An Evaluation of the DoD Transdermal Fentanyl Pharmacy Edit. LTC Stacia Spridgen, MSC, USA Director, DoD Pharmacoeconomic Center

Transcription

1 An Evaluation of the DoD Transdermal Fentanyl Pharmacy Edit LTC Stacia Spridgen, MSC, USA Director, DoD Pharmacoeconomic Center 1

2 TRICARE Eligible Beneficiaries Monthly Average, FY08 Retirees & Family Members 65 Retirees & Family Members < 65 Other 2.2% Active Duty FY Million 1.9M 1.7M 20.1% 18.3% 2.3M 3.2M 25.3% 34.1% FY03 FY04 FY05 FY06 FY07 FY08 Active Duty Family Members 8.9 Million 9.1 Million 9.2 Million 9.2 Million 9.2 Million 9.3 Million DoD Pharmacoeconomic Center Source: M2 2

3 History of transdermal fentanyl Fentanyl Patch Safety Program 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 3

4 Fentanyl Patch Patient Safety Program Mail and Retail Fentanyl patch Rx written PDTS checks patient profile. Has the patient received a strong opioid in the last 60 days? NO YES PA built in PDTS Rx pays and is dispensed Rx does not pay; rejects with warning (88SR reject) Pharmacist overrides using intervention & outcome codes after checking profile, talking w/patient, MD Rx pays and is dispensed TRRx: MD may contact PBM; PBM performs review YES NO MD contacted; patient receives alternative Pharmacist does not override Patient does not receive alternative Patient pays cash or uses OHI

5 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

6 Evaluation period SO defined as basically any CII Definition of Opioid Tolerance 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 6

7 As planned Implementation Issue Resolved 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

8 Analysis Evaluate impact of the automated profile review policy on fentanyl patch (FP) use among opioid-naïve patients using retail or mail order 8

9 Study Key Questions What patients were affected? What was the response? Did we target the right patients? 9

10 Methods Retrospective observational cohort study Data from PDTS Study Subjects Analysis 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 Means and standard deviations for continuous data Counts and percentages for categorical data 10

11 Fentanyl patch Rx written 26,366 patients Pharmacist overrides using intervention & outcome codes after checking profile, talking w/patient, MD 7,982 patients or 80% of 88SRs Rx pays and is dispensed TRRx: MD may contact PBM; PBM performs review YES NO PDTS checks patient profile. Has the patient received a strong opioid in the last 60 days? NO 10,025 patients or 38% of total Study Cohorts Mail and Retail YES Rx pays and is dispensed Rx does not pay; rejects with warning (88SR reject) MD contacted; patient receives alternative 16,341 patients or 62% of total PA built in PDTS 2,043 patients or 20% of 88SRs Pharmacist does not override Patient does not receive alternative Patient pays cash or uses OHI

12 0 0 0 Demographics 88SR n=10,025 No 88SR* n=16, Age 300 Mean 70 Median Mean 65 Median Gender 68% Female 69% Female Beneficiary Category 33% non-ad 4% ADFM 1% AD 32% non-ad 7% ADFM 2% AD 61% non-ad FM 59% non-ad FM * Retail & mail only

13 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 13

14 Patients with an 88SR Reject (n = 10,025) Was the Rejection Overridden? Patients Pharmacist did not override 88SR (n=2,043) Pharmacist overrode 80% of 88SR rejects (n=7,982) Aug-07 Sep-07 Oct-07 Nov-07 Dec-07 Jan-08 Feb-08 Mar-08 Apr-08 May-08 Time (months) 14

15 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 15

16 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) 16

17 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% 50% 88SR reject No 88SR reject % of total for each group 40% 30% 20% 10% 0% 12MCG/HR 25MCG/HR 50MCG/HR 75MCG/HR 100MCG/HR Source: PDTS 17

18 0 0 Patients with 88SR Rejects Demographics 88SR overridden n=7,982 88SR not overridden n=2, Age Mean 70 Median Mean 67 Median Gender 69% Female 67% Female Beneficiary Category 33% non-ad 4% ADFM 1% AD 62% non-ad FM 33% non-ad 6% Unknown 6% ADFM 1% AD 54% non-ad FM

19 Patients with 88SR Rejects Opioid Exposure in Previous Year 88SRs overridden (n=7,982) 88SR not overridden (n=2,043) Any opioid 7,880 (99%) 1,463 (72%) Strong opioid 7,432 (93%) 757 (37%) Long-term strong opioid 7,322 (92%) 559 (27%) Weak opioid 6,592 (83%) 1,242 (61%) FP 7,276 (91%) 472 (23%) 19

20 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 20

21 Patients with 88SRs Not Overridden Who Did Not Receive Opioids Through 15 Jun 08 (n=832) Other pain meds after 88SR* 86 (10%) mostly NSAIDs Evidence of OHI in previous year 56 (7%) No paid claim after 88SR* 399 (48%) No paid claim after 88SR* or in previous year 178 (21%) *through 15 Jun 08 Mean follow-up period = 167 days (SD 93); median 164; range

22 Prior Opioid Use MTFs vs. Purchased Care Based on opioid Rxs in last 60 days prior to the 1 st FP Rx during the study period MTFs (n=4,341) FP* Another SO** FP or SO 43% (1,853) 57% (2,460) 78% (3,374) Purchased care patients with no 88SRs at retail or mail plus patients with 88SR who received FP (n=24,872) FP* Another SO** FP or SO 38% (9,405) 43% (10,655) 67% (16,548) Time periods include day of 1st FP Rx for strong opioids *(only occurred through 9/29/2007) ***based on as implemented def

23 Prior Opioid Use MTFs by Branch of Service Based on opioid Rxs in last 60 days prior to the 1 st FP Rx during the study period Army (n=2432) FP* Another SO** FP or SO 38% (926) 61% (1498) 79% (1926) Navy (n=1074) 44% (476) 52% (561) 76% (816) Air Force (n=835) 54% (451) 48% (401) 76% (632) Time periods include day of 1st FP Rx for strong opioids *(only occurred through 9/29/2007) ***based on as implemented def

24 Discussion Approximately 38% of patients who were prescribed FP during the study period were flagged as potentially opioid-naïve The program provided an additional warning to the pharmacy for patients that appeared to have a higher risk of adverse drug events Patients affected by the program had lower initial doses of FP compared to those not affected due to prior opioid exposure 24

25 When overrides occurred, they appeared to be managed promptly by the pharmacy Discussion Despite the program, the retail network appears to have a higher rate of FP use among seemingly opioid-naïve patients than do MTFs Effect of corrections implemented on 17 Jul 2008 PAs remain on profiles; changes only apply to patients newly starting on FP If strong opioid in look-back period, establishes short-term PA (7 days) to allow Rx to be filled; future rejects can occur Anticipate increase in number of 88SRs due to more conservative definition of prior strong opioid use 25

26 Conclusions The automated profile review policy reduced the use of FP among seemingly opioid-naïve patients Novel application of the automated profile review that provides additional information to pharmacists during prospective drug utilization review Additional research should examine the association between the policy and risk of respiratory depression in the MHS 26