PTC & Hospital Formulary

Pharmacy and Therapeutic Committee (PTC) & Hospital Formulary

The Pharmacy and Therapeutic Committee (PTC) is an advisory group that considers essentially all the matters related to the use of drugs in a hospital including evaluation of drugs & dosage forms and safe use of investigational drugs.

What is a pharmacy and therapeutics committee?
Pharmacy and Therapeutics (P&T) is a committee at a hospital or a health insurance plan that decides which drugs will appear on that entity's drug formulary.

2. Pharmacy&TherapeuticCommittee(PTC)isanadvisorygroup
ofthemedicalstuffandservesastheorganizationallineof
communication between medicalstuffandpharmacy
department.
Thecommitteeiscomposedwithminimumthree(03)physician,
one(01)pharmacistone(01)nurse.
Purpose of PTC
PrimarypurposesofPTCare–
Advisor
Educational

3. PTCcomposedofminimum03physician,apharmacist&anurse,
whoareappointedbygoverningboardorelectedmedicalstuff
Hospitaladministratororhisdesignatedshouldbeanexofficio
memberofthecommittee.
Chairmanofthecommitteefromamongthephysician&pharmacist
isdesignatedassecretary.
PTCwillmeetregularly,nolesthantwiceinayear.
Committeecaninviteexpertsfromwithinorwithouthospitalwho
cancontributehisspecializedknowledgeandexperience.
Anagendashouldprepareandcirculatedtothemembers in
sufficienttimebeforemeeting.
Minutesshouldpreparedandpreservedbythepharmacist.
Recommendations ofthePTCshallbeplacedtothemedicalstuffor
appropriatecommitteeforadsorption.

4. Functions of PTC
serveasanadvisorycapacityinallmattersrelatedtothe
useofdrug.
serveasanadvisorycapacityintheselection&choiceof
drug.
evaluateclinicaldataregardingnewdrugsorproposed
drugsforhospitaluse.
preventunnecessaryduplicationofsamebasicdrugor
theircombination.
recommendadditionsanddeletionsfromthelistofdrug
acceptedforuseinthehospital.
developabasicdruglistorformulary,whichrequire
constantreview.

5. Functions of PTC
recommended drugstobestockedinpatientunit.
plansuitableeducationalprogrammeformedicalstuffon
drug&theiruses.
recommend policiesregardsthesafeuseofdrugsin
hospital.
studyontheproblemsinvolveinproperdistribution&
labelingofdrugsforin&outpatient.
studyproblemsrelatedtothedrugadministration.
reviewreportedadversereactionofdrugs.
evaluatemedicalrecordsintermofdrugtherapy.

6. 6
Drugsafetyincludesresponsibilityfromdispensingof
drugstodrug-administrationandthentoobserve
possibleadverseeffects.PTCcanplayamajorrolein
ensuringthedrug-safety.
Followingguidelinesmaysubservethecommitteein
ascertainingtheadequatesafetyfactorofthehospital
pharmacy.
1.Appointaregisteredpharmacist
2.Notpermitnon-pharmacistperssonelfordispensing
3.Asufficientnumbersofqualifiedperssonelappoint
4.Adequatesafe,workspace,andstoragefacilities
5.Havenecessaryequipment

7. 7
6.Automaticstopfororder-narcotics,hypnotics,anti
coagulants
7.Firmpolicyforresearchdrugs
8.Shouldhaveacompletedrugformulary
9.Arrangeoutsideitsworkinghours(offhour
dispensing)
10.Segregatepoisonousmaterials-nonpoisionous
materials
11.Separateexternalusedrugs-internalusedrugs
12.Needqualitycontrolmeasures, GMP during
processing
13.Planforsuitableteachingprogramme
14.Designperiodicalinspection
15.Establishadequatereferencelibrary
Roleof PTC inDrug-Safety

8. 8
AnADRisdefinedasanyunusualofunexpected
harmfulreactionincludingacute poisoningsby
narcotics,barbiturates,andamphetaminesaswellas
industrialpoisonings.
PROFORMA FORMONITORING OFADR
1.Do not leave any item blank
2.Mark tick in the appropriate box
3.Type or write in BLOCK LETTERS
Roleof PTC inAdverseDrugMonitoring

9. AdverseDrugMonitoring Form Proforma
1)Centre Name: ___________________________________________
2) Type of patient: Inpatient (1)Outpatient (2)3)Serial No: ______
4) Name of the patient: _____________________________________
5) Address(complete): ______________________________________
6) Age: ______ Years 7) Sex: Male (1) Female (2)
8) Occupation: ________________________
9) Hospital Record No.: ________ 10) Registration Date: ________
11) Dietary Habit: Veg. (1)Non-veg. (2)
12) Smoking Habit: No(1) Yes (2); if yes, duration: _______ (yrs.)
13) Alcohol Habit: No(1) Yes (2); if yes, duration: _______ (yrs.)

10. AdverseDrugMonitoring Form Proforma
14) Relevant Medical History: If yes, details
Allergy No(1)Yes (2)
Environmental exposure No(1)Yes (2)
Occupational exposure No(1)Yes (2)
Previous drug reaction No(1)Yes (2)
Pregnancy 0/1/2/3 Trimester
Family history of ADR No(1)Yes (2)
15) Background sings symptoms: ______________________________
_________________________________________________________
_________________________________________________________
16) Provisional Diagnosis: ____________________________________
17) Treatment Schedule (including traditional medicine):

11. AdverseDrugMonitoring Form Proforma
17) Treatment Schedule (including traditional medicine):
Drug Name
Trade & Generic
Indication
(Diagnosis)
Total Daily
Dose
Route Duration
18) Date of End of Treatment: ______________________________
19)OutcomeofManagement:Recovered(1);StillunderR
x(2);
Died(3);Losttofollowup(4);ADRsuspected(5)
20)If ADR is suspected fill in the PROFORMA-II: No (1)Yes
(2)
Everycaseofadversedrugreactionmustbefirstreportedby
theattendingphysiciantothechairmanofthePTCwhointurn
periodicallyforwardessentialdatatothecentralcommitteeon
AdverseReactionsformedbythedrugcontrolauthorities.

12. 12
Roleof PTC in Developing Emergency
Drug Lists
Sincetimefactorisofverygreaturgencytomosttrue
emergencysituations,itisabsolutelynecessaryforthe
PTCofahospitaltogetpreparedboxescontaining
emergencydrugswhichshouldbealwaysavailable
readilyforuseatthebed-side.
Listofsuchdrugsandothersuppliesshouldbe
compliedbythecommittee,anditshouldfindtheir
placeinemergencykits.

13. 13
Roleof PTC in Drug Product Defect
Reporting Programme
Thedrugspurchasedbyhospitalmaybedefectivein
quality.Itisforthecommitteetogetinformation
aboutthedefectivedrugproductsandtoinformitfirst
tothemanufacturerforappropriateaction.
Ifsatisfactoryanswerisnotobtainedfromthe
manufacturerorsupplier,itshouldbereportedtothe
FoodandDrugControlAdministration.

14. Name of the Hospital: ____________________________________________
Address: ______________________________________________________
HOSPITAL PHARMACIST’S DRUG DEFECT REPORT
Reference No.: ______________ Date received: _______________
1. Trade Name: __________ Dosage form: _________ Strength: _______
2. Lot No: ___________________ Expiry Date: _______________
3. Date Purchased: ____________________
4.Name of the supplier: ___________________________________________
5. Name and address of the manufacturer: ___________________________
_____________________________________________________________
6. Reporting pharmacist’s name: ___________________________________
7. Defects noted or suspected:
Date:____________ Signature of the chairman of PTC: ________________

15. 15
Drug utilizationincludesprescribing,dispensing,
administeringandingestingofprescriptionofdrugs.
Hospitalpharmacistshouldtakemedicationhistorythat
shouldincludefollowinginformation.
1)Medicationbeingtakenatthetimeofadmission,
duringadmission,homeremedies(OTC)drugs.
2)Drug-allergiesandidiosyncrosytowardsfood
productsetc.
Roleof PTC in DrugUtilizationReview

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Name of the patient: _________________________________________
Address: __________________________________________________
Age: _______ Years Sex: _M / F_DOA: ____________________
Admission Diagnosis: ________________________________________
Other Pathology: ____________________________________________
Pre Operative Medications Used: _______________________________
Date Drugs DoseRouteStartedDiscontinuedRemarks

17. 1.Tohelpimproveddrugprescribingpracticesbypromotingthe
safeandrationaluseofthedrugs.
2.Todetectandhelppreventdrug-interactions.
3.Tohelpdetectandpreventadversedrugreactions.
4.TodetectandpreventsIVadditiveincompatibilities.
5.Todetectdrug-induceddiseases.
6.Todetectpossibledrug-induceddiseases.
7.Tohelpdetectandpotentialdrug-toxicities.
17
Roleof PTC in DrugUtilizationReview

18. 18

19. Hospital Formulary
Thehospitalformularyisacontinuallyrevisedcompilationof
pharmaceuticals,whichreflectsthecurrentclinicaljudgment
ofthemedicalstuff.
Guiding Principle of Hospital Formulary
medicalstuffshallappointPTC&outlineit’spurpose,
organization,function&scope.
medicalstuffbasedupontherecommendations ofPTCshall
sponsortheformulary.
medicalstuffshalladoptwrittenpolicies&producersgoverning
thehospitalformularysystemasdevelopbythePTC.
hospitalformularyshallnotcontainanypolicieswhichhamper
thephysician’sjudgment,evenwhenhe/sheprescribeadrugin
proprietaryname.Howevertheybeencouragedtodispensethe
druginnon-proprietaryname.

20. Hospital Formulary
medicalstuffshalladoptthepolicyof,andformulatethe
procedurefor,includingdrugsintheformularybytheirnon-
proprietaryname.
thepharmacistmustdispensethebrandprescribed,bearingin
mindhisprofessionalrighttogivewiththephysicianshould
theprescribedbrandbeunavailable,whenthewrittenpolicies
areabsence.
nursingpersonnelareinformedinwrittenabouttheexistence
offormularyinhospital.
theterms‘substitute’&‘substitution’shouldbeavoidinthe
formulary.
Guiding Principle of Hospital Formulary
(continue…….)

21. Guiding Principle of Hospital Formulary
(continue…….)
provisionshallbemadetoexplainthemedicalstuffof
changesintheworkingofthehospitalformularysystemorin
thecontentofthehospitalformulary.
medicalstuffshallmakeprovisionfortheevaluation&use:
a.ofdrug(s)notincludedinhospitalformulary
b.ofinvestigationaldrugs.
pharmacist,withtheadvice&guidanceofPTC,shall
responsibleforpreparethespecificationsofalldrugs,
chemicals,biologicals&pharmaceuticalsusedinthehospital.
labelingofthemedicationsshouldbeinnon-proprietary
name.
Hospital Formulary

22. Legal Basis of Hospital Formulary
Differentmethodsareusedtoimplementhospitalformulary,
whichinclude–
Onecommonmethodistheuseofsuitablewordedimprinton
theprescriptionform.eg.–“GenericEquivalentPermitted”or
“Dispensedinaccordwiththehospitalformularysystem”.In
somehospital,theconsentstatementisfollowedbyacheck
boxwitha‘yes’&‘no’,wherephysicianscangivetheir
opinion.
Secondmethodisobtainingaconsentformmedicalstuffs
duringappointmentasbylawortherules&regulationsofthe
institute.
Thirdmethodisobtainingpriorconsenttotheoperationofa
hospitalformularysystemistoexpressthepolicytemina
separatedocument&requestthatallphysicianssingit.
Thesecond&thirdmethodshavelongbeencriticizedonthe
basisoftheirapproach.Finallyfirstmethodisacceptbymostto
adoptthesysteminhospital.

23. Admission & Deletion of Drug(s) in
Hospital Formulary
Followingcriteriaareusedtoselectadrug(s)foradmission&
deletionfromformulary–
Firstcriteriaiswhetherornotthelocalgeneral&specialtystuff
considerthedrugtobeprovenclinicalvale.
SecondmaybethattheBP,USP,NFortheirsupplementsmust
recognizethedrug.
Thirdmaybethatthemanufacturerofthedrugmustbeofproven
integrity&dependabilityaswellashavingthereputationofinitiating
&supportingresearchactivitiesofmerit.
Fourthcriterionmaybethatnoprescriptionofsecretcomposition
willbeconsideredoradmittedtotheformulary.
Fifthcriterionmaydealwithproductsofmultiplecomposition.

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4
•Therapeutic
•Economic
•Educational
•Rational drug use
Advantages of Hospital Formulary
Disadvantages of Hospital Formulary
•Deprivethephysicianofhisrightandprivilegetoprescribe
andobtainthebrandofhischoice.
•Permitsthepharmacisttoactasthesolejudgeofwhichbrands
ofdrugsaretobepurchased&dispensed.

25. Primary objectives:
a)Information on drug
b)Information on hospital policies & procedures
c)Special information about drugs
In accordance with these objectives, the formulary should consist of
three main parts:
a)Information on hospital policies & procedures concerning drugs.
b)Drug products listing
c)Special information
Content and Organization of Hospital Formulary

26. •Drug use
•Description of PTC
•Hospital regulations about prescribing, dispensing & administration of
drug, rules for Medical Reps, emergency drug products,
•Pharmacy operating procedures
•Information on using formulary
Content and Organization of Hospital Formulary

27. Formulary item entries:
Alphabetically by generic name
Alphabetically within therapeutic class
Type of information:
Dosage form, strength, packaging Active ingredients
Adult/pediatric dose
Route of administration Cost
Indexes to the drug products listing:
Generic name/brand name
Therapeutic /pharmacological index
Content and Organization of Hospital Formulary

28. •Equivalent dosages of similardrugs
•Hospital approvedabbreviations
•Rules for calculating pediatricdosages
•List of sugarfree drugs
•List of dialyzablepoisons
•Metric conversiontables
•Poison controlinformation
•Table of druginteractions
Content and Organization of Hospital Formulary

29. 29
AJ
FORMULARY
•Listingofdrugsbytheir
genericnamesfollowedby
informationonstrength,form,
posology,toxicology,use&
recommendedquantitytobe
dispensed.
•Preparedlocallybyitsown
clinicalstaff.
•Informationprovidedissubject
tolocalneedsanddesires.
DRUG LIST (e.g. I.N.F)
•Genericnamesfollowedby
dataonstrength&form.
•Preparedbycountry’s
outstanding clinicians,
pharmacologists and
pharmacists.
•According to their
pharmacologicalproperties
Formulary Vs Drug List