University of Southern California School of Pharmacy Medication
Contents
1. arervention Codes see table below Intervention Description of event ei ut wets Accepted Resolved ity ii or iii Drug s involved Indication p MUST complete for Severity ii or iii pADEs amp all ADEs optional optional s Problem Recommendation Outcome MRP For pADE ADE For Intervention if 5 17 gt if A D gt pADE Recommend A E B F C G D H O ves O Modified Yes ONo Glyburide In the example a total daily dose of glyburide at 40 mg day is excessive for treatment goals dose interval or duration which is category number 5 a 14 Abnormal lab result not addressed E i Appropriateness and Effectiveness 15 Pharmacy dispensing error Potential Adverse Drug Event pADE i Potential for minimal would 101 DC drug s 1 Untreated medical problem 16 Medication overuse or misuse A No med error event but potential for require patient self 102 Substitute drug s 2 Drug dosing not adequate for treatment 17 Dose discrepancy between patient use amp ADE identified management or no harm 103 Add drug s goals dose interval or duration prescribed therapy B Med error event DID NOT reach patient ii Potential for moderate harm 104 Change dose dose interval 3 Treatment not optimal based on current 18 Using expired medication s C Med error event reached patient but no would require healthcare 105 Change duration of tx2. MEDICATION ERROR A preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of a health care professional patient or consumer POTENTIAL ADVERSE DRUG EVENT pADE Medication errors that are stopped before harm can occur i e near misses ADVERSE DRUG REACTION ADR Harm directly caused by a drug at normal doses during normal use aka Side Effects http www nccmerp org aboutMedErors http www pbm va gov vamedsafe Adverse 20Drug 20Reaction pdf Nebecker et al Ann Intern Med 2004 140 795 801 This manual describes how to complete the USC Medication Therapy Intervention amp Safety Documentation Form and includes descriptions and examples of all categories A database version of the form is available free of charge for FileMaker Pro users but can easily be adapted for any commercial database or spreadsheet program 1 4 6 2012 Steven Chen PharmD Sun Han PharmD USC School of Pharmacy How to Use the Pharmacist Intervention and Medication Safety Documentation Form The form provided is designed to document interventions for a single patient per page 3 rows are provided to document up to 3 different interventions If there are more than 3 interventions for a given patient additional forms should be completed An alternative form was previously developed that supported documentation for multiple patients per pa
3. qty evidence guidelines Nonadherence and Patient Variables harm professional intervention or 106 Change PRN to schedule 4 Monitoring standards not being followed 19 Medication underuse poor adherence D Med error event reached patient hospitalization to resolve 107 Change schedule to PRN or P AD 20 Dosage form is not reasonable for patient monitoring or intervention required to iii Potential for severe harm 108 Order lab dx tic test 5 Drug dosing excessive for treatment goals 2 ient self management of confirm no harm permanent disability or 109 Educate patient her non drug variables Adverse Drug Event ADE death 110 Refer to other service 22 Patient dissatisfied or refuses treatment no E Event occurred resulting in temporary 111 Clarity Rx 7 No indication for medication prescribed rational reason given harm and requiring intervention 112 Substitute dosage form 8 Polypharmacy Rx not needed duplication Miscellaneous P F Event occurred resulting in temporary 113 Make appt w provider 9 Contraindication 3 Drug not available in prescribed strength harm and requiring hospitalization 114 Provide Rx compliance box 10 Adverse drug reaction ADR 24 Inadequate refills between scheduled visits G Event occurred resulted in permanent 115 Other 11 Allergy 25 Nonformulary not cost effective drug choice harm disabilit 12 Drug interaction 26 Illegible prescription H Event occurred life threatening 13 Lab diagno
4. Refer to other service 22 Patient dissatisfied or refuses treatment no E Event occurred resulting in temporary 111 Clarity Rx rational reason given harm and requiring intervention 112 Substitute dosage form moaplgaeaags r A F Event occurred resulting in temporary 113 Make appt w provider 9 Contraindication 23 Drug not available in prescribed strength harm and requiring hospitalization 114 Provide Rx compliance box 10 Adverse drug reaction ADR 24 Inadequate refills between scheduled visits Event occurred resulted in permanent 115 Other 11 Allergy 25 Nonformulary not cost effective drug choice harm disabili 12 Drug interaction 26 Illegible prescription Event occurred life threatening 13 Lab diagnostic test indicated not ordered pe anidan appointment with PCP Event occurred resulted in death 5 y Safety pADE ADE 5 Drug dosing excessive for treatment goals dose interval or duration 6 Incomplete improper directions 7 No indication for medication prescribed 8 Polypharmacy Rx not needed duplication In the current example assume that the dosage for glyburide was reduced to 10mg BID The appropriate selection would be 104 Change dose dose interval 5 4 6 2012 Steven Chen PharmD Sun Han PharmD USC School of Pharmacy Description of event This last section must be completed if the intervention is an ADE i e A B C or D in Column Il or a Severity Rating ii or iii
5. loss smoking cessation to help reach treatment goals Examples 10 4 6 2012 Steven Chen PharmD Sun Han PharmD USC School of Pharmacy 22 e Diabetes patient continues to consume large amounts of foods with high sugar and carbohydrate content e Heart failure patient consuming excessive amounts of salt and fluids leading to frequent exacerbations Patient dissatisfied or refuses treatment no rational reason given Patient refuses treatment or states that he she cannot and will not take a prescribed medication no explanation or rational reason given Examples e Refusal to start insulin therapy due to false beliefs about associated negative consequences e g will result in blindness dialysis despite A1c of 12 MISCELLANEOUS 11 23 24 25 26 27 28 Drug not available in prescribed strength Medication prescribed is not commercially available in strength requested Examples e Mevacor 80mg lovastatin does not come in 80mg e Toprol XL 150mg Toprol XL does not come in 150mg Inadequate refills between scheduled visits Number of refills of medication are inadequate to last until next scheduled visit Examples e Asthma patient receives Advair 250 50 with no refills next appointment with PCP is 45 days later e Patient receives metformin 500mg i BID 60 with 2 refills but next appointment with PCP is 4 months later Nonformulary not cost effective drug choice Provider prescribed a medica
6. the first time develops full body rash hives and exhibits difficulty breathing e Adult h o NSAID induced hives and SOB receives prescription for Celebrex Drug interaction A drug drug drug food or drug lab test interaction Examples e Drug drug warfarin 5mg take as directed and ibuprofen 800mg 1 tab q8h prn pain increased anticoagulation effect e Drug food Lipitor 10mg and gt 1 quart grapefruit juice daily CYP p450 inhibition by grapefruit juice will increase serum Lipitor levels e Drug lab test Spironolactone resulting in falsely elevated digoxin level via RIA Lab diagnostic test indicated not ordered A medication related lab or diagnostic test is indicated for a patient based on diagnosis comorbidities etc according to guidelines or current evidence but has not been ordered This is intended to identify potential or actual medication related harm as opposed to 4 which focuses on testing related to disease status Examples e Patient is receiving clozapine CBC with differential not ordered e Spironolactone initiated no follow up BMP ordered Abnormal lab result not addressed Abnormal lab values returned for patient action required but none taken Examples e Recent CMP results include K 3 0 patient taking HCTZ 25mg daily no action taken by PCP e Recent AST ALT is gt 3ULN patient taking statin therapy and has received no follow up instructions Pharmacy dispensing error Any error that occurs during t
7. 1 F it 0 O yes 1 f Glyburide c G eo gt O Modified Yes H iii 0 s O No us Description of event MUST complete for Severity ii or iii pADEs amp all ADEs Resolved optional Drug s involved Indication Problem Recommendation Outcome 2 4 6 2012 Steven Chen PharmD Sun Han PharmD USC School of Pharmacy Next enter the Intervention Codes that apply to the intervention The Intervention Codes section of the form is outlined with a black bolded border Intervention Codes Column The codes for the first column MRP Medication Related Problem are shown in the table at the bottom of the form There are 28 different MRPs grouped by category this grouping was derived from the Patient Centered Primary Care Collaborative Medication Management resource guide see http www pcpcc net files medmanagepub pdf e Appropriateness and Effectiveness MRPs 1 4 e Safety ADEs pADEs MRPs 5 18 e Nonadherence and Patient Variables MRPs 18 22 e Miscellaneous MRPs 23 28 Select the MRP code from the list in I Medication Related Problem MRP It is highly recommended that you select a single MRP code for each intervention in order to support data aggregation For multiple MRPs itemize each in a single row A complete description and examples of each MRP is provided in the Appendix INTERVENTION Each row Is for an individual intervention i e one MRP per row
8. C 6 8 D H o6 A O No hypoglycemia FPG via SMBG 60 70 meee 6 4 6 2012 Steven Chen PharmD Sun Han PharmD USC School of Pharmacy Appendix Definitions and Examples of Medication Related Problems MRPs APPROPRIATENESS AND EFFECTIVENESS 1 Untreated medical problem A medical problem that is not being addressed or treated Examples e Post MI patient with LDL C above goal and no lipid modifying therapy prescribed no contraindications e No antiplatelet therapy for post MI patient no contraindication e Adult with Type 2 DM and albumin creatinine ratio 76 no ACEi nor ARB and no contraindications 2 Drug dosing not adequate for treatment goals dose interval or duration Dosing is insufficient to reach treatment goals based indication recommended target dose duration of therapy etc Examples e Adult with Type 2 DM and BP gt 130 80 x last 3 visits treated with lisinopril 2 5mg daily as monotherapy e Post MI patient with LDL C of 100 mg dL receiving atorvastatin 40mg daily e Asthma patient with at least moderate persistent asthma receiving only Asmanex 1 inhalation QPM as controller therapy 3 Treatment not optimal based on current evidence guidelines Treatment deviates from clinical guidelines or current literature evidence without reasonable explanation such as contraindications or allergies to preferred therapies Examples e Newly diagnosed obese adult Type 2 DM patient NOT receiving metformin e Moderate pers
9. University of Southern California School of Pharmacy Medication Therapy Intervention amp Safety Documentation Program User Manual v 7 0 last updated 4 6 2012 Steven Chen Pharm D Associate Professor chens usc edu Background In the course of ensuring optimal drug therapy through the spread of pharmacy services many medication related problems are identified and resolved However no national standard has been established for identifying categorizing and reporting medication safety interventions in the outpatient setting This program adapts several multidisciplinary and or national medication related standards into a system for identifying categorizing rating severity of and reporting the impact of pharmacy services on the quality and safety of medication use including the detection of adverse drug events ADEs and potential adverse drug events pADEs For this manual the term medication therapy intervention refers to any medication related problem MRP identified requiring an action to resolve If the medication related problem is a safety issue the problem either caused harm ADE or had the potential to cause harm pADE Definitions of ADEs and pADEs as well as other medication safety terms are provided in the following diagram and illustrated to clarify their relationships Medication Safety Management amp Prevention of Drug related Harm ADVERSE DRUG EVENT ADE Injury resulting from the use of a drug
10. a A D oO devoid Recommend ses Problem Recommendation Outcome O yes Glyburide G O Modified Yes H 1 i 14 Abnormal lab result not ab result not addressed Appropriateness and Effectiveness 15 Pharmacy dispensing error Potential Adverse Drug Event pADE i Potential for minimal would J 101 DC drug s Untreated medical problem 16 Medication overuse or misuse A No med error event but potential for require patient self 102 Substitute drug s Drug dosing not adequate for treatment 17 Dose discrepancy between patient use amp ADE identified management or no harm goals dose interval or duration prescribed therapy B Med error event DID NOT reach patient ii Potential for m Treatment not optimal based on current 18 Using expired medication s C Med error event reached patient but no would require healthcare j evidence guidelines Nonadherence and Patient Variables harm professional intervention or 106 Change PRN to schedule Monitoring standards not being followed 19 Medication underuse poor adherence D Med error event reached patient hospitalization to resolve 107 Change schedule to PRN 20 Dosage form is not reasonable for patient monitoring or intervention required to ii Potential for severe harm 108 Order lab dx tic test 21 Inadequate patient self management of confirm no harm permanent disability or 109 Educate patient lifestyle and other non drug variables Adverse Drug Event ADE death 110
11. box Entered in computer database indicates that the information on the form has been transferred into a database or spreadsheet Intervention Documentation As previously described each form contains 3 rows to document up to 3 interventions i e a single intervention per row Enter the name s of the specific drug s involved in the first column and the indication s involved in the second column For example S T is a 60 yo Hispanic female who presents for diabetes MTM She has been experiencing what she describes as 10 really bad hypoglycemic episodes since her last visit with her primary care provider She claims that she has not changed her diet nor activity level She checked her blood glucose levels during several of these episodes and the readings ranged from 60 to 70 mg dL she managed these episodes by consuming fruit juice or bread and rechecking her blood glucose every 15 minutes as directed Upon completing your medication reconciliation you find out that her dose of glyburide was recently increased from 10mg BID to 20mg BID Problem S T was prescribed 40mg day of glyburide maximum dose is 20mg day 10mg day is considered to be the maximum effective dose INTERVENTION Each row Is for an individual intervention i e one MRP per row Intervention Intervention Codes see table below po ers accepted MRP For pADE ADE Intervention optional if 5 17 gt if A D gt Recommend sees A E F 10
12. eous i F Event occurred resulting in temporary 113 Make appt w provider 9 Contraindication 23 Drug not available in prescribed strength harm and requiring hospitalization 114 Provide Rx compliance box 10 Adverse drug reaction ADR 24 Inadequate refills between scheduled visits G Event occurred resulted in permanent 115 Other 11 Allergy 25 Nonformulary not cost effective drug choice harm disabili 12 Drug interaction 26 Illegible prescription H Event occurred life threatening 13 Lab diagnostic test indicated not ordered henge appointment with PCP Event occurred resulted in death 5 er 5 Drug dosing excessive for treatment goals dose interval or duration 6 Incomplete improper directions 7 No indication for medication prescribed 8 Polypharmacy Rx not needed duplication Intervention Codes Column IV This column must be completed for ALL interventions MRPs The codes for Column IV can be found in the last column of the table below under IV Action Intervention More than one action intervention code may be circled for each intervention MRP INTERVENTION Each row Is for an individual intervention i e one MRP per row Intervention Codes see table below Intervention Description of event ee Le Accepted Resolved MUST complete for Severity ii or iii pADEs amp all ADEs a Drug s involved Indication For pADE ADE Intervention optional optional if ei gt
13. er E should be circled in Column II i e this isan ADE The event that occurred resulting in temporary harm is hypoglycemia and the intervention required was patient self management followed by the changes made at this visit If S T experienced a hypoglycemic event that required hospitalization the appropriate Column II to select would be F Error occurred resulting in temporary harm and requiring hospitalization Intervention Codes Column Ill If category A through D is selected in Column Il then a pADE was identified and Column III must be completed If any letter other than A through D was selected for Column Il then DO NOT complete Column lll The purpose of Column Ill is to classify the severity of the pADE The premise for this categorization is that pADEs are broad ranging in terms of what could have happened to the patient if the patient was harmed by the event e g a patients who previously experienced an ACEi cough who is re prescribed the same ACEi vs a patient with hyperkalemia and renal impairment prescribed spironolactone Clearly the latter is a much higher severity problem prevented As a result taxonomy was derived and simplified from Medicare Nursing Home Levels of Harm http www medicare gov NHCompare static related incdrawlevelofharm asp language English amp version d efault to provide 3 levels of potential harm severity which are described in the table under pADE Severity Rating Only one seve
14. er If the recommendation is accepted by the primary care provider the Yes box should be checked If the primary care provider agrees that the medication related problem identified is a problem that needs to be acted upon but changes the course of action recommended e g chooses to add ezetimibe instead of increase the dose of statin for a patient who is not meeting LDL C target then the Modified Yes box should be checked The No box is checked if the recosmmendation is not accepted The Resolved column allows the user to track whether the problem identified was fully resolved For interventions with a clinical or surrogate clinical outcome as a goal Resolved is defined as achievement of the goal Please note that FTR stands for Failed to Return INTERVENTION Each row Is for an individual intervention i e one MRP per row Description of event Intervention Codes see table below Intervention i wett Accepted Resolved MUST complete for Severity ii or iii pADEs amp all ADEs Drug s involved Indication MRP For pADE ADE For Intervention optional optional if 5 17 gt if A D gt pADE Recommend sss Problem Recommendation Outcome A E 0 rr Glyburide increased O yes from 10mg BID to Gia raha ne to 10mg BID A1C hypoglycemia P 2 by PCP rypogly if Glyburide c 6 O Modified Yes mehe Piimas eaae increase was A1
15. ge but through trial and error it was determined that limiting the form to one patient per page is better for supporting filing of the original forms and for quality control purposes PATIENT INFORMATION Medication Therapy Intervention amp Safety Documentation Form version 7 8 24 11 Date Site MRN DOB Gender Insurance Ethnicity amp Language Point of Care Initials l Oa O None O Caucasian O English O MTM DSM 3 Os O Meaid O Black O Non English Aak PharmD __ O Entered in tof Oc i f OmOrF Omeare D Latino O Med review computer database Oo C Other D Asian pharmacy Student Oe D Other dispensary Demographic information is collected on the top of the form including the intervention date and check boxes for the specific site if there are multiple sites in the health system medical record number MRN date of birth DOB gender insurance status ethnicity and whether English language is spoken Point of care refers to the type of pharmacy service being provided when the intervention was made The purpose is to differentiate between those encounters that occur during a relatively more extensive medication therapy management MTM disease state management DSM visit as opposed to brief encounter for medication review e g pharmacist or student conducted medication reconciliation or counseling session in a pharmacy or dispensary Initials by students or pharmacists will help with quality control reviews and the check
16. he process of processing filling and dispensing medications to a patient Examples e Patient was prescribed hydrochlorothiazide 25mg but was dispensed hydroxyzine 25mg instead wrong medication dispensing error e Maria E Hernandez is picking up her medications but went home with Maria E Fernandez s medications instead wrong person dispensing error e Label for simvastatin 20mg is placed onto Synthroid 200mcg bottle wrong medication dispensing error 4 6 2012 Steven Chen PharmD Sun Han PharmD USC School of Pharmacy e Prescriber writes for fentanyl 25mcg transdermal patches 1 patch Q72H but was typed and dispensed with fentanyl 25mcg transdermal patches 1 patch Q24H typing error dispensing error 16 Medication overuse or misuse Patient is over misusing a medication in a manner that he she was not instructed or prescribed This includes misuse of drug delivery and related devices Note This is different from 2 and 5 where inadequate or excessive dosing is due to the prescriber It is also different from 18 which is specifically underuse or poor adherence to medication Examples e ProAir HFA is prescribed as 1 2 puffs Q4 6H prn SOB wheezing but patient is taking 2 puffs Q2H while awake overuse e Patient is swallowing Foradil capsules instead of inserting into Aerolizer and puncturing for inhalation e Patient is using the adhesive overlay for Catapres TTS instead of the medicated patch misu
17. istent asthma patient receiving Singulair as controller e Systolic dysfunction heart failure patient not receiving beta blocker 4 Monitoring or testing standards not being followed Monitoring or testing standards for a given disease state are not being followed based on treatment guidelines and or current evidence This is intended to capture monitoring for progression control of disease as opposed to medication related side effects See 13 Examples e Lipitor 10mg initiated over 1 year ago with no follow up FLP ordered e Thyroid hormone replacement without f u TSH T4 T3 ordered SAFETY 5 Drug dosing excessive for treatment goals dose interval or duration Dose interval or duration of a particular medication therapy exceeds guidelines or other evidence based recommendations Note that this is the opposite of 2 Examples e Toprol XL 100mg 1 tab BID Toprol XL should be taken once daily e Glyburide 20mg 1 tab BID approved max 20mg day e Ciprofloxacin 500mg 1 tab BID x 3 months for UTI inappropriate length of tx 7 4 6 2012 Steven Chen PharmD Sun Han PharmD USC School of Pharmacy 6 10 Incomplete improper directions Prescription is incomplete or does not have proper instructions Examples e Ativan 0 5mg tablets take as needed missing dose frequency and indication e Zofran ODT 4mg tablets 1 tablet SL prn nausea vomiting should be ON the tongue No indication for medication prescribed There is
18. itoring or intervention required to ii Potential for severe harm 108 Order lab dx tic test S Drug dodiag eucessive for trasteveiit goals 21 Inadequate patient self management of confirm no harm permanent disability or 109 Educate patient lifestyle and other non drug variables death 110 Refer to other service dose interval or duration Dri AD 6 Incomplete improper directions 7 No indication for medication prescribed 8 Polypharmacy Rx not needed duplication 9 Contraindication 10 Adverse drug reaction ADR 11 Allergy 12 Drug interaction 13 Lab diagnostic test indicated not ordered 22 Patient dissatisfied or refuses treatment no rational reason given Miscellaneous 23 Drug not available in prescribed strength 24 Inadequate refills between scheduled visits 25 Nonformulary not cost effective drug choice 26 Illegible prescription 27 No follow up appointment with PCP 28 Other Event occurred resulting in temporary harm and requiring intervention 111 Clarity Rx m 112 Substitute dosage form 113 Make appt w provider 114 Provide Rx compliance box 115 Other harm and requiring hospitalization G Event occurred resulted in permanent harm disability H Event occurred life threatening Event occurred resulted in death Continuing with the example since S T s MRP is a safety ADE pADE problem 5 18 and S T experienced harm hypoglycemia the lett
19. no medical condition for which this medication is indicated This is different from 8 below in that there is NO indication Examples e Patient receiving omeprazole 20mg QAM AC x 3 years with no GI condition diagnosed patient has no recollection of why medication was given and cannot recall h o GIB nor GERD sx s e Patient has albuterol inhaler for PRN use no diagnosis of pulmonary disease Patient is nonsmoker with no recollection of h o asthma COPD or related testing such as spirometry Patient cannot recall why albuterol was prescribed Polypharmacy Rx not needed Duplication Although the patient has an indication for the medication the medication is unnecessary for reaching treatment goals or duplicative of another medication Examples e Patient is receiving an ACEi from your clinic through PAP but is also being prescribed lisinopril 10mg filled by CVS prescribed by a provider at another clinic duplicative ACEi therapy e Patient is using Advair 250 50 from your clinic through PAP but is also using Serevent inhaler from another provider duplication in salmeterol therapy e Patient with uncomplicated HTN is taking lisinopril 20mg daily chlorthalidone 25mg daily and sustained release atenolol 25mg daily BP 128 74 DC of atenolol results in BP 132 80 atenolol unnecessary for reaching treatment goals Contraindication Medication is contraindicated based on patient s age medical history laboratory data laboratory tes
20. pADE Column IV This information is intended to help clarify the event and the likelihood that the event is associated with the drug These details will allow the organization to easily compile a qualitative summary of important interventions to share with stakeholders Separating the fields into brief descriptions of the Problem Recommendation and Outcome provides a simple format that when summarized in a report is easy to read and understand INTERVENTION Each row Is for an individual intervention i e one MRP per row serarvention Codes see table below Intervention Accepted optional eee Description of event MUST complete for Severity ii or iii pADEs amp all ADEs were ve For pADE ADE For Intervention if 5 17 gt ie A D O pADE ilada from 10mg BID to Reduce glyburide R O yes 5 Tna ein CA to 10mg BID A1C ig pera ifie os x3 months 1 O Modified Yes 10 episodes of WNL before dose CESK Resolved Indication optional Drug s involved Problem Recommendation Outcome Glyburide increased ONo hypoglycemia FPG increase was via SMBG 60 70 made Intervention Acceptance and Resolution of Medication Related Problems OPTIONAL FIELDS These two columns are optional The first Intervention Acceptance should be completed if the action taken is a recommendation as opposed to an action that is implemented through a protocol or standing ord
21. rity category should be circled Our example involving S T does NOT apply for Column III since S T experienced harm an ADE hypoglycemia Using the brief examples cited above to illustrate the use of Column III e Ifa patient is prevented from receiving a prescription for an ACEi from which he or she previously experienced a confirmed ACEi cough then the MRP Column I would be 10 ADR the ADE pADE Classification Column II would be B Med error event DID NOT reach patient and the pADE Severity Rating Column III would be i Potential for minimal would require patient self management or no harm 4 4 6 2012 Steven Chen PharmD Sun Han PharmD USC School of Pharmacy e If a patient with hyperkalemia K 5 6 and renal impairment who is already receiving ACEi therapy is prevented from receiving a prescription for spironolactone then the MRP Column I would be 9 Contraindication the ADE pADE Classification Column II would be B Med error event DID NOT reach patient and the pADE Severity Rating Column III would be ii Potential for moderate harm would require healthcare professional intervention or hospitalization to resolve 1 MEDICATION RELATED PROBLEM MRP 14 Abnormal lab result not addressed IL_ADE pADE CLASSIFICATION IV INTERVENTION RECOMM Appropriateness and Effectiveness 15 Pharmacy dispensing error Potential Adverse Drug Event pADE i Potential for minimal would 9 101 DC drug s Un
22. rug s involved Indication MRP For pADE ADE optional optional eee Problem Recommendation Outcome For Intervention if 5 17 gt if A D gt pADE Recommend Oils amp B 0 O yes G Ra F Glyburide c 5 O Modified Yes D H O No 14 Abnormal lab result not addressed Appropriateness and Effectiveness 15 Pharmacy dispensing error Potential Adverse Drug Event pADE i Potential for minimal would 101 DC drug s 1 Untreated medical problem 16 Medication overuse or misuse A No med error event but potential for require patient self 102 Substitute drug s 2 Drug dosing not adequate for treatment 17 Dose discrepancy between patient use amp ADE identified management or no harm 103 Add drug s goals dose interval or duration prescribed therapy B Med error event DID NOT reach patient ii Potential for moderate harm 104 Change dose dose interval 3 Treatment not optimal based on current 18 Using expired medication s C Med error event reached patient but no would require healthcare 105 Change duration of tx qty evidence guidelines Nonadherence and Patient Variables harm professional intervention or 106 Change PRN to schedule 4 Monitoring standards not being followed 19 Medication underuse poor adherence D Med error event reached patient hospitalization to resolve 107 Change schedule to PRN Safety pADE ADE 20 Dosage form is not reasonable for patient mon
23. se 17 Dose discrepancy between patient use and prescribed therapy A situation where the current medication regimen listed in the medical record differs from how the patient is actually taking the medication yet the patient has met treatment goals Example e Medical record indicates that pt should be taking metformin 500mg BID but pt is taking metformin 500mg daily with A1C consistently below 7 18 Using expired medication s Patient is using medications that are expired or should no longer be used Example e Patient continues to use insulin from vial beyond 30 day expiration e Patient poorly adherent with Foradil continues to use capsules beyond 4 month expiration NONADHERENCE AND PATIENT VARIABLES 19 Medication underuse poor adherence Patient is taking less than the prescribed dose frequency duration of medication Examples e Patient with persistent asthma who is not using QVAR inhaler e Patient taking only 2 of 4 HTN medications which cannot be attributed to an ADE 20 Dosage form is not reasonable for patient Given the patient s circumstances the dosage form is not appropriate reasonable Examples e Controlled release medication prescribed to a patient who is NPO and has a G Tube e Burn victim patient with very little normal skin being prescribed transdermal patches 21 Inadequate patient self management of lifestyle and other non drug variables Patient not making necessary changes in lifestyle e g diet exercise wt
24. stic test indicated not ordered rae vA follow up appointment with PCP Event occurred resulted in death a The Intervention Codes Column Il Column Il is to be completed ONLY if the MRP in Column I is 5 through 18 i e a safety problem that either resulted in some level of harm ADE or no harm pADE harm was avoided If the MRP is 5 through 18 classify the ADE or pADE in Column II using categories A through below under Il ADE pADE CLASSIFICATION This classification scheme is derived from the National Coordinating Council for Medication Error Reporting and Prevention NCC MERP Medication Error Index http www nccmerp org medErrorCatIndex html Wording has been slightly modified since NCCMERPs nomenclature is intended for categorizing ERRORS whereas this program categorizes EVENTS Letters A through D identify pADEs i e medication errors or events that either did not reach the patient OR reached the patient but did not cause harm Letters E through identify ADEs that occurred resulting in varying levels of harm Only one category can be selected in Column Il 3 4 6 2012 Steven Chen PharmD Sun Han PharmD USC School of Pharmacy INTERVENTION Each row Is for an individual intervention i e one MRP per row k table below Intervention Description of event 3 Pee i Accepted Resolved MUST complete for Severity ii or iii pADEs amp all ADEs D
25. tion that is not on the formulary or a prior authorization is denied and an alternative drug therapy appropriate for the patient is on the formulary Illegible prescription Pharmacy personnel is unable to read the prescription No follow up appointment with PCP No follow up appointment with a PCP has been made and the patient clearly needs follow up care This is a problem caused by the health system not the patient i e this problem is not to be used to identify patients who fail to keep follow up appointments Other Anything medication related problem that is not described in the above categories 4 6 2012 Steven Chen PharmD Sun Han PharmD USC School of Pharmacy
26. treated medical problem 16 Medication overuse or misuse A No med error event but potential for require patient self 102 Substitute drug s Drug dosing not adequate for treatment 17 Dose discrepancy between patient use amp ADE identified management or no harm 103 Add drug s goals dose interval or duration prescribed therapy B Med error event DID NOT reach patient ii Potential for moderate harm 9 104 Change dose dose interval Treatment not optimal based on current 18 Using expired medication s C Med error event reached patient but no would require healthcare 105 Change duration of tx qty evidence guidelines Nonadherence and Patient Variables harm professional intervention or 106 Change PRN to schedule Monitoring standards not being followed 19 Medication underuse poor adherence D Med error event reached patient hospitalization to resolve 107 Change schedule to PRN Safety PADE ADE 20 Dosage form is not reasonable for patient monitoring or intervention required to iii Potential for severe harm 108 Order lab dx tic test 21 Inadequate patient self management of confirm no harm permanent disability or 109 Educate patient lifestyle and other non drug variables Adverse Drug Event ADE death 110 Refer to other service 22 Patient dissatisfied or refuses treatment no E Event occurred resulting in temporary 111 Clarify Rx rational reason given harm and requiring intervention 112 Substitute dosage form Miscellan
27. ts etc Examples e Verapamil prescribed for patient with heart failure EF 30 e Patient with hyperkalemia K 5 6 and renal impairment who is already receiving ACEi therapy is prescribed spironolactone e 32 yo female planning on becoming pregnant prescribed ACEi Adverse drug reaction ADR An ADR is harm directly caused by a drug at normal doses during normal use ADRs are side effects but the term side effects tends to minimize the importance of the reaction and therefore ADR is the preferred terminology These reactions may not necessarily be severe Adverse drug reactions can be augmented pharmacologic effects idiosyncratic effects chronic effects delayed effects end of treatment effects or failure of therapy Please note that 11 below Allergy is a form of ADR but is specifically mediated by the immune system 4 6 2012 Steven Chen PharmD Sun Han PharmD USC School of Pharmacy 11 12 13 14 15 Examples e Lower extremity edema from Norvasc 10mg daily for HTN e Tylenol with Codeine 3 1 2 tabs q4 6h prn pain leading to severe drowsiness or constipation e Cough from ACEi therapy Allergy A specific form of ADR that is mediated by the immune system The allergy can be to a new medication or to a medication that is re prescribed to which the patient had a previous allergic reaction Examples e Toddler is prescribed penicillin v potassium 250mg TID x 10 days for streptococcal infection for
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