As Rx products go over the counter, pharmacists need to be ready to help consumers.
As Rx products go over the counter, pharmacists need to be ready to help consumers.
Over the past 30 years, the FDA has converted more than 700 products containing 1 or more of 110 formerly prescription-only active ingredients to OTC status.1,2 Among the first ingredients converted to OTC status were the antihistamines brompheniramine and chlorpheniramine, which were approved for OTC use on September 9, 1976. Since then, products ranging from sleep aids to intranasal steroids have made the transition.2 The availability of a range of OTC products enables selftreatment of a variety of minor illnesses, improves access to care, and reduces the cost of care for consumers and the health care system as a whole.
The Value of OTC Medications
In 2010 alone, 240 million people in the United States spent approximately $23 billion on OTC products enabling them to self-treat cold symptoms, headaches, allergies, and many other common illnesses. For each dollar spent on OTC medications, the US health care system saves approximately $6 to $7, totaling an estimated $102 billion in value. At the same time, consumers save an estimated $13 billion per year in medical costs through use of OTC products.3,4 Highlighting this savings, the Consumer Healthcare Product Association estimates that an additional 56,000 full-time medical professionals would need to be added to the US workforce if OTC medications were not available.4
Although the savings associated with OTC medications are considerable, OTC medications continue to be underused. Primary care physicians estimate that 10% of visits to their offices could have been avoided by the use of an OTC medication, and 92% of physicians agree that OTC medications are effective and appropriate for the first-line treatment of minor illnesses.4
Over the past 2 years, the FDA has transitioned 4 additional prescription-only medications to OTC status. These include 2 intranasal corticosteroids for allergic rhinitis (Nasacort Allergy 24HR and Flonase Allergy Relief), a transdermal patch to treat overactive bladder (Oxytrol for Women), and a proton pump inhibitor (Nexium 24 HR).5
The Regulatory Perspective
The current OTC drug approval system has been in place since 1972, when the FDA set up the OTC drug review process. The prescription-only status of a product can be changed by (1) citizen petition or (2) a time and extent application, which is typically initiated by the manufacturer. The system is overseen by 2 government agencies: the Federal Trade Commission, which uses the OTC monograph system, and the FDA, which uses the new drug application system.1,6
OTC products must be labeled with drug facts, including information that enables consumers to determine whether a medication is appropriate for them. The benefits of making a medication available over the counter must also outweigh the risks associated with the product, and consumers must be able to understand product warnings and potential side effects. In addition, new OTC medications must have a low potential for misuse and abuse, consumers must be able to use the medication without the direction of a health care professional, and patients must be able to diagnose themselves for the condition the product is intended to treat.1,6,7
FDA officials have expressed an interest in using technology to promote appropriate use of OTC medications and increase consumer accessibility to medications that are currently available by prescription. Since 1972, when the current regulations were put in place, consumers have become more reliant on technology for health information. Technology also enables diagnostic monitoring and sharing of information among many different health care professionals. With technology such as mobile health (mHealth) applications, the FDA is likely to broaden the OTC availability of many types of medications.8-10
The first signs of this change came in 2012 when the FDA established the Nonprescription Safe Use Regulatory Expansion (NSURE) task force to evaluate new strategies for converting prescription-only drugs to OTC medications. Experts have proposed using technologies, such as smartphone apps, to enable self-care for conditions such as hyperlipidemia, benign prostatic hypertrophy, and migraine (Table 1).8-10
TABLE 1: MEDICATIONS THAT MAY BE FUTURE CANDIDATES FOR OTC STATUS8-10
Potential OTC Candidates
Sildenafil, Tadalafil, Vardenafil
Almotriptan, Eletriptan, Naratriptan, Rizatriptan, Sumatriptan, Zolmitriptan, Frovatriptan
Atorvastatin, Lovastatin, Pravastatin, Simvastatin
Solifenacin, Tolterodine, Trospium
Benign prostatic hypertrophy
Adapted from references 8-10.
According to David Wendland, vice president of Hamacher Resource Group, changes to OTC sales pursued by the NSURE task force will “keep the pharmacist in the driver’s seat of consultation,” although pharmacists can expect more use of innovative technologies to help the right patients make use of newly available OTC medications.11
The emphasis on technology in distribution of certain medications has led some individuals to refer to this proposed new set of medications as “e-OTC drugs.” For these medications, product selection might include use of in-store kiosks or tablet-based applications to assess patient eligibility. Such electronic resources would also enable participation by health care professionals through an electronically integrated system that tracks test results and patient records. OTC medication and technology integration should improve patient access to medications while continuing to involve physicians and pharmacists in the treatment process.11
As more prescription products make the transition from prescription to OTC availability, pharmacists need to be prepared to help consumers with the process. The transition of products from prescription status to OTC status is often accompanied by difficulties in obtaining reimbursement, and potentially higher out-of-pocket costs to consumers. When such switches occur, pharmacists are often left with a queue of insurance rejections, a list of prescribers to contact, and no guarantee that alternative medications will be acceptable to patients or paid for by prescription insurance plans.12
In 2002, a major insurer of prescription drugs successfully petitioned the FDA to convert loratadine (Claritin) from a prescription product to an OTC product. After noncoverage of prescription loratadine went into effect, a later analysis of prescription records in patients with Medicaid found that prior users of loratadine were more than twice as likely to switch to a different prescription-only antihistamine as they had been prior to the medication’s OTC debut.13
Although the availability of OTC medications should reduce prescriber visits, some evidence indicates that those cost savings may be overstated. For instance, after the introduction of OTC vaginal antifungal products, the number of monthly prescriptions for vaginal antifungal medications covered by Fallon Community Health Plan (FCHP) in Massachusetts fell by 45%. Over the study period, a small reduction in physician visits for vaginitis was observed (0.66 fewer vaginitis-related visits per 100 female patients per year).14 In another case, after OTC availability of histamine2 (H2)-receptor antagonists, investigators associated with FCHP identified a reduction in prescription sales of H2-receptor antagonists, but no concurrent reduction in physician visits related to gastrointestinal complaints.15
In addition, converting a prescription-only product to OTC status has, in some cases, led to drug resistance. In New Zealand, scientists recorded increasing rates of drug-resistant skin infections following availability of mupirocin as an OTC topical antibiotic. However, resistance rates rapidly declined after the return of topical mupirocin to prescription-only status.16
In some European countries, treatments for high cholesterol, irritable bowel syndrome, and migraine have already been made available over the counter. Some of these treatment, such as azithromycin for chlamydia, are available only after consultation and, in some cases, diagnostic testing by a pharmacist (Table 2).17,18 Existing models of health care provision are changing. With increasing consumer reliance on technology for health information, and a worldwide trend toward expanded OTC product availability, pharmacists in the United States can expect to see a broadening of their role in the provision of OTC treatments for a broader range of illnesses. Pharmacists will be an important part of this movement toward greater patient autonomy and expanded access to health care.
TABLE 2: SELECTED MEDICATIONS THAT ARE AVAILABLE OVER THE COUNTER OUTSIDE THE UNITED STATES17,18
Countries with OTC Availability
Austria, Denmark, Finland, France, Hungary, and Italy
Belgium, Hungary, and Italy
Denmark, Hungary, United Kingdoma
Finland, United Kingdoma
Germany, Sweden, United Kingdom
Iptratropium bromide (nasal)
Belgium, Czech Republic, Estonia
Finland, Italy, Spain, Sweden, The Netherlands
aOnly available through pharmacies.
bOnly available through pharmacies for the treatment of chlamydia after urine testing.
Michael R. Page earned his PharmD from the Ernest Mario School of Pharmacy at Rutgers University. He has worked as a community pharmacist at CVS Pharmacy and is currently clinical editor in clinical and scientific affairs at Pharmacy Times.
1. Oliver E. An overview of the US regulatory system for OTC products. Regulatory Rapporteur. 2013;10(3):4-9.
2. Consumer Healthcare Products Association. Ingredients & dosages transferred from Rx-to-OTC status (or new OTC approvals) by the Food and Drug Administration since 1975. www.chpa.org/SwitchList.aspx. Accessed January 2015.
3. Pawaskar MD, Balkrishnan R. Switching from prescription to over-the counter medications: a consumer and managed care perspective. Manag Care Interface. 2007;20(1):42-47.
4. Consumer Healthcare Products Association. The value of OTC medicine to the United States. www.yourhealthathand.org/images/uploads/The_Value_of_OTC_Medicine_to_the_United_States_BoozCo.pdf. Published January 2012. Accessed January 2015.
5. FDA. Prescription to over-the-counter (OTC) switch list. www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm106378.htm. Accessed January 2015.
6. FDA. Now available without a prescription. www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143547.htm. Accessed January 2015.
7. Sood NJ, Sun E, Zhuo X, Blume-Kohut M. Potential effects of introducing behind the counter drugs. www.rand.org/pubs/working_papers/WR608.html. Published August 2008. Accessed January 2015.
8. Engelberg Center for Health Care Reform at Brookings. Exploring implications of the Nonprescription Drug Safe Use Regulatory Expansion (NSURE) Initiative on Reimbursement and Access. www.brookings.edu/~/media/events/2013/11/04%20nsure%20engelberg/discussion%20guide_nsure%20114.pdf. Accessed January 2015.
9. Stomberg C, Philipson T, Albaugh M, Sood N. Utilization effects of Rx-OTC switches and implications for future switches. SciRes. 2013;5:1667-1680.
10. Engelberg Center for Health Care Reform at Brookings. Innovative technologies and nonprescription medications: addressing undertreated diseases and conditions through technology enabled self care. www.brookings.edu/~/media/events/2013/5/09%20innovative%20technologies%20nonprescription%20medicines/09%20innovative%20technologies%20nonprescription%20medications%20presentation%20slides.pdf. Accessed January 2014.
11. Oldfield E. e-OTC concept can aid in Rx-to-OTC switches. www.pharmacytimes.com/publications/issue/2014/sept2014/e-OTC-Concept-Can-Aid-in-Rx-to-OTC-Switches. Published September 2014. Accessed January 2015.
12. Baker DE. Nonprescription drug safe use regulatory expansion. Hosp Pharm. 2013;48(6):448-450.
13. Mahecha LA. Rx-to-OTC switches: trends and factors underlying success. Nat Rev Drug Discov. 2006;5(5):380-385.
14. Gurwitz JH, McLaughlin TJ, Fish LS. The effect of an Rx-to-OTC switch on medication prescribing patterns and utilization of physician services: the case of vaginal antifungal products. Health Serv Res. 1995;30(5):672-685.
15. Andrade SE, Gurwitz JH, Fish LS. The effect of an Rx-to-OTC switch on medication prescribing patterns and utilization of physician services: the case of H2-receptor antagonists. Med Care. 1999;37(4):424-430.
16. Upton A, Lang S, Heffernan H. Mupirocin and Staphylococcus aureus: a recent paradigm of emerging antibiotic resistance. J Antimicrob Chemother. 2003;51(3):613-617.
17. Association of the European Self-Medication Industry. OTC ingredient database. www.aesgp.eu/facts-figures/otc-ingredients/. Accessed January 2015.
18. World Self-Medication Industry. Prescription to nonprescription medicines switch. www.wsmi.org/pdf/wsmi_switchbrochure.pdf. Published 2009. Accessed January 2015.