Policy responses and statements

Name of organisation:

National Clinical Dataset Development Programme (NCDDP)

Name of policy document:

National Clinical Data Standards for Adverse Reactions

Deadline for response:

30 May 2008

Background: The National Clinical Dataset Development Programme team requested feedback on a package of data standards for National Clinical Data Standards for Adverse Reactions. Feedback is essential since these data items and definitions will be those which will be used in any Electronic Patient Record in Scotland. Systems which adhere to these data standards will be able to communicatie with each other and share information (for instance between primary and secondary care and between hospitals) - this is vital to optimise the care of patients. The NCDDP team therefore wishes to consult as widely as possible.

• The Clinical Data Standards for Adverse Reactions will:
• Support direct patient care, being informed by prevailing best practice guidance.
• Support secondary data requirements where possible including data to support clinical governance.
• Be freely and widely available on through publication on the online Health & Social Care Data Dictionary.
• Incorporate agreed national clinical definitions and implement national terminology.

COMMENTS ON
NATIONAL CLINICAL DATASET
DEVELOPMENT PROGRAMME (NCDDP)
NATIONAL CLINICAL DATA STANDARDS FOR ADVERSE REACTIONS

The Royal College of Physicians of Edinburgh is pleased to respond to the NCDDP on its consultation on the National Clinical Data Standards for Adverse Reactions.  In responding to this consultation, the College has sought the views of Fellows with expertise in toxicology and clinical pharmacology.

General Comments

1. The College welcomes the concept of setting standards for data collection in this important area, but is concerned about the focus of the offered standards and therefore the potential to support public health in Scotland.  There is a real danger of collecting information which is of no practical use, whilst missing the opportunity to do things in the area of pharmaco- and toxico-vigilance, both for medicinal products and other environmental products. 

2. The College believes that there is enormous potential for the outlined strategy to deliver key information to healthcare providers and, more importantly, to external agencies including the MHRA.  However, the authors appear to confuse adverse events and adverse reactions, and these definitions are crucial to the usefulness of the dataset to be collected.  This may explain why the document seems rather focussed in very particular areas, not all of which may be of most relevance to public health in Scotland. 

3. The College notes that the classification and data systems have been taken from existing systems.  However, the consultation document has not been referenced to allow the reader to understand the source documents used to arrive at the specific proposals, and why the framework has been developed as presented.  It may have been helpful to seek comments from a smaller number of interested individuals in Scotland before issuing the document for wide public consultation.

4. The College notes the inclusion of the Yellow Card Centre (YCC) in the list of consultation stakeholders, and believes their views on the monitoring of drug reactions and links with the MHRA will be helpful.  There will be enormous public health gain if ADR Reports as entered into any NHS Computer system could be linked with (where appropriate) anonymised patient details to a central collection data point, and this would include feeding into MHRA systems.  Clearly, there is an opportunity to take electronic data directly from the electronic record and paste it into a Yellow Card report for forwarding to the MHRA electronically.  The College is concerned that the proposed standards may not take full account of this opportunity.

5. Additionally, there is enormous potential to collect data on areas currently under-reported and which remain a serious public health hazard, specifically adverse affects of herbal medicines and household and other chemical products used in the environment. The whole approach would need to be in line with existing IT structures, specifically using coding systems that are truly UK national and international, rather than local to Scotland.  This may require some rewriting of the presently proposed coding systems, but should be considered given the potential public health benefit.

6. The College is concerned that, although the MRHA is mentioned at various points in the document, the coding structures are not aligned with standard MHRA systems.  The balance of the document may focus on food to the detriment of other surveillance objectives, particularly herbal medicines, plants and chemicals agents in the environment. 

7. The College is disappointed that the scope of these standards specifically excludes drug interactions where there is significant risk, and the opportunity to develop an improved surveillance system.

Specific Comments about the Framework

a)    Exposure Details

1. There seems an excessive weight place on the exact timing of the adverse reaction

2. Medication and devices have been separated from “causative agent” for reasons that are not clear (page 6).  These will be among the most common causes of reaction and consideration should be given to subdividing between prescribed medication and self-medication.  The College assumes that the authors are defining a sub-table for this class, and that the Centre for Adverse Drug Reaction Scotland is contributing to this work.

3. The causative agent exposure details do not reflect current approaches in experienced existing systems, and it may be helpful to discuss these with others who have expertise in this area eg Health Protection Scotland, and National Poisons Information Services.

4. The mode of exposure and details of these again appear non-standard internationally, and the authors should consider rewriting. 

5. The consultation document advises that the values in the causative data tables are examples and not exhaustive (page 9).  This should be more prominent within the guidance and/or tables to be reviewed, as some are too detailed and others deficient eg the list of food by comparison with the list of food additives and sheep, cows and goats have been omitted from the list of animals as causative agents.

6. The Cosmetics and Toiletries list (page 12) should comply with other international standards, and as presently presented are not comprehensive.  Discussions with the National Poisons Information Service could be helpful here.

7. The chemical list is also non-standard.  Creosote was banned in the UK 3-4 years ago, and mercury bichloride seems an unusual chemical to select on its own while other groups of more significance (eg organic solvents) are classed as one.

8. It is unclear how the items within the environment category (page 14) have been selected; this may not be wholly helpful within an adverse reaction standard.

b)    Reaction Details

1. The reaction details algorithm (page 16) is too simplistic, and does not reflect reality in medicine ADR detection.  Immunological reaction type should be a sub-class of clinical adverse reaction type. The reaction details should be discussed with the MHRA who have had significant (40 years) experience in this area.

2. The concept that the immunological reaction type can always be detected is incorrect, since the cause of many reactions may not be clear.  Immune causation may be missed (eg liver reactions) or incorrectly diagnosed (eg anaphylactoid reactions to aspirin).  Suggestions that skin sensitivity testing is useful may be misleading and potentially extremely dangerous.

3. The adverse reaction dictionary needs to link to a tested information source, and the College suggests that further discussion with the MHRA on this whole section would be helpful.