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Abdul Wail Khan University Mardan Clinical Pharmacy 2

Submitted by: Somayya Wali

Submitted to: Sir Saleemulllah Department: Pharmacy R.No: 03 Topic: Non-compliance Date: 15th March 2019

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NON-COMPLIANCE CONTENTS:  Patient compliance  Non-compliance  Types of patients 1. 2. 3. 4.

Non compliers Partial compliers Over-compliers Adequate compliers

 Types of non-compliance 1. Failure to have prescripton dispensed or renewed 2. Omission of dose 3. Error of dosage 4. Incorrect administration 5. Error in the time of administration 6. Premature discontinuation

 CAUSES OF NON-COMPLAINCE: 1. 2. 3. 4.

Patient related problems Disease related problems Therapeutic regimen related problems Health professional related problems

 Solution for non-compliance  Importance of non-compliance  Detection of non-compliance  

Direct method Indirect method

 Factors associating with non-compliance  Improving compliance 1. 2. 3. 4. 5. 6.

identification of risk factor development of treatment plain patient education patient motivation compliance aids monitoring therapy

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3

NON-COMPLAINCE PATIENT COMPLAIINCE: The degree or extent to which a patient follows or completes a prescribed diagnostic, treatment, or preventive procedure Or The degree or extent to which a patient follows the instruction given by physician, pharmacist or nurse regarding medication usage

NON-COMPLAINCE: When the patient not following the instruction given by physician, pharmacist or nurse regarding medication usage is said to be non-compliance or we can say failure or refusal to conform to follow rules ,regarding or the advice or wishes of another EXAMPLES:  Patient does not take his or her medicine at all  Improper dosages are taken  The medicine is taken along with unprescribed drugs (including traditional medicine). This can lead to adverse interactions.  Not following advice on nutrition e.g. during pregnancy and lactation

Hippocrates wrote: keep watch also on the faults of the patients, which often make them lie about taking of things prescribed Compliance as a partnership between patients, physicians and even managed care to achieve desired health outcomes-now called concordance

FOUR TYPES OF PATIENTS: 1. Non compliers: those who do not accept the diagnosis and need for treatment at this time 2. Partial compliers: those who accept the diagnosis and need for treatment but cannot fulfil the recommended actions sufficiently to reach targeted improvement in their health 3. Over-compliance: Those who take more than recommended amount of medication or who diet or exercise in excess 4. Adequate complaiers: those who follow the health advice adequately (i.e enough medication,diet,exercise,to improve or control their medical disorder)

TYPES OF NON-COMPLAINCE: The situations most associated with the non compliance with the drug therapy include 7. Failure to have prescripton dispensed or renewed 4

8. Omission of dose 9. Error of dosage 10. Incorrect administration 11. Error in the time of administration 12. Premature discontinuation

1. FAILURE TO HAVE PRESCRIPTON DISPENSED OR RENEWED Some patients for whom medication has been prescribed do not even take their prescription to the pharmacy or those who take their prescription to the pharmacy fail to pick them up when they are completed the most common explanation for not taking their prescription to the pharmacy or not picking them up is that the patient thinks that his condition become good and he did not need medication any more or he has medication like this at home they do not like to take medication or the cost is very high or they forget to take the prescription sometime in case of infection some drugs may relieve the initial condition like decrease in the temperature with paracetamol the patients thinks that he is recovering from the disease and lets the patients to think that it is not necessary to have a prescription dispensed 2. OMISSION OF DOSE: Omission of dose is one of the most common type of non-compliance and more likely to occur in the medication is to be administered at frequent interval or for an extended period of time 3. ERROR OF DOSAGE Error of dosage include the situation in which the amount of individual dose or frequency of administration is incorrect e.g. not using the proper technique in using MDI . 4. INCORRECT ADMINISTRATION: some time incorrect administration may led to non-compliance

5. ERROR IN TIME OF ADMINISTRATION: This may include the situation in which medication is administered in an appropriate relationship to meals. Certain drugs such as tetracycline, alendronate administered apart from meal to achieve optimal absorption ,the time of the day at which the drug is administered may also be important for example diuretics are best administered in morning 6. PREMATTURE DISCONTINUATION: It occurs commonly with the use of antibiotics or in the treatment of chronic disorder such as hypertension . the patient must be informed about the importance of medication and educate him that 5

even if he is asymptomatic or the infection subsides quickly after starting therapy he must stick with his medication

CAUSES OF NON-COMPLAINCE: 5. 6. 7. 8.

Patient related problems Disease related problems Therapeutic regimen related problems Health professional related problems

1. Patient related problems i. ii. iii. iv. v. vi.

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 color and size. b. Physical Limitations

i.

When pharmacy is at distant

ii.

Working hours are odd

iii.

Inhalers and aerosol needs coordination between fingers and breathing of patient C. Social and religious believes

i.

No belief on medications

ii.

No belief of benefit

iii.

Fear of ADR

iv.

Muslims do not take alcohol

v.

Muslims do not take medicines through dawn to dusk in Ramadan. d. Socioeconomic status of patient i.

High cost of therapy and poor economic status leads to non-compliance

2 . Disease related problems a. Psychiatric disease Psychiatric disease make patient uncooperative towards therapy e.g. forgetfulness is major cause. b. Chronic disease Some chronic disease are not associated with symptomology such as HTN and hypercholestremia makes the patient non compliant. c. Improved disease conditions Improved disease conditions make the patient ready to discontinue the therapy. d. Disease leading to Disability 6

There are many diseased conditions that interfere with patient ability to comply with prescription. For example, arthritic/epileptic/patients with parkinsonism patient my have problem in opening of containers. 3. Therapeutic regimen related problems a. 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. e.g. 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 loss. b. Frequency of administration Higher the frequency of administration, lower the patient compliance. c. Duration of therapy Greater the duration of therapy, higher is the patient non compliance. Chronic diseases makes the patient more 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’s a major determinant in the infection reoccurrence in TB patients. d. Adverse drug reactions The ADR like nausea, vomiting, hair loss associated with anti neoplastic agents cause distress. Some drugs cause depression. Some drugs cause sexual dysfunction, like anti depressants and anti HTN medications. Patients on sedatives or with CNS depressants must be advised to avoid beverages during therapy as it cause excessive depression. e. Cost of therapy Non compliance may result when drug cost is very low or very high. Both factors give rise to non compliance. F. Taste and smell of medications If taste and smell of medication is objectionable particularly in pediatrics , then rate of non compliance is more. For example, Kcl preparations have bad taste and many people discontinue the use. Therefore we add colorants and flavourants to attract for medication. g. Poor labeling Poorly written leaflets or hand written labels.

4. Health professional related problems a. patient-physician interaction Patients are more compliant to those physicians who give them respect. b. Quality of health care practice •

patient motivation 7

• •

Counseling communication Patient care plan

Solutions to Noncompliance Although there is no simple solution to the problem of poor compliance, certain strategies can be implemented. They must be patient-specific, and they require that the health care provider take a little extra time with a patient. These strategies include the following techniques. 1.Simplifying the Medication Regimen The simpler the regimen is, the higher the rate of compliance is. If a confusing dosage regimen is the cause of noncompliance, therapeutic alternatives (eg, once-a-day dosing) should be considered to ensure that the patient will adhere to the treatment plan. 2.Educating the Patient About the Disease Patients need to be properly educated in a clear and concise way about their disease states and the need for treatment. Persons with hypertension, for example, will be more likely to comply if they understand the risks of high blood pressure? especially important because they generally feel fine. 3.Explaining Potential Side Effects and What to Expect If side effects are not addressed initially, patients commonly will eventually stop taking the medication. Pharmacists should discuss with patients not only the potential side effects associated with a drug, but the importance of consulting with their physician if an adverse effect becomes intolerable, so that an alternative drug may be substituted. Points to cover with patients to improve compliance include the following:  How the medication works  How the medication is dosed  Major adverse effects  What to do in the event of an adverse effect  How the treatment will be followed or monitored 4. Encouraging the Use of Patient Reminder Aids

Another reason why many patients fail to take their medication is that they simply forget. For those patients who have difficulty remembering, cues or reminder aids may be helpful. For instance, patients can integrate taking their medication into their daily routine of getting up, brushing teeth, eating, and so on. Patients also may place colored stickers on a calendar once they have taken a pill. Some patients do well with a pillbox with a compartment for each day of the week. Other memory devices include inexpensive wristwatches with alarms and pill bottles with alarms in the cap that record the exact time the bottle was last opened. Electronic vial tops also are available that provide signals corresponding to a dosing schedule. If the cap is not removed on schedule, the device will beep and flash.

IMPORTANCE OF NON-COMPLAINCE 8

o As former surgeon DR.C,Everett Koop said : “drugs do not work in patients who do not take them” prescription medications are only effective when they are taken In many pharmacy circles, the term medication “ADHERENCE” and medication “COMPLAINCE” are used virtually interchangeably. However in most recent year the pharmacy prefession in pharmaceutical industry has gravitated more towards medication adherence is the term of choice. Adgerence to a medication regimen is usually defined as . the extant to which patient take medication as prescribed by their health care providers o Non-adherence is a serious problem, using thousands of premature deaths abd demanding care that would otherwise have been unnecessary. According journal of managed care pharmacy everyday 342 people die because of poor medication adherence. That’s 125,000 Americans who die unnecessarily each year because of not taking their medication is directed by their physician and pharmacist o In terms of economic impact of poor medication adherence, the new England healthcare institute estimates that the annual cost of patients not taking medications as prescribed approaches 290 billions o But unfortunately there is no single magic bullet for poor medication adherence o Mieixa, a company dedicated to improve patient outcomes with prescription drug therapy has determined that patient non-adherence is best addressed through comprehensive medication therapy management services. The most effective MTM programs achieve the highest return when those services are delivered by a pharmacist o But education also is key and essential part of successful patient adherence program. Physicians must directly engage payients to discuss the importance of prescription drug therapy. Then, pharmacists need to help patients understand their important role as a partner in their healthcare o However, education alone rarely works. A fully integrated approach with support resources and innovative tools appears to be the best approach o Creating, a culture which embraces patient adherence can be a win-win-win situation. With a good patient adherence program, the patient has better outcomes when taking their medications correctly. When incentives are properly aligned, the prescribing physician has a patent who is being well treated and responding to his or her prescription drug therapy. And, the health plan does not have to pay fo unnecessary hospital admissions o Innovative medication packaging can also help improve compliance. MWV is a national leader in patient adherence and compliance- enhancing packaging. By developing patient cantered packaging solutions that help pharmacies improve patient medication adherence, MWV has also been able to minimize medication errors and reduce the overall cost of health care. According to a new study published in the May 2011 issue of clinical therapeutics, the manner in which a medication is packaged can have a significant impact on whether patients take it as prescribes. The study showed that compliance-enhancing packaging was associated with an improvement in prescription adherence behaviour in patients when compared with traditional pill vials o Medcation adherence is serious problem which need to be addressed. At the center of Health Transformation (CHT), we are collecting best practices and innovative strategies to help patients, pharmacist, physicians, and health plans improve patient compliance . later this year, we will be publishing a second publication dedicated to advancing those strategies, programs and best practices which help improve patient adherence while reducing healthcare costs

Detection of non-compliance Like the diagnosis noncompliance is necessary requirement for the treatment 9

The methods used for the detection are 1 Indirect Method 2 Direct Method

Indirect method A : Self report and interview with the patient : it is the most simplest and common way to detect noncompliance in which the patient is interviewed exactly or in detail about the medication but the problem with this that the some patient do not remembered their medication B : pill count is the another method which is most commonly used in clinical trials in this method the compliance may be assist by difference between the medication dispensed initially and the number remaining in the container however the pills dumping done by the patient may lead to over estimation of the compliance rate. C: The achievement of the goals such as normalizing the BP glucose level etc may sometimeuse to assist the compliance of the patient However the patient may take their medication just before their visits such behaviour is called TOOTH BRUSH effect after the way people brush their teeth before seeing the dentist D: MEMS (medication event monitoring system) is a computerized method of detecting noncompliance in which a microprocessor housed is cap of medication container which record the data each time when the patient open the container and remove the lead to take the medication the microprocessor is then connected with the computer to see the data

Direct Method Direct method include biological markers traces compounds and determination of the drug concentration Biological markers such as glycosylated haemoglobin in patient with diabetes mellitus given an objective assessment of metabolic controlled drugs during the preceding 3 months periods. Traces compounds with small quantities of agent with large biological half-life such as phenobarbital has been added to the drugs in some studies and measured in the biological fluids as pharmacological indicators of compliance. Determination of drug concentration the plasma of patient may be use but this method has some limitation such that plasma level of the drug may be affected by different things such as Individual difference in absorption distribution metabolism and excretion etc.

FACTORS ASSOSIATING WITH NONCOMPLIANCE Following are the the factors which are most commonly associated with non-compliance. 1: disease condition such schizophrenia in which patient forget to take medication 2: multi drug therapy the greater the number of drugs a patient is taking higher is the risk of non-compliance 3: fervency of Administration: the administration of medication at frequent interval makes at more likely that the patient will forget to take the medication in the busy routine of life. 4: duration of therapy: higher duration of therapy more is the risk of noncompliance. 5: adverse drug event: sometime development of unpleasant ADE leads the patient to stop medication for some time. 10

6: patient maybe asymptomatic are the symptom’s subsides quickly due to which the patient thinks that his condition is recovered and he do not need further medication. 7: cost of medication is also another important cause of noncompliance sometime the patient cannot afford the full prescription and leads to partial compliance. 8: administration of medication: wrong root of administrationand not appropriately measuring the dose is also a key factor contribute to non-compliance. 9: test of medication which is most common in the children with liquid oral dosage form. 10: Patient and health professional interaction. 11: poor understanding of the instruction given by the patient.

IMPROVING COMPLIANCE A number of strategies to enhance patient compliance have been proposed for strategies to improve patient compliance to effect health care professionals must not only believe that non compliance is an important problem but also bevelling to make a greater commitment do the steps that will helps their patient to the compliance pharmacist have a particularly value opportunity to uncharged compliance since their advice accompanies the actual dispensing of the medication and they usually are the least health professionals to see the patient prior to the time medication to be used. Following steps should be followed by health care professionals to improve patient compliance 1: identification of risk factor 2 development of treatment plain 3: patient education 4: patient motivation 5: compliance aids 6: monitoring therapy 1: IDENTIFICATION OF RISK FCTOR All patient should be viewed as potential non compliance. A first step to an efforts to improve the compliance should be to recognize individuals who are the most likely to be noncompliance by identifying the risk factor such as disease stat polypharmacy age of the patient economic condition etc 2: DEVELOPMENT OF TREATMENT PLAIN The more complex the treatment regimen the greater is the risk of noncompliance and this must be recognized in the development of treatment plain following consideration should keep in mind while developing a plain     

The use of longer acting drugs in therapeutic class Dosage form that are administered Less frequently The treatment should be individualized according to the patient needs To help reduce inconvenience and forgetfulness the regimen should be tailored so that the dosage of medication are administered at times that corresponds to regular activities in the patient’s daily life. 11

3: PATIENT EDUCATION Patient education is the one of the most important way to improve the patient compliance patient education can be performed in different way it may be in the form of oral communication written communication and control therapy 4: PATIENT MOTIVATION Many health care professionals assume that the patient who are knowledgeable about their medication and illness are likely to be more compliant although this premise is valid for many patients increase knowledge does not necessary alter patient behaviour and compliance therefore there must be an awareness of the need to motivate patient to knowledge they have acquired to achieve optimum benefit from the therapy 5: COMPLIANCE AIDS There are certain compliance aids which if need to medication package of the patient may help to improve their adherence to their medication some of them are  Labelling  Medication calendars and drug reminder charts  Special medication container caps and systems  Compliance packaging  Dosage form 6:MONITORING THERAPY Monitoring of the therapy is also another way to improve the compliance it may be  Self-monitoring  Pharmacist monitoring  Directly observed treatment or DOT therapy

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