Cha # 05 Non Compliance

By Mr.Iftikhar (09-14)
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CHAPTER # O5 NON-COMPLIANCE
Compliance
It is using of medication according to physician instruction by patient for the treatment of some
illness.
Non compliance
Failure to obey the instructions of physician by the patient for the management of illness.
Lack to comply with the instructions of physician by the patient in taking medication, diet,
exercise, smoking and drinking habbits.
Adherence
This term is used to emphasize that patient s free to decide or to adhere to the physician
instructions and in case of non-compliance only patient is not blamed.
Concordance
This term is used to denote the drug to which the patient and physician agree about nature of
illness and need of treatment.
Level of compliance
It is expressed by % compliance.
% compliance = NDP NME x 100
NDP
NDP = No of doses prescribed
NME = No of medication errors
If the result is less than 90 %, then it is called suboptimal usage of drug or non-compliance.
Non-compliance not only involves failure to obey physician instructions but also involves the
under utilization or overutilization of medication. Therefore non-compliance varies in intensity,
extent and frequency.
Examples:
i. A drug is prescribed three times a day and the patient takes it once a day.
ii. Instead of 250 mg prescribed, taking of less than 250 mg or more than 250 mg will be
non-compliance.
Cha # 05 Non Compliance
By Mr.Iftikhar (09-14)
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iii. Generally, antibiotics are prescribed for 7-days. So taking of antibiotics for less or more
than seven days will be non-compliance.
Importance of non-compliance
Non-compliance not only produce problems for patient but also for physician, lab technician and
even medicines (in the form of resistance). For examples;
1. It is estimated that significant % of population do not take complete duration/course of
therapy and may result in resistance to that drug as in case of antibiotics.
2. Failure to take any single contraceptive pill may lead to unwanted pregnancy.
3. Non-compliance with anticonvulsant drugs result in uncontrolled seizures.
4. Failure to take single dose of clonidine or insulin will result in fatal consequences.
5. Sometimes the taste or smell of drug is good and the patient may take more than
prescribed. This is over utilization and may result in toxicity.
6. Less dosage, less dose units or discontinuation of drug result in under utilization which
ultimately result in over utilization of drug or re assessment of the patient.
7. An important outcome of non-compliance is destruction of the outcomes of clinical trials.
8. Due to non compliance there is wastage of expensive medicines.
9. Non compliance may also lead to misuse of drug e.g. taking double dose after missing a
dose.
10. Non compliance can also result in drug abuse.
Detection Of Non Compliance/Methods Of Assessment Of Non Compliance
The methods of assessment of non compliance can be classified into two categories:
1. Direct methods
2. Indirect methods
1. Direct methods
It includes :
i. Patient self reports
ii. Pill count
iii. Change in dose of metered dose inhaler
Cha # 05 Non Compliance
By Mr.Iftikhar (09-14)
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iv. Computerized compliance monitoring system
v. Observing clinical outcomes
i. Patient self report/ patient interview/ interrogation method
Patient self report may be prepared by ;
- Patient interview
- Or interrogation method
During patient interview, the physician will ask questions in a non-judgmental
manner where as interrogation method is used in clinical trials.
In this case, a study questioner is prepared and patient data is collected. The
questions may include:
- Incidence of side effects.
- Inconvenience of dosage regimen.
- Clarity of labell instructions.
- Overall level of comprehension.
The data obtained is subjective and has notorious effect on the study protocoal.
This method has ;
- Low cost
- Poor feasibility
- Poor accuracy
ii. Pill count
It is based upon the difference in the tablets initially made available to the number
of tablets remaining at the end of the coarse of treatment. It is also known as
residual tablet count method.
This method gives over estimation of compliance.
iii. Change in weight of metered dose inhaler
A metered-dose inhaler (MDI) is a device that delivers a specific amount of
medication to the lungs at actuation. So in this case, the the change in weight of
the MDI can be used to assess the compliance.
Cha # 05 Non Compliance
By Mr.Iftikhar (09-14)
Page |4
iv. Computerized compliance monitoring system/Medication event monitoring
system
In this case, a microprocessor is fixed in container and it will count each time the
container is inverted and from this we can assess the patient compliance. Anyhow,
inversion can occur intentionally and even unintentionally. Example is automatic
eye drop dispenser.
v. Observing outcomes
In this case the physician assess the patient compliance by asking him for follow
up and seeing at the outcome. However, sometimes in cases like diabetes,
hypertension etc the patient has to take medicines throughout life. A patient may
obey physician instructions for the ist week. Then he/she may non-compliance for
some days and then, before visiting his/her physician, the patient starts following
the physician instructions in the last week. This is called pre-appointment
behavior or tooth-brush behavior. Thus a patient of controllable disease may
avoid precautionary measures which can not be assessed.
vi. Rate of prescription refill methods
In this method, patient card is issued and then refilled after specific time interval.
From the prescription refilling, patient compliance is assessed.e.g. in case of T.B
patient has his/her own patient card which he/she refills at the specified date.
2. Direct methods
These include;
i. Biological markers
ii. Tracer compounds
iii. Drug analysis
i. Biological markers
These are to be detected in biological fluids, especially in urine and blood. If these
are present, it means the patient is showing compliance. Special markers are
added in the preparation which should be;
- Pharmacologically inactive
- Non-accumulative
Cha # 05 Non Compliance
By Mr.Iftikhar (09-14)
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- Should Not show physical or chemical interaction or attraction.
- Rapidly and completely excreted in biological fluid.
- Best urine marker is riboflavin (vit-B2).
- Glycosylated haemoglobin in the blood of diabetic patient shows objective
assessment of compliance preceeding 3-months.
ii. Tracer compounds
Tracer compounds are incorporated in the drugs. These should be used in very
small quantity but should have greater t. for example, Phenobarbital and
digoxin.
iii. Drug analysis/ Drug assay
In this method the drug is directly measured in in the sample. In present times, it
is a very rapid and quick method due to advanced technology.
Examples are rapid chromatographic technique and rapid immunoassay
technique.
This method shows excellent accuracy , however is expensive.
Causes Of Non Compliance
The causes of non-compliance can be well highlighted under the following headings.
1. Patient oriented problems
2. Disease state related problems
3. Therapeutic regimen related problems
4. Physical limitations
5. Miscellaneous problems
6. Poor labeling
7. Socioeconomic or dimorphic of the patient
8. Deliberate deviation
9. Inappropriate packaging
10. Inappropriate labeling
11. Social isolation
12. Mental friality
13. Patient interaction with physician
Cha # 05 Non Compliance
By Mr.Iftikhar (09-14)
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1. Patient oriented problems
i. Patient is willing to take the medication but he/she has ;
Forgetfulness
Poor eye sight
Too small writing of the prescription or confusion
Misprinting
Language problem
Misunderstanding
Illiterate person
Patient thinks that the drug prescribed by the physician to him is not good for him.
The patient visits two or more pharmacies or physician.
2. Disease state related problems
i. Psychiatric diseases make the patient non cooperative towards the medicine.
ii. Some diseases which are not related to symptomology such as hypertension and
hypercholestrimia make the patient non compliance.
iii. Vomiting associated with the medicines lead to non compliance.
iv. There are certain conditions which interfere with the condition of the patient,
thus non compliance results.
v. When the symptoms disappear, the patient becomes ready to discontinue the
therapy. This is called asymptomatic
vi. Compliance is directly proportional to disability. If disability is greater, patient
will show compliance and vice versa.
3. Therapeutic regimen related problems
i. Multiple drug therapy
It is generally agreed that as the number of drugs in a prescription increases, the
chance of non compliance increases e.g if there are five drugs in a prescription
and are to be taken at different intervals, patient may get confuse and thus non
compliance may results then.
Cha # 05 Non Compliance
By Mr.Iftikhar (09-14)
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ii. Frequency of administration
A research was conducted on three groups of patients to demonstrate the relation
b/w frequency of administration and compliance. The result was as under:
Frequency of
administration
Compliance showed
3 times a day 59 %
Two times a day 74 %
Once a day 85%
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iii. Duration of therapy
If duration of therapy is less, chances of compliance are more and vice versa e.g.
in T.B the duration of therapy is long and thus, the chances of compliance are
less.
iv. Adverse drug reactions
Nausea, vomiting and alopecia associated with the antineoplastic agents create
problems for the patient. Similarly, prolong use of antihypertensive drugs such
as -blockers and anti depressant produce sexual dysfunction. Due to such
adverse reactions, the patient may show non compliance.
v. Cost of the drugs
Both low cost and high cost may be responsible for non compliance. In case of
low cost, a patient may think that probably the quality of drug is of low standard
while in case of too much high cost, the patient may not afford the high price of
the medicine. Thus both cases may be responsible for non compliance.
vi. Taste or smell of the drug
Sometimes a drug may have bitter taste or bad smell ( e.g. potassium chloride
solution ) and the patient may be reluctant to take that. So in order to improve
the compliance flavourants are added.
Cha # 05 Non Compliance
By Mr.Iftikhar (09-14)
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4. Physical limitations
Physical limitations also add to the non compliance of the patient. For examples;
i. When the pharmacy is at distant.
ii. When working hours are odd.
iii. Certain dosage forms such as suppositories, enemas, eye drops, ear drops etc
require specific instructions and some companion.
iv. Inhalers require relation between the fingers of patient and rate of breathing.
All the above mentioned and other similar factors produce barier between the
compliance and patient, either the one way or other.
5. Miscellaneous problems
i. Social and psychological believes such as;
- No benefit of medicines
- Fear of ADRs
- Danniel (refusal to take medicines)
ii. Confidence and trust over the doctor
iii. Religious believes. For examples;
- Muslims do not take alcohol.
- Jeus do not take procaine insulin.
- Hindu do not use gelatin.
- Muslims do not take medicines from dawn to dusk (i.e during fast).
6. Poor labeling
It is estimated that more than 25 % of the prescription do not contain adequate labeling.
Usually the prescription contain the label Take when required . this sentence is
interpreted by different persons in different manner. This is poor labeling because taking
of medicine w.r.t time is undefined. Instead, it should be labeled with the terms like B.I.d
or T.I.D etc.
7. Socio-economic / Dimorphic of patient
Socio-economic status of the patient is one of the major fctor for non compliance.
According to a survey, non compliance is more in unemployed people as compared to the
employed. Similarly in unmarried and divorce patient, non compliance is more.
Cha # 05 Non Compliance
By Mr.Iftikhar (09-14)
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8. Deliberate deviation
i. Taking all the medication at one time.
ii. Not to obey prescriber instructions due to prescriber behavior.
iii. Using of antibiotics without meal.
iv. Taking of antihistamine at day time.
v. Taking of diuretic at night.
However, sometime deliberate deviation is advantageous e.g. skipping diuretic at
morning before long drive.
9. Inappropriate packaging
It is stated that inappropriate packaging has negative impact on the patient compliance
e.g. use of child resistant container for geriatric patients. Similarly, in case of
parkinsonism fine fingers movements are missing, so the patient feels difficulty in
opening of the container, leading to non compliance.
Arthritic patients may feel difficulty in opening of container.
10. Inappropariate labeling
It is also known as poor understanding of label instructions.
For some drugs such as tetracycline auxiliary labels are not available which results in
poor understanding of the patient about drug use.
Similarly, Diltiazem-SR cap should be labeled with clear instruction Swallow with
water. If they are inappropriately labeled, the patient may chew them, causing death of
the patient.
11. Social isolation
Social isolation is one of the important cause for non compliance. It is common,
especially in geriatric patients. So they need a loyal companion for administration of
drug.
12. Mental friality
Sometime if patient forget to take a single dose, it may make no difference at all. But if
the patient continues to repeat doing so, surely it will cause problems.
In case of psychiatric patients, they may mix the medicines or may take frequent doses,
leading to non compliance.
Cha # 05 Non Compliance
By Mr.Iftikhar (09-14)
Page |10
13. Interaction with Physician
Patient needs pure attention. So generally patient may show more incline to the physician
who give proper consultation time and thus, he/she will give more attentions to the
instructions and will show compliance. In most often cases, when the physician does not
show interaction with the patient, the patient shows non compliance.
Extent Of Non Compliance
As far as extent of non compliance is concerned, different methods are available to reveal the
extent of non compliance.
According to one review 25-60 % of geriatrics patient shows non compliance upto such an extent
that they can produce harmful effects as well as affecting interventions and financial conditions.
Strategies To Improve Compliance
Compliance can be improved by using following strategies.
1. High standards of dispensing practice
2. Supplementary labeling
3. Development of patient medication packaging
4. Simplicity of therapeutic regimen
5. Patient education
1. High standards of dispensing practice
i. For selection of container, highly effective container, rather than cost should be
the main criteria.
ii. Preferably palm size transparent size container should be used, provided that
product is not light sensitive.
iii. Discretion (patient judgment) should be made when child resistant container are
used for elderly patient.
iv. Size of the container depends upon the label specifications. Label instructions
must be simple, explicit and comprehensive.
v. In case of hospitalized patient, Unit Dose Dispensing is adopted. However
alternative methods may be used by the pharmacist in case of genuine problems.
Cha # 05 Non Compliance
By Mr.Iftikhar (09-14)
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vi. If Take as necessary/required, then mention the total number of doses required
per 24 hrs.
vii. The containers of the pharmaceutical industry should not be reused.
viii. Any prescription leaving the pharmacy bearing the instruction Take as
formerly must be prevented by pharmacist and should tell the patient about
appropriate dose of medicines.
2. Supplementary labeling
In order to improve the compliance, some additional information may also fruitful.e.g.
i. Personal use of the patient reduces the non compliance.
ii. Description of drug action in lay terminologies also improves the compliance.
iii. Use of symbols and graphics also improves the compliance.
3. Simplicity of therapeutic regimen
i. Complexity of the regimen is also one of the major causes of non compliance
where as simplicity of the regimen can greatly improves patient compliance.
e.g. once daily dose (odd) of propranolol and phenytoin shows compliance and
effectiveness as compared to the same drug administered in divided dose.
ii. Sustained release and long acting preparation also improves the compliance.
iii. Both physician and pharmacist can improve compliance of the patient by
decreasing the complexity of the regimen.
iv. Combination of drugs also improve the compliance e.g. Myrin-P, Septran etc.
v. Taking of dose at evening for sedative drugs also improves compliance and
reduce chances of non compliance.
4. Development of patient medication packaging methods
i. UDD:
Use of unit dose dispensing improves compliance as compared to loose
packaging.
ii. Mediset:
It is divided into segments corresponding to number of days in a week and each
day is further sub-divided into four portions. This device is known as Mediset.
iii. Calendar packing
Calendar packing also improves the compliance e.g. Tenormin.
Cha # 05 Non Compliance
By Mr.Iftikhar (09-14)
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iv. Medication event monitoring system
In this case, a microprocessor is fixed in container and it will count each time the
container is inverted and from this we can assess the patient compliance.
Example is automatic eye drop dispenser.
5. Patient education
Patient education is also known as patient-pharmacist interaction. It is one of the most
important tools to improve patient compliance. Patient education can be done in one of
the following ways.
i. Verbal counseling
It is nearly impossible to counsel all the patients verbally. However priority
should be given to to give verbal counseling :
- For prophylactic use of drugs.
- For drugs having serious withdrawl effects.
- For drugs used for long term therapy.
- Premature discontinuation of drugs produce fatal consequences.
The pharmacist should tell the patient about side effects i.e
It may disappear
Either the patient has to tolerate that side effects.
Or the situation requires medical emergencies.
Counseling should be in simple language, preferably in patient mother
language.
ii. Imprinted information
These include warning cards, individualized patient medication cards, package
inserts etc.
iii. In-patient training program
The patient is given proper training during his/her stay in the hospital, so that after
discharge the patient show improved compliance.
iv. Compliance clinic
The physician refers the patient to the pharmacist in compliance clinic and that
pharmacist will try to improve the patient compliance.
Cha # 05 Non Compliance
By Mr.Iftikhar (09-14)
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