SYNTHESIS of the
Clearinghouse of Safe Practices Meeting on
As a project of the SOS Rx coalition, the March 31st meeting
was the first step toward reaching the objective of developing a clearinghouse
of safe practices for high-risk situations regarding outpatient
medications. The clearinghouse would i
The meeting on March 31 i
During the course of the all day meeting, the issues set forth below were discussed, and agreement was reached on most issues.
1. Focus of the clearinghouse is on safe, not best, practices
Safe practices do not necessarily mean the best practice. The difficulty with the term “best practice” is that it implies a “standard,” a requirement. A glossary of definitions will have to be developed as a component of the development process.
· Develop glossary of terms
2. Focus is on medication use by the elderly in the outpatient setting
This is the focus of the SOS Rx coalition. There will be some cross over to other settings and populations, where it is determined to have relevance to the medication process, and the outpatient setting, but the focus is as stated above.
3. Agreed to create a framework of i
The framework of the clearinghouse could be based on the following dimensions:
1) Steps in the medication process
2) Conditions or diseases
3) Specific medications
4) Types of information – citations and abstracts, single articles, synthesized articles, specific case studies on implementation
- will i
6) Patient populations
· Define the steps in the medication process (without having narrow definitions)
· Review AHRQ Report “Making Health Care Safer” and confirm that chaplets could provide some of the framework
The content of the clearinghouse will be hierarchical. The content will capture different kinds of studies and literature. The following levels were agreed upon:
1) Safe practices literature – a single, individual study on a safe practice
2) Synthesized article – article based on an evidence-based review of the existing literature on a safe practice
3) Case study – study on implementing a safe practice
In general there was also agreement that there needs to be
boundaries to optimize integrity of the clearinghouse. Very important to decide
on the i
· Determine if clearinghouse should capture all practices, or focus on a few and do it well
More specifically set forth the i
· Determine if the clearinghouse will actually perform the synthesis research or just identify the synthesis research that already exists.
· Decide the process of reviewing studies – scale of project depends on this
5. Levels of evidence;
While there will be different levels of evidence in the clearinghouse, these various levels will be recorded. The level of evidence will need to be determined, defined, and then recorded for each study or report that is part of the clearinghouse. Must clearly convey the different levels of evidence.
Should have higher evidence standard for consumer level access of information.
It is also important to i
Often time implementations fail because of system barriers. The clearinghouse’s role can be to identify these barriers. For example, penicillin was a failed intervention because no one wanted to take the new drug.
· Determine and define the levels of evidence – higher for consumer information
· Develop system for recording the levels of evidence on the reports that are part of the clearinghouse
· Determine how to handle those practices in experimental stages
· Develop section on exchange of ideas, or shared learning opportunities
6. The clearinghouse will be virtual or web based, with some information on paper;
While it was decided that this will be mostly a virtual clearinghouse, with some opportunity for paper for certain users, need to decide what form of paper, and how to distribute. An option could be to provide flexibility and facilitate individuals and organizations to create hard copies of sections of the clearinghouse.
· Determine which sections of the clearinghouse would be made available in paper form, and how to distribute
· Determine how to facilitate individuals and organizations to create hard copies of sections of the clearinghouse
7. Implementation costs and feasibility;
The more you specify up front – scope, levels of evidence, etc., the less expensive the project will be. When changes are made to the basic design, it becomes very expensive.
Scale of project is about 1 to 1.5 million annually.
8. Need to clarify the scope of the project - whether it will be active or passive;
Should be a broad scope, since may miss information if too narrow. Focus on identified stakeholders.
How interactive does the clearinghouse want to be? To be active takes a large amount of time. AHRQ has created a clinical computerized clinical support list serve that works to get information from the clearinghouse to practitioners in real time.
· Clarify scope – broad, but needs to be useful and meaningful
· Determine how interactive the clearinghouse should be – the more interactive, the more staff time needed
9. Audience will be health care professionals, and patients;
Health care professionals will i
Patients are secondary targets. Clearinghouse can inform them of the practices their health care providers should be implementing. Consumers need to know what to expect from healthcare providers.
Audience is those who what to fix the safety gaps. Those who have seen a failure and are empowered to make change.
10. Site will have free access and be externally funded;
11. Agreed on operational competencies;
The organization that will house the clearinghouse must possess the following operational competencies:
AHRQ has offered the possibility of housing the
clearinghouse on their Quality Tools website.
Other institutions that may be able to house the clearinghouse i
· Further consideration of existing organizations that could house clearinghouse
12. Four tiered approach to governance;
An entity with all the above operational competencies manages the clearinghouse, and then governance as follows. Operational competencies define the organization that will do the work, versus governance that defines who will oversee the work process. Governance is more critical to specify in the early stages.
Four tiered approach to governance: 1) external funding source, 2) steering committee, with membership from a critical mass of end users and stakeholders 3) expert panel/advisory group 4) Actual management and operation
Regarding the funding source for the clearinghouse, there are different models for funding:
· Further develop governance model – composition of steering committee and expert panel
· Begin to establish possible funding sources
Different stages of the clearinghouse will have different budgets.
1) Prototype – small effort, mock up of a clearinghouse on a CD-ROM, non-interactive, possibly based on one safe practice. To develop will need input from those who are knowledgeable on the content, as well as those with technical expertise. Will use the prototype to market and describe the clearinghouse. Budget - $10,000
2) Pilot project – development of an interactive tool, with deployment and evaluation testing. To develop will need input from those who are knowledgeable on the content, technical experts, and the end users (providers and patients). Budget - $100,000 – $150,000.
3) Full scale project - about 1 to 1.5 million dollars annually. Need funding in perpetuity, not just initial seed money
· Develop more detailed budget for prototype
· Develop budgets for different stages of development of the clearinghouse
· Develop a list of possible funding sources (see below)
14. Potential funding sources.
Private sector foundations – unlikely to fund an on going
project, but might fund a feasibility study.
Foundations that could be approached i
Federal government – could seek federal legislation for an earmark of funds for this project. IOM has a funded mandate for safe use of medications. This could be a possible source of funding. IOM study will not be released for 18 months. The SOS Rx coalition needs to set forth what they think about funding. If they think government should do this, then should publicize that. If there is already seed money for a project, it might work to obtain additional government funding. CMS may also be a possibility because of the prescription drug program for seniors.
Other options- state insurance commissioners who regulate PBMs may be willing to set aside some funding for this. Drug companies may also want to fund. National Pharmaceutical Council is also an option.
· Develop draft of funding request document, based on this synthesis
· List of funding sources – Drug manufacturers, National Pharmaceutical Council, foundations
Consider government funding, i
· Present options to SOS Rx coalition at June 30th meeting
· Begin to approach the funding sources listed above
15. Integration with other efforts
Until more defined, hard to say how it will integrate with other efforts. The clearinghouse is a long-term project.
Need to contact the following
organizations: NQF, National Patient
Safety Agency in the
Follow up Questions and Answers
1. We are setting forth criteria for i
No, an endorsement is not planned.
2. Will the clearinghouse be a library of information for providers (i.e., like a mini-PubMed just for this topic)?
If some information gets excluded because of the criteria for i
The statement will be the listing of the
criteria for i
4. What happens when there are multiple (possibly conflicting) practices about how to improve safety for a particular medication, for example?
All will be i
5. Will it be clear from the start that the clearinghouse will be a neutral source of information vs. a repository for best models/best practices whose use should be encouraged?
We will make it clear that it is a neutral source of information.
6. Although the focus of SOS Rx is on seniors, the clearinghouse would likely have broader appeal if it applied to all patients and considered the importance of other high-risk patients for medication safety. Limiting it to just seniors could make getting funding more challenging since there are many other high-risk areas that could benefit from this clearinghouse.