Warfarin Campaign Framework Document

DRAFT

11/15/04

 

Background

 

In the fall of 2003, the SOS Rx coalition convened a retreat in Wye, Maryland to bring further focus to its mission of making the outpatient use of medications safer.  Participants engaged in discussion and debate, and eventually settled upon four specific projects designed to address the stated objective through consumer behavior and health care system change.  This framework document provides a detailed rationale and proposal for moving forward with one of the four projects – the warfarin campaign (formerly referred to as the “Consumer Action” campaign).   Jill Birdwhistell-Pierce, American Medical Women’s Foundation, provides ongoing consultation to NCL staff working on this SOS Rx project.

 

   Project Evolution

 

In its early stages, the Coalition determined that one of the four projects should be a consumer-directed campaign.  The stated objective of this campaign was “to educate consumers about risks of interactions when taking certain high-risk medications, such as warfarin, and the importance of monitoring.” 

 

 The coalition approved the following project summary, which was presented in the original “Consumer Action” project work plan: 

 A public education campaign will target consumers taking high-risk medications in the outpatient setting and inform them that other medications and substances they may be taking (prescription, OTCs, dietary supplements, and herbals as well as food), could interact with the specified medication. Consumers will be provided with a framework for discussing the risk of interactions and the importance of monitoring with their doctor, pharmacist or other health care professional.  While warfarin will be the drug of initial focus, the resulting campaign will be a template that could be customized and applied to education used for other high-risk medications. 

 

In subsequent Coalition meetings, it has become apparent that a broader campaign is needed to achieve the desired behavior change (i.e., lead to a reduction in dangerous interactions associated with high-risk medications – initially warfarin).  In fact, at the Coalition meeting on June 30th, it was suggested that any truly effective campaign should target three general audiences – patients, providers, and health care system administrators – and specifically define target audiences within those three groups.  This transition from a focused consumer campaign to a broader stakeholder campaign has significant implications in terms of project effort, resources, and time.  However, the mandate of this Coalition is to address gaps in patient safety, and it is clear from our research that the challenges associated with outpatient anticoagulation management present a critical need for action.


Moving Forward

Based on the most recent recommendations of the Coalition, NCL plans to move forward with a warfarin campaign that includes a unique set of messages and media for each target audience.  The following sections lay out the framework for this proposed effort, including:

Ø      Evidence Base for Action,

Ø      The Campaign

§         Goals

§         Research plan

Ø      Timeline

Ø      Resources

Ø      Assessment/Evaluation

 

I.                   Evidence Base

A.     What is Warfarin & When is it Used?

Warfarin is the most widely used oral anticoagulant in the world.[1][N1]   Anticoagulants are among the most common medication categories associated with preventable adverse drug events.[2] 

 

Warfarin inhibits the synthesis of clotting factors, thus preventing blood clot formation.[3] Blood clots can occur in the veins of the lower extremities, usually after periods of immobility. These clots can break off and become lodged in the blood vessels of the lung (pulmonary embolism), causing shortness of breath, chest pain, and even life-threatening shock. Blood clots can also occur in the atria of the heart during atrial fibrillation, and around artificial heart valves. One of these clots can also break off and obstruct a blood vessel in the brain, causing an embolic stroke with paralysis. Since its approval by the FDA in 1954[N2] , warfarin has been an important tool for preventing the formation of blood clots. It also has been used to help prevent extension of clots already formed, and to minimize the risk of blood clot embolization to other vital organs such as the lungs and brain. [4]

 

B.      How is Warfarin dosed & Monitored?

Warfarin comes in the following doses: 1mg, 2mg, 2.5mg, 3mg, 4mg, 5mg, 7mg, 7.5mg, 10mg, and may be taken with or without food.[5]  Because it is metabolized by the liver and excreted by the kidneys, dosages need to be lowered in patients with liver and kidney dysfunction. Frequent blood tests should be performed to measure blood clotting time (e.g., protime or PT) during treatment.[6]  The INR test results help health care providers to adjust medication doses and avoid excessive blood thinning and risk of bleeding.  Ideally, patients starting warfarin treatment should be tested daily during the induction phase (2-4 days), then weekly, and eventually bi-monthly or monthly for the duration of therapy to ensure accurate dosing.[7]  Despite these efforts to dose appropriately, warfarin is metabolized very differently by people, and its effects on the body can easily be altered by intake of other drugs, vitamins, herbal supplements, and foods.[8]


 

C.     What are the interactions & risks associated with Warfarin Use?

Many drugs (both prescription and OTC) as well as vitamins, herbal supplements, and foods, can affect the anticoagulant action of warfarin.[9] Some medications can enhance its action and cause excessive blood thinning and life-threatening bleeding.[10] A few examples of such medications include Aspirin, Tylenol,

 ibuprofen, cimetidine, certain vitamins, and antibiotics.[11]  Others, such as barbiturates and some cholesterol drugs, actually inhibit action.[12]

The two most serious side effects associated with warfarin use are bleeding and necrosis (gangrene) of the skin.[13] Also, in the case of inhibitors, blood clots can form.  Bleeding can occur in any organ or tissue. Bleeding around the brain can cause severe headache and paralysis. Bleeding in the joints can cause joint pain and swelling. Bleeding in the stomach or intestines can cause weakness, fainting spells, black tarry stools, vomiting of blood, or coffee ground material. Bleeding in the kidneys can cause back pain and blood in urine. [14]

Other side effects include purple, painful toes, rash, hair loss, bloating, diarrhea, and jaundice (yellowing of eyes and skin). Signs of overdose include bleeding gums, bruising, nosebleeds, heavy menstrual bleeding, and prolonged bleeding from cuts.[15]

D.     How are Warfarin Patients Currently Managed?

Unfortunately, there is broad variation in the management of patients taking warfarin.  Some are treated very successfully with regular INR tests and aggressive provider follow-up.  Other patients are monitored less frequently, if at all.  Complicating this scenario is the fact that patients can radically alter – unwittingly - their desired INR levels by taking contraindicated drugs, supplements, and foods. The medical literature is filled with reports of serious adverse events – and sometimes death – resulting from such interactions.[16]

 

E.     What Strategies Work?

Recognizing the importance of monitoring patients regularly to maintain an acceptable INR, some medical institutions and insurers suggest (or require) participation in a warfarin management program.  A variety of protocols exist for these programs, but the over-arching theme is that patients are proactively educated, frequently monitored, and contacted regularly to ensure compliance.

 

Numerous studies have determined that participation in warfarin management programs (e.g. anticoagulation clinics) improves patient outcomes and reduces the risk of complications.[17]  There also are data suggesting that patient self monitoring of INR levels, at more frequent intervals, provides even further benefit in terms of achieving and maintaining results in the desired range.  [18]

 

In addition to clinical interventions, numerous health care providers, associations, patient safety groups, pharmacy benefits managers, hospitals, and insurers have developed web and paper-based education materials designed to help patients use warfarin safely.[19]   These efforts may have improved anticoagulation management, but there is no evidence base to suggest that education alone effectively mitigates the risks associated with warfarin use. 

 

 

II.                The Campaign

The SOS Rx Coalition is committed to developing a campaign that will motivate patients, providers, and other actors within the health care system to adopt behaviors that will lead to safer and more effective use of oral anticoagulation therapy in the outpatient setting. 

 

In earlier discussions, the coalition has considered the following as possible positive outcomes of this campaign:

a.       Preventing warfarin patients from initiating use of any other medications without first consulting a healthcare professional,  

b.      Increasing patient understanding of how medications, foods, and other products may interact and cause dangerous side effects,

c.       Increasing awareness/use of warfarin management clinics and potentially,

d.      Catalyzing demand for self-monitoring tools (e.g., reimbursement).

 

To achieve these goals, we need to think critically about the target audiences for the campaign, the actions we want them to take, and the rewards that would accrue to them if they adopted these behaviors.  We also will need to identify appropriate dissemination strategies for each of the messages and audiences.  

 

Given the level of research and coordination required for this type of undertaking, NCL is planning to collaborate with an external consultant that specializes in audience research and message development.  We will be requesting proposals from at least two research firms. 

 

As part of this collaboration, we plan to conduct research with three different - broadly defined - groups:

q       Patients taking warfarin;

q       Providers (possibly including cardiologists, internists, family physicians, nurses, nurse practitioners, and other health care professionals) managing patients taking warfarin;

q       System stakeholders (e.g., medical directors of large health plans and managers of anticoagulation clinics).

 

Research with warfarin users will help inform the development of an effective message strategy.  In addition, because these patients will likely turn to their health care providers for care and advice, it will be important to provide this group with helpful information as well. Therefore, it is critical that the perspectives of both consumers and providers be considered in the development of informational materials and interventions for patients receiving warfarin. 

 

The abovementioned research will largely be focus group-based but, before engaging in this process, we also plan to conduct several telephone interviews with health plan medical directors and anticoagulation clinic managers.  Through this process, we hope to gain a better understanding of the messages and management techniques that have helped patients taking warfarin. In addition, we will consult a small group of those within the SOS Rx coalition as we work collaboratively with the consultant on this research.  The pharmacist, caregivers and providers already part of SOS Rx can help guide this process. 

 

As a starting point, we will consider five key questions that help inform the development of any effective message strategy.  Thus, this project will conduct research with key target groups to address the following:

·        Through which target audiences can we achieve the most benefit?

·        What specific actions should our key audiences take to improve adherence? 

·        When are the target audiences open to receiving and acting postively on these messages?

·        What rewards will our audiences receive if  adherence improves?

·        What evidence supports this behavior change?

The answers to these questions will be used by SOS Rx to formulate the actual message campaign.  In addition to formulating the messages, the Coalition will need to develop dissemination strategies for these messages.  We envision that SOS Rx coalition partners can participate in numerous ways - ranging from branded message dissemination of new, campaign-specific media (e.g., distribution of stand-alone print messages), to generalized message content dissemination as part of existing outreach efforts (e.g., printing message in a news bulletin to members). The coalition will need to ensure that the basic message stays intact, while promoting the use and widespread distribution of the messages.

     

III.  Timeline 

 

February/March

  • Background research
  • Consult experts (see Addendum for list of those consulted)
    • Health professionals
    • Other healthcare resources

 

April – June

§         Report to full coalition on progress

§         Continue Research

§         Continue Outreach

 

July

§               Develop framework document for campaign

 

August / September  

§               Solicit proposals from research firms

§               Finalize and circulate framework document to coalition 

§               Establish SOS Rx advisory workgroup for project 

§           Confirm research firm 

 

October / November

§         Consult with SOS Rx advisory workgroup on warfarin project

§          Finalize work plan

§         Draft interview guides

 

December / January

§         Interview experts on warfarin use (system managers, providers, etc.) 

§         Conduct focus groups of patients and providers

 

February / March

§         Final Report on research

§         SOS Rx developing messages based on research

§       SOS Rx developing plan for delivery method of messages

§       Finalize messages and launch first wave of public education campaign.

 

2005

  • Ongoing monitoring of campaign
  • Evaluation of the campaign

 

 

IV. Resources 

NCL has initial funding from Express Scripts, founding sponsor of SOS Rx, to conduct basic media work.  SOS Rx is currently seeking additional funding for the education campaign.

 

 

 


 

Addendum

 

List of organizations contacted regarding warfarin project, as of September 2004.

 

AARP

Abington Memorial Hospital and anticoagulation clinic

Academy of Managed Care Pharmacy

American Academy of Family Physicians

American Geriatrics Society

American Heart Association

American Health Care Association

American Medical Women’s Association

American Pharmaceutical Association

Anticoagulation Forum

Agency for Healthcare Research and Quality

AstraZeneca

Bristol Myers Squibb

Centers for Disease Control

Centers for Education and Research on Therapeutics

Centers for Medicare and Medicaid Services

Food and Drug Administration

Kaiser Mid-Atlantic Coumadin management clinic

National Alliance for Hispanic Health 

National Association of Chain Drug Stores

National Council on Patient Information and Education 

Rite Aid

United States Pharmacopeia

Dr. Jerry Gurwitz 



 

[1] Horton JD, Bushwick BM.  Warfarin Therapy:  Evolving Strategies in Anticoagulation. American Family Physician 1999 Feb 1 at 1, at http://www.aafp.org/afp/990201ap/635.html.

 

[2] Gurwitz, et.al, Incidence and Preventability of Adverse Drug Events Among Older Adults in the Ambulatory Setting,  JAMA  March 5 2003; 289: 1107-1116.   See also Making Health Care Safer:  A Critical Analysis of Patient Safety Practices, Chapter  9 Protocol for High Risk Drugs:  Reducing Adverse Events Related to Anticoagulants,  AHRQ Publication 01-E058, July 20, 2001.

 

[3] Id. at 3.

 

[4] Patient Education:  The Basics on Coumadin/Warfarin, at 1(Abington Memorial Hospital).

 

[5]  Id. at 5.

 

[6] Id. at 1; Horton JD, Bushwick BM.  Warfarin Therapy:  Evolving Strategies in Anticoagulation. American Family Physician 1999 Feb 1

 

[7] Horton JD, Bushwick BM.  Warfarin Therapy:  Evolving Strategies in Anticoagulation. American Family Physician 1999 Feb 1 at 5.

 

[8] Patient Education:  The Basics on Coumadin/Warfarin, at 3, 1-8 (Abington Memorial Hospital); see also Horton JD, Bushwick BM.  Warfarin Therapy:  Evolving Strategies in Anticoagulation. American Family Physician 1999 Feb 1  (“In most instances, the interacting drugs either inhibit or induce warfarin metabolism.”)

 

[9] Wong RS, Cheng G, Chan TY. Use of Herbal Medicines by Patients Receiving Warfarin. Drug Saf. 2003;26(8):585-88; Heck, A., Potential Interactions Between Alternative Therapies and Coumadin, Am J. Health-Sys. Pharm 57 (13):  1221-1227 (2000);  Stenton, B.S., Interactions between Warfarin and Herbal Products, Minerals and Vitamins:  A Pharmacist’s Guide, Can J. Hops. Pharm 2001: 54: 186-92.  

 

[10]  Drug Guide:  Warfarin (Abington Memorial Hospital)

at  http://www.amh.org/library/healthguide/en-us/drugguide/topic.asp?hwid=multumd00022a1#d00022a1-avoid

 

[11]  Id.  Bristol Meyers Squibb Company, Coumadin® Full Prescribing Information (2002).

 

[12] Bristol Meyers Squibb Company, Coumadin® Full Prescribing Information (2002).

 

[13] Bristol Meyers Squibb Company, Coumadin® Full Prescribing Information (2002).

 

[14]  Bristol Meyers Squibb Company, Coumadin® Full Prescribing Information (2002).

 

[15] Bristol Meyers Squibb Company, Coumadin® Full Prescribing Information (2002).

 

[16] Gandhi TK, Shojania KG, Bates, DW Chapter 9. Protocols for High-Risk Drugs:  Reducing Adverse Drug Events Related to Anticoagulants, 87-99 (AHRQ, Publication No. 01-E058, 2001).

available at www.ahrq.gov/clinic/ptsafety/chap9.htm.

 

[17] Hitchens K. Are Major Changes Looming in Anticoagulation? Drug Topics. 2004 Jun 21;148:48, (more patients participating in inpatient/outpatient anticoagulation clinics had INRs within the targeted range than compared to patients in routine care)

available at www.drugtopics.com/be_core/search/show_article_search.jsp?searchurl=/be_core/content/journals/d/data/2004/0621/dxcoag06b.html&title=Cover+Story%3A+ARE+MAJOR+CHANGES+LOOMING++IN+ANTICOAGULATION%3F&navtype=d&query=anticoagulation. 

 

[18] See, e.g.,

Sawicki PT. A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled trial.  JAMA.  1999 Jan 13;281(2):182-83;  Watzke HH, Forberg E, Svolba G, Jiminez-Boj E, Krinninger B.  A prospective controlled trial comparing weekly self-testing and self-dosing with the standard management of patients on stable oral anticoagulation. Thromb Haemost. 2000:83(5):661-65. (self-monitoring of patients compared to routine care).    See also,  Gandhi TK, Shojania KG, Bates, DW Chapter 9. Protocols for High-Risk Drugs:  Reducing Adverse Drug Events Related to Anticoagulants, 87-99 (AHRQ, Publication No. 01-E058, 2001). (superior anticoagulation found in self-monitoring when compared to clinics) available at www.ahrq.gov/clinic/ptsafety/chap9.htm,  Cf.  Cromheecke ME, Levi M, Colly LP, de Mol BJ, Prins MH, Hutten BA, Mak R, Keyzers KC, Buller HR.  Oral anticoagulation self management and management by a specialist anticoagulation clinic:  a randomised cross-over comparison.  Lancet.  2000 Jul 8;356(9224):97-02. (comparison of patient participating in self-monitoring and patients using services of an anticoagulation clinic where the self-monitoring patients achieved equivalent or better results than those in the clinic and the self-monitoring patients were happier with their lifestyle)

 

 

[19]  See http://www.amh.org/newsinfo/innovatoraward.htm;  http://peir.path.uab.edu/coag/cat_index_16.shtml; http://xnet.kp.org/permanentejournal/sum99pj/frcpas.html

 


 [N1]  Warfarin is not the only oral anticoagulant available in the outpatient setting, but it is the most commonly used one.  Other oral anticoagulants include indanedione derivatives, including anisindione (tradename Miradon) and dicumarol, and both are used in patients who do not respond well to Warfarin.

 

 [N2]the generic version of Coumadin (warfarin) was approved in 1996