Thursday, March 24, 2016

More drugs, more supplements, and potentially more problems

drugs and supplements

Early in my career I was fortunate to be offered a role as a hospital pharmacist, working on an inpatient ward along with physicians, nurses, and a number of other health professionals. My responsibilities included conducting a detailed medication review with each newly admitted patient. We would sit together, often with family members, going through what was sometimes a literal garbage bag full of medications, and documenting the drug, the dose, and the reason for use. I can’t remember the most medications I ever counted, but a dozen or more was normal. Some were taking medications four or five times per day, every day. Were all these drugs necessary? In many cases, no. They’d been started at different times, often by different physicians. Some drugs treated the side effects of other medications. Few had ever had a health professional document them all in a single list. There had rarely been an overall review for safety and appropriateness. Few patients knew the treatment goals with their medications. Often, they’d never been asked about their treatment preferences.

In addition to auditing every prescribed medication, I asked about vitamins, supplements and over-the-counter drugs. I usually encountered the same scenario – multiple products, often without any clear medical need. There were vitamins for “eyes”, tonics for “the blood” and supplements believed to treat or prevent illness. There was regular (and sometimes dangerous) over-the-counter painkiller consumption. Sometimes all of these combinations were clearly antagonistic: concurrent laxatives and treatments for diarrhea, or sleeping pills taken along with stimulants. Worryingly, few had disclosed the use of many of these products to their physician before.

Medication reviews were a tremendous amount of work – but enormously rewarding. It was not difficult to find one or more cases of drugs potentially causing harm, or situations with clear drug-drug or drug-supplement interaction. In some cases, it was the medications that had put them in the hospital in the first place. Working with the residents and medical staff we could usually find ways to simplify their regimen, often discontinuing one or more drugs, reducing the doses of others, and suggesting ways to cut their supplement and over-the-counter drug use – or at a minimum, reduce the risk that these products could cause problems. Not only did patients end up with simpler medication schedules, we were helping them feel better, too. Before every patient was discharged, they’d get a follow-up visit from me. I’d provide a detailed list of current medications with a simplified designed to make medication use easier. We’d provide copies for them to take to the pharmacy and to any specialist. In many cases, patients were still a long list of drugs. But we’d cleaved away the harmful and unnecessary, trying to leave only the medications that were appropriate.

As medication reviews became part of my job, I grew familiar with the term “polypharmacy”. Polypharmacy describes the concurrent (and usually inappropriate) use of multiple medications. As I have written many times before, all drug have expected benefits and potential risks. A decision to take any drug needs to consider both. Polypharmacy complicates matters. There is good evidence to demonstrate that the total number of medications you take concurrently is a strong risk factor for medication-related harms.  The higher the number, the greater the likelihood of inappropriate use, and the greater the risk of medication-induced problems, like drug interactions. Making matters wore, the growing use of supplements means more people using drugs and supplements concurrently. The consequence may be more medication- and supplement-induced harms.

Seniors are at the biggest risk of polypharmacy. Chronic medical conditions are more common, and each may require medical therapy. And despite how frequently we use medications in the elderly, there’s often less information available about their relative risks and benefits. Kidney and liver function can decline as you age, leading to changes in how the body eliminates drugs (and supplements) from the body. New side effects can emerge and be be mistaken for new medical conditions, and treated with more drugs (or supplements). The consequences can be severe: cognitive impairment, falls, and overall increases in the risk of injury or death.

Two new papers published this week in the Journal of the American Medical Association give some new statistics on the trends in polypharmacy among seniors.

The first paper is from Dima M. Quato and colleagues and is entitled Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011. This is a survey of older Americans (aged 62 to 85) who consented to in-home interviews and direct audits of medication, supplement, and over-the-counter drug use. One group was audited in 2005, and the other in 2011. There were over 2000 participants in each group, with few differences between them from a demographic perspective.  If a drug or supplement was taken on a “regular schedule”, they were included.  The researchers subsequently compared the medication audits of the two groups,, and that data is summarized in this paper. Considering 2005 versus 2011, there were several significant findings:

  • The overall prevalence of prescription medication use increased slightly from 84.1% to 87.7%
  • The concurrent use of more than five prescription medications increased from 53.4% to 67.1%
  • The use of over-the-counter medications decreased from 44.4% to 37.9%
  • The use of dietary supplements increased from 51.8% to 63.7%
  • The concurrent use of two or more dietary supplements increased from 31.6% to 47.0%

Because these audits captured the names of every product taken, it allowed for some interesting observations beyond the numbers. There was an increase in the overall use of statins, anti-platelet drugs, anti-inflammatory medications, and stomach-acid-suppressing proton pump inhibitors. Other categories, like drugs for hypertension, were relatively consistent between the periods. Among supplements, multivitamins, minerals and calcium supplements remained the most commonly used. There were increases in the use of omega-3 fish oils, vitamin D, and coenzyme Q10. The use of vitamin E and folic acid, conversely, declined.

The audits also identified the possibility of drug-drug and drug-supplement interactions. 15.1% of all older adults were taking medication combinations with the combination for a major interaction. This was an increase from 8.4% just six years earlier. In an ideal world, each of these interactions would have been reviewed carefully for appropriateness. But the review found that potentially serious interactions (like simvastatin and amlodipine) were increasing.

Drug-drug interactions and drug-supplement interactions can be serious, and it’s difficult for patients and health professionals to avoid them without the cooperation and participation of patients who are ultimately making their own decisions about what products (prescription or otherwise) that they decide to take. This leads to the second paper I want to highlight, which also appeared in JAMA this week. It’s a research letter entitled Nondisclosure of Complementary and Alternative Medicine Use to Primary Care Physicians: Findings From the 2012 National Health Interview Survey.The authors are Judy Jou and Pamela Jo Johnston, who introduce their work with an odd defense of CAM and a plead for “integration”:

Although one-third of US adults report using complementary and alternative medicine (CAM), integration of CAM into the conventional medical system is inconsistent. Patients have shown a desire for their primary care physicians to inquire about CAM and refer to CAM practitioners (acupuncturist, massage therapists, etc), but primary care physicians rarely initiate conversations with patients about their use of CAM. Patients have also expressed concerns about discussing the use of CAM with their physicians, fearing disapproval.These communication barriers may prevent CAM from becoming fully integrated into patients’ treatment and self-care routines, especially if patients do not disclose their use of CAM to their primary care physicians.

It seems this paper was funded by the University of Minnesota’s “Integrative Health and Wellbeing Program” at the “Center for Spirituality and Healing”. That program offers (among other courses) university credits on topics like aromatherapy, Ayurveda, reiki, acupressure, and “healing imagery”, which may explain the pro-CAM perspective. Having said that, their analysis is quite interesting and complements the Quato paper’s findings on the growing presence of polypharmacy.

The authors analyzed the National Health Interview Survey, an annual survey conducted by the National Center for Health Statistics. That survey contains an “Adult Alternative Medicine” supplemental questionnaire. The sample studied included civilian adults who voluntarily completed the CAM questionnaire, had used some form of CAM during the past 12 months (more on this below), and indicated that the had a family physician.

In the questionnaire, respondents were asked to indicate the nature of their CAM use, and indicate if they had told their family physician about the CAM they felt was “most important to their health in the previous year”. This table summarizes the overall findings, and the disclosure rate by type of CAM:

Table 1

There were 34,525 adults who completed the CAM questionnaire in 2012. Of those, 29.6% reporting using CAM at least once in the past year, and 66.3% had a primary care physician, resulting in 7493 adults who met both criteria. In this group, 42.3% did not disclose the use of CAM. This sounds concerning, but the details are somewhat more reassuring.

From a polypharmacy perspective, the objective is to reduce the risk of drug- or supplement-induced harm. Reassuringly, the products with the greatest likelihood of causing interactions with drug (supplements and herbs) were noted as being disclosed to the physician 75% of the time. That’s not ideal, but it’s much better than the 42.3% in the overall findings. One reason for the very low reporting rate might have been influenced by what was considered CAM. This questionnaire included yoga as CAM, and non-disclosure was highest with yoga, at about 65%. I don’t find this surprising. I do yoga occasionally, and I’ve always thought of it as exercise, not medicine, and definitely not CAM. It would never occur to me to mention this to a physician if asked about CAM usage. Similarly, only about half of the people using homeopathy were disclosing it to their physician. Partial disclosure isn’t ideal, but there’s no real risk of incremental polypharmacy harms with homeopathy, given homeopathy is an elaborate placebo system where many remedies don’t contain a single molecule of any medicinal ingredient. What is important, however, is a shared understanding about why CAM products like supplements and even homeopathy are being used, so that there can be a candid discussion about the best therapeutic approach.

If respondents said they hadn’t disclosed their CAM use, they were asked why.

table 2I found this finding reassuring, to some extent. It’s rare that participants were worried about their physician’s reaction or knowledge. Not disclosing was more likely due to the physician not asking, or the patient not thinking that the physician needed to know. The reasons for this lack of disclosure can be rectified fairly easily: health professionals need to ask, and they need to create an environment of trust where patients feel comfortable talking about their own approaches and preferences. In particular, identifying CAM with the greatest potential to cause supplement-drug interactions is essential. An open dialogue, with specific questions about supplement and CAM use, may help address this issue.

The biggest concern about concurrent supplement use with medication goes beyond their lack of efficacy. As I have written before, because the quality standards for supplements and other “natural health products” are not as rigorous as they are for drug products. Not only is there (in most cases) little information to support routine supplement use use, there is evidence to show that CAM (like herbal remedies) products can be adulturated or even lack the ingredient that’s listed on the label – a state of affairs that is virtually unheard of when it comes to drug products approved by regulators like the FDA.

Polypharmacy can absolutely be harmful, but it can also be justified. My time as a hospital pharmacist showed me that while medications can cause harms, they can also be essential. Some seniors would be much better off if we discontinued several of their medications. Others would be dead. The absolute numbers of medications, supplements and over-the-counter drugs taken isn’t the problem – but it is a big red flag to proceed cautiously. Polypharmacy is growing and so are the risks of harms. Health professionals, particularly physicians and pharmacist, need to do more. We need to ask more questions, and ensure our patients treat supplements and over-the-counter drugs just like medicines. We need to ensure our advice and decisions are guided by the evidence – what works, and what’s best for a patient given the circumstances and the treatment goals. The patient as partner in these discussions, whenever possible, is critical. It’s only with a patient-centred discussion, with the health professional giving treatment advice and recommendations that considers a patient’s own preferences, that we can be confident that we’re managing medications appropriately.


Photo via flickr user Derek K. Miller used under a CC licence.

More drugs, more supplements, and potentially more problems Scott Gavura

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