Study on Consumer Knowledge of Drug Quality

No. 0910-0847

Expiration Date: 11/30/2020

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FDA Consumer Knowledge of Drug Quality Questionnaire

SURVEY INVITATION

DO NOT PROGRAM THE INTRO. START WITH S1

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 TAKE THE SURVEY  NO THANKS SCREEN OUT

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S1. Are you currently living in the United States?

1. Yes

2. No TERMINATE

SET UP AS QUOTA QUESTION

S3. What is your age? (Please type in your answer.)

_______ years old RANGE 1-100, IF <18 SCREEN OUT

INSERT 1 TEXT BOX

CODE AGE RESULTS INTO RANGES: 18-24, 25-34, 35-44, 45-54, 55-64, 65-74, 75+

SET UP AS QUOTA QUESTION

Rx Drug Use

1. Have you used any of the following in the past 3 years? (Select all that apply.)

RANDOMIZE

1. Prescription brand-name drug

2. Prescription generic drug

3. Neither of the above EXCLUSIVE

4. Not sure EXCLUSIVE

SET UP AS QUOTA QUESTION

OTC Drug Use

2. Have you used any of the following in the past 3 years? (Select all that apply.)

RANDOMIZE

1. Over-the-counter brand-name drug

2. Over-the-counter generic/store-brand drug

3. Neither of the above EXCLUSIVE

4. Not sure EXCLUSIVE

RANDOMIZE ORDER OF QUESTIONS 3/4

IF Q1 = “A” OR “A AND B”

Overall Quality of Drugs

3. The overall quality of prescription brand-name drugs you have taken is…

1. Excellent

2. Very Good

3. Good

4. Fair

5. Poor

IF Q1 = “B” OR “A AND B”

4. The overall quality of prescription generic drugs you have taken 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? (Select one response per row.)

Prescription generic drugs…

RANDOMIZE	Strongly Agree	Somewhat Agree	Neither Agree Nor Disagree	Somewhat Disagree	Strongly Disagree
	5	4	3	2	1
1…are as safe as the prescription brand-name version
2…are equal in purity to the prescription brand-name version
3…are as effective as the prescription brand-name version
4…are of equal quality to the prescription brand-name version

RANDOMIZE ORDER OF QUESTIONS 6/7

IF Q2 = “A” OR “A AND B”

6. The overall quality of over-the-counter brand-name drugs you have taken is…

1. Excellent

2. Very Good

3. Good

4. Fair

5. Poor

IF Q2 = “B” OR “A AND B”

7. The overall quality of over-the-counter generic/store brand drugs you have taken 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 that over-the-counter generic/store-brand drugs… (Select one response per row.)

Over-the-counter generic/store-brand drugs…

RANDOMIZE	Strongly Agree	Somewhat Agree	Neither Agree Nor Disagree	Somewhat Disagree	Strongly Disagree
	5	4	3	2	1
1…are as safe as the over-the-counter brand-name version
2…are equal in purity to the over-the-counter brand-name version
3…are as effective as the over-the-counter brand-name version
4…are of equal quality to the over-the-counter brand name version

Factors indicative of quality

9. To what extent do you agree or disagree that each item below is an indicator of drug quality? (Select one response per row.)

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 my health care practitioner (physician, nurse practitioner, physician assistant, etc.)
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

Aided Awareness – entity responsible for regulating drug quality

11. What entity is/entities are responsible for drug quality in the U.S.? (Select all that apply.)

RANDOMIZE

1. Local government

2. State government

3. Federal Government

4. Pharmaceutical companies

5. Pharmaceutical industry association(s)

6. Other entity/entities ANCHOR

7. No entity is responsible EXCLUSIVE ANCHOR

8. Not sure ANCHOR EXCLUSIVE

PROGRAMMER—NO BACK BUTTON ON THIS QUESTION

Aided Awareness – agency responsible for regulating drug quality

12. The Federal Government is responsible for the regulation of drug quality.

Which Federal Government entity is the one responsible for the regulation of drug quality? (Select one.)

RANDOMIZE

1. Department of Commerce (DOC)

2. Department of Agriculture (USDA)

3. Department of Homeland Security (DHS)

4. Food and Drug Administration (FDA)

5. Surgeon General

6. Bureau of Alcohol, Tobacco, and Firearms (ATF)

7. Department of Justice (DOJ)

8. Other EXCLUSIVE ANCHOR

9. Not sure ANCHOR EXCLUSIVE

PROGRAMMER—NO BACK BUTTON ON THIS QUESTION

Aided Awareness—FDA

13. The Food and Drug Administration (FDA) is the Federal agency responsible for the regulation of drug quality.

Which, if any, of the following are functions of the FDA in this role? (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

14. 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

15. Compared to drugs manufactured within the US, 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 Q15 = D OR E

Quality of drugs manufactured outside the US

16. 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

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

1. Yes

2. No

3. Not sure

Drug Shortage

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

1. Yes

2. No

3. Not sure

Reasons for shortage

19. 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

PROGRAMMER—NO BACK BUTTON ON THIS QUESTION

Impact of shortage on quality of drug

20. 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.

PROGRAMMER A HIGH PRECISION SLIDER BELOW; DON’T SHOW NUMBERS

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

RANDOMIZE THE FOLLOWING 2 VERSIONS.

Please indicate where you think the FDA should stand on this tradeoff by moving the slider below to “constant availability” or to “quality and safety,” or somewhere between the two.

Constant Quality

Availability ------------------------ slider -------------------- and Safety

Please indicate where you think the FDA should stand on this tradeoff by moving the slider below to “quality and safety” or to “constant availability,” or somewhere between the two.

Quality Constant

And Safety ------------------------ slider -------------------- Availability

Products regulated by the FDA

21. 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 Questions

Please note, once again, that all responses in this survey are confidential. Results are reported only in aggregate.

21. In which state or U.S. territory do you live?

DROP DOWN LIST OF STATES, PLUS DISTRICT OF COLUMBIA, PLUS PUERTO RICO, PLUS “OTHER U.S. TERRITORY OR PROTECTORATE”

please program into region variables below.

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

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

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 DON'T INCLUDE D.C. IN “J,” INCLUDE HERE PUERTO RICO AND “OTHER U.S. TERRITORY OR PROTECTORATE”

21. How would you describe your location of residence?

1. Urban

2. Suburban

3. Exurban (farther outside of city than suburban, but more populated than rural)

4. Rural

SET UP AS QUOTA QUESTION

21. What is your sex?

1. Female

2. Male

21. What is your marital status? (Select one)

1. Married

2. Domestic partner/living together

3. Never married/single

4. Divorced/ Separated/ Widowed

5. Prefer not to answer

21. What is your approximate household income before taxes? (Select one.)

1. Under $10,000

2. $10,000 - $19,999

3. $20,000 - $29,999

4. $30,000 - $39,999

5. $40,000 - $49,999

6. $50,000 - $74,999

7. $75,000 - $99,999

8. $100,000 - $149,999

9. $150,000 - $199,999

10. Over $200,000

11. Rather not say

21. Including yourself, how many people currently live in your household? Please type in your answer.

________ live in my household [RANGE 1-30]

[PROGRAMMER INSERT 1 TEXT BOX]

PLEASE CODE A HOUSEHOLD SIZE VARIABLE AS 1; 2; 3; 4; 5; 6+

SET UP AS QUOTA QUESTION

21. Are you of Hispanic, Latino, or Spanish background? single punch. do not randomize

1. Yes

2. No

SET UP AS QUOTA QUESTION

21. What is your race? (Select one or more)

single punch. do not randomize

1. White

2. Black or African American

3. Asian

4. American Indian or Alaska Native

5. Native Hawaiian or Other Pacific Islander

29. Which of the following best describes the highest level of education you have completed? (Please select one.)

single punch. do not randomize

1. Some high school or less

2. High school graduate/GED

3. Vocational school/Technical school

4. Some college (no degree)

5. Associate’s degree

6. Bachelor’s degree

7. Some post graduate

8. Post graduate degree

29. Which of the following describes your current employment status? (Please select one)

single punch. do not randomize

1. Employed full-time

2. Employed part-time

3. Self-employed full-time

4. Self-employed part-time

5. Not currently employed

6. Retired

7. Student

Decliners

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