How Do US Gastroenterologists Use Over-the-Counter and Prescription Medications in Patients With Gastroesophageal Reflux and Chronic Constipation?

Table 1.  Study participant characteristics (N =830)

Variable	Categories	N	%
Age	<45	206	25
	46–60	412	50
	>60	207	25
Gender	Male	711	86
	Female	119	14
Race	Caucasian	618	75
	Asian	131	16
	Native American/Native Alaskan	28	3.4
	Hispanic/Latino	22	2.6
	African American	20	2.5
Employment status	Private practice	434	52
	Academics	241	29
	Multispecialty group	99	12
	Health maintenance organization	41	5
	Other	15	2
Practice years	0–10	159	20
	11–20	239	30
	>20	398	50
Geographic location	Northeast	215	26
	Midwest	191	23
	West	257	31
	South	166	20

The total number of patients for each characteristic may not add to total (N=830) because of missing data.

Table 2.  First-line treatment for typical acid reflux

Medicine	First-line treatment, % (N=830)	"Always" or "very often" direct patients to buy store brand product, % (N=513)
OTC antacid	3.1% (26)	65% (17/26)
OTC H2 antagonists	12.7% (105)	56% (59/105)
OTC PPIs	50.1% (416)	47.5% (198/416)
Rx PPI	34.1% (283)	—

OTC, over the counter; PPI, proton pump inhibitor; Rx, prescription.

Table 3.  First- and second-line treatments for the typical patient with chronic constipation

Medicine	First-line treatment	Second-line treatment
OTC fiber	52%	6%
OTC docusate	4%	3%
OTC osmotics	40%	46%
OTC stimulants	1%	14%
Rx osmotics	1%	7%
Rx lubiprostone	1%	14%
Rx linaclotide	1%	10%

OTC, over the counter; Rx, prescription.

Table 4.  Proton pump inhibitor cost comparison

Drug name	Brand name	Rx vs. OTC	Package size (tablets)	AWP Pkg price (%)a	AWP unit price (%)a	ARP Pkg price (%)b	ARP unit price (%)b
Lansoprazole 15 mg delayed-release capsules	Prevacid	Rx	30	364.33	12.15	—	—
Lansoprazole 15 mg delayed-release capsules	Generic	Rx	30	67.80	2.26	—	—
Lansoprazole 15 mg delayed-release tablets	Prevacid 24HR	OTC	28	21.34	0.76	24.91	0.59
Lansoprazole 15 mg delayed-release tablets	Store brand	OTC	42	14.39	0.34	16.97	0.40
Lansoprazole 30 mg delayed-release capsules	Prevacid	Rx	100	1,214.45	12.15	—	—
Lansoprazole 30 mg delayed-release capsules	Generic	Rx	30	67.80	2.26	—	—
Omeprazole 20 mg tablets	Prilosec	Rx	30	262.49	8.74	—	—
Omeprazole 20 mg tablets	Generic	Rx	30	90.16	3.00	—	—
Omeprazole 20 mg tablets	Prilosec OTC	OTC	42	27.07	0.64	23.93	0.56
Omeprazole 20 mg tablets	Store brand	OTC	42	12.76	0.51	16.88	0.40

ARP, average retail price; AWP, average wholesale price; OTC, over the counter/nonprescription; Pkg, package; Rx, prescription.
^aData from Micromedex RED BOOK Online.
^bAverage online price of store brand formulation from Target and/or Walmart.

Table 5.  Miralax/PEG 3350 cost comparison

Drug Name	Brand name	Rx vs. OTC	Package size, g	AWP Pkg price (%)a	AWP unit price (%)a	ARP Pkg price (%)b	ARP unit price (%)b
PEG 3350 17 g/dose	Miralax	Rx	510	19.68	0.65	—	—
PEG 3350 17 g/dose	Generic	Rx	850	29.12	0.58	—	—
PEG 3350 17 g/dose	Miralax	OTC	850	—	—	23.51	0.47
PEG 3350 17 g/dose	Store brand	OTC	850	—	—	17.99	0.35

ARP, average retail price; AWP, average wholesale price; OTC, over the counter/nonprescription; PEG, polyethylene glycol; Pkg, package; Rx, prescription.
^aData from Micromedex RED BOOK Online.
^bAverage online price of store brand formulation from Target and/or Walmart.

Authors and Disclosures

Stacy B. Menees, MD, MS^1,2, Amanda Guentner, MD³, Samuel W. Chey¹, Richard Saad, MD, MS¹ and William D. Chey, MD¹

¹Division of Gastroenterology, University of Michigan Health System, Ann Arbor, Michigan, USA; ²Division of Gastroenterology, Ann Arbor Veterans' Administration Hospital, Ann Arbor, Michigan, USA; ³Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA

Correspondence
Stacy B. Menees, MD, MS, Division of Gastroenterology, University of Michigan Health System, 3912 Taubman Center, SPC 5362, Ann Arbor, Michigan 48109-5362, USA. E-mail: sbartnik@med.umich.edu

Conflict of interest
Guarantor of the article
Stacy B. Menees, MD, MS.

Specific author contributions
Stacy B. Menees: survey development, statistical analysis, analysis and interpretation of data, drafting of manuscript and draft revision; Amanda Guentner and Samuel W. Chey: data acquisition and draft revision; Richard Saad: survey development and draft revision; William D. Chey: study concept and design; analysis and interpretation of data; critical revision of the manuscript for important intellectual content; obtained funding; study supervision.

Financial support
This study was supported by an unrestricted grant from Perrigo. The sponsor played no role in design of the survey or analysis of the results.

Potential competing interests
Dr W.D. Chey has worked as a consultant for Astra-Zeneca, Ardelyx, Asubio, Forest, Ironwood, Prometheus, OOL Medical, Salix, SK, Sucampo, and Takeda. The other authors declare no conflict of interest.

Sidebar

Study Highlights

• Little is known about gastroenterologists' use of prescription, over-the-counter (OTC) brand name, and store brand products for reflux and constipation.

• OTC medications dominate primary therapy for gastroesophageal reflux disease (GERD) and chronic constipation (CC).

• Gastroenterologists believe that OTC brand name and store brand medications are equivalent.

• A minority of physicians direct their patients to purchase the store brand-equivalent medication.

• A significant amount of gastroenterologists underestimate the savings associated with store brand medicines.

Appendix 1

1. Please list your age at your last birthday:______

2. Gender:

□ Male

□ Female

3. For your race, do you consider yourself primarily:

□ Caucasian/White

□ Asian-American/Pacific Islander

□ African-American/Black

□ Hispanic/Latino

□ Native American/Native Alaskan

□ Other, please list:__________________________________________

4. My current employment status is:

□ Full-time

□ Part-time

□ Retired

□ Disabled

5. On average, how many outpatients do you see in a week?__________

6. On average, how many outpatients do you see in a week for acid reflux?________ For constipation?_______

7. Please specify your type of practice?

□ Private practice

□ Multi-specialty group

□ Academic practice

□ Health maintenance organization (HMO)

□ Other

8. How many years have you been in practice?__________

9. Please specify the state in which your practice is located:

□ AK	□ IA	□ MN	□ Ny	□ VA
□ AL	□ ID	□ MO	□ OH	□ VT
□ AR	□ IL	□ MS	□ OK	□ WA
□ AZ	□ IN	□ MT	□ OR	□ WI
□ CA	□ KS	□ NC	□ PA	□ WV
□ CO	□ KY	□ ND	□ RI	□ WY
□ CT	□ LA	□ NE	□ SC	□ Guam
□ DE	□ MA	□ NH	□ SD	□ Puerto Rico
□ FL	□ MD	□ NJ	□ TN	□ U.S. Virgin Islands
□ GA	□ ME	□ NM	□ TX	□ Washington, DC
□ HI	□ MI	□ NV	□ UT

10. For your typical acid reflux patient, what do you recommend for first line treatment?

□ Over-the-Counter (OTC) antacid treatments

□ OTC H2 antagonists

□ OTC proton pump inhibitors (PPIs)

□ Prescription PPIs

11. If you checked any of the OTC products for question 10, how often do you specifically direct your patient to purchase the store brand (rather than name brand) option?

□ Always (greater than 90% of the time)

□ Very often (60 to 90% of the time)

□ Sometimes (30 to 59% of the time)

□ Rarely (less than 30% of the time)

□ Never

12. When recommending an OTC PPI as treatment for a patient with typical acid reflux complaints, how commonly do you specifically direct your patients to purchase a brand name product (Prilosec OTC, Prevacid OTC, Zegerid OTC)?

□ Always (greater than 90% of the time)

□ Very often (60 to 90% of the time)

□ Sometimes (30 to 59% of the time)

□ Rarely (less than 30% of the time)

□ Never

13. When recommending an OTC PPI as treatment for a patient with typical acid reflux complaints, how commonly do you specifically direct your patients to purchase the OTC store brand PPI option?

□ Always (greater than 90% of the time)

□ Very often (60 to 90% of the time)

□ Sometimes (30 to 59% of the time)

□ Rarely (less than 30% of the time)

□ Never

14. How commonly do you write a prescription for PPIs as first line treatment for a patient with typical acid reflux complaints?

□ Always (greater than 90% of the time)

□ Very often (60 to 90% of the time)

□ Sometimes (30 to 59% of the time)

□ Rarely (less than 30% of the time)

□ Never

15. To what extent do you agree with the following statement? Store brand PPIs have the same bioequivalence (pharmacokinetic and pharmacodynamic characteristics) as name brand PPIs.

□ Strongly agree

□ Agree

□ Undecided

□ Disagree

□ Strongly disagree

16. Compared to name brand PPIs (Prilosec OTC, Prevacid OTC, Zegerid OTC), what is your impression of the clinical effectiveness of OTC store brand PPIs?

□ OTC store brand PPIs are significantly more effective

□ OTC store brand PPIs are slightly more effective

□ They are equivalent in effectiveness

□ OTC store brand PPIs are slightly less effective

□ OTC store brand PPIs are significantly less effective

17. For the same dose and quantity of a PPI, what is your impression of the cost of a store brand OTC medication compared to a name brand product?

□ The store brand is much more expensive than the name brand (>20% more)

□ The store brand is a little more expensive than the name brand (<20% more)

□ The store brand and name brand are similarly priced

□ The store brand is a little less expensive than the name brand (<20% less)

□ The store brand is much less expensive than the name brand (>20% less)

18. For the typical patient with chronic constipation, what would you be most likely to recommend for first line treatment?

□ Prescription osmotics (sorbitol, lactulose)

□ OTC Fiber supplements (psyllium, methylcellulose, polycarbophil etc…)

□ Prescription Amitiza (lubiprostone)

□ OTC Stimulants (bisacodyl, senna, cascara etc…)

□ Prescription Linzess (linaclotide)

□ OTC Osmotics (Magnesium Hydroxide, polyethylene glycol 3350 (PEG) etc…)

□ OTC Stool softeners (docusate)

19. For patients with chronic constipation that don't get better with your chosen first line treatment, what would you be most likely to recommend for second line treatment?

□ Prescription osmotics (sorbitol, lactulose)

□ OTC Fiber supplements (psyllium, methylcellulose, polycarbophil etc…)

□ Prescription Amitiza (lubiprostone)

□ OTC Stimulants (bisacodyl, senna, cascara etc…)

□ Prescription Linzess (linaclotide)

□ OTC Osmotics (Magnesium Hydroxide, polyethylene glycol (PEG) 3350 etc…)

□ OTC Stool softeners (docusate)

20. If you chose any of the OTC products for question 18 or 19, how often do you specifically direct your patient to purchase the store brand option?

□ Always (greater than 90% of the time)

□ Very often (60–90% of the time)

□ Sometimes (30–59% of the time)

□ Rarely (less than 30% of the time)

□ Never

21. Compared to the name brand product (Miralax), what is your impression of OTC store brand PEG laxative 3350?

□ OTC Peg laxative 3350 is significantly more effective

□ Slightly more effective

□ Equivalent

□ Slightly less effective

□ Significantly less effective

22. For the same dose and quantity of a PEG 3350 laxative, what is your impression of the cost of store brand OTC medications compared to a brand named product?

□ The store brand is much more expensive than the name brand (>20% more)

□ The store brand is a little more expensive than the name brand (<20% more)

□ The store brand and name brand are similarly priced

□ The store brand is a little less expensive than the name brand (<20% less)

□ The store brand is much less expensive than the name brand (>20% less)

23. How would you rate your knowledge of the drug approval process for store brand OTC products?

□ Extensive knowledge

□ Some knowledge

□ Little knowledge

□ No knowledge

24. During your medical school, residency or fellowship training, to what degree were store brand OTC medications discussed as a treatment option for your patients with GI problems?

□ Extensively discussed

□ Some discussion

□ Little discussion

□ No discussion

25. To what extent do you agree with the following statement? The bioequivalence of store brand OTC medications among the different retailers (i.e. Target, Walgreens and CVS) are the same.

□ Strongly agree

□ Agree

□ Undecided

□ Disagree

□ Strongly disagree

26. Which of the following statements is most correct?

□ The majority of store brand OTC medications come from manufacturers which produce the same name brand medication.

□ The majority of store brand OTC medications come from 1–2 manufacturers.

□ The majority of store brand OTC medications come from 3–5 manufacturers.

□ The majority of store brand OTC medications come from greater than 5 manufacturers.

27. To what extent do you agree with the following statement? Production standards and FDA inspections are similar for facilities producing store brand OTC medications and those producing name brand products (i.e.—Prilosec, Miralax).

□ Strongly agree

□ Agree

□ Undecided

□ Disagree

□ Strongly disagree