Introduction of Pharmacotherapy

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    Pharmacotherapy I

    By : Lolita

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    Component of Assessment

    Mid term exam : 30%

    Final term exam : 30%

    Task : 35% Other component / attendance : 5%

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    Main Theme by System

    Before mid

    Rational Pharmacotherapy (1x) : Mrs. Lolita

    Pain and Inflammation (4x) : Mrs. Lolita

    Gastrointestinal (2x) : Mrs Woro Supadmi

    After mid

    Gastrointestinal (4x) : Mrs. Woro Supadmi

    Infection (3x) : bacterial, viral, parasite, protozoa :

    Mrs Sudewi and Lolita

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    Specific Issues

    Pain & Inflammation1. Nociceptic & Neuropatic pain : central,

    peripheral

    2. Headache disorders/cephalgia (migraine,vertigo, tension, cluster, sinus)

    3. Joint pain : (osteoarthritis, rheumatoid

    arthritis, gout, bursitis)4. Post-operative pain & cancer pain

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    Learning Indicator

    Patophysiology

    Clinical Data Interpretation

    Pharmacotherapy Specification of Drug

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    ReferencesPrimary :

    Dipiro, JT., Hamilton, CW.,Schwinghammer, TL., and Wells,BG, 2000, PharmacotherapyHandbook, McGraw Hill, NewYork.

    Greene, RJ and ND Harris, 2000,Patology and Therapeutics forPharmacists : a basic for clinicalpharmacy practice

    Secondary :

    Lacy C. F., Armstrong L. L.,Goldman M. P., Lance L. L., 2010,Drug Information Handbook, Lexi-Comp Inc., Ohio.

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    The Benefit Outcomes

    Assist students in understanding the use of the

    drug in specific disease

    Students are able to choose the right medicine

    Students are able to provide drug information (for

    example about the side effects of drugs, drug

    contraindications, drug interactions with other

    drugs or drug interactions with food, and etc)

    Students are able to interact with physicians andother medical personnel

    Students help patients perform self-medication

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    RationalePharmacotherapy

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    Pharmacotherapy

    Greek : Pharmacon & Therapeia

    Pharmacotherapyis the treatment of disease through

    the administration of drugs.

    Choose a drug based on the types and signs of disease.

    Area of pharmacy practice that is responsible for

    ensuring the safe, appropriate, and economical use of

    drugs in patient care.

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    Therapy

    Approach

    Nonpharmacology

    Pharmacology

    Pharmacotherapy

    Alternative therapy

    Radiotherapy

    Surgery

    Genetherapy

    Drug therapy

    Imunotherapy

    1600 chemical agents40.000 formulations100.000 OTC

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    Pharmacotherapy Process

    Symtoms/Signs

    Diagnose

    Treatment Methods

    DRUG THERAPY

    Drug Selection

    Dosage Adjustment

    Prescription

    Drug Administration

    Drug Utilization

    Effect

    Bad Response Good response

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    Rational Drug Therapy

    Prescribing and choosing the drug in manner

    that maximizes clinical effect (maximizing

    efficacy and minimazing toxicity), functional

    status, overall patient satisfaction, health

    quality of life at the lowest possible total cost.

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    The rational use of drugs requires that patients

    receive medications appropriate to their clinical

    needs, in doses that meet their own individual

    requirements for an adequate period of time, and at

    the lowest cost to them and their community. correct drug appropriate indication appropriate drug considering efficacy, safety, suitability

    for the patient, and cost

    appropriate dosage, administration, duration no contraindications correct dispensing, including appropriate information for

    patients patient adherence to treatment

    WHO conference of experts Nairobi 1985

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    Clinical

    featuresof illness

    Patientexpectations

    Potentialconsequences

    Presentingsymptoms

    2. Understanding

    pathophysiology

    1. Making Dx

    3. Reviewing menuof Rx options

    4. Selectingoptimal drug/dose for patient

    5. Choosingendpointsto follow

    6. Making alliancewith patient,followingendpoints

    Clinical

    outcomesefficacytoxicitymorbiditymortality

    Patient

    satisfaations

    Costsdirectindirect

    Functional Outcomerelief of symptoms

    Patient Presentation Process of Rational

    Therapeutics

    Result of

    Intervention

    Process of rational drug therapy

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    The Purpose of Prescribing

    Maximise

    effectiveness

    Minimise risks

    Minimise costs

    Respect patients choice

    The most effective

    The most safest

    The most affordable

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    The challenge of

    prescription

    Prescribing

    Patient Compulsion

    Economic

    Pressure

    Limited time

    Individual

    preference

    Unknowledge

    Pharmaceutical Companies Interference

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    Rational Drug Used

    Right

    Follow upDiagnosis

    Indication

    Types of drug Information

    Dosage, route and frequence

    Patient condition

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    Why Rational Use ?

    Drug explosion

    Efforts to prevent the development of

    resistance Growing awareness

    Increased cost of the treatment

    Consumer Protection Act. (CPA)

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    % Primary Health Care patients treated

    according to guidelines

    0

    10

    20

    30

    40

    50

    60

    70

    1990/1 1992/3 1994/5 1996/7 1998/9 2000/1

    Africa Asia

    Source: WHO database on drug use 2003

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    WHO, Dept. Essential Drugs and Medicines Policy

    % drugs that are prescribed unnecessarilyestimated by a comparison of expected versus actual prescription

    Chalker HPP 1996, Hogerzeil et al Lancet 1989, Isah et al 2000

    010

    20

    30

    40

    50

    60

    70

    80

    Nepal Yemen Nigeria

    % antibiotics % injections % drugs % cost

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    5-55% of PHC patients receive injections -

    90% may be medically unnecessary

    0% 10% 20% 30% 40% 50% 60%

    Eastern Caribean

    Jamaica

    El Salvador

    Guatemala

    Ecuador

    L.AM ER. & CA R.

    Nepal

    Indonesia

    Yem en

    ASIA

    Zimbabwe

    Tanzania

    Sudan

    Nigeria

    Cameroon

    Ghana

    A FR IC A

    % of primary care patients receiving injections

    Source: Quick et al, 1997, Managing Drug Supply

    15 billion injections per year globally

    half are with unsterilized needle/syringe

    2.3-4.7 million infections of hepatitis B/C

    and up to 160,000 infections of HIV peryear associated with injections

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    30 to 60 % of PHC patients receive antibiotics -

    perhaps twice what is clinically needed

    0% 10% 20% 30% 40% 50% 60% 70%

    Guatemala

    Jamaica

    El Salvador

    Eastern Caribean

    L.AMER. & CAR.

    Bangladesh

    Nepal

    Indonesia

    ASIA

    Zimbabwe

    Tanzania

    Ghana

    Cameroon

    Swaziland

    Sudan

    AFRICA

    % of PHC patients receiving antibiotics

    Source: Quick et al, 1997, Managing Drug Supply

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    WHO, Dept. Essential Drugs and Medicines Policy

    Prescribing by dispensing and non-dispensing doctors in ZimbabweTrap et al 2000

    2.31

    28.4

    58

    8.65

    1.67

    9.5

    48

    13

    0 10 20 30 40 50 60 70

    no.drug items/Px

    % Px with injections

    % Px with antibiotics

    consultation time (mins)

    dispensing doctors non-dispensing doctors

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    Problems with Irrational Pharmacotherapy :

    1. Complex diseases or health problems:Example: A patient has many symptoms, but is embarrassed totalk about the main one, so the situation does not get addressed

    2. Lack of appropriate training skills by prescribers to giveproper diagnosis:Example: Prescriber does not do a physical exam and prescribesdrugs based solely on oral information provided by the patient

    Diagnosis

    3. Overworked prescribers:Example: health facility has only one prescriber, and an average of 300 patients per day

    to consult

    4. Lack of basic diagnostic equipment and testsExample 1: No microscope or reagents to examine blood & urine

    Example 2: No x-ray machine to test a patient suspected of having

    tuberculosis

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    Prescribing

    1. Using expensive drugs when equivalent ones are availableExample 1: The antibiotic cefalexin is more expensive than co-trimoxazole in

    treating simple infectionsExample 2: Ampicillin injection is prescribed when the patient could

    take ampicillin tablets, which are cheaper, easy to take, andinvolve lower risk of side effects

    2. Selecting the wrong drug for the patients illnessExample: An antidiarrhoeal drug is prescribed when the patient is

    dehydrated with simple diarrhoea and only ORS is needed

    3. Prescribing several drugs when fewer drugs wouldprovide the same effect

    Example: Sulfadoxine/pyrimethamine and paracetamol are prescribed whenthe patient has fever, but not malaria

    4. Prescribing drugs when the disease is self limiting andthe patient would get better without taking any drugs

    Example: Ampicillin is prescribed when the patient has a simple cold, withoutsore throat, cough or fever

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    1. Wrong interpretation of the prescription:Example: Ampicillin is prescribed, but amoxicillin is dispensed.

    2. Wrong quantity dispensedExample: Artemether/Lumefantrine is prescribed to be taken four

    tablets two times daily for three days (should be a total of 24 tablets),but the patient only receives 16 tablets, which is sufficient for only 2 days

    3. Labelling incorrect or inadequateExample: Sulphadoxine/pyrimethamine (white tablet) is dispensed, but

    the name of the drug is not written on the container label,meaning that the drug will be unidentifiable once the patientleaves the pharmacy

    Dispensing

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    4. Incorrect/insufficient dispensing information:

    Example: paracetamol 250mg is prescribed for a

    child, but only paracetamol 500mg isavailable in the pharmacy. The higherdosage pill is given to the childs motherwithout telling her to divide the tabletbefore giving it to the child

    5. Unsanitary practices:

    Example: 20 tablets of paracetamol 500mg werebeing counted, when some tablets fell to the floor.These were picked up and dispensed to be given to the

    patient anyway

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    Packaging

    1. Poor quality of packaging material

    Example: packaging material must protect the drug against the

    sun and humidity in order to ensure the integrity and

    quality of the dosage form required by the patient

    2. Inadequate container size when repackaging the product

    Example: the size of the packaging material must conform to the

    quantity of medication dispensed. In the case of oral

    drugs, too large a container could cause break-up ofthe items packed within

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    Poor Compliance

    Compliance is the degree to which the patientcarries out the physicians instructions onhow to take the prescribed drug and

    treatment.Many studies about outpatient compliance carriedout in developing countries indicate that only about50% of patients follow the instructions given by the

    physician

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    Poor Compliance

    Causes of poor compliance include:

    1. Improper labelling

    Neither the name of the patient, nor the name of thedrug is on the container labels when dispensed. If

    two or more drugs are dispensed together, thepatent does not know which drug he/she is taking

    2. Inadequate instructions:

    The instructions on dosage frequency must be

    written on the drug label, or the patient couldforget how to take it when he/she arrives home andbecomes involved in other activities

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    3. Treatment /instructions that do not consider the

    socio-economic and cultural aspects of thepatient

    Example: In cases where the patient does not know how

    to read, proper instructions would includegraphic symbols of how to take the drug.

    For a treatment of three days, for example, you could number

    the days 1 to 3, and then below each day, make a mark for eachtime the drug must be taken that day

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    Explanations Poor Compliance :

    Lack of knowledge

    Influenced by others

    Negative attitudes

    Own experience

    Own perceptions

    Difficult/complicated regimenExtremes of age and need for assistance

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    Consequences in Irrational Therapy

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    Public Health and Economic Consequences

    Adverse possibil i ty lethal effects, e.g. due to antibiotic

    misuse or inappropriate use of drugs in selfmedications

    L imited eff icacy, e.g. in the case of under-therapeutic

    dosage of antibiotic, tuberculosis or leprosy drugs

    Antibiotic resistance, due to widespread overuse of

    antibiotics as well as their use in under-therapeutic

    dosage

    Drug dependence, e.g. due to daily use of pain killersand of tranquilizers

    Risk of infection due to improper use of injections:

    abscesses, polio, hepatitis and HIV/AIDS

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    WHO, Dept. Essential Drugs and Medicines Policy

    Adverse drug eventsReview by White et al, Pharmacoeconomics, 1999, 15(5):445-458

    4-6th leading cause of death in the USA

    Estimated costs from drug-related morbidity &

    mortality 30 million-130 billion US$ in the USA

    4-6% of hospitalisations in the USA & Australia

    commonest, costliest events include bleeding,

    cardiac arrhythmia, confusion, diarrhoea, fever,

    hypotension, itching, vomiting, rash, renal failure

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    WHO, Dept. Essential Drugs and Medicines Policy

    Overuse and misuse of antimicrobials contributes

    to antimicrobial resistance

    Malaria

    choroquine resistance in 81/92 countries

    Tuberculosis

    2 - 40 % primary multi-drug resistance

    Gonorrhoea 5 - 98 % penicillin resistance in N. gonorrhoeae

    Pneumonia and bacterial meningitis

    12 - 55 % penicillin resistance in S. pneumoniae

    Diarrhoea: shigellosis

    10-90+ % amp, 5-95% TMP/SMZ resistance

    Source: DAP, EMC, GTB, CHD (1997)

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    Ecomomic consequences

    Inappropriate drug use or irrational therapyhave also a impact on household and nationalhealth budgets,

    Example :- the use of expensive brand-name product

    while cheaper generic drug are available,

    - combinations preparation,- multi-drug prescribing

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    Improve Rational Therapy

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    Educational

    InterventionType

    Managerial

    Financial

    Regulatory

    Prescribers

    Consumers

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    3. Managerial Strategies Essential drug list

    Kit system distribution

    Pre-printed order form

    Stock control

    Course-of-therapy packaging

    Effective package labelling

    4. Financial interventions Drugs are sold at a slightly higher price to create a fund for

    improving PHC services

    Making people pay for drugs could reduce overconsumption

    Improve drug supply and cost-sharing

    5. Regulatory strategies Banning unsafe drugs

    Limiting the import of drugs on the market

    I i d / i

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    Interventions targeted at consumers/patients

    1. Educational materials

    Patient education Public education

    2. Managerial stategies

    Course of therapy packagingBlister packs facilitated patient adherence to

    leprosy treatment

    The use of antimalarial drug packaging resulted

    in a significant improvement in patientcompliance

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    3. Financial interventions

    Community revolving drug funds

    4. Regulatory strategies Regulatory strategies are not targeted at

    consumers

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    Six Key Steps When Practising

    Approach Pharmacotherapeutics

    1. Making an accurate diagnosis

    2. Understanding the pathophysiology of disease

    3. Reviewing the menu of pharmacotherapeutic options

    4. Selecting patient-spesific drug and dose

    5. Selection end point to follow

    6. Maintaining a therapeutic alliance with the patient

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    Approach to rational therapeutics

    1. Knowing the diagnosis with reasonable certainly

    i. Problem that lead to empiric therapy

    Febrile leukemic patient, now neutropenic

    with chemotherapy, who is approptriately

    started on broad-spectrum antibiotics.

    ii. Inappropriate acceptance of empiric treatment

    The rule for treatment of febrile

    immunosuppressed patient often are

    generalized and applied to other populationof patient who donot cancer, have not

    recieved chemotherapy, are not

    immunosuppressed and are not neutropenic.

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    2. Understanding the pathophysiology of the patients

    disease

    i. Confusion between syndrome and disease

    Hyponatremia (psychogenic polydepsia,

    bronchogenic carcinoma, servere lossed of

    salt and water, adrenal insufficiency)

    ii. Being misled by a name Lupus erythematosus and lupus

    anticoagulant

    iii. Further advantages of understanding the disease

    Proper understanding of disease not onlyleads to appropriate therapeutic plan but also

    appropriate preventive measures as well

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    3. Understanding the pharmacology of useful

    drugsi. Drugs that have no evidence of efficacy

    ii. Prescribing drugs because it makes

    sense

    iii. Factors that perpetuate incorrect

    information about drugs

    4 O ti i i l ti f d d d

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    4. Optimizing selection of drug and dose

    The option of not using a drug.

    New drug information not provided by the

    manufacture Increasing knowledge of drugsadverse effects

    Impact of drug costs

    Irrational beliefs

    Detailing and counterdetailing

    Conflicts of interest.5. Selection of appropriate therapeutic end point

    Appropriate end points of efficacy

    End point reflecting toxicity

    The prescription as an experiment

    6. The physician-patient relationship

    Patient-physician communication can affect the

    choice of therapy and its outcome

    Attention to rational therapeutics

    Guiding Principles of Pharmacotherapy

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    Guiding Principles of Pharmacotherapy

    1. There should be justified and documented indication for everymedication that is used

    2. A medication should be used at the lowest dosage and for the

    shorten duration that is likely to achieve the desired outcome.3. When patient is adequated treated with a single dose,

    monotherapy is preferred4. Newly approach medication should be used only if there are clear

    advantages over older medication.5. Whenever possible, the selection of a medication regimen should

    be based upon evidence obtained from controlled clinical trial.6. The timing of drug administration should be considered as a

    possible influence on drug efficacy, adverse effects, andinteractions with other drugs and food.

    7. A medication regimen should be simplified as much as possible to

    enhance patient adherence.8. A patients prescription of illness or the risks and benefits oftherapy may affect adherence and treatment outcome.

    9. Careful observation of a patients response to treatment isnecessary to confirm efficacy, prevent, detect, or manage adverseeffect, assess compliance, and determine the need for dosage

    adjustment or discontinuation of drug therapy.

    Guiding Principles of Pharmacotherapy (cont )

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    10. A medication should not be given by injection when givingby mouth would be just as effective and safe.

    11. Before medications are used, lifestyle modification shouldbe made, when indicated, to obviate the need for drugtherapy or to enhance pharmacotherapy outcome.

    12. Initiation of drug regimen should be done with fullrecognition that a medication may cause a disease, sign,

    symptom, syndrome or abnormal laboratory test.13. When a variety of drugs are equally efficacious and equallysafe, the drug that result in the lowest health care cost or ismost convenient for the patient should be chosen.

    14. When making a decision about drug therapy for individualpatients, societal effects should be considered.

    15. The possible reasons for failure of medication regimeninclude inappropriate drug selection, poor adherence,improper drug dose or interval, misdiagnosis, concurrentillness, interaction with foods or drugs, environmentalfactors, or genetic factors.

    Guiding Principles of Pharmacotherapy (cont. .)