Adherence Compliance Concordance:pDifficulties following medical advice

Alex J MitchellAlex J Mitchell

Ack. Dr Shoka, Dr Shanka, Dr Selmes

“Adherence”

The extent to which the patientsThe extent to which the patients behaviour coincide with the clinical prescription/advice [ Haynes et al 1979 ].prescription/advice [ Haynes et al 1979 ].

Wh t if di l d i iWhat if medical advice is wrong, inadequate or missing?

Sometimes, does the patient know best?Sometimes, does the patient know best?

Does not attend / delays asymptomatic screening

At Risk Population

Does not attend / delays asymptomatic screening (if offered)

Symptoms

Dela s or does not seek helpDelays or does not seek help (where available)

Diagnosis

R l di i

Adherence and attendanceare linked

Reluctant to accept diagnosis (if told)

Early Treatment

Reluctant to start treatment (if offered)

Follow Up

Does not attend further appointments (if offered)

Continuation Treatment

Does not follow course as prescribed

Types of Medication difficulty

Ladder of Discontinuation

Full discontinuationIs unmonitored

Trial discontinuationIs harmless

T i l Di ti ti

Full Discontinuation4

Missing odd doses has no adverse effects

Partial non-adherence

Trial Discontinuation3

Benefits are unclearOr hazards are clear

Partial non-adherence

Thoughts of stopping

2

Medication is costlyor a hassle or linkedwith stigma

Concordant

g pp g

0

1

Concordant0

Poor Compliance is Normal (Barber et al)N Barber et al Patients’ problems with new medication for chronic Patients’ conditions.Qual Saf Health Care 2004;13:172–175.

Taking All Medication As Prescribed& Problem Free & with sufficient information 10%

Taking some Medication As Prescribed & Problem Free

Taking some Medication As Prescribed with Issuesg

Stopped taking medication against medical advice

10%

Types of Adherence Problems

Initial vs follow upInitial vs follow upRefusal vs discontinuationNon-attendance vs drop outNon-attendance vs drop out

Partial vs Full vs OverPartial vs Full vs OverPartial attender, takes some medication, takes too much medicationtakes too much medication

Overview

Y

Initial TreatmentRefusal

Medication Course StartedN

Course interrupted

Conversion to discontinuationExtra Doses

Full non-adherence Partial non-adherence

Discontinuation Missed Dosesu o ad e e ce a t a o ad e e ce

Course interrupted

Y

Initial TreatmentRefusal

Medication Course StartedN

Conversion to discontinuation

P ti t i h d t dj t di ti d ?P ti t i h d t t t ki di ti ?

Extra DosesFull non-adherence Partial non-adherence

Discontinuation Missed Doses

Patient wished to adjust medication dose?Patient wished to stop taking medication?

Y Y

intentional Non intentional Intentional Non-Intentional

Y Y NN

External Internal External Internal

Explanation

Course interrupted

Y

Initial TreatmentRefusal

Medication Course StartedN

Course interrupted

Patient wished to adjust medication dose?Patient wished to stop taking medication?

Extra DosesFull non-adherence Partial non-adherence

Discontinuation Missed Doses

intentional Non intentional Intentional Non-Intentional

Patient wished to stop taking medication?

Y Y NN

External Internal External InternalWith medical advice?*

Lapse or SlipBarrierWith medical advice?*

Lapse or SlipBarrier

Collaborative Self-DirectedCollaborative Self-Directed

Y YN N

Collaborative Self Directed

Based on adequate information?

Collaborative Self Directed

Based on adequate information?

* Advice implies consultation and discussion of risk and benefits not necessary sanction to act

Low Risk of HarmHigh Risk of HarmLow Risk of HarmHigh Risk of Harm

Y YNN

Course interrupted

Y

Initial TreatmentRefusal

Medication Course StartedN

Course interrupted

Conversion to discontinuation

Patient wished to adjust medication dose?Patient wished to stop taking medication?

Extra DosesFull non-adherence Partial non-adherence

Discontinuation Missed Doses

intentional Non intentional Intentional Non-Intentional

Patient wished to stop taking medication?

Y Y NN

External Internal External InternalWith medical advice?*

Lapse or SlipBarrierWith medical advice?*

Lapse or SlipBarrier

Collaborative Self-DirectedCollaborative Self-Directed

Y YN N

Collaborative Self Directed

Based on adequate information?

Collaborative Self Directed

Based on adequate information?

* Advice implies consultation and discussion of risk and benefits not necessary sanction to act

Low Risk of HarmHigh Risk of HarmLow Risk of HarmHigh Risk of Harm

Y YNN

Examples of Medication difficulty

Compliance: Rheumatoid ArthritisCompliance: Rheumatoid Arthritis

40 345

35.7

40.3

30

35

40

Consistently

23.8

20

25

30

%

Compliant

Consistently Non-compliant

5

10

15 Other - ?partialcompliance

0

5

•556 pts with RA followed for 3 years

Viller F et al. J Rheumatol. 1999;26:2114-2122.

•Compliance assessed annually by interview

Compliance: Hypertension

50% 44%

40%

50%

Very Regular25%

20%20%

30%Very Regular

Regular

Irregular

2%10%

Forgetful

0%

Mallion et al, Mallion et al, J HypertensionJ Hypertension, 1998, 1998

The problem of poor compliance

80

90Patients not adhering by disease area

55

Arthritis

Epilepsy

Hypertension

disease area (%)

3540 40 Diabetes

Asthma

Contraceptionp

Whitney HAK et al. Annals of Pharmacotherapy 1993.

Medication Problems in Mental Health

Percentage of Patients Discontinuing Antipsychotics in 18month CATIE Trial

7480

74

60

70

40

50

14 9

23.7

29.9

20

30

5.5

14.9

0

10

0Other Intolerability Lack of Eff icacy Patient Decision Total

Discontinuations

Compliance challenges affect almost ALLCompliance challenges affect almost ALL patients*

5.2% 7.1%100

Continuous Medication

ANY Days Without Medication

350

Mean Number of Days Without Medication

92.9%94.8%

60

80

200250300350

snts

)

20

40 125.0110.2

50100

150200

Day

s

Patie

n(%

)

0Atypical Conventional

050

Atypical Conventionaln = 349 n = 326n = 349 n = 326 n = 349 n = 326

Mahmoud et al, 2004. Clin Drug Invest:24(5):1

n = 349 n = 326

Partial compliance increases with time

7080

75%Com

plia

nt

405060

50%Up to 25%Part

ially

C

102030

p

of P

atie

nts

010

7-10 Days 1 Year 2 Years* † †

% o

Keith & Kane. J Clin Psychiatry 64:11; 2003

Time From Discharge

Adherence in general clinical practice is poorAdherence in general clinical practice is poor

AntipsychoticsAntipsychotics(3–24 months)

(24 studies)Antidepressants p(1.5–12 months)

(10 studies)Non-psychiatric

0 20 40 60 80 100

(0.25–10 months)(12 studies)

Adherence (%)

Wide range of estimates across studies may reflect difficulty of assessing covert non adherence

Cramer & Rosenheck. Psychiatr Serv 1998;49:196–201

difficulty of assessing covert non-adherence

Data shown are mean and range

Predicting Medication difficulty

Why Do Patients Have Difficulty?

With medication?With medication?

With i t t ?With appointments?

Predictors of Difficulty with Medication

Medication not working (efficacy)Medication not working (efficacy)Medication harming (side effects)M di ti tiMedication stigmaMedication costsMedication availabilityMedication has helped (now not needed)Medication has helped (now not needed)

Predictors of Difficulty with Appointments?Predictors of Difficulty with Appointments?

Clinician not helping (efficacy)Clinician not helping (efficacy)Clinician harming (criticism/hostile)A i t t tiAppointment stigmaAppointment travel (costs)Appointment availabilityClinician has helped (now not needed)Clinician has helped (now not needed)

Doctor-Patient FactorsTherapeutic alliance

Perceived helpfulness

Perceived Benefits of Care

Reduced symptoms

Perceived Costs of Care

Previous bad experiences

F d d t

Barriers to CareLack of transportation

Financial inequalities Perceived helpfulness

Communication style

Adequacy of explanation

Adequacy of monitoring

Prevention of complications

Enhanced therapeutic relationship

Improved Health Related QoL

Feared adverse events

Financial costs

Dislike of medical model

Inconvenience

Financial inequalities

Infrequent appointments

Inconvenient appointments

Stigmatization

Ideal Concordance Disengagement (drop-out)

Self-Medication Behaviour Attendance Behaviour

Desire to stop

Good Concordance

Partial Concordance

Low ConcordanceDesire to continue

medical care

Low Attendance

Partial Attendance

Good AttendanceDesire to stop medical care

+ DistractersCues to Act

Reminders

Discontinuation+ Encouragement

Non-intentional IntentionalIllness Factors

Ideal Attendance

Insight into current symptoms

Perceived risk of future decline

Previous treatment responsiveness

Likelihood of treatment benefits

Reminders

Flexible booking / Open access

Delivery or collection of medication

Encouragement / support by others

May Not be Disclosed

Reasons incoherent

No alternatives

Non-intentional Intentional

Likely to be Disclosed

Reasons coherent

Alternatives discussedLikelihood of treatment benefitsconsidered

Adherence and Satisfaction

Audience: what is the relationship?Audience: what is the relationship?

Higher rated treatment success => drop outHigher rated treatment success => drop-outLow rated clinician => drop-out

Rossi, A., Amaddeo, F., Bisoffi, G., et al (2002) Dropping out ofcare: inappropriate terminations of contact with community basedpsychiatric services British Journal of Psychiatry 181psychiatric services. British Journal of Psychiatry, 181,33 –338.

Measuring Medication difficulty

Measurement of adherence

INDIRECTClinicians enquiryClinicians enquiryPatient or relative report

DIRECTMeasurement of the medicationMeasurement of a biological markerMeasurement of a biological marker

Different Ratings Different ResultsDifferent Ratings, Different Results

Two separate studies found that both patients* and clinicians†

overestimate compliance

Rated as Compliant94.7

67.56080

100

of P

atie

nts Rated as Compliant

38.1

10.3204060

rcen

tage

o

0Pill Count Patient MEMS Cap Clinician

Per

*Criterion: ”took all pills.”†Criteria: >70% of days (MEMS cap); score >4 on clinician rating scale.

*Lam YWF et al. Poster presented at: Biennial Meeting of ICOSR; March 29 – April 2, 2003; Colorado Springs, Colorado.

†Byerly M et al. Poster presented at: Annual Meeting of APA; May 17-22, 2003; San Francisco, California.

Consequences of Medication Difficulty

Poor Compliance Affects Rehospitalisation Rates

Percentage of patients with a psychiatric admissionPercentage of patients with a psychiatric admission

35

40

20

25

30

P t

5

10

15Percent

0

10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 110% 120% 130%

Medication Possession Ratio

Valenstein M, et al. Medical Care. 2002;40:630-639.

Continuous vs intermittent maintenance: 1 year relapse rates

5533

10

Carpenter, et al.

30

297

10

Jolley, et al.

Herz, et al.Continuous therapy

I t itt t th

35

30

20

15

S h l l

Pietzcker, et al.Intermittent therapy

3220

0 10 20 30 40 50 60

Schooler, et al.

Rates of Relapse (%)Kane et al, 1996. N Engl J Med;334:34-41.

Relapse in 1st episode patients over 1 year: according to compliance

35

25

30

35

15

20

25

RelapseWell

5

10

15 Well

0

5

Compliant Non-compliant

Novak-Grubic & Tavcar P. Eur Psychiatry 2002;17:148-54

Helping with Medication difficulty

4 Steps

1 Basic communicationEstablish a therapeutic relationship and trustIdentify the patient’s concernsTake into account the patient’s preferencesExplain the benefits and hazards of treatment optionsInvolve patients in decisions

Don’t force medication as “one size fits all”Don t force medication as one size fits all

2 Strategy-specific interventions2 Strategy specific interventionsAdjust medication timing and dosage for least intrusionintrusionMinimise adverse effectsMaximise effectivenessMaximise effectivenessProvide support, encouragement and follow-upup

3 Reminders3 RemindersConsider adherence aids such as pill boxes and alarmsand alarmsConsider reminders via mail, email or telephonepHome visits, family support, encouragment

4 Evaluating adherencegAsk about problems with medicationAsk specifically about missed dosesp yAsk about thoughts of discontinuationWith the patient’s consent, consider direct methods: pill counting, measuring serum

Liaise with GP & pharmacists re prescriptions

Off lt tiOffer alternatives

Extras

Potential to Improve Relapse Rates With Depot vs Oral Antipsychotics

Difference in Relapse Rates

StudyNumber of subjects Oral Depot

Relapse Rates (oral minus depot) (%)

Studyduration

Crawford and Forest 29 40 k 27 0

Relapsed (%)

Crawford and Forest (1974) 29 40 weeks 27 0

del Guidice et al (1975) 82 1 year 91 4348

27

Rifkin et al (1977) 51 1 year 11 9

Falloon et al (1978) 41 1 year 24 40 -16

2

Hogarty et al (1979) 105 2 years 65 40

Schooler et al (1979) 214 1 year 33 24 9

24

Mantel-Haenszel: P < 0.0002.Davis JM et al. Drugs. 1994;47:741-773.

— +

Degree of difficulty to produce adherence sufficient for therapeutic effectfor therapeutic effect

Weight Reduction

Flossing

Exercise

Schizophrenia

Weight Reduction

Diabetes (oral)

Diabetes (insulin depot)

Hypertension

g

Asthma

Rheumatoid Arthritis

Depression

Headache

Birth Control Pills

Strep Throat

20 40 60 80 100Easy Difficult

Keith & Kane J Clin Psychiatry, 2003; 64: 1308-1315

Oral medication Tips

[ Churchill et al] proposed the following i t t t iimprovement strategies ;

Keeping the regime simple.Providing explicit written informationProviding explicit written information.Involving patients in decision making.Encourage patient participation in their own care.g p p pImplementing drug regimes gradually.Tailoring to daily rituals.Providing warm positive feedback.

Interventions to improve adherence

Osterberg et al 2005 grouped intervention inOsterberg et al 2005 grouped intervention in to four categories;

Patient educationPatient education.Improved dosing schedules of medication.Increasing clinic hours.Improved communication between the p

therapist and the patient.

Contd - 2

Further interventions studied include ;Providing more information [ both written and oral

material and programmed learning ].Compliance therapy.Manual tele follow up.S i l i d ill kiSpecial reminder pill packing.Appointment and prescription refill reminders.L d dLeverage and rewards.

Contd - 6

Other interventions ;In a systematic review [ Bennett & Glaziou 2003 ]

which included 26 RCTs of computer generated medication reminders or feedbacks provided tomedication reminders or feedbacks provided to the pts / health care providers concluded that the reminders are effective than feedback in improving adherenceimproving adherence.

Mugford et al showed that information was most effective when presented close to the time of d i i kidecision making.

Conclusion

In a systematic review [ McDonald et al 2005 ] of RCT f i t ti t i t ti tRCTs of interventions to assist patient adherence to meds concluded in psychiatric disorders the overall combination interventions and compliance counselling for pts appeared to be effective for improving adherence followed closely by family oriented therapies . The y y y peducation oriented therapies on their own were generally unsuccessful in improving the adherenceadherence.

Conclusion

Evidence for any single intervention toEvidence for any single intervention to improve adherence is weak however a combination of educational, cognitive andcombination of educational, cognitive and behavioural measures [ collaborative care ] have shown to improve the adherence to] have shown to improve the adherence to medication with the psychiatric patients. Further research is needed.Further research is needed.