PEX^P07 — Product Experience

The HL7 message dedicated to the formal report of a product experience: typically a drug or device adverse event, transmitted from the EHR or hospital pharmacy to an authority (ANSM, FDA FAERS, EMA EudraVigilance) or a sponsor (manufacturer).

Purpose

An adverse event detected in a ward must be reported to the competent authority (pharmacovigilance, materiovigilance, hemovigilance). Before the ICSR (Individual Case Safety Report) ICH E2B(R3) XML for EudraVigilance, the HL7 v2 PEX^P07 channel is still used to transmit a report between hospital systems and to some sponsors.

The message carries PES (Product Experience Sender), PEX (Product Experience), PCR (Possible Causal Relationship), RXR (Pharmaceutical Route), OBX (clinical observations) and NTE (narrative notes) segments.

Segment structure

PEX_P07
  MSH                    Message Header
  EVN                    Event Type
  PID                    Patient Identification
  [ NK1 ]                Next of Kin
  [ PV1 ]                Patient Visit
  PES                    Product Experience Sender
  { PEX                  Product Experience (1..*)
    { PCR                Possible Causal Relationship (1..*)
      [ RXE ]            Pharmacy Encoded Order
      [ { RXR } ]        Pharmaceutical Route
      [ RXA ]            Administration
      [ { OBX } ]        Observations
      [ { NTE } ]        Notes
    }
    [ { NTE } ]
  }

Real-world example

Patient hospitalised for acute hepatitis attributed to amiodarone, reported to ANSM:

MSH|^~\&|EHR|HOSP01|VIG|ANSM|20260516141500||PEX^P07^PEX_P07|MSG-PV-2026-3344|P|2.5.1|||AL|NE
EVN|P07|20260516141500|||PHARMACOVIG^Pharmacovigilance
PID|1||MRN201234^^^HOSP^MR||MARTIN^MARIE^^^MRS.||19761110|F|||50 RUE DE PARIS^^LYON^^69001^FR
NK1|1|MARTIN^PIERRE^^^MR.|SPO^Spouse
PV1|1|I|CARDIO^301^B^HOSP01|RT|||DRDUBOIS^Dubois^Jean^M^^DR.|||CAR
PES|VIG|GLOBAL-ID-998765|REPORTING-001
PEX|1|R02|20260514|20260516|||S
PCR|||DRUG^AMIODARONE|||||||||AMIODARONE 200MG||N|N|||L
RXR|PO^Oral
OBX|1|TX|HEPATIC^Hepatic toxicity^L||Acute hepatitis with markedly elevated transaminases. ALT 1500 IU/L, AST 1200 IU/L. Onset 2 days after dosage increase.
NTE|1||Hospitalisation required, close hepatic monitoring. Treatment discontinued.

• PES-1 = event type (R02 — Hospitalization).
• PCR-3 = suspect substance (AMIODARONE).
• RXR-1 = route (PO oral).
• OBX-3 = narrative MedDRA code (Hepatic toxicity) with ALT/AST values.
• NTE = pharmacologist assessment.

Acknowledgment (ACK)

MSH|^~\&|VIG|ANSM|EHR|HOSP01|20260516141501||ACK^P07^ACK|ACK-PV-2026-3344|P|2.5.1
MSA|AA|MSG-PV-2026-3344

Common errors

• No PCR: causality (possible cause) is the core of the report. PCR is mandatory.
• Uncoded substance: use ATC, RxNorm or ChEMBL in PCR-3, not free text.
• Start / end dates mismatched: PEX-3 (onset) and PEX-4 (report date) must be consistent.
• OBX without MedDRA / WHO-ART coding: for agencies, adverse events must be MedDRA-coded.
• Confidentiality not protected: PEX carries sensitive patient data; transport must be encrypted (TLS, AS2).

Related messages

See also: FHIR AdverseEvent — R5 equivalent.