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Monthly Archives: February 2016
Most Pharmacists rely on the foundation that their “evidence-based” mantra is being followed. A simple Google search shows us that:
“Alternative medicine is any practice that is put forward as having the healing effects of medicine, but does not originate from evidence gathered using the scientific method, is not part of biomedicine, or is contradicted by scientific evidence or established science.”
Just in case you were wondering, Google defines biomedicine as “a branch of medical science that applies biological and other natural-science principles to clinical practice. The branch especially applies to biology and physiology”.
This last one is important as we shall see, because it opens the window for recommendations to be made even in the absence of placebo controlled randomized trials (but yet remain outside of the realm of alternative medicine). It allows biochemistry and physiology and biology to guide recommendations to patients, even though direct studies on humans measuring an effect compared to placebo are lacking. For example, if you are thirsty, drink water or you will eventually die. There really are no such studies to prove this but we believe it anyway. Fair enough. Let’s agree on this for a minute or two as we look at our “go to” recommendations we do every day in the pharmacy.
In 2012 the International Journal of Pharmacy Practice published a research paper that looked into the effect of evidence-based training on Pharmacists everyday recommendations. It found that Pharmacists did not routinely utilize evidence-based resources when making decisions about OTC medicines and some felt uncomfortable discussing the evidence-base for OTC products with patients. (1)
In fact most pharmacists go by three things when making OTC recommendations, what they were taught in school (since most OTC ingredients don’t really change all that much from year to year or decade to decade), what they learn through continuing education and what they see works in their patients over time (also known as clinical experience). This is why I gave up recommending OTC teeth whitening products. I do however recommend specialized toothpastes for sensitive teeth even though I have never read one independent RCT on either subject – because I routinely hear results from many customers. (2)(3)
These are simple recommendations that on the surface seemed to be a great idea. Not that the success of OTC teeth whitening grew into an urban myth to me but it really didn’t seem right to recommend something I had no scientific proof to back me up and make a profit on it plus lacked the positive feedback from my customers. Perhaps that is alternative therapy?
It’s part of every retail pharmacist’s day, stepping out from behind the dispensary counter and making recommendations that draws from the vast pool of for the most part, unchanging static list of ingredients in the front store. I draw a fair share of comments that claim some recommendations I make are “alternative” or “complimentary”, sometimes referred to as CAM therapies. The definition of this term seems to change with whomever makes up the argument. Some arguments against CAM are certainly legitimate, and some include categories that show some effectiveness but are not mainstream. Some involve treatment, cure or prevention of Health Canada Schedule A disorders, which include many conditions that we try to help daily – we just can’t advertise the products as such. They include obesity, hypertension, diabetes, acute anxiety and others. Either way, there are some regular recommendations made by Pharmacists daily that said Pharmacist assumes is proven to work based on mainstream suggestions, but are you making recommendations based on the same science that backs up the prescriptions you hand out daily. Furthermore, if these therapies do not meet these same evidence based standards, are they automatically shuffled into the CAM category or is there another category they might be moved into? Perhaps urban myths make mainstream otc pharmaceutical suggestions. Lets look at what the current literature says about common therapies. Are there any studies at all that back up what you are suggesting to your customer as fact? If there are studies, do they have the power to the same? If not, what is your rationale for making these recommendations and at what point do we call the recommendations as alternative or not evidence based. In fact, pharmacists do not always rely on the definition of evidence based in making an OTC recommendation.
Turning to the Cochrane Data Base, there are a few reviews for common OTC cough medications. In reviewing 29 trials involving 4835 people (adults and children – studies were current up to March 2014), the Cochrane Library stated “ We found no good evidence for or against the effectiveness of OTC medications in acute cough”. In a 2006 statement, the American College of Chest Physicians stated that its recommendation for cough due to cold was to treat with an antihistamine/decongestant combination. (4)(5) Also, the findings of using codeine or antihistamines for cough showed neither was superior to placebo. A study in the Archives of Pediatrics and Adolescent Medicine found that in Parent reported cough response to buckwheat honey, a DM cough syrup flavored with honey and a placebo, the honey alone treatment was superior to the DM syrup or the placebo in children. (6)(7) Popular cough syrups that use pine needle oil and Canadian Balsam in a capsicum tincture are popular in all pharmacies but lacking evidence.
Narcotics for pain
Marketing by drug companies has been quite successful in the widespread use of narcotics today. In fact when various types of pain are treated with opioids, NSAIDS, and acetaminophen, narcotics’ recommendations often fall at the bottom. Dental pain, while often treated with narcotics, has been shown by the Cochrane Database to be treated more effectively with combination ibuprofen and acetaminophen and back pain has also been shown to have more favorable outcomes when treated with non-opioid medications. (8) Historically pharmacists police OTC meds, sometimes blind while trying to keep patients restricted to a days supply. This is now going to be easier with the dawn of the Drug Information System (DIS) in Nova Scotia, giving more real time data than the triplicate prescription monitoring system. Logging in OTC codeine products allows pharmacists to see in real time the profile of the patient at other pharmacies that are also on the system.
It is becoming more and more clear that opioids are to be the exception rather than the rule when it comes to most pain relief. Terminal conditions involving pain are a clear indication for opioids. The numbers needed to treat are typically higher in the opioids compared to the non-opioid medications and in acute pain to chronic pain conditions the opioids are not preferred unless absolutely necessary. Jumping to OTC codeine has not proven to be the answer with most patients based on science.
Next to cough and cold, and analgesics, acid suppressing agents are a main staple in a pharmacist’s OTC toolbox. Three main categories are antacids, H2-blockers and PPI’s, all available OTC. Most pharmacists may be under the impression that when these are given, they help neutralize acid in the stomach in their own way and relieve reflux symptoms, and that’s that. It turns out these three medications have differing effects that must be kept in mind to help the patient. Antacids have a role in neutralizing acid in the esophagus transiently but do not significantly affect the pH in the stomach. As a result it has been found that in cases of chronic heartburn, repeated administration of antacids commonly result in erosive esophagitis. For this reason it is important to recommend them only in cases of GERD that is temporary or intermittent in nature and to realize that ulcer healing will be minimal. With the H2 blockers, there is a tolerance that can develop rather quickly with these medications that unfortunately is not dose dependent and there is also a secondary analgesic effect on the tissue of the esophagus. (9)
The key in OTC recommendations is recognizing the strengths and the limitations of each of these medications. Simply giving an antacid for a patient with “heartburn” without knowing the exact details of frequency goes against the indication for that suggestion. Monographs for these medications state a six week course and should not be used long-term for acid suppressing agents. It is important to not continue to give antacids too frequently in order to prevent further damage to the esophagus. In fact there is no evidence to support long-term treatment with H2 blockers or PPI’s.
While it was something pharmacists had suspected for years, it has now been shown in clinical trials that the effectiveness of the pediculicide known as permethrin has dropped from 99% in 1996 to 25% in 2009. In 2010 this effectiveness was estimated to be 18% as opposed to 46% for isopropyl myristate, which is now a popular alternative for head lice. This is a case of staying on top of current literature. (10) Although something may have been proven to work before, it may not have the same effectiveness now and is continued to be used assuming older data is still appropriate.
One of the most commonly recommended laxatives for both occasional and chronic constipation as well as narcotic induced constipation is senna. There are no well designed randomized placebo controlled trials for senna and for the most part I think most pharmacists are unaware of this and go by clinical results in making this recommendation. Also no known studies comparing stand alone efficacy of docusate over placebo exist. Fiber, fluids and exercise show surprisingly little results unless the patient is deficient in any of them. (11)
One of the common arguments against alternative therapy is not so much a lack of studies, but a lack of what is considered quality studies by the one against alternative therapies. Sometimes it is what the majority of us do that removes something from alternative. While there are no lack of studies on nicotine replacement therapy OTC in smoking cessation there are many limitations to many of the studies (12). This is a common argument against treatments that are considered alternative. At some point however we need to treat somehow and we see clinical results, based on science (RCT or biology) and we use this to guide our recommendations safely.
Having said all this, the point is from our experience most over the counter meds really do work for their intended uses. If we required iron clad prescription drug quality studies to flip through on all of our front shop recommendations, we may very well cut the front store medicine section in half, not to mention the prescription medications that are prescribed off label. Certainly a lot of the cosmetic anti-aging and skin cream products would fall away. We also must remember that although we counsel based on past results with patients, we still make recommendations based on our education. Being against alternative medicine, whatever your own definition, may mean supplements, nutraceuticals, hormone therapy or herbal products to you. Maybe you consider selling vitamins as alternative. Some bad examples of irresponsible alternative therapy have painted all therapies with the same brush, and some reported side effects and hospitalizations of patients using alternative therapies fail to mention hospitalizations of patients on conventional medicine. As pharmacists, we value what is considered modern medicine but it’s not all that is out there that works. We must be considered the drug expert in all therapies, whether they are proven and safe to completely unproven and unsafe and everything in between in order to make an informed recommendation. Perhaps “evidence based” is a point we try to achieve but never completely reach until we change our definition of what it is. Based on how we defined alternative medication at the start of this article, perhaps alternative therapies are not as uncommon in pharmacies as is claimed by those that are against them.
1) Lezley-Anne Hanna and Carmel Hughes; The influence of evidence-based medicine training on decision-making in relation to over-the-counter medicines: a qualitative study; International Journal of Pharmacy Practice Volume 20, Issue 6, pages 358–366, December 2012
3) Ilze Maldupa, Anda Brinkmane, Inga Rendeniece, Anna Mihailova ;Evidence based toothpaste classification, according to certain characteristics of their chemical composition ; Stomatologija, Baltic Dental and Maxillofacial Journal, 14:12-22, 2012
4) Smith SM, Schroeder K, Fahey T. Over-the-counter (OTC) medications for acute cough in children and adults in community settings. Cochrane Database of Systematic Reviews 2014, Issue 11. Art. No.: CD001831.
5) Smith SM, Schroeder K, Fahey T. Over-the-counter medications for acute cough in children and adults in ambulatory settings. Cochrane Database Syst Rev. 2008;(1)
6) Paul IM, Beiler J, McMonagle A, Shaffer ML, Duda L, Berlin CM Jr Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents Arch Pediatr Adolesc Med. 2007 Dec;161(12):1140-6.
7) An De Sutter. There is no good evidence for the effectiveness of commonly used over-the-counter medicine to alleviate acute cough ; Evid Based Med 2015;20:98 doi:10.1136/ebmed-2014-110156 Systematic review
8) Dr Donald Treater M.D. Evidence for the Efficacy of Pain Medications. National Safety Council (NSC.org)
9) McRorie, J. W., Gibb, R. D. and Miner, P. B. (2014), Evidence-based treatment of frequent heartburn: The benefits and limitations of over-the-counter medications. American Assoc Nurse Prac, 26: 330–339
10) Sanofi-Pasteur , Evidence Based Management of Head Lice 2014
* (Sanofi-Pasteur is a manufacturer of ivermectin lotion)
11) Lawrence Leung, MBBChir, FRACGP, FRCGP, Taylor Riutta, MD, Jyoti Kotecha, MPA, MRSC, and Walter Rosser MD, MRCGP, FCFP Chronic Constipation: An Evidence-Based Review . Journal of the American board of family medicine July-August 2011 Vol. 24 No. 4 pp 436-451
12) Nicotine Replacement Therapy for Smoking Cessation or Reduction: A Review of the Clinical Evidence [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Jan 16. SUMMARY OF EVIDENCE.