Drug Details

This section provides additional information about the drug details.

May be multiple occurrences per submission (0..*)

Start of Section - Administration Measurement Per Daily Total Dose (0..1)

End of Section - Administration Measurement Per Daily Total Dose

Administration Date Choice (1..1)

Choice 1

End of Choice 1

Choice 2

End of Choice 2

End of Administration Date Choice

Start of Section - Dose Modification (0..1)

End of Section - Dose Modification

The following data items has been removed from SACT v4:

• 52 – DM+D
  • no longer required due to inaccurate data submission during pilot phase
• 34 – Administration Date
  • replaced with two new data items

Drug Name

This is a mandatory data item. The ‘Drug Name’ is the name of the SACT drug given to a PATIENT during an Anti-Cancer Drug Regimen. The name is taken from British National Formulary (BNF).

Notes:

• SACT would like to receive all anti-cancer drugs
  • please note that the term ‘anti-cancer drugs’ can include BCG, bisphosphonates, biological therapies, and hormonal treatments
• if you happen to include anti-sickness drugs, SACT will accept them
• all anti-cancer drugs by any administration route are included in SACT, but local arrangements may be necessary to add these to the download
• for drugs not yet in the BNF, use the approved name as this will usually be the drug name used by the pharmacy

Daily Total Dose Per Administration

Record the daily dose for the drug administered or dispensed.

Notes:

• this data item has an updated name and description in v4
• SACT will accept the dose entered by the clinician, to represent the dosage up to a maximum of 8 digits
  • specify the correct unit as specified in the following data items

Administration Measurement Per Daily Total Dose

Record the actual unit of measurement used for the daily dose of each administration in a SACT cycle.

Notes:

• this data item has an updated name and description in v4
• PFU is the acronym for Plague-Forming Unit

Additional notes:

• the following two data items are part of a new section which is required
  • therefore, if you do not know this information, you do not have to submit any data
• however, both data items are mandatory within the section
  • therefore, you cannot submit one without the other

Administration Measurement Per Daily Total Dose

Record ‘other’ if there is another unit of measurement used for an administration in a SACT cycle, which is not in the list above.

Note:

• this data item has an updated name and description in v4

Other - Administration Measurement Per Daily Total Dose

Record the other unit of measurement for the total daily dose of each administration in a SACT cycle if not available within [administration measurement per actual dose] field. This must be completed if 98 - Other is selected

Note:

• this data item has an updated name and description in v4

Unit of Measurement (SNOMED CT DM+D)

Record the SNOMED CT® concept ID from the NHS Dictionary of Medicines and Devices, which is used to identify the unit of measurement.

Notes:

• this data item is ‘Required’ in v4, previously ‘Optional’
• You can use the support at the end of the user guide to find the correct SNOMED CT unit of measurement

SACT Administration Route

Record the prescribed method of delivery for each administration in a SACT cycle.

Route of Administration (SNOMED CT DM+D)

Record the SNOMED CT® concept ID from the NHS Dictionary of Medicines and Devices which is used to identify the route of administration.

Note:

• this data item is ‘Required’ in v4, previously ‘Optional’

Administration Date Choice

The following two new data items, form a choice where either the drug infusion or drug dispensed details can be recorded. This is a Mandatory [1..1] section, therefore one or the other must be selected depending on the treatment being delivered.

Choice 1:

Administration Timestamp (Infusion): If selected, this is a mandatory data item. Record the date and time when the anti-cancer drug was administered to a patient (an infusion commenced).

These data can be entered using separate ‘user friendly’ fields as follows:

• Administration Date (Infusion Administered):
  • the date of the infusion must be recorded, and this can be obtained from the clinic date where the infusion was administered
• Administration Time (Infusion Administered):
  • the time of the infusion must be recorded, and this can be obtained from the clinic (appointment) time where the infusion was administered, seconds can be recorded/defaulted as :00
  • if the time is not known, then a default code can be used as detailed below
    • Examples of valid formats are:
      • 08:15:30 or 15:35:00

For developers: A time must always be submitted; a default time can be set to 00:00:00.

For reporting, the date and time must be combined and include the correct British Summer Time (GMT + 1 Hour), or Greenwich Mean Time addition. It would not be expected that service users would be required to input these additional variables (only the time as indicated above).

Example of a valid reporting format:

• 2024-09-01T10:15:00+(time zone offset either 01:00, 00:00, or Z)

Choice 2:

Administration Date (Oral Drug Dispensed): If selected, this is a mandatory data item. For continuous oral chemotherapy, the administration date will be the date on which an oral drug was dispensed to the patient or prescription issued.

Notes:

• for this date there is no change to the v3.0 format, in that only the date is required, and this must be recorded using the standard date format:
  • all date formats must be ccyy-mm-dd
  • SACT will not recognise or accept American date formats

Cycle Length in Days

This is a new data item for v4. Record the length of the cycle (in days) for the drug administered or dispensed. This has a range of 1-366 days (which covers a leap year).

Number of Cycles Administered (On A Named Day)

This is a new data item for v4. Record the number of cycles administered on the named day for the drug administered or dispensed. This has a range of 1-20.

Organisation Identifier of SACT Administration

Record the ‘Organisation Identifier’ of the organisation for each administration in a SACT cycle. This is the 3 or 5-digit code of the organisation.

Note:

• this could also include the new ANANA codes, created for new organisations.

These grouped data items form a section, which identifies if there was modification to the dose.

This is a Required [0..1] section, however the data is important and where applicable must be selected as follows:

• if ‘No’ is selected, then no further data is required
• if ‘Yes’ is selected, then additional questions will be asked, and in some cases additional linked data items may also be valid and needs answering:
  • these additional questions are important, and validations will be used as you upload your data onto the NDRS API
  • these are required to improve and enforce data quality and prevent illogical data returns
  • it is important that you implement processes to ensure your data is correct

Dose Modification

This is a new data item in v4. Record if there was a modification to the dose.

Note:

• if you are recording a dose modification, this data item becomes mandatory within the section

Reason For Dose Modification

This is a new data item in v4. Record the reason for any changes to the dose. More than one option can be selected, where appropriate.

Notes:

• 2 - Organisational (Trust) Issues, is where a modification was due to organisational issue such as protocol, capacity, IT & infrastructure
• 3 – Patient (Clinical) Factors, is where a modification was due to Genomics e.g. DPYD variant, Frailty, Comorbidities or Other
• 4 - Toxicity, identifies that toxicity arising from the patient’s regimen was a factor in modifying the dose and/or schedule of their regimen

Reason For Dose Modification - Patient (Clinical) Factors

This is a new data item in v4. Record the clinical factors that were a factor in modifying the dose.

More than one option can be selected, where appropriate, but can only be selected if ‘3-Patient (Clinical) factors’ is selected in ‘Reason for Dose Modification’

Notes:

• 1 - Genomics e.g. DPYD variant, is the gene encoding the Dihydropyrimidine Dehydrogenase (DPD) enzyme that affects how bodies break down fluorouracil and capecitabine derived chemotherapy drugs
• 2 - Frailty, identifies that the patient’s frailty was a factor in modifying the dose and/or schedule of their regimen
• 3 - Comorbidities, identifies that the patient’s comorbidities were a factor in modifying the dose and/or schedule of their regimen
• 8 - Other, identifies other reasons that were a factor in modifying the dose and/or schedule of their regimen

Toxicity Grade (Dose Modification)

This is a new data item in v4. Record toxicity score/rating using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Notes:

• only one grade can be selected, per ‘Reason for Dose Modification’
• this data item must only be selected if ‘4- Toxicity’ is selected in ‘Reason for Dose Modification’