Tag Archives: alternative

Your Pharmacy is Most Likely an Alternative, Complimentary, Off Label, Patient Centred One
avatar

 

IMG_8697

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.

Cough Therapy

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.

 

Antacids

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.

 

Head Lice

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.

 

Chronic Constipation

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.

 

 

 

 

References

 

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

2) Demarco FF, Meireles SS, Masotti AS. Over-the-counter whitening agents: a concise review. Braz Oral Res. 2009;23 Suppl 1:64-70

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.

Posted in Nutritonal Supplements, Stone's Pharmasave | Tagged , , , , , , , , , , , , | Leave a comment

Off label use of medications – cherry picking at its best
avatar

IMG_2313[2]I had a conversation with our local palliative care and pain clinic doctor the other day. As a disclaimer, this physician is open to treating patients with the safety of the patient first in mind and he also has what I refer to as an “open mind” when it comes to doing whatever we can to alleviate pain and suffering. A lot of the time it involves using medications and therapies that most physicians would prescribe. It also involves therapies that are safe and effective but are shunned by other physicians either because of lack of knowledge or experience with them or because they claim it is an off label use or one that lacks either a firm recommendation from a governing body or has not been recommended at a recent conference they attended.

Off label prescription writing is certainly not a stranger to my daily dispensing of drugs. Some reviews put this practice as high as 10% of prescriptions written in Canada. A May 2012 MacLean’s article discusses this as a major issue and a huge gamble for the physicians writing these prescriptions. As a pharmacists, I can assure you that this practice is the norm and for the most part doesn’t land people in the hospital any more often than officially approved writing of any other prescription medication such as NSAIDS, narcotics, blood pressure or heart meds, or antibiotics, to name a few. There are hundreds of examples of off label uses of drugs now being written for. A few common ones listed by the Lexicomp Facts and Comparisons Off Label are:

 

ASA for high risk coronary artery disease

Clonidine for hot flashes

Erythromycin for acne vulgaris

Folic acid for neural tube defects

Gabapentin for diabetic neuropathy

Nifedipine topical for anal fissures

Trazodone for insomnia in the elderly

Amitriptyline (oral or topical) for neuropathic pain

Childhood and adolescent uses of many medications

 

Note the use of the amitriptyline topically. Topical compounds are notoriously listed here although there are studies showing they work for various types of pain when used correctly at the right strength. Granted many of these studies are small but many are well designed and like I always say, nothing beats the experience of the first patient a physician tries and sees the topical preparation working and the lack of side effects compared to oral medications is an added bonus.

Most consider topical pain therapy to be limited to capsaicin, lidocaine and camphor menthol combinations.  There is an entire universe out there of other ingredients used in these preparations. And for those who like a few references here you go.

Dubinsky RM, Kabbani H, El-Chami Z, Boutwell C, Ali H; Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter: treatment of postherpetic neuralgia: an evidence-based report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2004;63(6):959-965.[PubMed 15452284]

Ho KY, Huh BK, White WD, Yeh CC, Miller EJ. Topical amitriptyline versus lidocaine in the treatment of neuropathic pain. Clin J Pain. 2008;24(1):51-55.[PubMed 18180637]

Lynch ME, Clark AJ, Sawynok J, Sullivan MJ. Topical 2% amitriptyline and 1% ketamine in neuropathic pain syndromes: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2005;103(1):140-146.[PubMed 15983466]

Lockhart E. Topical combination of amitriptyline and ketamine for post herpetic neuralgia. Poster presented at: American Pain Society Annual Meeting; May 6-9, 2004; Vancouver, BC. http://www.ampainsoc.org/db2/abstract/view?poster_id=2185#893. Accessed November 4, 2008.

 

-Lexicomp

 

Now a common complaint is that I supply studies that cherry pick what I am trying to prove, although I assume that whomever is asking has plenty of studies to favour something against my side. The point is, when you know something works, and it’s safe, you tend to care more about potential patients and less about converting non believers. Topical pain relief is just one of those “alternative” therapies. Many would consider off label use to be alternative therapy by definition. If alternative therapy is something that wanders past a monograph or official indication, then many practice alternative medicine. If that therapy is “recommended” by a medical group then for most it becomes accepted therapy and therefore not alternative. Although this may make them more comfortable with prescribing choices, alternative therapy’s definition is one that changes based on the one defining it.

Posted in Compounding, Stone's Pharmasave | Tagged , , | Leave a comment

What’s worth more? A favorable statistical p value or clinical results?
avatar

testpostWith the recent talk of p-values and their value in scientific journals it brings to light an important interpretive tool in efficacy of therapies, clinical experience.  P value is the chance of getting a positive response in a scientific study when there is no real effect after all, also known as a false positive.  The smaller this number, the better the certainty that what you are observing is truly an effect of what you are studying.  This number often is given as p .05 meaning that only 5% of the time would you see this happen by chance, the rest of the time it is a true effect of what you are studying.  Put another way, you can say that you are rejecting the “no effect” assumption, and come to the conclusion that drug A has effect B on the body and claim that your results are statistically significant.

This has been the backbone of science forever to determine if what you are seeing is not a fluke.  On closer examination though this value may not be as strong as we first thought.  Don’t get me wrong, it is an awesome way to reduce bias in a study and the best we have to weed this out as long as we don’t play around with this p value after our calculations are done.  What if we applied this 5% theory to a supplement that was being tested for a certain condition.  If we wanted to try 100 supplements for a given condition and only one of these supplements actually did something to improve the condition, we would find 5 supplements that appeared to help (false positives) and one extra that actually did, the one effective supplement in the bunch.  Of the six supplements you came away with thinking worked for the condition, really only one worked.  This means that out of those six conclusions that claim to help the problem, only 1 in truth really does.  You are incorrect 83% of the time in your determination of effective products even though you successfully eliminated 94 ineffective products!  Imagine, a randomized, placebo controlled trial with a p value of 0.05 with this kind of result.

Retractions of published papers also appear to be on the rise and after being involved myself this past year in a scientific study, there really is a lot of pressure felt by the authors to get published in a scientific journal.  It’s almost like a final approval by the cool kids in class and seems to psychologically give a stamp of approval on your work not only to the authors that did the study, but by the public and scientific community that will read or hear about the study.  If you aren’t published, there is almost a sense of failure felt towards the whole project, regardless of how astounding the results are.

This brings us to the world of the front line where these products are actually handed out to the public, the Pharmacy.  Many times I see products written on prescription that work exactly the way they are supposed to but sometimes they fail miserably.   Regardless of how many studies were done on a drug, if a patient paid $100 for it and it didn’t work, they really don’t care how many studies were done or what the p value was; they are out $100 and they now need to fork over more money for another product.  This doesn’t mean the studies that brought this to market were bad, it’s just that they were some of the outliers in the results that didn’t respond to the drug.

When you deal with supplements you often are labeled and dare I say it with  “alternative therapy”, you are always searching for these studies.  They are often small studies but you still look for them.  The same is true for pain compounding.  It is not difficult to be labeled a quack or a charlatan when you try to help someone that doesn’t seem to fit into the regular modern medicine model or wants to try another way first.   Nothing replaces clinical experience in determination of a product’s net worth and if studies are done correctly your results should mimic the studies you originally read.  Keep in mind that this may mean a 70% success rate as determined by the studies.   It is only when you see something work before your own eye(s) that makes you comfortable suggesting it more.  Those products that showed promise in studies and it doesn’t pan out with your patients, these products fall away rather quickly.  When you deal with people that are paying out of pocket for something, you know it is working when they come back for more to spend more money on.  I have had physicians steer away from a product because of one or two bad experiences with it with their own patients.  As always, patient safety is key with any product.  Will this therapy harm this patient based on their existing meds, allergies or medical condition?   Will it cause a dangerous delay in treatment with another more proven product?  These are important questions to as when a patient looks for an alternative medication.

Clinical experience with pain compounding creams has completely change the thinking of a lot of physicians I deal with at the pharmacy level.  Many of these doctors haven’t read even one of the studies I have on the response rate of this type of therapy but when they took a leap of faith with just one patient, then another and another, they realized the value of a therapy they were not taught in school.  When I get in my car and turn the key, a lot goes on to start the car and keep it running.  I haven’t read any studies on car engines but I do it because it seemed to work for others and it works for me for the most part as well.

False positives and subjective results can happen this way as well, but when a patient that was previously addicted to hydromorphone prefers a pain cream or an addition of omega-3 with their pain medication, it helps to alleviate thoughts that they are pretending the pain went away.   As one palliative care physician said to me, “If the placebo effect is 30% on drug X, I’ll take that kind of response rate”.  When there are doubts as to the effectiveness of a well-designed trial, clinical experience acts as an effective filter to refine one’s beliefs.

Posted in Nutritonal Supplements, Stone's Pharmasave | Tagged , , , , , , | Leave a comment