DRAFT

SOS Rx

SYNTHESIS of the

Clearinghouse of Safe Practices Meeting on March 31, 2004

 

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 include past practices currently housed in different places.  The clearinghouse will be a comprehensive dynamic resource to which healthcare professionals can turn for guidance on safe practices when prescribing medications.  The first phase of this project convened an expert panel to define the scope of this project. 

 

The meeting on March 31 included 17 people representing 13 organizations, including representatives from the FDA, National Quality Forum, AHRQ, CMS, Institute of Safe Medication Practices, the Department of Veterans Affairs, Massachusetts Coalition for the Prevention of Errors, the Americans Association of Nurse Practitioner, and Stanford University Evidence-based Practice Center, Medstat, AARP, Ottawa Health Research Institute, and the National Consumers League. The list of participants is attached to this document.

 

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.    

 

Next steps:

·             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 inclusion based on the medication process

 

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

 

5) Setting  - will include material of a generic nature, but not exclusively focused on the outpatient setting or the geriatric patient population

 

6) Patient populations

 

Next steps:

·             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

 

4.  Inclusion of practices will be based on a hierarchy and multi-tiered;

 

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 inclusion criteria, to define what will be included in the clearinghouse early in the process.   It is more important to cover all practices, then to cover just a few and have more robust coverage.   

 

Next steps

·             Determine if clearinghouse should capture all practices, or focus on a few and do it well 

·             More specifically set forth the inclusion criteria

·             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 include those practices in the experimental stage and not written up for peer review.  By also including the “test phase” of practices, organizations can see what these practices are achieving before they approve and/or implement them.

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.

 

Next steps

·             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.

 

Next steps

·             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 include doctors, pharmacists, and the full team of those who provide health care to consumers.

 

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:

.  

Efficiency,

Content expertise,

Methodological expertise,

Technical expertise

Organizational expertise

 

AHRQ has offered the possibility of housing the clearinghouse on their Quality Tools website.  Other institutions that may be able to house the clearinghouse include – National Quality Forum, Cochrane, CERTs, CMS.  Need a nonprofit group that will provide credibility and that is not biased toward any set of stakeholders, no conflicts of interest. 

 

Next steps

·             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:

Private

Government 

Foundation

Combination

 

Next steps

·             Further develop governance model – composition of steering committee and expert panel

·             Begin to establish possible funding sources

 

13.  Funding 

 

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

 

Next steps

·             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 include: Commonwealth, Robert Wood Johnson, and the Markle Foundation.

 

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. 

 

Next steps

·             Develop draft of funding request document, based on this synthesis

·             List of funding sources – Drug manufacturers, National Pharmaceutical Council, foundations

·             Consider government funding, including CMS

·             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.

 

Next steps

·             Need to contact the following organizations:  NQF, National Patient Safety Agency in the UK (David Cousins), also Don Berwick.  Need to reach out to those other entities and have open line of communication.

 

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Follow up Questions and Answers

 

1.  We are setting forth criteria for inclusion in the clearinghouse.  Does that mean the practices included would carry some sort of endorsement/stamp of approval by the entity that houses the clearinghouse?   

 

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)?  

 

Yes.

 

3.   If some information gets excluded because of the criteria for inclusion, then what statement is the governing body making about the practices that are included - that they are best practices to use?  

 

The statement will be the listing of the criteria for inclusion, and the intended use---to inform generally.

 

4. What happens when there are multiple (possibly conflicting) practices about how to improve safety for a particular medication, for example? 

 

All will be included.  Where feasible, and on a focused basis, a synthesis of the literature will be developed.  

 

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. 

 

.   Generic relevant information, even if not specific to the outpatient setting or the elderly, will be included, i.e. even if specific to a single setting, but applicable to all settings and all populations, but relevant to seniors.