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December 2010

A quarterly publication of PMSI Clinical Services


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Year in Review : 2010 Medication Updates

Year in Review: 2010 Medication Updates

As 2010 comes to a close, we take a step back to look at the past year's medication updates that will impact the workers' compensation and pain management markets. Many of the agents that have been introduced this year will have lasting affects on patient care, utilization trends, and total costs. The U.S. Food and Drug Administration (FDA) has been busy with new generic approvals, such as Actiq® (fentanyl citrate), Opana® (oxymorphone) and Skelaxin® (metaxalone); new product formulations, such as the ButransTM (buprenorphine) patch and most recently the voluntary recall of propoxyphene products. The more than 20 market approvals, introductions or changes discussed in this edition represent the vigor of the everchanging array of pharmaceuticals available to treat workers' compensation injuries. Morphine Sulfate Oral Solution 20 mg/mL FDA Approved Formulation Available: January 2010 Class: Opioid Analgesic Skelaxin (metaxalone) Generic Available: March 2010 Class: Skeletal Muscle Relaxant Approved and released in early 2010, metaxalone became the next generically available skeletal muscle relaxant to enter the U.S. market. Similar to other agents in this class, the pharmacologic benefit of metaxalone is believed to be due to its sedative properties. Compared to other skeletal muscle relaxants, such as carisoprodol and cyclobenzaprine, metaxalone is thought to possess a decreased potential for abuse. Similar to the brand-name product, generic metaxalone is only available in 800 mg tablet form. The generic formulation entered the market at 10% less than the price of the brand-name product. Given the high utilization of this medication within the workers' compensation industry, the availability of this generic formulation resulted in significant improvements in the generic dispense rate for metaxalone.

Reference: Sandoz announces launch of first generic version of leading muscle relaxant Skelaxin®, with ANDA exclusivity. FiercePharma. http://www.fiercepharma. com/press_releases/sandoz-announces-launch-firstgeneric-version-leading-muscle-relaxant-skelaxin-anda-e <Accessed October 22, 2010>


Opioids REMS Delayed Until 2011

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FDA MedWatch Reports

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In early 2010, the FDA granted approval to Roxane Laboratories to market the only FDA-approved morphine sulfate 20 mg/mL oral solution available JANUARY on the U.S. market. Despite a lack Morphine Sulfate of formal FDA approval until this Oral Solution point, marketed morphine sulfate approved oral solutions, as well as several other opioid analgesics, had been available. Currently, only four drug manufacturers (Glenmark Pharmaceuticals Limited, Lannett Company, Inc., Paddock Laboratories, Inc., and Roxane Laboratories) possess approved morphine sulfate products. For the complete list of unapproved opioid pain relievers identified by the FDA, please visit the following website: GuidanceComplianceRegulatory Information/EnforcementActivitiesby FDA/SelectedEnforcementActionson UnapprovedDrugs/ucm165587.htm.

Reference: FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain. FDA NEWS RELEASE. pressannouncements/ucm198667.htm <Accessed September 21, 2010>

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Skelaxin generic launched Actiq generic launched


Qutenza released OxyContin new formulation Pennsaid released Exalgo released

Actiq (fentanyl citrate) Generic Available: March 2010 Class: Opioid Analgesic Also in March, Mallinckrodt Baker announced the availability of an AB-rated version of fentanyl citrate. Although a non-rated generic version of Actiq has been available since 2006 through Teva Pharmaceutical Industries Ltd., an actual AB-rated equivalent was not available until this point. This new categorization has translated into an increase in generic use. Similar to the brand-name formulation, the new AB-rated generic equivalent is only FDA indicated for the treatment of cancer-related breakthrough pain in patients already utilizing around-theclock opioid pain relievers. Although the new AB-rated status of generic Actiq places it in compliance with the FDA's generic approval process, the product remains unchanged in its formulation or clinical significance.

OxyContin® (oxycodone controlled-release) New Formulation Available: April 2010 Class: Opioid Analgesic Subsequent to concerns about misuse of the existing controlled-release formulation, OxyContin's manufacturer, Purdue Pharma L.P., redesigned the release mechanism for its long-acting opioid analgesic. According to the manufacturer, the new formulation was developed to make it more difficult to extract the active ingredient by inappropriate means. Until this time, the oxycodone component of OxyContin could be easily accessed via alterations to the tablet (e.g., crushing, dissolving, chewing, etc.) leading to potentially life-threatening amounts of the opioid being released at once instead of the intended 12-hour release period. Although the formulation was modified, Purdue indicated patients would experience no change in the pain-relieving characteristics of this agent.

Reference: New OxyContin Formulation to Help Prevent Abuse of the Drug. NATIONAL ASSOCIATION OF BOARDS OF PHARMACY. http://www.nabp. net/news/new-oxycontin-formulation-to-help-prevent-abuse-of-the-drug/ <Accessed September 21, 2010>

Reference: First-time generic approvals for 2009. DrugManagementForumTM. http:// <Accessed October 4, 2010>

Qutenza® (capsaicin) Topical Patch New Medication Launch: April 2010 Class: Dermatologic NeurogesX® announced in April availability of the first prescription strength capsaicin topical patch. FDA approved Reference: Pennsaid ® Launch Brings New Treatment to Knee Osteoarthritis Patients. Medical News Today. for treatment of neuropathic (nerve) pain following shingles <Accessed September 22, 2010> (postherpetic neuralgia), clinical trial data released by the company indicates application of the patch for one hour ExalgoTM (hydromorphone extended-release) can provide up to three continuous months of pain relief. New Formulation Available: April 2010 Formulated as a synthetic version of capsaicin, a naturally Class: Opioid Analgesic occurring compound found in chili peppers, administration After suffering a brief delay in the approval process in of Qutenza must take place in a physician's office, under January 2007 direct supervision of a medical doctor. Although not approved November 2009, the FDA formally approved the only pms for treatment of other neuropathies, it is possible that this agent available, long-acting formulation of hydromorphone. Similar to immediate-release formulations, Exalgo was approved for may soon be utilized in an off-label manner for treatment treatment of moderate-to-severe pain; with the exception that of generalized neuropathic pain. Considering an average it only be utilized in patients requiring around-the-clock pain wholesale price of slightly over $800, the use of this agent is pms coverage. 4% more expensive than an equivalent regimen with gabaA quarterly publication of PMSI Clinical Services Reference: Highlights of Prescribing Information. Mallinckrodt Inc., pentin (three-month supply) and 31% more expensive than nfo Quarterl a Covidien Company. Lyrica® (three-month supply).

Reference: Qutenza (capsaicin) 8% Patch for Treatment of Post-Shingles Pain Now Available. Medical News Today. php <Accessed September 22, 2010> FullPrescribingInformation.pdf <Accessed September 21, 2010>

Pennsaid® (diclofenac sodium) Topical Solution New Formulation Available: April 2010 Class: Non-steroidal Anti-inflammatory Drug Approved in late 2009, Covidien introduced the first available topical diclofenac sodium solution into the U.S. market in early 2010, as an analgesic option for signs and symptoms of osteoarthritis knee pain. Similar to other topical non-steroidal anti-inflammatory drugs (NSAIDS), such as Flector®, Pennsaid is quickly gaining acceptance and is being utilized in an off-label manner for treatment of an assortment of painful conditions.

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SprixTM (ketorolac) Intranasal Spray New Formulation Approval: May 2010 Class: Non-steroidal Anti-inflammatory Drug Representing the first intranasal formulation of ketorolac tromethamine, Sprix was approved early this year for treatment of acute moderate-to-severe pain normally requiring opioid-level analgesia. In clinical trials, use of Sprix led to a decrease in need for supplemental opioid administration, as compared to patients not utilizing intranasal NSAID. Although introduction of Sprix provides a new non-opioid alternative for patients requiring opioidlevel pain relief, its use is limited to a maximum of five consecutive days of therapy due to possible adverse effects. This will limit its use in chronic workers' compensationrelated pain conditions, however may prove to be useful for as-needed conditions such as migraines.

Reference: FDA Approves Roxro Pharma's Sprix Nasal Spray. The Medical News. <Accessed September 22, 2010>

RybixTM (tramadol) Orally Disintegrating Tablet New Formulation Available: June 2010 Class: Opioid Analgesic Approved in mid-2010, Rybix introduced the first orally disintegrating formulation of tramadol products intended for management of moderate to moderately severe pain in adults. Similar to other short-acting formulations of immediate-release tramadol, Rybix was approved for treatment of breakthrough pain episodes; it is not intended for around-the-clock pain coverage.

Reference: Rybix Prescribing Information. Victory Pharma. http://www. <Accessed September 21, 2010>


Sprix approved (not yet available)


Butrans approved (not yet available) Rybix launched


Effexor XR generic capsules launched Zuplenz approved

Butrans (buprenorphine) Topical Patch New Formulation Approval: June 2010 Class: Opioid Analgesic A re-enlivened direction for the use of buprenorphine products in pain management, the Butrans topical patch by Purdue Pharma L.P. is the first outpatient buprenorphine product FDA approved for baseline pain relief. Although an intravenous/intramuscular formulation is currently available for pain treatment, the Butrans patch is the first buprenorphine product approved for treatment of pain outside of a healthcare setting (e.g., hospital, physician's office). Although Purdue has yet to set an official release date, it is expected this agent may become a popular option for patients who experience uncontrolled around-theclock pain, and in those for whom a reduced abuse liability and toxicity profile is desired.

Reference: Butrans Highlights of Prescribing Information. Purdue Pharma, L.P. http://www. <Accessed September 21, 2010>

Effexor XR® (venlafaxine extended-release) Capsule Generic Available: July 2010 Class: Antidepressant The FDA announced approval of the first AB-rated generic version of Effexor XR capsules for treatment of major depression in mid-2010. Although a non-rated, extendedrelease venlafaxine tablet alternative has been available on the U.S. market, it is not considered a true generic equivalent due to differences in the drug's formulation (capsule versus tablet). The FDA indicates generic extended-release venlafaxine capsules possess the same safety warnings as the brand-name product. First shipments of the new generic product began in July 2010, with a cost savings of roughly 10% compared to the brand-name formulation.

Reference: FDA Approves First Generic Effexor Extended Release Capsules to Treat Major Depressive Disorder. FDA NEWS RELEASE. Newsroom/PressAnnouncements/ucm217624.htm <Accessed October 22, 2010>

ZuplenzTM (ondansetron) Oral Soluble Film New Formulation Approved: July 2010 Class: Anti-emetic Following difficulties with the FDA approval process in early 2010, Strativa Pharmaceuticals announced in July 2010 that its oral soluble film formulation of the anti-nausea medication, ondansetron, was approved for use. Similar to other formulations of ondansetron already on the market, Zuplenz is indicated for the treatment and prevention of nausea and vomiting following surgery or cancer therapy. Although use of an orally dissolving film may benefit patients who already have trouble swallowing tablets due to vomiting, the effectiveness of this agent is expected to be similar to already available ondansetron products. Anticipated to have become commercially available in the third quarter of 2010, the release date for this product has not yet been announced.

Reference: FDA Approves Zuplenz. Drugs.comTM. fda-approves-strativa-pharmaceuticals-zuplenz-ondansetron-oral-soluble-film-2208. html <Accessed September 23, 2010>

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OleptroTM (trazodone extended-release) New Formulation Available: August 2010 Class: Antidepressant Approved in February 2010 and released in August, Oleptro is the first extended-release formulation of trazodone available. Similar to regular-release trazodone, Oleptro is FDA indicated for treatment of Major Depression Disorder (MDD) in adults. Although clinical studies have been conducted comparing the amount of medication in the bloodstream of patients using both Oleptro and regular-release trazodone, there appears to be no clinical significance (i.e., changes in AUGUST depressive symptoms) between these Oleptro launched agents. Aside from a decreased dosing frequency, it is unknown whether Oleptro presents a clinical advantage over generically available trazodone formulations.

opioid pain reliever indicated for treatment of moderate to severe pain. Although an extended-release tablet is currently available in a brand-only formulation, patent settlement issues may bring about a generic formulation of this product by 2011 or 2012. Similar to other new generic entries into the pain management market, the generic formulation of this product is priced roughly 10% below the brand-name product.

Reference: Generic Prospective Pipeline Summary. CVS Caremark. October 2010.


Silenor launched Opana generic launched

Reference: Labopharm Receives FDA Approval for Oleptro. PR Newswire. news-releases/labopharm-receives-fda-approval-foroleptrotm-83429037.html <Accessed October 1, 2010>

Ambien CRTM (zolpidem extended-release) Generic Available: October 2010 Class: Sedative/Hypnotic After much anticipation, the popular sleeping aid, Ambien CR, was launched in the generic form of zolpidem, in late 2010. Although two different strengths of the brand-name product are available, 6.25 mg and 12.5 mg, only the 6.25 mg strength generic form was approved. At this time, it is unknown when a generic equivalent of the 12.5 mg strength tablet may be approved. Similar to other generic products, the average wholesale price for this agent is 10% less than the brand-name version.

Reference: FDA approves Actavis' generic Ambien CR. Drug Store News.


Ambien CR generic launched Vivitrol new formulation Botox new indication approved Vimovo launched

Botox® (onabotulinumtoxinA) pms New Indication: October 2010 Reference: Silenor, Somaxon Pharmaceuticals. http:// Class: Miscellaneous Injectable <Accessed Used for a number of off-label indications, including October 4, 2010> prevention of migraine headaches and neuropathic pain, the pms Opana (oxymorphone) publication of PMSI Clinical Services formally approved onabotulinumtoxinA in late 2010 for FDA A quarterly Generic Available: September 2010 the prevention of headaches in adult patients suffering from nfo Quarterl chronic migraines. The newly approved treatment strategy is Class: Opioid Analgesic designed to be administered by a healthcare professional every Regular-release oxymorphone 5 mg and 10 mg tablets were 12 weeks, in an effort to help prevent headaches from introduced in late 2010 as the next generically available

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Silenor® (doxepin) New Dose Available: September 2010 Class: Sedative/Hypnotic Available as of late 2010, Somaxon Pharmaceuticals is now supplying Silenor to pharmacies around the country. Indicated specifically for treatment of sleep-maintenance insomnia, Silenor is identical to other doxepin-containing products, with the exception of its indication and formulation of 3 mg and 6 mg tablets. Somaxon Pharmaceuticals expects patients to experience a low occurrence of side effects with Silenor. It is uncertain if this agent will largely impact the insomnia market, due 2007the January to availability of generic competitors.

Vivitrol® (naltrexone extended-release) Injectable Solution New Formulation Available: October 2010 Class: Opioid Antagonist In response to increased concerns over the utilization of opioid analgesics, the FDA recently approved Vivitrol, a once monthly injectable treatment to prevent relapse in patients who have participated in an opioid detoxification program. Until this point, naltrexone products were only available in an oral tablet formulation. Although the injectable formulation of this product is likely to increase costs, this may be offset by the once monthly dosing schedule offered with this particular formulation.

Reference: FDA approves injectable drug to treat opioid-dependent patients. FDA NEWS RELEASE. October 12, 2010. PressAnnouncements/ucm229109.htm <Accessed October 22, 2010>




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developing. Given the injectable nature of this product, it is likely to have a higher cost than other migraine prevention alternatives.

Reference: FDA approves Botox to treat chronic migraine. FDA NEWS RELEASE. October 15, 2010. PressAnnouncements/ucm229782.htm <Accessed October 22, 2010>

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VimovoTM (naproxen/esomeprazole) New Combination Available: October 2010 Class: Non-steroidal Anti-inflammatory Drug Released in mid 2010, Vimovo represents the newest NSAID addition for the treatment of a range of painful conditions. Composed of a combination of naproxen (a non-steroidal anti-inflammatory drug) and esomeprazole (a proton pump inhibitor), Vimovo's manufacturer indicates that it should be considered a good option for patients requiring antiinflammatory therapy who are also at high risk for gastric complications. Although the combination of an antiinflammatory and proton pump inhibitor is logical, the cost for this agent is comparably high, especially considering the generic availability of both naproxen and esomeprazole as stand-alone agents.

Reference: Vimovo. Pozen Inc. Market Announcement. product/vimovo.asp <Accessed September 30, 2010>

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Cymbalta® (duloxetine) New Indication: November 2010 NOV Class: Antidepressant Cymbalta new After multiple attempts by Eli indication for pain Lilly and Company to obtain FDA approved approval for the use of Cymbalta Propoxyphene for the treatment of pain, the FDA voluntary recall recently announced approval of this agent for management of chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. Previously, Cymbalta had been indicated for the treatment of depression, diabetic neuropathic pain, anxiety, and fibromyalgia. It has also been used for generalized neuropathic pain in an off-label manner. Although other agents with similar mechanisms are available (i.e., Effexor®, Savella®), only Cymbalta has received approval by the FDA for treatment of musculoskeletal pain. Given the high utilization rate of this agent, it is expected that Cymbalta will make an even greater impact in workers' compensation.

Reference: FDA clears Cymbalta to treat chronic musculoskeletal pain. FDA NEWS RELEASE. ucm232708.htm <Accessed November 5, 2010>

Darvon®/Darvocet® (propoxyphene-containing products) Voluntary Recall: November 2010 Class: Opioid Analgesic The FDA's concern over the use of propoxyphene-containing products is in reaction to new data indicating that potential risks involved with its use may outweigh its pain relieving benefits. In 2009, the FDA disagreed with an advisory panel recommending the removal of propoxyphene products from the market. Subsequent to reviewing new clinical data regarding the potential for serious heart rhythm abnormalities, Xanodyne Pharmaceuticals, Inc. agreed with the FDA to voluntarily recall Darvon and Darvocet products from the market. The FDA indicates that generic manufacturers of propoxyphene and propoxypheneacetaminophen products have also been informed of the voluntary recall by Xanodyne; it is the FDA's intention that these products also be voluntarily recalled. Due to the large number of alternative short-acting analgesics available, patients currently utilizing propoxyphene products are not expected to experience a lack of effective pain management.

Reference: Xanodyne agrees to withdraw propoxyphene from the U.S. market. FDA NEWS RELEASE. http://www. PressAnnouncements/ucm234350.htm <Accessed November 19, 2010>

Click here to see PMSI's Drug Advisory about Propxypene Products

PMSI Clinical Services


Opioid REMS Delayed Until 2011

Shortly after the FDA's advisory committee voted to reject the initial plan for opioid risk evaluation and mitigation strategies (REMS), the FDA announced it will not release its REMS for opioid analgesics until 2011. Instead, the FDA is evaluating input received from the advisory committee and the public before making any final decisions on the REMS program. As a result, the FDA extended the period for public comments until October 19, 2010, and currently is working to finalize their new recommendations. After the recommendations are made, they must provide the industry four months to respond, which means it is unlikely that any new opioid-REMS programs will be implemented prior to the spring or summer of 2011. There were at least two issues that led to the FDA advisory panel's rejection of the proposed plan. First, the FDA proposed that opioid REMS include only extended-release (ER) or long-acting (LA) opioid analgesics and exclude all short-acting opioids. The committee indicated it would like to see all opioid analgesics included in the REMS plan since all formulations are associated with abuse, overdose, and addiction. Including all opioid analgesics, could result in prescribers not prescribing short-acting opioids for acute pain


due to added requirements, even though these agents might be clinically necessary. However, if REMS include only ER/LA formulations, overutilization and potential inappropriate use of less restrictive short-acting opioids for chronic pain could occur. Second, the need for more training of healthcare providers in effective and safe opioid prescribing has been stressed repeatedly. The debate lies in whether this education should be voluntary or mandatory. The advisory panel has expressed its opinion that this education should be a requirement of U.S. Drug Enforcement Administration (DEA) licensing to prescribe opioid analgesics; however, this would require Congressional approval. In addition, it is possible that healthcare providers would decide to forego prescribing opioids, instead of participating in the mandatory training. In the next few months, the FDA will attempt to balance their efforts to protect the public from negative side effects of opioid analgesics, while preserving appropriate utilization, without eliminating access for those patients who require therapy with opioid analgesics.

Reference: U.S. FDA Delays Opioid REMS Until 2011. Pain Topic Treatments.

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After a short break for the holidays during November Skeletal Muscle Relaxants and Dermatologics and December, the PMSI Clinical Department will January 25 continue the very popular Therapeutic Drug Information Click here to register 2 ­ 2:30 p.m. EST Series in A quarterly publication of PMSI Clinical Services January. These webinars are presented every fourth Tuesday at 2 p.m. (EST). Please use the links Anti-anxiety, Antipsychotics and Sedatives provided to enroll. February 22 Click here to register 2 ­ 2:30 p.m. EST

Note: These informational webinars are not eligible for Continuing Education Credits.

pms nfo Quarterl





Posted: October 22, 2010--The FDA notified healthcare professionals and patients that laboratory testing has identified a fentanyl patch that released its active ingredient faster than the approved specification. Accelerated release of Fentanyl can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing). Fentanyl Transdermal System is indicated for the management of persistent, moderate-tosevere chronic pain that requires both continuous, aroundthe-clock opioid administration for an extended period of time, and cannot be managed by other means, such as non-steroidal analgesics, opioid combination products, or

MedWatch Reports

Highlighting Important Safety Issues from the FDA

Fentanyl Transdermal System: Recall ­ Potential for Active Ingredient to Release Faster Than Specified

immediate release opioids. In the U.S., the product is manufactured for Actavis by Corium International. Wholesalers and pharmacies are being asked to check and return any affected product they have on hand or in stock. For more information regarding the 18 affected lot numbers in this recall, please visit Actavis' press release at http://www. The Control/Lot number appears on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left corner.

Reference: Fentanyl Transdermal System: Recall - Potential for Active Ingredient to Release Faster Than Specified. FDA Medwatch. MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm230639. htm <Accessed October 25, 2010>

Tylenol Eight Hour Caplets Recalled

Posted: October 19, 2010--Recently, McNeil Consumer Healthcare recalled Tylenol 8 Hour caplets, 50-count bottles, to the retail level, following a small number of complaints of a musty or moldy odor. The uncharacteristic odor is thought to be caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. This voluntary action was taken as a precaution and the risk of adverse medical events is remote. To date, observed events reported to McNeil were temporary and non-serious. McNeil has indentified only products with lot number BCM155 as affected by this recall. The product lot number can be found on the side of the bottle label. Consumers should stop using the affected product and contact McNeil Consumer Healthcare, either at, or by calling 1-888-222-6036 (MondayFriday 8 a.m. to 8 p.m. ET, and Saturday-Sunday 9 a.m. to 5 p.m. ET) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.

Reference: Tylenol 8 Hour Caplets 50 Count: Recall. FDAMedwatch. http://www.fda. gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ ucm230218.htm <Accessed October 25, 2010>

PMSI -- Proven Solutions for Cost Containment. Founded in 1976, PMSI is a leader in developing solutions to control the growth of medical costs in workers' compensa-

tion. As one of the nation's largest and most experienced companies focused solely on workers' compensation, we deliver proven solutions for cost containment across the claims lifecycle. PMSI's solutions for Pharmacy, Medical Services and Equipment, and Settlement Solutions deliver quantifiable results and improve the quality of care for injured workers. We provide our customers with the innovation, focus, expertise, analytics and technology needed to successfully deliver workers' compensation benefits.

Managing Editor: Nelson Aragon, PharmD Contributors: Everett Lawson, RPH, MBA, Katie Rummel, PharmD Mary Todd, PharmD

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