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UNIT
1
PrinciplesofTherapeutics
1
IssuesforthePractitionerinDrugTherapy
VeronicaF.Wilbur
LearningObjective
Afterreadingthischapter,thereaderwillbeableto:
1.DescribetheapprovalprocessforprescribeddrugsintheUnitedStates.
2.Analyzethepractitioner’sroleandresponsibilitiesinprescribing.
3.Explaintheprocessforprescribing,whetherinwritingorthroughtheelectronichealthrecord.
INTRODUCTION
Drugtherapyisoftenthemainstayoftreatmentofacuteandchronicdiseases.Anessentialroleofhealth
carepractitionersistodevelopatreatmentplanwiththepatient,andanintegralpartofthetreatmentplan
ofillnessandhealthpromotionisdrugtherapy.AccordingtoCenterforDiseaseControlasreportedin
theHealth intheUnitedStates(2018), from2013 to2016, amongindividuals aged45 to64, 64%of
malesand73%offemalesusedthreeormoreprescriptiondrugsand13.3%usedfiveormoreduringthe
last30days.Additionally,accordingtotheNationalAmbulatoryMedicalSurvey(2016),therewere2.9
billion drugs (73.9%) prescribed during office visits, 365.8 million drugs (72.5%) prescribed during
visitstoahospitaloutpatientdepartment,and286.2milliondrugs(81.1%)prescribedduringvisitstoa
hospitalemergencydepartment(Rui&Kang,2017).InananalysisbytheAARPPublicPolicyInstitute,
therehasbeenaconsistentincreaseindrugpricesthatishigherthaninflationbetween2006and2017
(RxPrice Watch,2019). Even though the price of generic drugs has dropped, the amountspent out of
pocket annually for a chronic generic drug of a Medicare patient can equal $365 (Schondelmeyer &
Purvis, 2018). Therefore, prescribers must have a breadth of knowledge about the principles of
prescribing.
Indevelopingatreatmentplanthatincludesdrugtherapy,theprescribingpractitionerconsidersmany
issuesinachievingthegoalofsafe,appropriate,andeffectivetreatment.Amongthemaredrugsafetyand
productsafeguards,thepractitioner’s roleandresponsibilities, the step-by-stepprocessofprescribing
therapy and writing the prescription, and follow-up measures. Particularly noteworthy are promoting
adherencetothetherapeuticregimenandkeepinguptodatewiththelatestdevelopmentsindrugtherapy.
DRUGSAFETYANDMARKETSAFEGUARDS
DrugsafetyisensuredintheUnitedStatesprimarilybytheU.S.FoodandDrugAdministration(FDA),
whichisthefederalagencychargedwithconductingandmonitoringclinicaltrials,approvingnewdrugs
for market and manufacture, and ensuring safe drugs for public consumption. Although the federal
government supplies guidelines for a pure and safe drug product, guidelines for prescribers of drug
therapyaredictatedbothbystateandbyfederalgovernmentsandbylicensingbodiesineachstate.
ClinicalTrials
Various legislated mechanisms are in place to ensure pure and safe drug products. One of these
mechanismsistheclinicaltrialprocessbywhichtheFDAcarefullychecksnewdrugdevelopment.Every
newdrugmustsuccessfullypassthroughseveralstagesofdevelopment(seeFigure1.1).Thefirststageis
preclinicaltrials,whichinvolvetestinginanimalsandmonitoringefficacy, toxiceffects,anduntoward
reactions.AnapplicationtotheFDAforinvestigationaluseofadrugoccursafterthepreclinicaltrials
arecompleted.
FIGURE1–1Phasesofdrugdevelopment.
Clinicaltrials,whichbeginonlyaftertheFDAgrantsapprovalforinvestigation,consistoffourphases
and may last up to 9 years before the adoption of a drug for widespread use. During clinical trials,
performedon informed volunteers, dataare gathered aboutthe proposed drug’s purity, bioavailability,
potency,efficacy,safety,andtoxicity.
PhaseIofclinicaltrialsistheinitialevaluationofthedrug.Itinvolvessupervisedstudieson20to100
healthy people and focuses on absorption, distribution, metabolism (sometimes interchangeable with
biotransformation),andeliminationofthedrug.InphaseI,themosteffective administrationroutesand
dosagerangesaredetermined.DuringphaseII,uptoseveralhundredpatientswiththediseaseforwhich
thedrugisintendedaresubjects.ThetestingfocusisthesameasinphaseI,exceptthatdrugeffectsare
monitoredonpeoplewiththedisease.
PhaseIIIbeginsoncetheFDAdeterminesthatthedrugcausesnoapparentseriousadverseeffectsand
thatthedosagerangeis appropriate.Double-blindresearchmethodsareutilizedduringthis phase.The
investigators are blinded to who is receiving the study drug or placebo. Usually, several thousand
subjectsareinvolvedinthisphase,whichlastsseveralyears,andduringthistime,mostoftherisksfor
thedrugbecomeevident.After phaseIII,theFDAevaluates datapresentedandacceptsor rejects the
applicationforthenewdrug.Approvaloftheapplicationmeansthatthedrugcanbemarketed—butonly
bythecompanyseekingapproval.
Onceonthemarket,thedrugentersphaseIVorpostmarketingsurveillance.Objectivesatthisstageare
(1)tocomparethedrugwithothersonthemarket,(2)tomonitorforlong-termeffectivenessandimpact
onthequalityoflife,and(3) toanalyzecost-effectiveness(CenterWatch,2015).Duringpostmarketing
surveillance,drugscanbetakenoffthemarketorrestrictedifadditionalfindingsemergeofthedrugand
sideeffects.
FoodandDrugAdministrationFastTrack
Insomecases,itiscrucialtoincreasethespeedofapprovalfordrugsthattreatseriousdiseasesandmeet
anunmetmedicalneed.However,fastdoes notmeanthesacrificeofsafety. There arefourcategories
wherebypharmaceuticalcompaniescanrequestforreviewoftheirproducts.Thefirstcategoryiscalled
the fast track, where the company developing the drug gets more frequent communication and has a
rolling review. The second category is breakthrough therapy, where clinically significant surrogate
endpointsareusedtoshoweffectivenessagainstirreversiblemorbidityormortality.Thethirdcategoryis
accelerated approval, and the last category is a priority review. Accelerated approval is another
exampleofsurrogateclinical endpointsfor approval.Finally,priorityreview decreases theamountof
timeto6monthsfrom10months.
Inthecaseofapublichealthemergency,theFDAcanauthorizeadrugforuseunderanEmergencyUse
Authorization(EUA)(FDA,2020).Thisisdoneinthepublic’sbestinterest,butisinlightofthefactthat
theFDAdoesnothavealltheevidenceitwouldusuallyhavetoapproveadrug.TheEUAprocesswas
invoked to approve the drug remdesivir for the treatment of COVID-19, along with the approval of
severalvaccinesusedtocombattheCOVID-19epidemic.
PreventionofHarmandMisuse
ThepassageoftheFDA’sControlledSubstancesActof1970establishedthescheduleoftherankingof
drugsthathavethepotential forabuseormisuse.Thedrugsontheschedule are consideredcontrolled
substances.Thesedrugshavethepotentialtoinducedependencyandaddiction,eitherpsychologicallyor
physiologically.Box1.1definesthefivecategoriesofscheduleddrugs,withSchedule1drugshavingthe
mostsignificantpotentialforabuseandSchedule5drugstheleast.
ScheduleddrugscanbeprescribedonlybyapractitionerwhoisregisteredandapprovedbytheU.S.
DrugEnforcementAgency(DEA).Insomestates,practitionersmustpossessacontrolledsubstance(CS)
licenseaswell.TheDEAissuesapprovedapplicantsanumber,whichmustbewrittenontheprescription
for a CS for the prescription to be valid. The prescriber’s DEA number must also appear on a
prescriptionthatwasfilledinanotherstate.
TheincidenceofoverdoseemergenciesandabuseofscheduleddrugscontinuetoincreaseintheUnited
States.Whiletheoverallrateofoverdosedeathsdecreasedin2018to67,367,down4.1%fromits2017
figure, there is still significant mortality in the United States (Hedegaard et al., 2020). Currently, the
numberofprescriptionsforopioidpainmedicationsin2019is191millionandvariesfromstatetostate.
In the effort to promote safe prescribing practices, many states have enacted legislation requiring the
implementationofprescriptiondrugmonitoringprograms(PDMPs).Theseprogramshaveinterconnected
databases that collect a variety of information about the prescribing of substances from the DEA
schedules 2 to 4. According to the National Association of State Controlled Substance Authorities
(NASCSA),in2014,49of50stateshadaPDMP.TheprogramallowsprescribersofaCStolookup
patients for previousprescriptions of CSs, including the typeof medication, amount,andnameofthe
prescriber.Theinformationobtainedfromthisprogramhelps toreveal thosepatientswho“prescriber
shop”andarereceivingtoomanyCSs.However,theseprogramsare notwithoutcontroversy,duetoa
lack of consensus on the scope of PDMP outcomes on patient care. Despite these concerns, the
informationfrom the PDMPhelps tostart a conversationwith thepatients, exploringtheir healthcare
needswhenusingpotentiallyaddictivedrugs.
Box1.1 ScheduledDrugs
Schedule1drugshaveahighpotentialforabuse.Thereisnoroutinetherapeuticuseforthesedrugs,
andtheyarenotavailable for regular use. Theymaybe obtainedfor “investigational useonly” by
applyingtotheU.S.DEA.ExamplesincludeheroinandLSD(lysergicaciddiethylamide).
Schedule2drugshaveavalidmedicalusebutahighpotentialforabuse,bothpsychologicaland
physiologic. In an emergency, a Schedule 2 drug may be prescribed by telephone if a written
prescriptioncannotbeprovidedatthetime.However,awrittenprescriptionmustbeprovidedwithin
72hourswiththewordsauthorizationforemergencydispensingwrittenontheprescription.These
prescriptions cannot be refilled. A new prescription must be written each time. Examples include
certainamphetaminesandbarbiturates.
Schedule3drugshaveapotentialforabuse,butthepotentialislowerthanfordrugsonSchedule2.
Thesedrugscontainacombinationofcontrolledandnoncontrolledsubstances.Useofthesedrugscan
causea moderateto lowphysiologic dependence anda higherpsychological dependence.Averbal
order canbe givento thepharmacy,and the prescription canbe refilled up to five times within 6
months.Examplesincludecertainnarcotics(codeine)andnonbarbituratesedatives.
Schedule 4 drugs have a low potential for abuse.They cancausepsychologicaldependency but
limitedphysiologicdependency.Examplesincludenonnarcoticanalgesicsandantianxietyagents,such
aslorazepam(Ativan).
Schedule5drugshavetheleastpotentialforabuse.Theycontainamoderateamountofopioidsand
areusedmainlyasantitussivesandantidiarrheals.
NationalProviderIdentifier
TheAdministrativeSimplificationprovisionsoftheHealthInsurancePortabilityandAccountabilityAct
of 1996 (HIPAA) mandated the adoption of standard unique identifiers for health care providers and
health plans. This identification system improves the efficiency and effectiveness of electronically
transmittinghealthinformation.TheNationalProviderIdentifier(NPI)FinalRule,publishedonJanuary
23,2004, throughtheCenters forMedicare &MedicaidServices (CMS)developedtheNationalPlan
andProviderEnumerationSystem (NPPES)toassigneachprovider auniqueNPI.Coveredhealthcare
providers andall healthplans andhealthcare clearinghouses must useNPIsinthe administrative and
financial transactions adopted under HIPAA. The NPI is a 10-position, intelligence-free numeric
identifier (10-digitnumber). TheNPIdoesnotcarryother information about thehealthcare provider,
suchasthehealthcareprovider’sspecialtyorinwhichstatetheproviderpractices.Coveredproviders
mustalsosharetheirNPIwithotherproviders,healthplans,clearinghouses,andanyentitythatmayneed
itforbillingpurposes.
The purpose of the NPI is to identify all health care providers by a unique number in standard
transactions such as health care claims. NPIs may also be used to identify health care providers on
prescriptions,ininternalfilestolinkproprietaryprovideridentificationnumbersandotherinformation,
in the coordination of benefits between health plans, in inpatient medical record systems, in program
integrityfiles,andindifferentways.TheNPIistheonlyhealthcareprovideridentifierthatcanbeusedin
standardtransactionsbycoveredentities.
PrescriptionversusNonprescriptionDrugs
Many drugs are now available that could previously be obtained only with a prescription and at the
prescriptiondosage.Althoughthesedrugsareaccessibleoverthecounter(OTC)withoutaprescription,
theFDAstillapprovesdrugswithspecificindications,doses,cautions,andboxedwarnings.Eventhough
thesemedicationsarewithineasyreach,manyhavethepotentialforinteractingadverselywithprescribed
drugsorcomplicatingtheexistingdisease.Theself-prescribeduseofOTCdrugsmaydelaythediagnosis
andtreatmentofpotentiallyseriousproblems.Additionally,individualsdonotconsidertheseagentstobe
drugs and often overuse or misuse the medication. On the other hand, the use of OTC drugs can be
beneficialforthetreatmentofself-limitingdisordersthatarenotserious.
GenericDrugsversusBrandNameDrugs
Substitutingagenericdrugforabrandnamedrugisacommonpractice,andinmanystates,itisrequired.
Whenthepatentonabrandnamedrugexpires,otherdrugmanufacturerscanthenproducethesamedrug
formulaunderitsgenericname(thegenericname andformulaofa drugare alwaysthesame;onlythe
brandnameschange).Duetotherisingpricesofbrandnamedrugs,usinggenericdrugscanyieldsavings
fortheconsumeronthecosts ofmedication.Onaverage,over 2016 through2017, the costofgeneric
medicinesdroppedby9.3%incomparisontotheinflationrateof2.1%(Schondelmeyer&Purvis,2018).
Toensuresafety,theFDA mustapprove genericdrugs,andrigoroustestingisagainrequired toensure
that all medicines meet specifications for quality, purity, strength, and potency. Generic drugs must
demonstratetherapeuticequivalencetothebrandnameequivalentmatchingthesamestrictstandardsofa
brandeddrug. Theprocessincludesadministeringthegenericmedicationinasingledosetoatleast18
healthyhumansubjects.Next,peakserumconcentrationandtheareaundertheplasmaconcentrationcurve
(AUC)aremeasured. The values obtainedfor thegenericdrugmustbe within80%to 125% of those
measuredforthebrandnamedrug.MostgenericdrugshaveameanAUCwithin3%ofthebrandname
drug.Therehasbeennoreportedtherapeuticdifferenceofaseriousnaturebetweenbrandnameproducts
and FDA-approved generic products. For more information, see Table 1.1, which presents FDA
equivalencyratingsforbrandnameandgenericdrugs.
TABLE1.1
FoodandDruqAdministrationTherapeuticEquivalenceRatings
Rating Definition
Scale
A TherapeuticallyEquivalent
AA Productsinconventionaldosageformsnotpresentingbioequivalenceproblems
AB Productsmeetingnecessarybioequivalencerequirements
AN Solutionsandpowdersforaerosolization
AO Injectableoilsolutions
AP Injectableaqueoussolutionsand,incertaininstances,intravenousnonaqueoussolutions
AT Topicalproducts
B NotTherapeuticallyEquivalent
BB DrugproductsrequiringfurtherFDAinvestigationandreviewtodeterminetherapeuticequivalence
BC Extended-releasedosageforms(capsules,injectables,andtablets)
BD Activeingredientsanddosageformswithdocumentedbioequivalenceproblems
BE Delayed-releaseoraldosageforms
BN Productsinaerosol–nebulizerdrugdeliverysystems
BP Activeingredientsanddosageformswithpotentialbioequivalenceproblems
BR Suppositoriesorenemasthatdeliverdrugsforsystemicabsorption
BS Productshavingdrugstandarddeficiencies
BT Topicalproductswithbioequivalenceissues
BX Drugproductsforwhichthedataareinsufficienttodeterminetherapeuticequivalence
AB Productsforwhichpotentialequivalenceproblemshavebeenresolvedwithadequateinvivoorinvitro
evidencesupportingbioequivalence
FDA,FoodandDrugAdministration.
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of
PharmaceuticalScience,OfficeofGenericDrugs.(2010).Approveddrugproductswiththerapeuticequivalenceevaluation(30thed.).
ComplementaryandAlternativeMedicine
IntheUnitedStates,theuseofherbalpreparationsastreatmentsfordiseaseanddiseasepreventionhas
increasedtremendously.AccordingtotheNationalCenterforComplementaryandIntegrativeHealth,the
mostrecentsurveyaboutalternativemedicines,in2012,foundthatapproximately33%ofadultsand11%
ofchildrenusesomeformofcomplementarymedicationintheirhealthcare.Thefindingsmirrorresults
ofsimilarsurveysfrom2007.Themostpopularproductsforadults(7.8%)andchildren(1.1%)arefish
oils or Omega-3 fatty acids. These are followed byglucosamine with or without chondroitin (2.6%),
probiotics/prebiotics(1.6%)andmelatonin(1.3%)foradults,andmelatonin(0.7%)forchildren(Clarke
etal.,2015).
Historically, herbswerethefirsthealingsystemused.Herbal medicinesarederived fromplantsand
thoughtbymanytobeharmlessbecausetheyareproductsofnature.Someprescriptiondrugsincurrent
use, however, such as digitalis, are also “natural,”whichis not synonymouswith“harmless.” Before
1962,herbalpreparationsweredrugs,butnowtheyaresoldasfoodsorsupplementsandthereforedonot
require FDA approval as drugs. Hence, there are no legislated standards on the purityor quantityof
activeingredientsinherbalpreparations.Measurementofthevalueofherbaltherapyreliesonanecdotal
reports and is notverified byresearch.Like synthetic products,herbalpreparationsmayinteract with
otherdrugsandmayproduceundesirablesideeffectsaswell.
The Dietary Supplement Health and Education Act (1994) passed by the 103rd Congress, specific
labeling is required abouttheeffectofherbal productsonthebodyandrequires the statementthatthe
herbal product has not been reviewed by the FDA and is not intended to be used as a drug.
Complementaryandalternativemedicine(CAM)isdiscussedinwithineachchapter.
ForeignMedications
In today’s global society, practitioners will experience encounters with patients from many countries.
Theseindividualsmayrequestrefillsofdrugsfortreatingtheirchronicconditions.Thesedrugsmayhave
unrecognizable names, different dosages/dosage forms, or different active ingredients. Additionally,
patientsmaygettheirdrugsfromonlinepharmaciesinothercountriesbecausetheyare lessexpensive.
AccordingtotheNationalAssociationofBoardsofPharmacy(2019),thereareover35,000activeonline
pharmacies,and96%violateapplicableU.S.laws.AccordingtotheWorldHealthOrganization,thereis
a global problem with substandard and falsified medical products (2018). The U.S. FDA has many
resources for the practitioner to guide patients toward sound decision-makingabout prescription drug
acquisition.
DisposalofMedications
Manymedicationscanbepotentiallyharmfuliftakenbysomeoneotherthanthepersonforwhomtheyare
prescribed. Improperlydisposed drugscanleak into the environment,andthebest disposal method is
throughcommunitydrugtakebackprograms.Almostallmedicinescanbesafelydisposedofiftheyare
mixed with an undesirable substance, such as cat litter or coffee grounds, and placed in a closed
container.Any personalinformationshould be removed fromthecontainerbyusinga blackmarker or
ducttape.Manycommunitieshavea drugtake-backprogramfordisposal,or drugscanbedisposedof
whenthecommunitycollectshazardousmaterial.Drugsshouldnotbe flusheddownthetoiletordrain
unlessthedispensingdirectionssaythisisallowed.
THEPRACTITIONER’SROLEANDRESPONSIBILITIESINPRESCRIBING
Beforeprescribingtherapy,thepractitionerhasaresponsibilitytogatherdatabytakingathoroughhistory
andperformingaphysicalexamination.Oncethedataarecollectedandevaluated,oneormorediagnoses
areformulatedandatreatmentplanestablished.Asnoted,themostoften-usedtreatmentmodalityisdrug
therapy,usuallywithaprescriptionorOTCdrug.
If a drug is deemed necessary for therapy, the practitioner needs to understand the responsibility
involved in prescribing. The decision-making process includes the class of medication that is most
appropriatefor the patient. The decision is reached based ona thoroughknowledge of diagnosis and
treatment.
DrugSelection
Manyresponsibilitiesareinherentinprescribingmedication.Whiledeterminingthebesttherapyforthe
patient,thepractitionerconductsarisk–benefitanalysis,evaluatingthetherapeuticvalueversustherisk
associated with each drug to be prescribed. The practitioner then selects from a vast number of
pharmacologicagentsusedfortreatingthespecificmedicalproblem.Factorstoconsiderwhenchoosing
thedrugordrugsarethesubtleorsignificantdifferencesinaction,sideeffects,interactions,convenience,
storageneeds,routeofadministration,efficacy,andcost.Anotherfactorinthedecisionmayinvolvethe
patientpressuringthepractitionertoprescribemedicationbecausethatistheexpectationofmanypatients
atthebeginningofahealthcareencounter.
Initialquestionstoaskwhenselectingdrugtherapyinclude“Isthereaneedforthisdrugintreatingthe
presentingproblem ordisease?”and“Isthisthebestdrugforthepresentingproblemordisease?”See
additionalquestionslistedinBox1.2.
ConcernsRelatedtoEthicsandPractice
Specificethicalandpracticalissuesmustbeconsideredaswell.Oneoverridingquestionmaybethelack
ofa clinicalindicationforusingmedication.As mentioned,manypatients visita practitionerwiththe
sole purpose ofobtaininga prescription.Inseekingmedical attention,theill patientexpectsthehealth
careprovidertopromoterelieffromsymptoms.Intoday’sworld,anabundanceofinformationavailable
inbooks,magazines,television,Websites,andothermediasuggeststhatthehealthcareprovidercando
thisbyprescribingthatmedication.Thisexpectationthatamagicpillorpotion—theprescription—isthe
ticketthatwillrelievereflux,killgerms,endpain,andrestorehealthputspressureonthepractitionerto
prescribeforthesakeofprescribing.Atypicalexampleofthisinvolvesthepatientwithacoldwhoseeks
anantibiotic,suchaspenicillin.Insuchasituation,thepractitionerhasaresponsibilitytoprescribeonly
medicationsthatarenecessaryforthewell-beingofthepatientandthatwillbeeffectiveintreatingthe
problem.Intheexampleofthepatientwithanuncomplicatedheadcoldthatisviral,anantibioticwould
notbeuseful,andtheresponsiblepractitionermustbepreparedtomakeanethicalandprudentdecision
nottoprescribeanantibioticandexplainittothepatient.
Box1.2 QuestionstoAddressWhenPrescribingaMedication
•Isthereaneedforthedrugintreatingthepresentingproblem?
•Isthisthebestdrugforthepresentingproblem?
•Arethereanycontraindicationstothisdrugwiththispatient?
•Isthedosagecorrect?Orisittoohighortoolow?
•Doesthepatienthaveallergiesorsensitivitiestothedrug?
• What drug treatment modalities does the patient currently use, and will the potential new drug
interactwiththepatient’sotherdrugsortreatments?
•Isthereaproblemwithstorageofthedrug?
•Doesthedosageregimen(schedule)interferewiththepatient’slifestyle?Forexample,ifachildis
inschool,adrugwithaonce-ortwice-dailydosingscheduleismorerealisticthanonewithafourtimes-dailyschedule.
•Istherouteofadministrationthemostappropriateone?
•Istheproposeddurationoftreatmenttooshortortoolong?
•Canthepatienttaketheprescribeddrug?
•Hasthepatientbeeninformedofpossiblesideeffectsandwhattodoiftheyoccur?
•Isthereageneticcomponenttoconsider?
•Whatisthecostofthedrug?
•What,ifany,prescriptionplandoesthepatienthave?
PatientEducation
Anintegralpartofthepractitioner’sroleandresponsibilityiseducatingthepatientaboutdrugtherapy
andtheintendedtherapeuticeffect,potentialsideeffects,andstrategiesfordealingwithpossibleadverse
drugreactions.Theseexplanationsincludeanyblackboxwarningsthatinvolvethespecificdrugs.FDA
black box warnings take their name from the black border around the warning information. These
warningsnotifythepublicofserious,permanent,orfatalsideeffects.Anyinstructionsaboutthedrug(s)
maybeexplainedverbally,withwritteninstructionsgivenwhenappropriate.Instructionsthatareprinted
andhandedtothepatientmustbereadable,inalanguagethatthepatientcanunderstand,andintheproper
healthliteracy. Ifsideeffectsare discussed inadvance,thepatientwillknowwhattoexpectandwill
contacttheprescriber withsymptoms.Whenpatientsarewellinformed, theymaybelesslikelytostop
thedrugbeforediscussingitwiththeprescriber.
Medicationscanalsohaveaplaceboeffect.Patientsmustbelievethatthedrugwillworkforthemto
becommittedtotaking itasrecommended.Withoutabeliefthemedicationworks,thedrugmaynotbe
perceivedaseffectiveandmaynotbetakenasdirected.
The practitioner may want to recommend that the patient use only one pharmacy when filling
prescriptions.Thechoiceofonlyonepharmacyhasseveraladvantages,whichincludekeepingarecord
of all medications that the patient currently receives and serving as a double-check for drug–drug
interactions.
PrescriptiveAuthority
The prescribing practices of each practitioner are regulated by the state in which the practitioner
practices.Eachstatedeterminespracticeparametersbystatutes(lawsenactedbythelegislature),rules,
and regulations (administrative policies determined by regulatory agencies). Each practitioner is
responsibleforknowingthelawsandregulationsinthestateofpractice.
Dependingonthestate,theStateBoard ofNursingcanregulateprescriptive authority, sometimesin
conjunctionwiththeBoardofMedicineorBoardofPharmacy,dependingonthestate.Statesvaryinthe
level of practice authority for prescribers, allowing full practice authority, collaborative practice,
supervised practice, or delegated practice. Full practice authority has no requirements for mandatory
physician collaboration or supervision. Collaborative practice requires a formal agreement with a
collaboratingphysician,ensuringa referral–consultantrelationship.Supervised practice isoverseenor
directed bya supervisoryphysician.Delegatedpractice meansthatprescriptionwritingisa delegated
medicalact.TheDivisionofProfessionalRegulationforprescribersineachstateholdstheregulations.
DrugSampling
Relatedtoprescriptiveauthorityissuesistheissueofdrugsamples.Mostdrugcompaniesengageinthe
promotional practice ofdistributingsample drugstopractitionersforusebypatients.ThePrescription
Drug Marketing Act (PDMA), which was enacted in 1988 to protect the American consumer from
ineffective drugs, also affects the receipt and dispensing of sample drugs. Prescription drugs can be
distributedonlytolicensedpractitioners(oneauthorizedbythestatetoprescribedrugs)andhealthcare
entitypharmacies attherequestofalicensedpractitioner.Thereare penaltiesforviolationsoftheact.
Thisactaffectsthedistributionanduseofpharmaceuticalsamples.
TheprovisionsofthePDMAprotectsthepublicinseveralways:
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