Criteria for Outpatient Use Guidelines

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[Developed, January 1994; Revised, October 1995, October 1996, September 1997, September 1998,
October 1999, November 1999, August 2000, September 2000, August 2001, September 2002, August 2003, January 2006, October 2007; January 2011; March 2011]
MEDICAID DRUG USE REVIEW CRITERIA FOR OUTPATIENT USE

Information on indications for use or diagnosis is assumed to be unavailable.  All criteria may be applied retrospectively; prospective application is indicated with [*].

1.*  Dosage

       Nonselective oral and rectal NSAIDs are FDA-approved for use in rheumatoid arthritis/juvenile
       rheumatoid arthritis (JRA), osteoarthritis, ankylosing spondylitis, pain management, dysmenorrhea,
       fever, migraines and cluster headaches.  JRA is now also known as juvenile idiopathic arthritis (JIA)
       or juvenile arthritis (JA).

Adults
The adult maximum daily dose of an NSAID should not exceed the dose listed in Table 1.

 

       Pediatrics
Safety and effectiveness of many NSAIDS in children have not been well established.  Only ibuprofen 200 mg tablets and 100 mg/5 ml oral suspension are FDA-approved for short-term management of fever and mild to moderate pain and long-term management of JRA/JIA/JA in pediatric patients.  Indomethacin is not FDA-approved in children less than 15 years of age, but in those JRA/JIA/JA patients between 2 and 14 years of age who have experienced toxicity/lack of benefit from other medications, indomethacin may be administered up to a maximum dose of 3 mg/kg/day but no more than 200 mg/day orally.  Aspirin, while FDA-approved for use in fever and pain for adolescents, should not be used to treat fever and muscle aches occurring with viral illness due to the possible association with Reye’s syndrome.  Dosages for NSAIDs with pediatric indications are summarized in Table 2.  Dosages exceeding these recommendations will be reviewed.

 

 

 

Table 2 Pediatric NSAID Recommended Maximum Daily Doses
DRUG	MAXIMUM RECOMMENDED DAILY DOSE
Choline magnesium trisalicylate	< 37 kg:  50 mg/kg/day > 37 kg:  2250 mg/day adolescents:  3000 mg/day
Diflunisal	> 12 years of age:  1500 mg/day
Etodolac extended-release	JRA/JIA/JA:      > 6 years of age:             20-30 kg:  400 mg/day            31-45 kg:  600 mg/day            46-60 kg:  800 mg/day            > 60 kg:  1000 mg/day
Aspirin	JRA/JIA/JA:       130 mg/kg/day, or dose that achieves salicylate serum level of 150-300         mcg/ml fever/pain:      > 12 years of age:  4000 mg/day
Ibuprofen (200 mg tablets, 100 mg/5 ml suspension only)	6 months to 2 years (suspension):      fever, mild to moderate pain:  40 mg/kg/day, in divided doses      JRA/JIA/JA:  50 mg/kg/day, in divided doses 2-11 years (suspension):      fever, minor pain:         24-35 lbs (2-3 yrs):  400 mg/day, in divided doses         36-47 lbs (4-5 yrs):  600 mg/day, in divided doses         48-59 lbs (6-8 yrs):  800 mg/day, in divided doses         60-71 lbs (9-10 yrs):  1000 mg/day, in divided doses         72-95 lbs (11 yrs):  1200 mg/day, in divided doses 12 years and older (fever, mild to moderate pain, JRA):  1200 mg/day
Indomethacin	> 15 years of age:      immediate-release:  200 mg/day      extended-release:  150 mg/day
Meclofenamate	> 14 years of age:  400 mg/day
Mefenamic acid	> 14 years of age:  1250 mg/day on day 1; 1000 mg/day on days 2-7
Meloxicam	JRA/JIA/JA:      > 2 years of age:  0.125 mg/kg once daily, not to exceed 7.5 mg            once daily
Naproxen	JRA/JIA/JA:      > 2 years of age:  15 mg/kg/day (suspension preferred)
Oxaprozin	JRA/JIA/JA:      > 6 years to 16 years of age:  1200 mg/day
Tolmetin sodium	JRA/JIA/JA:      > 2 years of age:  30 mg/kg/day, not exceeding 1800 mg daily

2.    Duration of Therapy

1. Therapy Limits

 

     The duration of therapy derived for NSAIDs may be long-term and indefinite when prescribed for chronic indications; however, the lowest effective dosages for the shortest possible time period should be utilized.  NSAIDs should be prescribed cautiously, if at all, to patients at high risk for gastrointestinal complications and patients with known cardiovascular disease.  High-risk patients include those with a history of peptic ulcer disease or gastrointestinal bleeding, those with concurrent prescriptions for anticoagulants or corticosteroids, those prescribed high NSAID doses, those with a history of alcohol use and/or smoking, and the elderly.  High-risk patients unable to discontinue or reduce NSAID use may benefit from adjunctive therapy with gastroprotective agents such as misoprostol or proton pump inhibitors. 

     Treatment duration is limited for mefenamic acid to minimize the occurrence of adverse events.  Mefenamic acid should be prescribed for no longer than seven days for pain management and no longer than three days for dysmenorrhea to reduce the incidence of diarrhea associated with the use of this drug.

1. NSAID Use in Elderly Patients

 

Elderly patients frequently utilize prescription and nonprescription NSAIDs to manage acute and chronic pain. Several issues surface with NSAID use in elderly patients, including potential adverse effects and drug interactions.  NSAID-induced gastrointestinal and renal toxicity as well as adverse central nervous system effects are more prevalent in elderly patients due to changes in metabolism, underlying disease states, and concurrent drug therapy.  The potential for increased cardiovascular risk with NSAID use is also a factor when evaluating NSAID therapy in elderly patients.  Elderly patients prescribed NSAIDs, especially those at higher risk, should be evaluated for appropriateness of therapy as well as potential for drug-drug interactions.  Appropriate therapy duration as well as appropriate dosages should also be evaluated.  Preventive measures such as gastric antisecretory agents should be considered in some individuals to reduce GI complications.  Medication profiles of elderly patients greater than 60 years of age prescribed NSAIDs with increased risk factors for adverse events or drug-drug interactions will be reviewed.

       c.  NSAID Use and Cardiovascular Risk

Some clinical trials have shown that patients prescribed selective and nonselective NSAIDs may be at increased risk for serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, all of which can be fatal.  Patients at greater risk are those with known CV disease or risk factors for CV disease.  Due to the lack of long-term clinical trial data, the Center for Drug Evaluation and Research has determined that the increased risk of CV events associated with NSAID use should be considered a class effect for both selective and nonselective NSAIDs until more results are available.   Patients should be prescribed the lowest effective NSAID dose for the shortest possible treatment duration to minimize the potential for cardiovascular adverse events.

NSAIDs may induce new onset hypertension or worsen pre-existing hypertension in some patients, which may contribute to the development of cardiovascular adverse events.  Blood pressure should be routinely monitored in patients prescribed NSAIDs.

NSAIDs may cause fluid retention or edema in some patients, and should be used cautiously in patients with a history of fluid retention or heart failure.

3.*  Duplicative Therapy

The combination of two or more NSAIDs is not recommended except the use of < 325 mg daily of aspirin plus another NSAID.  (Unfortunately, aspirin use is not usually included in a Medicaid database.)

Concurrent administration of an NSAID and ketorolac, another NSAID utilized primarily for pain management with a limited treatment duration, is contraindicated due to the potential for increased gastrointestinal adverse events.

The combined use of specific COX-2 inhibitors like celecoxib and nonspecific COX-1/COX-2 inhibitors does not provide additional therapeutic benefit and may result in additive adverse effects, including gastrointestinal toxicity. Concurrent therapy with specific COX-2 inhibitors and nonspecific COX-1/COX-2 inhibitors is not recommended and will be reviewed.

4.*  Drug-Drug Interactions

Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions.
Drug-drug interactions considered clinically significant for NSAIDs are summarized in Table 3.  Only those drug-drug interactions classified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed:

REFERENCES

1. Diclofenac sodium/misoprostol tablets (Arthrotec®) Package Insert.  Pfizer, December 2010.
2. Mefenamic acid capsules Package Insert.  Mylan Pharmaceuticals, November 2006.
3. Mefenamic acid capsules Package Insert.  Paddock Laboratories, Inc., December 2010.
4. Oxaprozin caplets (Daypro®) Package Insert.  Pfizer, June 2009.
5. Indomethacin capsules Package Insert.  Sandoz, Inc., March 2007.
6. Ibuprofen tablets (400 mg, 600 mg, 800 mg) Package Insert.  Qualitest Pharmaceuticals, November 2009.
7. Ibuprofen suspension (100 mg/5 ml) Package Insert.  Perrigo®, July 2008.
8. Children’s Advil® suspension liquid.  Available at:  http://www.advil.com/OurProducts/Childrens-Advil-And-Infants-Advil.aspx.  Accessed January 14th, 2011.
9. Ibuprofen tablets (200 mg) Package Insert.  Rite Aid Corporation, August 2010.
10. DRUGDEX® System (electronic version). Thomson Reuters (Healthcare) Inc., Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com.libproxy.uthscsa.edu.   Accessed January 17th, 2011.
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22. U.S. Food and Drug Administration.  Center for Drug Evaluation and Research.  Public health advisory: Non-steroidal anti-inflammatory drug products (NSAIDs).  (December 23rd, 2004)  Available at:  http://www.fda.gov/cder/drug/advisory/nsaids.htm.  Accessed October 3rd, 2007.
23. U.S. Food and Drug Administration.  Center for Drug Evaluation and Research. COX-2 selective (includes Bextra, Celebrex, and Vioxx) and non-selective non-steroidal anti-inflammatory drugs (NSAIDs). (July 18th, 2005) Available at: http://www.fda.gov/cder/drug/infopage/COX2/default.htm.  Accessed October 3rd, 2007.
24. U.S. Food and Drug Administration.  Center for Drug Evaluation and Research.  Alert for healthcare professionals.  Non-selective non-steroidal anti-inflammatory drugs (NSAIDs).  Available at:  http://www.fda.gov/cder/drug/InfoSheets/HCP/NS_NSAIDsHCP.htm.  Accessed October 4th, 2007.
25. Bell GM, Schnitzer TJ.  COX-2 inhibitors and other nonsteroidal anti-inflammatory drugs in the treatment of pain in the elderly.  Clin Geriatr Med. 2001;17:489-502. 
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28. Lazzaroni M, Battocchia A, Porro GB.  COXIBs and non-selective NSAIDs in the gastroenterological setting:  What should patients and physicians do?  Dig Liver Dis. 2007;39:589-96.
29. Waksman JC, Brody A, Phillips SD.  Nonselective nonsteroidal antiinflammatory drugs and cardiovascular risk:  are they safe?  Ann Pharmacother. 2007;41:1163-73.
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31. Prince OMH, van Suijlekom-Smit LW.  Diagnosis and management of juvenile idiopathic arthritis.  BMJ.  2010;341(03):c6434.
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Prepared by:  Drug Information Service, The University of Texas Health Science Center at San Antonio, and the College of Pharmacy, The University of Texas at Austin.