with a primary focus on pharmacists. NIOSH, part of the Centers for Disease
Control and Prevention (CDC), is a federal
organization responsible for researching and
suggesting solutions for preventing workrelated injuries. The SACs are state specific
Tracking Trends
Beginning in 1982, the Drug Enforcement Administration (DEA) formed the Organized Crime Drug
Enforcement Task Force (OCDETF). These 2,500
agents work to identify and manage drug
trafficking operations and are overseen by the
18
centers that collect and track various data. As of
2009, five states are already tracking data for the
partnership. Their hope is to create a comprehensive database of retail pharmacy crimes using
NIOSH and state-specific law enforcement data
managed with SAC technology. These records
can then be used by NIOSH to develop recommendations for improving the safety of pharmacy employees in the workplace.
have immediate access to narcotics. In addition to
being an anti-theft automation device, the unit
also maintains a perpetual inventory of each drug
per DEA requirements.
As drug overdoses climb to the second leading
cause of death in the United States, a concurrent
concern arises as the public seeks alternatives to
obtain these drugs. Unfortunately, pharmacists,
the only medical profession directly accessible to
customers, are at risk of being in the center of a
hostile situation as they are a direct means to
medications. The DEA Fusion Center and the
NIOSH/SAC databases are enormous steps
forward to taking action in securing the safety of
pharmacy employees nationwide. Additionally,
the advent and increase of security cameras,
security personnel, and pharmacy safes may
deter robberies, improve employee safety, and
limit the availability of prescription medications
for illicit purposes.
Safety in Automation
The PharmaSafe, a store-level anti-theft technological advancement, will be available to pharmacies beginning in 2010. The creator of the
PharmaSafe noticed that the most effective innovation to deter convenience store robberies was
the cash drop safe. As word spread that large
amounts of cash were not available to cashiers,
the thieves stood to gain less profit at each holdup, therefore making robberies far less beneficial.
The same idea applies to the PharmaSafe. Medications may only be removed from the safe when
a prescription is entered into the pharmacy’s
computer system. After the prescription is
entered, the unit automatically dispenses the
prescribed quantity into a vial. That pre-poured
quantity can then be removed after a
pre-determined length of time by the pharmacist
with a password, electronic fingerprint, or
electronic key. Posted notices are placed at the
front of the store and at the pharmacy counter,
notifying the public that the pharmacist does not
References:
1) http://www.usdoj.gov/dea/pubs/cngrtest/ct051607.html
2) U.S. Department of Heath and Human Services,
Substance Abuse Treatment Advisory; Spring 2009, v8.
3) http://www.usdoj.gov/dea/pubs/history/2003-2008.pdf
4) http://www.cdc.gov/niosh/blog/nsb021709_pharm.html
5) JRSA Forum Newsletter. NIOSH Teams with SACs to Study
Violence against Pharmacy and Healthcare Workers;
September 2009, Vol. 27, No 3.
6) Modern Medicine e-newsletter. PharmaSafe: Dispensing
protection for pharmacies. January 15, 2010.
19
Genzyme Takes First Bold Step Towards Medication Tracking
An initiative between Genzyme and the Healthcare Logistics division of the United Parcel
Service (UPS) began in 2008 to develop serialization for shipping and tracking pharmaceuticals.
Genzyme is one of the world’s leading biotech companies, responsible for the research and
design of medications for many specialties, such as oncology, immunology, and orthopedics.
Accenture, a technology management consulting company, assisted with the partnership to
design and implement the program.
As a result of the new tracking system, Genzyme will be able to follow the location of their products from warehouse, to wholesaler, to pharmacy. Previously, no mechanism existed by which
drug manufacturers could be certain where their products were distributed, except from
reports by pharmacies and wholesale companies. The new tracking system will be a great
improvement in product security and the emerging issue of drug diversion may be reduced.
Pharmacies receiving medication via one or more distributors will be able to validate that the
medication originated from the actual manufacturer as opposed to a counterfeit source.
UPS has now designed warehouse practices to include the use of this tracking system. An electronic code, called a GS1 barcode, is affixed to each individual package and shipping container.
UPS created an electronic scanner to read the code, which then communicates to the main
database. The company reports that this is “the largest system change [it has] made in nearly a
decade.” UPS will be able to offer the service to other healthcare clients as well. In addition, it
promotes the expectation of seeing improved tracking of items with the ability to link shipments to other order processing procedures.
The tracking process is expected to begin in 2010, long before state mandates are set in place.
California has discussed mandatory medication tracking for many years due to the everincreasing amount of diversion present in the state. However, such mandates are delayed until
at least 2015 due to poor economic standings. The commitment and achievement of Genzyme
is commended by many law makers, as it is a voluntary first step forward in the battle against
drug diversion.
References:
1) http://www.pharmaceuticalcommerce.com/frontEnd/main.php?idSeccion=1348
2) http://www.worldtrademag.com/Articles/Column/BNP_GUID_9-5-2006_A_10000000000000752028
3) http://www.ean-int.org
20
The Changing Landscape of Repackaged Medications
The growing dilemma of repackaged medications continues to emerge as a
hot button issue for a number of states. This is perhaps best highlighted by the
recent legislative dispute in Florida over House Bill 5603. The bill would have
included language amending the pharmacy fee schedule to specifically
include repackaged and repriced medications. Another state that is addressing repackaged medications is Mississippi. Mississippi has adopted new fee
schedule language specifically aimed at medication repackagers.
Repackaged medications are typically products which were purchased at one
price and sold in smaller unit-of-use packaging for a higher price. This practice
raises serious cost-management concerns because repackaged medications
are frequently neither subject to state fee schedule limits nor do they provide
adequate information through which pricing can be controlled. In fact, several
state fee schedules do not include specific provisions to capture physician-dispensed medications, the setting in
which the majority of repackaged medications are dispensed. Even in the presence of a fee schedule that limits
physician dispensing, the fact that most repackaged medications do not include an original manufacturer’s
National Drug Code (NDC) label makes finding correct medication pricing difficult.
Payers are becoming acutely aware of how repackaged medications add cost to the workers’ compensation system.
Early responses to these concerns resulted in the creation of fee schedule changes in a handful of states, with
Florida and Mississippi being the most recent.
Florida
As to the aforementioned Florida legislation, House Bill 5603 would have included an amendment to Florida Statute
440.13, the fee schedule. Specifically, the amended fee schedule language would have included repackaged and
repriced medications in the prescription types covered by the fee schedule. Additionally, the amended language
would have allowed repackaged medications to be priced using the manufacturer’s original per unit Average Wholesale Price (AWP), multiplied by the number of units dispensed. Unfortunately, the amendment was vetoed by Governor Crist because of the overwhelming public opinion that the amended language had not been sufficiently debated
in the legislature. In November, the newly elected legislature explored the possibility of overriding the veto, but
passed at the last moment on raising that issue during a special session.
Mississippi
For its most recent fee schedule revision (effective July 1, 2010), Mississippi
chose to make specific inclusions for physician-dispensed and repackaged
medications. Repackaged and physician dispensed medications will now be
priced using a “lesser of” formula which allows the AWP to be determined by
1) the NDC of the underlying drug product from the original labeler; or 2) the
therapeutic equivalent drug product from the original labeler’s NDC.
As states continue to address this dilemma, Coventry and First Script will
continue to work with legislators and administrators to push for the curtailment of unnecessary prescription expenditures. We have created integrated
Pharmacy Benefit Management and Bill Review Solutions to bring down these
costs in jurisdictions that allow such reductions to occur. We continue to
believe that physician dispensing can and does fill an important need in the
responsible clinical treatment and the quick return-to-work of injured workers. Accordingly, we intend to work with physician groups to find practical
solutions that limit wasteful spending, but ensure quality patient care.
Physiciandispensed
pharmaceuticals
accounted for
17% of workers’
compensation
drug costs in
2008, up 8% from
the prior year.
Source: NCCI Holdings Inc.
References:
1) 2009 Arizona Pharmacy Fee Schedule
2) Florida House Bill 5603 (2010)
http://www.myfloridahouse.gov/Sections/Documents/loaddoc.aspx?FileName=_h5603er.docx&DocumentType=Bill&BillNumber=5603&Session=2010
3) 2010 Mississippi Fee Schedule: http://www.mwcc.state.ms.us/services/2010finaldraft.pdf
21
fsAlert Triggers
The First Script Pharmacy Benefit management program provides quality pharmaceutical management and safety to injured
workers while providing cost savings to the
payor. One aspect of the First Script program
that is used to assist in claim oversight is our
fsAlert tool. fsAlert monitors the daily
prescription file and sends alerts when a
drug is being filled that has been identified.
Because this message is sent following the
prescription being filled, it does not prevent
the injured worker from receiving the medication; rather, it is a means for identifying
claims that may require additional attention.
Below is a list of possible triggers that can be
activated by First Script.
Controlled Medication Alert
The injured worker’s profile is reviewed for the
specified time frame and if the medication is a
controlled substance, an alert will be generated.
Generic Opportunity Alert
A brand name medication was dispensed
that had a generic equivalent product in the
market place.
Over-Utilization of Short-Acting and
Sustained-Release Narcotics Alert
A claimant received a prescription for either a
short-acting narcotic or a sustained-release
narcotic where the daily dose exceeds the
specified maximum daily dose.
Dollar Value Exceeded Alert
This alert works in conjunction with the claims
file to identify medical only versus lost-time
(indemnity) claims. The alert may be configured to set a different threshold for medical
only and indemnity claims. The injured
worker’s prescription history is reviewed,
dollars used are totaled, and if the total is
greater than the agreed upon threshold, an
alert is generated.
Target Drug Alert
This alert is set to review the injured worker’s
profile to determine if the targeted medications have been filled previously; if not, an
alert is generated.
Excessive Muscle Relaxant Utilization Alert
An alert is generated after thirty consecutive
days (or client specified time frame) of muscle
relaxant utilization.
New Narcotic Prescriber Alert/
New Prescriber Alert
A new physician was identified that has not
previously prescribed narcotics or is new to
the injured worker.
The chart on the next page summarizes the
alerts and provides importance and considerations.
22
Alert
Importance
Considerations
Target Drug
Identifies new medications as
specified by the client
Review treatment plan; consider
non-pharmacological treatment modalities;
challenge the prolonged use of these medications.
Over-utilization of
Sustained-release
Narcotics
Identifies possible excessive
dose of SR narcotics
Review history of narcotic usage and treatment plan.
Is there something else occurring, such as impending surgery or other procedure that may induce
greater pain for the short term? If not, the dosing
should be challenged.
Over-utilization of
Short-acting Narcotics
Identifies possible excessive
dose of short-acting narcotics,
especially those containing
acetaminophen
Review history of narcotic usage and treatment plan.
Is there something else occurring such as impending
surgery or other procedure that may induce greater
pain for the short term? If not, the dosing should be
challenged. Would the claimant benefit from a
long-acting narcotic for a short duration for pain
management?
Excessive Muscle
Relaxant
Utilization
Identifies muscle relaxant
utilization above the
recommendation of the Official
Disability Guidelines and
product labeling
Review history to determine appropriate utilization
of muscle relaxants; is use intermittent or consistent?
If use is consistent, are there other potential
treatment options? If use is consistent, are there
other issues occurring outside of painful muscle
contractions?
New Narcotic
Prescriber/ New
Prescriber
Identifies a new physician
prescribing narcotic
medication for the claimant
Review history to determine whether physician has
prescribed medication previously (more than 90 days
prior to date of service). Determine if new physician
is a specialist and, if so, has something changed?
Is there a possibility of “doctor shopping” in order to
obtain more narcotics?
Controlled
Medication
New controlled medication is
now being utilized by claimant
Review history to see if new product is replacing an
existing medication. Review strength of new of
medication; is it stronger than similar products seen
on the profile? Is the medication in addition to other
narcotics; consider possible tolerance or addictions
issues. How is the treatment plan being managed?
Generic
Opportunity
Identifies the medical necessity
of the brand name product
Has the claimant tried the generic version? What
was the outcome? Obtain adjuster approval to
review the medical need for the branded product.
Dollar Value Exceeded
Dollar thresholds may be
applied to both medical only
and indemnity claims
Review claim to determine need to move to
indemnity status or review indemnity claims for
claim management intervention.
23
Drug Utilization Assessment
and Physician Peer Discussions
Improve Claim Outcomes
Drug Utilization Assessment
As injuries progress to a chronic phase, prescribed
medications often increase in an attempt to improve a
patient’s quality of life. Often these medications
consist of expensive, sustained-release narcotics and
anti-convulsants. If the chronic nature of the pain
disrupts the patient’s sleep patterns or appetite,
additional medications may be added to the regimen.
 Examines a claimant’s current pharmaceutical
medication regimen based upon a review of
the submitted medical treatment records
and prescription medication histories
 Identifies utilization issues, such as
brand/generic substitution,
overuse/underuse, over-prescribing of
drugs, and elimination due to duplication
therapy, thus leading to cost savings
Studies have shown that the cost per prescription
doubles by the time a claim reaches four years. Fee
schedules and the substitution of generics can
address cost but do little to reduce over-utilization or
abuse.
 Recommends alternatives, if necessary, to
the current regimen based on medical necessity,
current official guidelines, and best practice
medical guidelines
Simple medication reviews alone are not always
sufficient to persuade the prescribing physician to
change the medication regimen, and many treating
physicians insist on analyses that incorporate more
than merely a listing of the recommended uses of the
medication.
 Outlines current annual drug cost and
possible savings based on recommended
changes
 Permits licensed clinical pharmacists to review the
functional status of the patient and employ
best practice guidelines in evaluating
proper dosing
In such circumstances a Drug Utilization Assessment
(DUA) that examines a claimant’s current pharmaceutical medication regimen based upon a thorough
review of medical records and pharmacy claim data,
has demonstrated significant success in changing
prescription regimens. This program recommends
alternatives, if necessary, to the current regimen based
on medical necessity, current official guidelines, and
best practice medical guidelines. Once a DUA has
been completed, a medical Peer-to-Peer (P2P) review
can be performed in order to facilitate the adoption of
the pharmacy recommendations.
 Provides a basis and report for a Peer-to-Peer
review.
DUAs and P2Ps are also tied into the First Script
Pharmacy Program, which includes a variety of drug
utilization tools that identify utilization history. Overutilization is monitored for each pharmacy transaction, and when a medication is identified for retrospective review, an alert is sent to the adjuster or case
manager. The claim management team can discuss
the alert with the pharmacist for recommendations,
including the possibility of a DUA.
24
basis of a comprehensive approach to the management of prescription medications.
The DUA offers a 360 degree view of the patient,
including co-morbid conditions, diagnostic tests,
treatment modalities, and the patient’s specific
medical history, all as they relate directly to the
medications being prescribed. It has shown great
value when applied earlier in a case. The DUA
provides the opportunity to discover circumstances
where there may be multiple prescribers recommending the same medications or medications, which,
when taken together, may cause the patient to have
adverse reactions.
A DUA and P2P may be effective in the following
circumstances:
 More than one prescribing physician
 Utilization of narcotics
 Duplicative therapies (i.e., two drugs in the
same therapeutic class)
 Prescription medication costs exceeding
$5,000 annually
As a clinically based document, the DUA serves as a
basis for discussion with the prescriber or prescribers.
The discussion can be between the adjuster, a
telephonic nurse, a field case nurse or, when necessary, through a physician peer discussion.
 Recommendations for brand name drugs
rather than generics
Physician Peer-to-Peer (P2P)
 An in-house Medical Director reviews the Drug
Utilization Assessment
A recent Coventry study involving a large national
carrier revealed that the physician Peer-to-Peer (P2P)
discussion resulted in agreement to change the
regimen in 86% of the cases. When applied to the
rebuttal process on two recent Medicare Set-Aside
cases, one Coventry customer realized savings in
excess of $740,000.00.
 Coventry’s Medical Director contacts the
prescribing physicians to discuss implementation
of the recommendations outlined in the Drug
Utilization Assessment
 A report summarizes the communication and
outlines the specific agreed upon modifications
and the rationale for any non-compliance with the
drug utilization recommendations
Recently, the DUA’s value was further enhanced when
the Centers for Medicare and Medicaid Services
indicated that it is no longer necessary to allocate for
medications used “off-label” as defined by the FDA.
DUAs identify specific circumstances where medication usage may be “off-label”.
The DUA, integrated with telephonic or field case
management or physician P2P discussions, forms the
25
Containing Out-of-Network Prescription Costs
This year First Script introduced a multifaceted approach to address third-party billing concerns in an
effort to further contain workers’ compensation prescription costs for our clients. First Script historically
has employed a strong, integrated out-of-network program that uses bill review data to drive the next
prescription fill back into our network by placing an outbound call to the pharmacy. While this process
has been very successful, we recognize there is an opportunity for enhancement. The following projects
greatly increase our ability to control third-party billing costs.
Re-Indexing with Major Pharmacy Chains
First Script has developed direct pharmacy relations with major retail chains to help increase the
in-network capture of pharmacy transactions. These relationships allow First Script to lock in eligibility
to the First Script program for participating pharmacy chains at the claimant level. This will minimize
third-party and direct billing activity and provide First Script with the means to capture more transactions at the contracted rate.
Repackager Re-pricing Initiative
Repackagers take previously manufactured medications, “repack” them into smaller units, create a new
National Drug Code (NDC), and oftentimes inflate the Average Wholesale Price (AWP) of the medication.
These inflated AWPs are then used to determine fee schedule pricing through the bill review engine. To
address this, First Script has implemented a repackager re-pricing program in Florida to identify an AWP
that more closely reflects the “originating” manufacturer’s AWP price. First Script flags repackaged and
relabeled medications through the bill review engine. This allows us to identify these medications and
reduce the cost. First Script is currently researching other states that are candidates for the repackager
program.
Clinic Bill Normalization and Re-pricing Initiative
While First Script does not take the position that physicians should not dispense medications, we do
support cost management for those transactions. In the third quarter of 2010, First Script began working with a clinic partner to provide a list of clients, which will be identified as First Script participating
employers. For these identified employers, prescriptions will be billed directly through First Script. We
are also in the process of expanding this program to include additional clinics.
Third-Party Biller Relationships
Third-party billers are often used by pharmacies to ensure they receive reimbursement for workers’ compensation prescriptions. To reduce the pharmacy’s desire to use a third-party biller, First Script has
developed relationships with third-party billers that will alleviate third-party biller communication for
the claims examiner, reduce the time needed to address prescriptions that are filled through these
providers, and ultimately reduce the costs charged by third-party billers.
All of the phases listed above are critical to increasing network penetration and reducing costs. This
focus also decreases claims examiner and injured worker involvement by better managing both retail
and non-retail client drug spend.
26
Upcoming Patent Expirations
Manufacturers of brand name medications typically hold patents on their products between seven and
fourteen years. Once the brand name patent expires, only then are manufacturers permitted to gain
Food and Drug Administration (FDA) approval to sell a chemically and biologically comparable generic.
It is important to note that the introduction of a generic medication to the marketplace sometimes has
no bearing whatsoever on the branded product's original patent expiration date. There are often patent
challenges and extensive litigation trials between companies. Sometimes a generic manufacturer can
challenge a patent and gain approval before the original expiration date and, contrarily, sometimes the
brand manufacturer can file for extensions, preventing generics for years longer than the original expectation. Often times the first manufacturer to gain approval for their generic is granted a 180 day exclusivity period during which no other generic may be sold.
The following list details some common workers’ compensation brand name medications and their
patent expiration dates.
BRAND DRUG
GENERIC DRUG
THERAPEUTIC CLASS
PATENT EXPIRATION
Lyrica
Celebrex
Lidoderm
Cymbalta
Ambien CR
Nexium
Lexapro
Lunesta
Kadian*
Avinza
Flector
Opana ER
Seroquel
Provigil
Amrix
Voltaren Gel
Arthrotec
Advair
Rozerem
Aciphex
Abilify
Pregabalin
Celecoxib
Lidocaine
Duloxetine
Zolpidem CR
Esomeprazole
Escitalopram
Eszopiclone
Morphine ER
Morphine ER
Diclofenac
Oxymorphone ER
Quetiapine
Modafinil
Cyclobenzaprine ER
Diclofenac
Diclofenac/misoprostol
Fluticasone/salmeterol
Ramelteon
Rabeprazole
Aripiprazole
Anticonvulsant
Anti-inflammatory, NSAID
Anesthetic
Antidepressant, Non-TCA
Hypnotic agent
Anti-ulcer
Antidepressant, Non-TCA
Hypnotic agent
Sustained-release narcotic
Sustained-release narcotic
Dermatological/Topical
Sustained-release narcotic
Anti-psychotic
Central nervous system stimulant
Muscle relaxant
Dermatological/Topical
Anti-inflammatory, NSAID
Allergy/Asthma
Hypnotic agent
Anti-ulcer
Anti-psychotic
October 2013
November 2013
May 2012
June 2013
December 2019
May 2014
September 2011
January 2012
March 2010
November 2017
April 2014
September 2013
March 2012
April 2012
November 2023
October 2010
February, 2014
March 2011
March 2017
May 2013
October 2014
(If multiple patents, earliest date is listed)
*Although Kadian’s patent has expired, there are no approved generics for this product on the market
Note: Dates listed are subject to change and may not necessarily reflect dates that generics will be available
References:
1) U.S. Food and Drug Administration, The Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
Accessed online July 14, 2010. Available at: http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm.
2) Drug Topics, “Going, Going, Gone” August 10, 2009.
3) The Pharmacist’s Letter, 2009; 25(10):251011.
27
Drug Delivery Methods
Drug delivery refers to the manner in which medications enter the body. Due to advances in medicine, drugs may
be administered in a variety of ways utilizing many different delivery systems, including orally (capsules, tablets,
caplets, elixirs, syrups, emulsions or suspensions); sublingually (under the tongue); topically/transdermally
(patches, ointments, creams, pastes, lotions, or gels ); rectally or vaginally (suppositories); ophthalmic (into the eye),
otic (into the ear), nasally (into the nose); inhaled (through the lungs); subcutaneously (injection directly under the
skin); intramuscularly (into the muscle); or intravenously (through the vein).
In the workers’ compensation industry, commonly utilized medications may be grouped into the categories of
solids, liquids, injectables and topicals.
Solids
Medications in this category include capsules, tablets, and lozenges. These can further be divided into:
 Immediate release: The drug immediately begins to release upon ingestion.
and Neurontin® capsules.
Examples are Vicodin® tablets
 Time-released: The medication dissolves slowly and releases over time upon ingestion. These medications are
also known as Sustained Release (SR), Sustained Action (SA), Extended Release (ER, XR, or XL), Modified Release
(MR) Controlled Release (CR), and Continuous Release (CR or Contin). The most common example is OxyContin®
tablets.
 Buccal tablets: Utilized differently because they are not swallowed, but rather placed between the cheek and
gum where they remain in place until they are dissolved and the medication is absorbed across the lining of
the mouth. An example of this dosage form is Fentora®, a narcotic pain medication containing fentanyl.
 Lozenges: Medications also designed to be held in the mouth and dissolved slowly. An example of this is
Actiq® (fentanyl), a narcotic pain medication approved for break-through cancer pain.
Liquids
Medications in this category are used on a much smaller scale than solid drugs, largely because of their bulky
nature. They include: elixirs, emulsions, syrups, and suspensions. An example of a liquid is Lortab® elixir, a narcotic
used for pain relief.
Injectables
Drugs in this category (also called parenterals) are liquid medications that are taken into the body or administered
in a manner other than through the digestive tract or gastrointestinal system. They can be administered intravenously (IV), intramuscularly (IM), or subcutaneously (SC, SQ or subQ) An example of an injectable is Fentanyl.
Topical
Medications in this category contact the skin surface and penetrate by three potential pathways.
a). Through the sweat ducts
b). Through the hair follicles and sebaceous or oil glands
c). Directly across the outer most layer of the skin called the stratum corneum.
The two most commonly used topicals in the workers’ compensation industry are patches and gels.
Include drugs in some form of membrane. An example of this is Duragesic®
(fentanyl) patches and Lidoderm® (lidocaine) patches both used for pain.
 Patches -Adhesive pads:
 Gels-Solid jelly like materials: Can range from soft to hard. By weight, gels are mostly liquid but they are
thicker in the container and liquefy upon contact with the skin. An example is Voltaren® Gel, a non-steroidal
anti-inflammatory analgesic for pain.
Reference: Cross, S E Roberts, m s curr.-Delivery, 2004, 1.81-92, www.fda.gov, and Drugs Facts and Comparison
28
2010 Pipeline Drugs
Pipeline drugs are medications that a pharmaceutical company has under development or
testing. The development of drugs involves various phases that can be grouped into three
stages: (a) Pre-clinical trials, (b) Clinical trials and (c) Marketing or post-approval. The drugs listed
in the table below are all in the clinical trial stage and are awaiting approval by the Food and
Drug Administration (FDA).
Drug
Manufacturer
Indication
Therapeutic
Category
Estimated
Launch Date
Abstral
(Fentanyl)
Orexo AB
Breakthrough Cancer
Pain
Opioid Analgesic
Unknown
Retigabine
GlaxoSmithKline
Antiepileptic
Broad Spectrum
Anticonvulsant
3rd Quarter 2010
Naproxcinod
NicOx S.A.
Osteoarthritis
New NSAID-CINODS Unknown
Contrave
(Bupropion SR/
Naltrexone SR)
Orexigen
Therapeutics, Inc.
Obesity
CNS Inhibitor
4th Quarter 2010
Civanex Cream
(Zucapsaicin)
Winston Laboratories,
Inc.
Osteoarthritis
Topical Analgesic
Unknown
Eladur
(Bupivicaine Patch)
King Pharmaceuticals,
Inc.
Chronic Low Back
Pain
Topical Patch
Unknown
Xarelto
(Rivaroxaban)
Johnson & Johnson
Ortho-McNeil
Thrombo-Embolism
Oral Anticoagulant
3rd Quarter 2010
JZP-6 Oral Solution
(Sodium Oxybate)
Jazz Phamaceuticals,
Inc.
Fibromyalgia
CNS Depressant
Unknown
Sativex
(TetrahydrocannaBinol -THC) and
Cannabinol -CBD)
Otsuka
Pharmaceuticals
Severe NeuropathicRelated Cancer Pain
Cannabis Extract
Sublingual Spray
Unknown
DM-1796
(Gabapentin
Extended Release)
Abbott Products, Inc.
Neurological Pain
Anticonvulsant
Unknown
Horizant ER
Gabapentin
(Enacarbil)
GSK
Moderate to Severe
Restless Leg
Syndrome
Anticonvulsant
Unknown
Zenvia
(Dextromethorphan
and Quinidine Sulfate
Avanir
Pharmaceuticals, Inc.
Diabetic Peripheral
Neuropathy Pain
CNS Inhibitor
4th Quarter 2010
NP-1
(Ketamine and
Amitriptyline
Cream)
EpiCept Corporation
Post Herpetic
Neuralgia
Topical Analgesic
Unknown
Reference: www.drugs.com/new-drug-applications Formulary: FDA Pipeline Preview, June 2010
29
Coventry Workers’ Comp Services, a division of Coventry Health Care, Inc.
(NYSE: CVH), is the leading provider of cost and care management
solutions for property and casualty insurance carriers, (workers’
compensation and auto insurers), third-party administrators and selfinsured employers. We design best-in-class products and services to
help our partners restore the health and productivity of injured
workers and insureds as quickly and as cost effectively as
possible. We accomplish this by developing and maintaining
consultative, trusting partnerships with our clients and
stakeholders, built on a foundation of innovative and
customized solutions that support the claims
management process.
First Script understands the unique requirements of
pharmacy benefits management and durable
medical equipment programs. We offer not only
an extensive pharmacy network, but also a fully
integrated first fill program that provides
complete control of pharmacy services through
out the life of a claim. First Script also goes
beyond traditional durable medical equipment
programs to offer a national network of
local providers for all types of workers’
compensation claimant products
and services.
First Script
155 N. Rosemont Blvd., Suite 201
Tucson, Arizona 85711
www.coventrywcs.com
Solutions to restore health and productivity.