Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5475_Библиотеки_им_академика_М_И_Перельмана.pdf
63
Therapeutic Drug Monitoring
DEVELOPMENT OF TDM SCENARIO IN INDIA
In India, Therapeutic Drug Monitoring (TDM) was initiated in 1980s. During the
last 20 years, awareness for TDM has been markedly increased especially with the
development of department of clinical pharmacology. Initially, TDM was started with
the three antiepileptic drugs—phenytoin, phenobarbitone and carbamazepine as an
adjunct to the epilepsy clinic run by the neurology department. There are two types of
TDM services in India. In big sized teaching hospitals, TDM service is available through
departments of clinical pharmacology, and in the private sector, where TDM service is
provided by clinical biochemistry departments with least interpretation.
The service is regularly improved each year to add more and more drugs for TDM.
Again, advancement in pharmaceutical care system has increased the number of
TDM to provide safety and efficient healthcare. Automation and the development
of technically simple methods for quality have made TDM service available even in
rural areas. Despite this, TDM in several hospital service centres is confined within the
clinical biochemistry departments., that carry out the interpretation service. Clinical
pharmacologist, clinical pharmacist and analytical chemist, who is available at only a
few places, are a part of TDM team. In addition, limited data provided by TDM team
and inability of physicians to interpret the TDM satisfactorily due to lack of training
are some negative considerations in Indian scenario.
EXERCISE
Multiple ChoiCe Questions
Tick mark the appropriate choice
1. Which one of these need TDM?
(a) Digoxin (b) Paracetamol (c) Aspirin (d) Ibuprofen
2. The therapeutic index is defined as:
(a) Plasma drug concentration to optimize the outcome of therapy.
(b) Specific drug dose, causing minimum toxicity.
(c) Comparison of two drugs, used for same indication.
(d) Ratio of average toxic and therapeutic dose.
short Questions
3. Why therapeutic drug monitoring is needed? Explain with examples.
4. Discuss the importance of therapeutic drug monitoring in brief.
long Questions
5. What is therapeutic drug monitoring? Discuss the factors affecting TDM.
6. Discuss the Indian scenario for therapeutic drug monitoring.
Answer to MCQs
1. (a) 2. (d)
64
Chapter
Medication Adherence
Medication adherence usually refers to adherence or compliance of patients to take
their medications as per prescribed schedule (e.g. twice daily), for recommended period
indicated in prescription. Outcome of therapy solely depends on adherence of patients
to medication schedule. Medication non-adherence of patients is a serious problem for
physicians, and other stakeholders (e.g. payers), which not only affects the patient but
also the complete healthcare system. It may lead to substantial worsening of disease,
death and increased healthcare costs for patients.
Causes of Medication Non-adherence
Various reasons for medication non-adherence are categorized into 5 broad groups as per
World Health Organization. These include patient, condition, therapy, socioeconomic,
and health system related factors. Each group is illustrated in Table 8.1. Patient related
factors, which are responsible for non-adherence, are poor understanding of disease
may be due to younger age and mental illness. The second reason for medication
non-adherence includes asymptomatic and chronic disease that requires long-term
therapy. The complexity of the dosage regimen, more numbers of medicines in dosage
regimen and occurrence of side effects are therapy related factors which can impact
adherence to medication. Socioeconomic factors which affect the adherence include
lower education level, poor health literacy, lack of health insurance coverage, lower
socioeconomic status, etc. It is also a fact that chronic therapy for treatment of diseases
like hypertension, diabetes mellitus, hypercholesterolemia, cardiac diseases, etc.
involve the requirement of more finance, which may result in greater non-adherence to
medications. Finally, friendly behaviour of healthcare profession or poor communication
may be another factor for medication non-adherence.
Table 8.1: Reasons for medication non-adherence
Factors affecting adherence Examples
Patient’s related factors Eye sight related problems, cognitive impairment, mental illness,
poor health understanding, etc.
Condition Clinically silent or asymptomatic chronic diseases, in which
symptoms do not appear. Hence, patient does not take
medicines. Mental diseases like depression are its example.
(Contd.)
8
65
Medication Adherence
Table 8.1: Reasons for medication non-adherence (Contd.)
Factors affecting adherence Examples
Treatment related factors Use of more numbers of medicines, occurrence of undesirable
side effects
Social and economic related factors Poor health literacy; costly medicines, lack of social support
Healthcare system related factors Absence of sympathetic behaviour of healthcare professional,
poor communication; lack of healthcare facilities, etc.
METHODS TO IMPROVE MEDICATION ADHERENCE
The outcome of therapy depends on use of effective medication and patient adherence
to the therapy. Adherence to medication or therapy can be improved by patients himself
as well as healthcare providers associated with well-organised healthcare systems.
The combined interventions techniques are more advisable to improve the medication
adherence to prescribed treatment instead of single one. Various methods which can
be instituted to improve medication adherence are as follows:
1. Prescribing Style of Medication
Implementation of collaborative approach for prescribing medicines: To encourage the
feeling of ownership, if possible, prescriber may make the patient as a part of treatment
or therapy plan and share his decision in prescribing their medications especially the
convenient dosage form. More appropriately, patient characteristic should be considered
during prescribing of medicines and most simplified regimen should be used at the first
instance. For example, single dose of procaine penicillin for the treatment of gonorrhoea
is effective and there is better patient compliance.
2 Instruction to the Patient with Good Communication Skill
Give key points during prescribing the medicine: Focus on the key points about the
drugs. The word what, why, when, how, and how long regarding the drug should be
explained with good communication skill. Information about the possible common side
effects, if any, should be shared with the patient, which otherwise may lead to non-
medication adherence. The patient should be guided in advance about the methods to
avoid the side effects.
Use of improving aids to follow the dosage regimen: To specify the schedule
fortakingthemedicines, drug card or calendar maybeprovidedtothepatient.
Sometimes,pillboxesorunitdosepackingorspecialcontainerindicatingthetime
ofdosewhichareavailableinthemarketcanbeusedtospecifythescheduletime
fortakingthemedicines.
Behavioural support for compliance: Encourage the patient to make a medication
regimen, a part of routine life especially in chronic therapy. This type of recommendation
is more essential in case of complex drug regimens and elderly patients.
3 Follow-up for Routine Feedback
Follow-up for monitoring medication adherence: Monitoring of medication adherence
can be done by scheduling patient follow-up, although it is not a reliable method. This
type of method to monitor medication adherence depends on patient characteristics as
66
Textbook of Pharmacy Practice
well as on drug. Physician as well as pharmacist can monitor this type of medication
adherence.
Identification of barriers related to non-adherence: Itisvitalforhealthcareproviders
toidentifytheunderlyingcausesofpatientnon-adherencetodetermineappropriate
interventionalstrategy,whichmaybe:
• Additionofflavouringagenttoattractthechildrentotakemedication.
• Useofliquiddosageform,whenthereisdifficultinswallowingthetablet,especially
forchildrenandelderlypatient.
• Usealternativedosageformincaseofadversedrugreactions.
• Incaseofforgetfulnesstotakethemedicationasperschedule,calendarpackcanbe
usedtoremindthepatientfortakingtheirmedicines,e.g.packsoforalcontraceptives
orbeta-blockers.
4. Educational Training of Patients
Educational training of patients is also an alternative to improve medication adherence
in certain conditions like diabetes, tuberculosis, HIV, etc. In all of these conditions,
knowledge and necessity of medicines for treatment of disease, educational training
play a significant role in improving the medication adherence.
Medication adherence is also enhanced by providing the leaflets having drug
information and instruction to take the medicine. This is particularly helpful for ear
drops, pessaries, and suppository.
MONITORING METHODOLOGY OF MEDICATION ADHERENCE
Various methods for assessing adherence to medications are categorised by Osterberg
into direct and indirect methods.
Direct methods compriseofmeasurementofthedrugoritsmetaboliteinblooddirectly.
Sometimes, there is a measurement of the biologicalmarker in blood. These direct
methodsareconsideredtobemoreeffectivethanindirectmethods,buttherearealso
somelimitations.Forexample,patientisnon-cooperativeandmayhidepillsintheir
oralcavityanddiscardthemlater.Theremaybevariationinmetabolicprocess,which
resultsinfalseimpressionofresult.Quantitativeprofileofdrugsmaybeinfluencedby
variationinbioavailabilityandrenalclearanceofdrugs.Furthermore,althoughdirect
methodsareaccuratemethodsbutnotpracticableforroutineclinicaluse.
Indirect methods ofadherenceassessmentinclude:
• Askingasetofquestionstocollectfeedbackfrompatients
• Reportsofpatient
• Countingoftabletsorcapsules
• Numberoftimesofrefillingofprescriptionrefills
• Judgementofpatient’sclinicalresponse
• Usingelectronicmedicationmonitors
• Evaluationofphysiologicalmarkers
• Checkingofpatientdiaries
Self-report given by patient, tablet counting and number of times of refilling are most
common indirect methods, used in clinical practice. Morisky Medication Adherence Scale,
also called Morisky Scale, has been developed as a valuable device indicating the various
67
Medication Adherence
adherence concerns, such as forgetting to take medications or discontinuing medications
without consulting healthcare professional. Various short behavioural questions are
compiled in a specific pattern to avoid ‘yes-answer’ bias, commonly used in patient
with chronic disease. This encourages the patient to answer the questions or disclose
complete information about non-adherence of medication honestly in a good mood to
the healthcare professional. High patient score on the scale, indicates more adherent
but lower score on the scale, is considered struggling of patient with non-adherence.
With the understanding based on the patient score on the scale, clinicians and health
organizations can identify causes that prevent patients. Each of the above methods has
advantages and disadvantages. Hence, the specific method, based on clinical scenario
and availability of the data to evaluate medication adherence should be used.
Electronic system isbecoming morewidely available, and this isone of the more
frequentlyusedmethodsintheliterature.
The medication event monitoring system (MEMS) developed in the 1970s is a major
innovation in the field of evaluation of medication adherence. It becomes easy task with
the help of MEMS to know about medication adherence on a day-to-day basis. Hence,
dosing histories for long periods can be taken. Conceptually, electronic monitoring
system can easily record, when the bottle was opened to take the dose.
Electronic pill containersconsistofapillbottlewithanelectroniccapthatcontainsa
microchip.Thistypeoftechnologyrecordsadate-and-timeofopeningofpillbottleto
takeadose.
ROLE OF PHARMACIST IN MEDICATION ADHERENCE
Training through medication adherence program organized by pharmacists can improve
the medication adherence for better outcome of therapy. It also reduces readmissions
to decrease the total health expenditure. Some steps, which pharmacist must follow for
improving medication adherence:
a. Inform the patient about the medications
• Forwhichdiseasemedicationisgiven?
• Whatiscourseofexpectedactionofmedication?
• Whatisperiodforonsetofaction?
• Aboutanychangesinroutinelifewithintakeofmedication
• Whatmaybethesideeffectsoftherapy?
• Encouragethepatienttoaskmedicationrelatedpatientquestionsforthereply
b. Suggest a method to remind to patient to take their medications. Usingstrip-
packagingtechnology, prescription medicationsare packagedfor each patient
accordingtodayandtimeofdose.Thismakesiteasyforpatientstocomplywith
medicationregimensandsimplifiesadherenceforbothpatientsandcaregivers.
c. Encourage the chronic disease patients to make medications a part of life.
d. Suggest a method for storing the drugs during travelling.
e. Cost
• Suggest an alternative medication or generic medication ifmedication non-
adherenceisduetocostfactor.
• Preventdiseasesfromgettingworse.
68
Textbook of Pharmacy Practice
f.Medication Therapy Management
• Pharmacistplaysaprominentroleinmanagingcompletemedicationsincluding
theOTCproducts(vitamins/herbals):
Forinteractions
Forsideeffects
Costsavings
• Advicetothepatientforadherenceandcompliance.
• Increasepatientknowledgeforprescribedmedications.
• RemindthepatientbysendingSMSorgivingalarmonmobilefortakingmedicine,
especiallypatientforwhomhighlevelofadherenceisverymuchessentialfor
successoftherapy(e.g.antiretroviraltherapyforHIVpatient).
g. Always advice to patient to remember
• Takingthemedicineasperscheduleisnecessary.
• Non-adherencecanworsenthediseasecondition.
• Donothidetherapyrelatedproblemswithyourpharmacistsanddoctors.
• Pharmacistisalwaysreadytohelpthepatienttoovercomebarriersrelatedwith
non-adherenceandnon-compliance.
EXERCISE
Multiple ChoiCe Questions
Tick mark the appropriate choice
1. According to the health belief model, the extent of medication adherence in patients depends
upon ______.
(a) Severity of disease
(b) Chances of developing diseased condition
(c) Understanding of beneficial effects of the therapy by patients
(d) All of these
2. Which ONE of the following is NOT a reason for unintentional medication adherence?
(a) Forgetfulness
(b) Physical difficulties
(c) Not understanding the dose regimen
(d) Concerns regarding side effects
short Questions
3. Explain the causes of medication non-adherence in brief.
4. Write a direct method for monitoring medication adherence.
long Questions
5. What is medication adherence? Discuss the methods to improve medication adherence.
6. Discuss the role of pharmacist in medication adherence.
7. Discuss the methodology of monitoring medication adherence.
8. What are the various factors affecting medication adherence? Explain the role of pharmacist
in improving adherence.
Answer to MCQs
1. (d) 2. (a)
69
Chapter
Patient Medication
History Interview
It is a routine process to take medication history during the interaction with patient at
initial level. Medical history is a detailed, accurate and complete information regarding
all prescribed and non-prescribed medications that a patient had taken or is currently
taking prior to a newly initiated treatment in hospitals or in other clinical settings.
It may also include information about allergies, illnesses, surgeries, immunizations, and
results of tests. The entire information is collected by interviewing a patient, which is
referred to as medication history interview. It is a regular practice, followed in hospitals,
health centers, doctors or other healthcare centers.
It furnishes beneficial perceptions regarding patient’s allergic tendencies, compliance
to pharmacological and non-pharmacological treatments, social drug use and probable
self-medication tendencies with complementary or/and alternative medicines.
Conduct of medication history interview is the initial role of clinical pharmacist
along with various other roles executed by him. Interview process provides information
regarding the use of complete medicines prescribed by other healthcare professionals
to clinical pharmacist. Medication history interview is conducted for both—inpatients
and outpatients. Practically, it is not feasible to interview all the hospital patients, hence,
it is advisable to select those patients who can be benefitted. The patients who can be
benefitted include:
i. Patientsinseriouscondition,whomaybeunstable.
ii. Patienttakingspecificmedications,ortakingdrugshavinglowtherapeuticindex.
iii. Patientmanagedbytreatmentwithcomplexdrugregimens.
iv.Patientwhoseprescribedmedicationshavebeenchanged.
v. Agedoradolescentpatients.
vi. Unintentionalnoncomplierpatients.
vii. Patientshavinglanguageunderstandingproblemsandilliterate
Medication historyisanimportantcomponenttothepatientinterview,whichexplores
theperspective of illness and itstreatment. Itis the prime area where pharmacist
shouldfocustoidentifythepatientneed.Patientmaytakemedicationswhichinclude
prescription,non-prescriptiondrugs (OTC drugs) and home remedy products.
Themedication history provides information regarding the patient’s currentand
past medication, adverse drugreactions orallergies, adherence,the patient’sown
interpretationabouthisorherdrugtherapyandanyotherconcernsrelatedtohisorher
medications.Apartfromthis,accuratemedicationhistoryalsohelpfulinthefollowing:
9
70
Textbook of Pharmacy Practice
• Predictingadrugrelatedadverseeffect.
• Avoidstheinteractionofdrugwithanotherdrug,food,etc.
• Monitoringoftheclinicalsigns/symptoms,whichmaybesuppressedbyadrug.
• Appropriateanalysisoflaboratorytestresults,ascertaindrugsmaychangetheresults.
• Preventsprescribingmistakes.
• Makingajudgementaboutsocialhabitssuchassmoking,drinkingalcohol,illicitdruguse.
TIPS FOR MEDICATION HISTORY
• Ifvialmedicationisused:
Evaluateeachmedicationvials
Confirmdrugcontentofvials
Confirmthecorrectnessofdirectionsgiveninprescriptionforuseofmedicationvial
• Ifmedicationsarelisted:
Criticallyrevieweachmedicationmentionedinthelistwithpatient
Confirmtheaccuracy
• Ifbubblepacksmedicationavailable:
Evaluateeachmedicationinbubblepack
• Confirmtheintakeofallprescribedmedicinesasperdirection
Notifythe important points by makingrepetition toavoid confusion in patient
understanding.
It is also recommended to take medication history information from relative, friend or
caretaker in case of children and patient with in practice. This may be with the children
and adult with impaired mental condition.
MEDICATION HISTORY INFORMATION CARD
Medication history script
Allergies:
• Do you have an allergy to or avoid any
medications due to side effects?
• What type of reaction do you have?
Prescription medications:
• What prescription medications do you take on
a regular basis?
• When do you take them?
Non-prescription medications:
• What non-prescription over-the counter
medications do you take on a regular basis?
• When do you take them?
• What herbal, natural or homeopathic remedies
do you take?
• What vitamins or minerals do you take?
• When do you take them?
Additional questions
Do you use any:
• Eye drops
• Nose sprays
• Puffers (inhalers)
• Medicated lotions or creams
• Medicated patches
Do you receive any:
• Needles (injections)
• Samples from the doctor's office
• Study medications
Do you take any medication on a regular basis
for:
• Sleep
• Your stomach
• Your bowels
• Pain
Did you or your doctor recently change or stop
any of your medication?
71
Patient Medication History Interview
EXAMPLE OF CASE STUDY: HOW TO GET MEDICATION HISTORY INFORMATION THROUGH
INTERVIEW PROCESS
Pharmacist Ashok: Good morning, Mr. Anil (Patient). My name is Ashok and I am
your pharmacist in-charge.
Opening purpose: Ijustwanttoask,whatmedicines,youaretaking.Becomfortable
andrelax,MrAnil.
Mr Anil:Hello,MrAshok.Iamcomfortablenow,thankyou.Thereisnopain,after
givinginjectionbytheward,nurse.
Ashok:Iamextremelysorry,fornothavingmuchprivacyinthisward.Areyouable
tolistenandunderstandclearlyifItalkhere?
Mr Anil:Yes,itisOK.
Pharmacist Ashok:That’sfinenow.Iwanttoknow,whatmedicinesyouhavetaken
recently?Isthereanydifficulty?
Then, using the good communication skill, the pharmacist initiates the interview to
collect data as given in patient’s medication history card (Appendix 9.1).
Appendix 9.1: Patient medication history card
72
Textbook of Pharmacy Practice
Requirement to conduct interview for patient medication history: An imprecise
orimperfect medication history can affectthe treatment plan, recommended by
healthcareprofessionalsforpatient’smedicalcare.Sometimes,itmayleadtoadverse
drugreactions.Priorwellmanagedconditionmayworsenifamedicineisnottakenas
perscheduleornotfollowedthedirectionforuseorgivenatsubtherapeuticdosefor
anindividualpatient.Patient'sconditionmaydeteriorateifadministereddrugsthat
werepreviouslystoppedduetoallergicreactionsorifprescribedahigherdosethan
thatnormaltherapeuticdose.Theplannedinterviewfortakingmedicationhistorycan
identifyundesirableADRs,whichisaccountableforapproximately5%ofallinpatients.
The information collected can be practiced to:
• Correlatemedicationchartwiththemedicationadministrationrecordandpointout
anydisparityifpresent.
• Authenticatemedicationhistoryinformation,collectedbyotherhealthcarestaffsand
providesupplementinformation,ifnecessary.
• Recordknownmedicineallergiesandadversedrugreactions.
• Monitorfordruginteractions.
• Judgethetendencyofpatientmedicationcompliance.
• Exploretherationalefordrugprescribedtopatient.
• Evaluatethechancesofdrugabuse.
• Reviewthedrugadministrationmethodology.
• Examinetheneedsformedicalattendant.
• Documentpatientmedicationmanagementplan(MMP)torecordthekeystepsof
medicationreconciliation.
Importance of accurate drug history
• Medicationhistoryinformationaboutpatientcanavertprescriptionerrors,toprevent
consequentriskstopatients.
• Medication history information if collected viaproperlyconducted interviewcan
determinedrug-relatedpathologyorchangesinclinicalsignsresponsibleforoutcome
ofdrugtherapy.
• Accuratelycollectedmedicationhistoryincludetheinformationaboutthepresently
prescribedmedicines,OTCproducts,includingherbaloralternativemedicines,home
remedies,oralcontraceptives,knownADRsincludingallergicreactions,etc.Italso
recordstheadherencetotherapyforthebetterandsafeoutcome.
• Goodmedicationhistory
± Pointoutpatients’necessities
± Investigatesthepatient’sprospectofillnessanditstreatment(needsandconcerns)
EXERCISE
Multiple ChoiCe Questions
Tick mark the appropriate choice
1. Medication history is important _______________
(a) To avoid possible allergies and adverse reactions
(b) To decrease the cost
(c) To help the patients
(d) All of the above