An Evaluation of the DoD Transdermal Fentanyl Pharmacy Edit LTC - - PowerPoint PPT Presentation

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An Evaluation of the DoD Transdermal Fentanyl Pharmacy Edit LTC - - PowerPoint PPT Presentation

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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

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DoD Pharmacoeconomic Center

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An Evaluation of the DoD Transdermal Fentanyl Pharmacy Edit

DoD Pharmacy Outcomes Research Team

LTC Stacia Spridgen, MSC, USA Director, DoD Pharmacoeconomic Center

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DoD Pharmacoeconomic Center

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TRICARE Eligible Beneficiaries

Monthly Average, FY08 Retirees & Family Members < 65 Retirees & Family Members 65 Active Duty Family Members Active Duty

1.9M 1.7M 2.3M 3.2M

25.3% 34.1% 20.1% 18.3%

Other 2.2% FY02 8.6 Million FY03 8.9 Million FY04 9.1 Million FY05 9.2 Million FY06 9.2 Million FY07 9.2 Million FY08 9.3 Million

Source: M2

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DoD Pharmacoeconomic Center

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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 Pharmacy Outcomes Research Team

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Fentanyl Patch Patient Safety Program

Mail and Retail

Fentanyl patch Rx written

PDTS checks patient profile. Has the patient received a strong

  • pioid in the last

60 days?

Rx pays and is dispensed

NO YES

Rx does not pay; rejects with warning (88SR reject)

Pharmacist

  • verrides using

intervention &

  • utcome codes

after checking profile, talking w/patient, MD Rx pays and is dispensed Pharmacist does not override MD contacted; patient receives alternative Patient does not receive alternative Patient pays cash or uses OHI TRRx: MD may contact PBM; PBM performs review YES NO

PA built in PDTS

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DoD Pharmacoeconomic Center

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88SR rejection code

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– National Council on Prescription Drug Programs (NCPDP) – standards development

  • rganization

– 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

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DoD Pharmacoeconomic Center

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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 Pharmacy Outcomes Research Team

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DoD Pharmacoeconomic Center

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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 Pharmacy Outcomes Research Team

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DoD Pharmacoeconomic Center

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Analysis

  • Evaluate impact of the automated profile

review policy on fentanyl patch (FP) use among opioid-naïve patients using retail or mail order

DoD Pharmacy Outcomes Research Team

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DoD Pharmacoeconomic Center

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Study Key Questions

  • What patients were affected?
  • What was the response?
  • Did we target the right patients?

DoD Pharmacy Outcomes Research Team

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DoD Pharmacoeconomic Center

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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 Pharmacy Outcomes Research Team

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Study Cohorts

Mail and Retail

Fentanyl patch Rx written

PDTS checks patient profile. Has the patient received a strong

  • pioid in the last

60 days?

Rx pays and is dispensed

NO YES

Rx does not pay; rejects with warning (88SR reject)

Pharmacist

  • verrides using

intervention &

  • utcome codes

after checking profile, talking w/patient, MD Rx pays and is dispensed Pharmacist does not override MD contacted; patient receives alternative Patient does not receive alternative Patient pays cash or uses OHI TRRx: MD may contact PBM; PBM performs review YES NO

PA built in PDTS

26,366 patients 10,025 patients

  • r 38% of total

16,341 patients

  • r 62% of total

7,982 patients

  • r 80% of 88SRs

2,043 patients

  • r 20% of 88SRs
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SLIDE 12 100 200 300 400 500 10 20 30 40 50 60 70 80 90 100 100 200 300 400 10 20 30 40 50 60 70 80 90 100

Demographics

88SR n=10,025 No 88SR* n=16,341 Age Gender Beneficiary Category

Mean 70 Median 73 Mean 65 Median 67

69% Female 68% Female 59% non-AD FM 32% non-AD 7% ADFM 2% AD 61% non-AD FM 33% non-AD 4% ADFM 1% AD

* Retail & mail only

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DoD Pharmacoeconomic Center

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Prior Opioid Use

Patients with no 88SR Reject at Retail or Mail (n=16,341)

DoD Pharmacy Outcomes Research Team

Time periods include day of 1st FP Rx for strong opioids

FP* Another SO** FP or SO 57% (9,332) 61% (9,983) 97% (15,815)

  • Based on opioid Rxs in last 60 days prior to

the 1st FP Rx during the study period

*(only occurred through 9/29/2007) ***based on original implementation

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DoD Pharmacoeconomic Center

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Patients with an 88SR Reject (n = 10,025)

Was the Rejection Overridden?

DoD Pharmacy Outcomes Research Team

200 400 600 800 1000 1200 1400 1600 Aug-07 Sep-07 Oct-07 Nov-07 Dec-07 Jan-08 Feb-08 Mar-08 Apr-08 May-08 Time (months) Patients Pharmacist overrode 80% of 88SR rejects (n=7,982) Pharmacist did not

  • verride 88SR (n=2,043)
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DoD Pharmacoeconomic Center

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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 Pharmacy Outcomes Research Team

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DoD Pharmacoeconomic Center

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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 Pharmacy Outcomes Research Team

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DoD Pharmacoeconomic Center

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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)

DoD Pharmacy Outcomes Research Team

88SR reject No 88SR reject

0% 10% 20% 30% 40% 50% 60%

12MCG/HR 25MCG/HR 50MCG/HR 75MCG/HR 100MCG/HR

% of total for each group

Source: PDTS

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Patients with 88SR Rejects

Demographics

Age Gender Beneficiary Category 88SR overridden n=7,982 88SR not overridden n=2,043

50 100 150 200 250 300 10 20 30 40 50 60 70 80 90 100

Mean 70 Median 73

67% Female

10 20 30 40 50 60 70 10 20 30 40 50 60 70 80 90 100

Mean 67 Median 71

54% non-AD FM 33% non-AD 6% Unknown 1% AD 6% ADFM 69% Female 62% non-AD FM 33% non-AD 1% AD 4% ADFM

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DoD Pharmacoeconomic Center

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Patients with 88SR Rejects

Opioid Exposure in Previous Year 88SRs

  • verridden

(n=7,982) 88SR not

  • verridden

(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%)

DoD Pharmacy Outcomes Research Team

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DoD Pharmacoeconomic Center

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Patients with 88SRs Not Overridden (n=2,043)

Subsequent Opioid Use

  • Any opioid use (includes strong & weak
  • pioids, 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 Pharmacy Outcomes Research Team

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DoD Pharmacoeconomic Center

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Patients with 88SRs Not Overridden Who Did Not Receive Opioids Through 15 Jun 08 (n=832)

  • Mean follow-up period = 167 days (SD 93); median

164; range 16-319

DoD Pharmacy Outcomes Research Team

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

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Prior Opioid Use

MTFs vs. Purchased Care

FP* Another SO** FP or SO 43% (1,853) 57% (2,460) 78% (3,374)

  • Based on opioid Rxs in last 60 days prior to

the 1st FP Rx during the study period

  • MTFs (n=4,341)
  • 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)

*(only occurred through 9/29/2007) ***based on “as implemented” def Time periods include day of 1st FP Rx for strong opioids

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Prior Opioid Use

MTFs by Branch of Service

FP* Another SO** FP or SO 38% (926) 61% (1498) 79% (1926)

  • Based on opioid Rxs in last 60 days prior to

the 1st FP Rx during the study period

  • Army (n=2432)
  • Navy (n=1074)

44% (476) 52% (561) 76% (816)

*(only occurred through 9/29/2007) ***based on “as implemented” def Time periods include day of 1st FP Rx for strong opioids

  • Air Force (n=835)

54% (451) 48% (401) 76% (632)

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DoD Pharmacoeconomic Center

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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

DoD Pharmacy Outcomes Research Team

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DoD Pharmacoeconomic Center

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Discussion

  • When overrides occurred, they appeared to be

managed promptly by the pharmacy

  • Despite the program, the retail network appears to

have a higher rate of FP use among seemingly

  • pioid-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

DoD Pharmacy Outcomes Research Team

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DoD Pharmacoeconomic Center

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Conclusions

  • The automated profile review policy reduced the use
  • f 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

DoD Pharmacy Outcomes Research Team