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Thank you Marijuana for taking the bad press off of bioidentical hormone therapy.
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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.

 

References:

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

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Essay on the life of J. Esmonde Cooke (1990)


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Copy of letter from the Canadian League Against Epilepsy

 

For Information Only, For Those on Frisium/clobazam.  Re: SHORTAGE SITUATION.  Letter posted online June 4, 2016

 

Canadian League Against Epilepsy I Ligue canadienne contre l’épilepsie

Clobazam Shortage?Suggestions for Management of Pediatric & Adult Patients with Epilepsy

June 4, 2016

There are shortages of clobazam, generic and brand name (Frisium). The situation has worsened during the past month reaching a crisis level.

Health Canada arranged a teleconference on June 3, 2016 to discuss the clobazam supply situation. Canadian League Against Epilepsy members participated in this meeting to convey the serious implications of a widespread clobazam shortage for patients with epilepsy.

Improvements in the clobazam supply are expected by late June to early July. Apotex Inc., the major supplier of clobazam in Canada, will be returning to regular supply levels. Several batches of Apo-Clobazam are expected to be released to wholesalers during the last two weeks of June.

Also, there should be additional Frisium (brand name clobazam) in the coming weeks from Lundbeck LLC.

There may continue to be some serious supply problems during the next three to four weeks. It is hoped that efforts will be made to identify sources of clobazam in the drug supply chain in order to protect patients.

Clobazam is a Level 1 Critical Drug for patients with epilepsy, according to the Canadian Pharmacists Association classification.

Prescribers asked to switch a patient from clobazam to an alternate drug, due to the shortage, should first request that the patient’s pharmacist double check all supply avenues to obtain either the same formulation or an interchangeable form (generic or brand) of clobazam. In addition to regular wholesalers, pharmacists can explore if supply is available from other wholesalers, other pharmacies or directly from one of the manufacturers.

All supply avenues should be exhausted before a patient who has been stabilized on clobazam is switched to an alternate drug. A decision must be made more quickly if the patient has minimal supply remaining to prevent interruption in therapy.

Clobazam is a 1,5-benzodiazepine with a long duration of action and has been marketed as an antiseizure drug in Canada for nearly 20 years. This medication is commonly used to treat epilepsy.

Interruption or sudden discontinuation of antiseizure drug therapy can cause a loss of seizure control, or worsening of a patient’s condition, with significant short- and long-term implications for patient safety, independence and quality of life. Breakthrough seizures can have potentially fatal consequences.ii

There are additional concerns related to this particular drug shortage. Sudden discontinuation of clobazam can cause benzodiazepine withdrawal syndrome.iii Abrupt discontinuation of clobazam may exacerbate seizures and cause other benzodiazepine withdrawal symptoms.iv Abrupt withdrawal of clobazam can also put patients at risk of life-threatening status epilepticus.v

Suggestions for Patient Management During the Clobazam Shortage

Patients who require de novo treatment?In patients who require de novo treatment with an antiseizure medication during the clobazam shortage, physicians should consider whether an alternative medication could be used at least initially.

Patients currently taking clobazam?If all supply avenues have been exhausted and there is no clobazam available, an alternate medication should be substituted until clobazam can be resupplied to the patient.

The following rationale for the selection of clonazepam as an alternative medication to clobazam during a drug shortage is from a document written by J.C. Martin del Campo, MD, FRCP and Jorge G. Burneo, MD, MSPH in 2013vi:

From the benzodiazepine group, only two other drugs have been found useful for the chronic management of seizure disorders: nitrazepam and clonazepam.

While there is no published evidence of efficacy under the circumstances, the most reasonable substitute for clobazam is clonazepam.

It is not known if this will be efficacious in all patients or if the recommended equivalent will result in a decompensation of the seizure disorder, but it is reasonable to surmise that it may prevent the development of a withdrawal state resulting in status epilepticus. Any given dosage will need to be carefully monitored by the prescribing physician and adjustments made where necessary.

While making these recommendations, it is hoped that the health authorities and pharmaceutical companies will protect the public by urgently implementing a strategic plan that will prevent such shortages from occurring. It is imperative to be reminded of the potentially fatal consequences of breakthrough seizures.vii

Reproduced with permission from del Campo and Burneo.

Recommendations for Therapeutic Substitution of Clonazepam for Clobazam

Clonazepam (brand name Rivotril) is a 1,4-benzodiazepine. This medication is available as an oral tablet in 0.25 mg, 0.5 mg, 1 mg and 2 mg formulations.

ClonazePAM and cloBAZam have similar lipophilicity and protein binding therefore likely very similar CNS penetration.

Clonazepam is more potent than clobazam. It is at least 10X more potent than clobazam if not ?20X, therefore, 1 mg of clonazePAM may be similar in potency to 10 mg of cloBAZam but could be as potent as 20 mg of cloBAZam.viii

Following conversion to clonazepam, some dose titration may be required to achieve the desired therapeutic effect. Clinical judgement is necessary to determine the optimum dose for each patient.

Patients should be carefully monitored for changes in seizure frequency, as well as the emergence of any adverse effects (excessive sedation, ataxia, increased difficulty handling secretions, worsening liver function) following the switch. ClonazePAM causes more sedation than equipotent doses of cloBAZam and tolerance may be more likely to develop to its antiseizure activity.

The excipients and non-medicinal ingredients between formulations may be different so caution should be exercised in patients with known hypersensitivity to excipient. These, along with any differences in adverse event profiles, can be verified in the appropriate Product Monographs and labels. The Product Monographs are available from the Health Canada Drug Product Database.ix

ADULTS? Initiate at 0.5 mg clonazePAM for every 10 mg clobazam (1:20)x; in 3-5 days, in the absence of adverse effects, increase to 1 mg clonazePAM for every 10 mg clobazam if required, to a maximum of 3 mg clonazepam/day.

Consider initiating clonazepam with a simultaneous gradual tapering of cloBAZam by 5-10 mg/week if supply allows.

PEDIATRICS?Initiate at 0.5 mg clonazePAM for every 10 mg clobazam (1:20); direct substitution can be made, tapering of clobazam is not mandatory. Dose titration, up or down, should be based on patient response.

Dose increases in pediatric patients, if required, are typically 0.25-0.5 mg/day every 5-7 days to a maximum of 0.1 mg/kg/day (or 0.2mg/kg/day for patients on enzyme-inducing drugs)xi

SENIORS, PATIENTS WITH LIVER DISEASE OR PATIENTS ON MEDICATIONS THAT INHIBIT P450-3A4 Initiate clonazepam at lower dosages in the elderly, in patients with liver disease, or in patients who are currently on medications which inhibit cytochrome P450-3A4.

 

Drug Metabolism and Pharmacokinetics

CloBAZam and clonazePAM are primarily metabolized by CYP 3A4. CloBAZam’s active metabolite, N- desmethylclobazam, is primarily metabolized by CYP 2C19. When substituting clonazePAM for cloBAZam, a thorough drug interaction assessment should be done taking these metabolic paths into consideration.

Information and Support for Practitioners and Patients

Should practitioners have reservations or concerns about the clinical management of their patients with epilepsy during this shortage, they should consult their nearest neurologist with epilepsy expertise or comprehensive epilepsy centre.

Patients and caregivers can contact their local Canadian Epilepsy Alliance agency for information and support by calling 1-866-EPILEPSY (1-866-374-5377).

i “Level 1 Critical Drug: Drug therapy for disease is essential and cannot be interrupted for even one dose or one day.” From: Canadian Pharmacists Association (2010), Drug Shortages: A Guide for Assessment and Patient Management www.pharmacists.ca/cpha-ca/assets/File/cpha-on-the-issues/DrugShortagesGuide.pdf?ii Steinhoff, B.J., et al. (2009) Substitution of anticonvulsant drugs. Ther Clin Risk Manag., 5, 449–457. www.ncbi.nlm.nih.gov/pmc/articles/PMC2701486/pdf/tcrm-5-449.pdf

iii Frisium Product Monograph (2015) iv ibid

vii Steinhoff, B.J., et al. (2009) Substitution of anticonvulsant drugs. Ther Clin Risk Manag., 5, 449–457.?viii Sankar, R. et al. (2014) Clinical considerations in transitioning patients with epilepsy from clonazepam to clobazam: a case series. J. Med. Case Rep., 8: 429. www.ncbi.nlm.nih.gov/pmc/articles/PMC4302143/pdf/13256_2014_Article_3028.pdf?ix Product monographs are available for download from the Health Canada Drug Product Database: www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php?x Benzodiazepine equivalence table http://www.benzo.org.uk/bzequiv.htm (accessed May 16, 2016)?xi Farrell, K. and Michoulas, A. (2008) Benzodiazepines. In J.M. Pellock et al. (Ed), Pediatric Epilepsy: Diagnosis and therapy, 3rd Edition. Demos Medical Publishing, New York, page 559.?xii Brodie, M.J., et al. (2016) Clobazam and clonazepam use in epilepsy: Results from a UK database incident user cohort study. Epilepsy Research 123, 68-74.?xiii ibid?xiv Comparison of benzodiazepines http://www.vhpharmsci.com/vhformulary/tools/benzodiazepines- comparison.htm (accessed May 18, 2016)

Drug Benzodiazepine Group Active Metabolite Half-life of parent (hrs) Half life of active metabolite (hrs)
cloBAZam 1,5-benzodiazepine N-desmethylclobazam 30xii 80xiii
clonazePAM 1,4-benzodiazepine   18-39xiv

v Engel, J. (2013). Seizures and Epilepsy, 2nd Edition. Oxford University Press, New York, page 557.?vi Del Campo, M. and Burneo, J. (2013). Therapeutic alternative to clobazam: Medical recommendation for adults with epilepsy. Retrieved from Epilepsy Ontario website: epilepsyontario.org/wp- content/uploads/2014/01/Clobazam_Therapeutic-alternative-for-adults_Jan2013.pdf

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Have we allowed Medical Insurance Plans to Have too Much Control of our Health?
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IMG_2313[2]   Who is it that really makes the final call on what your treatment is for any of your medical conditions? Most would say their doctor. As a pharmacist however I see something different. It is common to see a patient come to the dispensary counter after their physician has already phoned to see if a first choice drug is covered. Maybe I call the Doctor after I see the prescription and tell them the patient’s plan doesn’t pay for that choice. I see people go without therapy that used to be covered but isn’t anymore. OTC meds are often considered for the most part as “off the radar” for these plans, as if OTC means something useless or not Doctor or Pharmacist recommended. It is often frustrating for medical professionals to feel like their hands are tied and that they are being told what to write for. Newer and more expensive medications that may have obvious benefit over older drugs may be left out in the cold for lengthy waits until a plan decides to cover them. As well, unrealistic hoops may be required to be jumped through before an effective one is covered. It is not uncommon for refills to be made for an unused and ineffective drug that is not taken for weeks or months to show a plan that a drug is being “tried” in order to get the next one approved. Meanwhile the patient suffers needlessly until the more effective one is paid for by the plan.     Slow prior approval processes can become mired down in a way that has patients waiting needlessly for letters from physicians, OT’s, and other specialists.

Unbeknownst to the rest of the world is the strangle hold these plans have on pharmacies. While it is true that pharmacies fill more prescriptions when patients have third party plans, it becomes a profit based on volume that puts big chain pharmacies that avoid smaller communities at an advantage and smaller more community minded independents out. Gone are the days when pharmacies had some say in their dispensing fee, now a four letter word to the public but the main way dispensaries make money. Pharmacies used to be and should be able to run based on their pharmacy sales but not so much any more. dispensing fees don’t cover the cost of filling a prescription for most pharmacies.  For the first time we are now seeing a decrease in dispensing fees. It has become a take it or leave it contract.

Small communities that have relied on the donations of these strong businesses have seen this drop off or eliminate altogether, reducing spinoff benefits. Keep in mind that small independent pharmacies have a more timely and positive response to the types of charity requests seen daily. Preferred provider contracts give lower prescription prices at specific chains, something that used to be illegal. The drop in pharmacy revenue causes front store prices to climb and customers find themselves paying for services that they assumed should be for free, like tax receipts, refill extensions, med reviews, calling the doctor and consultations – things that we are accustomed to getting gratis.

So, physicians are somewhat dictated to, pharmacies are told their price for what they are selling and who is it that controls your health? Of course there are benefits. Most wouldn’t afford the healthcare they have without their plan and that plan is a business that deserves to have some control over its own costs. It should not be a dictatorship that slowly undermines our entire healthcare model.

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The Value of a Local Independent Pharmacy
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The Value of a local Independent Pharmacy

It’s difficult to find anything for free these days.   I see bills for such things as faxing to a local number, photocopying, corking fee to open wine bottles at a function, cutting up a cake, supplying year end receipts, filling out health insurance forms, consultations, supplying information, It is also difficult to have a donation request responded to without a waiting period for most people.

So what does a pharmacy do differently? (especially a small town or independent pharmacy). Well we give volumes of donations to local causes after weekly and sometimes daily requests. Quite often we give you your year end tax receipts free, call your doctor for free, fax your form to your drug plan (after we have filled it out for you), talk to you on the phone for 10-15 minutes at a time or sit down for even longer about your health concerns for free.   In my area I am the only pharmacy and often a temporary charge medications if a patient doesn’t have the money, I do public speaking for free for anyone who asks. I do glucose and cholesterol tests for free, make deliveries daily to our nursing home and supply free INR tests to their residents as needed, and OTC counselling off and on all day long. Most people assume many of these things are done readily for free by their local pharmacy. Other services eek their way out as well, like a 45 minute grocery store tour to help people eat better http://www.stonespharmasave.com

While it is true that pharmacies charge a dispensing fee for filling a prescription, it is that one fee that fuels most of these other daily contributions and tasks.   Keep in mind that some pharmacies charge for some of these services and some do not. As well, lots of businesses do stuff for free. Should I be charging for all of these services? Some would say yes. The local independent pharmacy that sticks out its neck and serves the small community that bigger name pharmacies don’t go is invaluable to the community in more ways than just a place to fill prescriptions.

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Looking for the rabbit in the field: my study disproves your study.

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When I am asked to “prove” something by showing a study, it reminds me of how backwards we can be when it comes to stacking studies against each other to make a point.  We come up with rebuttals like, “the patient size was too small”,  “the study is too old” and “the study wasn’t double blinded”.  In fact, virtually every study that has ever been done can be debated for some reason or other.  As well, it is safe to say that not much has ever been proven of any value or consequence by just one study alone.

Let’s say that a colleague and myself have a disagreement on whether or not chromium has the ability to prevent hypoglycemia.  This can start out with a quick exchange of some handpicked positive and negative outcome studies that may be well designed or not or maybe had the power to determine the outcome or not.  Maybe a study hid some of the data or the statistical analysis was done improperly.  Maybe my colleague had 10 times as many studies compared to mine.  Is that what decides the outcome of all of these scientific studies?  That one person can scrounge up more studies than someone else?  How does that person explain a well-designed study that doesn’t back up his or her argument?  Do they quietly pass off the study as a fluke or placebo effect or do they start to see what scientific study is for us – many studies that create a whole picture much like individual pieces of a puzzle make a picture.

Let’s say we have a puzzle.  It is a puzzle of a field of green grass on a sunny day with blue sky and some white clouds.  It turns out that this picture is a picture of a rabbit sitting in the field, only a very small part of the picture, less than one percent is taken up with the rabbit.  This translates into just 2 pieces of the 500 piece puzzle.  Let’s say my colleague and I divide the puzzle in two and each take half of the puzzle home with us.  We separately lay out the pieces and get a vague idea about what the picture shows.  It turns out I have both pieces that make up the rabbit, statistically not what we would expect but it happened.  I call my colleague and tell him about the picture we are looking at and how it appears to be one with a rabbit in the field.  He says, “that’s crazy, there’s no rabbit in this picture”.  He said he’s looked at all of his pieces and no evidence of any rabbit.

So who is correct?  Well based on what is in front of each of us, we are both correct.  When we both meet to put the puzzle together on one table, the entire picture becomes clear.  The puzzle changes from a field on a sunny day to a rabbit on a sunny day.  Each piece of the puzzle is a scientific study.

This exercise shows us what the power of a study means, or an analysis of many studies can show.  For an infrequent result, the amount of pieces that are required to find the rabbit are large.  My colleague arrived at what would be called a negative result and mine was a positive result.  In a book called Statistics Done Wrong, (Alex Reinhart) it is described that in a review of studies between 1975 and 1990 in prestigious medical journals, almost a third of these studies yielded negative results.  A full 64% of these studies didn’t have the power to determine a 50% difference in the primary outcome they were looking for between treatment groups.  When a 25% difference was present, a full 84% of studies didn’t have the power to find this.

As always, I believe that scientific studies are the best thing we have to unlock what we do not know.   One study however, can be deceiving when taken as a single data point on a graph.  Scientific studies are a group effort.

 

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What’s the real reason for not counselling and missing interactions?

Lately we have heard stories of Pharmacists not doing their job correctly.  To be exact, in a survey of a sample of pharmacies, it was discovered that medications that are kept in the pharmacy but did not need a prescription, there was insufficient or completely absent counselling on behalf of the pharmacist.  These medications are in a special class in that they can only be sold in a pharmacy, behind the counter of the dispensary, and the customer must ask for the medication in order to be screened for interactions with existing medications and medical conditions, as well as proper use of the medication so that it is safely used and gives the best results.

Although there were arguments that the sample size used in this observation was too small to make an overall conclusion, just 50 pharmacies, and that the study was not scientific, showing even one pharmacy not counselling this type of medication is not good.  As pharmacists we don’t shoot for a certain percentage of jobs done correctly across the country in the run of a day.  We more importantly look at any incidence of improper counselling and try to better ourselves by looking at why we didn’t do our job correctly.  Undoubtedly spurred on by a few recent reports of dispensing errors across the country, this survey began in BC and spread across the country based on the results in that one province.  Trust me, when a pharmacist makes a mistake, it hits them like a ton of bricks, regardless of the outcome.

This nationally broadcast report was fuelled by a week long buildup that caught the eyes of pharmacists and general public alike.  Word began to spread in the New Year about the story and certainly when it finally came to air, there was a huge reaction from those who watched it.  Many pharmacists chimed in.  Initially claiming unfair reporting in that it made pharmacists look completely inept.  Others claimed that the story completely avoided the good that pharmacists do that is totally ignored for the most part.  This was followed by examples of what we do as pharmacists every day.  The reporter afterwards quickly claimed that the show was more about quotas imposed on pharmacists to increase script count than exposing pharmacists not doing their job correctly.  It was certainly a perception of mine leading up to the program and certainly after watching the program that the latter was the case.

As someone that works for an independent in a small community, the concept of pressure imposed by quotas for increased prescription count is definitely foreign to me and one I must admit I had never heard of before.  Pharmacists interviewed for the program claimed that this pressure to increase script count was responsible for other parts of their job slipping, including counselling these behind the counter medications and focussing properly on the filling and checking process.  Let’s suppose this were true, and maybe it is.  Then obviously it is something eroding pharmacy that needs to be addressed.  These pharmacists interviewed pointed to the problem of non pharmacists  now able to own pharmacies – something new over the last couple of decades.  The profession of pharmacy is certainly not against change, but the change we have seen over the last 20 years has absolutely lead to great things, but in some cases has also lead to the erosion of the profession.

Before I graduated from the College of Pharmacy in 1993, things were strict.  You kept things professional by not being able to advertise “free prescription delivery”, you couldn’t connect any incentive to a prescription like “points” for your prescription purchase or bonuses for transferring your prescription file to a pharmacy, you couldn’t say “accurate prescription filling” because it was unprofessional and implied someone else had inaccurate prescription filling, among other strict rules.  Gradually, we saw big box stores start to include incentives to their employees when they had their prescription filled at their banner, then drug plans that are affiliated with the pharmacy with restrictions that you are covered when you get your prescription filled only at that pharmacy chain and no other.  While on the subject of third party plans, in my opinion the most dramatic effect overall in the pharmacy business today, we have seen a very gradual undermining of the pharmacy business because dispensing fees and reimbursement to pharmacy from the third party plan has not grown with what is reality in dispensing.  Dispensing has become a volume business in order to show a real profit.  In fact we are starting to see decreases in dispensing fees from third party plans.  In a lot of ways I feel these plans are a part owner in my business.

A sweeping move initiated by provincial governments across the country was a huge hit to the bottom line of pharmacies, like Nova Scotia’s Fair Drug Price Act.  A move that seemingly made sense to the general population in that it aimed at lowering prescription prices by coming up with an imaginary dollar value for various popular generic medications, regardless of what the pharmacy paid for it.  This move came about from the practice of generic companies giving rebates for purchases, a common practice in many types of business.  The government saw this as their money.  These were the main dollars we used to run the programs of our pharmacy and the dollars we used for donations and community programs that came to us for help.  Very quickly this money was gone.  In effect, this attempt by the government to lower prescription drug prices was accomplished on the backs of the pharmacies in the provinces.  Our communities are now realizing the effect of lack of income in their community pharmacies.  Before too long, we saw other third party plans jump on this bandwagon, and gone were more dollars we used to run health programs we conceived on our own for the health our community.

Enter the expanded scope of practice.  We as pharmacists were allowed now to write prescriptions in certain cases of minor ailments, extend existing prescriptions, do med reviews, injections, adaptation of prescription, and order and interpret lab tests.  The reason was we can charge for these services to make up for what we were losing on the other end with rebates.  Definitely this is an honourable theory: make money for actually doing something that helps with the health of our patients.  The problem being that there was now no money to run these new services anymore and most plans weren’t on board with paying for them .

One might argue, “then why not just drop your affiliation with third party plans?”  Then we could set our own prices bases on our own pharmacy needs and staff levels .  Small town low volume stores could have better control over their income and not allow third party plans to control what they earn on a prescription.  Instead of getting paid 12 dollars for a prescription that costs 15 dollars to fill, you could charge what you paid for the drug and a fee that allows the dispensary to make money on its own regardless of the front shop.  Well we do this because it allows our patients to afford their medications and they probably fill more prescriptions for their health when they have coverage, not to mention that all pharmacies not dropping plans means patients shop for pharmacies that take these plans.

This brings us back to the original issue of why are we dropping essential counselling and why are we too busy to catch interactions?  Well perhaps the pressure we should be looking at isn’t the pressure to fill more prescriptions, it’s the pressure imposed by third party plans on the pharmacy whereby they don’t make enough on each prescription to pay for itself in the first place.  Maybe this is the reason for the “quota” being imposed on pharmacies to fill more.  The lack of reimbursement forces any pharmacy to scratch for more prescriptions since they cannot afford to hire the staff to run these extra programs and give time to the pharmacist to do their work of not only bettering health, but preventing harm from meds.

To top off the issue of missed interactions because of lack of time, consider the thought process involved with each and every prescription when the possibility of the patient dying from the medication exists each time a prescription is filled.  The side effect of any  medication is death and there are so many side effects and potential warnings on any given medication it would take an hour to explain them all to each patient.  On top of that, the sheer volume of prescription interactions with other meds or disease states makes the evaluation of these interactions an art that is not just based on book smarts, but also on clinical experience.  If there is a 0.00001 chance of a dangerous interaction occurring do you call the doctor, alert the patient and change the drug?  Is the evaluation of these interactions a black and white science or is it based on followup with the patient on their overall health and history.  Recently I wrote a blog on a type of interaction called prolonged QT interval ( http://stonespharmasave.com/blog/?p=694 ) that describes the complex evaluation involved with just one interaction.  There are thousands of such interactions to evaluate for each fill and you reset your brain when you fill the next prescription.  If I give you a prescription there is a very slight chance you might leave the pharmacy, take the medication, have an adverse reaction or interaction with another medication and die.  Perhaps I will be on the evening news for not telling the patient this.  Do I tell you this?  Not necessarily.  But if I evaluate the probability of this reaction occurring then I am in a better position to act on it.  When we take off in an airplane do we sign off on the fact that it might crash?  There is inherent risk in taking any medication.  It’s our job to make sure you have the best possible medication and outcome from that medication.

Getting back to the lack of counselling in these behind the counter medications – guilty.  We accept that.  The more pharmacy and pharmacies are left to be run by corporations (big box stores and third party plans) and not pharmacists, the more and more this profession will erode and show up on more undercover specials.

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Long QT Syndrome
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Without a doubt one of the more prominent medical issues to watch for not only with individual drug administration, but with drug interactions as well is the problem with Long QT Syndrome.  It appears that over the last 20 years this crops up more and more.  The issue with this syndrome is that most people don’t know if they have this medical problem or not.  Although some people have had themselves hooked up to an EKG at some point in their life for an unrelated issue and this problem would have been caught, most haven’t and when this drug/disease or drug/drug interaction pops up, we are left wondering how to deal with the problem.

In measuring the electrical activity of a heartbeat, a typical sinus rhythm should show up.  There are distinct landmarks on the graph: P,Q,R,S,and T.

The interval between Q and T is the time it takes for the electrical impulse to flow through the lower chambers of the heart until the heart is ready for its next beat.  If this interval is longer than normal, it is called Long QT syndrome.

One of the frustrating things is that this syndrome is that it may not be present all of the time.  It may only be present during times of stress, exercise, cold water on the face such as when swimming, auditory stimuli, when you are startled, it may be during the night when sleeping, or it may be caused by certain medications.  This syndrome may be inherited or acquired.  Theses patients often have no symptoms.  They may have a history of fainting, seizures, or an abnormal heart rate at times.  The danger is that the syndrome can lead to cardiac arrest or sudden death.

Not everyone metabolizes or handles drugs the same way.  In some of our testing procedures we find that some of us metabolize some medications very fast or very slow. Some take a medication for sleep that gets metabolized so fast it can never work to put them to sleep.  Others metabolized so slowly that they are completely hungover in the morning from one pill at bedtime.  This shows that we are all different when it comes to our response to medications and how some people will experience long QT from one drug and some don’t or that a long QT side effect occurs from a drug/drug interaction in one person and not another.

These individuals should also avoid the following agents:

  • Anesthetics or asthma medication (eg, epinephrine, lidocaine)
  • Antihistamines (eg, diphenhydramine)
  • Antibiotics (eg, macrolides (azithromycin(4)), quinolones, trimethoprim and sulfamethoxazole, pentamidine)
  • Antidepressants (tricyclic, citalopram, trazodone, venlafaxine)
  • Cardiac medications (eg, quinidine, procainamide, disopyramide, sotalol)
  • Decongestants
  • Gastrointestinal medications (eg, domeperidone (1), metoclopramide(3))
  • Antifungal medications (eg, ketoconazole, fluconazole, itraconazole)
  • Psychotropic medications (eg, tricyclic antidepressants, phenothiazine derivatives, butyrophenones)
  • Potassium-loss medications (eg, indapamide, other diuretics; medications for vomiting/diarrhea)

Risk factors for drug induced LQT syndrome and TdP include: female gender, concomitant cardiovascular disease, substance abuse, drug interactions, bradychardia, electrolyte disorders, anorexia nervosa, and congenital Long QT syndrome, elderly population, history of fainting or seizures. Careful selection of the medication and identification of patient’s risk factors for QTc prolongation is applicable in current clinical practice.(2)  At www.crediblemeds.org there is an invaluable source that is updated regularly to help the clinician evaluate the dispensing of an offending drug so that you and the physician aren’t left guessing on the potential seriousness of the interaction.  Registration is free but it is a great resource to have in your back pocket.

This is certainly an important interaction to be able to evaluate and share with the physician.  Being able to make recommendations makes you a valuable member of the healthcare team

1. http://www.ncbi.nlm.nih.gov/pubmed/20394569

2. http://www.ncbi.nlm.nih.gov/pubmed/20210726

3. http://www.pharmacologyweekly.com/articles/how-does-metoclopramide-increase-the-risk-of-qt-interval-prolongation-and-polymorphic-ventricular-tachycardia

4. http://www.ncbi.nlm.nih.gov/pubmed/24285766

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Maybe it’s not your testosterone or your adrenals or your thyroid, maybe it’s your growth hormone
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So many complaints can overlap many different causes when it comes to hormones.  What about these symptoms?

thinning muscles, impaired social status, exhaustion and long recovery times, erectile dysfunction, low self esteem and self confidence…well that sounds like low testosterone.

chronic anxiety, depression, poor sleep, weight gain…wait, that could be adrenals.

light sleep…maybe melatonin?

intolerance to cold, more fatigue ?…thyroid

In fact, all of these issues may be a sign of low growth hormone (GH).  And GH can effect levels of other hormones and vice versa.  What can you do to increase this (remember as always testing of the deficiency is key)?  Initial treatments plan involves the most common recommendations for good health, adequate sleep, maintain ideal weight, eat organic, avoid alcohol and caffeine, avoid sugar, and all excess and refined carbs, avoid stress, get sufficient amino-acids (protein)and eat paleo.  Feeling better already?  Why not add  Niacin, argentine, glutamine.  As well, maintaining adequate levels of testosterone, estrogens, progesterone, thyroid hormone, melatonin and adequate insulin secretion all help with GH levels.  You’ll have to check back on previous blogs on how to do this, but it’s not all about actual hormone replacement therapy necessarily.

Just a glimpse into how intertwined your hormone levels are, and sometimes the levels of the hormones can be deceiving because you may actually be part of the population that gets more hormones into your cells where they actually work, or maybe your sex hormone binding globulin is off, the protein that binds with hormones and carries them around until they separate and then the hormone gets to work. This is why symptoms are so important to determine an action plan for dealing with hormones.

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What Is Melatonin And What Can It Do For Me?

So you have had trouble sleeping and you have gone to the pharmacist and they recommended something called melatonin.

photo credit: hang_in_there via photopin cc

photo credit: hang_in_there via photopin cc

 

You’ve heard of it before and are told it is relatively safe to use, but what exactly is this hormone used for in the body and how do you know if you are low in the production of it?

Symptoms can have many reasons, especially with hormone levels, but some of the symptoms of melatonin deficiency are: Continue reading

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