Prepared for: The National Consumers League September 21, 2005 J23715 The Use of Oral Anticoagulant Medications PRESENTATION: Key Findings from Surveys.

Prepared for:

The National Consumers LeagueThe National Consumers League

September 21, 2005

J23715

The Use of Oral Anticoagulant The Use of Oral Anticoagulant MedicationsMedications

PRESENTATION: PRESENTATION: Key Findings from Surveys of Key Findings from Surveys of

Patients, Caregivers, and PhysiciansPatients, Caregivers, and Physicians

2

BackgroundBackground

• The National Consumers League (NCL), on behalf of the SOS Rx Coalition (The Coalition), is working on an outpatient medication safety campaign aimed at consumers, caregivers, and physicians.

• The initial focus of this campaign is on oral anticoagulant drugs.– Oral anticoagulants, or blood thinners, are highly effective at preventing

blood clots and are used for numerous indications, including stroke and coronary event prevention.

– Despite their benefit, these agents are known to be relatively difficult to manage, require frequent monitoring, and may be associated with a large number of potential interactions with other medications or food.

– The SOS Rx Coalition would like to further explore these potential issues among patients, caregivers, and physicians in order to help design outreach and educational campaigns to help consumers and providers better manage this drug.

• Harris Interactive was commissioned to conduct a survey exploring use of and experiences with oral anticoagulants.

3

ObjectivesObjectives

– Gain insight into the experiences of patients who are taking oral anticoagulants particularly issues around managing their medication regimen, adherence to recommendations, relationships and communications with their doctors, and sources used for information to help manage their regimen.

– Gain insight into the experiences of caregivers who assist in the management of patients’ anticoagulant regimen.

– Gain insight into the physician’s point of view on issues around the use and management of oral anticoagulant medication.

– Identify opportunities for improving education and communication about oral anticoagulant treatment, which could improve patient compliance, safety, and outcomes.

4

MethodologyMethodology

• Harris Interactive conducted surveys with patients, caregivers, and physicians about the use of oral anticoagulants.

• All three surveys were conducted online within the United States.

• Patients – A total of 426 patients were interviewed. – Patients were sampled from the Harris Interactive Chronic Illness Panel.– Eligible respondents have been taking an oral anticoagulant medication for

at least 3 months and are at least 30 years of age.– Interviews conducted between April 4 -15, 2005.

• Caregivers– A total of 109 caregivers were interviewed. – Caregivers were sampled from the Harris Interactive Panel, prescreened as

being the caregiver of someone who is chronically ill. – Eligible caregivers are taking care of a person who has been on an oral

anticoagulant medication for at least 3 months and is at least 30 years of age. Further, caregivers must assist the patient in at least 2 out of 11 care-giving tasks around anticoagulant use.

– Interviews conducted between May 19 - 26, 2005.

5

Methodology, continuedMethodology, continued

• Physicians – A total of 101 physicians were interviewed. – Physicians were sampled from the Harris Interactive Physician Panel.– Eligible respondents are primary care providers (specializing in family

practice, internal medicine or general medicine) and cardiovascular specialists, practicing for at least 5 years, spending at least 70% of their time in direct patient care and treating 5 or more patients who are on an oral anticoagulant medication.

– Interviews conducted between August 11 - 18, 2005.– Eligible respondents received a $50 honorarium for completing the survey.

6

Summary of Key FindingsSummary of Key Findings

7

Summary of Key Findings: PatientsSummary of Key Findings: Patients

1. People on oral anticoagulants face complex health problems and have considerable health management needs.

2. Almost all patients on oral anticoagulants also take other prescription drugs and many take over-the-counter (OTC) drugs and vitamins/supplements.

3. According to patients, physicians are overall doing a good job educating new oral anticoagulant users, but there are gaps in education about dietary considerations, drug interactions, and possible side effects.

4. There are gaps in the management of the health care of patients on oral anticoagulants.

5. There is room for improvement in the relationship between oral anticoagulant users and their physicians.

Continued >

8

Summary of Key Findings: Patients, Summary of Key Findings: Patients, continuedcontinued

6. Communication about blood test goals should be improved.

7. Patients are fairly knowledgeable about the things they should and should not do when taking an oral anticoagulant. However, actual behavior could be improved upon.

8. Patients have some difficulties and concerns about being on an oral anticoagulant.

9. Adverse reactions to oral anticoagulants are common. Many do not change their behavior or seek help.

10. Patients could use more assistance with management of their oral anticoagulant use. Such assistance is associated with improved awareness, behavior, and confidence around the management of oral anticoagulant use.

11. Doctors are the most used, perceived as being the most useful, and most trusted source of information about what patients should and should not do when taking an oral anticoagulant.

9

Summary of Key Findings: CaregiversSummary of Key Findings: Caregivers

1. Caregivers are assisting oral anticoagulant users who have considerable health management needs.

2. Caregivers are highly involved in helping their family members manage their oral anticoagulant regimen.

3. Caregivers are generally aware of the complexity of oral anticoagulant medication, knowledge of precautions could be improved.

4. Caregivers could use more assistance in helping their family members with management of their anticoagulant regimen.

5. Nearly one in four caregivers is less than very confident that their family members are taking the anticoagulant correctly; Family members need encouragement to follow recommendations for safe use of medication.

10

Summary of Key Findings: Caregivers, Summary of Key Findings: Caregivers, continuedcontinued

6. A small but troubling minority of caregivers report that their family members experienced adverse reactions to anticoagulant medications that led to an ER visit and/or hospital stay.

7. Caregivers rate physicians highly on their responsiveness to patients; However there is room for improvement in explanations of precautions both to caregivers and family members.

8. Doctors are the most used source of information on the dos and don’ts of managing and anticoagulant regimen.

11

Summary of Key Findings: PhysiciansSummary 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.

12

Executive SummaryExecutive Summary

13

Three Key Themes Across GroupsThree Key Themes Across Groups

1. Oral anticoagulant use presents a challenge to patients, caregivers, and physicians.

2. There are gaps in education around oral anticoagulant use, both for patients and caregivers.

3. There are gaps in the health care management of oral anticoagulant patients.

14

Key Theme #1 Key Theme #1

Oral anticoagulant use presents a challenge Oral anticoagulant use presents a challenge to patients, caregivers and physicians.to patients, caregivers and physicians.

15

Patients on oral anticoagulant medications have Patients on oral anticoagulant medications have complicated health needs, use numerous medications, complicated health needs, use numerous medications, and see multiple doctors.and see multiple doctors.

• 3 in 5 suffer poor or fair health• Most suffer four or more conditions• Almost all take multiple medications, and many take OTCs• Almost all see multiple doctors, with 2 in 5 seeing 4 or more

doctors• Half of patients have been hospitalized or have gone to the ER

past 12 months

• Generally, caregivers report even greater health management challenges among their family members

• Most caregivers care for someone memory impairment

16

0%

9%

32%

39%

20%

Excellent Very Good Good Fair Poor

3 in 5 oral anticoagulant users suffer poor or fair 3 in 5 oral anticoagulant users suffer poor or fair health.health.

Q310 In general, how would you describe your own health? Base: Qualified respondents (n=426)

59%

How would you describe your own health?

Caregiver response in contrast:

Fair/Poor: 69%

17

More than half of oral anticoagulant users suffer four or more More than half of oral anticoagulant users suffer four or more of these conditions.of these conditions.

Q335 Have you been told by a doctor that you have . . .? Base: Qualified respondents (n= 426)* Less than 1 percent

Diagnosed with: %

Any of these conditions 92

Four or more of these conditions 54

Hypertension, sometimes called high blood pressure 66

Heart disease, including heart attack 60

Atrial Fibrillation also known as “Afib” 51

Arthritis 47

Stroke or stroke-like symptoms 38

Diabetes 35

Depression 23

Blood clot, thromboembolism or pulmonary embolism 22

Heart valve replacement 20

Asthma, Emphysema, or any other chronic lung problems 19

A high red blood cell count (polycythemia) 2

Sickle cell anemia *

In contrast: Caregivers reporting that their family member suffers from four or more of these conditions

43

18

Most oral anticoagulant patients are taking Most oral anticoagulant patients are taking multiple prescription medications and OTCs. multiple prescription medications and OTCs.

Q500 Including your blood thinning medication, how many different prescription medications do you take on a regular or ongoing basis? Q507 In addition to anticoagulant, are you also taking Plavix on a regular basis? Q510 Are you taking any over-the-counter medications such as aspirin, Motrin, Tylenol, Tagamet, or Zantac, on a regular or ongoing basis? Q512 Are you taking any vitamins or supplements, such as ginkgo, ginseng or St. John’s Wort, on a regular or ongoing basis? Q508 Are you taking aspirin as a blood thinning medication? Base: Qualified respondents (n=426)

Rx and OTC Use: %

Number of prescription medications taken on regular basis:

1 (anticoagulant only) 2

2-4 23

5-7 35

8 or more 38

Mean number of Rx: 7

Currently taking Plavix on a regular basis 6

Currently taking aspirin as a blood thinner 37

Currently taking any OTCs on regular basis (not including aspirin) 27

Currently taking vitamins or supplements on a regular basis 46

19

Oral anticoagulant users see multiple Oral anticoagulant users see multiple doctors, in addition to their regular doctor.doctors, in addition to their regular doctor.

Q410 In addition to your regular doctor, how many other doctors, including specialists, have you seen in the past year? Base: Qualified respondents (n= 426)

6%

14%18%

20%

14%11%

16%

Regulardoctor only

1 2 3 4 5 6 or more

In the past year, number of doctors seen in addition to regular doctor;

41%

Caregiver responses in contrast: 65% of their family members see for

4 or more doctors

20

Most caregivers are caring for someone with memory Most caregivers are caring for someone with memory impairment.impairment.

32%

35%

29%

4%

No Memory Impairment

Mild Memory Impairment

Moderate MemoryImpairment

Severe MemoryImpairment

68%

Q820 Does your family member suffer from memory impairment? If so, how severe is this impairment?

Base: Qualified respondents (n=109)

21

Following the oral anticoagulant Following the oral anticoagulant treatment regimen is difficult for many.treatment regimen is difficult for many.

• A substantial minority of patients are less than very confident that they are taking the oral anticoagulant medication correctly.

• 1 in 5 caregivers are less than very confident that their family member is taking the medication correctly. Assistance with following treatment recommendations is needed.

• 2 in 5 caregivers feel that family members need encouragement to follow recommendations. A small minority needs a great deal of encouragement (8%).

• Physicians report that patient non-compliance with medication regimen and recommended blood tests are the top challenges to treating anticoagulant patients.

• Physicians indicate that nearly half of patients are managing their anticoagulant regimen less than very well. They report that 1 in 4 patients have a difficult time following the recommendations.

22

46%

37%

12%4% 1%

ExtremelyConfident

Very Confident Fairly Confident SomewhatConfident

Not At AllConfident

A substantial minority of patients are less than very A substantial minority of patients are less than very confident that they are taking the oral anticoagulant confident that they are taking the oral anticoagulant correctly.correctly.

Q645 Overall, how confident are you that you are taking the anticoagulant the correct way to ensure that the drug works at its best and does not cause any problems?Base: Qualified respondents (n=426)

17%

Confidence that they are taking anticoagulant medication the correct way

23

Nearly 1 in 4 caregivers are less than very confident that their Nearly 1 in 4 caregivers are less than very confident that their family members are taking the oral anticoagulant medication family members are taking the oral anticoagulant medication correctly.correctly.

1%4%

17%

39%39%

Not at all confidentSomewhat confidentFairly confidentVery ConfidentExtremely confident

Q530 Overall, how confident are you that you family member is taking his/her oral anticoagulant medication the correct way?


22%

24

96%

96%

95%

80%

78%

62%

90%

80%

84%

46%

49%

19%

Tell all doctors that they are taking ananticoagulant

Have their blood tested as often asrecommended

Tell dentist that they are on anticoagulantbefore dental work

Talk to doctor/pharmacist before taking OTCs

Tell pharmacist that they are taking ananticoagulant

Follow a consistent diet

Believe that behavior is extremely or very important

Always comply with behavior

Patients recognize the importance of safe Patients recognize the importance of safe behaviors; Compliance is more difficult.behaviors; Compliance is more difficult.

Q640 As far as you know, how important is it for people who take anticoagulants to . . . ? Q610 How often do you do the following?Base: Qualified respondents (n=426)

Importance of and compliance with anticoagulant precautions

25

27%

10%

8%

7%

7%

6%

2%

1%

Eat a diet appropriate for somebody who takes ananticoagulant

Avoid taking OTCs w/o first checking withdoctor/pharmacist

Avoid taking supplements/vitamins without firstchecking with doctor/pharmacist

Avoid taking other Rx medications without firstchecking with doctor/pharmacist

See doctor about blood levels on a regular basis

Get blood tested on a regular basis

Remember to tell other doctors/dentists that you areon anticoagulant

Remember to take anticoagulant

Finds it very orsomewhat difficultto…

Following an appropriate diet is difficult for many Following an appropriate diet is difficult for many patients. patients.

Q910 How easy or difficult is it for you to . . . ?” Base: All respondents (n=426)

26

2 in 5 of caregivers feel that family members need at least 2 in 5 of caregivers feel that family members need at least some encouragement to follow instructions associated with some encouragement to follow instructions associated with taking the anticoagulant medication safelytaking the anticoagulant medication safely

8%

32%

38%

22%

A Great Deal ofEncouragement

needed

SomeEncouragement

needed

Very littleEncouragement

needed

No Encouragementneeded

40%

Q520 How much encouragement does you family member need to follow all o the instructions associated with taking an oral anticoagulant medication?


27

Most caregivers report that their family members need at least Most caregivers report that their family members need at least some assistance following recommendations.some assistance following recommendations.

39%

41%

36%

39%

32%

29%

29%

32%

31%

29%

15%

11%

12%

9%

9%

12%

10%

10%

6%

8%

17%

17%

19%

17%

22%

18%

19%

16%

17%

14%

Eat a diet appropriate for somebody who takes ananticoagulant

Check doctor/pharmacist for possible interactions OTC andvitamins

Check doctor/pharmacist for possible interactions with otherRx drugs

Follow all of his/her doctor's recommendations related to takingthe oral anticoagulant medication

Get his/her blood tested regularly

Keep up with prescribed changes in dosage

Read info about drug provided by pharmacy

Tell other doctors/dentist that patient is taking drug

Understand blood test results

Remember to take drug

Needs some assistance Needs a great deal of assistance Completely depends on others

70%

67%

63%

69%

64%

59%

58%

54%

51%

60%

Q510 How much assistance does your family member need to follow these recommendations related to taking his/her anticoagulant?Base: Qualified respondents (n=109)

28

Physicians feel that patient non-compliance with medication Physicians feel that patient non-compliance with medication regimen and recommended blood tests are the top challenges regimen and recommended blood tests are the top challenges when dealing with oral anticoagulant patients. when dealing with oral anticoagulant patients.

48%

46%

39%

30%

27%

26%

16%

15%

15%

11%

4%

2%

Patients not being compliant with the medication regimen

Patients not getting their blood tested as directed

Interactions with drugs prescribed by other physicians

Patients not returning for follow-up visits

Patients not following a consistent diet

Patients taking OTCs that they should avoid

Problems getting lab results

Problems resulting from use of generic versions

Pharmacies that change the supplier of their generic versions

Patients not reporting symptoms or complications

Problems reaching or communicating with pharmacists about patients

None of these

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

29

Physicians report that almost half of patients are Physicians report that almost half of patients are managing their anticoagulant regimen less than very managing their anticoagulant regimen less than very well (Case Study)well (Case Study)

19%

31%

15%

2%

1%

33%

Extremely well

Very well

Fairly well

Somewhat well

Not at all well

Not sure

Q555 Overall, how well do you think this patient is managing his/her oral anticoagulant? Base: Qualified Respondents (n=101)

48%

Percent of physicians indicating how well the patient is managing oral anticoagulant use:

30

Physicians report that 1 in 4 patients have difficulty Physicians report that 1 in 4 patients have difficulty following recommendations (Case Study)following recommendations (Case Study)

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)

29%

45%

24%

2%

1%

Very easy

Somewhat easy

Somewhatdifficult

Very difficult

Not sure

26%

Percent of physicians indicating how difficult it is for the patient to follow all of their recommendations:

31

Adverse reactions due to oral anticoagulant use are Adverse reactions due to oral anticoagulant use are not uncommon. Many patients do not change their not uncommon. Many patients do not change their behavior or seek help.behavior or seek help.

• Almost all patients have experienced at least one side effect to the anticoagulant medication.

• A troubling minority have been to the ER and/or the hospital because of problems related to their medication.

• Only about 2 in 5 patients contacted their doctor in response to a problem.

• Only about half say that they did anything to change their behavior in response to a problem.

• A majority of physicians report that, in the past 12 months, they have had anticoagulant patients who called or visited the office and/or went to the ER or hospital due to problems with their medication.

32

93%

82%

54%

48%

46%

46%

27%

21%

20%

Any of these (Net)

Easy bruising

Bleeding that would not stop from a cut

Dizziness

Nose bleeds or bleeding gums

Bloated stomach or gas or stomach cramps

Skin rashes

Nausea or vomiting

Internal bleeding

Most patients have experienced adverse reactions to Most patients have experienced adverse reactions to oral anticoagulant use.oral anticoagulant use.

Q615 How often, if at all, do you experience any of the following as a result of taking the anticoagulant? Base: All respondents (n=426)

Ever experienced any of these adverse reactions as a result of taking their anticoagulant

Note: Percentages shown are the sum of responses ‘always’, ‘most of the time’, ‘sometimes’, and ‘rarely’.

33

A troubling minority of patients have been to the hospital A troubling minority of patients have been to the hospital or emergency room because of problems with their oral or emergency room because of problems with their oral anticoagulant.anticoagulant.

Q630 In the past 12 months, have you gone to the emergency room or been admitted to the hospital because of a problem related to taking the anticoagulant. Base: Qualified respondents (n=426) [NOTE: RECALCULATED TO BASE OF ALL QUALIFIED RESPONDENTS]

No hospital/ER use due to anticoagulant:

92%

Admitted to hospital due to anticoagulant problem:

3%

Went to ER due to anticoagulant problem:

5%

8%8%

Caregiver responses in contrast: 11% say their family member went

to the ER or hospital due to anticoagulant problem

34

7% 6% 6% 5%11%

51%

Changed/monitored diet

More careful/Avoid cuts and

bruises

Adjusteddosage

Made lifestylechanges*

Other Did nothing/ Nochanges

Half of patients who experience adverse Half of patients who experience adverse reactions do nothing to change their behavior.reactions do nothing to change their behavior.

Q635 After you have experienced side effects or other adverse reactions due to taking anticoagulant, what, if anything, are you doing differently now?Base: Qualified respondents who experienced at least 1 side effect (n=395)

Change in behavior after experiencing side effects from anticoagulant use

*Lifestyle changes: test regularly, changed/added medications, monitored health status, etc.

35

41%

22%

9%

3%

37%

6%

Telephoneddoctor

Went to seedoctor

Went to ER Admitted tohospital

Nothing Not sure

Many patients who experience adverse reactions do not Many patients who experience adverse reactions do not contact their doctor about the problem.contact their doctor about the problem.

Q620 What did you do when you experienced side effects from taking anticoagulant? Please select all that apply.Base: Qualified respondents who experienced at least 1 side effect (n=395)

Response to experiencing side effects from anticoagulant use

36

84%

82%

52%

51%

7%

Called the office

Visited the office

Went to ER

Went to hospital

None of these

Most physicians have anticoagulant patients who contact them Most physicians have anticoagulant patients who contact them with problems due to their anticoagulant use; Half have with problems due to their anticoagulant use; Half have patients who end up in the ER or hospital.patients who end up in the ER 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)

37

Caregivers struggle to help manage the complex Caregivers struggle to help manage the complex care needs of their loved ones.care needs of their loved ones.

• Many oral anticoagulant users have family members or friends assisting with their care, physicians report that more than 1 in 3 new anticoagulant patients are accompanied by a caregiver

• Caregivers are involved in a multitude of aspects related to their family members anticoagulant regimen, from accompanying them to the doctor to keeping track of all their medication

• Many of these caregivers feel that it is their responsibility to ensure that their family member takes their anticoagulant medication as prescribed

• Many caregivers find it difficult to assist with the oral anticoagulant regimen

38

4%

9%

27%

2%

12%

13%

7%

11%

5%

5%

5%

<5%

11 - 25%

31 - 40%

51 - 60%

71 - 80%

91 - 100%

Q413B Proportion of patients who come to initial consultation for anticoagulant medication with a caretaker.Base: Respondents who have 5 or more patients on oral anticoagulants (n=94)

4%: Decline to answer

According to physicians, 1 patient in 3 was accompanied According to physicians, 1 patient in 3 was accompanied by a caregiver when their oral anticoagulant treatment by a caregiver when their oral anticoagulant treatment was initiated.was initiated.

Physician reports of proportion of patients with caregiver at initial appointment

34%

39

Caregivers are involved in all aspects of anticoagulant Caregivers are involved in all aspects of anticoagulant management.management.

Tasks: %

Go with family member to the doctor who prescribes his/her oral anticoagulant medication

82

Help family member keep track of ALL of the medications that he/she is taking, including prescription drugs, OTC drugs, vitamins, and supplements

80

Pick up prescriptions for anticoagulant medications 76

Find out results of the blood tests (eg. INR level) that are part of family member’s regimen

74

Help monitor family member’s diet 68

Go with family member to have his/her blood tested as part of his/her regimen

64

Remind family member about the special things he/she needs to be careful about when taking his/her oral anticoagulant medication

57

Remind family member to take his/her oral anticoagulant medication 55

Assist with self-testing of blood to determine INR level 15

Q340 Do you assist your family member in any of the following ways?

Base Qualified respondents (n=109)

40

2 in 5 caregivers feel that they are primarily responsible for 2 in 5 caregivers feel that they are primarily responsible for ensuring that their family member takes the oral ensuring that their family member takes the oral anticoagulant correctlyanticoagulant correctly..

55%

39%

3%

2%

1%

0%

0%

0%

Family member himself/herself

Me, as his/her caregiver

His/Her nurse

His/Her doctor

Someone else

Another family member

His/Her pharmacist

Not sure

Q630 Who do you think is primarily responsible for ensuring that your family member takes his/her oral anticoagulant medication as prescribed and follow all of the recommended actions related to taking this medication?


Patient responses in contrast: Patient himself/herself 82%Doctor 11%Spouse or Caretaker 3%Pharmacist 2%Nurse 2%

Percent of caregivers identifying who is primarily responsible for ensuring that family member follows recommendations:

41

Many caregivers find it at least somewhat difficult to assist with Many caregivers find it at least somewhat difficult to assist with their family member’s oral anticoagulant regimen.their family member’s oral anticoagulant regimen.

24%

15%

12%

10%

8%

8%

6%

5%

Keep track of multiple prescription medications

Keep family member motivated to follow the anticoagulantregimen

Remember all special things to do while taking anticoagulant

Assist family member with getting blood tested regularly

Getting blood test results in timely matter

Getting clear explanation of blood test results

Getting doctor's appointments

Keeping track of when blood tests need to be done

Q700 How difficult or easy do you find the following when assisting your family member managing his/her use of oral anticoagulant medication?


Percent of caregivers finding it very difficult or somewhat difficult to…

42

Physicians see care for oral anticoagulant patients Physicians see care for oral anticoagulant patients as a challenge, requiring more time than patients as a challenge, requiring more time than patients with other chronic conditionswith other chronic conditions

• According to physicians, oral anticoagulant patients require more time than other patients with other chronic diseases.

• The average anticoagulant patient visits the doctor 7 times a year, with more than 1 in 5 making 10 or more visits a year

43

Anticoagulant patients require more of physicians’ Anticoagulant patients require more of physicians’ time than other chronically ill patients.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%

Somewhat less time

%

About the same

amount of time

%

Some-whatmore time

%

Much more time

%

Net of more time

%

Amount of time adjusting medication 1 3 17 51 28 79

The amount of time I need to review and relay their test results

- 5 26 48 22 69

The amount of time I have to spend with the patient (both in person and on phone/email consultations)

- 6 27 53 14 67

The amount of time that other staff in my practice need to spend with the patients

- 4 34 39 22 60

44

2%

11%

19%

16%

16%

15%

5%

5%

0%

5%

1%

6%

8%

1

2

3

4

5

6

7

8

9

10

11

12

More than 12

Q531 How many times have you seen this patient in the past year? If you are not sure, your best estimate will do. Base: Qualified Respondents (n=101)

According to physicians, the average anticoagulant According to physicians, the average anticoagulant patient visits the doctor 7 times a year (Case Study)patient visits the doctor 7 times a year (Case Study)

Not sure: 2%

Average number of visits a year: 7

Percent of physicians who report the number of times they have seen their most recent anticoagulant patient in the past year:

45

Key Theme #2 Key Theme #2 There are gaps in education around oral There are gaps in education around oral

anticoagulant use, both for patients and caregivers.anticoagulant use, both for patients and caregivers.

46

Need for greater education, particularly around dietary Need for greater education, particularly around dietary considerations, drug interactions, and side effects.considerations, drug interactions, and side effects.

• While most patients and caregivers recognize the importance of following the precautions, there are some gaps in knowledge, particularly around dietary concerns, potential interactions, and side effects.

• Troubling minorities of patients report that their doctor did not tell them about important elements of their anticoagulant regimen.

• Many physicians also admit that they do not tell all their patients this important information when they first start them on anticoagulant medication. Opportunities for education at initiation of treatment are being lost.

47

96%

96%

95%

80%

78%

62%



Tell dentist that they are on anticoagulant beforedental work




Believe that behavior is extremely or very important

Patients recognize the importance of safe Patients recognize the importance of safe behaviors, with some weaker areas.behaviors, with some weaker areas.

Q640 As far as you know, how important is it for people who take anticoagulants to . . . ? Base: Qualified respondents (n=426)

Importance of anticoagulant precautions

48

There are some gaps in caregiver knowledge about dietary There are some gaps in caregiver knowledge about dietary concerns, potential interactions, and side effects.concerns, potential interactions, and side effects.

25%

21%

13%

9%

4%

Special dietary considerations

Potential interactions between oral anticoagulants andother prescriptions and OTC medicaitons

Side effects

How often he/she needs to have blood tested

Why he/she needs oral anticoagulant

Q500: Regarding your family member’s use of their oral anticoagulant, do you understand the following…?

Base: Qualified respondents (n=109).

Percent of caregivers who have no understanding or are unsure:

49

A small but troubling minority of caregivers have had problems A small but troubling minority of caregivers have had problems with a lack of information or conflicting information.with a lack of information or conflicting information.

14%

10%

9%

Not enough information about the things he/sheis supposed to do when taking an oral

anticoagulant

Conflicting information about what he/she issuppose to do when taking an oral anticoagulant

Not enough counseling and support from healthcare professionals to keep compliant with the

regimen

Considering it a big problem or somewhat of a problem

Q710 How much of a problem has each of the following been for your or your family member?


50

There are gaps in education of new oral anticoagulant There are gaps in education of new oral anticoagulant patients.patients.

Q520 Thinking about the first time when the doctor prescribed the anticoagulant for you, did he or she. . .? Base: Qualified respondents (n=426)

When your doctor first prescribed your anticoagulant, did he or she: Yes%

No%

Not Sure%

Tell you about any special dietary considerations you should know while taking this medication

74 21 5

Explain potential interactions between the anticoagulant and other prescription or over-the-counter medication, vitamins or supplements

76 19 5

Explain any side effects you might experience when taking the anticoagulant

78 17 5

Tell you symptoms to watch for and when to seek further care or treatment

79 15 6

Give you clear instructions about how to take the medication 94 4 1

Tell you how often you should have your blood tested 96 2 1

Explain to you why you need to take the anticoagulant 98 1 1

51

Many physicians do not tell their patients important information Many physicians do not tell their patients important information when they first start patients on and anticoagulant medication.when they first start patients on and anticoagulant medication.

Q402 First, 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

44 47

Explain potential interactions between the oral anticoagulant and other prescription or over-the-counter medications, vitamins or supplements

42 59

Explain any side effects they may experience 34 66

Tell them about symptoms to watch for and when to seek further care or treatment

28 74

Give them specific instructions about how to take the medication 28 72

Tell them about how often they should have their blood tested 20 80

Explain why they need to take it 15 85

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

83 16

52

Key Theme #3Key Theme #3There are gaps in the health care There are gaps in the health care

management of oral anticoagulant patients.management of oral anticoagulant patients.

53

Improvement is needed in communication Improvement is needed in communication between doctors and patients about the between doctors and patients about the management of their treatment regimen. management of their treatment regimen.

• Many physicians do not always contact patients with reminders about blood test results, appointments, or to check on health status.

• Patients and physicians do a good job managing multiple prescriptions; Could improve management of OTCs.

• During physician visits, many patients are not being asked about compliance, problems they may be having, and diet.

• Serious gaps in the management of and communication around blood testing.

54

Good communication and information are seen by physicians Good communication and information are seen by physicians as most effective in increasing patients’ compliance with oral as most effective in increasing patients’ compliance with oral anticoagulant medication.anticoagulant medication.

Physician ratings of the following approaches:Very

Effective%

Extremely effective%

Net4/5%

Improve the speed and accuracy of blood testing29 21 50

Improving communication about blood results – consistent feedback loop, regardless of whether INR results are good or bad

42 18 59

Better information available to patients about what they should or should not do

33 18 50

Having more patients visit anticoagulant clinics for routine care

31 16 47

Nurses or other health-care professionals providing ongoing disease management for patients

37 15 51

Physicians spending more time with patients to provide counseling and support

41 11 51

Providing rewards to patients who show perfect compliance with their medication regimen

24 11 35

Patient self-testing their blood for INR level 26 9 35

Pharmacists spending more time educating and counseling patients

26 7 33

Q620 How effective do you think the following approaches to increasing patient oral anticoagulant compliance would be? Base: Qualified Respondents (n=101)

55

The majority of physician offices do not contact their patients The majority of physician offices do not contact their patients every time to remind them about their next appointment or to every time to remind them about their next appointment or to have their blood tested.have their blood tested.

Follow-up contactEvery time

%

Less than every time

%

Remind them of their next appointment 43 56

Remind them to have their blood tested 45 55

To check how well they are doing 21 76

Q416 How often, if ever, do you or your office staff contact your oral anticoagulant patients to….?Base: Qualified respondents (n=101)

56

Patients and physicians do a good job managing multiple Patients and physicians do a good job managing multiple prescriptions; Could improve management of OTCs. prescriptions; Could improve management of OTCs.

Q505 In the past year, have any of the following people reviewed with you all of the prescription drugs you are taking? Base: Respondents taking more than one prescription medication (n=424)Q440 Do all of the doctors you see know that you are taking the anticoagulant?Base: Respondents seeing more than one doctor (n=398)Q515 Does the doctor who prescribes your anticoagulant know that you are taking these over-the-counter medications, vitamins, or supplements? Base: Respondents who take OTCs/Vitamins (n=323)•Less than 1 percent** Includes decline to answer (2%)

Medication management:Yes%

No%

Not Sure %

In the past year, has a doctor, nurse, or other health care professional reviewed with you all of the prescription medication you take

96 4 *

Do all of the doctors you see know that you are taking an anticoagulant

98 1 1

Does your doctor know you are taking OTCs, vitamins, or supplements in addition to the anticoagulant

87 5 7**

57

While physicians are doing well with reviewing While physicians are doing well with reviewing medication, many patients are not being asked about medication, many patients are not being asked about compliance, problems, and diet. (Case Study)compliance, problems, and diet. (Case Study)

On this patient’s most recent visit did you…?Yes%

No%

Not sure%

Review the patient’s latest blood test results 96 4 -

Review all of the patient’s medications, including over-the-counter medications, vitamins and supplements

84 14 2

Ask the patient whether he/she is taking the oral anticoagulant as prescribed

83 17 -

Ask the patient whether he/she is having any problems related to taking the oral anticoagulant

79 20 1

Ask the patient about his/her diet 50 49 1

Q529 On this patient’s most recent visit did you…?Base: Qualified respondents (n=101)

58

There are considerable gaps in knowledge and There are considerable gaps in knowledge and communication about the blood test goals.communication about the blood test goals.

Q830 Has a health care professional ever told you what your “number” should be?Q840 Does your ”number” usually stay within the desired range?Base: Qualified respondents (n=426)

Blood test goals:Yes%

No%

Not Sure %

Has a health care professional ever told you what your “number” should be?

79 14 7

Does you number usually stay in the desired range?

61 33* 7

*includes respondents saying “it fluctuates”

59

1%

9%

41%

12%

2%

3%

28%

0.1 - 0.9

1.0 - 1.9

2.0 - 2.9

3.0 - 3.9

4.0 - 4.9

5.0+

Not Sure

Many patients do not know their latest PT/INR Many patients do not know their latest PT/INR number.number.

Q835 What was your “number” when you were last tested? Base: Respondents who were told of INR (n=426)

PT/INR number last time they had their blood tested

4%: Decline to answer

60

Many patients are not always getting clear Many patients are not always getting clear and timely feedback about blood test resultsand timely feedback about blood test results..

Q815 After having a blood test, how often, if ever, does someone contact you to give you your blood test results?Base: Qualified respondents who get blood checked (n=419)Q825 Last time you had your blood tested, did someone explain the results in a way that you could understand?Base: Qualified respondents who get blood checked (n=419)Q818 If nobody from your doctor’s office contacts you to give you your blood test results, do you usually contact the doctor’s office yourself?Base: Qualified respondents who do not get contacted every time (n=73) [NOTE: SMALL BASE]

Contacting about blood test results: %

Frequency of contact about blood test results:

Every time 83

Less than always (NET) 17

(Usually 12%; Rarely/Never 5%)

The last time he/she had their blood tested:

Results were not explained/Respondent was not contacted 5

Results were explained, but not clearly 6

Of those who are not contacted about blood tests, frequency of contacting the doctors’ office oneself:

Every time 18

Less than always (NET) 82

(Usually 33%; Rarely/Never 49%)

61

67%

22%

5%

2%

1%

8%

0%

I or someone else in my office always call patients withINR results.

I or someone in my office call patients with INR results,but only when there is a change in the numbers.

My office always mails a letter to patients with INRresults.

My office mails a letter with INR results, but only whenthere is a change in the numbers.

My office generally does not contact the patient with INRresults.

None of these describe my office’s approach tocontacting patients with INR results.

Not sure

Q425 Which 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.

One in four physicians do not always call or mail the One in four physicians do not always call or mail the patients to inform them about their INR test results.patients to inform them about their INR test results.

62

Q435 What terminology do you generally use to describe INR test results to your oral anticoagulation patients? Base: Qualified Respondents (n=101)

When informing their patients about their INR test results, When informing their patients about their INR test results, many physicians do not tell their patients their actual many physicians do not tell their patients their actual numeric INR value.numeric INR value.

53%

31%

11%

5%

Tell them the actualnumeric INR value

Describe the bloodcharacteristics (e.g.,too thick or too thin)

Describe the results interms of “good” or

“bad”

Other

63

Caregivers also need better ongoing communication Caregivers also need better ongoing communication with physicians to help assist patients manage their with physicians to help assist patients manage their treatment.treatment.

• Many caregivers find it difficult to speak to their family members’ doctor.

• Caregivers see areas for improvement in communication between themselves and their family members doctor, particularly around education about treatment requirements.

64

Many caregivers find it difficult to speak with somebody in the Many caregivers find it difficult to speak with somebody in the doctor’s office when they have questions about the use of the doctor’s office when they have questions about the use of the anticoagulant; Pharmacists are more accessible.anticoagulant; Pharmacists are more accessible.

8%

23%

Reach apharmasist

Speak withhis/her doctor orsomeone in thedoctor's office

Very Difficult/Somewhat Difficult

How easy or difficult is it for you to…

Q620 When you or your family member have questions about the use of anticoagulant, how difficult or easy is it to reach someone at his/her doctor’s office who can answer questions about the use of the anticoagulant? Q625 When you or your family member have questions about the use of the anticoagulant, how difficult or easy is it to reach a pharmacist who can answer questions about the use of the anticoagulant? Base: Qualified respondents (n=109)

65

Caregivers see areas for improvement in communication with Caregivers see areas for improvement in communication with their family members’ physician.their family members’ physician.

24%

23%

19%

19%

18%

Explaining to your loved one all of the things he/sheneeds to know to effectively take the oral

anticoagulant medication

Explaining to you all the things need to know as acaregiver

Being responsive to questions about the medication

Being responsive to questions about being aneffective caregiver

Explaing the importance of the medication

Rate their family member's physician less than very good

Q610 How would you rate your family member’s physician on each o the following criteria?


66

Assistance is needed to remain compliant with Assistance is needed to remain compliant with treatment requirements and goals. Caregivers need treatment requirements and goals. Caregivers need assistance in helping their loved ones to do so.assistance in helping their loved ones to do so.

• 2 in 5 patients do not have the assistance of a health care professional, in addition to their doctor, to help them manage their blood thinning medication.

• Almost 2 in 5 physicians do not have a nurse or other health care professional in their office to help patients manage their oral anticoagulant.

• Many patients and caregivers do not receive written instructions about all of the things they need to do when taking an oral anticoagulant.

• Better health care management is associated with improved awareness, behavior, and confidence around the management of oral anticoagulant use.

67

31%

9%

25%

41%

1%

A Nurse A Pharmacist Some other healthcare professional

No Not sure

2 in 5 respondents do not have an additional health care 2 in 5 respondents do not have an additional health care professional to help manage oral anticoagulant use.professional to help manage oral anticoagulant use.

Q435 In addition to the doctor who prescribes your blood thinning medication, is there a nurse, a pharmacist or another health careprofessional who helps you manage your blood thinning medication?


58%

Note: Multiple responses allowed

% indicating another health care professional, in addition to their doctor, helps manage anticoagulant

68

Nearly 2 in 5 physicians do not have a nurse or other health Nearly 2 in 5 physicians do not have a nurse or other health care professional in their office to help patients manage their care professional in their office to help patients manage their oral anticoagulant.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)

46%

18%

37%

Yes, a nurse

Yes, another health-care professional

No

69

Most caregivers feel they would benefit from having someone Most caregivers feel they would benefit from having someone in the doctor’s office they could call for information. Other in the doctor’s office they could call for information. Other solutions could also be of help. solutions could also be of help.

34%

36%

39%

37%

28%

38%

31%

26%

24%

32%

A nurse or other healthcare professional in the doctor'soffice who could be called for information

Someone at the doctor's office giving information aboutwhat to do

More and better information about the things he/she issuppose to do when on medication

Pharmacist giving more education about medication

Healthcare professional who checks in regularly withthe caregiver and patient

Would benefit somewhat Would benefit a great deal

Q720 How much do you think you and your family member would benefit from the following supports to help you manage your oral anticoagulant use?


72%

67%

65%

61%

61%

70

25%

18%

14%

12%

11%

10%

9%

7%

5%

5%

4%

4%

18%

9%

3%

Give written guidelines/handouts

Regular counseling/checkups

Keep doctor informed about any changes/problems

Clearly state goals/risks of taking anticoagulant

Watch the diet

Check with physician before taking other medications or OTCs

Regular blood tests

Take medication as directed

Help them understand INR test results

Face-to-face communication

Raise awareness of bleeding

Done by hospital/clinic

Other

Nothing

Don’t know/ not sure

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)

Written communication is seen by many physicians as Written communication is seen by many physicians as a good method of relaying information. a good method of relaying information.

71

Just over half of patients received written instructions Just over half of patients received written instructions about taking the oral anticoagulant.about taking the oral anticoagulant.

Q528 Has a doctor, nurse or other health care professional ever prepared for you written instructions about taking the anticoagulant, including what you should and should not do , such as following a specific diet, not taking certain prescription and over-the-country medications, getting your blood test regularly, etc.? Please do not include being given an informational insert that comes with your medication or from the drug maker. Base: Qualified respondents (n=426)

Received written instructions:

55%

Did not receive written instructions:

40%

Not sure: 5%

Caregiver responses in contrast: 24% did not receive written instructions64% received written instructions12% were not sure

72

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)

1 in 3 physicians does not provide any of their oral 1 in 3 physicians does not provide any of their oral anticoagulant patients with written instructions.anticoagulant patients with written instructions.

38%

31%

32%

Yes, give writteninstructions to allpatients taking an

anticoagulant

Yes, give writteninstructions to somepatients taking an

anticoagulant

No, do not give writteninstructions

73

Patients with access to another health care professional Patients with access to another health care professional have better management of blood testinghave better management of blood testing..

Q815 After having a blood test, how often, if ever, does someone contact you to give you your blood test results? Q825 Last time you had your blood tested, did someone explain the results in a way that you could understand? Base: Qualified respondents who get blood checked (n=419)Q830 Has a health care professional ever told you what your “number” should be? Base: Qualified respondents (n=426)Q835 What was your number when you were lasted tested? Base: Respondents who were told of INR (n=338)

Access to Another Health Care Professional

Managing blood testing:Yes%

No%

Frequency of reminders about blood testing:

Always 60 40

Never 20 39

Were told what PT/INR “number” should be 84 73

Knows what PT/INR number was the last time they were tested 76 56

Frequency of contact about blood test results:

Every time 86 77

Less than always (NET) 13 23

The last time he/she had blood tested, results were explained clearly 91 85

74

Health Care Management Score Health Care Management Score

Health care management score %

Have a health care professional, in addition to the doctor, helping to manage oral anticoagulant use (1 point)

58

The first time doctor prescribed the oral anticoagulant, did he/she…. (% yes)

Explain to you why you need to take anticoagulant 98

Tell you how often you should have your blood tested 96

Give you clear instructions about how to take the medication 94

Tell you about symptoms to watch for and when to seek further care 79

Explain any side effects you might experience 78

Explain potential interactions between anticoagulant and other Rx or OTC 76

Tell you about any special dietary considerations 74

Received ALL of the above (1 point) 37

Patient was provided written instructions about anticoagulant precautions (1 point) 55

The last time he/she had blood tested, results were explained clearly (1 point) 88

Health Care Management ScoreHealth Care Management Score (total of 4 points)

Poor/Fair health care management (0-2 point) 43

Good health care management (3-4 points) 57

75

94%

91%

92%

66%

66%

44%

98%

99%

97%

90%

87%

76%







Poor/Fair health care management Good health care management

Patients with better health care management are more Patients with better health care management are more aware of the importance of oral anticoagulant precautions.aware of the importance of oral anticoagulant precautions.

Q640 As far as you know, how important is it for people who take anticoagulants] to . . . ? Base: Qualified respondents (n=426)

% who believe that behavior is extremely or very important

76

86%

72%

77%

30%

35%

6%

93%

87%

90%

57%

59%

29%








Patients with better health care management are more Patients with better health care management are more compliant with oral anticoagulant precautions.compliant with oral anticoagulant precautions.

Q610 How often do you do the following?Base: Qualified respondents (n=426)

% who indicate they always do the following…

77

33%43%

16%7%

2%

57%

32%

8%2% 1%

ExtremelyConfident

Very Confident Fairly Confident SomewhatConfident

Not At AllConfident


Patients with better health care management are more Patients with better health care management are more confident that they are taking the medication correctly.confident that they are taking the medication correctly.

Q645 Overall, how confident are you that you are taking the anticoagulant the correct way to ensure that the drug works at its best and does not cause any problems?Base: Qualified respondents (n=426)

Confidence that they are taking anticoagulant medication the correct way

78

83%

82%

70%

64%

59%

57%

48%

25%

87%

88%

81%

77%

70%

70%

63%

38%

Remember to take the anticoagulant

Remember to tell doctors/dentists about anticoagulant use

Get blood tested regularly

Avoid taking Rx without checking with doctor/pharmacist

See doctor about blood levels

Avoid taking vitamins/supplements without checking withdoctor/pharmacist

Avoid taking OTCs without checking with doctor/pharmacist

Eat an appropriate diet


Patients with better health care management find it easier to Patients with better health care management find it easier to follow the precautions of oral anticoagulant use.follow the precautions of oral anticoagulant use.

Q910 How easy or difficult is it for you to…Base: Qualified respondents (n=426)

% indicating it is very easy to follow the following precautions…

79

Preliminary ConclusionsPreliminary Conclusions

80

Education, ongoing communication, and assistance with Education, ongoing communication, and assistance with health care management are key to improving oral health care management are key to improving oral anticoagulant treatment.anticoagulant treatment.

• It is important to strengthen the education provided by physicians (and/or nurses in physician offices), both at the time of first prescription and ongoing.

• Doctors are the first line of education, but nurses, pharmacists and other health professionals can take on some of the burden.

• Patients and caregivers need more resources for information and counseling. Pharmacists and designated nurses at physician offices could be important resources.

• Written information about the precautions associated with anticoagulant use would be a simple and effective educational tool, yet many patients do not receive this.

• Educating patients about the importance of blood testing and the meaning of blood test results is key to improving compliance and positive outcomes.

• Caregivers need to be educated and recognized for their role in provision of care for anticoagulant patients. Physicians, nurses, pharmacists and other health care professionals involved in patient’s care need to be accessible to caregivers.

Prepared for: The National Consumers League September 21, 2005 J23715 The Use of Oral Anticoagulant Medications PRESENTATION: Key Findings from Surveys.

Documents

anticoagulant use

experiences of caregivers

eligible caregivers

oral anticoagulant treatment

use of oral anticoagulants

oral anticoagulant drugs

surveys of patients

experiences of patients