February 24, 2015
A recent on-line article in Pharmacy Times1 has reported that the Rx to OTC movement is generating increasing momentum. The author states that in 2010 alone over 240 million Americans spent approximately $23 billion on OTC medications. With a reported 6:1 return on investment (ROI) in avoided health care system costs, this is an estimated $102 billion value for the US health system, and a $13 billion value for consumers. Primary care physicians estimate that 10% of office visits could be avoided if OTCs were used appropriately and 92% of them agree that they are effective and appropriate for initial treatment of minor illnesses.2
Initial classes of medications moving from prescription to OTC status have included antihistamines, decongestants, NSAIDS, acid reducers (H2s and PPIs), and most recently transdermal anticholinergics for bladder control and nasal steroids.
In 2012, the FDA established the Nonprescription Safe Use Regulatory Expansion (NSURE) task force charged with evaluating new strategies and future Rx to OTC targets. Possible candidates for OTC status include medications for erectile dysfunction, migraine, hypercholesterolemia, overactive bladder and benign prostatic hypertrophy (BPH).3
While there is certainly something to be said for savings billions of dollars and demonstrating impressive ROIs, let’s take a different slant on what is happening here. Let us repeat the Rx to OTC list in a different way: first generation sedating/confusing antihistamines, blood pressure elevating decongestants, GI-bleeding implicated NSAIDS, first generation sedating/confusing H2s, and drug-drug interacting and osteoporosis implicated PPIs; and coming soon: drug-drug interacting erectile dysfunction and migraine medications, muscle and liver antagonizing statins, anticholinergic bladder medications and blood pressure crashing BPH alpha-blockers. So remember the last time you looked at the labeling on an OTC container? Imagine also the patient insert for these future OTC targets being reduced to consumer labels. Bad enough for most of us, but consider the risk for our older adult population.
ActualMeds Principle Scientist and co-founder Patricia J. Neafsey, PhD has made patient self-medication behavior her life’s work. Participating in the recent Gerontological Society of America (GSA)/Consumer Healthcare Products Association (CHPA) OTC Summit, Neafsey and her colleagues advise: “Ensuring that consumers safely and effectively use OTC products is critical in order to minimize potential drug–drug interactions and unintentional misuse. Yet we know surprisingly little about the ways older adults select OTC medications and decide when to start or stop use, how older people actually take these medications, or how involved clinicians and family members are in older adult OTC behavior”.4
The NSURE task force advocates the need for increased awareness for consumers on the benefits and risks of OTC use. The rapid increase in information via healthcare technology can help. But older adults may not be “plugged in” to the on-line information highway, and may have physical and cognitive impairments that prevent them from getting the information they need from packaging, labels or patient educational materials. The GSA/CHPA Summit participants outlined a five stage process necessary for effective self-medication decision-making, and warn that older adults may be more vulnerable to failures in any one of the components that other consumers. Older adults need to be exposed to the information, they must perceive that the information is a warning, they must encode the fact that the warning applies to them, they must comprehend the call to action of the warnings, and they must take the necessary action i.e. recognize that the OTC medication is inappropriate for them to use.
Ok so how do we capitalize on the good OTCs can offer, while avoiding the medication adverse events that a poor choice might bring? We can do it through technology and teamwork.
There are many web-based medication management systems, drug interaction decision support tools, medication reconciliation applications and population-based medication analysis services available. All rely on accessing prescription medication claims data and/or EHR medication orders to begin to paint the picture of a patient’s medication use and the co-incident risks. Only the most unique technology and service solutions will be able to add OTC medications to the picture. These tools and services must have a robust patient interview capability to be able to completely capture and characterize OTC use, and thus present clinicians with the total picture of medication risk for their patients. The more that potent Rx medications are transitioned to “hidden” OTC status, the more important engaging the patient to capture OTC use will be. In addition medication “alert” algorithms need to be able to digest multiple-ingredient OTC formulations and easily integrate them into the medication risk assessment to make sure that our patients’ self-medication behaviors are helping and not hurting their overall quality of life.
Once we have brought the patient into the picture, and have made sure that our technology and practices are “OTC friendly,” we need to make sure that the rest of the care team is engaged. Neafsey’s research shows that point of care counseling on self-medication use can improve patients’ choices and improve their overall health.4,5 All medication management systems need to make the results of patient encounters actionable, and accessible to the patient’s entire health care team. Each team member needs to act at their highest and most efficient level of practice on behalf of the patient, making sure the patient’s self-medication choices are identified, shared with and acted upon by all team members as appropriate to their discipline.
1Rx-to-OTC Switches: Trends to Watch http://www.pharmacytimes.com/publications/issue/2015/february2015/rx-to-otc-switches-trends-to-watch/P-2
2Consumer 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. February 2015
3Engelberg 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 February 2015
4Albert, M.A., Bix, L., Bridgeman, M.M., Carstensen, L.L., Dyer-Chamberlain, M., Neafsey, P.J., Wolf, M.S. (2014). Promoting Safe and Effective use of OTC Medications:CHPA-GSA National Summit. The Geontologist, 54, No.6, 952-963
5Neafsey, P. J., M’Lan, C. E., Ge, M., Walsh, S. J., Lin, C. A., & Anderson, E. (2011). Reducing adverse self-medication behav-iors in older adults with hypertension: Results of an e-health clinical efficacy trial. Ageing International, 36, 159–191.
Joseph Gruber, RPh, CGP, FASCP: Chief Clinical Officer, ActualMeds Corporation. Past President, American Society of Consultant Pharmacists. @jgactualmeds