Previous Page TOC Index Next Page

7.11.2 PEO - product experience observation segment

Details related to a particular clinical experience or event are embodied in the PEO segment. This segment can be used to characterize an event which might be attributed to a product to which the patient was exposed. Products with a possible causal relationship to the observed experience are described in the following PCR (possible causal relationship) segments. The message format was designed to be robust and includes many optional elements which may not be required for a particular regulatory purpose but allow a complete representation of the drug experience if needed.

A PEX message can contain multiple PEO segments if the patient experienced more than one event but must contain at least one PEO segment.

Figure 7-21. PEO attributes

SEQ

LEN

DT

OPTC

RP/ #

TBL #

ITEM #

ELEMENT NAME

1

60

CE

O

Y


01073

Event Identifiers Used

2

60

CE

O

Y


01074

Event Symptom/Diagnosis Code

3

26

TS

R



01075

Event Onset Date/Time

4

26

TS

O



01076

Event Exacerbation Date/Time

5

26

TS

O



01077

Event Improved Date/Time

6

26

TS

O



01078

Event Ended Data/Time

7

106

XAD

O



01079

Event Location Occurred Address

8

1

ID

O

Y

0237

01080

Event Qualification

9

1

ID

O


0238

01081

Event Serious

10

1

ID

O


0239

01082

Event Expected

11

1

ID

O

Y

0240

01083

Event Outcome

12

1

ID

O


0241

01084

Patient Outcome

13

600

FT

O

Y


01085

Event Description From Others

14

600

FT

O

Y


01086

Event From Original Reporter

15

600

FT

O

Y


01087

Event Description From Patient

16

600

FT

O

Y


01088

Event Description From Practitioner

17

600

FT

O

Y


01089

Event Description From Autopsy

18

60

CE

O

Y


01090

Cause Of Death

19

46

XPN

O



01091

Primary Observer Name

20

106

XAD

O

Y


01092

Primary Observer Address

21

40

XTN

O

Y


01093

Primary Observer Telephone

22

1

ID

O


0242

01094

Primary Observer’s Qualification

23

1

ID

O


0242

01095

Confirmation Provided By

24

26

TS

O



01096

Primary Observer Aware Date/Time

25

1

ID

O


0243

01097

Primary Observer’s identity May Be Divulged

7.11.2.0 PEO field definitions

7.11.2.1 Event identifiers used (CE) 01073

Components: <identifier (ST)> ^ <text (ST)> ^ <name of coding system (ST)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^ <name of alternate coding system (ST)>

Definition: This field may be used to transmit the event identifier used by other entities for this event. The entry would typically contain a unique alphanumeric identifier assigned by an entity with the text component null or repeating the unique alphanumeric identifier followed by the organization’s identifier. An event identifier might be GB1234^GB1234^PharmaGiant for example.

7.11.2.2 Event symptom/diagnosis code (CE) 01074

Components: <identifier (ST)> ^ <text (ST)> ^ <name of coding system (ST)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^ <name of alternate coding system (ST)>

Definition: This field is the coded diagnosis or problem description which best describes the event. A text representation of the coded item should routinely be included. MEDDRA and WHO-ART are examples of appropriate coding schemes, as are the patient and device codes included in the FDA Center for Devices and Radiologic Health’s coding manual for Form 3500A.

7.11.2.3 Event onset date/time (TS) 01075

Definition: This field contains a report or best estimate of the date/time of onset of the event The date/time can be recorded to any level of precision it is known (hour, day, month, year).

7.11.2.4 Event exacerbation date/time (TS) 01076

Definition: This field identifies the best estimate of the date/time the event was exacerbated.

7.11.2.5 Event improved date/time (TS) 01077

Definition: This field identifies the best estimate of the date/time the event improved.

7.11.2.6 Event ended data/time (TS) 01078

Definition: This field identifies the best estimate of the date/time the event resolved.

7.11.2.7 Event location occurred address (XAD) 01079

Components: <street address (ST)> ^ <other designation (ST)> ^ <city (ST)> ^ <state or province (ST)> ^ <zip or postal code(ST)> ^ <country (ID)> ^ < address type (ID)> ^ <other geographic designation (ST)>^ <county/parish code (IS)> ^ <census tract (IS)>

Definition: This field identifies the location at which the event started. Often this will specify only the country in which the event started.

7.11.2.8 Event qualification (ID) 01080

Definition: This field is contains a classification of the type of product experience this event is considered to represent. Refer to HL7 table 0237 - Event qualification for valid values.

Table 0237 - Event qualification

Value

Description

I

Interaction

O

Overdose

A

Abuse

M

Misuse

D

Dependency

L

Lack of expect therapeutic effect

W

Drug withdrawal

B

Unexpected beneficial effect

Unexpected beneficial effects would not often be reported but are required by certain countries.

7.11.2.9 Event serious (ID) 01081

Definition: This field indicates whether the event was judged as serious. If the event did not meet the criteria for seriousness but the sender judges the event significant on other grounds, the event can be identified as significant [but not serious]. Refer to HL7 table 0238 - Event seriousness for valid values.

Table 0238 - Event seriousness

Value

Description

Y

Yes

S

Significant

N

No

7.11.2.10 Event expected (ID) 01082

Definition: This field indicates whether the observed event was expected or unexpected as judged. Refer to HL7 table 0239 - Event expected for valid values.

Table 0239 - Event expected

Value

Description

Y

Yes

N

No

U

Unknown

7.11.2.11 Event outcome (ID) 01083

Definition: This field identifies the consequence of the event on the patient. If the consequence of the event is not understood or not available, the patient outcome element may be used although neither is required. May be repeated if more than one is appropriate. Refer to HL7 table 0240 - Event consequences for valid values.

Table 0240 - Event consequence

Value

Description

D

Death

L

Life threatening

H

Caused hospitalized

P

Prolonged hospitalization

C

Congenital anomaly/birth defect

I

Incapacity which is significant, persistent or permanent

J

Disability which is significant, persistent or permanent

R

Required intervention to prevent permanent impairment/damage

O

Other

7.11.2.12 Patient outcome (ID) 01084

When an event specific outcome is not available, the patient outcome element may be used to represent the patient’s overall outcome if that information is known. Refer to HL7 table 0241 - Patient outcome for valid values.

Table 0241 - Patient outcome

Value

Description

D

Died

R

Recovering

N

Not recovering/unchanged

W

Worsening

S

Sequelae

F

Fully recovered

U

Unknown

7.11.2.13 Event description from others (FT) 01085

Definition: This field contains a summary narrative text description of the event that occurred written by the sender. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative. By representing clinical information in OBX segments rather than in the narrative, these data become much more useful and flexible.

7.11.2.14 Event description from original reporter (FT) 01086

Definition: This field contains a summary narrative text description of the event provided by the original reporter. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative.

7.11.2.15 Event description from patient (FT) 01087

Definition: This field contains a summary narrative text description of the event obtained directly from the patient. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative, which will allow the data to be more readily represented and manipulated..

7.11.2.16 Event description from practitioner (FT) 01088

Definition: This field contains a summary narrative text description of the event provided by the practitioner most familiar with the event. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative.

7.11.2.17 Event description from autopsy (FT) 01089

Definition: This field contains a summary narrative text description of the autopsy results. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative.

7.11.2.18 Cause of death (CE) 01090

Components: <identifier (ST)> ^ <text (ST)> ^ <name of coding system (ST)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^ <name of alternate coding system (ST)>

Definition: This field identifies the coded cause of death. May be repeated as necessary to list multiple contributing causes. A text description can be included by including text but no code or coding system. For example, if the cause of death is to be determined at autopsy but results are not yet available, the cause of death element could be ^Pending autopsy^. The date/time of death can be sent in the PID and the autopsy results sent in the event description from autopsy element of the PEO segment.

7.11.2.19 Primary observer name (XPN) 01091

Components: <family name (ST)> ^ <given name (ST)> ^ <middle initial or name (ST)> ^ <suffix (e.g., JR or III) (ST)> ^ <prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (ST)> ^ <name type code (ID) >

Definition: This field identifies the name of the person who initially described the event.

7.11.2.20 Primary observer address (XAD) 01092

Components: <street address (ST)> ^ <other designation (ST)> ^ <city (ST)> ^ <state or province (ST)> ^ <zip or postal code(ST)> ^ <country (ID)> ^ < address type (ID)> ^ <other geographic designation (ST)> ^ <county/parish code (IS)> ^ <census tract (IS)>

Definition: This field identifies the address of the person who initially described the event.

7.11.2.21 Primary observer telephone (XTN) 01093

Components: [NNN] [(999)]999-9999 [X99999] [B99999] [C any text] ^ <telecommunication use code (ID)> ^ <telecommunication equipment type (ID)> ^ <email address (ST)> ^ <country code (NM)> ^ <area/city code (NM)> ^ phone number (NM)> ^ <extension (NM)> ^ <any text (ST)>

Definition: This field identifies the telephone number of the person who initially described the event.

7.11.2.22 Primary observer’s qualification (ID) 01094

Definition: This field contains the qualification of the primary observer which may assist in assessing the validity of the observations. Refer to HL7 table 0242 - Primary observer’s qualification for valid values.

Table 0242 - Primary observer’s qualification

Value

Description

P

Physician (osteopath, homeopath)

R

Pharmacist

M

Mid-level professional (nurse, nurse practitioner, physician's assistant)

H

Other health professional

C

Health care consumer/patient

L

Lawyer/attorney

O

Other non-health professional

7.11.2.23 Confirmation provided by (ID) 01095

Definition: This field contains the qualification of the health professional who confirmed the observation if the primary observer was not a health professional. Refer to HL7 table 0242 - Primary observer’s qualification for valid values.

7.11.2.24 Primary observer aware date/time (TS) 01096

Definition: This field identifies the date/time the primary observer became aware of event.

7.11.2.25 Primary observer's identity may be divulged (ID) 01097

Definition: Indicates whether or not the primary observer, if known to the sender, grants permission to disclose his or her identity to the product manufacturer for the purpose of further investigating the event. If the element is absent, the assumption should be made that permission is not granted. Refer to HL7 table 0243 - Identity may be divulged for valid values.

Table 0243 - Identity may be divulged

Value

Description

Y

Yes

N

No

NA

Not applicable

Previous Page TOC Index Next Page