Prepared for: The National Consumers League September 20, 2005 J23716 The Use of Oral Anticoagulant Medications: Survey of Physicians: Key Findings

2 Table of Contents Background & Objectives Sample and Methodology Key Findings Respondent Profile

3 Background and Objectives: Physicians The physicians survey is the final phase of a research project designed to inform the development of an outpatient medication safety campaign aimed at consumers, caregivers, and physicians. The physician survey was designed to gain insight into the physician’s point of view about issues around the use and management of oral anticoagulant medication.

4 Background and Objectives, continued Specific areas of inquiry include: –Treatment and counseling of patients on oral anticoagulants. –Patient experiences with oral anticoagulant regimen. –Ongoing treatment and monitoring patients

5 Sample and Methodology This survey was conducted online within the United States with members of the Harris Interactive Physician Panel. Interviews were conducted between August 11, 2005 and August 18, A total of 101 physicians were interviewed. –Eligible respondents were practicing medicine in the U.S.: Primary care providers (specializing in family practice, internal medicine or general medicine) and cardiovascular specialists; Practicing for at least 5 years and spending at least 70% of their time in direct patient care; Treating 5 or more patients who are on an oral anticoagulant medication. Eligible received received an honorarium of $50 for completing the survey.

6 Summary of Key Findings

7 Summary of Key Findings: Physicians 1.Managing patients on anticoagulant medication is a challenge for physicians. 2.Most physicians feel that the effort to manage multiple conditions and medications is the main reason why oral anticoagulant patients experience difficulties with their regimen. 3.There is room for improvement in communication by physicians about oral anticoagulant regimen requirements and blood test results. 4.Physicians could be doing more to help their patients with ongoing management of their oral anticoagulant regimen. 5.Improving blood testing, communication, and involvement with health care professionals are seen as key components in helping patients comply with their oral anticoagulant regimen.

8 Case Study We asked physicians to tell us about their most recent visit with a patient on oral anticoagulant medication. This review gives us a glimpse into both the “average” patient on anticoagulant medication and the important exceptions. It also gives us insight into what physicians are routinely doing to help manage their anticoagulant patients. We will first present findings from this case study, focusing both on the average patient and the crucial exceptions. We will then elaborate on key findings, which are illustrated by this case study.

9 Q505For the next few questions, we would like you to think about the most recent visit that involved a patient who is taking an anticoagulant medication. Is this patient…? Base: Qualified Respondents (n=101) Q511 Approximately how old is the patient? Base: Qualified Respondents (n=101) Case Study: Gender and Age Most anticoagulant patients are male, but many are female. The average anticoagulant patient is 64 years old.

10 Q510 What is the primary condition for which this patient was prescribed an anticoagulant medication? Base: Qualified Respondents (n=101) Case Study: Primary Condition The average patient is taking an oral anticoagulant for atrial fibrillation.

11 Q520 Please indicate the name of the patient’s anticoagulant medication. Base: Qualified Respondents (n=101) Case Study: Type of Oral Anticoagulant Medication The anticoagulants most often taken are Coumadin or Jantoven and Warfarin.

12 Q515 For approximately how long has this patient been taking the oral anticoagulant ? Base: Qualified Respondents (n=101) Case Study: Length of Time on Medication 56% Typical anticoagulant patients are in all stages of treatment longevity. More than half have been taking the medication for a year or longer.

13 Q517 In your opinion, for how long will the patient need to remain on this therapy? Base: Qualified Respondents (n=101) Case Study: Length of Treatment The large majority of these patients will be taking an oral anticoagulant for the rest of their lives.

14 Q525Prior to this visit, how long ago was this patient’s last visit? Base: Qualified Respondents (n=101) Case Study: Frequency of Physician Visits 57% More than half of anticoagulant patients have been to see their doctor more than once in the last month.

15 Q526Was this patient’s most recent visit for routine care or related to an event or some type of problem he/she was having? Base: Qualified Respondents (n=101) Case Study: Reason for Recent Visit Most doctor visits are for routine care, but visits in reaction to a problem are not uncommon.

16 Case Study: Communication During Physician Visit Q529On this patient’s most recent visit did you…? Base: Qualified respondents (n=101) On this patient’s most recent visit did you…? Yes % No % Not sure % Review the patient’s latest blood test results964- Review all of the patient’s medications, including over-the- counter medications, vitamins and supplements Ask the patient whether he/she is taking the oral anticoagulant as prescribed Ask the patient whether he/she is having any problems related to taking the oral anticoagulant Ask the patient about his/her diet50491 While physicians are doing well with reviewing medication during patients’ visits, many patients are not being asked about compliance, problems they may be having, and diet.

17 Q531How many times have you seen this patient in the past year? If you are not sure, your best estimate will do. If you don’t know, please enter 888. Base: Qualified Respondents (n=101) Case Study: Number of Physician Visits in Past 12 Months Not sure: 2% The average anticoagulant patient visits the doctor 7 times a year.

18 Case Study: Compliance with Medication Regimen Q540To the best of your knowledge, is this patient taking his/her anticoagulant medication as prescribed? Base: Qualified Respondents (n=101) The large majority of patients take their anticoagulant medication as prescribed. % of physicians reporting that patient is taking medication as prescribed

19 Case Study: Compliance with Blood Testing Q545 Does this patient follow your recommendations to have his/her blood tested regularly? Base: Qualified Respondents (n=101) 48% About half of patients could use improvement in compliance with their doctor’s recommendations for blood testing.

20 Case Study: INR in Desired Range Q550Is this patient’s INR consistently in the desired range? Base: Qualified Respondents (n=101) % of physicians reporting that patient’s INR is consistently in the desired range 1 in 4 patients INR is not consistently in the desired range.

21 Case Study: Patient’s Management of Oral Anticoagulant Regimen Q555 Overall, how well do you think this patient is managing his/her oral anticoagulant? Base: Qualified Respondents (n=101) 48% Almost half of patients are managing their anticoagulant regimen less than very well. % of physicians indicating how well the patient is managing oral anticoagulant use

22 Case Study: Ease in Following Treatment Recommendations Q560 To the best of your knowledge, how easy or difficult is it for this patient to follow all of your recommendations related to taking his/her oral anticoagulant? Base: Qualified Respondents (n=101) 26% 1 in 4 patients have a very or somewhat difficult time following their doctor’s recommendations related to their anticoagulant regimen. % of physicians indicating how difficult it is for the patient to follow all of their recommendations

23 Case Study: Caregivers Q565 To the best of your knowledge, does this person have a family member or other caregiver who is actively involved in assisting with his/her oral anticoagulation management? Base: Qualified Respondents (n=101) % of physicians who say that patient has assistance in anticoagulant management 45% of patients have a caregiver assisting with their medication management. For 1 in 10 patients, the physician does not know if a caregiver is involved.

24 Key Finding #1: Managing patients on anticoagulant medication is a challenge for physicians. Compared to other chronically ill patients, oral anticoagulant patients require more time spent adjusting medication, reviewing and relaying test results and other consultations. Two in five patients suffered a significant life-threatening event that precipitated treatment with blood thinning medication. Side effects or problems due to oral anticoagulant use are not uncommon. Majorities of physicians report that their oral anticoagulant patients have had problems due to their anticoagulant medication. In general patients called and/or visited the physician’s office, however, more than half of physicians report the their patients went to the emergency room and/or the hospital as a result of these complications. Physicians frequently have to make adjustments in dosage and counsel patients about guidelines because of problems related to their oral anticoagulant use. Physicians see patient non-compliance with their medication and blood testing regimen as the biggest challenges they face in managing these patients.

25 Chart 1: Anticoagulant patients require more of physicians’ time than other chronically ill patients. Q605 Compared to your patients on other medications for other chronic conditions (such as diabetes, arthritis, chronic lung disease, heart condition, or high blood pressure), do you find that your oral anticoagulant patients require more or less time from you or your staff for the following activities? Base: Qualified Respondents (n=101) Time anticoagulant patients require: Much less time % Some-what less time % About the same amount of time % Some- what more time % Much more time % Net of more time % Amount of time adjusting medication The amount of time I need to review and relay their test results The amount of time I have to spend with the patient (both in person and on phone/ consultations) The amount of time that other staff in my practice need to spend with the patients

26 Q404 Proportion of patients that had a significant event Base: Qualified respondents (n=101) Chart 2: More than two in five physicians report that more than half of their patients suffered a significant life-threatening event that precipitated treatment with blood thinning medication. Proportion of patients that had a significant life-threatening event that precipitated the decision to initiate therapy 41% of physicians say that more than half of patients experienced a life-threatening event

27 Chart 3: Majorities of physicians report that their patients experienced problems with their anticoagulant medication, leading to doctor visits and trips to the emergency room or hospital. Q440 In the past 12 months, have any of your patients done any of the following because of a problem related to taking their oral anticoagulant medication? Base: Qualified respondents (n=101)

28 Chart 4: Physicians frequently have to make adjustments in dosage and counsel patients about guidelines because of problems related to their oral anticoagulant use. Percentage of physicians who do the following because of patient problems related to taking oral anticoagulants: Every time % Less than Every time % Advised/Reminded patient to follow recommended guidelines for his/her treatment regimen (e.g. compliance, diet, regular blood testing, etc.) 2279 Adjusted dose of oral anticoagulant 1586 Suggested adjustments to use of over-the-counter medications, vitamins, or supplements the patient was taking in addition to his/her oral anticoagulant 891 Made adjustments to another prescription medication that patient was taking in addition to his/her oral anticoagulant 496 Switched patient to another brand of anticoagulant 296 Q445Thinking about all of your patients on oral anticoagulants, how often have you had to do the following because of a problem related to their oral anticoagulant medication? Base: Qualified Respondents (n=101)

29 Chart 5: Physicians feel that patient non-compliance with medication regimen and recommended blood tests are the top challenges when dealing with oral anticoagulant patients. Q610 Thinking about your experiences managing patients who take oral anticoagulants, which would you say are the biggest challenges you face? Base: Qualified Respondents (n=101) Percent who indicated items as one of top 3 challenges

30 Key Finding #2: Most physicians feel that the effort to manage multiple conditions is the main reason why oral anticoagulant patients experience difficulties with their treatment regimen. Nearly two in three physicians (61%) believe that managing multiple health problems is the number one reason why patients have difficulties with their anticoagulant treatment regimen. Lack of patient motivation to follow recommendations is also seen by many doctors as a key reason for problems. Lack of patient information about requirements when taking an oral anticoagulant and too little time to spend with these patients also seen as factors.

31 Chart 6: Physicians see management of multiple conditions and non-compliance with recommendations as the main factors leading to patient problems. Q615 What do you think are the main reasons why patients taking oral anticoagulants experience difficulties with their regimen? Base: Qualified Respondents (n=101) Percent indicating items as top 1 or 2 reasons that patients experience difficulties with their regimen

32 Key Finding #3: There is room for improvement in communication by physicians about oral anticoagulant regimen and blood test results. Many physicians do not tell all their patients important information such as dietary considerations and potential drug interactions when they first start them on anticoagulant medication. One in three physicians do not provide any of their oral anticoagulant patients with written instructions. While most physicians receive INR test results within 24 hours, a large minority has to wait at least two days. One in four physicians do not always call or mail the patients to inform them about their INR test results. One in five of the most commonly questions asked by patients relates to INR results and the frequency of blood testing. Very few physicians leave a message with the patient’s INR results, most will wait until they have made personal contact with the patient. When informing their patients about INR test results, many physicians do not tell their patients the actual numeric INR value.

33 Chart 7: Many physicians do not tell their patients important information such as dietary considerations and potential drug interactions when they first start patients on and anticoagulant medication. Q402First, please think about the situations when you start a patient on an oral anticoagulant or when you see a patient immediately after he or she has been started on an oral anticoagulant in a hospital. In these situations, how often do you talk to your patients about the following issues when you give them an oral anticoagulant prescription for the first time. Base: Qualified respondents (n=101) *1% not sure Issues that doctors talk about when initiating oral anticoagulant medication for the first time: Less than every time % Every time % Tell them about any special dietary considerations they should know while taking this medication 4447 Explain potential interactions between the oral anticoagulant and other prescription or over-the-counter medications, vitamins or supplements 4259 Explain any side effects they may experience 3466 Tell them about symptoms to watch for and when to seek further care or treatment 2874 Give them specific instructions about how to take the medication 2872 Tell them about how often they should have their blood tested 2080 Explain why they need to take it 1585 Advise them to wear a medical information emblem (bracelet or identifier) or carry a piece of paper that indicates the name of their anticoagulant medication 8316

34 Q407 Do you or does someone else in your office give written instructions about taking anticoagulant medications to your patients? These written instructions may inform patients about what they should and should not do with regard to diet, concomitant prescription and over-the-counter medication use, blood tests, etc. Please do not include the informational insert that comes with the medication or from the drug maker. Base: Qualified respondents (n=101) Chart 8: One in three physicians do not provide any of their oral anticoagulant patients with written instructions.

35 Q420On average, how soon after testing do you receive your patients’ INR results from the lab? Base: Qualified respondents (n=101) Chart 9: While most physicians receive INR test results within 24 hours, a large minority has to wait at least 2 days for them. 77% 20% 3%

36 Q425Which of the following best describes your office’s general approach to contacting patients regarding their INR results? Base: Qualified Respondents (n=101). Note: Multiple responses question, respondents could say that they phone and send letters. Chart 10: One in four physicians do not always call or mail the patients to inform them about their INR test results.

37 Q708 What is the most common question your oral anticoagulant patients ask you about their treatment regimen? Base: All respondents (n=101) Chart 11: One in five of the most commonly questions asked by patients relates to INR results and the frequency of blood testing. 20%

38 Q430 If you or another health-care professional in your office cannot reach a patient personally when calling with the INR results, which of the following are you most likely to do? Base: Respondents Who Call Patients With INR Results (n=98) Chart 12: Very few physicians leave a message with the patient’s INR results, most will wait until they’ve made personal contact with the patient.

39 Q435What terminology do you generally use to describe INR test results to your oral anticoagulation patients? Base: Qualified Respondents (n=101) Chart 13: When informing their patients about their INR test results, many physicians do not tell their patients their actual numeric INR value.

40 Key Finding #4: Physicians could be doing more to help their patients with ongoing management of their oral anticoagulant regimen. Nearly 2 in 5 physicians do not have a nurse or other health care professional in their office to help patients manage their oral anticoagulant. The majority of physician offices do not contact their patients every time to remind them about their next appointment or to have their blood tested.

41 Chart 13: Nearly 2 in 5 physicians do not have a nurse or other health care professional in their office to help patients manage their oral anticoagulant. Q410 Is there a nurse or another health-care professional in your office who helps patients manage their oral anticoagulant? This may include calling them regularly to check how well they are doing, reminding them about appointments for blood testing, reviewing their blood test results with them, etc. Please do not include a receptionist calling the patient about appointments. Base: Qualified respondents (n=101)

42 Chart 14: The majority of physician offices do not contact their patients every time to remind them about their next appointment or to have their blood tested. Follow-up contact Every time % Less than every time % Remind them of their next appointment4356 Remind them to have their blood tested4555 To check how well they are doing2176 Q416 How often, if ever, do you or your office staff contact your oral anticoagulant patients to….? Base: Qualified respondents (n=101)

43 Key Finding #5: Improving blood testing, communications and involvement with health care professionals are seen as key components in helping patients comply with their oral anticoagulant regimen. Physicians report that the most effective ways to help patients comply with their anticoagulant regimen involve improvements in blood testing: –Improving the speed and accuracy of blood testing –Improving communication about blood results Better information for patients and more assistance with management of their treatment are also seen as solutions. Written communication is seen by many physicians as a good method of relaying information. Regular counseling and check ups are also key to conveying the rules and guidelines anticoagulant patients should follow. Physicians trust clinic staff at anticoagulant clinics and different doctors in their own offices the most to help in the management of their anticoagulant patients. Continued >

44 Chart 15a: Good communication and information are effective in increasing patients’ compliance with oral anticoagulant medication. Effective approaches: Very Effective % Extremely effective % Net 4/5 % Improve the speed and accuracy of blood testing Improving communication about blood results – consistent feedback loop, regardless of whether INR results are good or bad Better information available to patients about what they should or should not do Having more patients visit anticoagulant clinics for routine care Nurses or other health-care professionals providing ongoing disease management for patients Physicians spending more time with patients to provide counseling and support Providing rewards to patients who show perfect compliance with their medication regimen Patient self-testing their blood for INR level Pharmacists spending more time educating and counseling patients Q620 How effective do you think the following approaches to increasing patient oral anticoagulant compliance would be? Base: Qualified Respondents (n=101)

45 Chart 15b: Patient self-testing and more time spent with patients are seen as less effective approaches. Effective approaches: Somewhat Effective % Not at all effective % Net 1/2 % Having more patients visit anticoagulant clinics for routine monitoring Providing rewards to patients who show perfect compliance with their medication regimen Better information available to patients about what they should or should not do Patient self testing their blood for INR level Nurses or other health-care professionals providing ongoing disease management for patients Pharmacist spending more time educating and counseling patients Improve the speed and accuracy of blood testing Improving communication about blood results – consistent feedback loop, regardless of whether INR results are good or bad Physicians spending more time with patients to provide counseling and support Q620 How effective do you think the following approaches to increasing patient oral anticoagulant compliance would be? Base: Qualified Respondents (n=101)

46 Q705 Please specify any particularly good methods you use or are aware of to communicate to your patients the “rules and guidelines” they should follow because they are on an oral anticoagulant therapy. Base: All respondents (n=101) Chart 16: Written communication is seen by many physicians as a good method of relaying information.

47 Q710How much would you trust each of the following to help your patients manage their anticoagulant regimen? Base: All respondents (n=426) Trust a Great Deal % Trust Completely % Net % Dedicated oral anticoagulation clinic staff A different doctor (in my office) The nurse or other health-care professional in my office My patient’s other doctors (not in my office)38947 Registered dietician14721 My patients’ pharmacists26632 Technicians at the lab21324 A paid caregiver (such as a nurse’s aid or home-health worker) An unpaid caregiver (such as a family member of the patient) Chart 17a: Physicians trust clinic staff at anticoagulant clinics and different doctors in their own offices the most to help in the management of their anticoagulant patients.

48 Q710How much would you trust each of the following to help your patients manage their anticoagulant regimen? Base: All respondents (n=426) Trust Very Little % Do Not Trust at All % Net % Technicians at the lab A paid caregiver (such as a nurse’s aid or home-health worker) Registered dietician22729 An unpaid caregiver (such as a family member of the patient) My patients’ pharmacists20525 The nurse or other health-care professional in my office 224 My patient’s other doctors (not in my office)11112 A different doctor (in my office)213 Dedicated oral anticoagulation clinic staff3-3 Chart 17b: Physicians trust laboratory technicians the least to help them manage their anticoagulant patients.

49 Respondent Profile

50 Physician Profile Gender % Male84 Female16 Gender % Male84 Female16 Specialty % Family Practice (FP) 27 Internal Medicine (IM) 27 General Medicine11 Cardiovascular Diseases11 Geriatrics FP10 Geriatrics IM 15 Specialty % Family Practice (FP) 27 Internal Medicine (IM) 27 General Medicine11 Cardiovascular Diseases11 Geriatrics FP10 Geriatrics IM 15 Practice Type % Solo practice29 Single-specialty partnership/group36 Multi-specialty partnership/group35 Practice Type % Solo practice29 Single-specialty partnership/group36 Multi-specialty partnership/group35 Total Number of Respondents = 101 Age % * MEAN45 Age % * MEAN45 Number of Years in Practice % 1- 5 years years years years years years years years1 Number of Years in Practice % 1- 5 years years years years years years years years1