Confronting the Challenge of Polypharmacy

It’s one of the biggest threats to our nation’s public health, contributing to tens of thousands of premature deaths annually, and adding untold sums to the cost of health care. As a cause of morbidity and mortality, it’s right up there with heart disease, cancer and infectious diseases.

The problem is polypharmacy: the routine consumption of five or more prescription medicines, often in combination with several over the counter meds and/or dietary supplements. The irony is, that the very medications we’re prescribing to prevent or treat serious disease have become a serious pathology unto themselves.

For perspective, consider these facts: prescription drug spending, the fastest growing component of health care spending in the US, increased 18% annually from 1997 through 2001 (Gen’l Acc’ting Office doc. No. 03-177: Prescription drugs. FDA oversight of direct-to-consumer advertising has limitations. October 2002; Bootman J. Arch Intern Med. 1997; 157: 2089–2096).

According to a survey by the Kaiser Family Foundation, the number of retail prescriptions filled per capita reached an average of 12.3 for US adults in 2005, up from 7.9 in 1994.

Polypharmacy is particularly prevalent among the elderly, many of whom are on multiple medications that they’ve been taking for years, if not decades. Individuals over age 65 currently account for roughly 13% of the nation’s population, but they account for 50% of all medication consumption.

A Fistful of Tablets

According to estimates from Omnicare, a pharmacy benefits management company, the average American over age 65 takes up to 6 prescription drugs daily, along with up to 4 OTC products. Ninety percent of all older adults are on at least 2 medications; in long term care facilities, the average is 7.

And we’re only at the beginning of the aging Boomer wave. By the year 2030, over 70 million people will be aged 65 years or older, with half over the age of 75.

What’s the net result of all this medication consumption? Adverse events, that’s what!

When prescription drugs, to say nothing of OTC medications and supplements, are consumed in vast quantities by massive numbers of people, some of the so-called rare and infrequent side effects become, well … not so rare anymore.

According to Rosemary Laird, MD, assistant professor of medicine, University of Kansas Medical Center’s Center on Aging, the most consistent risk factor for adverse drug effects is … you guessed it … the number of drugs an individual is taking! Risk for AEs rises exponentially as the number of drugs increases. Dr. Laird notes that 10 out of every 100 patients who take 10 medications daily experience adverse events.

Omnicare’s analysts estimate that 35% of all people over age 65 have experienced an adverse drug reaction.

One need not scour the medical literature too hard to find examples: There are injurious falls linked to commonly prescribed medications (Smith R. J Am Podiatr Med Assn. 2003; 83: 42–50). There’s the increased risk of hip fractures associated with long term proton pump inhibitor use (Yang Y, et al. JAMA. 2006; 296: 2947–2953), and of course the widely publicized gastrointestinal problems associated with frequent NSAID use (Smalley W. Gastroenterol Clin North Am. 1996; 25: 373–396), to say nothing of the phen/fen debacle nearly a decade ago (Gardin J. JAMA. 2000; 283: 1703–1709). Need we say anything more about COX-2 inhibitors?

Then there are the drug interactions, the potential for which naturally increases with the number of drugs someone takes. Nowadays, with so many people using supplements, we’ve got to be concerned with drug/supplement interactions (i.e., SSRI anti-depressants and St. John’s Wort or SAMe), as well as drug/food interactions (i.e., Zocor or calcium channel blockers and grapefruit) and supplement/supplement interactions (i.e., vitamin C, vitamin E, turmeric, garlic and risk of bruising/bleeding due to effects on platelet aggregation).

Pharming the Land

How have we turned into Medication Nation? Well, it’s hard to ignore Big Pharma’s two-fold push to bring new medications to market via “fast track” FDA approvals, and direct-to-consumer advertising in print and broadcast media. The latter “educates” consumers about medical conditions and stokes demand, putting pressure on physicians to prescribe more medications over longer time periods.

The pharmaceutical industry is always developing new products to treat old conditions, and clinicians’ efforts at early detection of disease states has translated into earlier therapeutic interventions. The result is more people on more drugs for longer periods of time.

Has all this medicating saved lives? No doubt. But it has also cost lives. We, as medical professionals, need to reckon with this.

Rx Doesn’t Stand for Reflex!

The big questions we must ask ourselves is this: are all the medications we prescribe truly necessary? Are there other ways to manage the common disorders for which we are prescribing drugs? Have we truly exhausted all the non-pharmaceutical options before we reach for the prescription pad?

Put another way, can clinicians do a better job of keeping people off medications?

To the latter, The Lewin Group, an independent research firm, studied patients over 65 years of age and reported that a simple evidence-based dietary supplement strategy can keep seniors healthy, active and productive. First, Omega-3 fatty acids, at a dose of 1,800 mg per day, can reduce physician office visits and reduce coronary heart disease. Next, 6 mg–10 mg of Lutein may reduce relative risk for vision loss. Finally, adequate vitamin D intake for women may contribute to positive bone health outcomes and reduced fractures (DaVanzo J. The Lewin Group. An evidence-based study of the role of dietary supplements in helping seniors maintain their independence. Jan. 20, 2006).

Note that these positive outcomes are achievable without prescription medications. That said, supplement-based self-care must be guided by the advice and consent of a holistic physician and integrative clinical pharmacist.

When prescription meds are necessary, or when working with patients who are already on several drugs, physician-directed de-escalation of polypharmacy may be one solution in reducing the potential for drug-related problems. A number of prominent authors have addressed this issue in recent years, as the impact of polypharmacy has become more clear (Avorn J. JAMA. 2001; 286: 2866–2868; Fick D. Arch Intern Med. 2003; 163: 2716–2724; Hanlon J. J Am Geriatr Soc. 2002; 50: 26–34. Lazarou J. JAMA. 1998; 29: 1200–1205).

De-Escalating Polypharmacy

As there are often several approaches to treating any health condition, physicians could try different techniques to reduce medication usage. Also, try to assess and incorporate patients’ personal values, beliefs, and fears regarding lifestyle changes and stress management. Your goal is to move patients from reliance on more invasive and side-effect ridden interventions to less invasive holistic strategies.

Whenever possible, try to consolidate or de-escalate your patients’ medication regimens, using one or more of the following techniques:

  • Prescription Medication Holidays. Remember that medications are researched in clinical trials for relatively short time periods compared with length of actual use out in the real world. Make it a routine to reassess patients’ need to continue prescription medications. By way of example, the FLEX study, a major trial published last year showed no meaningful difference in fracture rates between women who discontinued alendronate therapy after 5 years and those who continued on for 10 years (Black DM, et al. JAMA. 2006; 296: 2927–2938).
  • Alternate Medication Schedules (www.mypillbox.org). Alternate medication regimens may reduce the risk of medication-related side effects. For Zocor and other statins, you might consider every other day instead of daily dosing. For drugs like Cardizem, consider sustained-release once-daily dosing instead of multiple immediate-release daily doses. Whenever possible, think about topical or inhaled forms instead of oral or intravenous dosing (i.e., steroid inhalers for asthma, topical bio-identical estrogen and progesterone cream for local menopausal-related symptoms). In some circumstances, you can improve a drug’s efficacy through optimizing the timing of the doses. For example, it makes the most sense for patients to take anti-hypertensive meds at bedtime, since blood pressure is known to rise in the early morning hours.
  • Factor in Off-Label Pharmacology of Prescription Medications. The complete pharmacology of a prescription drug may not be fully known at the time it is approved. We didn’t know, for example that HMG-CoA inhibitors could affect osteoporosis or that statins had pleiotropic effects including modulation of procoagulant activity and platelet function. In time, as clinical research and real-world experience reveal previously unexpected benefits from a given drug, we can sometimes use this information to obviate the need for other drugs, thus reducing polypharmacy.
  • Therapeutic Equivalents. This technique involves reducing the number or doses of existing prescription medications by combining them with USP/NF German Commission E dietary supplements. For example, you can use a low dose prescription statin plus red yeast rice, cinnamon, or soy to manage hyperlipidemia.
  • Herbs, Vitamins, or Other Dietary Supplements Instead of Prescription Medications. Specific conditions that are good candidates for this strategy include: 1) Menopause: utilizing phytoestrogens for the management of hot flashes instead of prescription estrogen (i.e., black cohosh); 2) Arthritis (i.e., ginger, turmeric, glucosamine, chondroitin instead of prescription NSAIDs); Cholesterol-lowering with one of the following supplements: garlic, high dose niacin, guggul, red yeast rice, oatmeal, cinnamon, soy, flaxseed oil, or dietary fiber. Patients with these conditions could benefit from other holistic modalities such as Guided Imagery, health affirmations, meditation, and yoga, in addition to a good exercise regimen and healthy diet.
  • Lifestyle or Diet Alone. For conditions related to stress such as GERD, non-invasive approaches including lifestyle changes, nutritional changes, and stress management with massage, acupuncture or biofeedback may offer support and obviate the need for antacids or proton pump inhibitors.
  • Sleep Hygiene. Good sleep is extremely important for good health. Examine a patient’s lifestyle choices that affect sleep, which in turn influences overall daily energy and refreshment, and sense of peace. Refer patients to sleep specialists when appropriate.
  • Accentuate the Positives (e.g., Health Affirmations). Teach patients to think positively about chronic illness as much as possible with affirming scripts (i.e., ‘My joints are strong and flexible.”) This is an excellent component of mind/body medicine.

Reducing a patient’s reliance on medications will, inevitably, involve some lifestyle changes—something not everyone is ready to take on. But if you work together with your patients and develop a rapport, you can help many of them make the changes that can help them avoid a life dominated by pill bottles.

How to Prepare Patients for Lifestyle Change

  1. Conduct a comprehensive, integrative health assessment to determine what conditions/symptoms may be appropriate for medication or supplement de-escalation strategies.
  2. Assess the patient’s readiness to change, and talk about barriers to adherence to new recommendations.
  3. Partner with your patient and invite him/her to journal medication de-escalation strategies that you choose together.
  4. Develop common health outcome goals with your patient and periodically reassess them.
  5. Let a patient know he/she has the right to refuse a medication, and explain what is likely to happen if he or she does not take it.
  6. Put together a list of credible integrative health practitioners and modalities, and plan how best to use them.
  7. Explain that most integrative services are not covered by third party insurance or Medicare, so there may be some out-of-pocket cost to the patient. But it’s still a good deal compared with a life-threatening drug adverse event.
  8. Ask your patient if she/he has any spiritual concerns that she/he wishes you to know. If comfortable, you may appeal to a higher power and ask for support in your patient’s pursuit of healing and health. Faith, prayer, spiritual beliefs can play an important role in helping patients recover from illness.
  9. Hand out a patient satisfaction survey at the end of the visit for feedback.

In summary, I believe we can reduce the burden of polypharmacy and ‘polysupplement’ usage if we focus on fully optimizing the use of non-invasive, non-pharmaceutical holistic modalities.

Cathy Creger Rosenbaum, PharmD, MBA, RPh, is founder & CEO of Rx Integrative Solutions, Inc, a holistic pharmacy in Cincinnati, OH. Visit her website at: www.rxintegrativesolutions.com. Feel free to contact her with questions at: drcathy@rxintegrativesolutions.com. (513) 382-5184.