Tag Archives: PubMED

Pharmacists want more information

pmcIn a First of it’s kind study posted to PubMED shows that pharmacists want more information about medical cannabis.   The study conducted in Minnesota prior to Minnesota’s medical Cannabis program implementation shows that Pharmacists want more information on medical cannabis.  The Study was done by Joy Hwang, PharmD, MPH, Tom Arneson, MD, MPH, and Wendy St. Peter, PharmD

First the report determines that Minnesota Pharmacists, in general, have limited Knowledge of cannabis polices, regulations and felt they were not adequately trained.

Pharmacists reported limited knowledge of Minnesota state-level cannabis policies and regulations and felt that they were inadequately trained in cannabis pharmacotherapy. Most pharmacists were unprepared to counsel patients on medical cannabis and had many concerns regarding its availability and usage. Only a small proportion felt that the medical cannabis program would impact their practice. Pharmacists’ leading topics of interest for more education included Minnesota’s regulations on the medical cannabis program, cannabis pharmacotherapy, and the types and forms of cannabis products available for commercialization.

Unlike most states which have legal medical Cannabis Minnesota and a couple others have Licensed Pharmacists as the dispensers.  However in Minnesota these pharmacists are trained by their respective companies and have a great deal of knowledge about Cannabis use for medical purposes.

In these three states, pharmacists provide registered patients with consultations at one of the state-approved cannabis distribution centers. Moreover, they are the only health care professionals who are permitted to dispense cannabis products. This distinguishes these states from most other legalization states, where cannabis products—both medical and recreational—can be purchased from retail dispensaries that operate under the guidance of certified personnel known as “budtenders.”

The study was done to assess gaps in knowledge and concerns of Minnesota pharmacists.  The study conducted voluntarily via a web-based survey and had a 10% response rate by the states Pharmacists. The questionnaire had 14 questions they asked the pharmacists and also room for them to put in their own comments.

The majority of the respondents completed the survey and reported little concern about medical cannabis.

Most pharmacists rated themselves on the lower end of the Likert scale for self-perceived knowledge about medical cannabis and readiness to counsel patients on medical cannabis use (1 = poor; 7 = excellent) and concerns about medical cannabis use under the Minnesota program (1 = no concern; 7 = most concern)

Almost 90% of the respondents responded that they were less than moderately prepared to provide counseling services to patients using cannabis for medical purposes.

Pharmacists in general want more education.  This survey is of all pharmacists registered in Minnesota. Of those only a small number of them actually work with cannabis patients in the clinics that are available.  However it’s clear from this study that they want more education on Cannabis.

Respondents were very interested in learning more about medical cannabis in the following areas: state-specific rules and regulation (87%), pharmacotherapy (88%), and available types and forms of products on the market (82%). Fifty-three percent were interested in learning more about federal laws related to marijuana. Only 7% indicated no interest in learning more about any of these topics.

The study was conducted 2 months prior to Minnesota implementation of it’s cannabis program and there was a great deal of confusion about it.  Since the time of the survey information from a variety of sources including educational presentations to many hospitals, clinics, and hospital-clinic organizations in Minnesota with pharmacists as part of the audience, The University of Minnesota College of Pharmacy, Medical School and School of Nursing, full-day educational symposium on medical cannabis in April 2016, the Minnesota Pharmacists Association (MPhA) and the Minnesota College of Clinical Pharmacists.

The Study Concludes:

This study suggests that Minnesota pharmacists were not sufficiently prepared to work with patients in the medical cannabis program. Of those who provided survey responses, an overwhelming majority felt incompetent in medical cannabis clinical knowledge; however, almost half were unconcerned about the potential impact the program’s implementation would have on their practice. Nonetheless, pharmacists were interested in learning about medical cannabis and its state-specific regulation. Targeted education regarding cannabis pharmacotherapy, product availability and variability, and state-specific regulations should be available for health care professionals practicing in states with medical cannabis programs prior to program implementation and patient access.

 

Link to the study here – LINK

Copy of the study here – minnesota-pharmacists-and-medical-cannabis_-a-survey-of-knowledge-concerns-and-interest-prior-to-program-launch

 

Cannabis, Safe & Effective

There are a lot of studies that have been completed and many more that are awaiting start.  You can find studies on what cannabis at ClinicalTrial.Gov and search for Cannabis – Marijuana – Cannabinoids and other terms and come up with all kinds of results.

fedregWhere you can really find heads up is the Federal Register.  There you will find people that are applying to obtain licenses from the DEA to handle Cannabis (search for 7360 the DEA code for Marijuana).  When they apply under law there is a comment period where persons, organizations and companies can make comment on the application.  Most of the time there is no comment made and then the DEA decides if they are going to grant or not. However if there are comments made then the DEA incorporates these comments into their reply to the application when they grant or deny.

nih1Finally there is also PubMed where you can search all kinds of different things.  You will find information like this from  Medical Marijuana: Just the Beginning of a Long, Strange Trip? C.D. Ciccone, PT, PhD, FAPTA, Department of Physical Therapy, Ithaca College.

Although there is still a need for randomized controlled clinical trials, preliminary studies have suggested that medical marijuana and related cannabinoids may be beneficial in treating chronic pain, inflammation, spasticity, and other conditions seen commonly in physical therapist practice. Physical therapists should therefore be aware of the options that are available for patients considering medical marijuana, and be ready to provide information for these patients. Clinicians should also be aware that marijuana can produce untoward effects on cognition, coordination, balance, and cardiovascular and pulmonary function, and be vigilant for any problems that may arise if patients are using cannabinoids during physical rehabilitation.

So it’s clear from the information available that THC, Cannabidiol along with all of the other cannabinoids and substances in Plant based Cannabis

  •  does not produce any unknown adverse effects or other effects that are extremely common in Pharmaceutical preparations.
  •  does not have an unattainable LD-50 level (another indicator of overall safety).
  • has shown therapeutic actions that are beneficial to many patients.

So there is no reason why companies should need to rely on synthetic versions of the various cannabinoid and plant compounds.  They should be allowed to use the whole plant and the various strains of the plant to treat any condition.

Given the safety of the substances, the variety of administration methods there is no reason not to use trial and error.  As has been seen with Charlotte’s Web there are strains that work better for some conditions.  As the science of cannabis expands so will the introduction of strain specific treatments.  There isn’t a reason to not be able to move from one concentration of substances to another just like doctors change medications that aren’t producing the desired results to ones that do work.

Not every medication works for every person.  It happens all the time in medicine, a doctor prescribes something and it just doesn’t work or produce the desired effect.  Change drugs to something similar and bingo it works.  Doctors can’t explain it, Pharmacy companies can’t explain it, the FDA can’t explain it.  Given the great number of varieties already developed and those that will be developed that lots of conditions can be treated with cannabis.

Cannabis has a long history of being safe and effective.  There is no reason that all cannabis can’t be used by patients because of this safety when used.  Unlike other medications that can produce irreversible affects, cannabis just doesn’t do that to patients.

Effects of Vaporized Marijuana

clinicalWhat are the affects of Effects of Vaporized Marijuana?  Are there any adverse events?  How about Serious adverse events? According to a small study done at the University of California, Davis with the collaboration of the Center for Medicinal Cannabis Research, VA Northern California Health Care System, nope.

In a study on Effects of Vaporized Marijuana on Neuropathic Pain they not only found that a significant number of participants benefited with lower pain levels, they also reported No Events of any significance.  The study included what they call low (1.29% THC) and medium (3.53%) and a placebo.

Surprisingly this study has been sitting on ClinicalTrials.gov since it’s completion in 2013

Here is a link to the study – ClinicalTrials.gov NCT01037088

 

USP Door For Cannabis?

uspThere are a number of ways that Cannabis could be recognized as a medical substance or at least treated differently than it is now.  One is the DEA, well we already know how helpful they are.  Another would be the FDA, they already supply the misinformation used by the DEA so are they an option?  Maybe.  The other is to get something back into the Formulary through the USP.

The USP has legal authority given to it by the FDA back in 1966:

The U.S. Federal Food, Drug, and Cosmetics Act designates the USP–NF as official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding.

Could the USP be a door for Medical Cannabis?  The USP (United States Pharmacopeia) is one of several formularies used by Health Care Practitioners and the FDA to determine medical value of substances and plants.

What most people don’t know is that while the USP creates monographs for chemicals they do the same for Food Ingredients and Dietary Supplements.  Again with legal authority given to them by the FDA

Currently, over 200 FDA regulations cited in the U.S. Code of Federal Regulations incorporate the food ingredient standards that USP publishes in the Food Chemicals Codex (FCC) compendium. The first edition of the FCC, which was published in 1966 by the Institutes of Medicine, was given quasi-legal recognition in July 1966 by means of a letter of endorsement from FDA Commissioner James L. Goddard, which was reprinted in the book. The letter stated that “the FDA will regard the specifications in the Food Chemicals Codex as defining an ‘appropriate food grade’ within the meaning of Sec. 121.101(b)(3) and Sec. 121.1000(a)(2) of the food additive regulations, subject to the following qualification: this endorsement is not construed to exempt any food chemical appearing in the Food Chemicals Codex from compliance with requirements of Acts of Congress or with regulations and rulings issued by the Food and Drug Administration under authority of such Acts.”

and

USP’s standards for dietary supplements may be found in USP–NF and Food Chemicals Codex (FCC) compendia. Legal recognition varies depending from which compendia the standards are published.

To do this the USP works with manufacturers to develop monographs for items:

USP develops public standards to provide quality oversight for dietary supplements and their ingredients. Public input and interaction are vital to the development of these standards, which originate from the draft monographs and data provided by dietary supplement manufacturers, users, and suppliers. USP’s scientific staff and the volunteer Dietary Supplements Expert Committee review data, conduct necessary laboratory tests, and ensure that the information is subject to a process of public review and comment.

They do this through several public forums which they operate:

Proposals for new or revised dietary standards from USP–NF and FCC that appear in the DSC are first published for public review and comment in either the Pharmacopeial Forum or the FCC Forum. Through these free online forums, interested parties have the ability to provide feedback on the proposed standards and revisions and participate in the USP standards-setting process.

They encourage people to submit their substances for inclusion:

USP encourages you to submit draft monographs for the dietary supplements you manufacture or supply. Your draft monograph will become the starting point for the public standard. USP staff will involve you in the public process of review and comment to refine and finalize the monograph for publication in the next USP-NF edition or supplement.

The USP sounds like it is an avenue that is open to Medical Cannabis in the form of a Food Ingredient or as a Dietary Supplement and they tell you how to do it.