ID

37817

Description

Sentinel: Overview and Description of the Common Data Model v7.0.0 "The primary goal ofSentinel is to build and operate a national public health surveillance system to monitor the safety of FDA-regulated medical products, including drugs, biologics, and devices. Sentinel is part of the Sentinel Initiative, the FDA’s response to a congressional mandate to create an active surveillance system using electronic health data.The Sentinel program will undertake three major types of activities: (1) prospective evaluation of accumulating experience about specific medical products and specific suspected safety problems; (2) evaluation of the impact of FDA actions (e.g., labeling changes) on medical practice and health outcomes; and (3) rapid assessment of past experience in response to FDA questions about specific exposures and outcomes." For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org The SCDM Outpatient Pharmacy Dispensing Table contains one record per unique combination of PatID, NDC, and RxDate. Each record represents an outpatient pharmacy dispensing. Rollback transactions and other adjustments should be processed before populating this table.

Link

www.sentinelsystem.org

Keywords

Versions (4)
  1. 1/8/17 1/8/17 -
  2. 1/29/17 1/29/17 -
  3. 8/25/19 8/25/19 -
  4. 8/25/19 8/25/19 -
Copyright Holder

FDA's Sentinel Initiative

Uploaded on

August 25, 2019

DOI

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License

Creative Commons BY-NC-ND 3.0
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Sentinel Common Data Model Pharmacy Dispensing

English

Sentinel Common Data Model Pharmacy Dispensing

1 forms  
Pharmacy Dispensing
Description

Pharmacy Dispensing

Alias
UMLS CUI-1
C0947323
Patient ID
Description

Arbitrary person-level identifier. Used to link across tables. Note: PatID is a pseudoidentifier with a consistent crosswalk to the true identifier retained by the source Data Partner. For analytical data sets requiring patient-level data, only the pseudoidentifier is used to link across all information belonging to a patient.

Data type

text

Alias
UMLS CUI [1]
C2348585
Dispensing Date
Description

Dispensing date (as close as possible to date the person received the dispensing).

Data type

date

Alias
UMLS CUI [1,1]
C0947323
UMLS CUI [1,2]
C0011008
National Drug Code
Description

Please expunge any place holders (e.g., ‘-‘ or extra digit).

Data type

text

Alias
UMLS CUI [1]
C1708005
Days supply
Description

Number of days that the medication supports based on the number of doses as reported by the pharmacist. This amount is typically found on the dispensings record. It should not be necessary to calculate this variable for use in the SCDM. Positive integer values are expected. Note: Rollback transactions and other adjustments that are indicative of a dispensing being canceled or not picked up by the member should be processed before populating this table. This may be handled differently by Data Partners and may be affected by billing cycles.

Data type

integer

Alias
UMLS CUI [1,1]
C0243163
UMLS CUI [1,2]
C1948053
Amount dispensed
Description

Number of units (pills, tablets, vials) dispensed. Net amount per NDC per dispensing. This amount is typically found on the dispensings record. It should not be necessary to calculate this variable for use in the SCDM. Positive values are expected. Note: Rollback transactions and other adjustments that are indicative of a dispensing being canceled or not picked up by the member should be processed before populating this table. This may be handled differently by Data Partners and may be affected by billing cycles.

Data type

text

Alias
UMLS CUI [1]
C0805077
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Similar models

Sentinel Common Data Model Pharmacy Dispensing

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pharmacy Dispensing
C0947323 (UMLS CUI-1)
PatID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
RxDate
Item
Dispensing Date
date
C0947323 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
NDC
Item
National Drug Code
text
C1708005 (UMLS CUI [1])
RxSup
Item
Days supply
integer
C0243163 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
RxAmt
Item
Amount dispensed
text
C0805077 (UMLS CUI [1])
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