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83
Chapter
Pharmacy and Therapeutics
Committee
There is a requirement of proper and effective operational program for rational use of
drugs in hospitals due to the following factors:
i. Availabilityofwiderangeofdrugs
ii. Needforsafeandeffectiveuseofdrugs
Pharmacy and therapeutics committee (P&T) is the organizational mainstay and
policy implementing body for providing effective strategies to supply the safe and
effective drugs. Rational use of drugs in a hospital setting is also encouraged by this
committee. Physicians from various departments, pharmacists, and other healthcare
professionals selected with the guidance of the hospital medical staff are the important
components of P&T committee. It also co-ordinates the medical staff members of hospital
with pharmacy department.
OBJECTIVES OF THE P&T COMMITTEE
These are as follows:
1. Implementation of policies and procedures: The P&T committee frame the
policiesandimplementthemforassessment,andselectionfortherapeuticuse
ofdrugs and relateddevicefor theirsafe and effectiveusein thehealthcare
system.Thisalsoincludesguidelinesforselection,procurementandsupplyof
drugsin addition tomedication administrationmethod in ahospital. Under
theseguidelines,specifictypesofmedicationsaresuppliedatparticularlocations
forthe hospital(i.e. intensive care unit)or underspecific conditions (i.e. by
chemotherapycertifiednurse).Finally,itisanimportantbodytodevelopthe
formularymanagementprocessincludingmedicationlist,prepareguidelines
fortheevaluationofmedications,reviewtheadditionordeletionofdrugsin
theformulary,etc.
2. Educational: Thecommitteesuggestsorhelpsintheprogramsdesignedtomeetthe
needsoftheprofessionalstaff(physicians,nurses,pharmacists,andotherhealthcare
practitioners)forcompleteupdatedknowledgeonmattersrelatedtoclinicaluse
ofdrugs.Aprofessionalnewsletterisoftenusedtospreadthesedecisionsamong
variousstaff members.The newsletter may also incorporate updated clinical
informationondrugsaddedtotheformulary,drugtherapyguidelinesimplemented,
andavailablemedicationsafetyprofile.
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Textbook of Pharmacy Practice
3. Advisory: TheP&Tcommitteeisconsideredasanadvisorygroupofthemedicalstaff.
Members of the committee are from representatives from medical staff of various
departments, pharmacy, nursing, and administration.
Thecommitteeendorsestheadditionordeletionofdrugsfromhospitalformulary,
monitorsandevaluatesmedicationuse,anddevelopsandimplementspoliciesfor
appropriaterationaldruguse in thehospital. The committeeisalso responsible
forprovidingclinicalupdateofnewlyaddedformularydrugsalongwithsafety
guidelinesthroughnewsletter.
4. Drug safety and adverse drug monitoring: TheP&Tcommitteeperformsin-depth
evaluationsofavailabledrugstoprovideguidelinesabouttheiruseinparticular
condition.
For this, the committee monitors the drugs/drug categories for their safety,
efficacy, and overall therapeutics cost value, and then advisory service to the medical
staff and organizational administration in all matters related to the use of available
medications.
ORGANIZATION AND OPERATION
The composition and operation of the P&T committee may vary as per the need but a
generalized concept can be formulated as given here:
Composition
1. Electivemembers:
i. Physicians,threeinnumbersfromvariousdepartmentsofhospital.
ii. Pharmacist.
iii. Nurse.
iv.Administrator.
v. Quality-assurancecoordinator.
vi. Ex-officiomemberofcommitteeandothersrelevantstaffmember.
Thesize of the committee dependson the scope of services renderedby the
hospitalorganization.Committeemembersareeitherelectedmembersorappointed
byagoverningbody.Thegoverningbodyappointedphysicianorelectedphysician
isthechairpersonofP&Tcommittee.Generally,appointedorelectedpharmacist
actsassecretaryofP&Tcommittee.
Theremay besubcommittees from the various departmentslike cardiac,
oncology,etc.
Operation
1. Committeeconductsameetingataregularinterval,atleastsixtimesinayear,or
whenrequired.
2. Committeemayinviteanexpertfromwithinoroutsidetheorganizationtocontribute
oradviseonspecificmatters.
3. Secretoryusuallycompilestheminutesofmeetings,whicharekeptintheperpetual
recordsoftheorganization.
4. Secretorypreparesanagendaandsupplementarymaterials(includingminutesof
thepreviousmeeting)andcirculatestocommitteemembersforproperreviewin
welladvancetimebeforeeachmeeting.
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Pharmacy and Therapeutics Committee
5. Agendaofmeetingconsistsof:
• Lastmeetingminutes
• Reviewofthehospitalformularyfordeletingofproductsnotconsideredforuse
andaddingnewdrugsforupdatingthelist.
• Clinicaldataregardingcommerciallyavailablenewdrugs.
• Toreviewtheinvestigationaldrugscurrentlyunderprocessinthehospital.
• ReviewofADRs,interactionsofdrugs,etc.,officiallyreportedbyvarioushospital
departments
• Reviewofpharmacokineticdatafordeterminingdrugsafetyprofileinthehospital.
• Varioussub-committeesreports.
• Medicalauditreport
• Anyurgentorimportantmatter,ifpermittedbychairman
6. Recommendationsofthecommitteeshouldbecirculatedtothemedicalstaffthrough
appropriatecommitteeforacquisitionorrecommendation.
7. Makingalliancerelatedtorationaldrugusewithotherorganizationalcommittees
shouldbemaintained.
8.Guidelines framedor actions recommended byCommittee should be routinely
communicatedtothevarioushealthcarepersonnelinthehospital.
9. Thecommitteeshouldimplementtheguidelinesinanorganizedmannertoensure
theirobjectivity.
FUNCTIONS AND SCOPE
Some important functions of the P&T committee are:
1.Tomanagethe Hospital Drug Formularies toencourage safe use of drugin an
effectiveandaffordablecost-effectivemanner.
2. Tocarryoutinspectionofcommercialdrugformularies,themedicareformulary,
andthestateprogramsformularyforupdateofknowledge.
3. Toimplementmedicalpoliciesthatpromotethesafety,effectiveness,andaffordability
ofmedicationsusedinhospitalsettings.
4. Tomentorthemanagementofthedrugformularieswiththeframingofprinciples.
5.Tocarry out the reviewof newdrugs, drugclasses, newclinical indications,
therapeuticadvantages,newchemicalentities,recentsafetyinformation,etc.
6. Toreviewthevariouscategoriesofdrugsforadditionordeletionormodification
atleastonceinayear.
7. Toanalyzeandupdatepharmacymanagementpoliciesatleastannuallytoensure
theavailabilityof newclinicalinformation.Policiesarepublicizedregularlyina
plannedhospitalnewsletter.
8. Tomaintain aformulary process that facilitatesappropriateaccess to affordable
prescriptiondrug.
9. Toplayaroleofadvisorycapacitytoguidethemedicalandadministrativestaff
membersinallmatterspertaining to theuseofdrugs(includinginvestigational
drugs).
10.Toestablishprogramsandprocedurestoensuresafeandeffectiverationaledrug
therapy.
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Textbook of Pharmacy Practice
11.Tomonitorandevaluateadversedrugreactionsinthehospitalhealthcaresetting
andtomakeappropriateguidelinestopreventtheirreoccurrence.
12.To play an importantrole ininterpreting clinicaltrials and generating drug
monographstoensuretheutilizationofselectedmedicationseffectively.
ROLE OF P&T IN DRUG SAFETY
For ensuring patient safety, P&T committee should discourage the involvement of non-
pharmacy person in dispensing of drugs and other related substances. P&T committee
implement a methodology to review each new prescription for possible errors before a
delivery of prescribed medications to patient. These are helpful in preventing or avoiding
the adverse drug reactions. For making the delivery of medications, pharmacist fill
up the prescription and make billing through the medicaid computer program, which
checks the prescription against certain drug criteria. Here are the criteria, for which the
computer checks the prescriptions:
1. Doseofprescribeddrug,whichshouldbeneitherbelowtheminimumdoseornor
theoverdose.
2. Possibilityofduplicityoftheprescribeddrug.
3. Possibility of interaction of the prescribeddrugwithanotherdrugorOTCdrug
giventothepatient.
4. Check the other health problems, e.g. diabetes, hypertensionor pregnancyof
patient,inwhichprescribedmedicineiscontraindicated.Iftheprogramsuspects
apossibleproblem,thepharmacistdeliversawarningmessage.Hecanalsoshare
theinformationwiththepatient,andcancontactthephysician,ifnecessary.
ROLE OF P&T COMMITTEE IN EMERGENCY DRUG LIST
The P&T committee compile the list of emergency drugs, which should be always
available at nursing unit or patient care area for use in emergency. The compiled list of
such drugs and other supplies should be available in “Emergency Kits”, which is checked
at regular interval either by the hospital pharmacists or by nursing supervisor responsible
for the ward. The list of recommended emergency drugs and other articles includes:
Basic Supplies
• Syringeswithneedlesofdifferentgauge
• Adhesivetapes
• Deviceforbreakingtheampoule
• Firstaidmanual
• Breathingequipment
• Cottonballs
Drugs Likely to be Present in Emergency Box
• Atropinesulphate0.4mg/ml
• Digoxin0.25mg/ml
• Heparin10,000units/ml
• Neostigminemethylsulphate0.25mg/ml
• Mannitolinjection25%
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Pharmacy and Therapeutics Committee
• Sodiumchlorideinjection0.9%w/v
• Sterilewaterforinjection
Accessories for Cabinet Utility Room
• Oxygentherapyapparatus
• Lancet
• Resuscitationtube.
Miscellaneous Supplies
• Burnsheets
• Dextranandtubing
• Resuscitationcarts
ROLE OF P&T COMMITTEE IN ADVERSE DRUGS REPORTING
Adverse drug reaction is any unexpected harmful reaction, which may include acute
poisonings caused by narcotic drugs or stimulant drugs as well as industrial poisonings.
The P&T committee must undertake the responsibility to recommend the required
guideline for understanding, reporting and prevention of ADRs.
The healthcare professional (e.g. physician, nurse, pharmacist, etc.) can submit an
adverse drug reaction report to concert authority. The report can be filed by telephone or
through filling of prescribed form. Forms are usually kept on all nursing units, recovery
rooms and also can be downloaded from website. The patient address, the name of the
reporter and the name of the institution reporting the ADRs are not disclosed to general
public. Filled reporting form may be submitted at the pharmacy department by putting
it in the pharmacist’s order bin.
ROLE OF P&T COMMITTEE IN AUTO STOP ORDER
The P&T committee ensures the framing of policy related to automatic stop order (ASO)
in the healthcare organization.
“All drug orders for narcotics, sedatives, hypnotic anticoagulants, and antibiotics
(administered orally or parenterally) shall be automatically discontinued after 48 hours
unless the order indicates an exact number of doses to be administered, or the attending
physician, re-orders the medication”.
Medical orders or prescription for controlled substances like narcotics, sedatives and
hypnotics must be re-issued after every 24 hours.
ROLE OF P&T COMMITTEE IN DRUG UTILIZATION
The P&T Committee constantly analyzes the prescribing patterns, dispensing and
patient drug use with predetermined criteria. These are essential for assessing the safety,
effectiveness and appropriateness of drug therapy. A system should be implemented
under drug utilization review (DUR) program to rectify the discrepancies, if any and
improve prescribing pattern and use of drug by patient.
Every hospital organization has preferred drug list (PDL), which consists effective
and safe cost wise affordable drugs of each therapeutic class. Then, drugs are listed
by a member of P &T committee. The members are selected from the clinicians from
various specialties and also public advocates.
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Textbook of Pharmacy Practice
ROLE OF P&T COMMITTEE IN HOSPITAL FORMULARY SYSTEM
Hospital formulary consists of a list of medications available for use in a hospital
including the dosage forms, strengths and package sizes of each of the medications.
The updated list of drugs and related information, depicts the clinical judgment
of physicians, pharmacists, and other experts in the diagnosis and/or treatment of
disease. The P&T committee establishs a method for compilation of drug list. Apart
from medication efficacy, safety, and cost, certain other medication selection criteria are
also considered. These are:
• Duplicationofanexistingformularydrugifanyforthesameindication.
• Methodandtimeofadministration.
• Skillrequirementforadministration.
• Anyspecialconcernsrelatedtodrug.
ROLE OF P&T COMMITTEE IN DRUG PRODUCT REPORTING PROGRAM
Drugs supplied in hospital should be evaluated for safety and quality. The drug product
suspected of having a deficiency or defect should be communicated to the drug control
department or drug manufacturer.
ROLE OF P&T IN DISPENSING OF MEDICATIONS TO IPD AND OPD
Appropriate policy is framed or implemented with recommendation of P&T committee
which ensures the drug distribution to inpatients and outpatients departments.
Pharmacist must ensure genuineness and validity of prescription related to its
diagnosis and treatment in these departments. Pharmacists should also suggest for any
modification concerning with the dose regimen to prescriber.
P&T committee also monitors a steady supply of drugs as per the needs of the patients
and healthcare system. For this, IPD/OPD pharmacist must coordinate with inventory
control department, drug distribution in-charge, and physicians.
The P&T committee should also encourage the pharmacist to supervise the purchasing
orders, manage the material transfer across departments, and maintain smooth
functioning of drug distribution system in the hospital.
ROLE OF P&T COMMITTEE IN EDUCATIONAL PROGRAM
The P&T Committee can develop and organize an educational program to enlighten staff
members regarding common therapy problems. It is advantageous to improve prescribing
and dispensing practices. Recommendations through written, oral or electronic reminders
which contain patient and/or drug specific information and suggested changes in
prescribing or dispensing practices can be circulated by the committee. The committee
may also conduct reviews or monitor the selected prescribers or pharmacists.
EXERCISE
Multiple ChoiCe Questions
Tick mark the appropriate choice
1. Pharmacy and therapeutic committee include __________
(a) Three physicians from hospital medical staff, one pharmacist, nurse, and hospital administrator.
(b) Two physicians from hospital medical staff, one pharmacist, nurse, and hospital administrator.
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Pharmacy and Therapeutics Committee
(c) Three physicians from hospital medical staff, one pharmacist, nurse, and hospital owner.
(d) Two physicians from hospital medical staff, two pharmacist, nurse, and administrator.
2. The member secretory of pharmacy and therapeutic committee is _________
(a) Chief pharmacist (c) Purchase officer
(b) Senior physician (d) Medical officer
3. What is the function of PTC?
(a) Conducting interventions to improve drug use.
(b) Managing adverse drug reactions and medication errors.
(c) Informing all involved members about drug use issues, policies and decisions.
(d) All of the above.
short Questions
4. Define ‘pharmacy and therapeutics committee’. Give the functions of this committee.
5. Write the role of P&T committee in hospital formulary system.
long Questions
6. Discuss the organization, composition and functioning of pharmacy therapeutic committee.
7. Discuss the role of P&T committee in the following:
i. Auto stop order
ii. Drug utilization
iii. Dispensing of medications to IPD and OPD
Answer to MCQs
1. (a) 2. (a) 3. (d)
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Chapter
Drug Information Services
Due to advancement in pharmaceutical technology, new dosage forms of the existing
drug are continuously explored for developing effective and safe therapy. At the same
time, new drug molecules are continuously explored due to availability of new drug
discovery process, for getting more effective therapeutic outcome. Development of new
drug molecule is also desirable for the treatment of complicated disease like cancer,
HIV infection, etc. These are beneficial to healthcare system only, when there is an
access to these clinically relevant, updated, user-specific, and purposeful information
regarding the development of drug. Healthcare professionals including physician need
the meaningful information regarding the development of new drug or new dosage
form for patient care.
Sometime prescriber or patients have queries about uses of prescription and non-
prescription drugs, but sources are either not available or accessible to provide the
answer related to drug use.
To solve these problems, Drug Information Service Center (DISC) came into existence
to provide relevant and clinically applicable information to healthcare professionals.
The aim was to ensure the safe, appropriate and cost-effective use of medications. In the
year 1962, first ‘drug information centre’ (DIC) was started at the University of Kentucky
Medical Center, USA, with an objective to provide a selective and comprehensive source
of drug information. This service was provided for the doctors in a clinical practice.
Then, several information centres were developed including India, but such information
service centres are only available in big privatized hospitals in India.
Objectives of DIC
These are aimed:
1. Toprovideanorganizeddatabasesourceofinformationonspecificmedicinesor
newlydevelopedmedicinestohealthcareprofessionals.
2. Togiveimpartialdruginformationto healthcareprofessionals(e.g.pharmacists,
physicians,etc.)workinginthehospital.
3. Toanswerthe queries related to use of newdrugs ornew dosage forms to the
healthcareprofessionals.
4. Tomakeawarenessabouttheimportanceofmonitoringaboutthequalityofdrug
information.
5. Toprovidetheguidancetopharmacygraduatesregardingtheuseoftheexisting
ornewdrugs.
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Drug Information Services
6. ToencouragethesettingofDICatvariouslevelsandexemplifyitsbasicrequirements.
7.Topromotea learningcentre tostudent, pharmacists and other health sciences
studentsaboutthedruginformationexpertise.
8.Tohelpinthepromotionofclinicalpharmacyhealthcareservicesthroughoutthe
cityorstatewithcontributionofdruginformationservices.
9. ToencouragetheprofessionofpharmacythroughDICinvarioushealthmaintenance
programs.
10. Topromoteevidence-basedpracticethroughtherationaluseofmedicinesformaking
betterpatientcare.
SOURCES OF DRUG INFORMATION
Drug information sources are traditionally classified into three classes:
1. Primary sources aretheprimesource.Allothertypesofdruginformationsources
arebasedontheprimarysourcesorderivedfromprimarysources.Theseinclude
journalpublicationsincorporatingdrug-relatedsubjects,suchasreportsofclinical
drugtrials,casereports,andpharmacologicalresearch.Table12.1illustratessome
English-languagejournals that have strong editorial policies and peer review
processesto minimizethe possibilityof reportingunbiased or unsupportable
conclusions.
It is noted here that review articles or editorials, published in a journal are not
considered primary source.
Advantages of primary literature
i. Primarysourceprovidesthecurrent,original,andinnovative.
ii. Mostofthepublicationsarepeerreviewedbythesubjectexpertbeforeanarticle
isacceptedforpublication.Thesubjectexpertsincorporateunbiasedviewsand
suggestionstoimprovethequalityofthearticle.
Disadvantages of primary literature
i. Flawsinstudydesignpublishedinjournalmayleadtoinaccuratefindings.For
example,theremaybewrongconclusionfromtheresultofstudy,ifstatistical
analysisisnotappropriate.
ii.Knowledge ofscientific methods and statistics is essential to interpretthe
informationproperlyprovidedbytheprimarysource.
iii. Since,theinformationrepresentedintheprimaryliteratureisnottherecentbecause
thereisalwaysatimegapbeforewidelyacceptedinthemedicalcommunity.
2. Secondary sources refertosourcesthateitherindexorabstracttheprimarysource,
withtheaimofdirectingtheusertopointoutrelevantprimarysource.Excerpta
Medica,meta-analyses,indexes(e.g.IndexMedicus),abstracts(e.g. Interactional
PharmaceuticalAbstracts,chemicalabstract),IowaDrugInformationService(which
alsogives full-textreprints ofarticles), MEDLINE(abstracting serviceprovided
bytheNationalLibraryofMedicine),andcombinationsofabstractsandfull-text
reprintsareagoodexampleofsecondarysources.
Advantages of secondary sources
i. Guideforeasyandquickaccesstotheprimaryliterature,fromwhereinformation
canbeobtained.
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Textbook of Pharmacy Practice
ii. Furnishthebroadscopeand/orconciseinformationonspecificinterestbutit
isessentialtomakeasearchforspecificdesirableinformation.
iii. Secondarysourcesgenerallyprovidedirectionfortheuseofprimarysources
whicharereputedandpeerreviewed.
iv. Onlinecataloguesareavailableforgettingupdatedinformationfromsecondary
literature.
Disadvantages of secondary literature
i. Theremaybeatimelagbetweensubmissionofarticleandpublication/inclusion
intosecondarysources.Itusuallyvariesfromweekstoseveralmonthsdepending
ondatabase.
ii. Numberofjournalsindexedbyeachindexingsystemislimited;dependsupon
thescopeofthedatabase.Allthejournalsarenotincludedinabstractingservice.
Table 12.1: Primary information sources
Medical and Therapeutic Journals
Annals of Internal Medicine
British Medical Journal
Journal of the American Medical Association
Lancet
New England Journal of Medicine
Drug and Toxicology Information and Pharmacology Journals
British Journal of Clinical Pharmacology
Clinical Pharmacology and Therapeutics
European Journal of Clinical Pharmacology
Human and Experimental Toxicology
Journal of Toxicology and Clinical Toxicology
Medical Toxicology and Adverse Drug Experience
Pharmacy Journals
American Journal of Hospital Pharmacy
Annals of Pharmacotherapy
Clinical Pharmacy
Journal of Clinical and Hospital Pharmacy
Journal of Clinical Pharmacy and Therapeutics
Journals in Specific Areas
American Journal of Emergency Medicine
Annals of Emergency Medicine
British Journal of Obstetrics and Gynaecology
Critical Care Medicine
Journal of Antimicrobials and Chemotherapy
Journal of Infectious Diseases
Journal of Paediatrics and Child Health