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Clinical Pharmacy
• Guidingpatientstoadherewithmedicationregimenrecommendedbydoctorand
suggestaboutthebestwaytousemedications
• Providepatientcounsellingandeducationforeffectiveuseofmedicines
• Supportingthedirectcareofpatientsinhospitalsalongwithotherhealthprofessionals.
• Develop the continuing professional development (CPD) to enhance medical
competenceinmedicalknowledgeandskills.
Historically, the clinical pharmacist service was only confined to hospitals, nursing
homes and educational institutes, but now service approach has become broader which
more easily accessible to the public.
DAILY ACTIVITIES OF CLINICAL PHARMACISTS
Clinical pharmacy practice is relatively a new discipline of pharmacy practice in which
the focus is shifted from industrial products to patient care practice. Some of the activities
related to patient care practice (Fig. 17.1) are illustrated here:
a. Ward Round Participation
Ward rounds are the routine clinical rounds, made by team of healthcare professional
along with other team members to assess the health condition of patient or progress
Fig. 17.1: Hospital activities of clinical pharmacists (ADR: Adverse drug reactions; DI: Drug interactions;
TDM: Therapeutic drug monitoring)
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of drug therapy. The senior physician, junior doctors, nurse, pharmacist or any other
paramedical staff member are included in a team to visit the patient in the ward.
Usually, at least one or two ward rounds, is conducted every day to review the progress
of patient outcome.
Clinical pharmacists participating in medical ward rounds evaluate drug related
issues to encourage healthcare.
Objectives
The objectives of clinical pharmacist’s participation in ward rounds are:
• Tocloselymonitortheprogressofdrugtherapyandsuggestapromptintervention
toavoidadverseconsequencesifsuspected.
• Togetanunderstandingaboutpatients'clinicalstatusandprogresswithcurrently
plannedtherapeuticobjectives.
• Togetinformationondrugsutilized,theireffectiveness,andreportadverseeffects,
ifany.
• Topromotesuitabledrugselection,drugadministration,monitoring,andfollow-up
method,investigationofunusualdosestooptimizetherapeuticoutcome.
• Toprovideadditional information about the co-existing co-occurring conditions,
approachfor medication compliance, complementary medicineusethatmightbe
usefulintheirmanagementoftherapy.
• Todetect,manage,andpreventadversedrugreactionsanddruginteractions.
The physicians are visiting all the patients admitted in their unit in an order beginning
from the intensive care unit along with team members as mentioned above.
Participants in the Inpatient Discharge Planning
Pharmacists get learning opportunities by ward round participation. It helps the
pharmacist to observe, how drugs are prescribed, and used effectively on patients.
Interprofessionalships among the various healthcare professionals are strengthened
by ward round participation, which lead to better therapeutic outcome.
Advantages
• Wardroundteamisawell-organizedmultidisciplinaryteam,inwhicheachmember
contributeshis/herexpertise.
• Currentmattersandproblemsassociatedwithdiseasearehighlightedbyencountered
bywardroundparticipationandgivetheopportunitytohealthcareprofessionals
forrectification.
• Wardroundparticipationgivestheopportunitiestovarioushealthcareteammembers
tosharetheirexpertiseformakingthebestpatientcare.
• Forthebenefitsofpatient,wardroundparticipationisbestplatformtodiscussthe
issuesrelatedtopatientcare.
• Ward round team is a well-organized multidisciplinary team, each member
contributeshis/herexpertise.
b. Treatment Chart Review
Pharmacist reviews the patient’s drug treatment by treatment chart review or medication
chart review during his hospital admission. It also assesses the therapeutic efficacy of
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Clinical Pharmacy
each drug included in drug regimen and the progress of the therapy for conditions
being treated. It also takes into consideration various issues such as ADRs, drug–drug
interactions, and medication errors, ineffectiveness of drug, poor patient compliance,
sub-standard quality of life, economic consequences and patient experience as well as
understanding of the condition. Interprofessional collaboration including necessary
suggestion to clinician is essential for imparting better clinical services to the patients.
Objectives
• Tohelpininterpretationofmedicationcharttoclinicalpharmacystudents
• Tofacilitatethe students learning by definingthe targetas per need of patient’s
medicalconditionandtointervene,ifnecessary,duringtreatment.
• Totrainstudents for involvementin decision makingpolicies about treatments,
monitoringofpatients,dischargemedicationandpatientcounseling.
• Totrainstudentsindevelopingtheharmonyamongvarioushealthcareprofessional
withtheclinicalteammembers.
Procedure
The patient’s medical record should be analyzed and compared with the medication
administration record. For determining the correctness of current medication orders
and planning patient’s care, recent consultations, treatment plans and daily routine
progress should be considered. Review of current and recent medication orders
should be done.
Components of Medication Chart Review Include
1. Checkingthemedicationorderforsatisfyinglegalaswellastheneedofpatients.
2. Checking themedication orderforthe useof suitablemedical terminology and
improperdrugabbreviation.Highlightthecharttoprovideclarification,ifrequired.
3. Identifyingmedicationtowhichthepatientmaybehypersensitive/allergic.
4. Checkingtheappropriatenessofmedicationorderwithrespectto:
a. Previousmedicationorderofpatient.
b.Specificconsiderationslikediseasecondition,pregnancy,etc.ofpatient.
c. Doseofdrug,scheduleofdosage,especiallyrelatedtoage,improperrenaland
liverfunctioning.
d. Dosageformanditsrouteofadministration.
5. Checkingofduplicityindrugregimenalongwithinteractionsorincompatibilities
withotherdrugs.
6. Ensuringtheappropriatenessofadministrationtimesrelatedtofood,otherdrugs
andprocedures.
7. Checkingthemedicationadministrationrecordtoensuretheadministrationofall
drugsasindicatedintheorder.
8. Ensuringthecommencementofdrugadministration timingasmentionedinthe
order.
9. Specialprovisionsshouldbegivenforantibioticsandanalgesicsespeciallyinshort
coursetherapy.
10.Afterthe stoppage of drug therapy,theorder iscancelled fromall sections of
medicationadministrationrecord.
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Textbook of Pharmacy Practice
11. Recommendaformularyequivalent,ifappropriatefollow-upforanynon-formulary
drugorders.
12.Ensuringimplementationofappropriatetherapymonitoring.
13.Ensuringtheorderfornecessarymedication,e.g.premedication,prophylaxis.
14.Evaluatingmedicationorderforlow-costdrug.
15.Identificationofdrugrelatedproblems.
• Undiagnosedindication.
• Inappropriatedrugselection.
• Doseofdrug,whichissubtherapeuticdose.
• Undesirableadversedrugeffects.
• Failuretotakethedrug.
• InteractionswithotherdrugsorOTCproduct.
• Misuseofdruguseoruseofdrugwithoutindication.
• Overdosage,whichmaybelethal.
Thetreatmentchartreviewformisenclosedforreference.
c. Medication History
Medication history is a record of patient health. Record of information about all
prescribed and nonprescribed medications that a patient had taken or is currently
taking along with allergic tendencies, illnesses, surgeries, immunizations, and results
of physical exams and tests is included in properly collected medication history.
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It gives a valuable insight into adherence to pharmacological and non-pharmacological
interventions and self-medication with OTC products. Medication history interview
is a conduct of interview of patient or caretaker to collect the data to be included in
medication history.
Significance of Medical Drug History
Several reasons for collecting data for medication history are as follows:
Knowledge of the drugs.Futuretherapydirectionisoftenbasedonthetypeorcategory
ofdrugstakenbyapatientinthepastoriscurrentlytakingandtheirresponses.
Diagnosis of disease. Drugresponseisalwaysbasedondifferentialdiagnoses,because
drugscanactdirectlytocause—illnessordisease,orcaninteractwithotherdrugsto
causeundesirableeffects.
Masking of clinical sign. Clinicalsignsofdiseasearemaskedbydrugs.Forexample:
i. Tachycardia is prevented by β-adrenoceptor in a patient with hemorrhage.
ii. Abdominal pain and rigidity is prevented by corticosteroids in a patient with a
perforated duodenal ulcer.
Effect of co-administered drug on investigation. Resultsofsomeinvestigationsare
alteredbythedrugs.Forexample,thyroidfunctiontestresultisalteredbygivingdrug,
amiodarone(antiarrhythmicdrug).
Educational advice.Conduct of interview to collect medical historyprovide the
opportunityforinteractionwithpatienttoguidethepatientabouttheirmedications.
Miscellaneous. Medicalhistoryofpatientishelpfulinavoidingavertibleprescribing
errors.Itishelpfulatthetimeadmissioninhospitaltoprevent,unwantedduplication
ofdrugs,interactionwithotherdrug,discontinuationoflong-termtherapymedicines,
andfailuretodeterminedrug-relatedproblems.
d. Adverse Drug Reaction Monitoring
Adverse drug reaction (ADR) is an undesirable or unintended reaction resulting from
an intervention related to use of medication. ADRs may happen after either a single
dose or prolonged administration of a drug. It may also the result of interaction of
drug with other drugs when the combination of two or more drugs are used in therapy.
ADRs differ from side effects, which can be beneficial as well as harmful. ADRs are
undesirable. Pharmacovigilance is a science, which is concerned with the study of
ADRs. These are either predictable (Type A reactions due to exorbitant pharmacological
effect) or unpredictable (Type B reactions like allergic drug reaction, anaphylaxis, skin
rashes, idiosyncrasy).
Benefits of Adverse Drug Reaction Reporting
Benefits of ADRs monitoring and reporting programs are:
1. Informationrelatedtoqualityandsafetyofmedicinalproductsareobtained.
2. Helpfulinstartingrisk-managementplans.
3. HelpfulinevaluatingtheincidenceofADRsandpreventingpredictableadverse
effects.
4. Itprovidesawarenesstohealthcareteam,i.e.patients,pharmacistsandnursesabout
adversedrugeffects.
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5. ADRsmonitoringishelpfulinidentifyingthetypeandfrequencyofADRsthatcan
causetheadversereactions.
Role of Clinical Pharmacist in Reporting Adverse Drug Reactions
• Keepingtrackofpatients,whoareatgreaterriskofcausingADRs.
• Keepingtrackofpatients,prescribedwithdrugswhichhavegreaterrisktocauseADRs.
• Identifyinganddocumentingthepreviousallergicstatusofpatients.
• Appropriatenessofpatient’sdrugtherapyisjudged.
• Incaseofmultipledrugtherapies,possibledruginteractionsareidentified.
• Evaluatingteamofhealthcareprofessionalsengagedindetectionandassessment
ofADRs.
• Encouraging/promotingthereportingofADRsbyhealthcareprofessionals.
• Makingprovisionforrecordingofsuspectedreportedreactionsforfuturereference.
• End-result/outcomeoftheADRanditsmanagementareassessedbyfollow-upof
patients.
• GettinginterpretationaboutthereportedADR.
• EducatingthestaffmembersaboutthebenefitsofstudyofADRs.
• EducatingpatientstomanageADRs.
e. Therapeutic Drug Monitoring
Therapeutic drug monitoring (TDM) is the practice of determining concentration of
specific drugs in blood of patient at regular intervals to manage a constant therapeutic
level, for optimizing individual dosage regimens. It is used mainly for monitoring
drugs with narrow therapeutic indexes, drugs with marked pharmacokinetic variability,
medications for which target concentrations are difficult to monitor, and drugs known
to cause therapeutic and adverse effects. The drugs that are commonly monitored are
gentamicin, amikacin, tobramycin, vancomycin, carbamazepine, phenytoin, valproic
acid, lithium, theophylline, cyclosporine, digoxin, lidocaine, amitriptyline, nortriptyline
and imipramine. The procedure of TDM comprises six steps which are:
1. Ordering: Requestfromphysicianforgettingclinicalpharmacokineticservices.
2. Sample taking: Biologicalsampleistakenbythetechnicalperson.
3. Analysis of sample: Analysisofbiologicalsampleforaparticularcomponent/drug
inthelaboratory.
4. Result issue:Laboratorygivesthedrugconcentrationlevelresultandnotifiesifit
issub-therapeutictotheorderinghealthprofessional.
5. Interpretation of result: Resultsarecalculatedtomakeconclusion.
6. Action: Doseadjustmentisdonebasedonconclusionofresult.
f. Patient Counseling
Patient counseling provides information to patients and their representatives regarding
disease, drug therapy, and duration of therapy, side effects, and lifestyle modifications.
Through effective counseling process, pharmacists can exert a significant impact on
patient care and therapeutic outcomes. Patient’s poor knowledge about his disease
and medications is one factor that may lead to a patient’s nonadherence to medication
regimens, which can be rectified by pharmacist intervention to improve the medication
adherence.
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MEDICATION HISTORY AND PHARMACEUTICAL CARE
Medication History
Medication history (often abbreviated hx or Hx) of a patient includes the information,
collected by a physician through interview process. In this process, the answers of
specific questions are recorded either from the patient or caretaker, who can give suitable
information. These information are useful in diagnosis and planning for a therapy to
provide medical care to the patient. Symptoms of medical conditions referred to a
medically relevant complications reported by the patient or others caretaker of patient.
These differ from clinical signs, which are confirmed by direct examination of patient by
medical practitioner. In most of the cases, medical history is an important part, which
vary in their depth and focus. For example, there is restriction in getting medical history
including important details, such as name, history of presenting complaint, allergies,
etc. in case of a patient, who is coming in ambulance and require prompt attention. In
contrast, a medical history is frequently lengthy and in depth in psychiatric patient, in
much details about the patient's life are relevantly important and helpful in designing
plan for therapy in a psychiatric illness.
Medical history, together with the physical examination conducted by physician,
facilitates the process of diagnosis and treatment plan. If a diagnosis cannot be
concluded, a provisional diagnosis may be worked out, and other possibilities (the
differential diagnoses) may be added. Further investigations can be done for making
the diagnosis, which is necessary for planning the therapy.
Errors in medication history or delay in getting medication history can delay optimal
treatment, which may be risky for the patient. It contributes to higher readmission rates.
Pharmaceutical Care
Pharmaceutical care is a patient-centered, result-oriented pharmacy practice that requires
the pharmacist to work closely with the patient or caretaker to prevent disease. It is
also required to assess, monitor, initiate, and modify medication use to assure the safe
and effective drug therapy. The pharmaceutical care is aimed to improve the patient's
health-related quality of life, and achieve positive clinical results, within affordable low
budget. To achieve this goal, the following must be considered:
A. Establishment of Good Professional Relationship
Good professionalship is mandatory, which is achieved by a proper interaction of
pharmacist with patient. The pharmacist needs to develop some mechanisms to assure
the good pharmaceutical care to patients round the clock.
B. Collection and Documentation of Patient-Specific Medical Information
Pharmacists must collect complete information about patient's general health and his
activity status, previous medical history, medication history, social history, diet and
exercise habit, and economic status (financial and insured status). The patient medical
charts, pharmacist-conducted health/physical assessment interview, the patient's
family or caretaker, and other healthcare providers including physicians, nurses,
mid-level practitioners and other pharmacists are sources of information to conclude
medical history. Since this concluded medical history provide the platform regarding
the development and subsequent modification of the drug therapy plan, there is need
of timely, accurate, completed, and organized form of information in medical history.
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It should be readily available. Confidentiality should be maintained in keeping the
patient information.
C. Evaluation of Medical Information and Designing Drug Therapy Plan
Result-oriented drug therapy plan should be designed, based upon a thorough
understanding of the patient, his disease and its treatment, by a pharmacist with the
involvement of patient and other healthcare providers as necessary. The plan is required
to include each disease component. In designing the plan, the psycho-social aspects of
the disease as well as the potential relationship between the cost and/or complexity of
therapy and patient adherence must be considered by the pharmacist.
D. Assurance of All Supplies, Information and Knowledge to Patient Necessary for the
Drug Therapy Plan
The patient thorough understanding regarding the disease and the therapy/medications
prescribed in the plan must be assured by the pharmacist before starting the treatment.
The pharmacist providing pharmaceutical care must take ultimate responsibility for
assuring the capacity of patient to obtain any drugs and related products or equipment
required in the drug therapy plan.
E. Review, Monitoring, and Changing of the Therapeutic Plan if Necessary and
Appropriate, by Pharmacist in Concert with the Patient and Healthcare Team
Monitoring the patient's progress in getting the desired result according to strategy
followed in the drug therapy plan, must be assured by the pharmacist. Changes in the
plan must be done by pharmacist in coordination with the patient and connected other
healthcare providers, if necessary and appropriate to get the safety and effectiveness
of drug therapy at reasonable affordable low cost. Documentation of patient progress
is accurately done and communicated to the patient and to the other caretaker as
appropriate. The information should be shared by pharmacist with other healthcare
providers for change in the setting for assuring the continuity of care plan.
Effect of Pharmacokinetic Profile on Drug Therapy
Selection of the drug, the drug product, and the design of the dosage regimen are main
components for the success of drug therapy. On the basis of patient diagnosis and
physical assessment, physician selects the drug for therapy. The selection of the drug
product (e.g. fast release vs. modified release) and dosage regimen are based on the
individual patient's aspects, like absorption, metabolism, and elimination, collectively
known as pharmacokinetics of the drug. Dosage regimen has two variables—the dose
size and its frequency. Dosage regimen depends on the specific patient consideration,
which is known as individualization or optimization. Ideally, an optimal therapeutic
response with less adverse effects is desirable by maintaining constant blood level of
drug, which need good formulation of dosage regimen. Formulation and design of
dosage regimens become complicated with individual variation in pharmacokinetics
and pharmacodynamics. Therefore, the application of pharmacokinetics to dosage
regimen design must be correlated with proper clinical evaluation of the patient. For
certain critical-dose drugs, monitoring of the patient and drug regimen is important
for proper efficacy. For example, fluvoxamine (selective serotonin reuptake inhibitor
and σ
1
receptor agonist) is well absorbed after oral administration, widely distributed
in the body, and eliminated with a mean half-life of 15 hours. And has a range from
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9 to 28 hours. In hepatic problems but not in renal problems, its disposition is altered,
dose adjustment is required.
Effects of many drugs are changed in renal disease, particularly when active drug
moieties are renally eliminated. There is reduction of drug doses in renal disease due to
predicted reduction in clearance of the active drug moiety. Hence, it is desirable to consider
the patient factors to adjust drug doses, depending on the degree of renal impairment
and patient size. To adjust the dose of drug, factors which are to be considered include
the fraction of the drug excreted unchanged through urine and the drug’s therapeutic
index. Lithium, which is 100% renally eliminated and has narrow therapeutic index, is
used primarily in the treatment of bipolar disorder. Initial dose of lithium for treatment
is selected on the basis of renal function and subsequent dosing is guided by measured
drug concentrations and clinical response.
Effect of Pathological Disease on Drug Therapy
Smaller dose is indicated, if the organs, through which biotransformation or excretion
takes place, are impaired due to disease. For example, phenobarbitone, which is mainly
excreted by the kidneys, is given in smaller dose in case of renal impairment. Similarly,
in patients suffering from liver diseases, morphine is administered in smaller dose as
it is mainly metabolized by liver. Aspirin does not exert any effect on normal body
temperature but lowers the body temperature in patient having high temperature.
Quinine is useful in the management of complicated and uncomplicated malaria but
may precipitate blackwater fever in severe infection of P. falciparum.
EXERCISE
Multiple ChoiCe Questions
Tick mark the appropriate choice
1. Which one of the following is responsibility of the clinical pharmacist in direct patient care area?
(a) Evaluation of drug administration techniques.
(b) Providing drug information service to healthcare professionals including physician, nurses, etc.
(c) Identify drugs brought into the hospital by patients or caretaker.
(d) Reviewing periodically each patient’s drug administration forms to ensure the administration
of all doses.
2. Which one of these is a major role of clinical pharmacist?
(a) Patient counseling (c) Postmarketing surveillance
(b) Premarketing surveillance (d) Preclinical study
short Questions
3. Write the effect of pharmacokinetic profile on drug therapy.
4. Explain the role of clinical pharmacist in reporting ADRs.
5. Explain the scope of clinical pharmacy in healthcare system.
long Questions
6. Discuss the various activities of clinical pharmacist in hospitals.
7. What is treatment chart review? Explain its components along with importance of each component.
Answer to MCQs
1. (d) 2. (a)
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Chapter
Over-the-Counter
(OTC) Medications
INTRODUCTION
There are three different categories of drugs:
i. Generalorover-the-counter(OTC)drug.
ii. Pharmacydrugand
iii. Prescriptiondrug.
Sometimes, there may be a change in status of category of drug as per notification
by drug regulatory authorities.
Over-the-Counter (OTC) Drug
Over-the-counter drug is also referred to as non-prescription drug. Prescription is not
mandatory for OTC products. These are usually taken to manage the symptoms of minor
discomfort, illness, injury, which do not require the advice of healthcare professional.
These are a part of 'general sales list’ available at regular display counter. OTC drugs
include painkillers, such as paracetamol or aspirin, cold remedies and allergy relief
products.
Pharmacy Drugs
These can be purchased from a pharmacy counter under the supervision of a registered
pharmacist without the requirement of prescription from registered medical practitioner.
They are only sold by a pharmacist or another responsible person, who make sure that
these drugs are appropriate for the condition and age of the buying person. Hence, these
are not a part of display counter. Pharmacy drugs encompass antibiotic eye drops for
eye infections and in some cases, contraceptives for emergency use.
Prescription Drugs
Prescription drugs can only be purchased on the prescription, issued by a doctor, dentist
or another qualified medical professional. In future, suitably trained physiotherapists
and podiatrists will be able to prescribe drugs such as painkillers to provide relief to
their patients. Examples of prescription-only medicines include antibiotics and drugs
for the treatment of hypertension.
This chapter is concerned with OTC drugs.
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