NON COMPLIANCE

Nazia Tabassum (Assistant professor)

Faculty Of Pharmacy, UCP, Lahore.
 DEFINITIONS

 Compliance:
 Dictionary definition of compliance is: “An action in accordance with request or command”
 Compliance with therapy means a positive behavior in which the patient is motivated sufficiently
to adhere to prescribed treatment because of a perceived self-benefit and a positive outcome. It
is the extent to which a patient takes medicine in accordance with the directions given by
prescriber or medical/health advisor.
 Adherence:
 It is used to emphasize that the patient is free to decide or to adhere to physician instructions
and incase of failure, only patient should not be blamed.
 DEFINITIONS

Medication adherence

“The degree to which the person’s behavior corresponds

with the agreed recommendations from a health care
provider.”

– World Health Organization

Adherence vs. Compliance

Adherence is a more accurate term than

compliance
Compliance suggests a process in which
dutiful patients passively follow the advice of
their physicians
Adherence, in contrast, better fits how most
patients actively participate in their care and
decide for themselves when and whether to
follow their doctor’s advice
 DEFINITIONS

 Concordance:
 It is recently used to denote the drug to which the patient and clinician agree about nature
of illness and need for the treatment. This term is not alternative to compliance or
adherence because it relates to the process and outcome of medical consultation where
compliance or adherence describes patients behavior.
 Non compliance:
 “When a patient does not follow the treatment schedule suggested to him by physician for
the management of some illness he is said to be non compliant.”
 Patients sometimes are not taking the medications according to the instructions of
prescriber deliberately due to some reasons or accidently known as noncompliance.
LEVELS OF NON-COMPLIANCE

 Minor Non-compliance:

 Serious Non-compliance:

 Continuing Non-compliance:
 LEVELS OF NON-COMPLIANCE
 Minor Non-compliance:
 Minor non-compliance is a non-compliant incident that does not affect participants' safety,
compromise data integrity, violate participants' rights or welfare or affect participants' willingness
to participate in the research. Examples include a missed deadline for a continuing review,
inadvertent errors due to inattention to detail, misunderstanding, an oversight, or inadequate
training and supervision of research staff.
 Serious Non-compliance:
 Serious non-compliance is an activity that jeopardizes participants safety, rights or welfare, or the
integrity of the data.
 Examples: Conducting clinical research without Human Research Ethics Committee approval.
Research participants do not meet inclusion criteria but are still enrolled in an experimental study,
potentially or actually increasing risk and adversely affecting their rights and welfare as research
participants.
 LEVELS OF NON-COMPLIANCE

 Continuing Non-compliance:
 Continuing non-compliance is defined as a series of more than one non-compliant event in
reasonably close proximity that, if unaddressed, may compromise the integrity of the human
research protection programme. The pattern may reflect a lack of knowledge or a lack of
commitment on the part of the investigator and study team to protecting participants' safety and
welfare in research.
 Examples : Repeated failure to follow Human Research Ethics Committee policies and
procedures particularly after Committee has informed the investigator of the problem(s) and that
corrective action needs to be taken. An investigator has a record of non-compliance over a long
period or in a number of existing or previously approved studies.
 TYPES OF NON-COMPLIANCE

 1. Failure to have prescription dispensed or refilled or renewed:

 2. Omission of doses
 3. Error of dosage
 4. Incorrect administration
 5. Errors in the time of administration
 6. Premature discontinuation
 TYPES OF NON-COMPLIANCE

 Common types of noncompliance are as follow;

 1. Failure to have prescription dispensed or refilled or renewed:
 Patient does not even take their prescriptions to the pharmacy and some others who do take
their prescriptions to the pharmacy fail to pick them up when they are completed.
 Patient doesn't feel, he need the medications.
 Patient feel, he doesn't want to take it.
 Sometimes they are already taking the non-prescription medications and feel that condition is
improving so there is no need of filling the prescription or have a prescription refilled.
 2. Omission of doses
 It occurs when medication is to be taken at frequent intervals and/ or for extended period of
time so in that case patient fails or misses the dose.
 TYPES OF NON-COMPLIANCE

 3. Error of dosage
 It includes the situations where amount of individual dose or frequency of administration is
not correct like;
 Wrong dosing in case of liquid drugs.
 Spillage during pouring.
 4. Incorrect administration
 It includes;
 Inappropriate way to administer inhaler in case of metered dose inhalers.
 Taking the medication by wrong route.
 Taking medication with unprescribed vehicle like tetracycline with milk.
 TYPES OF NON-COMPLIANCE

 5. Errors in the time of administration

 Most of the patients take the antihistamines in the morning causes sedation.
 Some antibiotics act better when taken along with meal.
 Diuretics act best when given in the morning.
 6. Premature discontinuation
 It occurs with many antibiotics.
 It occurs in case of chronic diseases. As patient feels better he leaves the
medication.
 CAUSES OF NON COMPLIANCE
1. PATIENT RELATED PROBLEMS
a) Poor Understanding:
b) Physical Limitations:
c) Social And Religious Believes:
d) Socioeconomic Status of Patient:
2. DISEASE RELATED PROBLEMS
a) Psychiatric Diseases:
b) Chronic Diseases:.
c) Improved Disease Conditions:
d) Disease Leading To Disability:
3 THERAPEUTIC REGIMEN RELATED PROBLEMS:
a) Multiple Drug Therapy
b) Frequency of Administration
c) Duration of Therapy
d) Adverse Drug Reaction
e) Cost of Therapy:
f) Taste And Smell of Medications:
g) Poor Labeling:
h) Inappropriate Packaging:
4. HEALTH PROFFESIONAL RELATED PROBLEM
a) Patient-Physician Interaction
b) Quality Of Health Care Practice
 CAUSES OF NON COMPLIANCE

 1. PATIENT RELATED PROBLEMS

 a) Poor Understanding:
 Have poor eye sight.
 Too small or poor hand writing Language problem.
 Illiterate patient
 Misunderstanding and confusion.
 Difficulty in recognizing drugs of same colour and size.
 b) Physical Limitations:
 When pharmacy is at distant.
 Working hours are odd.
 Inhalers and aerosol needs coordination between fingers and breathing of patient.
 CAUSES OF NON COMPLIANCE

 c) Social And Religious Believes:

 No belief on medication.
 No belief of benefit.
 Fear of ADR.
 Muslims do not take alcohol.
 Muslims do not take medicine through dawn to dusk in Ramadan.
 d) Socioeconomic Status of Patient:
 High cost of therapy and poor economic status leads to non-compliance.
 An unmarried or divorced patient is at greater risk of withdrawal from treatment
and from preventive behave.
 CAUSES OF NON COMPLIANCE
 2. DISEASE RELATED PROBLEMS
 Psychiatric Diseases:
 Psychiatric diseases make patient uncooperative towards therapy e.g.
forgetfulness is a major cause.
 Chronic Diseases:
 Some chronic diseases are not associated with symtomology such as HTN and
hypercholestremia makes the patient non compliant.
 Improved Disease Conditions:
 Improved disease conditions make the patient ready to discontinue the therapy.
 Disease Leading To Disability:
 There are many diseased conditions that interfere with patient ability to comply
with prescription. For example, arthritic patient may have problem in opening of
containers.
 CAUSES OF NON COMPLIANCE

 3 THERAPEUTIC REGIMEN RELATED PROBLEMS:

 Multiple Drug Therapy
 It is generally agreed that the greater the number of drugs a patient is taking, the higher is
the risk of non compliance. For example, many elderly patients are taking 5 or 6
medicines several times a day at different times and rate of non compliance is more due
to memory lapses.
 Frequency of Administration We can understand this point by following table:

Frequency of administration Compliance percentage

3 times a day 59%
2 times a day 75%
Once a day 84%
 CAUSES OF NON COMPLIANCE

 c) Duration of Therapy •
 If there is a long duration of therapy as in case of chronic diseases makes patient non
compliant. For example, in case of TB a major reason for the development of resistance to
microbes is due to multiple anti TB agents and it is a major determinant in the infection
reoccurrence in TB patients.
 d) Adverse Drug Reaction
 The ADR like nausea, vomiting, hair loss associated with anti neoplastic agents cause
distress. Some drugs cause depression.
 Some drugs cause sexual dysfunction examples, like anti depressants and anti HTN.
Patients on sedatives or with CNS depressants must be advised to avoid beverages during
therapy as it causes excessive depression.
 CAUSES OF NON COMPLIANCE

 e) Cost of Therapy:
 Non compliance may result when drug cost is very low or very high. Both factors give rise to
non compliance. Prevalence of false concept that there is a direct relation between cost of drug
and its effect.
 f) Taste And Smell of Medications:
 If taste and smell of medication is objectionable particularly in paediatrics, then rate of non
compliance is more. For example, KCI preparations have bad taste and many people
discontinue the use. Therefore we add colourants and flavourant to attract children for
medication.
 g) Poor Labeling:
 Poorly written leaflets or hand written labels etc.
 CAUSES OF NON COMPLIANCE

 h) Inappropriate Packaging:
 Inappropriate packaging has a negative effect on patient compliance as in case of child
resistance containers. Some elderly and patient with arthritis have problem to open the
containers. There is also difficulty reported in case of opening of foil packed drugs.
 4. HEALTH PROFFESIONAL RELATED PROBLEM
 a) Patient-Physician Interaction
 Patients are more compliant to those physicians who give them respect.
 c) Quality Of Health Care Practice It is controlled by:
 i. Patient motivation.
 ii. Counseling communication
 iii. Patient care plan.
 MEASUREMENT OF COMPLIANCE

 A number of different methods for measuring compliance have been devised.

 1) Experimental Method:
 Mechanical Device
 Chip is built into cap of eye drops that records each inversion of bottle. Similar technique
can be adapted to openings of bottle tops.
 Urine Markers
 Accurate measurement of compliance is made by this method. Porter in 1969 outlined the
criteria for markers. They must be;
 Non-toxic.
 Pharmacologically inert.
 Quickly and freely excreted.
 Achieving peak urine conc. within few hours.
 MEASUREMENT OF COMPLIANCE
 Drug Analysis
 Drugs in body fluids can be detected easily by analysis.
 In previous times chromatography was used but now a days rapid assay techniques e.g.
enzyme immunoassays are used.
 Patient Reports
 This method relies on patient reporting their own compliance and may be conducted;
 Prospectively using diaries.
 Retrospectively by questionnaire or interview.
 Pills and Bottle Count
 A spot check is made to count the number of doses which have been removed from
container since the last check. It is widely used in clinical trial situations where patients are
requested to bring their bottle of medication back at each visit to clinic.
 MEASUREMENT OF COMPLIANCE
 2) Method Of Routine Practice
 Direct Observation
 Medicine administration in residential homes and in hospitals could involve observing that
patient actually takes the medicine. It is a useful tool when a level of skill is required in order to
use a medicine successfully.
 Outcome Measurement & Clinical Judgment
 In theory if an effective drug is taken correctly, there would be an observable improvement in
condition, which would not occur in case of poor compliance.
 Record of Prescription Order & Cashed
 A final method which is of great practical value is the frequency with which repeat prescriptions
are presented. This can be assessed by pharmacist working within general practice setting
and accessing GP computer systems or by reviewing their own patient medication record.
 STRATIGIES FOR IMPROVING COMPLIANCE
 1. Understanding
 A high level of understanding is required by the patient for this:
 Optimum communication skills must be used.
 Apart from routine counseling pharmacist must provide additional information to fill in the gaps
in understanding following the patient's consultation with the doctor.
 Along with verbal information written information must be provided.
 Written information must be in non-technical language to make it readily understood.
 2. Medicine Management
 There are three main approaches:
 Compliance Chart
 A diary of the day indicating on it the times at which each medicine should be taken is
simplest form of compliance chart. Color coding may be used to link the medicine bottle with
chart.
 STRATIGIES FOR IMPROVING COMPLIANCE

 Compliance Aids
 Memory aided devices: There is wide range of designs of memory aid devices for tablets
and capsules. The principle on which they operate is that compartments are used to hold
doses, each compartment corresponding to time of the day.
 Examples
 7-day pill organizer
 Automatic pill timer
 Daily pill minder
 c. Simplification Of Regimen
 Review he medicines to see if regimen can be simplified to make it easier to manage. For
example use of sustained release dosage form reduces dosage frequency.
 STRATIGIES FOR IMPROVING COMPLIANCE

 3. Solving Disease Related Problem

 Suggest non-child-resistant closure for elderly patients
 Devices are available to get tablets out of the blisters packs, which many people with arthritis
find particularly difficult
 A long arm roller is available to assist applying ointment and cream to part of skin that are
difficult to reach.
 4. Overcoming Physical Limitation
 Many compliance aids have been developed to assist people in using their medication.
 Inhalers
 Hale raid
 Spacer
STRATIGIES FOR IMPROVING COMPLIANCE

 Liquids
 Oral syringe
 Rota dose (liquid dispenser)
 Eye drops
 Auto drop
 Auto squeeze
 Tablets
 Pill-out (foil and blister pack tablet remover)
 Tablet crusher
 Tablet remover
 DESIGNING OF COMPLIANCE TRIALS

 Trial designed to assess patient compliance must have firm scientific basis and for this following
guidance is used;
 The term compliance should be clearly defined.
 Category of patient under trial and inclusion/ exclusion criteria should be described.
 Subjects are allocated to groups in randomized fashion.
 All individual features of patient and regimen should be recorded.
 Patient consent is questionable.
 Give attention to placebo group as control,
 Compliance improving scheme should be standardized.
 Compliance in short term therapy is different from that of chronic therapy.
 DESIGNING OF COMPLIANCE TRIALS

 Measurement should be performed on regular basis, use more than one methods of
assessment.
 When using residual tablet count method, provide excess of tablets.
 Correlate compliance with treatment goal or toxicity signs.
 Base line level for compliance should be estimated.
 Results are represented as compliance distribution histogram.