An Evaluation of the DoD Transdermal Fentanyl Pharmacy Edit LTC Stacia Spridgen, MSC, USA Director, DoD Pharmacoeconomic Center DoD Pharmacoeconomic Center DoD Pharmacy Outcomes 1 www.pec.ha.osd.mil Research Team
TRICARE Eligible Beneficiaries Monthly Average, FY08 Other Active Duty FY02 8.6 Million Retirees & Family 2.2% Members � 65 FY03 8.9 Million FY04 9.1 Million 1.7M 1.9M FY05 9.2 Million 20.1% 18.3% FY06 9.2 Million FY07 9.2 Million FY08 9.3 Million 2.3M 3.2M 25.3% Retirees & Family 34.1% Members < 65 Active Duty Family Members DoD Pharmacoeconomic Center Source: M2 2 www.pec.ha.osd.mil
Fentanyl Patch Safety Program • History of transdermal fentanyl – Jun/Jul 05 – Labeling strengthened due to reports of deaths, requires patients to be opioid-tolerant prior to start – Safety alerts (ISMP Aug 05, DoD PSC Sep/Oct 05) – 3 MTF incidents; DoD PSC alert Mar 06 – Jul 06 – AF policy enacted, limits providers, requires pharmacist DUR • Safety intervention recommended by DoD P&T in Nov 2006 and approved in Jan 2007 • Started 1 Aug 2007 at retail & mail order only – Issue is opioid tolerance – Uses an automated profile review, or APR process DoD Pharmacoeconomic Center DoD Pharmacy Outcomes 3 www.pec.ha.osd.mil Research Team
Fentanyl Patch Patient Safety Program Mail and Retail PDTS checks patient profile. Has the patient YES received a strong PA built Rx pays and is in PDTS opioid in the last dispensed Fentanyl patch 60 days? Rx written Rx does not pay; rejects with NO warning (88SR reject) Pharmacist does not override Pharmacist overrides using intervention & outcome codes TRRx: MD may after checking Patient does Patient pays contact PBM; PBM profile, talking not receive cash or uses w/patient, MD performs review alternative OHI YES NO MD contacted; patient Rx pays and is dispensed receives alternative
88SR rejection code – National Council on Prescription Drug Programs (NCPDP) – standards development organization DUR reject error; currently only applies to – fentanyl patch prescriptions – Message states “confirm opioid tolerance, no documented strong opioid use in prior 60 days” – Phone number for PBM – Overridden or not overridden – Requires interaction and outcome codes DoD Pharmacoeconomic Center 5 www.pec.ha.osd.mil
Definition of Opioid Tolerance • Evaluation period – SO defined as basically any CII – If CII in look-back period, established open-ended PA – no future rejects Program modified (Jul 08): New definition Strong opioid (SO • Fentanyl, morphine, oxycodone (not including combo products), hydromorphone, methadone, oxymorphone • Patients with > 60-day interval between Rxs would encounter another reject DoD Pharmacoeconomic Center DoD Pharmacy Outcomes 6 www.pec.ha.osd.mil Research Team
Implementation Issue Resolved • As planned – Strong opioid (SO) tightly defined: • Fentanyl, morphine, oxycodone (not including combo products), hydromorphone, methadone, oxymorphone – Patients with > 60-day interval between Rxs would encounter another reject • As implemented – SO defined as basically any CII – If CII in look-back period, established open-ended PA – no future rejects • Errors corrected 17 Jul 2008 DoD Pharmacoeconomic Center DoD Pharmacy Outcomes 7 www.pec.ha.osd.mil Research Team
Analysis • Evaluate impact of the automated profile review policy on fentanyl patch (FP) use among opioid-naïve patients using retail or mail order DoD Pharmacoeconomic Center DoD Pharmacy Outcomes 8 www.pec.ha.osd.mil Research Team
Study Key Questions • What patients were affected? • What was the response? • Did we target the right patients? DoD Pharmacoeconomic Center DoD Pharmacy Outcomes 9 www.pec.ha.osd.mil Research Team
Methods • Retrospective observational cohort study • Data from PDTS • Study Subjects • Individuals with a paid claim or an 88SR reject for FP between 1 Aug 2007 and 31 May 2008 (10 months) • Data pulled to 15 Jun 08 for follow-up measures • Analysis • Means and standard deviations for continuous data • Counts and percentages for categorical data DoD Pharmacoeconomic Center DoD Pharmacy Outcomes 10 www.pec.ha.osd.mil Research Team
Study Cohorts Mail and Retail 16,341 patients PDTS checks or 62% of total patient profile. Has the patient YES received a strong PA built Rx pays and is in PDTS opioid in the last dispensed Fentanyl patch 60 days? Rx written Rx does not pay; rejects with NO 26,366 patients warning (88SR reject) 10,025 patients or 38% of total 2,043 patients Pharmacist does not override Pharmacist or 20% of 88SRs overrides using 7,982 patients intervention & or 80% of 88SRs outcome codes TRRx: MD may after checking Patient does Patient pays contact PBM; profile, talking not receive cash or uses w/patient, MD PBM performs alternative OHI review YES NO MD contacted; patient Rx pays and is dispensed receives alternative
Demographics 88SR No 88SR* n=10,025 n=16,341 400 500 Mean 70 Mean 65 400 300 Median 73 Median 67 Age 300 200 200 100 100 0 0 0 10 20 30 40 50 60 70 80 90 100 0 10 20 30 40 50 60 70 80 90 100 Gender 68% 69% Female Female 4% ADFM 7% ADFM 33% Beneficiary 32% 1% AD 2% AD non-AD non-AD Category 61% 59% non-AD non-AD FM FM * Retail & mail only
Prior Opioid Use Patients with no 88SR Reject at Retail or Mail (n=16,341) • Based on opioid Rxs in last 60 days prior to the 1 st FP Rx during the study period FP* Another SO** FP or SO 57% (9,332) 61% (9,983) 97% (15,815) Time periods include day of 1st FP Rx for strong opioids * (only occurred through 9/29/2007) ***based on original implementation DoD Pharmacoeconomic Center DoD Pharmacy Outcomes 13 www.pec.ha.osd.mil Research Team
Patients with an 88SR Reject (n = 10,025) Was the Rejection Overridden? 1600 1400 Pharmacist did not 1200 override 88SR (n=2,043) 1000 Patients 800 600 Pharmacist overrode 80% of 400 88SR rejects (n=7,982) 200 0 Aug-07 Sep-07 Oct-07 Nov-07 Dec-07 Jan-08 Feb-08 Mar-08 Apr-08 May-08 Time (months) DoD Pharmacoeconomic Center DoD Pharmacy Outcomes 14 www.pec.ha.osd.mil Research Team
Patients with an 88SR Reject (n = 10,025) Intervention & Outcome Codes • The following code combinations were used to override 88SR rejects (n = 7,982) – 4,369 (55%) pharmacist review--filled as is – 2,070 (26%) prescriber interface--approval – 1,531 (19%) prescriber interface--filled as is DoD Pharmacoeconomic Center DoD Pharmacy Outcomes 15 www.pec.ha.osd.mil Research Team
Patients with an 88SR Reject (n = 10,025) Subsequent Fentanyl Patch Use • How many patients eventually received FP? – 82% (8,241) within 7 days – 83% (8,359) within 14 days – 86% (8,623) at anytime (through 15 Jun 08) • Among patients that received FP, what was the mean time between the rejection and subsequent paid FP claim? – 2.2 days (± 13.6 days) – 90% within one day – 95% within one week (~ 6 days) DoD Pharmacoeconomic Center DoD Pharmacy Outcomes 16 www.pec.ha.osd.mil Research Team
Strength of First FP in Study Period Patients with 88SR rejects (n=10,025) vs. those with no 88SR reject at Retail or Mail (n=16,341) 60% 88SR reject No 88SR reject 50% % of total for each group 40% 30% 20% 10% 0% 12MCG/HR 25MCG/HR 50MCG/HR 75MCG/HR 100MCG/HR DoD Pharmacoeconomic Center DoD Pharmacy Outcomes Source: PDTS 17 www.pec.ha.osd.mil Research Team
Patients with 88SR Rejects Demographics 88SR overridden 88SR not overridden n=7,982 n=2,043 300 70 Mean 70 Mean 67 60 250 Median 73 Median 71 50 200 Age 40 150 30 100 20 50 10 0 0 0 10 20 30 40 50 60 70 80 90 100 0 10 20 30 40 50 60 70 80 90 100 Gender 67% 69% Female Female 4% ADFM 6% Unknown 33% 33% 1% AD 6% ADFM Beneficiary non-AD non-AD 1% AD Category 62% 54% non-AD non-AD FM FM
Patients with 88SR Rejects Opioid Exposure in Previous Year 88SRs 88SR not overridden overridden (n=7,982) (n=2,043) Any opioid 7,880 (99%) 1,463 (72%) Strong opioid 7,432 (93%) 757 (37%) Long-term 7,322 (92%) 559 (27%) strong opioid Weak opioid 6,592 (83%) 1,242 (61%) FP 7,276 (91%) 472 (23%) DoD Pharmacoeconomic Center DoD Pharmacy Outcomes 19 www.pec.ha.osd.mil Research Team
Patients with 88SRs Not Overridden (n=2,043) Subsequent Opioid Use • Any opioid use (includes strong & weak opioids, such as tramadol) – 855 (42%) received any opioid within 7 days – 928 (45%) received any opioid within 14 days – 1,211 (59%) received any opioid ever DoD Pharmacoeconomic Center DoD Pharmacy Outcomes 20 www.pec.ha.osd.mil Research Team
Patients with 88SRs Not Overridden Who Did Not Receive Opioids Through 15 Jun 08 (n=832) 86 (10%) Other pain meds after 88SR* mostly NSAIDs Evidence of OHI in previous year 56 (7%) No paid claim after 88SR* 399 (48%) No paid claim after 88SR* or in 178 (21%) previous year *through 15 Jun 08 • Mean follow-up period = 167 days (SD 93); median 164; range 16-319 DoD Pharmacoeconomic Center DoD Pharmacy Outcomes 21 www.pec.ha.osd.mil Research Team
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