Study on Physician Knowledge of Drug Quality

No. 0910-0847

Expiration Date: 11/30/2020

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WebMD Survey, HCP Drug Quality (FINAL)

Objectives and design

Note: This information is for reviewers and is not seen by respondents.

Objective: Measure physicians’ understanding of and attitudes toward drug product quality for both prescription and OTC drugs.

Medium of data collection: 10-minute online questionnaire. Physicians will be recruited from Medscape physician members.

Quota:

• 400 PCPs

• 250 specialists (50 each: cardiologists, orthopedics, rheumatologists, dermatologists, diabetologists/endocrinologists)

Screening questions

1. What is your clinical title?

1. Physician

2. Nurse TERMINATE

3. Physician assistant TERMINATE

4. Other healthcare practitioner TERMINATE

5. Not a healthcare practitioner TERMINATE

2. What is your specialty? (Select one.)

1. Cardiology “SPECIALIST”

2. Dermatology “SPECIALIST”

3. Diabetes/Endocrinology “SPECIALIST”

4. Family Medicine “PCP”

5. Internal Medicine “PCP”

6. Orthopedics “SPECIALIST”

7. Rheumatology “SPECIALIST”

8. Other TERMINATE

3. How many years have you been in practice since your residency? (If less than one year enter 0.)

_____ years in practice since residency TERMINATE IF <5; RANGE = 0-100

4. What percentage of your time is devoted to direct patient care? (Please do not include research, administration, or other direct responsibilities.)

___% of time devoted solely to direct patient care TERMINATE IF <40%

5. What is your age?

____ age in years RANGE 1-100; TERMINATE IF <26

6. In a typical month, how many patients do you personally treat?

_____ TERMINATE < 20

SET UP AS QUOTA QUESTION

Rx Drug Prescriptions

1. In the past 30 days, to approximately what percentage of your total patients did you write prescriptions?

___% of total patients I wrote prescriptions for in the past 30 days RANGE 1-100; TERMINATE IF 0

1a. Approximately what percentage of total prescriptions written in the past 30 days were for brand-name drugs vs generic drugs?

____% brand-name Rx RANGE 1-100

____% generic Rx RANGE 1-100

MUST ADD TO 100

SET UP AS QUOTA QUESTION

OTC Drug Recommendations

2. In the past 30 days, to approximately what percentage of your total patients did you recommend/prescribe any over-the-counter medication or treatment?

___% of total patients I recommended/prescribed any over-the-counter medications or treatments in the past 30 days RANGE 1-100; TERMINATE IF 0

2a. Approximately what percentage of total over-the-counter medications or treatments recommended/prescribed in the past 30 days were for a brand-name vs generic?

____% brand-name OTC medication/treatment RANGE 1-100

____% generic OTC medication/treatment RANGE 1-100

MUST ADD TO 100

Main questionnaire

RANDOMIZE ORDER OF QUESTIONS 3/4

Overall Quality of Drugs

IF Q1A BRAND-NAME > 0%

3. In your opinion, the overall quality of prescription brand-name drugs you prescribe to your patients is…

1. Excellent

2. Very Good

3. Good

4. Fair

5. Poor

IF Q1A GENERIC > 0%

4. In your opinion, the overall quality of prescription generic drugs you prescribe to your patients is…

1. Excellent

2. Very Good

3. Good

4. Fair

5. Poor

Prescription generic vs. prescription brand-name

5. To what extent do you agree or disagree with the following statements about prescription generic drugs?

RANDOMIZE	Strongly Agree	Somewhat Agree	Neither Agree Nor Disagree	Somewhat Disagree	Strongly Disagree
	5	4	3	2	1
1. Compared to prescription brand-name drugs, prescription generic versions are just as safe
2. Compared to prescription brand-name drugs, prescription generic versions are equal in purity
3. Compared to prescription brand-name drugs, prescription generic versions are just as effective
4. Compared to prescription brand-name drugs, prescription generic versions are of equal quality

5a. How often do you write Dispense as Written (DAW) for prescription brand-name drugs when a prescription generic drug is available?

1. Always

2. Often

3. Sometimes

4. Rarely

5. Never

IF 5A = A, B, OR C

5b. What are the primary reasons why you write “DAW” for prescription brand-name drugs when a prescription generic is available? (Select all that apply.)

RANDOMIZE

1. Patients specifically request prescription brand-name drugs

2. I do not trust prescription generic drugs

3. Generic drugs may interact with other drugs a patient is taking

4. I am not always aware of what generic versions are available

5. I do it out of habit

6. Other ANCHOR

IF 5A = D OR E

5c. What are the primary reasons why you do not write “DAW” for prescription brand-name drugs when a prescription generic is available? (Select all that apply.)

RANDOMIZE

1. Patients specifically request prescription generic drugs

2. It’s cheaper for my patients

3. Prescription generic drugs provide the same clinical benefits as their brand-name versions

4. I trust prescription generic drugs because they are developed under the same FDA standards as brand-name drugs

5. Other ANCHOR

RANDOMIZE ORDER OF QUESTIONS 6/7

IF Q2A BRAND-NAME > 0%

6. In your opinion, the overall quality of over-the-counter brand-name medications/treatments you have recommended to your patients is…

1. Excellent

2. Very Good

3. Good

4. Fair

5. Poor

IF Q2A GENERIC > 0%

7. In your opinion, the overall quality of over-the-counter generic/store brand medications/treatments you have recommended to your patients is…

1. Excellent

2. Very Good

3. Good

4. Fair

5. Poor

OTC generic vs. OTC brand-name

8. To what extent do you agree or disagree with the following statements about over-the-counter generic/store-brand medications/treatments?

RANDOMIZE	Strongly Agree	Somewhat Agree	Neither Agree Nor Disagree	Somewhat Disagree	Strongly Disagree
	5	4	3	2	1
1. Compared to brand-name medications, over-the-counter generic/store-brand versions are just as safe
2. Compared to brand-name medications, over-the-counter generic/store-brand versions are equal in purity
3. Compared to brand-name medications, over-the-counter generic/store-brand versions are just as effective
4. Compared to brand-name medications, over-the-counter generic/store-brand versions are of equal quality

Factors indicative of quality

9. To what extent do you agree or disagree that each item below is an indicator of drug quality?

RANDOMIZE	Strongly Agree	Somewhat Agree	Neither Agree Nor Disagree	Somewhat Disagree	Strongly Disagree
	5	4	3	2	1
1. Drug's beneficial effect
2. Recommended or prescribed by other health care practitioners
3. Drug's safety profile
4. Brand-name drug
5. Approved for sale in the U.S.
6. Made by a pharmaceutical company I trust
7. Higher in cost
8. Have seen or heard an advertisement for the drug

Physical indicators of drug quality

10. Which of the following are indicators of drug quality? (Select all that apply.)

RANDOMIZE

1. The color, shape, or other similar characteristics of a drug

2. Taste

3. Whether pills/tablets crumble or break easily

4. Powdery feeling pills/tablets

5. Appropriate packaging (apart from pharmacist packaging)

6. Whether a liquid or cream appears to have separated

7. Whether particles are present in a bottle of liquid

8. Other ANCHOR

9. Not sure EXCLUSIVE ANCHOR

PROGRAMMER—NO BACK BUTTON ON THIS QUESTION

Aided Awareness—FDA

11. Which, if any, of the following are functions of the FDA in terms of regulating drug quality? (Select all that apply.)

RANDOMIZE

1. Oversee the research, development, manufacture, and marketing of drugs in the U.S.

2. Evaluate and approve new drugs before they can be sold

3. Make certain that all drugs marketed in the U.S.—brand and generic, prescription and over-the-counter—are safe and effective and that their health benefits outweigh known risks

4. Monitor truth in advertising for prescription drugs

5. Monitor the use of marketed drugs for unexpected health risks

6. Remove a drug from market if unexpected risks are detected after a drug is already approved

7. Manufacture drugs

8. Set prices for drugs

9. Prevent unapproved drugs from being imported to the U.S.

10. Test drugs

11. Work with other organizations, such as the United States Pharmacopeia (USP), to set quality standards for drugs

12. None of the above EXCLUSIVE ANCHOR

13. Not sure EXCLUSIVE ANCHOR

Quality of drugs imported to US

12. Do you believe drugs manufactured outside the U.S. and sold in the U.S. adhere to strict manufacturing standards and regulations required by the FDA?

1. Yes

2. No

3. Not sure

Quality of drugs manufactured outside of US

13. Compared to drugs manufactured within the U.S., do you think those manufactured outside the U.S. for sale inside the U.S. are…?

1. Much higher quality

2. Higher quality

3. About the same quality

4. Lower quality

5. Much lower quality

6. Not sure

IF Q13 = D OR E

Quality of drugs manufactured outside the US

14. Why do you believe that drugs manufactured outside the U.S. for sale inside the U.S. are of poor quality or poorer quality than drugs manufactured in the U.S.? (Select all that apply.)

RANDOMIZE

Drugs manufactured outside the U.S….

1. …are not strong enough

2. …cause more side effects

3. …are not as pure or could be contaminated

4. …use inferior active ingredients

5. …crumble, break, or chip more easily

6. …have an inferior appearance (shape, color, etc.)

7. …have a bad reputation

8. …may be from places that experience health and sanitation problems

9. Other (please specify: ________) ANCHOR AT BOTTOM DON'T FORCE ANSWER; IF LEFT BLANK CODE AS "Other"

10. None of the above EXCLUSIVE ANCHOR

11. Not sure EXCLUSIVE ANCHOR

Drug Shortage

15. Are drugs that are sold in the U.S. ever in short supply?

1. Yes

2. No

3. Not sure

Drug Shortage

16. Have your patients experienced any difficulty in filling prescription(s) due to drug shortage (not just a brief pharmacy delay for reordering)?

1. Yes

2. No

3. Not sure

Reasons for shortage

17. What are possible reasons for drug shortages? (Select all that apply.)

RANDOMIZE

1. Aging manufacturing facilities or manufacturing equipment

2. Quality/manufacturing problems (e.g., failure to produce the correct strength)

3. Production delays at the manufacturer

4. Safety problems (e.g., contamination/lack of purity)

5. Delays companies have experienced receiving raw materials and components from suppliers

6. Natural disaster (hurricane, earthquake, etc.)

7. Discontinuation of drug by manufacturer

8. FDA preventing sale of the drug from one or more manufacturers until required quality levels are met

9. Not sure ANCHOR EXCLUSIVE

10. None of the above ANCHOR EXCLUSIVE

EACH RESPONDENT RECEIVES Q18 OR Q18A. RANDOMIZE SELECTION.

ALLOW QUESTION TO BE SKIPPED IF RESPONDENT DOES NOT WANT TO ANSWER.

Impact of shortage on quality of drug

18. There are times when the FDA may take steps to maintain safety and quality standards for a drug, which can cause a supply shortage. This may be viewed as a tradeoff between constant availability of drugs on one side and quality and safety of drugs on the other. Please use the scale below to indicate where you feel that the FDA should stand on this tradeoff. The scale ranges from zero on one end, which indicates "constant availability" and ten on the other end, which indicates "quality and safety." You can choose any number on the scale to represent your opinion.

Constant                                                                                               Quality

Availability     0  1     2      3      4       5       6     7      8      9    10       and Safety

           

18a. There are times when the FDA may take steps to maintain safety and quality standards for a drug, which can cause a supply shortage. This may be viewed as a tradeoff between quality and safety of drugs on one side and constant availability on the other. Please use the scale below to indicate where you feel that the FDA should stand on this tradeoff. The scale ranges from zero on one end, which indicates "quality and safety" and ten on the other end, which indicates "constant availability." You can choose any number on the scale to represent your opinion.

Quality                                                                                                   Constant

And Safety     0  1     2      3      4       5       6     7      8      9    10       Availability

[Display each version as shown but record data to be identical across both versions: Constant Availability should always be stored as 0 and Quality and Safety should always be stored as 10]

Products regulated by the FDA

19. Other than prescription and over-the-counter drugs, what else does the FDA regulate? (Select all that apply.)

RANDOMIZE

1. Medical devices

2. Electronic products that give off radiation (e.g., microwave ovens, sunlamps)

3. Cosmetics

4. Moisturizers

5. Perfumes

6. Bottled water

7. Infant formula

8. Other food products such as some meat and poultry

9. Pet foods

10. Tobacco products including cigarettes, smokeless tobacco, etc.

11. Vaccines

12. Vitamins and supplements

13. None of the above ANCHOR EXCLUSIVE

14. All of the above ANCHOR EXCLUSIVE

15. Not sure ANCHOR EXCLUSIVE

Classification

These last few questions are for classification purposes.

20. What is your gender?

1. Female

2. Male

21. Which best describes your current work situation?

1. Self-employed/partner

2. Employee

3. Independent contractor

4. Other

22. Which one of the following best describes your current primary practice setting?

1. Owner (solo or group practice)

2. Group practice owned by a hospital

3. Hospital

4. Healthcare organization

5. Outpatient clinic

6. Academic (non-hospital), research, military, government

7. Other

23. In what state or U.S. territory do you practice? Select one from the dropdown menu

PROVIDE DROP-DOWN MENU WITH THE 50 STATES, DISTRICT OF COLUMBIA, PUERTO RICO, AND “OTHER U.S. COMMONWEATLH, TERRITORY, OR PROTECTORATE”

program into region variables below

1. Northeast (ME, NH, VT, MA, CT, RI)

2. Mid-Atlantic (WV, VA, DE, MD, DC, NC, PA, NJ, NY)

3. Great Lakes (OH, MI, IN, IL, WI, MN)

4. Southeast (SC, GA, FL, AL, MS, LA, TN, KY)

5. South Central (TX, OK, AR)

6. Southwest (AZ, UT, CO, NM, NV)

7. North Central (IA, MO, KS, NE, SD, ND)

8. Northwest (MT, WY, ID, OR, WA)

9. West (CA, AK, HI)

10. U.S. commonwealth, territory, or protectorate