ADVERSE REACTION TRACKING

Adverse Reaction Tracking (ART)

• The objective of the software is to track and report patient allergy and adverse reaction data.

• Different menus for different types of users

• Can set up site parameters based on how your facility plans to use the package

• Drug interactions will be interactive based on VA drug class in Outpatient Pharmacy v7.0 and Inpatient v5.0

• Establish mail groups and bulletins based on site parameters

Four Major Components

• 1. Data Entry Options– two options where a user can enter data.– a. Enter/Edit Patient Reaction Data

• allows the clinical users (i.e., doctors, nurses, other clinicians and clerks) to enter data into ART.

– b. Verify Patient Reaction Data• allows the verifiers designated by ART to verify

the correctness of data entered by the clinical users into ART.

Four Major Components (Cont)

• 2. Reporting options– report the patient causative agent data to

the user via a print option. Also, this data is made available to other software applications via a data extract utility.

• 3. Enter/Edit Site Configurable Files– allows the various site configurable files to

be modified to allow ART to better meet the needs of an individual site.

Four Major Components (Cont)

• 4. Adverse Drug Reaction (ADR) options– allows for the evaluation of a suspected ADR

by a qualified individual (e.g., clinical pharmacist, clinical pharmacologist) other than the attending physician.

– generates the reports needed by the FDA.

Four Major Users• 1. Clinical users

– are the doctors, nurses, other clinicians and clerks entering the data into ART.

– if the reaction was observed at the site, data pertaining to any possible legal action could be tracked. Data is made available to users of any service utilizing the Reporting options, avoiding errors in care.

– two other data elements that are tracked are: 1. date/time that the patient chart was marked, 2. date/time that the patient ID band was marked.

– automated mail bulletins sent to the appropriate users when the date/time patient chart marked data field has not been recorded.

Four Major Users (Cont.)

• 2. Verifiers – designated users by the site who verify the

correctness of the data in ART. – Need GMRA-ALLERGY VERIFY security key and

have the ART Verifier Menu. – May be clinical pharmacists, dietitians, and

other clinical personnel. Automated mail bulletins sent to the ART verifiers when an allergy/adverse reaction has been entered and signed (completed) by a user. Verification - important in observed instances of adverse drug reactions where a Quality Assurance (QA) investigation may be conducted.

Four Major Users (Cont.)

• 3. Pharmacy and Therapeutics (P&T) Committee users– members of the hospital's P&T Committee

and are assigned the P&T Committee Menu option. They review ADRs in the facility.

– Classify ADR’s as significant reactions and determine whether they are related to particular drugs.

– Depending on the severity of the ADR, may report it further to the FDA. A printed copy of the form can be generated by ART.

– Automated mail bulletins sent to the P&T Committee users when an observed drug reaction is entered into the system.

Four Major Users (Cont.)

• 4. Software developers– Utilize the data extract utility (GMRADPT

routine) to gather ART data for display within their specific DHCP application.

Security Keys

GMRA ALLERGY VERIFY• needed to verify allergy/adverse

reactions.GMRA SUPERVISOR• given only to those users who have the

authority to override the software’s security in order to edit data.

Mail Groups

Automatic mail bulletins sent to specific users:• 1) GMRA MARK CHART - A list of users who will need

to mark a patient’s chart to record an allergy/adverse reaction.

• 2) GMRA VERIFY DRUG ALLERGY - A list of all verifiers who will need to be sent drug reaction information.

• 3) GMRA VERIFY FOOD ALLERGY - A list of all verifiers who will need to be sent food reaction information.

• 4) GMRA VERIFY OTHER ALLERGY - A list of all verifiers who will need to be sent other types of reaction information (i.e., not drug or food).

• 5) GMRA P&T COMMITTEE FDA - A list of the members of the Pharmacy and Therapeutic (P&T) Committee.

Sample Mailman Message

• site manager can enter users into different mailgroups that will receive a bulletin when someone marks reactions as entered in error, when a non-verifier has entered a drug allergy, and when P&T type data (FDA report).

Subj: REACTION ENTERED IN ERROR [#20942] 30 Sep 03 17 Lines

From: POSTMASTER (DSD-RPMS) (Sender: STARR,JANICE) Page 1

------------------------------------------------------------------------------The following reaction has been ENTERED IN ERROR. Please ensure that the patient's Chart/ID Band are updated to reflect this change.

Patient: LOPEZ,BYRON SCOTT SSN: 10-95-68 Reaction: CAPTOPRIL Location: 3EAST Originator: STARR,JANICE Entered in Error by: STARR,JANICE Entered in Error on: Sep 30, 2003@14:47:28Comments: ENTERED IN ERRORDate: Sep 30, 2003@14:47:28 User: STARR,JANICE Title: Patient denies reaction, is taking Captopril with no

problems.Select MESSAGE Action: IGNORE (in WASTE basket)// D

Deleted !!

ART Menus

• 1) Adverse Reaction Tracking [GMRAMGR] - The top level menu. Given to the package’s support person.

• 2) Adverse Reaction Tracking User Menu [GMRA USER MENU] - Assigned to clerks who will enter adverse reaction data.

• 3) Adverse Reaction Tracking Clinician Menu [GMRA CLINICIAN MENU] - Assigned to clinicians who will use the package.

• 4) Adverse Reaction Tracking Verifier Menu [GMRA VERIFIER MENU] – Assigned to users who will verify adverse reaction data.

• 5) P&T Committee Menu [GMRA P&T MENU] - Given to Pharmacy and Therapeutic Committee members.

Enter/Edit Site CONFIGURABLE FILES

MENU• 1. Edit Allergy File• 2. Enter/Edit Signs/Symptoms Data• 3. Enter/Edit Site Parameters• 4. Sign/Symptoms List• 5. Allergies File List

Site can use to tailor ART to meet its needs. Get P&T consesus.

Enter/Edit Site Parameters (Cont)

• Allows site configuration for multiple divisions at the site

The site can configure the following:1. The list of the ten most common

signs/symptoms2. The autoverification of data.3. Whether originator of the data should provide

comments.4. Marking of a patient’s ID band or chart to

indicate the presence of an allergy/adverse reaction.

5. FDA reporting data6. Allows comments to be added to the reaction

data that is entered in error

Entering Site Parameters - Example

• Entering site parameters for a site that allows autoverfication of FOOD or OTHER allergies

• BUT requires verification of DRUG allergies

Select Enter/Edit Site Configurable Files Option: 3 Enter/Edit Site ParametersSelect GMR ALLERGY SITE PARAMETERS NAME: HOSPITAL Everyone has to enter HOSPITAL hereNAME: HOSPITAL// (No editing)Select DIVISION: NAME OF YOUR INSTITUTIONThe following are the ten most common signs/symptoms: 1. ANXIETY 6. DIARRHEA 2. ITCHING,WATERING EYES 7. HIVES 3. HYPOTENSION 8. DRY MOUTH 4. DROWSINESS 9. ANAPHYLAXIS 5. NAUSEA,VOMITING 10. RASHEnter the number of the sign/symptom that you would like to edit: 3REACTION: HYPOTENSION// DIZZINESSNote – there are 200 national sign/symptoms. You can enter ?? to see your choices.The following are the ten most common signs/symptoms: 1. ANXIETY 6. DIARRHEA 2. ITCHING,WATERING EYES 7. HIVES 3. DIZZINESS 8. DRY MOUTH 4. DROWSINESS 9. ANAPHYLAXIS 5. NAUSEA,VOMITING 10. RASH

Enter the number of the sign/symptom that you would like to edit: ENTERAUTOVERIFY FOOD/DRUG/OTHER: AUTOVERIFY FOOD/OTHERAUTOVERIFY OBSERVED/HISTORICAL: AUTOVERIFY BOTHAUTOVERIFY LOGICAL OPERATOR: ANDREQUIRE ORIGINATOR COMMENTS: NOMARK ID BAND FLAG: NOMETHOD OF NOTIFICATION: BULLETINALERT ID BAND/CHART MARK: NOSEND CHART MARK BULLETIN FOR NEW ADMISSIONS: NOFDA DATA REQUIRED: NOENABLE COMMENTS FIELD FOR REACTIONS THAT ARE ENTERED IN ERROR: YESREPORTER NAME: JONES, ALBERTADDRESS: RED LAKE INDIAN HOSPITAL, P.O. BOX 497CITY: RED LAKESTATE: MINNESOTAZIP: 56671PHONE: 999-999-9999OCCUPATION: PHARMDo you want to edit Reporter Information shown above? No// ENTER (No)

REPORTER NAME: JONES, CHARLESADDRESS: INDIAN HEALTH SERVICE HOSPITAL RT. 1, BOX 234CITY: ANY WHERESTATE: NEW MEXICOZIP: 87222PHONE: 505.848.5834OCCUPATION: PHARM

NOTE: The “Reporter” data fields contain the site’s default values that will appear on the FDA adverse reaction reports. This information may be left blank.

The user will be prompted for the reporter information when creating an FDA report.

Associating Drugs with Correct VA Drug Class

• Should do this matching procedure for most common drugs causing allergies or reactions before start

• Once you have matched even one patient to the drug and VA class, the next one that you do, will automatically attach the Class. If the VA Class has not been populated, then there will not be any matching by the program when you try to fill the prescription.

Select Adverse Reaction Tracking Option: 1 Enter/Edit Site Configurable Files 1 Edit Allergy File 2 Enter/Edit Signs/Symptoms Data 3 Enter/Edit Site Parameters 4 Sign/Symptoms List 5 Allergies File ListSelect Enter/Edit Site Configurable Files Option: 1 Edit Allergy FileSelect a LOCAL ALLERGY/ADVERSE REACTION: CODEINE Are you adding 'CODEINE' as a new GMR ALLERGIES (the 117TH)? No// Y

(Yes) GMR ALLERGIES ALLERGY TYPE: DRUGNAME: CODEINE// <ENTER>

Associating Drug with Correct VA Drug Class (Cont)

Select SYNONYM: <ENTER> 1 Drug 2 Food 3 OtherSelect the type(s) for this reaction: 1// <ENTER > Select DRUG INGREDIENT: CODEINE 1 CODEINE 2 CODEINE PHOSPHATE 3 CODEINE POLISTIREX 4 CODEINE SULFATECHOOSE 1-4: 1 CODEINE Are you adding 'CODEINE' as a new DRUG INGREDIENTS (the 1ST for this

GMR ALLERGIES)? No// Y (Yes)Select DRUG INGREDIENT: Select VA DRUG CLASSES: CN101 OPIOID ANALGESICS Are you adding 'CN101' as a new VA DRUG CLASSES (the 1ST for this GMR

ALLERGIES)? No// Y (Yes)Select VA DRUG CLASSES: <ENTER>

Entering a New Drug in ART File

Select DRUG INGREDIENT: ?Answer with DRUG INGREDIENTSYou may enter a new DRUG INGREDIENTS, if you wishEnter one of the drug ingredients that make up this allergy.Answer with DRUG INGREDIENTS NAMEDo you want the entire 3585-Entry DRUG INGREDIENTS List?

N (No)Select DRUG INGREDIENT: ENTER NAME OF DRUG<RET>Select VA DRUG CLASSES: ?Answer with VA DRUG CLASSESYou may enter a new VA DRUG CLASSES, if you wishAnswer with VA DRUG CLASS CODE, or CLASSIFICATIONDo you want the entire 494-Entry VA DRUG CLASS List? N

(No)Select VA DRUG CLASSES: AA000<RET>Select a LOCAL ALLERGY/ADVERSE REACTION:

Edit Allergy File

• enter allergies into the system.• Software is distributed with a list of

entries that is categorized as NATIONAL allergies.

• Can set autoverify ON for FOOD and OTHER allergies

• Recommended that all DRUG allergies be verfied

Example of an allergy addedSelect Enter/Edit Site Configurable Files Option: 1 Edit Allergy FileSelect a LOCAL ALLERGY/ADVERSE REACTION: STINKWEEDAre you adding ‘STINKWEED’ as a new GMR ALLERGIES (the 117TH)? Y (Yes)GMR ALLERGIES ALLERGY TYPE: ??This field contains the type(s) for this allergy/adverse reaction. Theuser can enter the type(s) separated by commas, or the following codes:D=Drug, F=Food, O=Other. If codes are used, do not use commas toseparate multiple codes. Examples of valid entries are: DRUG or DRUG,FOOD or D or DF or OTHER.GMR ALLERGIES ALLERGY TYPE: ONAME: STINKWEED// <RET>Select SYNONYM: WEEDAre you adding ‘WEED’ as a new SYNONYM (the 1ST for this GMR ALLERGIES)? Y (Yes)Select SYNONYM: <RET>1 Drug 2 Food 3 OtherSelect the type(s) for this reaction: 3// <RET>Select DRUG INGREDIENT: ? Answer with DRUG INGREDIENTSYou may enter a new DRUG INGREDIENTS, if you wishEnter one of the drug ingredients that make up this allergy.Answer with DRUG INGREDIENTS NAMEDo you want the entire 3585-Entry DRUG INGREDIENTS List? N (No)

Adding a Synonym to the National Allergy File

Select Enter/Edit Site Configurable Files Option: 1 Edit Allergy File

Select a LOCAL ALLERGY/ADVERSE REACTION: CAFFEINE NATIONAL ALLERGY

CANNOT EDIT NAME FIELD OF A NATIONAL ALLERGY.

Select SYNONYM: STIMULANTAre you adding ‘STIMULANT’ as a new SYNONYM

(the 1ST for this GMR ALLERGIES)? Y(Yes)Select SYNONYM: <RET>Select a Local Allergy/Adverse Reaction: <RET>

Enter/Edit Signs/Symptoms Data

• Addition/editing of the site-specific allergy reactions.

• Allows the site to add any data as appropriate.

- The signs/symptoms list provided by ART may be inadequate or need revising.

Enter/Edit SIGNS/SYMPTOMS DATA

Select Enter/Edit Site Configurable Files Option: 2 Enter/Edit Signs/Symptoms DataSelect a LOCAL SIGN/SYMPTOM: HAIR LOSSNAME: HAIR LOSS// <RET>Select SYNONYM: BALD// <RET>Select a LOCAL SIGN/SYMPTOM: <RET>

Sign/Symptom List

• Prints a list of entries in the Sign/Symptoms file

Select Enter/Edit Site Configurable Files Option: 4 Sign/Symptoms List

START WITH NAME: FIRST// <RET>DEVICE: RX01<RET> RIGHT MARGIN: 80// <RET>SIGN/SYMPTOMS LIST FEB 2,1996 08:21 PAGE 1

NAME Nat'l/Local SYNONYM--------------------------------------------------------------------------- AGITATION National AGRANULOCYTOSIS National ALOPECIA National ANAPHYLAXIS National

Allergies File List

• Prints a captioned list of all entries in the GMR Allergies file

START WITH NAME: FIRST// <RET>DEVICE: <RET> HOME RIGHT MARGIN: 80// <RET>GMR ALLERGIES LIST FEB 2,1996 08:21 PAGE 1------------------------------------------------------------------------------NAME: ADHESIVE TAPE ALLERGY TYPE: OTHERNATIONAL ALLERGY: NATIONAL ALLERGY

NAME: ALCOHOL ALLERGY TYPE: DRUG, FOODNATIONAL ALLERGY: NATIONAL ALLERGYDRUG INGREDIENT: ALCOHOL

NAME: ANIMAL HAIR ALLERGY TYPE: OTHERNATIONAL ALLERGY: NATIONAL ALLERGY

Adverse Reaction Tracking User Menu

• Assigned to all clerks of Adverse Reaction Tracking who are not clinicians, verifiers, or ADP coordinators.

• Allows user to enter, edit and display allergy/adverse reaction data.

Enter/Edit Patient Reaction Data

• allows entering and editing of patient allergies/adverse reactions.

• enter the name of the agent that caused the reaction• whether the reaction was observed during the

patient’s stay/visit at the facility • any signs/symptoms associated with the reaction • date and time the sign/symptom occurred • type of reaction (i.e., mechanism), • any appropriate comments concerning the entry, • whether the patient’s chart is marked for this

reaction.

Select Adverse Reaction Tracking User Menu Option: 1 Enter/Edit PatientReaction DataSelect PATIENT NAME: VASQUEZ,BOB 04-01-23 300000000 SCVETERANOBS/REACTANT VER. MECH. HIST TYPE-------- ---- ---- ---- ----ASPIRIN AUTO ALLERGY HIST DRUGReactions: CHILLS, DRY MOUTH, CHEST PAINDILANTIN YES ALLERGY OBS DRUG(PHENYTOIN)Reactions: DROWSINESSIBUPROFEN NO UNKNOWN OBS DRUGPENICILLIN YES UNKNOWN OBS DRUGReactions: HIVES, DROWSINESS

Enter Causative Agent: ANTIRABIES SERUMANTIRABIES SERUM OK? Yes// <RET> (Yes)(O)bserved or (H)istorical Allergy/Adverse Reaction: O OBSERVED

Select date reaction was OBSERVED (Time Optional): NOW (FEB 29, 1996@14:01)Are you adding 'FEB 29, 1996@14:01' as a new ADVERSE REACTION REPORTING? Y (Yes)No signs/symptoms have been specified. Please add some now.The following are the top ten most common signs/symptoms:1. CONFUSION 7. HIVES2. ITCHING,WATERING EYES 8. DRY MOUTH3. HYPOTENSION 9. CHILLS4. DROWSINESS 10. RASH5. CHEST PAIN 11. OTHER SIGN/SYMPTOM6. DIARRHEAEnter from the list above : 5Date(Time Optional) of appearance of Sign/Symptom(s): Feb 29, 1996@14:01//

The following is the list of reported signs/symptoms for this reaction:Signs/Symptoms Date Observed 1 CHEST PAIN Feb 29, 1996@14:01Select Action (A)DD, (D)ELETE OR <RET>: <RET>COMMENTS:1>severe chest pains and breathing troubleEDIT Option:Enter another Causative Agent? YES// N NOCausative Agent Data edited this Session: ADVERSE REACTIONANTIRABIES SERUM Reactions: CHEST PAIN OBSERVEDORIGINATORCOMMENTS:Date: Feb 29, 1996@14:01:21 User: MEAD,ANN

Title: NURSEsevere chest pains and breathing troubleIs this correct? NO// Y YESThis session you have CHOSEN:ANTIRABIES SERUMHave the Chart(s) been marked for this CAUSATIVE AGENT? Y (Yes)Select PATIENT NAME: <RET>

Active Listing of Patient Reactions

• Gives a brief listing of the active (i.e., data that is signed off and not entered in error) allergy/adverse reaction data for a selected patient.

• If the patient has no known reactions, the body of the report will display that the patient has no known allergies. If the patient was never asked if he/she has any allergy/adverse reactions, the body of the report will display a message stating that there are no reactions on file.

Select Adverse Reaction Tracking User Menu Option: 2 Active Listing of Patient ReactionsSelect PATIENT: ALMOND,BILLY 06-15-63 33354 2222 ACTIVE DUTYDEVICE: HOME// <RET> HYPER SPACEACTIVE ALLERGY/ADVERSE REACTION LISTINGRun Date/Time: 1/16/96 12:12:57 pmALMOND,BILLY 333-54-2222 JUN 15,1963 (32)OBS/ADVERSE REACTION VERIFIED HIST------------------------------------------------------------------------------TYPE: DRUG==========DEMECARIUM NO OBSReactions:ITCHING,WATERING EYES (Dec 13, 1995),NAUSEA,VOMITING (Dec 13, 1995),ANXIETY (Dec 13, 1995),DROWSINESS (Dec 13, 1995),HYPOTENSION (Dec 13, 1995)THE SP YES OBS

OBS/ADVERSE REACTION VERIFIED HIST------------------------------------------------------------------------------Reactions:ITCHING,WATERING EYES (Nov 06, 1995@14:01),TINGLING (Dec 01, 1995),NAUSEA,VOMITING (Dec 01, 1995),ANXIETY (Dec 01, 1995),ZINGLING (Dec 01, 1995)ITCHING,WATERING EYES (Oct 18, 1995@13:47),ANXIETY (Oct 18, 1995@13:47),HYPOTENSION (Oct 18, 1995@13:47)TYLOXAPOL YES OBSReactions: HIVES (Oct 26, 1995@13:05),ITCHING,WATERING EYES (Oct 26, 1995@13:05),NAUSEA,VOMITING (Oct 26, 1995@13:05),DIARRHEA (Oct 26, 1995@13:05),ANXIETY (Oct 26, 1995@13:05),DROWSINESS (Oct 26, 1995@13:05),DRY MOUTH (Oct 26, 1995@13:05),DRY NOSE (Oct 26, 1995@13:05),HYPOTENSION (Oct 26, 1995@13:05)

Adverse Reaction Tracking - Clinician Menu

• assigned to all clinicians of Adverse Reaction Tracking who are not verifiers or ADP coordinators.

MENU

1. Enter/Edit Patient Reaction Data2. FDA Enter/Edit Menu ...3. Reports Menu ...4. Edit Chart and ID Band5. Online Reference Card

Adverse Reaction Tracking - Verifier Menu

• given to the verifiers of the Adverse Reaction Tracking data.

• allows the user to edit/verify/print the data.

MENU1. Enter/Edit Patient Reaction Data2. Verify Patient Reaction Data3. Reports Menu ...4. Edit Chart and ID Band5. FDA Enter/Edit Menu ...6. Online Reference Card

Enter/Edit Patient Reaction Data

• Enter/Edit Patient Reaction Data– enter and edit patient allergies/adverse

reactions– Data Fields: Select a Causative Agent,

Whether was an Observed vs. Historical Reaction, Signs/Symptoms, Mechanism, Comments, FDA Data, Verification of Data, Generating Progress Notes, Mark Patient Chart and ID Band, Signing Off on an Entry

Example of Patients with no Reactions

Select Adverse Reaction Tracking Verifier Menu Option: 1 Enter/Edit Patient Reaction Data

Select PATIENT NAME: 109549JONES,DENISE RENAE F 06-11-1961 394026110

109549Does this patient have any known allergies or adverse reactions? :

No

Patient with Historical Reaction

Select PATIENT NAME: 109620TAFOYA,NICOLE LYNN F 10-27-1954 551513961

109620Does this patient have any known allergies or adverse reactions? :

YesThis patient has no allergy/adverse reaction data.Enter Causative Agent: CODEINE ...OK? Yes// <ENTER> (Yes)(O)bserved or (H)istorical Allergy/Adverse Reaction: H HISTORICALNo signs/symptoms have been specified. Please add some now.

The following are the top ten most common signs/symptoms:1. ANXIETY 7. HIVES2. ITCHING,WATERING EYES 8. DRY MOUTH3. DIZZINESS 9. ANAPHYLAXIS4. DROWSINESS 10. RASH5. NAUSEA,VOMITING 11. OTHER

SIGN/SYMPTOM6. DIARRHEAEnter from the list above : 5

Date(Time Optional) of appearance of Sign/Symptom(s): 1999 (1999)The following is the list of reported signs/symptoms for this reaction: Signs/Symptoms Date Observed--------------------------------------------------------------------------- 1 NAUSEA,VOMITING 1999Select Action (A)DD, (D)ELETE OR <RET>: <ENTER> Choose one of the following: A - ALLERGY P - PHARMACOLOGICAL U - UNKNOWNMECHANISM: UNKNOWN// P PHARMACOLOGICCOMMENTS: No existing text Edit? NO// <ENTER>Currently you have verifier access.Would you like to verify this Causative Agent now? Yes// <ENTER> (Yes)

CAUSATIVE AGENT: CODEINE TYPE: DRUG INGREDIENTS: CODEINEVA DRUG CLASSES: This is important. Drug-Allergy alerts in v7 and Inpatient v5.0 require this. OBS/HIST: HISTORICAL SIGNS/SYMPTOMS: NAUSEA,VOMITING (1999) MECHANISM: PHARMACOLOGICWould you like to edit any of this data? Y (Yes)CAUSATIVE AGENT: CODEINE// (Uneditable) 1 Drug 2 Food 3 OtherSelect the type(s) for this reaction: 1// <ENTER>Select DRUG INGREDIENT: CODEINE// <ENTER>Select VA DRUG CLASS: CN101 OPIOID ANALGESICS VA DRUG CLASS: OPIOID ANALGESICS// <ENTER>Select VA DRUG CLASS: <ENTER>(O)bserved or (H)istorical Allergy/Adverse Reaction: HISTORICAL//

The following is the list of reported signs/symptoms for this reaction: Signs/Symptoms Date Observed--------------------------------------------------------------------------- 1 NAUSEA,VOMITING 1999Select Action (A)DD, (D)ELETE OR <RET>: <ENTER> Choose one of the following: A - ALLERGY P - PHARMACOLOGICAL U - UNKNOWNMECHANISM: PHARMACOLOGIC// <ENTER>CAUSATIVE AGENT: CODEINE TYPE: DRUG INGREDIENTS: CODEINEVA DRUG CLASSES: CN101 - OPIOID ANALGESICS OBS/HIST: HISTORICAL SIGNS/SYMPTOMS: NAUSEA,VOMITING (1999) MECHANISM: PHARMACOLOGICWould you like to edit any of this data? N (No)

PATIENT: TAFOYA,NICOLE LYNN CAUSATIVE AGENT: CODEINE INGREDIENTS: CODEINE VA DRUG CLASSES: OPIOID ANALGESICS ORIGINATOR: STARR,JANICE ORIGINATED: AUG 07, 2003@11:35 SIGN OFF: NO OBS/HIST: HISTORICALID BAND MARKED: CHART MARKED: SIGNS/SYMPTOMS: NAUSEA,VOMITING (1999)Change status of this allergy/adverse reaction to verified? Y (Yes)Enter another Causative Agent? YES// NOThis session you have CHOSEN: CODEINEHave the Chart(s) been marked for this CAUSATIVE AGENT? Y (Yes)

Patient with Observed ReactionSelect PATIENT NAME: 109746 SALAZAR,JEREMIAH JAY M 07-17-1961 590395167 109476Does this patient have any known allergies or adverse reactions? : Yes This patient has no allergy/adverse reaction data.Enter Causative Agent: PENICILLIN PENICILLIN OK? Yes// <ENTER> (Yes)(O)bserved or (H)istorical Allergy/Adverse Reaction: O OBSERVEDSelect date reaction was OBSERVED (Time Optional): N (SEP 30,

2003@14:35) SEP 30, 2003@14:35 (SEP 30, 2003) Are you adding 'SEP 30, 2003' as a new ADVERSE REACTION REPORTING?

No// Y (Yes)No signs/symptoms have been specified. Please add some now.The following are the top ten most common signs/symptoms: 1. ANXIETY 7. HIVES 2. ITCHING,WATERING EYES 8. DRY MOUTH 3. DIZZINESS 9. ANAPHYLAXIS 4. DROWSINESS 10. RASH 5. NAUSEA,VOMITING 11. OTHER SIGN/SYMPTOM 6. DIARRHEAEnter from the list above : 9

Date(Time Optional) of appearance of Sign/Symptom(s): Sep 30, 2003// (SEP 30, 2003)The following is the list of reported signs/symptoms for this reaction: Signs/Symptoms Date Observed--------------------------------------------------------------------------- 1 ANAPHYLAXIS Sep 30, 2003@14:35Select Action (A)DD, (D)ELETE OR <RET>: <ENTER> Choose one of the following: A - ALLERGY P - PHARMACOLOGICAL U - UNKNOWNMECHANISM: UNKNOWN// A ALLERGYCOMMENTS: No existing text Edit? NO// <ENTER>Complete the observed reaction report? Yes// <ENTER> (Yes)DATE/TIME OF EVENT: SEP 30,2003// <ENTER>OBSERVER: STARR,JANICE// <ENTER> JS

SEVERITY: ?MILD - Requires minimal therapeutic interventions and does not prolong length of stay.MODERATE - Requires therapeutic intervention and/or prolongs hospitalization by at least one day.SEVERE - Life threatening or contributed to death or permanently disabling; recovery takes > 15 days. Choose from: 1 MILD 2 MODERATE 3 SEVERESEVERITY: 3 SEVEREDATE MD NOTIFIED: Sep 30,2003// <ENTER> (SEP 30, 2003Complete the FDA data? Yes// N (No)Currently you have verifier access.Would you like to verify this Causative Agent now? Yes// <ENTER> (Yes)CAUSATIVE AGENT: PENICILLIN TYPE: DRUG INGREDIENTS: PENICILLINVA DRUG CLASSES: AM050 - PENICILLINS OBS/HIST: OBSERVED SIGNS/SYMPTOMS: ANAPHYLAXIS (Sep 30, 2003) MECHANISM: ALLERGYWould you like to edit any of this data? N (No)

PATIENT: SALAZAR,JEREMIAH JAY CAUSATIVE AGENT: PENICILLIN INGREDIENTS: PENICILLIN VA DRUG CLASSES: PENICILLINS ORIGINATOR: STARR,JANICE ORIGINATED: SEP 30, 2003 SIGN OFF: NO OBS/HIST: OBSERVEDID BAND MARKED: CHART MARKED: SIGNS/SYMPTOMS: ANAPHYLAXIS (Sep 30, 2003@14:35)Change status of this allergy/adverse reaction to verified? Y (Yes)Enter another Causative Agent? YES// NOThis session you have CHOSEN: PENICILLINHave the Chart(s) been marked for this CAUSATIVE AGENT? Y (Yes)

Reaction Entered in ErrorSelect PATIENT NAME: 109568 LOPEZ,BYRON SCOTT M 11-25-1954 437219573 109568 OBS/REACTANT VER. MECH. HIST

TYPE-------- ---- ------- ---- ----

CAPTOPRIL YES UNKNOWN HIST DRUG

Reactions: COUGHINGCODEINE YES PHARM HIST DRUG Reactions: NAUSEA,VOMITINGSULFAMETHOXAZOLE/TRIMETHOPRIM YES ALLERGY OBS DRUG (SULFAMETHOXAZOLE, TRIMETHOPRIM)• Reactions: HIVES• TOMATO AUTO UNKNOWN HIST FOOD Reactions: HIVESEnter Causative Agent: CAPTOPRIL M 11-25-1954 437219573 109568

CAPTOPRIL CAPTOPRIL OK? Yes// <ENTER> (Yes

CAPTOPRIL OK? Yes// <ENTER> (Yes) PATIENT: LOPEZ,BYRON SCOTT CAUSATIVE AGENT: CAPTOPRIL INGREDIENTS: CAPTOPRIL VA DRUG CLASSES: ACE INHIBITORS ORIGINATOR: STARR,JANICE ORIGINATED: APR 05, 2002@17:02 SIGN OFF: YES OBS/HIST: HISTORICALID BAND MARKED: CHART MARKED: APR 05, 2002@17:04:55SIGNS/SYMPTOMS: COUGHING (1997) MECHANISM: UNKNOWN VERIFIER: STARR,JANICE VERIFIED: APR 05, 2002@17:04:08Is the reaction information correct? Yes// N (No)Mark this reaction as 'Entered-in-Error'? YESCOMMENTS: No existing text Edit? NO// YES[ WRAP ]==[ INSERT ]=======< COMMENTS >===[ <PF1>H=Help

Patient denies reaction, is taking Captopril with no problems.

<=======T=======T=======T=======T=======T>===Hit the <F1> key (or <PF1> on some dumb terminals) followed by the <E> key to save the information and exit the text field.Enter another Causative Agent? YES// NO

Verify Patient Reaction Data

• allows designated verifiers to verify the correctness of data entered by the clinical users.

• may select a single patient’s data to verify or a list or range (e.g., 1,3,7 or 1-10) of patients to verify.

• may select to view/verifydrug reactions only, non-drug reactions only, or drug and non-drug reactions.

Verify Patient Reaction Data (Cont.)

• answers YES to the “change status of this allergy/adverse reaction to verified” prompt, the reaction will be marked as verified. If the verifier answers NO to that prompt, the reaction is marked as entered in error.

• If no hospital location is associated with the patient, the verifier will be prompted to enter a location.

• A progress note is created. The verifier may electronically sign, edit or delete the progress note. The verifier may print the progress note, too.

Reports Menu - Verifier

• 1. Active Listing of Patient Reactions• 2. Print Patient Reaction Data• 3. Print an FDA report for a Patient• 4. Print all FDA events within D/T range• 5. Print Patient FDA Exception Data• 6. Print all FDA Exceptions within a D/T range• 7. List by Location of Unmarked ID Bands/Charts• 8. Patient Allergies Not Signed Off• 9. List by Location of Undocumented Allergies• 10.List Autoverified Reaction Data• 11.List by Location Not Verified Reactions• 12.List by Location and Date all Sign Reactions• 13.List FDA Data by Report Date

Active Listing of Patient Reactionsgives a brief listing of the active (data that is signed off and not entered in error) allergy/adverse reaction data for a particular patient.the report divides the data by reaction type (e.g., Drug) and lists the causative agent, the signs/symptoms and when they were observed or if they were historical, and whether it was verified.Print Patient Reaction Dataallows the user to get a captioned data display of all of the patient's allergy/adverse reaction data.can select the types of reactions to include in the report.Any combination of types can be selected (i.e., FOOD and DRUG)Any combination can be selected (i.e., ACTIVE and ENTERED IN ERROR).Print an FDA Report for a Patientallows the user to print an individual FDA report for a patient.produces a listing of all allergy/adverse reactions that are awaiting sign off by the person entering the data into the system.Print all FDA Events Within D/T Rangeprints all the FDA reports over a given date range, entered by the user.may choose to print Complete FDA Adverse Event Reports or an abbreviated listing of reports.

List by Location of Unmarked ID Bands/Charts-produces a list of all patients by ward/clinic who have not had their chart or ID bands marked.-report functions like the List of Patients Not Asked About Allergies optionPatient Allergies Not Signed Off-prints allergy/adverse reactions for patients that have not been signed off (completed) by the user entering data.-Users who have the GMRA-ALLERGYVERIFY key will see all reactions that are not signed off. Users who do not have that key will see just the entries that they created.List by Location of Undocumented Allergies-report is used to list all patients in the patient database who have never been asked if they have any known allergies.List Autoverified Reaction Data-lists autoverified reaction data by date/time range, location and mechanism.List by Location Not Verified Reactions-prints a list of patient reactions that have not been verified.-data is sorted by hospital location, patient and reaction.-report can be scheduled to automatically run at a regular interval (e.g., daily)option name to schedule this report to automatically run is: GMRA TASK A/AR NV

List by Location of Undocumented Allergies-report is used to list all patients in the patient database who have never been asked if they have any known allergies.List Autoverified Reaction Data-lists autoverified reaction data by date/time range, location and mechanism.List by Location Not Verified Reactions-prints a list of patient reactions that have not been verified.-data is sorted by hospital location, patient and reaction.-report can be scheduled to automatically run at a regular interval (e.g., daily)option name to schedule this report to automatically run is: GMRA TASK A/AR NV.

List by Location and Date all Signed Reactions-prints a list of all patient reactions that have been signed off (completed) for a user supplied date range.-data is sorted by location and date range.Edit Chart and ID Band-allows the user to enter if the patient ID band or the chart has been marked.-used by the personnel charged with the responsibility of making sure that the patient's paper chart has been marked to indicate that an allergy/adverse reaction is present.

FDA Enter/Edit Menu - Verifier

• given to people responsible for the FDA portion of Adverse Reaction Tracking as designated by the site.

• allows the user to edit the FDA data.MENU

1. Enter/Edit FDA Report Data2. Enter/Edit P&T Committee Data

Enter/Edit FDA Report Data

• allows users to enter and edit FDA related data concerning an adverse reaction.

• Five sections to the FDA Report1. Fields for Reaction Information2. Suspect Drug(s) Information3. Concomitant Drugs and History4. Manufacturer Information5. Initial Reporter

Enter/Edit P&T Committee Data

• allows the user to edit P&T data.• allows for the evaluation of a suspected

Drug Reaction (ADR) by a qualified individual (e.g., clinical pharmacist, clinical pharmacologist), other than the attending physician.

• can also track a report to see if it has been sent to the FDA or manufacturer.

P&T Committee Menu• should be given to the P&T Committee

members• allows the user to edit P&T data and print

FDA data.• allows for the evaluation of a suspected ADR

by a qualified individual (e.g., clinical pharmacist, clinical pharmacologist) other than the attending physician

MENU 1. Enter/Edit P&T Committee Data 2. Enter/Edit FDA Report Data 3. Reports Menu

Reports Menu - P&T Committee• 1. Print an FDA Report for a Patient• 2. Print all FDA Events within D/T range• 3. Print Patient FDA Exception Data• 4. Print all FDA Exceptions within a D/T range• 5. Patient Allergies Not Signed Off• 6. Print Patient Reaction Data• 7. Active Listing of Patient Reactions• 8. List by Location of Undocumented Allergies• 9. List Autoverified Reaction Data• 10.List by Location Not Verified Reactions

Reports Menu - P&T (cont)

• 11.List by Location and Date all Sign Reactions

• 12.List FDA Data by Report Date• 13.List of Fatal Reaction Over a Date Range• 14.Print Summary of Outcomes• 15.Frequency Distribution of Causative

Agents• 16.Frequency Distribution of Drug Classes• 17.Total Reported Reactions Over a Date

Range• 18. P&T Committee ADR Outcome Report• 19. P&T Committee ADR Report

List of Fatal Reaction Over a Date Range-lists all fatal adverse drug reactions over a date rangePrint Summary of Outcomes-prints a summary report of patient outcomes for a date rangeFrequency Distribution of Causative Agents-options prints a report of the frequency distribution of causative agents for a date range selectedFrequency Distribution of Drug Classes-prints a report of the frequency distribution of drug classes for a date range selectedTotal Reported Reactions Over a Date Range-prints a report of the total number of reported reactions for a date range selected

P&T Committee ADR Outcome Report-displays a list of Adverse Drug Reactions (ADRs) over a date range and a summary of the listed outcomes for those ADRs.P&T Committee ADR Report-displays a list of Adverse Drug Reactions (ADRs) over a date range. The Sign/Symptoms, Mechanism, Severity and Comments are displayed for each ADR.

Patient Allergies Not Signed Off-prints allergy/adverse reactions for patients that have not been signed off (completed) by the user entering data. Users who have the GMRA-ALLERGY VERIFY key will see all reactions that are not signed off.

List by Location of Undocumented Allergies-used to list all patients in the patient database who have never been asked if they have any known allergies.

Print Patient Reaction Data-allows the user to get a captioned data display of all of the patient's allergy/adverse reaction data.

Online Reference Card-provides the user with an online reference guide to the ART software