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7.11.3 PCR - possible causal relationship segment

The PCR segment is used to communicate a potential or suspected relationship between a product (drug or device) or test and an event with detrimental effect on a patient. This segment identifies a potential causal relationship between the product identified in this segment and the event identified in the PEO segment.

More than one PCR segment can be included in the message if more than one product is possibly causally related to the event.

Figure 7-22. PCR attributes

SEQ

LEN

DT

OPT

RP/ #

TBL #

ITEM #

ELEMENT NAME

1

60

CE

R



01098

Implicated Product

2

1

IS

O


0239

01099

Generic Product

3

60

CE

O



01100

Product Class

4

8

CQ

O



01101

Total Duration Of Therapy

5

26

TS

O



01102

Product Manufacture Date

6

26

TS

O



01103

Product Expiration Date

7

26

TS

O



01104

Product Implantation Date

8

26

TS

O



01105

Product Explantation Date

9

8

IS

O


0239

01106

Single Use Device

10

60

CE

O



01107

Indication For Product Use

11

8

IS

O


0239

01108

Product Problem

12

30

ST

O

Y/3


01109

Product Serial/Lot Number

13

1

IS

O


0239

01110

Product Available For Inspection

14

60

CE

O



01111

Product Evaluation Performed

15

60

CE

O


0247

01112

Product Evaluation Status

16

60

CE

O



01113

Product Evaluation Results

17

8

ID

O


0248

01114

Evaluated Product Source

18

26

TS

O



01115

Date Product Returned To Manufacturer

19

1

ID

O


0242

01116

Device Operator Qualifications

20

1

ID

O


0250

01117

Relatedness Assessment

21

2

ID

O

Y/6

0251

01118

Action Taken In Response To The Event

22

2

ID

O

Y/6

0232

01119

Event Causality Observations

23

1

ID

O

Y/3

0253

01120

Indirect Exposure Mechanism

7.11.3.0 PCR field definitions

7.11.3.1 Implicated product (CE) 01098

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 contains the coded identity of the product (drug, device, etc.) which is possibly causally related to the event. Includes the product identity number such as NDC, model or catalogue numbers. If a coded value is not available for the product a text description can be included as the second component of the CE data. See Chapter 2 for a listing of some recognized coding systems for drugs and devices.

7.11.3.2 Generic product (IS) 01099

Definition: This field indicates whether the product used was a generic or a branded product. Refer to user-defined table 0239 - Event expected for suggested values.

7.11.3.3 Product class (CE) 01100

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 contains the coded classification of the implicated product. For drugs, this would usually be the drug class - calcium channel blocking agents for nifedipine for example. For other products it would be the generic type of device, e.g., urinary catheter, cardiac pacemaker. If a coded value is not available for the class, a text description can be included.

7.11.3.4 Total duration of therapy (CQ) 01101

Components: <quantity> ^ <units>

Definition: This field represents the total duration of therapy with product listed. The treatment at the current dose and schedule are indicted in the quantity timing attribute of the RXE segment but the patient may have been treated for some time previously at a different dose or on a different schedule. The quantity in the second component of the CQ should be a time quantity.

7.11.3.5 Product manufacture date (DT) 01102

Definition: This field indicates the date the product was manufactured.

7.11.3.6 Product expiration date (DT) 01103

Definition: This field contains the expiration date indicated on the product packaging.

7.11.3.7 Product implantation date (DT) 01104

Definition: If an implantable medical device, this field identifies the date device was implanted.

7.11.3.8 Product explantation date (DT) 01105

Definition: If an implantable medical device and it was removed, the field identifies the date it was removed.

7.11.3.9 Single use device (IS) 01106

Definition: This field indicates whether the product was designed for a single use. Refer to user-defined table 0239 - Event expected for suggested values.

7.11.3.10 Indication for product use (CE) 01107

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 contains coded representation of the problem or diagnosis for which the product was used. See Chapter 2 for some coding systems which might be chosen to transmit diagnoses or problems.

7.11.3.11 Product problem (IS) 01108

Definition: A product problem would exist if a product malfunction could lead to death or serious injury. Refer to user-defined table 0239 - Event expected for suggested values.

7.11.3.12 Product serial/lot number (ST) 01109

Definition: This field is an alphanumeric descriptor which identifies the specific item or lot of drug. This descriptor would normally be obtained from the package labeling or item itself.

7.11.3.13 Product available for inspection (IS) 01110

Definition: This field indicates that the product is available for analysis. Refer to user-defined table 0239 -Event expected for suggested values. If the product was returned to the manufacturer, this would be indicated by including the date it was returned in the date product returned to manufacturer element.

7.11.3.14 Product evaluation performed (CE) 01111

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 indicates the type of product evaluation performed. The evaluation codes listed in SubPart B of the Coding Manual for FDA Form 3500A, "Type of Evaluation Performed" may be used. If no codes are available, text may be sent in the second component of the field.

7.11.3.15 Product evaluation status (CE) 01112

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 status of product evaluation. Subpart A Item H.3 of the Coding Manual for FDA Form 3500A may also be used. If no codes are available, text may be sent in the second component of the field. Refer to HL7 table 0247 - Status of evaluation for valid values.

Table 0247 - Status of evaluation

Value

Description

Y

Evaluation completed

P

Evaluation in progress

K

Problem already known, no evaluation necessary

X

Product not made by company

A

Evaluation anticipated, but not yet begun

D

Product discarded -- unable to follow up

C

Product received in condition which made analysis impossible

I

Product remains implanted -- unable to follow up

U

Product unavailable for follow up investigation

Q

Product under quarantine -- unable to follow up

R

Product under recall/corrective action

O

Other

7.11.3.16 Product evaluation results (CE) 01113

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 contains the results of the product evaluation.

7.11.3.17 Evaluated product source (ID) 01114

Definition: This field contains the source of the product evaluated. Refer to HL7 table 0248 - Product source for valid values.

Table 0248 - Product source

Value

Description

A

Actual product involved in incident was evaluated

L

A product from the same lot as the actual product involved was evaluated

R

A product from a reserve sample was evaluated

N

A product from a controlled/non-related inventory was evaluated

7.11.3.18 Date product returned to manufacturer (TS) 01115

Definition: If the product was returned to the manufacturer, this field contains the date it was returned may be reported.

7.11.3.19 Device operator qualification (ID) 01116

Definition: This field identifies the qualification of the person operating the device when the event occurred. Refer to HL7 table 0242 - Primary observers qualification for valid values.

7.11.3.20 Relatedness assessment (ID) 01117

Definition: This field represents the assessment of relatedness of the product to the event. Refer to HL7 table 0250 - Relatedness assessment for valid values.

Table 0250 - Relatedness assessment

Value

Description

H

Highly probable

M

Moderately probable

S

Somewhat probable

I

Improbable

N

Not related

7.11.3.21 Action taken in response to the event (ID) 01118

Definition: This field indicates the action taken as a result of the event. Segment may repeat if multiple categories of evidence are relevant. Refer to HL7 table 0251 - Action taken in response to the event for valid values.

Table 0251 - Action taken in response to the event

Value

Description

WP

Product withdrawn permanently

WT

Product withdrawn temporarily

DR

Product dose or frequency of use reduced

DI

Product dose or frequency of use increased

OT

Other

N

None

7.11.3.22 Event causality observations (ID) 01119

Definition: This field contains observations made about the event which may bear on causality. Refer to HL7 table 0252 - Causality observations for valid values. Segment may repeat if multiple categories of evidence are relevant.

Table 0252 - Causality observations

Value

Description

AW

Abatement of event after product withdrawn

BE

Event recurred after product reintroduced

LI

Literature reports association of product with event

IN

Event occurred after product introduced

EX

Alternative explanations for the event available

PL

Effect observed when patient receives placebo

TC

Toxic levels of product documented in blood or body fluids

DR

Dose response observed

SE

Similar events in past for this patient

OE

Occurrence of event was confirmed by objective evidence

OT

Other

7.11.3.23 Indirect exposure mechanism (ID) 01120

Definition: The patient identified in the PID segment, who experienced the event, might have been exposed to the potential causal product via an intermediary, e.g., an child might be exposed to a product through the placenta or in breast milk, or a transfusion recipient might be exposed via a blood product. If this is the case, the mechanism of product transmission is identified in this field, using the valid values in HL7 table 0253 - Indirect exposure mechanism. If this field is populated, the identity of the person through whom the product was transmitted is contained in NK1 and RXE segments which follow.

Table 0253 - Indirect exposure mechanism

Value

Description

B

Breast milk

P

Transplacental

F

Father

X

Blood product

O

Other

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