# Presentation: 812094

## UK Country ExperienceGPRD & New methodologiesJohn ParkinsonHead of GPRDMHRAMedicines & Healthcare Products Regulatory Agencyjohn.parkinson@mhra.gsi.gov.uk

- April 2007 VSE PMS Conference

## Some comments will be made that relate to potential changes to vaccine, device and medicine surveillance as undertaken by the MHRA-Regulator.

Others will be made that relate to the GPRD group activity. This covers the use of data for Risk Management Plans, that are part of the REGULATORY requirement but acted upon by the Product Licence Holders of Mediceins/Vaccines. In this case the GPRD logo will be on screen.

The GPRD Group at the MHRA is NOT a part of the Regulatory Divisions of the MHRA but acts to provide “0bservational” data streams to any or all parties involved with Medicines, Vaccines and Devices safety and effectiveness – Academics, Regulators and Commercial parties – all working under scientifically approved protocols, and full governance approvals.

- Others will be made that relate to the GPRD group activity. This covers the use of data for Risk Management Plans, that are part of the REGULATORY requirement but acted upon by the Product Licence Holders of Mediceins/Vaccines. In this case the GPRD logo will be on screen.
- _The GPRD Group at the MHRA is NOT a part of the Regulatory Divisions of the MHRA_ but acts to provide “0bservational” data streams to any or all parties involved with Medicines, Vaccines and Devices safety and effectiveness – Academics, Regulators and Commercial parties – all working under scientifically approved protocols, and full governance approvals.

**Disclaimer**

## What is GPRD

- The General Practice Research Database
- Data from a Primary Care (gatekeeper) NHS doctors IT system
- Generalisable 5.5% sample (E, S, W, Ni)
- Roster file- sex, DOB, age, SE class, Lifestyle- BMI, Smoking, alcohol, death
- GP/nurse contacts, symptoms, diagnoses, lab tests, hospital clinics, hospitalisations, additional clinical details- treatments- Rxs and _**Immunisations**_
- 3.4 Million actives, 12 million ever, 40 million Patient years of usable data
- Extensive QC of dataset
-  Guidelines, Internal, external checks, validity studies
- 500 Peer reviewed publications
- Over 100 studies in progress

## What is GPRD

**+ NEW** this year using NHS Universal ID
- RECORD LINKAGE – GPRD -other NHS datasets
- Central death data
- Full hospitalisation data (each episode)
- Disease registers
- Cardiovascular
- Cancer
- +++

## Also NEW to GPRD

- Randomise into GPRD (and other datasets)
- Large scale simple Phase 4 studies
- 	Normal care
- 	Consent to randomise
- 	A vs B
- 	Prescribe in normal manner- database
- 	Events etc- database
- Vaccine work by cluster randomisation
- Highly cost effective
- Easy to set up
- Rapid large n’s possible

## GPRD IMMUNISATION table

**GPRD IMMUNISATION table**

- Crown copyright 2007 ©

| RIN001 | Epidemic |  |
| --- | --- | --- |
| RIN002 | Special Risk Group |  |
| RIN003 | Routine Measure |  |
| RIN004 | Traveller |   |

| IME001 | Intramuscular |  |
| --- | --- | --- |
| IME002 | Oral |   |
| IME003 | Subcutaneous |  |
| IME004 | Intradermal |  |

**Operator ID**

**System date and time**

**Immunisation record**

**Immunisation sequence #**

**Patient ANON. ID**

**Consultation ID**

**Topic #**

**Type of contact- in clinic**

**Who acting on patient**

**Date**

**NHS or Private**

**READ Medical code**

**TEXT**

**READ code TEXT**

**Stage in sequence**

**Given, refused, advised**

**Compound**

**Source of**

**Batch #**

## UK Current  Drug and or Immunisation Surveillance/Research Systems

**UK Current  Drug and or ****Immunisation Surveillance/Research Systems**

- YELLOW CARD- MHRA, all UK, Doctors, HP, Patients- currently a passive system
- Green Card- DSRU, follow up of initial _Prescribed_ cohort- paper based, NO vaccine studies
- Orange Card- BPSU (RCPCH+HPA), research studies on rare childhood diseases
- Cohort, case control or other Epi studies- GPRD and others

## Yellow card reports and Immunisations

- Meningitis C Vaccine (18M)

## Thoughts on an IDEAL/ Active Surveillance System

- Nearly all healthcare systems have or are getting IT systems/clinical systems/billing systems
- Few countries, if any, will have one system with one database
- As a consequence - for significant volume ACTIVE SURVEILLANCE to work-
- data will have to come from many different systems
- How to get at such data- simply, conveniently
- A universal query tool- the Google approach (Jesse Goodman)

## Changes towards ACTIVE Surveillance- UK SceneNOT a THOUGHTA REALITY

- Made possible by massive NHS investment in IT
- Hardware, NHS intranet, Software
- Other software developed outside of NPfIT
- + HEALTHSPACE
- Each person in UK has web space on the NHS IT system
- ADRs (Yellow cards already open to public)
- UKCRC- CfH working groups (4)
- 	Surveillance and safety lead –John Parkinson on 	behalf of MHRA,NPSA, HPA, academics, 	pharma industry

## From Passive to Active systems

- Volumes of data
- Methods of analysis
- People able to undertake the required analysis

## The Universal Query Toolfor accessing DATAfor Surveillance and Risk Management

- Crown copyright 2007 ©

- Clinical or Billing IT system

- Database

- Surveillance database

-    **GPRD Licensed Powerful Intelligent Software**

- Permissions

- Already proven technology
- Resides in most/all UK clinical systems

**1**.        An **EXPOSURE** to medicine
-  and _**EVENTS**_ **TRACKING** system
- Hourly, daily, actually weekly

**2****. + methodology for analysis and use for ****	****- Risk Management Plans**
**	****- everyday clinical care**

- & vaccines

- Better analytic tools JG

- The more rapid-
- Easier to have controls

## The EXETRAC Powerful Intelligent Software

- Retrieves requested data or information from _any_ database
- 	with Knowledge of table and field structure
- 	Specific variables as in database
- 	The results of complex calculations performed on the database server based upon a series of variables- (GRID computing)
- 	AND OR NOT statements
- Highly relevant to vaccine data
- 	Very large ns
- 	Only want to move data that is really necessary

## ACTIVE SURVEILLANCEfrom many systems

- Is it POLITICALLY or .......otherwise acceptable?
- Who owns the data???
- Health and illness data is owned by the individual ...?
- Anonymous data
- Approved, audited purposes only
- SAFEGUARDING PUBLIC HEALTH
- What is not acceptable about that?
- Data of this nature should not be a commodity (traded) it is an essential that it should be available for the purpose of Public Health
- Such services, however, have to be paid for.
- What if you need to validate--- anon?
- The anon is “Effectively anonymised” using the domains of data concept. So there can be a way back

- john.parkinson@mhra.gsi.gov.uk