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13
Hospital Pharmacy and its Organization
Professional Liabilities of Hospital Pharmacists
These include:
• Reviewofprescriptionsforpointingouterrorsifany,toensuretheeffectiveandsafe
deliveryofdrugtopatientinhospitalsetting.
• Adviceonthemostappropriatedosageformofmedication.Dosageformcouldbe
tablet,injection,ointmentorinhaler.
• Providehisexpertguidanceaboutpreparationandsterilizationofparenteraldrugs
• Fillandproperlabellingofthedrugcontainer.
• Provideguidanceaboutproperdispensingofnarcoticorcontrolleddrug.
• Provideguidanceaboutmaintenanceoftherecordsofnarcoticorcontrolleddrug.
• Havethesufficientstockofantidotefortreatmentofpoisoningandmedicinerequired
inemergency.
• Havethesufficientstockofemergencymedicinesrequiredinhospital.
• Takepartinwardroundstoreviewtheprogressindrugtherapy.
• Cooperatetheothermedicalstaffmemberstosolve theproblems,whichpatients
mayexperienceduringtherapy.
• Discuss the issuesrelated totreatments withpatients’ relatives, community
pharmacistsandgeneralpractitioners.
• Toprovideguidancetoensurethefavourablestorageconditionsofmedicines.
• Toguideandsupervisetheworkingofnewlyrecruitedorinexperiencedstaff.
• Answerthedrugrelatedquerieswithinthehospital.
• Stay-up-todatewithresearchfindingsregardingnewdrugsinparticularfield.
• Implementtheguidelinesfordrugusewithinthehospital.
• Providenecessaryinformationonexpenditureondrugsinhospital.
• Checkthesterilityconditionofparenteralmedications,e.g.intravenousmedications.
• Executethedecisionofpharmacyandtherapeuticcommittee.
• Participateinconductingclinicaltrials.
• Organizeteachingprogrammewithinthepharmacydepartmenttoguidetheyoungstaff.
• Motivatepatientcounsellinginthehospital.
Organisation Structure of Hospital Pharmacy
Hospital pharmacy is generally placed at convenient place in hospital organization to
provide easy approach to patients and hospital staff. Pharmacy should be preferably
placed on the ground floor especially the dispensing unit in the multistorey building
of a hospital organization. It should be designed to provide easy and continuous flow
of men and materials (Fig. 2.1).
Facilities Required in Hospital Pharmacy
In small-sized hospitals, only one pharmacy room is sufficient and appropriate. It is
aimed to provide combination of services like dispensing, manufacturing, administrative,
etc. It can be controlled by single pharmacist. Apart from this, a separate room or area
is assigned to sterile products.
In large-sized hospitals, with 200 beds or more, hospital pharmacy is departmentalized
for diverse activities.
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Textbook of Pharmacy Practice
There are separate departments for:
• Inpatientandoutpatientservices
• Unitdosedispensing
• Compounding
• Prepackingandlabelling
• Storageroom
• Sterileproducts
• Druginformationservices
Apart from the above departments, there is a separate chamber for chief pharmacist
office and separate space assigned at nursing station for unit dose drug administration.
Floor Space Requirements
• Minimumof250sq.feetareaismustforhospitalpharmacyforanysizedhospital.
• 10sq.feetareaperbedismustfor100beddedhospitals.
• 6sq.feetareaperbedismustfor200beddedhospitals.
• Groundsurfaceofhospitalpharmacyshouldbesmooth,washableandacidresistant.
Wallsshouldbesmoothandpaintedinlightcolour.
Fig. 2.1: Structure of hospital pharmacy organisation
15
Hospital Pharmacy and its Organization
• Appropriatedrainsshouldbeprovidedinmanufacturingdepartment.
• Woodencabinetsshouldbecoveredandglazed.
• Fluorescentlampsshouldbefixedattheprescriptioncounter.
• PlaceforBunsenburnershouldalsobeprovided.
QUALIFICATION AND EXPERIENCE REQUIRED FOR HOSPITAL PHARMACIST
Hospital pharmacist, who is responsible to ensure for safe, appropriate and cost-effective
use of medicines, should be registered with State Pharmacy Council.
Registered pharmacist: Registeredpharmacistisanindividual,whosenameisentered
intheregisterofStatePharmacyCouncilofconcernstate,inwhichheisengagedin
theprofessionofpharmacy.
Candidate should have minimum qualification, required for registration.
Minimum Qualification for Registration as a Pharmacist
The diploma course in pharmacy is minimum qualification for registration as a
pharmacist in India. It should be from an institution recognized by the PCI. Individual
holding degree in pharmacy from an institution recognized by the PCI are also eligible
to apply for registration as a pharmacist. Other documentations vary from state to
state in India.
Documentation for Registration
• Certificates for educational qualification (Sr. Secondary), DPharm (firstyear and
secondyear),BPharmorPharmaD(marksheetofeachyear).
• Photoidentityproof.
• Residentialaddressproof.
• DOB(secondaryschool)certificate.
• Trainingcertificate(onlyforDPharmcandidate).
• Feepaymentreceipt.
• Letterofapprovalforpharmacyinstitution/college,fromwherecandidateispassedout.
• Diploma/Degreecertificate.
ROLE OF CHIEF PHARMACIST
Chief pharmacist is responsible for the management of hospital pharmacy and
compliance of staff and medicines as per legal and professional regulations. He
implements the guidelines for ensuring the safe delivery of drugs in a cost-effective
method. The chief pharmacist also imparts his expert pharmaceutical advice, at all
levels, on the effective, safe, economic use of medicines and various processes needed
in the department.
Qualifications
Essential
• PharmaorequivalentdegreefromthePCIapprovedpharmacyinstitution
• Oneyearexperienceinhospitalpharmacy
• RegisteredwiththeStatePharmacyCounciloftheconcernedstate
Desirable: This includes postgraduate qualification in pharmacy practice or management.
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Textbook of Pharmacy Practice
Workload Requirements
Pharmacists' workload depends upon characteristics of work and professional
liabilities. Former criteria include: (1) Working hours/week, (2) time period in which
person works as pharmacist in the pharmacy department week, (3) the number
of prescriptions dispensed, from the counter, where pharmacist is involved, and
(4) the number and types of interactions in a day with patients or others. Professional
responsibilities: Various activities such as medication dispensing, consultation,
counselling of patient, and management of drug utilization system, etc. are some
professional liabilities. All of these activities are performed via different sections, which
include dispensing section, manufacturing section, quality assurance and clinical
pharmacy departments. Minimum of three pharmacists are present in small-sized
hospitals, but this number may change as per need depending on either decrease or
increase in the bed strength in hospital. Requirement for the number of pharmacists,
based on total bed strength in a hospital is illustrated in Table 2.1.
Table 2.1: Based on bed strength, requirement for number of pharmacists in hospitals
Requirement for no. of pharmacist Bed strength
3 Up to maximum 50
5 Up to maximum 100
8 Up to maximum 200
10 Up to maximum 300
15 Up to maximum 500
EXERCISE
Multiple ChoiCe Questions
Tick mark the appropriate choice
1. Who was the chairman of first Drugs Enquiry Committee in India?
(a) Dr RN Chopra (b) Prof BN Ghosh (c) Prof ML Shroff (d) Prof FC Waldemar
2. Which is true regarding floor space requirement for hospital pharmacy?
(a) Minimum of 250 sq. feet area for hospital pharmacy department in any sized hospital.
(b) 100 bedded hospitals have minimum of 10 sq. feet area per bed for hospital pharmacy
department.
(c) 200 bedded hospitals have minimum of 6 sq. feet area per bed for hospital pharmacy department.
(d) All of the above
short Questions
3. What is the definition of hospital pharmacy?
4. Describe the various functions of hospital pharmacy.
long Questions
5. Draw the layout of hospital pharmacy. Describe the responsibilities and duties of hospital
pharmacists.
6. Explain the organization structure of hospital pharmacy including staff requirement.
Answer to MCQs
1. (a) 2. (d)
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Chapter
Adverse Drug Reactions
Appearance of noxious and unintended response of a drug even at therapeutic dose,
administered for the purpose of prophylaxis, or diagnosis, or therapy of disease is referred
to as adverse drug reactions (ADRs). There is only causal link of drug with ADRs.
Patient characteristics (e.g. age, sex, ethnicity, co-existing disorders, genetic or
geographic factors) are quite significant for occurrence and severity of ADRs. These
ADRs are also related with various drug factors like type of drug, route of administration,
duration of treatment, dosage form, and bioavailability. Occurrence of ADRs in elderly
is higher and harsher, causing significant burden in healthcare system.
COMPARISON OF SIDE EFFECTS AND ADVERSE EFFECTS
In Terms of Actions
Side effects may be both therapeutically beneficial and harmful.
Adverse effects are generally harmful and unwanted or undesirable.
Prior Prediction
Side effects can be usually predicted by the doctor.
Adverse effects cannot be predicted by the doctor.
Effect on the Treatment
Side effects generally do not impede the prime effect of the drug.
Adverse effects can impede the treatment, which may lead to more complications.
In Terms of Severity of Effects
Side effects are not severe in nature and can be resolved when compared to adverse effects.
Adverse effects are more harsh and sometime life-threatening.
CLASSIFICATION OF ADVERSE EVENTS
Traditional pharmacological classification, based on mechanism of action, there are two
types of adverse events: Type A and Type B.
‘A’ Type Adverse Event
These are continuation of usual pharmacological drug actions of the drug, hence
indicated by ‘A’ which means augmented. They are predictable or anticipated ADRs,
3
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Textbook of Pharmacy Practice
which are of mild nature and more common in comparison to type B adverse events
occurs. Type A adverse events are dose related, becomes more severe at higher dose.
Thus, type A adverse events can be avoided or prevented by adjusting the doses, based
on pharmacokinetic parameters of individual patient. Targeted or non-targeted receptors
are responsible for augmented pharmacologic actions, which may cause lateral effects,
parallel effects, or side effects. Type A adverse events are usually identified before
marketing during the clinical trials. There are two subclasses:
i. Desired overemphasized effect: Undesirable overemphasizedof a normal
pharmacologicaldrugeffectmayoccurduetooverstimulationoftargetedreceptors.
Itmayoccur eitheratusualclinicaldoseinasusceptibleindividualorathigher
dose.
Forexample,orthostatichypotension,observedwiththeadministrationofan
antihypertensivedrugisanexampleofexaggerateddesiredeffect.Otherexamples
whicharequitecommon,isdaytimestrongdesiretofallasleepaftertheintakeof
sedative-hypnoticdrug prescribedfor inducingsleep, andhypoglycemic shock
afteradministrationofinsulin.
ii. Undesirable effect: Theseareunwantedpharmacologiceffect,alsoknownaslateral
orparallelstimulation.Theseappeareitherafteranormalclinicaldoseoratoverdose
inasusceptiblepatient.Stimulationofuntargetedreceptorsbythetherapeuticdrug
isreasonforappearanceofundesirableeffects.Someoftheexamplesofundesirable
effectsinclude:
a. Constipativeeffectofmorphine.
b.GastrointestinalirritationorbleedingwiththeuseofNSAIDs.
c. Alopecia(hairloss)fromantineoplasticdrugs,and
d. Decreaseinsexualdesirewiththeuseofantidepressantdrugs.
‘B’ Type Adverse Events
These are unexpected or unpredicted pharmacological effects, or idiosyncratic adverse
reactions. In these, normal pharmacologic drug effects are extended, hence indicated
by word ‘B’ which means bizarre. These types of ADRs are not related to dose of drug.
These are of two types:
i. Immunologic reactions: Immunological mechanism is involved inallergic
orhypersensitivity types of ADRs.In these, pseudo-allergic or anaphylactic
reactionsoccurwiththereleaseofsomemediatorslikeimmunoglobulinE(IgE)
duringanimmunologicreaction.Hypersensitivityreactionsarequitecommon
withtheuseofpenicillin.Radiocontrastagents,NSAIDs,etc.,areotherexamples
whichmaycauseallergicreactions.
ii. Idiosyncratic reactions: In broadsense, theterm ‘idiosyncratic’ isused for
abnormal and unpredictable adverse reactions. It occurs rarely, onlyin an
individual,whoissusceptibletothespecificdrug.Skin,liver,andbonemarrow
aremajortargetsforidiosyncraticreactions.Itsmechanismisnotfullyunderstood
yet.Thesemayoccurduetogeneticreasoninsomecasesorduetoacquired
enzymeabnormalitywiththeformationoftoxicmetabolites.
For example, hemolytic anemia is inherited metabolic abnormality, manifested due to
G6P dehydrogenase deficiency or instability of RBCs membrane. Drug-induced lupus,
caused by isoniazid, is another example for idiosyncratic reaction.
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Adverse Drug Reactions
Like this, there are other adverse events (e.g. C, D, and E), which are not mechanistic
but have characteristics manifestation.
‘C’ Type Adverse Events
These are chronic adverse drug reactions, which are related to dose as well as time. The
word ’C’ designate the term chronic or continuous. These occur due to accumulation of
drug or with prolong use of drug. Some examples of type C adverse events are:
• Nephropathydevelopedonlong-termdruguseofanalgesics.
• Adrenalsuppression,causedbytheprolonguseofcorticosteroids.
• Osteonecrosisofthejawwithbisphosphonates,usedfortreatmentofosteoporosis.
‘D’ Type Adverse Events
Type D refers to ‘delayed” adverse reactions, related to time. These appear after a certain
gap period, generally appear due to continuous or prolonged use of drugs. These are
dose independent. For example,
• Carcinogenicitycausedbyimmunosuppressantdrugs(e.g.cyclophosphamide).
• Teratogenicity(e.g.fetal hydantoinsyndrome) dueto use of hydantoin during
pregnancy.
’E’ Type Adverse Events
These are unwanted effects of drugs, appear on sudden withdrawal of the drug.
For example, insomnia and anxiety are manifested on opiate withdrawal and
benzodiazepines withdrawal respectively. These types of adverse reactions, can be
treated by reintroduction of drug, followed by slow withdrawal.
‘F’ Type Adverse Events
In these, efficacy of drug undesirably increases or decreases, which results in unexpected
failure of therapy, hence designated by word ’F’, means failure.
Adverse ‘F’ event occurs due to interaction with other co-administered drug. There
is either enzyme induction or inhibition. These types of reaction are related to dose.
For example, failure of an oral contraceptive drug to prevent pregnancy, when used
with an enzyme-inducing drug like antiepileptic drug (e.g. phenytoin, carbamazepine,
etc.). Decreased effect of antibiotics due to antimicrobial resistance is also an example
of type ’F’ reaction. For treatment, either increase dosage or consider to change the
antibiotic as per need of the therapy.
CATEGORIZATION OF ADVERSE DRUG EVENTS
These are conveniently categorized into the following categories:
1. Augmentedpharmacologicalactions
2. Secondarypharmacologicalresponses
3. Idiosyncraticreactions
4. Allergicresponsetodrugs
5. Geneticallydeterminedabnormaldrugreactions
6. Unexpecteddrugwithdrawal
7. Druginteractions
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Textbook of Pharmacy Practice
Each of these different reasons causes adverse drug reactions, which are influenced
by other factors like recommended dosage, formulation, route of administration and
patient factors such as age, sex, weight, presence of underlying disease of kidney or
liver disease.
1. Augmented pharmacological effects: Augmented drug’s normal pharmacological
action is also responsible for adverse drug reaction. These adverse reactions may
appear at the usual clinical dose or overdose of drug. They are normally dose
dependent. Examples of this type of adverse reactions include:
• Hypotensiveconditionwithuseofantihypertensivedrugs.
• Hemorrhagicconditionwithuseofanticoagulantdruglikewarfarin.
• Respiratorydepressionwithuseofmorphine.
• DevelopmentofCushingsyndromewiththeuseofprednisolone(corticosteroid).
• Hypoglycemicconditionwiththeuseofinsulin.
• Drowsinessor"hangovereffect"withtheuseofbenzodiazepineslikediazepam
orflurazepam.Thesesideeffectsmaybecontinuedtothenextday,whichcauses
difficultiesinmotordrivingandotherdailyactivities.Thisbecomesmoresevere
andriskyintheelderlypatients.
Sometimes,adversereactionmayalsoappearatusual clinical dose due toits
normalpharmacologicaldrugactionsinunhealthypersonsufferingfromspecific
disease.Diseasedconditionsmayinclude:
i. Kidneydamageduetorenaldisease.Bodyisunabletoeliminatethedrugwhen
morethan70%impairmentinkidneyfunctionduetokidneydamage.Itresults
inaugmentationofdrugaction.
ii. Decreasedalbumin production(as inliver disease)or lossof albumin (as in
nephroticsyndrome)resultsinhypoalbuminemia,whichmaycausecirculatory
collapse.
iii. Extremesoftheageatbothlevels—high(geriatrics)orlow(infants).
Under these circumstances,it is advisable to predict the pharmacokinetic
parametersofdrugbeforeadministration.Onthebasisoftheseparametersdose
ofdrugcanbeadjustedtopreventorminimizetheadversedrugreactions.
2. Secondary pharmacological responses: Drug is prescribed only due to
its beneficial primary pharmacological action in spite of having several
pharmacological actions. These are referred to as secondary effects, which
also appear at usual therapeutic dose along with primary action. For example,
antihistamines are prescribed in allergic reactions on the basis of their
antihistaminic effect. These secondary pharmacological effects are responsible
for causing sedation, considered as side effects. These secondary actions are little
weightage when prescribed to patient suffering from allergy, but it may lead
to disastrous consequences, if a patient is driver by profession. This effect may
further enhance, if the patient is taking OTC products like cough suppressant
or consuming is alcohol for recreational purpose. The beta-adrenergic blockers
are generally prescribed for the treatment of hypertension due to their
primary pharmacological action but it also causes bronchospasm as secondary
pharmacological. Thus, use of beta blocker is contraindicated in asthmatic patient
for treatment of hypertension.
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Adverse Drug Reactions
3. Idiosyncratic reactions: Idiosyncratic drug reactions are adverse reactions, of which
mechanism is still unclear. These types of adverse reactions are not related to dose
and develop only in susceptible patients. These reactions are generally accountable
for 10% of total ADRs, but appear at higher rate of frequency. Idiosyncratic reactions
are neither related to a drug's normal pharmacologic effects nor allergic in nature.
These ADRs are due to genetically determined abnormal reactivity to a drug which
cannot explained by known mechanism. Idiosyncratic reactions can be categorized
into:
i. Firstcategoryincludesimmunologicalhypersensitivityreactions,whichrange
frommildskinrashestoeosinophiliaandsystemicsymptoms,whicharelife-
threatening.
ii. SecondcategoryofADRsinvolveunpredictablenon-immunologicalreactionsin
susceptibleindividual.Forexample,administrationofvalproatefortreatmentof
epilepsycauseslivertoxicityduetoabnormalproductionofreactivecytotoxic
metabolites.Inthese,thebody'sdrugmetabolizingsystemhasbeenimplicated
inthe development of the idiosyncraticreactions by non-immunological
mechanism.
Someexamplesofidiosyncraticadversedrugreactionareillustratedhere:
a. Haemolyticanaemiaoccurswithuseofprimaquine(anti-malarialdrug)insome
individuals,who aredeficient either in glucose-6-phosphate dehydrogenase
(G6PD)enzymeorinNADHmethaemoglobinreductaseenzyme.
b.Development of potential teratogenicity (e.g. formation of limb bud) by
administrationofThalidomidetofemaleduringinitialperiodofgestation.
c. Developmentofperipheralneuropathywiththeusesofisoniazidinpeoplewho
hasdeficiencyofenzymeN-acetyltransferase(orareslowacetylators).
4. Allergic response to drugs: Allergic drug responses vary from very mild skin
rashes to anaphylaxis, which may occur rarely after exposure to specific drug
but life-threatening. Characteristic features for allergic adverse reactions are as
follows:
i.Allergic reactionsdo not have anyresemblance withusual pharmacological
actionofthedrug.
ii. Allergicresponsedevelopedinsusceptibleindividualmaybemanifestedafter
atimegaponexposuretodrug.
iii. Repetitionofallergicresponsemayoccuronfurtherexposureeventotracesof
allergenicdrugs.
Allergicreactionsoccurduetoanyofthefourimmunologicmechanismsproposed
byGell and Coombs.Drug or its metabolite combineswith circulatingplasma
proteintoform antigenin the body. Whenan individual comesin contactwith
suchantigen,antibodyformation (re-sensitizedorallergicresponse)takes place.
Suchindividualonfurtherexposuretothesamedrugliberatethemediators(like
histamine,serotonin,prostaglandins,etc.),onreactionofantigenwiththeantibodies
inthebody.Thereleaseofthesemediatorsfrommastcellsisresponsibleforallergic
reactions.Theallergicreactionbecomesvisibledependingoncharacteristicofthe
mediatorandnotthedrug.Someexamplesofallergicreactionsandtheirinitiating
drugsareshowninTable3.1.
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Textbook of Pharmacy Practice
Table 3.1: Allergic drug reactions
Allergic response Causative drugs
Anaphylaxis Penicillin
Hemolytic anemia (RBC’s destruction) Penicillin, sulpha drugs, guanidine
Leucopenia (WBC’s destruction) Sulpha drugs, phenylbutazone
Rashes on skin Antibiotics such as penicillin, sulfasalazine
Allergic liver inflammation Chlorpromazine, INH
Interstitial nephritis NSAIDs
Arteritis Phenytoin, penicillin
Lupus erythematosus Hydralazine, INH
5. Genetical abnormal drug reactions (genotoxicity): Drug response varies due
to difference in rate of metabolism or excretion in individuals or sub-group of
individuals. This may result either in failure of therapeutic outcome or abnormal
drug reaction, referred to as adverse effects. Hence, DNA or chromosomal damage
occurs in patients of selected genetic makeup, which resulted in higher risk for
specific drug toxicity. A few examples of genotoxic abnormal drug action are
illustrated here:
• Glucose-6-phosphatedehydrogenase,requiredtoproduceenergyfromglucose,is
eitherlackingorinsufficientinAfricanandSouthEastAsiapopulation,sothere
isriskofdevelopinghemolyticanemiawiththeuseofprimaquine(antimalarial
drug).
• Barbituratesincrease theactivity ofaminolevulinic acid(ALA) synthetase
enzymes,whichisinvolvedinthesynthesisofheme.IncreasedALAsynthetase
activity,causedbybarbituratescancausedangerousexacerbationsofdisease
inpatients with porphyria. Hence, barbiturates are not advised to use
inpatientswithahistoryofporphyria.
• Succinylcholine (neuromuscularblocker) maycause paralysis in susceptible
individual,whohasenzyme,pseudocholinesterasedeficiency.
• Drugs,suchasisoniazid,procainamide,hydralazine,phenelzineanddapsone
areacetylatedindetoxificationmechanisminliver.Thecapacitytoacetylatethe
drugsvariesfromindividualtoindividual.Patientsarepronetodevelopment
ofabnormaladverseevents,whoareslowacetylators.
6. Unexpected withdrawal of drug: Drug withdrawal symptoms, referred to as adverse
reactions, appear on abrupt discontinuation or decrease in the intake of some
drugs, such as CNS depressants (e.g. opiates), hypnotics (e.g. barbiturates), some
antihypertensive drugs (e.g. clonidine), corticosteroids or recreational drugs (e.g.
alcohol).These occur due to drug dependence, which develops from consuming one
or more substances over a period of time.
Thepatientswhoareusedtocentralnervousdepressantssuchasbarbiturates
andsomebenzodiazepinesfortherapy, oralcoholforrecreationalpurpose, may
producemarked agitation, tachycardia,confusion, delirium andconvulsions on
abruptwithdrawaleven at clinicaldose.Clonidine, antihypertensive drug,may
causeseverehypertensiononsuddenwithdrawal.