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Monthly Archives: June 2017
I have seen many changes happen to pharmacy in the last 24 years. One of the most career-shifting has been the change in the reimbursement model that has forced pharmacy to revisit how it makes money to remain afloat while continuing the important work of patient care. The traditional work I am referring to is not something that carries the business for most independent pharmacies.
Even before this adjustment to our financial model, we were criticized for not charging for other everyday services. Now, not only are many of us leaving money on the table for uncharged services that would easily have been charged by other professions and accepted by the public, but we are charging for dispensary services in unsustainable ways that fail to reimburse the business. Specialty services like methadone, travel clinics, injections, med reviews, compounding, nursing home filling, and others have helped relieve some of the financial strain on some pharmacy businesses. Some day soon I am sure medical marijuana will be one of those services.
Take two of these programs: methadone and medical marijuana. One currently runs in many Canadian pharmacies and one is on the horizon. Both of these have and will continue to gain popularity for the pain patient that has been prescribed opioids. In the case of methadone, it becomes a specialty rescue plan to give the patient back at least a small part of normalcy, even if there is no projected hard endpoint in sight. It can allow patients to stay off of street drugs and steer away from opioid addiction, and in addition keep their family, hold a job (at least one that allows them to go for a witnessed ingestion daily), keep some financial stability and make plans for the future. While this system has its share of abusers, the theory is sound.
In the case of medical marijuana, we try to remove opioids in a less proven method perhaps, and use a CBD/TCH combination to deal with pain in a way that has shown to work, even though we still have much to learn about long-term effects. Compounding can be included here as well, as studies have demonstrated and I have personally seen a regular pattern of reduced oral medications for pain when topical compounded products are introduced.
These demonstrate a practise we have shown in modern medicine for “a pill for every ill.” This is your symptom so this is your medication. In our defense we do try to project wellness campaigns into our profession surrounding eating right and physical activity—both with huge potential benefits. We actively run screening programs for cholesterol and blood glucose—again, often in free clinic formats without much evidence to back up clinical outcomes, such as death rate or disease prevention. This is all in the hope of reminding people to think about their health.
We have all pursued prevention programs in our pharmacies in one way or another. I removed sugary beverages a few years ago (a public health campaign that still resonates with my store today). I filmed a 40-minute healthy grocery shopping tour for YouTube for anyone to watch for free, and I have also done the blood pressure and glucose/cholesterol clinics in my store. In an era where evidence-based practitioners are claiming random screening in healthy populations proves questionable benefit, we push on despite costs to our businesses in both time and money.
What about the patient with either an acute need for a strong pain reliever or the one who is the long-term pain patient? You must be living under a rock if this hasn’t caused you to stop and think about where this patient will be in a few years (especially if they are not handled properly by both you and their doctor). Every time you fill a methadone prescription should make you think even harder. Why do we go through the trouble to screen for other diseases and prevent health complications while at the same time filling an opioid prescription while thinking “is this patient early for their refill?” Most of us have spent more time talking to a diabetic patients about their health than an oxycodone user about where their health is going. Is the potential impact of where that opioid patient could be headed any less drastic than the diabetic patient if not monitored properly? Even the patient on regular naproxen is probably not on our radar as someone who may get switched to an opioid and develop misuse issues down the road.
There are many responsible narcotic users out there who just don’t seem to be heading for any addiction or misuse problems. These patients are no less important when it comes to our vigilance though. We have tools available to us to help screen out those who are more likely to misuse. None of these tools are scientifically proven but they are based on our experience with various patient groups with opioids.
Realistically, any pain patient requires more time than the average patient even from day one. As specialized as methadone is today, it has become a regular fill commodity where a hundred or more patients come in for a witnessed ingestion and leave. With these numbers, there isn’t much time for a ”sit down” with each and every one. In stores with a more realistic number of patients, such as 10-20, it is conceivable that pharmacy staff is able to discuss how therapy is going each time, if they are showing subtle signs of drug use. A more one-on-one environment that isn’t rushed might bring out other signs of sub par therapy, drug diversion and other misuse.
If third-party payers reimbursed for such a specialized service, it would improve health outcomes in the long run. Each patient should be interviewed with each renewal of their opioid and as an initial consultation. Pharmacists are in the best place to detect misuse. A patient that is yawning or restless in front of you, or perhaps agitated during the med review, may be showing signs of withdrawal from an opioid and could be a patient who is taking other sources of opiates along with their prescription. Urine drug testing should be discussed as a possibility early on with treatment as well so that it doesn’t offend patients later on when they are suspected of misuse.
It is estimated that 22% of patients will discontinue opioid therapy due to side effects. This may involve dose-limiting side effects that would require a dose reduction or even a discontinuation of the medication. This may include sedation, which should be assessed with high opioid doses (especially more than 200mg oral morphing equivalents) and with each dose increase. Although this will often resolve itself with tolerance, if suspected it should be monitored closely. Asking a patient to return to the pharmacy within a few hours after a dose may help.
Cognitive dysfunction follows the same warnings of dose increase and high dose as with sedation but can be trickier to pick out unless you take time to speak to the patient for a few minutes. It involves cloudy thinking, poor memory and diminished concentration. As with sedation, reducing the dose, discontinuing the drug or opioid rotation can help. Opioid-induced hyperalgesia is a side effect where this specialty service proves its worth. Again it tends to occur at higher doses and is a phenomenon where the pain threshold seems to drop, giving an increased sensitivity to pain as the opioid dose increases. Instead of a knee jerk increase in opioid dose, the dose should actually be tapered or a COX-2 inhibitor can be given concurrently. It has also been recommended that an NMDA receptor antagonist like Ketamine be tried. Quite often this molecule is used in our pain compounding.
A potentially serious side effect that can occur with opioids is sleep apnea, possibly due to the effect on sleep architecture. This may affect up to 30% of all patients on chronic opioid therapy and can significantly exacerbate a pre-existing sleep apnea condition. This is why it can be helpful for the partner of the patient to come with them to the interview with each fill. Extra information may be gleaned from this type of environment. Respiratory depression is a commonly known side effect of opioid use, however tolerance develops rather quickly and is often a problem only with patients with pulmonary disease like COPD or asthma. It can result in limiting the dose in these patients especially at higher doses.
Constipation, nausea, vomiting, dry mouth, pruritis, urinary retention, myoclonus, hormonal effects, immune suppression, and weight gain/sugar craving are all important side effects that should be addressed and monitored. It is difficult to do all of this with a typical prescription handout at the counter. Of course, the most important effect to monitor is addiction. Although the risk of this is low, it is still a real possibility and constant vigilant monitoring is important to cover your bases.
Tapering doses has become popular with recent warnings to keep patients below 90 oral morphine equivalents. The 2017 Canadian Guideline for Opioids for Chronic Non-Cancer Pain strongly recommends a coordinated multidisciplinary collaboration approach that involves several health professionals that are readily accessible to the physician. The Nova Scotia College of Pharmacists’ registrar Bev Zwicker released a communication to its members on June 26 explaining that the College of Physicians and Surgeons of Nova Scotia warning that the tapering of opioids needs to be done sensitively, collaboratively and with realistic expectations. It also confirmed that rapid withdrawal could be dangerous if done too quickly and that these high- -dose patients cannot be abandoned. These guidelines need to be reviewed by all involved especially pharmacists. Tapering should be considered if there are dose-limiting side effects that are intolerable, if the opioid trial is failed, if the pain has resolved itself, or if there is evidence of addiction or diversion. Most of these tapers are voluntary but the decision may be made by the physician unilaterally. Assessing the patient during the taper requires close monitoring for withdrawal symptoms.
This year, The Journal of the American Pharmacist Association published a paper where a pharmacist-led opioid exit plan for acute postoperative pain management can have benefits when involved at the point of admission, during the post operative recovery period and on discharge. A 2013 BMJ Open paper outlined an RCT where regular GP care was compared to pharmacist-led management of chronic pain and demonstrated improved pain outcomes with the pharmacist-led management.
A 2014 study involving a pharmacist-initiated intervention trial in osteoarthritis showed that patients experience quantifiable benefits from interprofessional collaboration among pharmacists, physicians and physiotherapists. We have also seen pharmacists’ involvement in the co-management of acute pain and substance use disorder improves patient safety and pain control.
Creating your own niche market where you are the go to pharmacy for beneficial outcomes in acute and chronic pain patients becomes key where you are trying to prevent opioid misuse and abuse. It starts with one on one time with the pharmacist and patient each time they come into your pharmacy. It can make your pharmacy the safe place for patients, from their initial prescription for pain to managing a chronic condition while avoiding addiction. Hopefully a patient or their third-party plan would pay for that service.
Ware et al CMAJ 2010; 182(4)
AMN The Prescribing Course—Safe Opioid Prescribing for Chronic Non-Cancer Pain 1st Ed Oct 2014 MacDougall/Fraser
Bruhn H, Bond CM, Elliott AM, et al. Pharmacist-led management of chronic pain in primary care; results from a randomized controlled exploratory trial. BMJ Open 2013;3:e002361
Marra, CA et al Cost-Utility Analysis of a Multidisciplinary Strategy to Manage Osteoarthritis of the Knee: Economic Evaluation of a Cluster Randomized Controlled Trial Study. Arthrit Care Res. 2014 June; 66 (6): 810-816
Andrews LB, et al, Implementation of a pharmacist-driven pain management consultation service for hospitalized adults with a history of substance abuse. Int J Clin Pract. 2013 Dec; 67 (12): 1342-9.
June 17, 2017 : looking back hardly a day or two goes by since this year began when a question about medical marijuana or as we call it out here “marijuana” and what is going to happen next July when it becomes real is asked. Last month I was asked by a group of Nurse Practitioners to present on a topic I rarely speak about but fill prescriptions for often – BioIdentical Hormone Replacement Therapy. I like to use the term supplement instead of replacement but it really made me think about the tough upward climb this category has had and continues to have based on a few position statements from such groups as SOGC and NAMS.
Looking at the marijuana issue, never before have we seen a couple of ingredients leap onto the potential healthcare market with the claim to relieve or cure so many, many health issues. Never before have so many N of 1, anecdotal reports driven an entire category of mostly unproven therapies. Granted there are some valuable uses of the drug that have been used for years but many have been very overblown with the main selling point of “no one has died”.
Turning to my upcoming presentation, I started mulling over the studies that have shown for years the benefits and limitations of all types of hormone therapy that I have collected and still continue to collect on the topic. Speaking to the public on a subject is different than talking to medical professionals. I speak to both groups all the time on all topics. To narrow down an hour worth of meaningful, compelling, convincing data that flows easily on a medical treatment that is foreign to a professional group so that you don’t lose them is daunting.
If I present on a topic I have a clear conflict of interest with such as this, I always open with that and some literature from the other side of the argument. There is no problem here with BHRT as lots of naysayers exist. In truth, I have found there are as many cases of overblown promises with BHRT and there are complete opposite downplay of any proven benefits and exaggeration of adverse effects. A segment from Climacteric from just this year was the best I could find that slammed this type of therapy over a dozen sentences. We now see less of an issue with the term BioIdentical, since estrogen and progesterone are both found in the commercial prescription drug industry in Canada more and more in a bioidentical form, especially since the Women’s Health Initiative Study over a decade ago that effectively stopped conjugated equine estrogen and medroxyprogesterone acetate from being dispensed overnight. So at least Big Pharma has caught up with compounding in some ways.
I continue in my talk to disprove the issues just laid out from the climacteric slide: that hormones do pass predictably through human skin and give resultant increases in the body (given the correct fluid is tested), that the stability of the hormone in the right base is predictable, that saliva testing is legitimate and useful in showing levels of active hormones (especially for topically applied hormones), and that all hormone therapies have benefits and risks associated with them, regardless of what hormone therapy that entails.
Given the criticisms the WHI received, one thing we did find from the CEE/MPA regimen was the decrease in fracture risk. With the older average age of the subjects in that study and the lack of topical hormone or actual BHRT used, there is very little to pull from that study for this talk. There are however many studies that can and do show the benefit of BHRT. Most of these are smaller studies than we are used to in the prescription world. One point to take away though is we have seen a top seller in our prescription market fall away to nothing and the public is looking at us and asking how could we be so wrong all these years about something that was so blatantly clear in a study that it cut the study short? Evidence slowly grows on bioidentical hormones but is showing even to our commercial drug industry that it is a safe benefit.
The International Journal of Pharmaceutical Compounding published a three part study on the topic of BHRT. In this small study, surveys were given to women on HRT. The response rate was 70 on BHRT and 53 on synthetic hormone therapy. Each survey consisted of 15 questions that probed such topics as symptom relief, reasons for starting hormone therapy, side effects, age of starting therapy and type of therapy. In the areas of hot flashes, night sweats, sleep quality, dry skin/hair, vaginal dryness, foggy thinking, mood swings and decreased libido, bioidentical therapy outperformed synthetic therapy in all counts. In side effects from therapy, bioidentical was preferred over synthetic for side effects like difficulty sleeping, weight gain, breast tenderness, bloating, upset stomach, breakthrough bleeding, foggy thinking, mood swings and leg pain. Drowsiness occurred more frequently with bioidentical than with synthetic.
A huge concern with bioidentical and compounded hormones is the threat of cancer in hormone therapy. In 2008 a study that looked at over 80,377 post menopausal women, 2354 of them developed invasive breast cancer. Compared to the women that never used HRT, estrogen alone therapy was associated with a 1.29 fold relative risk, 1.69 with estrogen/progestagen and a relative risk of 1 with the estrogen/progesterone women.
In other studies we have seen the benefits from BHRT in areas of insulin resistance, blood pressure, lipids, endothelial function, arteriosclerosis, thrombotic risk, and neuroprotection. More and more we are seeing studies unfolding showing not only is BHRT a healthy and safe option for women of all ages but is also brings quality of life to these patients that they have lost since the Women’s Health Initiative Study came out. Saliva testing for topicals is also shown to be useful as topically applied hormones aren’t reflected in blood draws like oral is. Oral hormone therapy has shown itself to be an unhealthy route for women and topical application has proven itself to be the preferred choice longterm.
So yes, thank you Marijuana, or more correctly CBD:THC. Your very sudden rush to the market has been touted for virtually every medical issue going right now. There are definite benefits in areas such as pain, perhaps PTSD (and a few others) but completely untested and unproven “benefits” in so many other areas. It has shown us that there are areas like BHRT that we’ve been told we had zero proof for but really do have volumes of proof when we compare it to the complete lack of proof in marijuana for many of the areas it is being used for.
Orozco ,P. et al. Salivary Testosterone is associated with higher lumbar bone mass in premenopausal healthy women with normal levels of serum testosterone. European Journal of Epidemiology 16:907-912,2000
Wright, JV. Bio-Identical Steroid Hormone Replacement. Selected Observations from 23 years of Clinical and Laboratory Practice. Ann.N.Y.Acad.Sci. 1057:506-524 (2005)
Hofling, M, MD et al. Testosterone inhibits estrogen/progestogen-induced breast cell proliferation in postmenopausal women. Menopause:The Journal of The North American Menopause Society. Vol 14, No.2, pp 183-190
Holtorf, MD. The Bioidentical Hormone Debate: Are Bioidentical Hormones (Estradiol,Estriol, and Progesterone) Safer or More Efficacious than Commonly Used Synthetic Versions in Hormone Replacement Therapy? Postgraduate Medicine, Volume 121, Issue 1, January 2009
Schwartz, E.T. MD. Hormones in Wellness and Disease Prevention: Common Practices, Current State of the Evidence, and Questions for the Future. Prim Care Clin Office Pract 35(2008) 669-705
Deleruyelle, LJ. Menopausal Symptom and Side Effects Experienced by Women Using Compounded Bioidentical Hormone Replacement Therapy and Synthetic Congugated Equine Estrogen and/or Progestin hormone Replacement Therapy: Part 3 . International Journal of Pharmaceutical Compounding Jan/Feb 2017 pp 6-16
Stephenson, K. MD FAAFP. Salivary Hormone Profile. International Journal of Pharmaceutical Compounding vol 8 no 6 November/December 2004
Wepler, ST. A Review of Bioidentical Hormone Replacement Therapy. International Journal of Pharmaceutical Compounding Vol.6 No.2, March/April 2002