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33
Adverse Drug Reactions
better as per prediction in the waiting period, the basic disease can be given treatment
with alternative medicines, if necessary. If the patient condition is not improving after
withdrawal of the initial drug, then physician may go to identify the next culprit, and
the process repeated. In that case, either second drug candidate should be replaced
(remembering the possibility of cross-sensitivity), or the dose of the same drug should
be minimized (if adverse event is dose-related). The second approach is more useful
if more than one drug is suspected as in an interaction was suspected or it is better to
withhold several drugs in view of severity of adverse event. Revive possibly essential
medicines one by one, beginning with the one, which has minimum chance to cause
adverse reaction. If the patient cannot manage without a suspected medicine (responsible
for an adverse reaction), give him symptomatic relief along with continuing necessary
treatment. For example, patients receiving chemotherapeutic drugs for treatment of
cancer have feeling of nausea and vomiting, are routinely treated symptomatically.
However, it is not advisable to introduce more medicines, only essential medicines are
given. There should be a well-defined therapeutic objective; only required treatment
for necessary durations should be provided. There should be a regular review of the
patient condition to simplify therapy.
EXERCISE
Multiple ChoiCe Questions
Tick mark the appropriate choice
1. Type A Adverse effects are related to __________.
(a) Augmentation of pharmacological drug action at the usual clinical dose.
(b) Allergy.
(c) Idiosyncratic reactions.
(d) None of the above.
2. Which one of these is a beneficial drug interaction?
(a) Probenecid and penicillin
(b) Sulphamethoxazole and trimethoprim
(c) Levodopa and carbidopa
(d) All of the above
short Questions
3. Define the term ’adverse drug reactions’. Discuss the various categories of adverse drug events.
4. Explain the three examples of idiosyncratic drug reactions.
long Questions
5. Discuss the procedure for reporting adverse drug reactions in detail.
6. Discuss the methods of detection of adverse drugs reactions in detail.
7. Classify the adverse drug reactions. Discuss each class with examples.
Answer to MCQs
1. (a) 2. (d)
34
Chapter
Community Pharmacy
INTRODUCTION
Community pharmacy, also known as chemists or drugstore, is an important component
of healthcare services. The prime task of a community pharmacy is to accomplish
compounding, counseling, and dispensing of drugs to the patients with care, accuracy,
and as per legal laws. All of these activities are performed under the supervision of
registered community pharmacist, who is also involved in the procurement, storage,
and documentation of medicines. For complying these activities, community pharmacist
must have required professional qualification and skills and expertise to deliver the
healthcare services to the society.
For this, community pharmacist should:
i. Havearequiredbackgroundforpharmaceuticalcare,drugtherapy,andhealth
promotionalactivities.
ii. Ascommunitypharmacyinvolvesinteractionwithpatient,sopharmacistshould
havebetter communication skills to deliverhis expertise patients and other
healthcareprofessionals.
iii. Play an intermediaryrole between the doctorand the patient by providing
effectiveandsafedrugsaswellasmedicaladvicewithoutthepriorappointment.
Medicaladviceshouldbeprovidedfreeofcost.
iv. Beresponsibleforkeepingthereadilyaccessiblerecordsas requiredby legal
authorityforeasyaccess.
Design of Retail and Wholesale Drugstore
Layout of retail and wholesale drugstore is designed with the objective to:
1. Designtoattractalargenumberofcustomersespeciallyinretailcommunitypharmacy.
2. Designtoprovideattractivedisplaytoattracttocustomerwiththeaimtoincrease
thesaleofstore.
3. Design to have sufficientlywide entrancedoorforincominggoods,appropriate
spaceformanagingreservestock,administrativeofficeandrelaxingplaceforstaff
membersofcommunitypharmacy.
4. Developthemethodstominimizesellingexpensesbudget.
5. Developtheproceduresinretailstoretogivecustomersatisfaction.
4
35
Community Pharmacy
6.Design to create a professional image and boost up thegeneral appearance of
communitypharmacy.
7. Arrangethestorebyprovidingcompletedisplayofgeneralproductswithminimum
movementofcustomer within the premises of the drugstore.
Schedule ‘N’ as mentioned in Drugs and Cosmetics Act, govern the requirements
to open a drugstore which should be fulfilled. To open a retail drugstore, a minimum
of 150 sq. feet area is required while a minimum of 200 sq. feet is recommended for
wholesale drugstore. The example of design for retail/wholesale drugstore is given in
Fig. 4.1.
On the basis of design, these are classified into five types as:
1. Traditional drugstores: Inthesetypesofdrugstores,theentireareaofdrugstore
isexposedtocustomers.Suchtypesofdrugstoresarefavourableforbothworkers
andcustomers.Generally,thesetypesalsohaveattractingappearance.Traditional
drugstoregivesopportunitytocustomers,toselectandbuythevariousitems
themselves.Thereispossibilityofincreaseinmaximumsaleswithdisplayofeach
iteminstore.Possibilityoftheftintraditionalstoreexistwhichcanbeavoided
orpreventedbyinstallingaCCTVcameratocheckthemovementofworkeras
wellascustomerinbigsizedtraditionalstore.
2. Personal service drugstores: Incontrasttotraditionaldrugstore,theentirearea
isnotexposedtothecustomerinthistypeofstore.However,inmostofthese
typesofstores,thecosmeticandgiftitemsaredisplayedinattractivemanner
tocustomer.Forbuyingtheparticularitem,customerapproachestodrugstore
personnelattheservicecounteronly.Hence,purchasingisdonethroughsalesman
orpharmacistprocess,thecustomerdemandsanitemandthepersonnelgives
therequireditems.Thedesigninthesetypesfacilitatesmaximuminteractionof
Fig. 4.1: Design of drugstore (a) Retail (b) Wholesale
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Textbook of Pharmacy Practice
drugstoreemployeeandthecustomers.Thecommunicationskillandfriendly
behaviouroftheemployeeattheservicecounteraretheessentialforthesuccess
ofthedrugstore.
3. Prescription oriented drugstore: Comfortableandgood-lookingwaitingareais
aprimerequirementinthesetypesofstores.Herepatientcanwaitduringthe
dispensingorfillingofhisprescriptionbythepharmacist.Inthistypeofdesign,
healthcarerelateditemsaredisplayedinthevicinityofwaitingarea.Orthopaedic
andsurgicalappliancesarealsodisplayedinaseparateroom.Cosmeticsand
giftitemsaredisplayedinthestoreforeasyaccesstothecustomer.
4. Pharmaceutical centre: Thistypeofstorehasmorefloorspacewhichisnicely
decorated.Generally,thesetypesofcentressellmedicines,luxuryconvenience
itemslikeskinandhaircareproducts,orthopaedicandsurgicalappliances.
5. Super drugstore: Suchtypesofdrugstoresaregenerallysquare-shapedwithhuge
floorarearangingfrom5,000to10000sq.feet.Entireareaofstoreisaccessible,
wherethecustomers,cansee,handleandselectarticlesincludingOTCdrugsof
theirchoice.Theserviceisonself-servicepatternbutfortheprescriptiondrugs
self-serviceisrestricted.
Legal Requirements for Opening Retail Drugstore
A.Competent person/pharmacist:Thereisaprimerequirementofpharmacist,who
mustbequalifiedandregisteredwithStatePharmacyCounciltogetalicencefor
openinga retail drugstore. Whole drugstoremusthave graduate with1 year of
experienceoranundergraduatehavingfouryearsofexperience.
B. License
a. General license: Differenttypesoflicencearerequiredforthesaleofdrugs,as
givenbelow.Therequirednumberofapplicationformforaparticularlicense
categoryismentionedinthebracket.
i. License issued forthe retailsale of allopathicdrugs other than those
specifiedinScheduleC,C(1)andXonForm20.(Applicationformnumber:
Form19)
ii. Licenseissued fortheretailsale ofrestrictedallopathicdrugs other than
thosespecifiedinScheduleC,C(1)andXonForm20A.(Applicationform
number:Form19A)
iii. Licenseissuedforwholesaleofallopathicdrugsotherthanthosespecifiedin
ScheduleC,C(1)andXonForm20B.(Applicationformnumber:Form19)
iv. Licenseissued for retail sale of homeopathic medicines on Form 20C.
(Applicationformnumber:Form19B)
v. Licenseissued for wholesale of homeopathic medicines on Form20D.
(Applicationformnumber:Form19B)
vi. LicenseissuedforretailsaleofallopathicdrugsspecifiedinScheduleCand
C(1)onForm21.(Form19)
vii. LicenseissuedforwholesaleofallopathicdrugsspecifiedinScheduleCand
C(1)onForm21B.(Form19)
viii. License issued for retail saleof restrictedallopathic drugs specified in
ScheduleC(1)onForm21A.(Form19A)
37
Community Pharmacy
ix. LicenseissuedforretailsaleofdrugsspecifiedinSchedule'X'onForm20F.
(Form19C).
x. License,issuedforwholesaleofdrugsspecifiedinSchedule'X'onForm20G.
(Form19C).
Conditions for General License
1. Display of licenseis mandatory in the prominentmain partof premises
whichisconvenientlyvisibletopublic.
2. LicenseshouldbeincompliancewiththeconditionsrecommendedinDrugs
andCosmeticsAct,andRule.
3. Reportthechangeinthequalifiedstaffifanytolicensingauthoritywithin
onemonth.
4. For Schedule CandC1,drugsprecautionimposedbylicensingauthority
shouldbeobserved.
b.Restricted licenses: Licenses for the restricted sale of drug are issued on the
form numbers as mentioned above. Conditions for restricted licenses are as
follows:
1. Licensee should sell the restricted drugin their original native container
only.
2. Rules recommended in Drugs and CosmeticsAct and Rules shouldbe
followedbylicenseeforthesaleofrestricteddrugs.
3. Drugshouldonlybepurchasedfromadulylicenseddealer.
c. Documents required for getting a drug license
• Applicationformintheprescribedformat
• Constitution of the entity likeMOA(Memorandum ofAssociation),AOA
(ArticlesofAssociation)foracompany,partnershipdeed,LLPagreementin
caseofpartnershipshouldbeenclosedalongwithapplicationform.
• Challanorfeereceiptdepositedforapplyingtogetlicense.
• ProofofRegistrationinStatePharmacyCouncilifownerispharmacist
• Proofofidentificationforapartner/director/proprietorhavingphotograph.
• Documents relatedto propertyin which drugstore isto be opened like
ownershipdocumentsorrentalagreementorNOCfromthepropertyowner.
• Siteplanandkeyplanofthepropertyshowingstoragespaceascoldstorage,
refrigerator,etc.
• Declaration of the proprietor/partner/director/registeredpharmacist/
competentpersonfornon-convictionintheformofaffidavit
• Affidavit ofregistered pharmacist/competent person indicating special
declarationofworkingfulltime.
• Appointmentletterofregisteredpharmacist/competentpersonifhired.
Documentationmayvarywiththetypeofdruglicensecandidateisopting
for.Forexample,ifcandidateisapharmacist,thenthedocumentsrequiredare
differentascomparedtothedocumentsrequiredinapartnershipfirm.
C. Staff (Personnel): The success of community pharmacy depends on selection of staff.
The competent staff is the most important aspect for an efficient operation of
community pharmacy. The competent staff for wholesale drugstore should be:
38
Textbook of Pharmacy Practice
i. Registeredpharmacistor
ii. Graduatewith1yearexperienceindealingindrugsor
iii. PersonwhohasS.S.L.Cwith4years’experienceindealingindrugs.
Competenttechnicalstaff(pharmacist)forretaildrugstoreshouldberegistered
withState Pharmacy Council. Registered pharmacist is requiredto be present
throughouttheworkinghoursofcommunitypharmacy.
Selection of staff: Undermentioned criteria should be followed for the selection of
the staff for community pharmacy:
1. Minimumstandardsforrecruitmentofemployeesshouldbemaintained.
2.Person who is highlyqualified should not be hired for job in community
pharmacy.Thistypeofselectionmayresultinanunfavourableeffectonstaff
moralandefficiency.
3. Theproprietorshouldsetajobspecificationprofileforeachpositioninpharmacy.
Thejobspecificationshouldcontainsuchdetailastypeofjob,itsrelationtoother
jobs,workinghours,andpayscale,etc.Itpreventsmisunderstandingaboutthe
natureofthedutiesofaparticularjob.
4. Promotionwithinapharmacystaffmay be right decision. But inmostofthe
cases,staffsarerecruitedthroughemploymentagencies,placementofficesof
schools,universities,andclassifiednewspaperadvertisingagencies.
Orientation and training of staff: Afterselectionprocedure,thereshouldbeadequate
orientationand training of the recruitedstaffmember.Thisresults in increase
productivityandreducedemployeeturnover.
Compensation: It is an important but difficult task of proprietor of community
pharmacy to retain the efficient staff member for long term. Provision for adequate
compensation should be made to retain as well as to encourage them to work toward
the overall goal and positive outcome.
D.Space requirement and storage facility: For opening anew community,
minimumof10squaremetrescarpetareaisrequired.Incase,therequestismade
forbothretailandwholesalepharmacies,theminimumof15squaremetresarea
isrecommended.Clean,ventilatedsufficientstoragefacilitiesarenecessaryfor
storingthemedicines.Somedrugs,particularlyvaccines,needtobestoredat
low-temperaturewhichmadetherequirementofkeepingtherefrigeratorand
airconditionerfacilitiesmandatoryforgettingadruglicensetostartcommunity
pharmacyinIndia.
IMPORTANCE OF CODING AND STOCKING FOR COMMUNITY PHARMACY
Code symbol or identification number is assigned to a particular item for its easy
recognition. It is important for an inventory system in a drugstore because;
1. Codingofeachitemlyinginthestoreincreasestheworkingofmanagementsystem
tokeepefficienttrackingrecord.
2. Uncertaintyindescriptionofeachitemisavoided.
3. Eachitemcanbeidentifiedbynumberorsymbol;thus,useofdescriptivelanguage
isminimized.
4. Codingprocedurealsoensuresthepresenceofitemlyinginthestoreinaneasy
andefficientway.
39
Community Pharmacy
5. Each item,lyingstoredcanbe easily identified,especiallywhen same itemsare
knownbymorethanonename.
6.Withthe helpof coding procedure,it is easy touse computer software for the
managementofinventoryinthecommunitypharmacy.
Stocking for Drug in Community Pharmacy
1. Drugsarekeptinanalphabeticalmannerincommunitypharmacy.
2. Thereisaneasychannelfordistributionofdrugsbystocking.
3. Stockingrequiressufficientspaceforstorageofdrugsandotheritems.
4. Drugsareeasilyaccessiblebystocking,requiredforadministration.
5. Vaccinesandantibioticsarestockedatalowtemperatureinrefrigerator.
Dispensing of proprietary medicines: Proprietary medicine is notincluded in the
currenteditionoftheIP(IndianPharmacopoeia)oranyotherpharmacopoeiaauthorized
bytheCentralGovernment.Thesemedicinesareownedorcontrolledbyanindividual
orindividuals,withthehelpofeitherthroughcopyrightortradename/patent.
Traditional medicines are less important in the present scenario and used in hospital
due to less cost. Now number of proprietary medicines are more and available in the
market to cover a very wide range of therapeutic categories of drugs. Physician working
in hospital system may prescribe compounded prescriptions but to a very limited extent.
Hence, it is required to pay more attention to dispensing of proprietary medicines.
Sometimes, proprietary medicines are having indistinguishable nomenclature that
makes the pharmacist's job much difficult. Pharmacist must clearly understand the
need of the prescriber and must avoid chances of confusion, error, etc. while dispensing
proprietary medicines. He must use computer software program in resolving such type
of problems.
Requirement for keeping various records in community pharmacy: It is very
important and essential to maintain various legal, financial and professional records in
a community pharmacy. Various types of essential records are as follows:
1. Legal records: Accordingtodrugcontroldepartment,theproprietorofpharmacyis
requiredtokeepofup-to-daterecordsofspecificcategoriesofdrugsandpoisonsas
perDrugsandCosmeticsAct1940aswellasPoisonAct1919.Thepharmacistisa
reliablepersonforkeepingaccuraterecordsrelatedtoacquisitionanddispositionof
certaindrugsthatcanbeeithermisusedorabused.Itisalsomandatorytomaintain
arecordofthedistributionofpoisonandhazardoussubstancestoavoidthelegal
actionandpenalties.
2. Patient records: Patientrecordsaremaintainedforkeepingtheawarenessregarding
thepatientmedicationhistoriesforgettingbetteroutcomeoftherapy.Theformat
ofrecordsdependsonneedofhospitalorganisation.Somehospitalorganisations
keepthehardcopieswhileotherlargesizedhospitalsusethecomputersoftware
system.Recordmaybekeptbasedonfamilyunitbasiswhichallowsthepharmacist
tokeepthetrackofdrugusageofeachmemberoffamily.Itgivesbasicinformation
abouttypesandnumbersofdrugstakenbyaveragepatients,toavoidtheproblems
relatedtodruginteractionsandindividual’sidiosyncraticreactionstodrugs.These
recordsalsousefultoprovideinformationforinsuranceclaimsandforincometax
deductionofthepatients.
40
Textbook of Pharmacy Practice
3. Financial records: Adequatelycollectedandorganizedfinancialdata:
a. Isessentialtoolforefficientmanagementforfutureplan,neededforprogress
ofcommunitypharmacy.
b. Is requiredfor efficient inventorycontrol; personnelmatters and growth of
organizationdependoncontroloffinancialrecords.
c. Arerequiredforevaluation ofpastoperations,controllingcurrentoperations
andgivinginformationforforecastingthefutureplan.
d. Are requiredfor analysing revenues and expenses andpredicting returnon
investment.
e. Mayberequiredforgettingloanfromstate,andlocalgovernmentalagencies.
f. Arealsohelpfulinensuringtheprofitableoperation.
EXERCISE
Multiple ChoiCe Questions
Tick mark the appropriate choice.
1. Which are the prime responsibilities of a community pharmacy?
(a) Compounding of drug
(b) Counseling and advice to patient
(c) Dispensing of formulation to the patients
(d) All of the above
2. What is true for proprietary medicine?
(a) Preparation that is owned or controlled by an individual or individuals
(b) Controlled by a copyright
(c) Controlled by trade name
(d) Controlled by a patent
(e) All of the above
short Questions
3. Classify the various types of drugstores.
4. What is restricted license? Explain in brief.
long Questions
5. What are the various legal requirements for opening a retail drugstore? Discuss in detail.
6. Write a note on maintenance of various records in community pharmacy.
Answer to MCQs
1. (d) 2. (e)
UNIT
II
5. Drug Distribution System in Hospitals
6. Hospital Formulary System
7. Therapeutic Drug Monitoring
8. Medication Adherence
9. Patient Medication History Interview
10. Community Pharmacy Management
