Evaluation of Adverse Reaction Data Collected in National, Primary Care Electronic Medical Records for its use in Pharmacovigilance Activities

TITLE: Evaluation of Adverse Reaction Data Collected in National, Primary Care Electronic Medical Records for its use in Pharmacovigilance Activities

SOLICITATION NUMBER: 1000155976

1.  The purpose and explanation of an ACAN

An Advance Contract Award Notice (ACAN) allows Health Canada contracting authorities to post a notice on MERX, for no less than fifteen (15) calendar days, indicating to the supplier community that a good, service or construction contract will be awarded to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the requirements set out in the ACAN, the contracting authority may then proceed with the award. However, should a Statement of Capabilities be found to meet the requirements set out in the ACAN, then the contracting authority will proceed to a full tendering process.

2.  Rights of suppliers

Suppliers who believe that they are fully qualified and available to provide the services or goods described in this ACAN may submit a Statement of Capabilities clearly demonstrating how they meet the advertised requirement. This Statement of Capabilities must be provided via e-mail only to the contact person identified in Section 12 of the Notice on or before the closing date and time of the Notice. If there is a reasonable level of evidence regarding capability, the requirements will be opened to electronic or traditional bidding processes.

3.  Proposed Contractor

The College of Family Physicians of Canada
2630 Skymark Avenue
Mississauga, Ontario
L4W 5A4

(on behalf of The Canadian Primary Care Sentinel Surveillance Network)

4.  Definition of Requirements or Expected Results

This project will evaluate the completeness and quantity of adverse reaction (AR) data that is collected in electronic medical records and is available in the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) database.  The initial phase of work is expected to generate evidence of the potential uses and deficiencies of national, primary care electronic medical record (EMR) data (as-is content and format) for Health Canada’s pharmacovigilance activities. Future phases of the project may provide opportunities to improve adverse reaction data quality and quantity through enhancements to data collection and processing, alignment with international data models, and feedback to participating physicians. The information obtained will inform the Marketed Health Products Directorate’s effort to create more proactive and systematic approaches for health product monitoring, including making increased use of electronic medical records.
									
The Contractor shall carry out (to the satisfaction of the Departmental Representative and/or Departmental Project Authority) the following tasks/deliverables:

PHASE I - Contract Award to April 30, 2014

Tasks: to evaluate the quantity and completeness of adverse reaction data available within Canadian primary care EMRs and how that data is collected and processed by CPCSSN.  

1)	Kick-off meeting (teleconference)
2)	Undertake an analysis of AR data within the CPCSSN national EMR database, including an investigation of each EMR platform for potentially relevant sources of AR data.
3)	Create, in a retrospective manner, a de-identified CPCSSN AR database for Health Canada internal review.  The data set provided for the suspected adverse reactions associated with selected health products (to be identified by Health Canada) will include the following, where available: 
Patient Information 
•	Generic identifier 
•	Age (at reaction onset)
•	Sex 
•	Height
•	Weight 
•	Ethnicity
•	Current disease/health conditions list (e.g. allergies, pregnancy, hepatic/renal dysfunction)
•	Previous drug reaction(s)

Adverse Reaction 
•	Outcome attributed to adverse reaction (e.g. recovered/resolved, recovering/resolving, not recovered/not resolved, recovered/resolved with sequelae, fatal, and unknown)
•	Seriousness of adverse reaction (e.g. Death; Life-threatening; Hospitalization; Hospitalization–prolonged; Disability; Congenital malformation; Required intervention to prevent damage/permanent impairment)
•	Reaction date 
•	Report/Record date
•	Reaction description 
•	Relevant diagnostic tests/laboratory data 

Suspected Health Product(s) 
•	Name, strength and manufacturer 
•	Dose, frequency and route of administration 
•	Therapy dates
•	Indication for use  
•	De-challenge information (e.g. reaction abated after use stopped or dose reduced?)
•	Re-challenge information (e.g. reaction reappeared after reintroduction?)
•	Lot # 
•	Expiration 
•	Concomitant health products (including OTC and herbals when available), excluding treatment of reaction (name, dose, frequency, route used and therapy dates)
•	Treatment of reaction (including dates)

Reporter/recorder Information 
•	Generic identifier (re-identifiable only by source)
•	Occupation (e.g. physician, pharmacist, nurse, other HCP)

Deliverables in Phase I.

1)	An Analytic Report of the AR data within CPCSSN, including:
a.	The rates of AR within the CPCSSN database for the selected health products;
b.	An estimate (based on information available) of the total number of patients exposed to the selected products, an estimate (based on information available) of the duration of their exposure, a description of the other prescribed medications, and other key characteristics of these patients; 
c.	A description of how the AR table is populated in CPCSSN including a mapping of the source tables from the EMR to the fields within the CPCSSN AR table;
d.	An investigation of each EMR for potentially relevant sources of AR data;
e.	An analysis of each of the above by province or territory;
f.	An analysis of each of the above by EMR platform.
2)	A gap analysis of the gaps within CPCSSN for AR reporting and surveillance.  
3)	A plan for phases two and three of this work (input from Health Canada will be required).
4)	A CPCSSN AR database that Health Canada can use for additional internal analyses comparing the signals from EMR data to other internal data sources.

This project will continue to a second phase of planning and testing if the MHPD finds that the CPCSSN database holdings provide a useful source of data for pharmacovigilance activities.  

PHASE II (May 1, 2014 – September 30th, 2014) OPTION to be exercised by Canada by contract amendment

Tasks: to develop a prioritized data enhancement strategy, describing key activities to address gaps and opportunities to improve data, and initiate testing of selected enhancement(s).

1)	Organize and host a planning workshop with key stakeholders, including representatives from within MHPD and CPCSSN, to plan how best to use primary care EMR data for ongoing pharmacovigilance in Canada. Discussion topics should also include international best practices (e.g., from the DSEN, the FDA Mini-Sentinel, and the FDA Observational Medical Outcomes Partnership).
2)	Prepare a detailed report outlining a plan for how to leverage Canadian primary care EMR data for pharmacovigilance.  This will include a prioritized data enhancement strategy, which describes key activities to address gaps and opportunities and highlights potential impacts (positive and negative) on point-of-care, CPCSSN and Health Canada resources.  The strategy may include (but not be limited to) improving completeness and standardization of data collected by CPCSSN's participating sites, changes in CPCSSN data processing, providing feedback to Sentinels to encourage meaningful use of records, mapping to recognized pharmacosurveillance data models, stimulated reporting, linking to administrative data sets, etc.
3)	Initiate validation/testing of selected enhancement(s) of the data improvement strategies identified in the workshop and report.

Deliverables in Phase II (if OPTION exercised).

1)	Planning workshop, as described above
2)	Data Enhancement Strategy Report
3)	Validation of selected enhancement(s)

PHASE III (October 1, 2014 – March 31, 2015) OPTION to be exercised by Canada by contract amendment

Tasks: to implement the Data Enhancement Strategy widely within CPCSSN, measure the change in data quality, and evaluate impacts of implementation on clinics and the Network.

1)	Develop and pilot test the implementation of selected enhancement(s) in targeted site(s), measure changes in the data quality and evaluate the impact of the implementation on the clinic and network. 
2)	Implementation of selected enhancement(s) in a larger group within CPCSSN, measure the changes in data quality and evaluate the impact of the implementation on the clinic and network.
3)	If appropriate, develop and implement additional enhancements, measure the change in data quality and evaluate the impact of the implementation on the clinic and network.
4)	Develop a framework for relevant AR data exchange between CPCSSN and Health Canada.

Deliverables Phase III (if OPTION exercised).

1)	Completed pilot of selected data enhancement(s) in targeted site(s) and Summary Evaluation Report 
2)	Completed implementation of selected data enhancement(s) to additional CPCSSN sites and Summary Evaluation Report 
3)	Framework for relevant AR data exchange between CPCSSN and Health Canada for pharmacovigilance activities.

The original contract will require the Contractor to complete Phase I as described above.  The authorization to proceed with Phase II and III shall be done by an amendment to the contract exercised by the Contracting Authority.  Health Canada reserves the right to terminate after each phase is completed.
	
	
	5.  Minimum requirements
	
	Any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements: 
	
a) Have direct access to patient demographic and clinical information related to adverse reactions recorded in primary care electronic medical records:
•	for at least 550,000 patients;
•	from across no fewer than 8 Canadian provinces and territories
	
	b) Have access and ability to extract patient demographic and clinical information related to adverse reactions from at least 10 different electronic medical record systems (e.g. Wolf, OSCAR, Nightingale, etc.) into The Canadian Primary Care Sentinel Surveillance Network database.
	
	c) Have implemented a Privacy by Design process by which extracted data is immediately anonymised, coded and stored in data repositories that meet ISO 27001/2 standards for IS management and technological security requirements.
	
	d) Have ability to analyse relevant patient demographic and clinical information related to adverse reactions for the purposes of pharmacosurveillance (e.g. beyond quality indicators).
	  
	e) Have a mechanism to provide timely feedback to primary care practitioners and which can be used to test and evaluate impacts of specific process changes to adverse reaction data collection at point-of-care within participating practices of The Canadian Primary Care Sentinel Surveillance Network.
	
	f) Principal Investigator must have an advanced degree (PhD) with specialization in epidemiology or biostatistics, or equivalent professional experience as demonstrated by publication record.  This senior epidemiologist must be able to provide expert epidemiologic, scientific, and technical leadership in designing and conducting epidemiologic investigations. The duties required in this position encompass advanced professional analytical work in the surveillance, detection, research, and prevention of diseases and injuries. Work involves overseeing and conducting advanced-level professional epidemiologic work by developing and designing methods of collecting, analyzing, and disseminating data and performing appropriate research.
	
	6.  Reason for non-competitive award
	
	For the proposed procurement, the following exception applies: (d) Only One Person or Firm is capable of performing the contract.
	
	7.  Applicable trade agreements and justification for limited tendering or the Procurement Strategy for Aboriginal Business
	
	The following Trade Agreements apply for this requirement:
	
	a) North American Free Trade Agreement (NAFTA)	
	b) Agreement on Internal Trade (AIT)
	
	8.  Ownership of Intellectual Property
	
	The Contractor will own the Copyright.
	
	9.  Period of the proposed contract
	
	The contract period shall be from date of contract award until the 30th of April, 2014. 
	
	10.  Estimated value of the proposed contract
	
	The total estimated value of the proposed contract should not exceed $719,615.00, including travel and living expenses, all applicable taxes and option years.
	
	Phase I – estimated value $85,974
	Phase II (OPTION to be exercised by Canada) – estimated value $282,390
	Phase III(OPTION to be exercised by Canada) – estimated value $351,251
	
	11. Closing date and time 
	
	The closing date and time for accepting Statements of Capabilities is:
	 January 10, 2014. 2:00 PM EST
	
	12.  Contact Person
	
	All inquiries with regard to this Notice must be addressed by e-mail to:
	
	Name: Randy Brown
	Title: Senior Procurement and Contracting Officer
	E-Mail: randy.s.brown@hc-sc.gc.ca