Preventing Medication Errors and the ISMP

One evening in late October of this year I sat down with a rep from a compounding pharmacy supply company to discuss how our compounding business was going.

One of the first topics he brought up was a story of a young Mississauga boy, Andrew, who had died from an apparent mix-up with a compounded medication.

The boy died of an overdose of baclofen after taking a prescription that was alleged to contain tryptophan for sleep. It was the first I had heard of the tragic story.

It is a scenario that mimics the worst possible case in the back of our heads each time we as pharmacists go to work each day.

As fallible human beings I consider us the strongest and weakest link in the chain of what has largely become an automated day—automated with humans that are capable of a momentary lapse of attention that can kill someone.

It not only focuses directly on errors but on almost any conceivable reason for them occurring

Almost exactly a month later, I am reading in Halifax’s Chronicle Herald of Ontario’s Health Minister Eric Hoskins desire to tighten the safety of his province’s pharmacy dispensing in the wake of this tragedy.

As part of that process he’s looking at how Nova Scotia has dealt with this issue (thechronicleherald.ca/novascotia/1416107-nova-scotia-pharmacies-lead-in-safe-medicine-practices, namely through an initiative called SafetyNET-Rx. ( http://www.safetynetrx.ca)

This story, of course, grabbed my attention, not only because I am a community pharmacist, but also because I also compound and live and practice in Nova Scotia.

I am further pulled into this story because the SafetyNET-Rx initiative mentioned was started at a former alma mater (St. Francis Xavier University in Antigonish, Nova Scotia), in part by a former classmate of mine from Dalhousie University College of Pharmacy (now Dean Neil MacKinnon at U of Cincinnati Winkle College of Pharmacy).

As a practising Nova Scotia pharmacist, I am fully involved with SafetyNET-Rx. Our pharmacy in Baddeck was part of the pilot project in 2010.

The Nova Scotia College of Pharmacists’ Standards of Practice (www.nspharmacists.ca/?page=standardsofpractice ) now outline that every pharmacy in the province must have a Continuous Quality Improvement (CQI) plan in place.

This is a requirement in the Practice Regulations to the Pharmacy Act of Nova Scotia.  For the first time we now have a monitored, effective QCI process that tracks quality related events (QREs).  It is the SafetyNet-Rx model we use now.

So what does this involve in our day-to-day work in the pharmacy? Mainly, anytime there is a QRE, we note it in a scribbler to be entered later into an online recording system.

These errors encompass everything that can go wrong, such as a prescription handed out for the wrong drug or directions or doctor (even if it exactly follows the actual prescription but was an unintended change).

Most of the recorded errors include mistakes made before the prescription actually gets to the patient’s hands. Every time we enter the wrong doctor, drug, strength or directions, it gets marked down. In a busy day we do the best we can to record these events but in reality some do get fixed and aren’t recorded.

These events are formally recorded online on the Community Pharmacy Incident Reporting site—ISMP (Institute for Safe Medication Practices).

Each pharmacy has its own username and login and can search based on several metrics the types of errors that occur, the days of the week they occur the most, who detected the error, contributing factors, degree of harm from the incident and what the error was—both for your pharmacy and combined aggregate of all pharmacies on the system.

It’s quite interesting to see these comparisons. All of this data is invaluable in helping to prevent future errors. Quarterly staff meetings are required and helpful in sharing this information.

Through this reporting system, we are keenly aware now of the most common source for errors, who is most likely to catch the error, why the error occurred and even when it is most likely to occur.

This allows us to plan staffing and make corrections that we would have normally made after a mistake is made; except now we can do it before the incident occurs.

We can see how we compare with all other community pharmacies and if a discrepancy occurs we can immediately make changes.

Knowing the most common errors prompts one to be extra careful in that field. For example, if you know your store has an inordinately high number of errors that involve number of doses dispensed compared to the aggregate, it becomes a focus until it is normalized.

If we find that many errors occur with incorrectly written prescriptions at the physician level, we would have that conversation with the physicians.

Along with this reporting system, there are several other checks in place.  Many of these are done by any other pharmacy in the country.  Staff emergency contacts are recorded, as are the numbers for all services used by the store from police and fire down to insurance, electrician, plumber, computer data and storage in case they are needed by any staff member.

Regular audits are done that range from removing outdated stock, adverse drug reaction reporting, monthly narcotic drug inventory reconciliation, equipment and facilities certification, adherence to standards of practice are recorded and annual staff performances.

Confidentiality agreements are signed, pandemic planning is completed, robbery and break-in procedures are made and reviewed and emergency response plans of all types are done (staff and customer accidents, fire, leaks, toxic spills and power outages).

For our pharmacy in Baddeck there were a few changes we made as a direct response from all of this monitoring.  We determined the time of day and day(s) of week that we were most likely to see an error and we adjusted staffing levels to be heavier at those times.

We also determined a certain physician that had a higher probability of making an error when writing a continuation prescription for a drug that the patient was already on. This alerted us to pay extra attention to this occurring with this physician.

We also added another satellite computer in the pharmacy, not only as a reminder to document but to allow easier, daily documentation of events.  When it wasn’t possible to do this we jotted them down for later entry.

Another interesting thing that came out from this was through the stringent narcotic self audits.  We started noticing that a certain brand of medication was short one tablet in each bottle we were getting so these bottles were counted upon opening and the rep was alerted to the problem.

We also realized that the most common “near miss” incidents were incorrect quantity and incorrect dose. Special attention was brought to this during the quarterly meetings so extra attention on filling the script would prevent the problem again.

Future reports of quality assurance demonstrate the effect of these changes, new problem areas are found and new targets are made. Regular Medication Safety Self Assessments are done. This is a valuable tool that assesses the pharmacy’s overall ability to function safely based on many parameters and is done on a regular basis.

It is really an environment full of information that was floating there unharnessed before that monumentally helps to improve the safety of our patients when acted on.

If it seems like a lot of extra work in an environment that has very little down time, then you are correct.  Personally though, I have always found a huge sense of calm knowing something extra was done to double check that a patient got what they were supposed to get when they leave my pharmacy.

The time involved though blends in with our work and is worth it.  Time management is a skill that becomes greater as a result.

Getting back to the original patient we spoke of, Andrew, would this event had occurred if all of this were in place?  It is difficult to speculate as the cause is before the courts right now.

One thing though is for certain, making an error is an opportunity to explore why that error occurred and make corrections so it won’t happen again.

In the December 1989 issue of the CAPSIL (The Canadian Association of Pharmacy Students and Interns), I wrote one of my first public articles (without the internet) on the topic of Medication Errors (http://capsi.ca/wp-content/uploads/2015/01/CAPSIL-JACEIP-1989-Dec.pdf ).

It is a subject that will never completely go away. It is a disservice to our patients to not act on each error as a learning experience. SafetyNET-Rx is an invaluable tool that really turbo charges your incident prevention and kudos to the Nova Scotia College of Pharmacists for implementing this requirement into their standards.

It not only focuses directly on errors but on almost any conceivable reason for them occurring. Hats off to my friend and Colleague Dean Neil MacKinnon for his role in its development.  This standard is a huge leap forward that has caught the attention of the rest of the country.

I had the pleasure of corresponding with Andrew’s Mom earlier this year who contacted me ahead of a meeting with the Ontario College of Pharmacists Task Force where a proposal for medication error reporting was on the agenda. The College also contacted me ahead of this meeting to share ideas on the ISMP and my experience with it. Andrew’s Mom was glad to see movement on this system and its potential introduction in Ontario and thanked me for writing about this topic for the national audience of Canadian Pharmaicsts on the Canadian Healthcare Network. Hopefully some good comes out of this tragedy.

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


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Pharmacy Starts Healthy Cooking Class for Its Patients Families
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In 2015 I took four months to film a healthy grocery shopping tour with the help of a local filmmaker where I went through all areas of the grocery store to help people make healthy choices for themselves and their … Continue reading

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Why Your Pharmacy Should Stop Selling Sugary Beverages

Two of the most common questions I get about my discontinuing of selling sugary beverages in September of 2014 is A) Did I notice a drop in income because of the lost sales of this line and B) Did I notice an increase in sales because of this move.

Before I stopped selling this line I would see perhaps $1000 on a good month in sales of these products. I don’t have a number of the extra sales made when customers came in to buy pop, juice, vitamin water, chocolate milk, or iced tea. This might be picked up by measuring a drop in sales beyond the regular amount of these beverages sold. Since there really wasn’t a drop in sales though, it is difficult to tell if these ancillary sales dropped or not.

One thing is for sure, the unexpected volume of free advertising it gave the store more than made up for anything lost on pop or any other extra product not being purchased with it. It elevated the reputation of the store to a destination where customers knew we were willing to try something bold to further their health, even if it meant less revenue.

One great offshoot of this event was the introduction it brought us to a key Canadian researcher, Leia Minaker at the University of Waterloo’s Propel Centre for Population Health Impact. She took notice of the activity in Baddeck and started a natural study to determine the effect this had in the selling of pop in Baddeck after that day in September. She collected sales data not only from us but from the two other major sellers in the Village and determined that there was no switching behavior in purchasing to these other outlets. The study was published in BMC Public Health in 2016. (Minaker LM, Olstad DL, MacKenzie G, et al. An evaluation of the impact of a restrictive retail food environment intervention in a rural community pharmacy setting. BMC Public Health. 2016;16:586. doi:10.1186/s12889-016-3281-9).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947263/

Another great find for me was Dr Yoni Freedhoff, one of this country’s most prominent voices not only on unhealthy marketing practices to everyone (especially children) but also on the larger topic of obesity.

After two and a half years I look back on this move as the best one I could have done for my Pharmacy. When I think of the doubt I had in the months or weeks leading up to this I now realize the worry was for nothing. In this day and age, we try to rock the boat as little as possible in our pharmacy models for fear of going out of business. I can assure you if by some stretch your pharmacy would close based on the lost sales of sugary beverages, then maybe you should be in a convenience store type of setting instead. If you know for a fact that the small amount of profit made on this loss leader (if any at all) won’t affect your store adversely, and you realize the huge price tag that the consumption of these beverages costs your country long term, what is the holdback in removing them from your business?  After all, shouldn’t we be partly responsible for this cost to the healthcare system by continuing to sell liquid calories and in effect promoting them? When asked about other snack foods, which we have overhauled as well at Stone’s, my response is that this is my contribution to educating the public on one of the most common sources of extra calorie consumption starting with children and moving right on up to older adults. If you own a pharmacy, make a mark by taking your own stand on something that you know is causing harm to your patients. You’ll feel better for it and so will your business.

 

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Why the Pharmacy OTC Section Will Be a Growing Target for Evidence Based Medicine Trolls
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The front store of the pharmacy has traditionally been where the pharmacist and patient relationship grows to a level beyond where it would be with just prescription counseling alone. It affords to pharmacists a selection of products that empowers the … Continue reading

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Going forward with the opioid crisis as a health practitioner.

If you’re a prescriber or pharmacist, you owe it to yourself to check out the Atlantic Mentorship Network’s Prescribing Course – Safe Opioid Prescribing for Chronic Non-Cancer Pain. I had the pleasure of attending this course this weekend in Halifax, Nova Scotia. Although I had been trying to get to this amazing course for quite some time, my schedule finally permitted me to get there this year. In fact it was such an incredible learning experience I felt I should share it with you. As a disclaimer: I am a pharmacist, I have presented for the Mentorship program before, I have no financial interest in the program although I am involved with the planning of the program’s Fall Conference in Inverness Cape Breton this year. Other than that I’m just a fan of the Network.

Chaired by Dr. Peter MacDougall and Dr. John Fraser, this day-long event goes through pearls on what best practices are to deal with the average person with pain. This is not end of life pain or cancer pain, where boundaries are much wider. It is the tough world of dealing with pain at a time that threatens the potential of addiction more than we were aware of at any other time. It threatens safety of prescriber, patient, and the public. Even Dr. MacDougall claimed what many of us were told years back when dealing with narcotics: that we used to think that as long as there was still pain, the chance of addiction was extremely rare. The Nova Scotia College of Physicians and Surgeons are quite active now in reducing the narcotic load in our patients, as are the other provinces in Canada as the wave of overdoses washes eastward. They have adopted the CDC guidelines for treating this type of pain, which includes more of an emphasis on non-narcotic and non-drug.

As someone who feels the burn of the “online” world of alternative treatments and skeptics’ treatment of them, believe me it was refreshing to be in an entire room full of 40 legitimate practitioners embrace whatever works for their patients. I have commented on this phenomenon before and it was evident here again. Terms like physiotherapy, chiropractic, massage, TENS, acupuncture, qigong, yoga and other terms used side by side are embraced by physicians as treatments that have clinical results that they may or may not have success with. I have been working as a pharmacist for almost 24 years and the most important clinical pearls I picked up were:

-If someone claims to be travelling away and needs their Narcotics early ask them when, how are they getting there and where are they staying. This allows you to call contacts (landline) while the patient is sitting in front of you in the office and gives an opportunity to ask (demand) to see plane/bus/train tickets.

– There are many Addiction Risk Assessment tools that really don’t have any evidence to back them up but they can be clinically effective tools in seeing who might be at the highest risk for addiction in the future and who may require special attention going forward with their therapy.

– Although many patients in our patient records claim to be allergic to morphine, this “allergy” may actually be a normal pruritis side effect from the morphine and not an allergy at all.

-An increased request for more narcotic dosing may occur after a previous increase in dose for many reasons. It may be from hyperalgesia from the narcotic causing more pain. It may be from the increased activity that the pain relief allowed – which causes more pain. The concepts of pseudoaddiction, tolerance, pseudotolerance, opioid withdrawal, failed opioid trial and chemical coping are all important factors to consider.

-One way to realize if an aberrant behavior more serious or less serious is to ask yourself,   “I would never think to do that” or “I wouldn’t even know how to do that”. If the answer is “yes”, then it is most likely a more serious behavior.

– Safety of the prescriber is paramount

– UDT or Urine drug testing (preferably onsite) and a patient contract should be a standard practice for your opioid patients. It should be kept in mind that not only is UDT an important piece to the overall puzzle, its limitations should be kept in mind.

– “It is the information and not the story” that should be considered with abberant behavior. Why you ran out early is less important than the fact that you ran out early.

– Evidence on opioid rotation is primarily anecdotal but it can be an important method to reduce narcotic load after a failed opioid trial.

– As much as the goal of no narcotics beyond 3 months for this pain is ideal, we will always see these medications given. The goal of “no pain” is not a concept we entertain, and function should always come before pain relief. PRN doses of narcotics on top of long acting narcotics only focuses on the pain relief and not the function. Long acting narcotics are perfectly ok for initiation of narcotics rather than the tried and tested method of “start with short acting meds then convert to long acting”. Patients will not feel the same on these two types of meds and it might be counter productive to have the patient switch to long acting and not feel as well as the short acting med made them feel.

– Determining the goals of the patient and the expectations of treatment are important.

If you can’t make it to this annual event (now in its 18th presentation), you should get to a similar program in your area. This one gets definite kudos from me. Well done!

 

Graham MacKenzie Ph.C.

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How Open Minded Your Physician is May Determine Your Pain Relief

When I graduated from Pharmacy school in 1993, topically applied preparations for pain relief were limited to lidocaine and capsaicin, or so I was told up to that point. I was also taught that narcotics were safe not only for short term pain relief but also for long term pain that was non palliative and non cancer related and that addiction was rare in cases where total pain relief had not been reached yet. Medication is a constantly evolving and changing world. 23 years has passed and all of this has changed in a drastic manner.

It’s difficult to know exactly how it all started, but many in the medical community like to lay blame on the shoulders of a company called Purdue that had its beginnings in New York City as a relatively small pharmaceutical firm in the early 1950’s when it was purchased by two psychiatrist brothers, Mortimer and Raymond Sackler. The success of OxyContin from this company generated billions of dollars in revenue and made the Sacklers one of the wealthiest families in the country. Unfortunately, we began to see a trend happening where claims of this company and the aggressive and inappropriate marketing practices resulted in the alarming abuse and trafficking of this medication over decades of use. The company had to pay 635 million dollars after executives plead guilty.

You’d think that would have been the end of it. However the Mundipharma associated foreign corporations are agressively marketing this same medication worldwide with no plans to scale back. They also are running training programs to physicians in these countries urging them to overcome “opiophobia” and to just go ahead and write for these painkillers. They also have campaigns urging patients to take what their doctors prescribe to them.

The issue now is we have created an entire continent of addicts who would not normally have been there without these recommendations. For example, Jane Doe gets in a car accident. She has undeniable pain from this and it is not handled with NSAIDS. She is given a narcotic based on the recommendations from companies like Purdue who claim their studies show this is a safe medication to prescribe in this patient. In a little while Jane needs a higher dose of the medication and after not too long, despite her repeated denials, is addicted to painkillers. She then is unable to get a continuous supply of the drug from her doctor who now recognizes the problem. She starts to purchase the medication off the street. Her addiction becomes stronger as her supply and quality of the medication becomes more and more questionable. She then finds herself injecting to keep up with her addiction. In the last number of years, she has lost her job, her husband, her children, her home, car, money, friends, and everything she owns is in a small bag that she uses as a pillow because she lives on the streets with a sole purpose of seeking her next supply of fentanyl.

Is this scenario typical of everyone on narcotics? Of course not. If you walked down Vancouver’s downtown Eastside and asked random passersby what their story is, you might hear this one. Canada has recognized this in a west – east manner this year. Canada’s largest mental-health/addictions hospital, the Centre for Addiction and Mental Health in Toronto called on Ottawa in November to remove these high dose opioids from the market and to launch a review of prescription painkillers across Canada.

In fact, in the last 4 years, the number of opioid prescriptions dispensed per 1000 population has decreased in the United States whereas in Canada the number has more or less remained the same over that time frame. The provinces in Canada have been steadily spending more and more each year on opioid addiction. Not surprisingly, BC has lead this spending. PEI and NB are 2nd and 3rd behind them surprisingly. NS is near the bottom of the list. Towards the end of the year, Nova Scotia’s chief medical officer, Dr. Robert Strang, made a statement where he wanted the provinces’ physicians to ween patients back from current prescribed levels of narcotics exceeding the 90 mg per day of morphine and to keep to max of 50 mg if possible. He also wants long-term fentanyl patients backed off this drug in an effort to fit in with upcoming guidelines. The Nova Scotia College of Physicians and Surgeons is endorsing the CDC guidelines for prescribing opioids.

Lately in the news on the west coast we had a story in the news of 13 overdose deaths in one day making emergency kits a necessity. Nova Scotia Pharmacists are now able to dispense rescue kits of naloxone for overdose and these kits are becoming more available as the awareness of the antidote and education spreads.

The CDC promotes the prescreening of patients to avoid addiction. Overdose concerns are more prevalent with those over 65 years of age, history of overdose, substance abuse disorder (including alcohol), history of depression, renal or hepatic impairment and sleep-disordered breathing. Any patient may be considered at risk for overdose if they combine opioids with benzodiazepines, on a longterm formulation or especially just starting this medication, on an opioid for longer than 3 months, or on more than 100 morphine mg equivalents. Addiction is more prevalent with this level of morphine equivalents as well as being on the opioid longer than 3 months.

Nova Scotia’s Dr. Mary Lynch has gone on the record as not being in favour with these strict guidelines and claims that there are many of her patients where there simply is no alternative drug for them. Many physicians are unclear as to what they are supposed to use to control the pain of their patients.

Unfortunately later this year we heard of a list of Doctors flagged by Ontario’s Ministry of health because they were prescribing the equivalent opioid dose of 150 Tylenol 3’s daily for some patients. 86 physicians were the target of this probe.

The recommendations include such non pharmacologic modalities as cognitive-behavioral therapy, exercise therapy, complimentary medicine (like yoga, meditation and acupuncture). Nonopioid analgesics recommended include acetaminophen, NSAIDS, Cox-2 inhibitors, anticonvulsants like gabapentin or pregabalin, and antidepressants like tricyclics and serotonin and norepinephrine reuptake inhibitors. Other therapies involve epidural injection and biofeedback.

With such a sense of urgency and recommendations of treatments not normally seen by physicians in general medicine, one would expect that physicians would be open to topical pain relief. In speaking to physicians I have found a friendly acceptance but a definite hesitance in writing for these compounds. These compounds are new to them and contain such familiar oral ingredients as ketamine, ketoprofen, clonidine, gabapentin, and lidocaine. They may also use lorazepam, carbamazepine, baclofen, cyclobenzaprine, dextromethorphan, and others. A recent article written by myself and a local palliative care doctor covers these ingredients.  Check it out here.

This is a tremendous opportunity to reduce opioid use and improve pain relief. As I have seen from physicians that have tried this and seen it working in their patients, confidence comes with numbers and experience. The lack of side effects, interactions and lowered dose is something they like. Contact a compounding pharmacy and ask them more.

 

Graham MacKenzie

Owner/Compounding Pharmacist

Stone’s Pharmasave

Baddeck, N.S.

www.stonesphamasave.com

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Does Barbequing Really Cause Cancer or Just a Perforated Bowel?
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barbequeThe world has a tremendous love of grilling. Most would think of it as a North American tradition, but in reality, there are many countries around the world that commonly utilize this unique form of food preparation. Australia, Argentina, Brazil, Japan, India, Jamaica and Vietnam all show a strong affinity for grilling. It would not be uncommon for many of us to recall growing up eating food prepared this way on occasion. We never gave it a second thought. Nothing could be more natural in food preparation: outside, over the open heat, with constant attention to detail, easy on the environment, and simple. It is almost caveman like.

But wait. Cavemen lived to an old age of 20 or 30 years of age if they were lucky. I suppose there are many reasons we could discuss for this change in life expectancy, the least of which is food preparation methods. However it is hard to navigate through a Summer season without coming across a news story on the harmful, cancer causing effects of grilling. Well laid out logical explanations of carcinogens created in the high heat process of cooking this way attempt to lead the public into a conclusion that each barbequed meal will bring you one day closer to cancer.

What evidence base is available to us to A) Show that these products are indeed created with grilling, B) That these products are carcinogens and C) That grilling does indeed result in increased cancer rates. In truth, the creation of heterocyclic amines (HCA’s) and polyaromatic hydrocarbons (PAH’s) not only occurs by the barbequing process, but we also know that these products are clear carcinogens. These two are now established fact. However the “evidence based” answer we are looking for is “does the consumption of meat that is barbequed lead to a higher incidence of cancer?” Answering this avoids jumping to conclusions when you have data that appears to lead to a conclusion without evidence to back it up.

Another fair question is if there is an increased incidence of cancer in a population that consumes more of this type of food, is it because of the HCA’s and PAH’s from the food or is it simply because of the increase in meat consumption – something that has shown to increase cancer rates. Red meat on its own may contribute to increased cancer rates by contributing to N nitroso compound (NOC) exposure, and this is dose dependently associated with the amount of red meat in the diet .  There are also other proposed causes of cancer from red meat such as heme iron and nitrate/nitrite levels We have seen some studies that appear to show an increase in cancer rates when rats are given a diet that has HCA’s and PAH’s but as is often done with thee studies, the levels of ingestion were much higher than you would experience in a normal diet. Extrapolating this to humans isn’t simple. This is yet another pitfall in evidence based medicine: animals vs human exposure.

Having said this, there are some studies that show a correlation specifically with high heat cooking and certain types of cancer. For example we have seen prostate cancer not correlate with total meat but very well done meat shows an increase in this cancer as opposed to no meat intake . Pancreatic cancer is associated with increased overall meat intake as well as red only and high temperature meat cooking .   One huge drawback of these longer term studies include the concept of self-reported dietary diaries, which can be inaccurate.

So, where does this leave us? The next time you hear a story on the news or read an article on the dangers of barbequing and cancer, how should you respond? I throw this food item in the same bin as nonorganic and GMO, there are small pockets of evidence that say MAYBE there MIGHT be SOME benefit in your body but if you are looking for definitive answers like the ones we give when we say “don’t drink turpentine”, we just aren’t there yet.  You probably are more likely to be harmed from undercooking the meat, getting a parasitic infection , consuming preserved meats or getting a metallic bristle ingested.   There has been a suggestion that you should eat twice as much vegetables as grilled meat, but that should probably go for any meal. It is hard to argue against a more veggies less meat diet in overall health. Also frequently turning the meat on the grill will help reduce the amount of HCA’s produced. If you have a choice and are looking to reduce exposure as much as possible, steering away from charcoal and towards gas grilling may be preferred. In fact, there is some evidence that the particulate matter in the indoor air of barbeque restaurants or if you are a neighbor of such a restaurant might be just as bad to your health based on measured air-born levels of hazardous agents (but again, no longterm proven effects). As an aside, if you do choose to grill, you may want to take our lead this week when the Home Hardware in Baddeck which the Drug Store owns, pulled all Metallic Bristle Grill Brushes off the shelves and stopped selling them for good. We suggest you do also for your good health.   There is however no harm or shame in choosing to eat a certain way or avoid a certain food on the basis that it might have the potential to harm you, as long as you are eating a balanced diet.

 

Graham MacKenzie, PhC

Stone’s Pharmasave

Baddeck, N.S.

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The Continuum of Evidence Based Medicine
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image002Should Pharmacists be blasted for selling what some call alternative therapies or products that are not “evidence based”? These criticisms can blindside unsuspecting Pharmacists trying to do what they can for their patients regardless of the fact that they are making a profit from it or not. What makes it more difficult is the way in which these criticisms are delivered, especially when delivered in an offensive type of online statement like most opinions are delivered today. It makes one grow thick skin if they wish to continue. As a pharmacist myself, I can reflect on the strong personal feelings we have towards our patients, especially in small community pharmacies. Not that many other health care professionals don’t have this deep feeling of ownership in their patient’s heath, it’s just that as pharmacists, the frequency we see these people is just so much higher, either in person or on the phone. We are one of the most if not the most accessible in their health care team and we answer a lot of questions from them, gladly.

Not only are we seeing these people regularly for health related concerns, but we also see them in passing when they need milk or a greeting card. In short, they feel and we feel like we see them more than some of our own family members sometimes. Couple this with the utter vastness of concerns this patient has and relies on us for.

Quite often these questions fall within the 80% of questions we hear every day. Prescription medications, interactions, side effects, screening what should go on to the doctor and what doesn’t need to, and OTC issues like supplements, cough and cold, pain relief, skin ailments, self treatable infections of all kinds, preventative measures, weight loss advice, and many more. During Med Review interviews, we uncover medical issues not being addressed fully or at all. There are medical issues that are treated in ways that the patient would prefer were treated a different way, either due to current side effects, potential side effects, interactions, or for the simple reason that they just want to be on fewer medications.

Now some may consider this an environment that sets up a scenario for a trap of giving the patient something that hasn’t been proven with studies of thousands and thousands of test subjects in randomized controlled trials. There has been no drug rep with glossy handouts showing graphs and impressive relative change overshadowing a less impressive absolute change in results. Perhaps the pharmacist has no idea of any studies that might exist for anything at their OTC disposal, no numbers needed to treat are at their fingertips (however unimpressive even Rx values for NNT are).

The truth is, a lot of these OTC treatments, even though we are taught them in Pharmacy school as recommended treatments, don’t have all that much in the way of studies to prove they work as I pointed out in a previous blog . This starts the slippery slope of evidence based to non evidence based medicine. This is a continuum rather than a conscious switch. As pharmacists who see the direct results of these recommendations daily, we begin to realize what the term “evidence based” means. It includes the evidence they see every day. Some refer only to large centre, many subject, randomized controlled trials for their definition of this term. Of course this is the basis of our scientific and medical knowledge and has extended lifespan many years. These people however may also recommend some things in what is known as off label use of some medications where the evidence is less plentiful. This is outlined in a recent blog: http://stonespharmasave.com/blog/?p=796 . The statistical method is a gift that helps us weed out chance encounters from truth (http://stonespharmasave.com/blog/?s=statistics ) . Anecdotal evidence can be notoriously prone to incorrect conclusions as it sidesteps statistics in its conclusions. Sometimes we just don’t have these studies available to us and must rely on smaller studies or a physiological basis for a recommendation.

I see this with topical pain compounding all the time. Repeated successful results with a scientific basis and numerous small studies and numerous anecdotal reports drive more recommendations and more feedback. This spreads to physicians that may be skeptical on how these products work. With one patient with a favourable results they become more comfortable in writing again. If a patient tries a prescription medication and it doesn’t work is the Doctor a quack?  Of course not.  Evidence based becomes what you see before you in your little world, regardless of what online bullies think, as long as your first priority is to keep the patient safe.

 

Graham MacKenzie Ph.C.

Stone’s Pharmasave

Baddeck N.S.

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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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