Rx-to-OTC Medications: Year in Review

Pharmacy Times, December 2015 Heart Health, Volume 81, Issue 12

As 2015 comes to an end, several medications have made the switch from prescription to over the counter.

As 2015 comes to an end, several medications have made the switch from prescription to over the counter. This feature discusses the medications that have hit the OTC shelves within the past year. For a list of these medications, their date of approval, and their dosing, see Table 1.1 This list includes 3 intranasal corticosteroids for allergic rhinitis (AR), a transdermal patch to treat overactive bladder (OAB), and a proton pump inhibitor (PPI):

• Oxytrol for Women

• Nasacort Allergy 24HR

• Nexium 24HR

• Flonase Allergy Relief

• Rhinocort Allergy Spray

As these medications show up on OTC shelves, pharmacists need to be prepared to counsel patients on them, as well as understand the implications these switches will have on health care and the patients we serve.

Table 1: Rx-to-OTC Medications

Medication

Dosage

Approval Date

Oxytrol for Women (oxybutynin)

3.9-mg patch applied every 4 days

1/25/2013

Nasacort Allergy 24HR (triamcinolone)

Adults and children 12 years and older:

● Once daily spray 2 times into each nostril while sniffing gently.

● When allergy symptoms improve, patients can reduce to 1 spray in each nostril per day.

Children aged 6 to 11 years:

● Once daily spray 1 time into each nostril while sniffing gently

● If allergy symptoms do not improve, increase to 2 sprays in each nostril per day.

● When allergy symptoms improve, reduce to 1 spray in each nostril per day.

Children 2 to 5 years of age:

● Once daily, spray 1 time into each nostril while sniffing gently

10/11/2013

Nexium 24Hour (esomeprazole)

20 mg daily in the morning

3/28/2014

Flonase Allergy Relief (fluticasone)

Adults and children 12 years and older:

● Week 1: use 2 sprays in each nostril once daily.

● Week 2 through 6 months: use 1 or 2 sprays in each nostril, as needed to treat your symptoms.

● After 6 months of daily use: ask your doctor if you can keep using.

Children 4 to 11 years:

● Use 1 spray in each nostril once daily.

● Talk to your child’s doctor if your child needs to use the spray for longer than 2 months a year.

7/23/2014

Rhinocort Allergy Spray (budesonide)

Adults and children 12 years and older:

● Spray 2 times into each nostril once daily while sniffing gently.

● When allergy symptoms improve, reduce to 1 spray in each nostril per day

For children 6 to 11 years:

● Spray 1 time into each nostril once daily while sniffing gently.

● If allergy symptoms do not improve, increase to 2 sprays in each nostril per day.

● Once allergy symptoms improve, reduce to 1 spray in each nostril per day

3/23/2015

Oxytrol

Oxytrol is the first OTC treatment for OAB for women. It is available as a patch and is applied to the abdomen, hips, or buttocks every 4 days. Each patch delivers 3.9 mg of oxybutynin per day, continuously, for 4 days and nights.2,3

Prescription versus OTC:

• It contains the same strength as pre-scription Oxytrol.

• Prescription Oxytrol recommends application twice weekly (every 3-4 days).

• The formulation intended for the treatment of men will continue to require a prescription.

Counseling Points:

• Oxytrol may cause sleepiness, dizziness, and blurry vision. Alcohol may intensify these adverse effects (AEs). Patients should be advised to avoid driving or operating heavy machinery until they know how this medication affects them.

• Oxytrol may cause itching, rash, or redness at application site. Patients should be instructed to rotate the application site.

• Patients should be instructed to apply the patch under their clothes and not expose it to sunlight.

• Patients should be instructed on proper application.

• Apply to a clean, dry, smooth area of the skin.

• Do not put the patch on oily, damaged, or irritated skin.

• Do not put the patch on skin covered with oils, lotions, or powders because they could keep the patch from sticking to your skin.

Nasacort Allergy 24HR

Nasacort Allergy 24HR was the first intranasal steroid approved for the management of AR. It is available as a nasal spray and is used once a day.4,5

Prescription versus OTC:

• It contains the same strength as prescription Nasacort AQ.

Counseling Points:

• Some symptoms may get better on the first day of treatment. It may take up to 1 week of daily use to achieve maximum benefit. If allergy symptoms do not improve after 1 week, patients should stop use and talk to their doctor.

• Patients should not use Nasacort Allergy 24HR for the common cold.

• An adult should supervise nasal spray use in children aged 2 to 12 years.

Nexium 24HR

Nexium 24HR is indicated to treat frequent heartburn that occurs 2 or more days per week. It is available as 20-mg capsules and is taken once a day in the morning.6

Prescription versus OTC:

• OTC Nexium is only available in 20-mg capsules compared with the 20-mg and 40-mg capsules available as prescription.

Counseling Points:

• Instruct patients to take this medication with a glass of water before eating in the morning.

• Capsules should be swallowed whole, not crushed or chewed.

• If they require Nexium for more than 14 days, instruct patients to stop use and ask a doctor.

Flonase Allergy Relief

Flonase Allergy Relief is indicated to relieve symptoms of hay fever or other upper respiratory allergies. It is available as a nasal spray and is used once a day.7

Prescription versus OTC:

• It contains the same strength as prescription Flonase. Counseling Points:

• Patients may start to feel relief after the first day of use and may achieve the full effect after several days of regular once-a-day use.

• Patients should use Flonase every day because full effectiveness is usually achieved after 3 or 4 days of continu- ous use.

• Parents should talk to their child’s doc- tor if their child needs to use the spray for longer than 2 months a year.

Rhinocort Allergy Spray

Rhinocort Allergy Spray is indicated to relieve symptoms associated with AR. It is available as a nasal spray and is typi- cally used once a day.8,9

Prescription versus OTC:

• It contains the same strength as prescription Rhinocort Aqua.

• When comparing prescription and OTC labeling, there is a slight difference in how the recommended starting and maximum doses are broken down between age groups.

Counseling Points:

• Patients may see an improvement in allergy symptoms within 10 hours of first using the nasal spray.

• Advise patients they must continue to use the nasal spray as directed because maximum benefit may not be achieved until approximately 2 weeks after they begin treatment.

How These Recent Switches Will Affect Our Health Care

With the continuous approval of pre- scription drugs for OTC availability, health care is moving toward a more self- care approach. Not only does this offer patients additional treatment options, but it allows patients more control over their health. The implications on cost savings and spending can go both ways. With the ability to self-treat, health care costs may decrease by reducing the number of doctor visits. However, health care costs may increase if there is an increase in the number of emergency department visits due to misuse and preventable adverse events. In addition, patients may no longer receive drug coverage on OTC medications once they make the switch. In turn, the costs are being transferred to the patient from insurance companies.

Implications of Nexium on our Health Care

PPIs are a top-selling drug class, and many patients continue to take them for long periods of time. Research has indicated that up to 70% of PPI utilization is for unapproved uses.10 With Prilosec and Nexium now available over the counter, patients have easy access to medications that were not only prescribed by a medical professional, but whose duration of treatment was determined by a medical professional.

Now, however, the decision to initiate treatment and continue treatment has been transferred from the doctor to the patient, which could lead to overuse and misuse. With this, comes the change for potential risks associated with certain drug—drug interactions and long-term use. If PPIs are used for a prolonged period, patients are at an increased risk for fractures, cardiac events, iron deficiency, Clostridium difficile infection, and pneumonia.10 In addition, study results show an increased risk of reinfarction in patients taking a PPI, especially those found over the counter, and Plavix (clopidogrel). This potential drug-drug interaction may go unrecognized if patients self-treat.10

Implications of Nasacort, Flonase, Rhinocort Nasal Sprays on Health Care

Having these nasal sprays available on OTC shelves provides a treatment option for patients who have high blood pressure and require treatment for nasal congestion. In the past, this population did not have any OTC treatment options because decongestants are not recommended in this population.

Increasing accessibility to steroid nasal sprays can become problematic, especially if patients continue to self-medicate without professional guidance and if they are not aware of the possible AEs. The use of steroid nasal sprays can lead to several serious AEs, such as an increased risk for infection, adrenal insufficiency, and eye problems that include glaucoma and cataracts. They can also lead to a lower growth rate among children using these sprays for prolonged periods of time without professional guidance. Parents should advise their children to use these nasal sprays for the shortest amount of time necessary to achieve symptom relief and to regu- larly check (or get checked) their child’s growth while using these types of sprays.

For a prescription medication to be eligible to make the switch to an OTC medication, several requirements need to be met11,12:

• The OTC indication must be similar to the prescription indication

• Patients can easily self-diagnose

• Patients can identify their symptoms and self-medicate appropriately based on their symptoms without professional guidance

• The medication does not require labora- tory monitoring for safety and efficacy

• The FDA looks at the potential for harm if taken as directed by the drug label and also considers the potential for harm if the medication is misused.11

Knowing what is considered for the switch, what are your thoughts on the classes of medications that may be mak- ing the switch in the near future? These include treatments for13:

• Benign prostatic hypertrophy

• Cholesterol • Hormone replacement

• Sexual dysfunction/erectile dysfunction

For a list of medications available over the counter in other countries, refer to Table 2.

Anyssa Garza received her doctor of pharmacy degree from the University of Texas at Austin. She was later recognized for her contributions to research in the area of alcohol dependence. She went on to act as director of pharmacy for a Central Texas Department of Aging and Disability facility where she provided care for underserved patients for several years.

References

  • Prescription to over-the-counter (OTC) switch list. FDA website. www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm106378.htm. Updated June 2, 2015. Accessed August 20th, 2015.
  • Oxytrol for Women. Oxytrol for Women website. www.oxytrolforwomen.com/. Accessed August 20th, 2015.
  • Oxytrol drug facts. Oxytrol for Women website. www.oxytrolforwomen.com/pdf/OXYTROL_LABEL_HORIZONTAL_v2.pdf. Accessed August 20th, 2015.
  • Nasacort frequently asked questions. Nasacort Allergy 24 HR website. http://nasacort.com/hcp/Default.aspx#faq. Accessed August 20th, 2015.
  • Nasacort Allergy 24HR [drug label] Chattanooga, TN: Chattem, Inc; 2014.
  • Nexium 24HR drug facts. Nexium 24HR website. www.nexium24hr.com/us/product-label. Accessed August 20th, 2015.
  • Flonase drug facts. Flonase website. www.flonase.com/about/drug-facts/. Accessed August 20th, 2015.
  • Rhinocort Allergy (budesonide) — new over-the-counter drug approval. Optumrx website. www.optumrx.com/vgnlive/HCP/Assets/RxNews/Drug%20Approvals_Rhinocort_2015-0326.pdf. Accessed August 20th, 2015.
  • Rhinocort [package insert]. Wilmington, DE: AstraZeneca LP; 2010.
  • Ament PW, Dicola DB, and James ME. Reducing adverse effects of proton pump inhibitors. Am Fam Physician. 2012;86(1):66-70.
  • Now available without a prescription. FDA website. www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143547.htm. Updated August 2, 2011. Accessed August 20th, 2015.
  • Jacobs LR. Prescription to over-the-counter drug reclassification. Am Fam Physician. 1998;57(9):2209-2214.
  • The US Market for Rx to OTC Switches. Research and Markets website. www.researchandmarkets.com/reports/3098816/the-us-market-for-rx-to-otc-switches-7th-edition. Accessed August 20th, 2015.
  • OTC ingredients. Association of the European Self-Medication Industry website. www.aesgp.eu/facts-figures/otc-ingredients/. Accessed August 20th, 2015.