EMR from Prespective of Pharma

Pharma companies have started working with clinical service providers and started using EMR's from two prespectives

• Data and Study Setup


• Secondary Users Service

Data and Study Setup

Data and Study setup can be incorporated in a EMR to exploit the following features

• Implement screening parameters into core EMR to identify prospective patients for pharma trials at point of care
• Setup data capture from trials as part of clinical care and clinical documentation workflow
• Populate data in care report forms automatically from EMR
• Embed care record forms as tabs in core EMR so data is collected and stored against patient record
• Implement clinical rules and alerts for compliance and range checks for data and structured documentation checks

Secondary Users Service

It can be used for the following

• Easier data extraction from EMR for proper reporting on adverse events
• Unified reporting of current and historical data
• Findings can be published as standard clinical documentation
• Monitor outcomes based on ICP’s and evidence based decision support

Example Implementations

Pfizer – Drug Safety -Supporting Physician Reporting of Adverse Reactions and Public Health Threats

NOVARTIS – Clinical Trial: Lab and Image Data - Innovating Clinical Data Capture for Labs and Images using EMR lab ordering and results reporting using HL7

Eli Lilly – Patient Visit Workflow – Streamlining the patient workflow using standard Inpatient and Outpatient workflows

genzyme – Disease Registry – Profiling diseases geographically and using other statistical profiling such as gender , age etc

SAIC – Biosurveillance -Standardizing and Facilitating Data Collection for Enhanced Biosurveillance

Ramblings about Electronic Patient Record

This post is a set of ramblings which may sound a bit incoherent but needed to be grouped together to give an overview about some of the things that needed to considered about Electronic Patient record/Electronic Medical record.

Mandatory Pre-Requisite

In my view a mandatory pre-requisite for meeting the many objectives of Electronic Patient Record (EPR) is the ability of that application to support semantic interoperability of clinical information. What I mean by that is the Entry, storage and communication of clinical information by the application in ways that allow it to be consistently reused, retrieved and processed by it and its ability to communicate that information to different software applications. However maintaining Semantic Operability is not so easy due to various issues

• Technical issues
– Different information models
– Different clinical terminologies
– Different interfaces between information models and terminologies
• Practical issues
– Different perspectives on similar information
– Different motivations for data entry
– Different methods of data entry
– Different expectations about the use of information

Barriers

From my practical experience, implementation/deployment of EPR is not very easy; there are lots of barriers in implementing EPR. I jotted down a few of the barriers which needed to bottomed down in the business plan before deciding to implement EPR.

• Financial and Capital costs associated with the EPR applications

• Adoption of the systems mainly by clinicians and to some extent by auxiliary clinicians. Most organizations underestimate the training required for their staff to adopt the new system but also fail to convince them.

• Defining technology and information standards and adhering to them. I know in some cases it becomes expensive to adhere to them but if you start compromising then there will be no end to it.

•In some cases if the organization already has a legacy system the transition phase adds work to an already overburdened IT staff.

•Of course the now famous Information Governance issues covering security, privacy and consent to access the electronic records.

• In some cases the failure to define clear and tangible benefits also becomes a barrier

Standards

EMR’s and almost any other information-oriented system in a clinical environment cannot be used without well-defined standards for representing and communicating information. Data need to be exchanged between multiple, heterogeneous systems and might be used by very different applications .The following points highlight the need for standards

• Unavailable standardized communication results in health hazards, e.g. drug hypersensitivity
• Patients are starting to demand that ”their” data should be available online
• Improve efficiency by enabling professional cooperation in new ways
• Quality management requires aggregated data
• Standards allow integration of modular systems from different suppliers
• Many standards issues require professionals and authorities not just industry
• Standards can lower costs of ICT support by expanding the market

Failure Reasons

The failure of certain organisations in implementing Electronic Patient Record in my view is the failure to understand basic standardisation approaches in healthcare organisations. There are two standardisation approaches in theory

• External standardisation
– Strategic planning tool
– Market reassurance
– Consensus approach
• Internal standardisation
– Strategic enhancement of the use of internal resources
– Change management is essential
– Class discussion: regulatory and laissez-faire approaches to internal standardisation

Implementing EPR at a single organisation of multiple organisations read hospitals is essentially setting an internal standard for information processes related to patient information
– Regulatory approach: set the standard way for all possible situations involving production of patient information
– Laissez-faire approach: describe all accepted standard procedures and allow hospital staff to choose which standards to use or invent their own procedures, if necessary

Just wished they had known which approach to use.