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The eighth full coalition meeting of SOS Rx was held on May
18, 2005, and included more than 45 participants. The meeting was held in the George Meany
Conference Room at the
Presentation
Dr. Lester Crawford, Acting Commissioner, Food and Drug Administration, presented information about FDA’s recent drug safety initiatives. A question-and-answer session followed Dr. Crawford’s comments. Highlights from his presentation and the discussion are listed below.
· As a result of the Cox-2 controversy and other drug safety issues in the past year, the FDA has responded with various safety initiatives.
· The Drug Safety Oversight Board will discuss emerging drug safety issues and be responsible for the information posted on the Drug Watch web site. It will report to CDER at FDA, since they are the experts on drug safety. The membership of the new Drug Safety Oversight Board will be announced later today.
· Drug Watch Website is a new channel to communicate up-to-date information on emerging safety issues to the public. This information will include emerging risks.
· Counterfeit drugs cases have increased and posed a threat to the public health. FDA initiated 58 counterfeit drug investigations in 2004, an increase from the 30 cases initiated in 2003. The National Consumers League developed an informative Web site with useful consumer information on counterfeit drugs.
· With the Medication Drug Benefit, and an increase in drug utilization among seniors, FDA should ensure that there is someone with experience on seniors and drugs safety on the Drug Oversight Board.
· Direct to Consumer Advertising - Industry needs to set standards and police itself to ensure that DTCA is balanced. Industry is beginning to do this.
· FDA supports the SOS Rx agenda and is interested in continuing to hear from this coalition.
Discussion of
Action Agenda
Each workgroup representing the four action agenda projects gave a progress report. After each presentation there were questions and discussion. Set forth below is a summary of each action agenda project and the discussions.
1. Clearinghouse of Safe Practices on High-Risk Situations – Lou Diamond, Medstat
Project Summary:
Develop a clearinghouse of
safe practices for high-risk situations in the outpatient medication arena. The
clearinghouse will be a comprehensive dynamic resource to which healthcare
professionals can turn for guidance on safe practices to be followed when
prescribing certain medications. The
clearinghouse will also contain consumer-friendly versions of the safe
practices.. SOS
Rx is currently seeking a partner organization with the capacity to help
develop and house the clearinghouse.
While various organizations have been contacted about partnering with SOS Rx to develop the clearinghouse, no partner has yet been identified. There is continuing conversation with AHRQ about the possibility of updating the AHRQ Safe Practices Report. Developing an updated Safe Practices Report with an associated Web–based clearinghouse component would make the information accessible to both patients and health care professionals.
Next Steps:
1) Contact organizations interested in the clearinghouse,
2) Find organization to develop a prototype of the clearinghouse,
3) Use prototype to obtain funding for pilot,
4) Develop and test pilot, and
5) Secure funding for the full clearinghouse.
2. Promoting Electronic Prescribing - Will Lang, American Association of
Colleges of Pharmacy
Project Summary:
To accelerate the use of E-prescribing the project will 1) adopt guiding
principles that define and encourage a patient role, 2) promote various ongoing
initiatives supportive of those principles, 3) launch a public awareness
campaign to educate patients about the potential benefits of
E-prescribing. The full coalition will
then approve and coordinate a media campaign to educate patients about the
benefits of E-prescribing and their role as health care consumers in advancing
its use.
Will Lang updated the coalition on the purpose of this
project and recent activities. The
purpose of the SOS Rx electronic prescribing effort is to research, develop, and implement
a campaign directed at the ultimate consumers of electronic prescribing –
patients. As a foundation for this
campaign, we hope to solicit feedback from consumers on what they currently
know of and understand about electronic prescribing. The anticipated next step after a research
phase would be to develop and launch a campaign to increase consumer awareness
of electronic prescribing as an important tool and to educate consumers about
the potential safety and convenience benefits associated with its use. While we know what we want to do, we are now
faced with two issues:
1)
How to secure project funding, and
2)
How to position this effort within some of the broader initiatives
for health IT such as Connecting for Health and others.
To the
first point, it was reported that we have had conversations with the eHealth Initiative about their possibly circulating a
funding request to their membership on behalf of SOS Rx. We have drafted a proposal letter and will be
sharing it with eHealth Initiative folks to get
feedback. To the second point, it was
reported that in the last few months, we have spent a considerable amount of
time thinking about how this effort fits in with other ongoing health IT
initiatives. We do not want to duplicate
efforts, but we also see that most of current activities are more broadly
focused on the full electronic health record, and specifically the provider
uptake and standards development issues.
NCL has been engaged in some of these activities, and continues to look
for opportunities to advance the Erx consumer
research effort.
Discussion
by the coalition focused on how best to position our effort with
potential funders and supporters; and how this effort
fits into the boarder health IT initiatives, given the emerging national
attention on health IT issues.
Participants discussed the importance of explaining why it is important
for consumers to become involved in this issue.
There was also discussion of standards development (and if the role of
consumers is considered) and who else is doing research on this issue.
There was general
consensus to move forward with the fund raising letter to support a consumer
campaign.
Next Steps:
1) Work with E-Health Initiative on fund raising letter
2) Continue involvement in ongoing IT health meetings and initiatives
3) Develop a framework strategy and timeline for the development of a public education campaign on E-prescribing with SOS Rx E-prescribing work group and continued collaboration with EHI.
3. Personal Medication Record – Andy Barbash
Project Summary:
With a personal medication record a patient is able to keep track of all medications (Rx, OTCs) as well as vitamins and herbal supplements he or she may be taking, regardless of the prescriber of the medications. While there are various initiatives ongoing, standards and uniformity are needed to ensure that such records are consumer-friendly, useful and easily incorporated into the health care experience. After reviewing an inventory of some of the current initiatives on personal medication records, an expert panel met in June 2004 to determine what information is critical to include in a PMR. A model PMR has been developed based on the panel’s findings. The coalition will promote the use and adoption of the model PMR by all stakeholders, including consumers. A public education campaign will encourage consumers to use personal medication records.
The progress report noted that since the last coalition meeting there has been ongoing interest in the PMR. We have been sending information and discussing possible use with several coalition partners. We also have discussed the PMR with the University of North Carolina School of Pharmacy, which has a geriatric medication management program. They are conducting research on medication management that will be looking at patient use of PMRs. There may be an opportunity to use the SOS Rx PMRs with their patients. AARP is using the chart PMR in its new online Web course. AARP presented information on its Web course to the coalition.
Next step is appropriate testing of the PMR. We would like to explore holding focus groups or some type of evaluation with consumers for both the broad campaign messages and proposed templates. These research efforts are dependent on funding. Ultimately, we would like to see an outreach campaign to encourage patients to keep track of medications and substances and to use some type of PMR.
Ed Staffa, National Association of Chain Drugstores, presented information on Medication Therapy Management (MTM). MTM is part of the new Medicare Drug benefit. Ed talked about NACDS efforts around this issue, and how the personal medication record fits into the broader MTM framework.
The coalition discussion included the following points:
· How SOS Rx can become more involved with the standards CMS will include as part of MTM, including a PMR.
· How best to promote the use of PMR
· Healthy People 2010 – one of the objectives is to keep track of medications.
Next Steps:
1) Continue exploring pilot test possibilities, as well as opportunities to integrate PMR with other efforts
2) Obtain funding for further consumer testing (focus groups) of templates
3) Obtain funding to develop and test campaign messages
4) Launch public education campaign on medication management
4. Oral Anticoagulant Education Campaign - Targeting high-risk situations - Jill Pierce, American Medical Women’s Association Foundation
Project Summary:
This project will educate consumers about the risks of various products
interacting with certain high-risk medications, such as oral
anticoagulants. A public education
campaign will target consumers taking high-risk medications and inform them
that other prescription and non-prescription medications they may be taking
(OTCs, dietary supplements, herbals), as well as some foods, could interact
with the prescribed medication. The
campaign will also target providers and dispensers to 1) reaffirm the
importance of interaction messages to patients and 2) provide them with
techniques that can be used to enhance awareness and message compliance among
their patients.
The progress report included a presentation by Bearing Point on the focus group result, and an update on the ongoing Harris Interactive surveys. The focus group findings included: significant differences between the “doer” and “non-doer” groups; pharmacists believe they can be effective partners in physician education efforts; and physicians expressed frustration with this medication and in getting blood results back from laboratories in a timely manner. For the education campaign it will be important to refine the target audience and define a clear call to action.
The Harris report included the results from the patient survey - data from the surveys of physicians and caregivers are forthcoming. Key findings from the Harris patient survey: that there are gaps in patient education; and patients face considerable health care management challenges and have little support.
The coalition discussed the key findings from the focus groups and survey and possible vehicles for dissemination. The advisory group for this project will meet directly after today’s full coalition meeting to start developing strategy for the education campaign and work on message development. The advisory group will work over the summer and early fall to develop messages.
There was agreement by the coalition to move forward with the campaign.
Next Steps:
1) Finish Harris surveys
2) Finalize survey report and focus group report
3) Develop messages with advisory committee based on surveys and focus group findings
4) Launch campaign
Other:
· Daniel Cobaugh, American Society of Health-Systems Pharmacist presented information on their application to become a CERT.
· Members may access the members-only section of the SOS Rx Website (www.sosrx.org) by using the following. User name: coalition Password: seniorsafety04
·
The next full meeting of the coalition will be
on Wednesday, November 9, 2005, from 10 am–2 pm (EST) at the