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
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.
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.
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.
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.
Definition: This field indicates the date the product was manufactured.
Definition: This field contains the expiration date indicated on the product packaging.
Definition: If an implantable medical device, this field identifies the date device was implanted.
Definition: If an implantable medical device and it was removed, the field identifies the date it was removed.
Definition: This field indicates whether the product was designed for a single use. Refer to user-defined table 0239 - Event expected for suggested values.
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.
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.
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.
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.
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.
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 |
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.
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 |
Definition: If the product was returned to the manufacturer, this field contains the date it was returned may be reported.
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.
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 |
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 |
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 |
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 |