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SHAIST, R.Choi
1. Andrew M et al. A Checklist for Medication Compliance and Persistence Studies Using
Retrospective Databases. Value Health. 2007 Jan-Feb;10(1):3-12
2. Steiner JF, Koepsell TD, Fihn SD, Inui TS. A general method of compliance assessment
using centralized pharmacy records. Description and validation. Med Care 1998;26:814–
23.
3. Farmer KC. Methods for measuring and monitoring medication regimen adherence in
clinical trials and clinical practice. Clin Ther 1999;21:1074–90.
4. Gundula Krack et al. Drugs Real World Outcomes. 2016 Sep; 3(3): 265–278. Claims Data A
nalysis of Tumor Necrosis Factor Inhibitor Treatment Dosing Among Patients with Rheum
atoid Arthritis: A Systematic Review of Methods
5. ELPT: Benner JS, Glynn RJ, Mogun H, et al. Long-term persistence in use of statin therapy
in elderly patients. JAMA 2002;288:455–6.
6. PDC: Li P et al. Adherence, discontinuation, and switching of biologic therapies in medicai
d enrollees with rheumatoid arthritis. Value Health. 2010 Sep-Oct;13(6):805-12
 MPR(Medication possession ratio )  “Chronic”
 Days of supply, DOS (e.g., 60 tablets BID  30 days supply)
 MPR(%) =Sum of days of supply(총처방일수)/ T (관찰기간)
 CMG (continuous measure of medication gaps)  “Acute, multiple Rx”
 Sum of the days in the gaps between refills in the observation period is divi
ded by time between the first and last fills
 The percentage of time the patient does not have the medication available f
or use.
 CMG(%)=Number of days of medication supplied within the refill interval/
number of days in refill interval
90 90 90 30 90 120 90 90 30 90
MPR = 540/810 = 66.6%
Andrew M et al. Value Health. 2007 Jan-Feb;10(1):3-12
 Persistence adds the dimension of time to the analysis
 The time over which a patient continues to fill a prescription, or the time from the ini
tial filling of the prescription until the patient discontinues refilling a prescription
 ELPT, Estimated level of persistence
 the percentage of individuals remaining on therapy (persistent) at a given time
 ELPT(%)=Proportion of patients refilling each subsequent prescription with (X*days
supplied) from fill n
 Persistence Curve (similar to Kaplan–Meier curve), Early drop out detection
Andrew M et al. Value Health. 2007 Jan-Feb;10(1):3-12
 PDC, Proportion of days covered(0-1 or %)
 A measure of patient compliance that has been used with increasing frequency
 the PDC has the advantage of simultaneously reflecting both C&P
Proportion of days covered according to Li et al. for subcutaneous drugs. DOS days of supply
Option
Andrew M et al. Value Health. 2007 Jan-Feb;10(1):3-12
Gundula Krack et al. Drugs Real World Outcomes. 2016 Sep; 3(3): 265–278
“Dosing considered”
 Example : PDC
Mean, Median, and Interquartile Range of the Proportion of Days Covered by Statin for Each Interval
Gundula Krack et al. Drugs Real World Outcomes. 2016 Sep; 3(3): 265–278
Li P et al. Value Health. 2010 Sep-Oct;13(6):805-12
 Persistent days : number of days to discontinuation and number of
prescription refills over a period of time
 The number of days to discontinuation
▪ a simple count of days from the index prescription to the date of the final
dispensing
▪ Option : inclusion of the days for which the final fill (e.g., final 30 days)
 The number of refills
▪ usually within 12 months of the index fill, could include patients who refill long
after the allowed 30- or 60-day gap for being considered non-persistent.
 “As needed medicine” e.g., treatments for seasonal allergy
90 30 90 30 90 210 90 30 90
Persistent days = 390 days
Gap days = 90 days
Persistent days = days supply + off days
If max off days > gap days(90days), then the patient is not persistent
Index date
off days off days off days
Option
Andrew M et al. Value Health. 2007 Jan-Feb;10(1):3-12

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Compliance and persistence

  • 2. 1. Andrew M et al. A Checklist for Medication Compliance and Persistence Studies Using Retrospective Databases. Value Health. 2007 Jan-Feb;10(1):3-12 2. Steiner JF, Koepsell TD, Fihn SD, Inui TS. A general method of compliance assessment using centralized pharmacy records. Description and validation. Med Care 1998;26:814– 23. 3. Farmer KC. Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice. Clin Ther 1999;21:1074–90. 4. Gundula Krack et al. Drugs Real World Outcomes. 2016 Sep; 3(3): 265–278. Claims Data A nalysis of Tumor Necrosis Factor Inhibitor Treatment Dosing Among Patients with Rheum atoid Arthritis: A Systematic Review of Methods 5. ELPT: Benner JS, Glynn RJ, Mogun H, et al. Long-term persistence in use of statin therapy in elderly patients. JAMA 2002;288:455–6. 6. PDC: Li P et al. Adherence, discontinuation, and switching of biologic therapies in medicai d enrollees with rheumatoid arthritis. Value Health. 2010 Sep-Oct;13(6):805-12
  • 3.  MPR(Medication possession ratio )  “Chronic”  Days of supply, DOS (e.g., 60 tablets BID  30 days supply)  MPR(%) =Sum of days of supply(총처방일수)/ T (관찰기간)  CMG (continuous measure of medication gaps)  “Acute, multiple Rx”  Sum of the days in the gaps between refills in the observation period is divi ded by time between the first and last fills  The percentage of time the patient does not have the medication available f or use.  CMG(%)=Number of days of medication supplied within the refill interval/ number of days in refill interval 90 90 90 30 90 120 90 90 30 90 MPR = 540/810 = 66.6% Andrew M et al. Value Health. 2007 Jan-Feb;10(1):3-12
  • 4.  Persistence adds the dimension of time to the analysis  The time over which a patient continues to fill a prescription, or the time from the ini tial filling of the prescription until the patient discontinues refilling a prescription  ELPT, Estimated level of persistence  the percentage of individuals remaining on therapy (persistent) at a given time  ELPT(%)=Proportion of patients refilling each subsequent prescription with (X*days supplied) from fill n  Persistence Curve (similar to Kaplan–Meier curve), Early drop out detection Andrew M et al. Value Health. 2007 Jan-Feb;10(1):3-12
  • 5.  PDC, Proportion of days covered(0-1 or %)  A measure of patient compliance that has been used with increasing frequency  the PDC has the advantage of simultaneously reflecting both C&P Proportion of days covered according to Li et al. for subcutaneous drugs. DOS days of supply Option Andrew M et al. Value Health. 2007 Jan-Feb;10(1):3-12 Gundula Krack et al. Drugs Real World Outcomes. 2016 Sep; 3(3): 265–278 “Dosing considered”
  • 6.  Example : PDC Mean, Median, and Interquartile Range of the Proportion of Days Covered by Statin for Each Interval Gundula Krack et al. Drugs Real World Outcomes. 2016 Sep; 3(3): 265–278 Li P et al. Value Health. 2010 Sep-Oct;13(6):805-12
  • 7.  Persistent days : number of days to discontinuation and number of prescription refills over a period of time  The number of days to discontinuation ▪ a simple count of days from the index prescription to the date of the final dispensing ▪ Option : inclusion of the days for which the final fill (e.g., final 30 days)  The number of refills ▪ usually within 12 months of the index fill, could include patients who refill long after the allowed 30- or 60-day gap for being considered non-persistent.  “As needed medicine” e.g., treatments for seasonal allergy 90 30 90 30 90 210 90 30 90 Persistent days = 390 days Gap days = 90 days Persistent days = days supply + off days If max off days > gap days(90days), then the patient is not persistent Index date off days off days off days Option Andrew M et al. Value Health. 2007 Jan-Feb;10(1):3-12

Editor's Notes

  1. 약물 순응도는 총 관찰 추적 기간 동안, 처방받은 약물군(A 또는 B군)의 총 처방 일수의 비율로 정의한다. 약물 순응도(%) = 총 처방 일수 (Total days supply) / 총 관찰 기간 (observation period)
  2. 약물 지속 기간은 관찰 추적 기간 중 최초의 약물 사용일로부터 중단 없이 사용한 약물의 사용 일수로 정의한다. 관찰 시작일로부터 중단 없이 지속된 약물 처방 및 사전에 정해진 휴지 기간을 넘지 않는 연속적인 동일 그룹(예: A군) 의 약물 처방으로 정의한다. 휴지 기간은 90일로 하며(변동될 수 있음) 만약 이 기간이 지나면 연속적인 처방이 아닌 것으로 간주하여 약물 복용을 지속하지 않은 것으로 판단한다.