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					                                                                                                                                                                                                                                                                               9/30/2009




                          Drugs don't work in patients who don't take them
                                                            Everett Koop, MD

                                                                                                                                                        Epidemiology of Diabetes: is there a
                                                                                                                                                        Problem?
   Estimating Patient Compliance in T2DM:                                                                                                               Issues on Compliance
   What Seems to Work and What Not:                                                                                                                              p
                                                                                                                                                        The Compliance in T2DM Pilot Study:y
                                                                                                                                                        Objectives
                                        Lessons learnt                                                                                                  Methods
                                                                                                                                                        Results
                                                                                                                                                        Discussion
                                                                                                                                                        Conclusion
                                                                                                                                                        Acknowledgements

                                                      Nadir Kheir, PhD
                                                                                                                                              9/30/2009                           College of Pharmacy- N Kheir                                                                  2




         Diabetes mellitus (DM) is increasing in 
         prevalence worldwide                                                                                                                             Country                        Year 2000            Year 2030                    % Increase
                                                                                                                                                          Oman                                 113,000                     343,000                         203%
         Number of people with diabetes projected to                                                                                                      Pakistan                          5,217,000                 13,853,000                           165%
         rise from 171 million in 2000 to 366 million in                                                                                                  Qatar                                 38,000                      88,000                         131%
         20301                                                                                                                                            Saudi Arabia                        890,000                   2,523,000                          273%

         In developing countries the prevalence is                                                                                                        United Arab 
                                                                                                                                                          Emirates 
                                                                                                                                                                                              350,000                     684,000                          185%
         projected to double between 2000 and 2030                                                                                                        Iraq                                668,000                  2,009,000                           200%
         In Qatar, the overall prevalence of DM among                                                                                                     Jordan                              195,000                     680,000                          248%
         adult population has been estimated to be as                                                                                                     Kuwait                              104,000                      319,000                         206%

         high as 17%2
        1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and
         projections for 2030. Diabetes Care 2004;27(5):1047‐1053                                                                            3. WHO Diabetes Program 2009. Available in: http://www.who.int/diabetes/facts/world_figures/en/index2.html
        2. Bener A, Zirie M, Janahi IM, Al‐Hamaq AO, Musallam M, Wareham NJ. Prevalence of diagnosed and undiagnosed
        diabetes mellitus and its risk factors in a population‐based study of Qatar. Diabetes Res Clin Pract 2009;84(1):99‐106.          3    9/30/2009                           College of Pharmacy- N Kheir                                                                  4




       Compliance: the degree or extent of conformity to                                                                                            Non‐compliance with just 10 drugs cost the 
       the recommendations about day‐to‐day treatment                                                                                               USA between $396 and $792 million each 
       by the provider with respect to the timing, dosage,                                                                                          year5
       and frequency with prescribed medication 4                                                                                                   Total cost estimated as $100bn annually6
       Successful pharmacological treatment of illness                                                                                                 d             d
                                                                                                                                                    Studies using medication possession ratio 
       significantly influenced by degree of compliance                                                                                             as measure of compliance:
       Compliance Research:                                                                                                                         The rate of hospitalization increased to 10.3% when 
       new complex treatment regimens and the risk of drug                                                                                          MPR was < 80%
       resistance                                                                                                                                   Rate of hospitalization increased to 15% when MPR was 
       Poor outcome of therapy, not due to ineffective medication,                                                                                  <40%
       but to poor compliance
                                                                                                                                                5. Department of Health and Human Services. Prescription drug products: patient pack insert requirements. Fed Register 1980;
4. LaRosa JH, LaRosa JC. Enhancing drug compliance in lipid‐lowering treatment. Arch Fam Med 2000;9(10):1169‐72                                 45: 60754–817
                                                                                                                                  1175          6. Lewis A. Non-compliance: a $100bn problem. Remington Report 1997;5:14–5
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                                                                                                                                              9/30/2009                                                 College of Pharmacy- N Kheir




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            Non‐compliance causes 125,000 deaths                                                                                                               So far, all studies on compliance were conducted 
            annually in the US7                                                                                                                                overseas in other cultural environments
            Non‐compliance leads to 10 to 25% of                                                                                                               We need to answer the question: how big is the 
                                                                                                                                                               problem in Qatar (and the ME)?
            hospital and nursing home admissions2                                                                                                              Also, what patient and system‐related factors likely 
            Non‐compliance with drug therapy is                                                                                                                contribute to poor compliance in Qatar?
            becoming an international epidemic8                                                                                                                Is the problem of sufficient magnitude to call for 
            In the US, it is estimated that ~50% of the                                                                                                        strategies to combat it? By whom, and how?
            prescriptions filled each year are not taken                                                                                                       Most importantly, we need first to validate methods 
            correctly                                                                                                                                          used to assess compliance
            7. Smith, D., Compliance Packaging: A Patient Education Tool, American Pharmacy, Vol. NS29, No 2 February 1989
            8. The New York Times June 2, 1998
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                                                             Hughes D. The Assessment, Determinants & Economics of Medication Compliance & Persistence.
                                                             Iinternational Society for Pharmacoeconomics and Outcomes Research;. Available in:
                                                             http://www.ispor.org/sigs/medication.asp

      9/30/2009                         College of Pharmacy- N Kheir                                                                              9       9/30/2009             College of Pharmacy- N Kheir                                    10




                                                                                                                                                              Wide spectrum of methodologies
                                                                                                                                                             1. Measuring biological serum: burdensome, 
                                                                                                                                                                      intrusive, D‐F interactions, drug t1/2
                                                                                                                                                             2 Using data derived from dispensing records: 
                                                                                                                                                             2.
                                                                                                                                                                      data completeness and data records reliability
                                                                                                                                                             3. Patient‐self‐assessment: bias, retrieval
                                                                                                                                                             4. Pill count: over‐estimating compliance
                                                                                                                                                             5. The use of compliance electronic devices (CED) : 
                                                                                                                                                                      the least studied, and may be the most 
                                                                                                                                                                      promising
      9/30/2009                         College of Pharmacy- N Kheir                                                                            11        9/30/2009                                             College of Pharmacy- N Kheir    12




                                                                                                                                                                                                                                                      2
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  Medication Event Monitoring System
                            (MEMS®)
                                                                       13



  A standard medication bottle with caps                                          To Assess the usefulness of the MEMS®  in 
fitted with a microprocessor that records                                         assessing compliance of patients with T2DM on 
every bottle opening (i.e. Event)                                                 oral medication
  Each monitor records information 
p         g             q    y
pertaining to the frequency and times that 
the medication container is opened and 
closed
                                                                                  This was an important part of a parent pilot study 
  Real‐time data were collected on the device                                     that aimed to assess the feasibility of the study’s 
and later transferred to a computer                                               logistical arrangements
  The MEMS® had been described as the 
‘gold‐standard’ for assessing compliance with 
oral medication, this (in our opinion) is a 
claim that is still to be substantiated 
              College of Pharmacy- N Kheir                9/30/2009         9/30/2009                            College of Pharmacy- N Kheir                                                                                  14




       An observational cross‐sectional study conducted in                       1 month supply of a oral antidiabetic medication 
       Hamad General Hospital (HGH) in Doha, Qatar                               was placed into a serially numbered medication 
       Qatari patients with T2DM attending an outpatient                         bottle (vial) with a cap fitted on
       Diabetic clinic in HGH were invited to participate                        The patients were instructed to take all doses of 
       Inclusion: Adult  Qatari  T2DM  On oral antidiabetic 
       Inclusion: Adult, Qatari, T2DM, On oral antidiabetic                      their metformin from the MEMS fitted bottle 
                                                                                 their metformin from the MEMS‐fitted bottle 
       medication (metformin)                                                    At the follow‐up appointment, the MEMS® devices 
       Consenting patients were administered face‐to‐face                        were collected from the patients
       interviews in the out‐patient pharmacy of HGH (the                        Data contained in the MEMS® were downloaded 
       Diabetes Habit & Beliefs Questionnaire)                                   using MEMS® software and any remaining pills 
                                                                                 were counted and documented in a data capture 
                                                                                 sheet (also return for re‐fill date and loss of bottles 
                                                                                 were documented) 
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       Descriptive and correlation statistics (bi and                       Compliance was assessed by computing dosage 
       multivariate) analysis were carried out using the                    compliance rate9 (MEMSd)= (The number of bottle 
                                                                            openings)÷(The number of doses prescribed)*100
       SPSS® (version 17.0)
                                                                            The regimen compliance rate9 (MEMSr)= (The number 
       Correlations were expressed as Pearson                               of days in which the dose regimen was taken as 
       correlation coefficient ‘r’ statistical significance                 prescribed) ÷(The total number of days for which the 
       was set at p<0.05.                                                   drug was prescribed) *100
       MEMS® data was extracted from the Aardex®                            An acceptable level of adherence by pill count was 
       database and analyzed using small series of                          achieved if 80% to 100% of the prescribed pills were 
       JMP® statistics package, SAS Institute, USA.                         not returned to the clinic (assumed taken)10
                                                                            9. Wu et al. Objectively measured, but not self‐reported, medication adherence independently predicts event‐free survival in patients with heart failure.
                                                                            J Card Fail 2008;14(3):203‐210.
                                                                            10. Lee et al. Assessing medication adherence by pill count and electronic monitoring in theAfrican American Study of Kidney Disease and
                                                                            Hypertension (AASK) Pilot Study. Am J Hypertens 1996;9(8):719‐
                                                                            725.
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                                                                                                                            An understanding of Knowledge, Attitude, and 
                                                                                                                            Practice will enable tailoring efficient processes 
                                                                                                                            of awareness‐creation based on the real needs 
                                                                                                                            of the community
                                                                                                                                      g               p
                                                                                                                            Knowledge domain: the patient’s knowledge    g
                                                                                                                            about diabetes
                                                                                                                            Attitude Domain: the patient’s beliefs about 
                                                                                                                            diabetes, and his/her general feelings and 
                                                                                                                            familiarity
                                                                                                                            Practice Domain: the ability of the patient to 
                                                                                                                            manage their time in respect to their diabetes 
                                                                                                                            management and in general

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                               College of Pharmacy- N Kheir




                                                                                                                              MEMSd
                                Mean Percentage of 4 domains (KAP-M)
                                                                                                                                                                             Quanti les                     Moments

                                                                                                                                                                              maximum     100.0%   136.67   Mean             67.72634
             100.0                                                                                                                                                                         99.5%   136.67   Std Dev          35.95826
                                                    86.4
                                                                                                                                                                                           97.5%
                                                                                                                                                                                           97 5%   136 67
                                                                                                                                                                                                   136.67       E Mean
                                                                                                                                                                                                            Std Error M       6.92017
                                                                                                                                                                                                                              6 92017
              80.0                                                                                                                                                                         90.0%   100.33   Upper 95% Mean   81.95084
                                                                                         66.2                                                                                 quartile     75.0%    92.22   Lower 95% Mean   53.50184
                                                                     59.1
              60.0                                                                                                                                                      15    median       50.0%    82.22   N                27.00000
                                49.8
                                                                                                                                                                              quartile     25.0%    45.00   Sum Weights      27.00000
         %




                                                                                                      Average %
                                                                                                                                                                        10                 10.0%     2.11
              40.0
                                                                                                                                                                                            2.5%     1.67
                                                                                                                                                                                            0.5%     1.67
                                                                                                                                                                        5
              20.0                                                                                                                                                            minimum       0.0%     1.67


                  0.0                                                                                                         0       25   50   75    100   125   150
                             Knowledge         Attitude          Practices            Mood
                                                           Domain


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    MEMSr

                                                    Quantiles                        Moments

                                                     maximum    100.0%      90.000   Mean             45.55556
                                                                 99.5%      90.000   Std Dev          32.90754
                                                                 97.5%      90.000   Std Error Mean    6.33306
                                                                 90.0%      87.333   Upper 95% Mean   58.57324
                                                     quartile    75.0%      80.000   Lower 95% Mean   32.53787
                                                     median      50.0%      50.000   N                27.00000
                                                     quartile    25.0%      10.000   Sum Weights      27.00000
                                                                 10.0%       0.000
                                                                  2.5%       0.000
     0       20         40     60      80     100                 0.5%       0.000
                                                     minimum      0.0%       0.000




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                                                                                                                                                                                                                                               4
                                                                                                                         9/30/2009




                                                                      Only  37  out  of  the  total  patients  enrolled  in 
                                                                      this  study  were  issued  their  medication  in 
                                                                      MEMS® containers (68%). 
                                                                      13  (35%)  patients  returned  their  medication 
                                                                      bottles later than the re‐fill date
                                                                      bottles later than the re fill date
                                                                      The mean delay in days was 13 (SD=17.6)
                                                                      Four  patients  (~11%)  have  not  returned  the 
                                                                      MEMS® despite multiple following‐up calls
                                                                      One  patient  admitted  that  she  threw  the 
                                                                      bottle (with our MEMS fitted) in the trash bin

9/30/2009           College of Pharmacy- N Kheir            25   9/30/2009       College of Pharmacy- N Kheir              26




     Overall compliance with daily doses (MEMSd)                      Pill counts were performed when each 
     was 67% (Median= 82.2%) , and with regimen was 
     46% ; however..                                                  MEMS® unit was returned
     The range of times the MEMS® was opened was                      The range of pills returned was 0‐78, with a 
     9‐155 (Median= 70).
     The number of days when the MEMS® was used                       mean of 6.74 
     by the patients ranged from 2‐42 per patient                     Compliance estimated using the pill count 
     (Median= 29)
     There was poor correlation between compliance                    method was 91.3% 
     rate  assessed  by  MEMS® and  age,  years  since                There was no significant correlation between 
     diagnosis, and education level (p>0.5)
     There was strong correlation between MEMSd &                     the compliance as assessed by pill count and 
     MEMSr  (p=0.000, r=0. 776)                                       MEMSd or MEMSr (p=0.335 & 0.238, respectively)

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     The use of MEMS® presented us with several                   Retrieval of MEMS® was an issue in terms of 
     challenges in relation to interpretation of results          delays or  failure to return the units  
     and devising methods for optimum usage in                    The frequent openings that occurred meant that 
     clinical trials                                              patients opened the container more than they 
                                                                  p          p                                 y
     The MEMS appears to be potentially valuable                  should
     tool for assessing compliance provided that                  Several patients regularly opened their MEMS 
     patients used it appropriately                               bottles at dose frequency less than what was 
     The biggest challenge remains to be the 
                                                                  prescribed
     medication‐taking behavior of the specific 
                                                                  The starting day for the 1st opening of MEMS 
     population of patients
                                                                  varied between patients
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                                                                                                                                                 9/30/2009




                                                               The poorer MEMSr compliance (46%) could be 
      The range of the number of days when                     due to the lower margin for error in calculating 
      MEMS‐fitted bottles  were ‘opened’ was 2‐42              MEMSr
      The 42 days indicated extra openings (dose               The regular wrong frequency of events by 
      taken or not)                                            some patients could be due to:
      The figure 2 meant either the medication was 
                                                                      Intentional decision to miss medications (rational 
      used scarcely (not supported by data), or pills                 non‐compliance)
      emptied in other container                                       intentional prescribing error, where some 
      Both indicate poor compliance with dosage                       physicians might be verbally telling the patient to 
      and regimen                                                     take the dose at a longer frequency, but prescribing 
                                                                      a dose with shorter frequency
9/30/2009       College of Pharmacy- N Kheir         31   9/30/2009             College of Pharmacy- N Kheir                                        32




                                                            While an attractive innovation, an ECD pose many challenges
     Compliance estimated using the pill count              The societal characteristics of patients are important factors 
                                                            that reflect on compliance studies using ECDs
     was 91.3%                                              The findings should help in recommending a number
     Considering the poor association between               of pre‐requisites that can maximize the expected benefits of 
                              d ll
     MEMS® cap opening and pill count, this h               ECDs if they are to be used to measure compliance in future 
     figure is probably an over estimation                  clinical trials:
                                                               Strategies to minimize potential for loss or delay of returning of the units 
     Possible reason for the high pill count‐                  must be made
     compliance is emptying the container in                   Focused dialog with the patient where the patient is educated on the proper 
                                                               use of MEMS® (sole source for pills, openings only to take a dose, etc)
     another bottle                                            Scheduled re‐fill date reminder phone calls


9/30/2009       College of Pharmacy- N Kheir         33   9/30/2009             College of Pharmacy- N Kheir                                        34




     The MEMS could have place in monitoring 
     compliance on individual patients, provided..

            hl                                l
     Meanwhile, assessing/monitoring compliance 
     seems to still be an issue (next slide!)
                                                                                                                    Vol 14; 4373; Saturday 26 Sep 2009




                                                                                                               Ingestible compliance Microchip
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                                                                                                                                                         6
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                                                                                                                          The input and involvement of the research 
     This publication was made possible by a grant from
                                                                                                                          team was invaluable in conducting this work. 
     the Qatar National Research Fund under its
                                                                                                                        Dr. Bill Greer (Sidra Medical & Research Center)
     Undergraduate Research Experience Program.                                                                                                       p
                                                                                                                        Dr. Adil Yousif (Statistics Department, QU)
                        ll h             bl      f h
     Its contents are solely the responsibility of the                                                                  Miss. Hajer AlGeed (College of Pharmacy, QU)
     authors and do not necessarily represent the official                                                              Miss. Randa Al Okkah (College of Pharmacy, QU)
     views of the Qatar National Research Fund                                                                        And our other collaborators:
                                                                                                                        Mrs. Manal Zaidan (HMC)
                                                                                                                        Dr. Mahmoud Zerie (HMC)


9/30/2009                   College of Pharmacy- N Kheir                                                         37   9/30/2009     College of Pharmacy- N Kheir            38




1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and
 projections for 2030. Diabetes Care 2004;27(5):1047‐1053
2. Bener A, Zirie M, Janahi IM, Al‐Hamaq AO, Musallam M, Wareham NJ. Prevalence of diagnosed and
Undiagnosed diabetes mellitus and its risk factors in a population‐based study of Qatar. Diabetes Res Clin
Pract 2009;84(1):99‐106.
3. WHO Diabetes Program 2009. Available in: http://www.who.int/diabetes/facts/world_figures/en/index2.html
4. LaRosa JH, LaRosa JC. Enhancing drug compliance in lipid‐lowering treatment. Arch Fam Med
2000;9(10):1169‐72
5. Department of Health and Human Services. Prescription drug products: patient pack insert requirements.
Fed Register 1980; 45: 60754–817
6. Lewis A. Non‐compliance: a $100bn problem. Remington Report 1997;5:14–5
7. Smith, D., Compliance Packaging: A Patient Education Tool, American Pharmacy, Vol. NS29, No 2 February 
  1989
8. The New York Times June 2, 1998
9. Wu et al. Objectively measured, but not self‐reported, medication adherence independently predicts
event‐free survival in patients with heart failure. J Card Fail 2008;14(3):203‐210.
10. Lee et al. Assessing medication adherence by pill count and electronic monitoring in theAfrican American
Study of Kidney Disease and Hypertension (AASK) Pilot Study. Am J Hypertens 1996;9(8):719‐725




9/30/2009                   College of Pharmacy- N Kheir                                                         39




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Description: MEMS Seminar Sep ppt Compatibility Mode high-margin pharmacies