Chapter 4: Medication Management
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Terms Terms and Defnitions: Defnitions: •
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Closed ormulary – list o medications which limits access o a practitioner to some medications, limit drugs to specifc physicians Drug ormulary – ormulary is a continually updated list o medications Drug monograph – written, unbiased evaluation o specifc medication Drug therapy guidelines – document describing the indications, dosage regimens or used o a specifc medication or medication clas Drug use evaluation D!"# – process used to assess the appropriateness o a drug therapy by engaging in evaluation o data Diagnosis – related D!" drug use evaluation completed on patients with specifc disease state or diagnosis $rescriber%related D!" drug use evaluation completed on patients managed by specifc physician drug Drug%specifc D!" use evaluation completed on a drug &'C!(%$D() – perormance perormance improvement model used by hospitals and health systems* +ncludes measuring the output o the process and modiying the process to improve the outcome
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&ormulary restriction – act o limiting the use o specifc ormulary medications to specifc physicians based on areas o epertise &ormulary system – ongoing process whereby a health care organi-ation, establishes policies on the use o products and therapies* .ealth%system board – committee o hospital and community members chosen to govern the a/airs o hospitals Medical eecutive committee – committee o hospital medical sta/ that has the primary authority or act related to sel governance Medication use review – perormance improvement method that ocus on evaluating and improving medication use process 0onormulary agent – medication that is no part o the drug ormulary 'pen ormulary – list o medications which has no limitations to access to a medication by a practitioner 'rder entry rules – logic established within the hospital ino system 'utcome assessment – systematic process o evaluating the appropriateness, appropriateness, saety, abd e1cacy o medication $op%ups – ino that appears on computer monitor when specifc actions are ta2en
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(top orders – physician orders that are automiatically terminated $3T committee – establish stop orders Therapeutic class review – evaluation o group medications with an established therapeutic class Therapeutic euivalent – drug products with di/erent chemical structures but same pharmacological or therapeutic class Therapeutic interchange – authori-ed echange o therapeutic alternatives in accordance with previously established
INTRODUCTION •
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Medication use management – process used to assure the sae and e/ective use o drugs in a cost conscious manner &ormulary system – 2ey to medication management in the health system environment
inormation, representing the clinical o pharmscists &ormularies – undamental to the ormulary system 'ngoing process which evaluates medication on ongoing basis Managed by P&T committee
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$rimary advantage: %
$rovides a systematic method to review scientifc evidence
Disadvantage: %
;educe the uality o care by limiting access to clinically indicated medications
PHARMACY AND THERAPEUTICS COMMITTEE %
'versight or medication management in the health system
Organization •
FORMULARY SYSTEM % %
5ist o medications routinely stoc2ed by health care system Developed in 6789, initially used to assure that physicians had adeuate and consistent supply o medications or their day to day needs*
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Discourage the use o marginally e/ective drugs Continually updated list o medications and related
Committee – policy recommending body to medical sta/ thru medica e!ec"ti#e committee group o hospital medical sta/ in charge o institutional governance and perormance* .ealth system board – non medical sta/ advisory committee o hospital and community members
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Meetings – 4%< times <9%79 mins# (ubcommittees:
Medication saety tas2 orce – charged with review o adverse drug events and medication errors
Drug review panels – ocused on particular specialty such as cardiology and inectious disease Medication use review tas2 – monitor one or moe medicatioin use review, evaluate the data and development plans to optimi-e specifc drug use
Committee Mem$er%i' %
+nclude pharmacists, nurses, physicians, administrators, ris2 or uality improvement managers Medication management – multidisciplinary process, include nonphysician members
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Medication selection critera:
Medication Use Evaluation (MUE) %
Methods or evaluating and improving the medication use processes with the goal o optimal patient outcomes
ey to the process:
Re%'on%i$iitie% % % % % % % %
"stablish the ormulary system (elects medications or ormulary inclusion "valuates medication use $revents adverse drug reactions "valuates drug therapy guidelines Develops policies or handling medications "ducates health proessionals to optimal use o medications
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Develops a list o medications or use in organi-ation Develop guidelines or optimal use o medications ;eview the medication list
Medication Selection and Review % %
"stablished methods or medications selection and review =ritten medication review is prepared rom available literature
Data to review )ction plan development &ollow up
Medication Safety Evaluation %
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Formulary system maintenance %
+s it a duplication o eisting ormulary agent> .ow should it be used> =hen + should it be used> =ho should use it> )re there any special concerns>
"valuated thru adverse drug reaction reports and medication error reports maybe local or global# Considered relative to the health system population, resources and alternatives !sed in considering whether a drug should be added to the ormulary, retained to ormulary, deleted rom ormulary
Drug Therapy uidelines %
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5isting o the indications, dosage regimens, duration o therapy, models o administration etc* Developed with oversight o practitioners with epertise on the use o specifc medication or management o a disease state*
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$ut into practice via pre%printed physician order sheet ;esult o a medication use review or medication saety evaluation
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!olicy and !rocedure Development $3T committee – responsible or medication use in the hospital Development o guidelines, responsible or the medication administration process Defne the ormulary managememt process
Commission on )ccreditation o ;ehabilitation &acilities C);&# These standards are dynamic and reuire vigilance by the pharmacy to assure compliance
PHARMACIST ROLE
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Education 0ewsletter – employed to communicate these decisions +nclude clinical inormation on drugs added to the ormulary, drug therapy , guidelines developed and medication saety ino 5imited to ?%4 pages
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RE(ULATORY AND ACCREDITIN( )ODIES %
;euire a $3T committee and defne its membership and responsibilities*
;egulatory bodies reuiring:
(tate Department o .ealth or @oard o $harmacy
)ccrediting bodies reuiring this activity:
The Aoint Commission )merican 'steopathic )ssociation )')#
$harmacists will guide the $3T committee act to assure optimal medication management "stablish $3T committee meeting agenda )naly-e and disseminate scientifc Conduct drug use evaluation and analy-e data ;ecord and archive $3T committee actions &ollow up with research Communicate $3T committee decisions
FORMULARY MANA(EMENT &ormulary – oundation o the ormulary system 5ist o medications available or use at hospital or health system +ncludes dosage orms, strengths and pac2ages si-es $atient care considerations – include medication e1cacy and saety &inancial considerations – cost o the drug and cost associated with stoc2ing 'pen ormularies – no limitation to access to a medication, generally large Closed ormulary – limited list o medications, limit to drugs to specifc physicians, patient care areas or disease states via *orm"ar+ re%triction%
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&ormulary restrictions – limitation o an antibiotic to restricted status +nstitute o Medicine +'M# evaluated the Beterans )dministration B)# 0ational &ormulary &ood and Drug )dministration &D)# – defnes the euivalence o individual chemical entities or generic euivalents )pproved Drug $roducts with Therapeutic "uivalence "valuation 2nown as Orange )oo, Therapeutic euivalents – drug products with di/erent chemical structure but are o the same pharmacologic or therapeutic class and have similar therapeutic e/ects and adverse Cephalosporins and histamine ? bloc2ers# Therapeutic interchange – authori-ed echange o therapeutic alternatives in accordance with established and approved written guidelines
relative saety and e1cacy o agents available or use in the health system $rocesses used in ormulary maintenance:
Ne- Prod"ct E#a"ation
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$3T guidelines: •
$harmacist – responsible or selecting generically euivalent products $rescribers – speciy a specifc brand $3T committee – determines therapeutic euivalents
$harmacist – responsible or the uality, uantity and source o all medications •
&ormulary maintenance – ongoing process o assuring
0ew product evaluation Therapeutic class review &ormulary changes 0onormulary drug use review
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eneric name – list o1cially approved name o all chemical entities in the drug product Trade name – list common trade names o drug product Therapeutic or pharmacologic class – state the pharmaceutical or therapeutic class to which the agent belongs $harmacology – describe the mechanism o action and related pharmacologic e/ects o drug $harmaco2inetics – describe how the drug is handled by the body +ndications or use – state the indications approved or use by the &D) Clinical studies – describe clinical study data supporting the indications or use )dverse e/ects warning – adverse e/ects associated with drug and reuency o occurrence Drug interactions – list drug – drug and drug%ood interactions associated with this agent
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Dosage range – list o dosage range or a di/erent routes o administration and indication or the drug Dosage orm and cost – list the dosage orm and strengths proposed or a ormulary addition (ummary – summari-e the ino provided in a single paragraph ;ecommendation – state the recommendation and rationale or the recommendation ;eerences – list o reerences used
(ources: )merican .ospital &ormulary (ervice Drug +normation and Drug &acts and Comparisons
THERAPEUTIC CLASS RE.IE/ %
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(hould not be so broad or all inclusive so as to not be meaningul Might include new medical ino, adverse event profles, purchase or use data and cost
FORMULARY CHAN(ES % %
Method or ma2ing additions and deletions to the ormulary May be written and verbal
;euirement:
)gent to be considered or addition or deletion ;ationale or reuest )lternative agents current in ormulary
NONFORMULARY DRU( RE.IE/
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$revent the erosion o the ormulary system by overuse o nonormulary agents $rocess should include a policy or the use o nonormulary drugs**
DRU( USE E.ALUATION D!" – systematic process used to assess the appropriateness o drug therapy by engaging in the evaluation o data Medication !se "valuation M!"# – encompasses the goals and obEectives o D!" "mphasi-es the need or a more multiaceted approach to improving medication use "stablished in 67F9 $rovide ongoing structurd, organi-ed approach to ensure that drugs are use appropriately 'utcome assessment – used to describe such programs
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&'C!(%$DC) & – &ind process to improve '% 'rgani-e a team that 2nows the process C% clariy current 2nowledge o process ! – understand causes o process variation (% select process improvement $lan Do Chec2 )ct Thrombolytic – high cost, high ris2 )ntibiotics – high use Diagnosis%related D!" – identiy indications or which select
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drugs may be appropriate or a given disease state $rescriber% related D!" – identiy specifc physicians whom the $3T committee has determined may use certain drugs Drug% specifc D!" – ocus on specifc aspects o a select drug such as dose or dosing reuency
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MEDICATION USE POLICIES %
Critical in the management o medications in the health care settings
$olicies:
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&ormulary managements $3T committee Medication prescribing, dispensing, administration
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Form"ar+ Management &ormulary policies – include ino on who may use a specifc agent, how drug is added an deleted &ormulary restriction policy – defne how items are selected or ormulary restriction Describe the method or a drug addition and deletion as well as nonormulary drug use*
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PHARMACY AND THERAPEUTICS COMMITTEE Medication Pre%cri$ing0 Di%'en%ing0 and Admini%tration •
=riting medication orders or prescriptions – defnes practitioners that may write
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medication orders in concert with state and ederal regulations Berbal orders – defnes who accept a verbal order and the transcription process o such an order (top orders – defnes the orders that are automatically terminated, how the prescriber is notifed, i appropriate, and the method or their reinstatement +nvestigational drug orders – defnes how investigational drugs are managed in the health care system Controlled substances – defne the Gow o controlled substances thru the health care system eneric and therapeutic substitution – defnes how a drug is selected or generic substitution and therapeutic euivalents approved by the $3T committee* (el%administration o medications – defnes the conditions and process or the administration o medication by the patient in the hospital setting Medication samples – defnes the conditions and process or use o medication samples in hospital &loor stoc2 – defnes criteria or selecting agents or Goor stoc2, process or modiying the stoc2 Defnition o order interpretation – defnes meaning o specifc types o orders including sliding scale orders
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Medication administration times – defne specifc medication administration times and rules or interpretation )dverse drug reactions – defnes an adverse, the reporting process, monitoring methods "thers – include pharmaceutical representatives
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Medication U%e Poic+ and Proced"re% %
PU)LISHED FORMULARY %
$rovide inormation on the medications approved or use
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5ist o medications approved or use, entries or each medications and indees to acilitate use
+nclusion o inormation on prescribing, dispensing, administration o medications in published ormulary
Medication U%e ("ideine% %
Medication Li%t ey element:
+nde – assist the user in locating the medication entry by generic name, both generic and trade name entries
Detail guidelines or medication use, which are approved or endorsed by $3T committee*
P"$i%ing te Form"ar+ %
Must be published regularly*
