Archive For: Medications

Medical Marijuana Myths

Smoking Out the Myths: Medical Marijuana

Does medical marijuana offer a solution to treating epilepsy, chronic pain, anxiety and neurogenerative diseases? Or is it an untested, potentially unsafe treatment that will eventually turn out to be more of a pipe dream? As with so many of today’s biggest questions, the truth is somewhere in between. We bring you a down-to-earth view of this much-discussed and yet oft-misunderstood topic to separate the hype from the hope.

While the marijuana or hemp plant has been used for more than 3,000 years, research and treatment today is primarily focused on the extract known as CBD, a cannabinoid. Unlike one of the other chemicals in the plant, THC (tetrahydrocannabinol,) CBD has no psychogenic effects and does not produce the “high” commonly associated with marijuana. Hundreds of CBD-related tests are now in progress, and CBD products are available at dispensaries, online and are making their way into everything from coffee and yogurt to pet treats.

Last June, a major milestone was reached when the U.S. Food and Drug Administration (FDA) approved the CBD drug Epidiolex for two rare, severe forms of treatment-resistant epilepsy.  Epidiolex, along with dronabinol and nabilone (which are synthetic cannabinoids previously approved to treat nausea from chemotherapy that has not responded to standard therapy), are now the only FDA-approved cannabis-based drugs.

The FDA was careful to note about Epidiolex: “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery.”

High hopes

The FDA’s cautionary tone was necessary because of the many well-publicized clinical and preclinical trials underway to test marijuana and its extracts. Interest continues to grow, as evidenced by the numerous research projects in progress. The most prominent studies are focused on chronic pain, trying to evaluate whether marijuana is a safer and less addictive alternative to opioids.Other research is aimed at testing if cannabinoids improve the symptoms of multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, anxiety and insomnia, as well as its potential role in anti-inflammatoryand antiviral activity, blocking cell growth and preventing the growth of blood vessels that supply tumors.1

As promising as the research appears, it’s important to realize that at this time, not enough large, clinical trials have been conducted to show that the benefits of marijuana outweigh the potential risks.  Research is still preliminary and much remains unknown about CBD and other cannabinoids’ optimal dosing range and the best route of administration (by mouth, inhaled, topically or sprayed under the tongue). Importantly, because they are not FDA-approved, the levels of THC or CBD can differ greatly from one dispensary to another or one batch to another.

Side effects are also hard to predict because potential impurities and variations in dosage are not addressed as they are in all FDA-regulated products. We are only starting to evaluate side effects which may range from minor dry mouth and dizziness, to death.  It is also unclear if the products interact with other medications. An added concern is that older and sicker people may be more vulnerable to the drug’s side effects.

Our bottom line: although CBD is readily obtainable in most parts of the United States, and laws legalizing its use for medicinal purposes continue to pass, we need to take a step back and realize the process is far from complete. The fact is the scientific evidence does not yet support many of the claims to ease symptoms of certain diseases, improve quality of life and relieve pain, nor has it been approved for use as a cancer treatment. As Cleveland Clinic’s head of Employee Health Services recently pointed out, medical marijuana has not yet undergone extensive clinical trials, public hearings and approval by the FDA, or been thoroughly tested for safety and efficacy. His recommendation is one we can all support – focus on research that isolates specific compounds found in marijuana, produces a dose-specific medication, and submit it to testing and regulatory processes.

1 National Cancer Institute, 2019

Did You Know?

330

Number of cannabinoid research projects supported by the National Institutes of Health in 2017

34

Number of states (including the District of Columbia) that have approved the medical use of cannabis as of 2018

The post Medical Marijuana Myths appeared first on Specialdocs Consultants.

Medical Marijuana Myths

Smoking Out the Myths: Medical Marijuana

Does medical marijuana offer a solution to treating epilepsy, chronic pain, anxiety and neurogenerative diseases? Or is it an untested, potentially unsafe treatment that will eventually turn out to be more of a pipe dream? As with so many of today’s biggest questions, the truth is somewhere in between. We bring you a down-to-earth view of this much-discussed and yet oft-misunderstood topic to separate the hype from the hope.

While the marijuana or hemp plant has been used for more than 3,000 years, research and treatment today is primarily focused on the extract known as CBD, a cannabinoid. Unlike one of the other chemicals in the plant, THC (tetrahydrocannabinol,) CBD has no psychogenic effects and does not produce the “high” commonly associated with marijuana. Hundreds of CBD-related tests are now in progress, and CBD products are available at dispensaries, online and are making their way into everything from coffee and yogurt to pet treats.

Last June, a major milestone was reached when the U.S. Food and Drug Administration (FDA) approved the CBD drug Epidiolex for two rare, severe forms of treatment-resistant epilepsy.  Epidiolex, along with dronabinol and nabilone (which are synthetic cannabinoids previously approved to treat nausea from chemotherapy that has not responded to standard therapy), are now the only FDA-approved cannabis-based drugs.

The FDA was careful to note about Epidiolex: “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery.”

High hopes

The FDA’s cautionary tone was necessary because of the many well-publicized clinical and preclinical trials underway to test marijuana and its extracts. Interest continues to grow, as evidenced by the numerous research projects in progress. The most prominent studies are focused on chronic pain, trying to evaluate whether marijuana is a safer and less addictive alternative to opioids.Other research is aimed at testing if cannabinoids improve the symptoms of multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, anxiety and insomnia, as well as its potential role in anti-inflammatoryand antiviral activity, blocking cell growth and preventing the growth of blood vessels that supply tumors.1

As promising as the research appears, it’s important to realize that at this time, not enough large, clinical trials have been conducted to show that the benefits of marijuana outweigh the potential risks.  Research is still preliminary and much remains unknown about CBD and other cannabinoids’ optimal dosing range and the best route of administration (by mouth, inhaled, topically or sprayed under the tongue). Importantly, because they are not FDA-approved, the levels of THC or CBD can differ greatly from one dispensary to another or one batch to another.

Side effects are also hard to predict because potential impurities and variations in dosage are not addressed as they are in all FDA-regulated products. We are only starting to evaluate side effects which may range from minor dry mouth and dizziness, to death.  It is also unclear if the products interact with other medications. An added concern is that older and sicker people may be more vulnerable to the drug’s side effects.

Our bottom line: although CBD is readily obtainable in most parts of the United States, and laws legalizing its use for medicinal purposes continue to pass, we need to take a step back and realize the process is far from complete. The fact is the scientific evidence does not yet support many of the claims to ease symptoms of certain diseases, improve quality of life and relieve pain, nor has it been approved for use as a cancer treatment. As Cleveland Clinic’s head of Employee Health Services recently pointed out, medical marijuana has not yet undergone extensive clinical trials, public hearings and approval by the FDA, or been thoroughly tested for safety and efficacy. His recommendation is one we can all support – focus on research that isolates specific compounds found in marijuana, produces a dose-specific medication, and submit it to testing and regulatory processes.

1 National Cancer Institute, 2019

Did You Know?

330

Number of cannabinoid research projects supported by the National Institutes of Health in 2017

34

Number of states (including the District of Columbia) that have approved the medical use of cannabis as of 2108

The post Medical Marijuana Myths appeared first on Specialdocs Consultants.

Pain Management: The New Approach

Fewer Pills, Lower Doses, More Vigilance: The New Approach to Pain Management

It’s hard to imagine a medical crisis more widely discussed, dissected and debated in the last two years than opioid abuse. As a result, clear action steps have been taken, including retooling of the 2016 guidelines for opioid-prescribing protocols – dosage recommendations, follow up assessments and ongoing monitoring were reconsidered and adjusted. In short, for patients with chronic pain not from cancer, nonpharmacological treatment and non-opioid medications should be evaluated first, and opioids used only when:

  • other alternative therapies have not provided sufficient relief, and
  • pain is adversely affecting a patient’s function and/or quality of life, and
  • potential benefits of opioid therapy outweigh

Following are details on the newest developments, and how they may impact the way you’re treated for pain, from hospital bed to physician office.

Minimize and customize dosage. Not surprisingly, the dosage recommendations for exercising caution are lower than in earlier guidelines, beginning with even relatively low doses (20-50 morphine milligram equivalents (MME) per day). The lowest effective dose, for the shortest period needed, will be used to treat acute pain. In most cases, even pain following surgery does not require opioids for more than three days. Several high-profile institutions have changed their opioid prescribing guidelines following surgery.

At Johns Hopkins, a panel of health care providers developed recommendations for the number of five-milligram oxycodone pills needed after almost two dozen common procedures, finding that some required none, while the maximum of 20 pills was appropriate for others. The prescribing limits were designed to help prevent patients from receiving unnecessary opioid pills after surgery and ultimately face a one-in-16 risk of becoming a long-term user.

“Prescriptions for pain meds after surgery should be custom tailored to the operation and a patient’s needs and goals, but the hope is that these guidelines will help reset ‘defaults’ that have been dangerously high for too long,” the study’s author reported in a recent Journal of the American College of Surgeons.

An open discussion. It is now acknowledged that opioids present a risk to all patients, and risks must be clearly presented when starting therapy. These range from common (constipation, nausea) to serious (respiratory problems, opioid use disorder, overdose).

Establish realistic treatment goals. It’s essential to realize there’s no cure for chronic pain, but work toward pain relief to improve function and quality of life. “SMART” goals – specific, measurable, attainable, relevant and time-limited – should be set at the start to determine end points and be continually reassessed.

Continual monitoring. Opioids should only be continued after confirming that clinically meaningful improvements in pain and function were realized without significant risks or harm. In regular checks, patients will be asked to rank their pain, and level of interference with their enjoyment of life and general activity. A 30 percent improvement from baseline scores would be needed to continue the therapy. Reassessments are recommended within a few weeks after starting, and at least every three months throughout the course of treatment.

Not recommended for elderly patients. A body of evidence shows possible harm from long-term opioid use in older patients, who metabolize medications more slowly and so may be prone to side effects such as respiratory and cognitive impairment. UCLA Comprehensive Pain Center experts advise a multidisciplinary approach using psychological support, physical therapy and other complementary therapies.

Proper disposal of unused opioids. Noting that a large part of the opioid abuse crisis was spurred by people taking medications not prescribed to them, new guidelines emphasize not leaving unused pills in the medicine cabinet “just in case.” Patients are advised to dispose of them as quickly and appropriately as possible.

New approaches to addiction. According to a recent editorial in Mayo Clinic Proceedings, looking beyond the “supply side” issue to target the “demand” side of opioid use is critical to addressing why patients were initially drawn to using opioids. The authors recommend screening for depression and other psychiatric disorders which are often the impetus for patients to over-use opioids. Other studies posit that as many as 65 percent of overdoses reported at poison control centers were actually suicide attempts, underscoring the need for comprehensive psychological evaluation and treatment.

Optimize use of non-opioid therapies. A growing list of options includes:

  • Acetaminophen (Tylenol®) or ibuprofen (Advil®)
  • Muscle relaxants
  • Anti-inflammatories
  • Cognitive behavioral therapy – a psychological, goal-directed approach in which patients learn how to modify physical, behavioral, and emotional triggers of pain and stress
  • Exercise therapy, including physical therapy
  • Medications for depression or seizures
  • Interventional therapies (injections)
  • Exercise and weight loss
  • Alternative therapies such as acupuncture

Did You Know?

70–80% – 70-80% Percentage of opioid pills prescribed after surgery not used by patients

Source: Johns Hopkins

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The Painful New Reality of Opioid Prescriptions

Health Wise Summer 2016 Hasson FINAL 300x291

Nothing erodes the quality of life faster than pain and unfortunately more than half of American adults report they live with it on a chronic, recurring basis. That makes it easy to understand why, when seemingly safe, effective opioid drugs became widely available in the 1990s, they were quickly embraced by physicians and patients. Considered one of the most promising developments in pain management in decades, opioids such as oxycodone (OxyContin, for example), hydrocodone (Vicodin) or meperidine (Demerol) had already proved highly effective on a short-term basis to treat acute pain. The mechanisms were clear: opioid molecules travel through the bloodstream into the brain, attach to receptors on the surface of certain brain cells and trigger the release of dopamine in the brain’s reward and pleasure center.

However, what was not known was how patients reacted to these medications when taken daily for weeks, months and years to treat chronic conditions ranging from headaches and stubborn lower back pain to neuropathy, fibromyalgia and severe degenerative joint disease. As use of opioids for chronic pain (defined as lasting longer than three months) became widespread, reports of unwanted side effects emerged, along with doubts about long-term efficacy and optimal outcomes. Most alarmingly, the potential for abuse and addiction materialized into a full-blown crisis, evidenced by stark statistics like these:

  • Opioid prescriptions increased 7.3% from 2007-2012; by 2013, 1.9 million people were reported to be abusing or dependent on opioids. As many as 25% of people prescribed opioids on a long-term basis struggle with addiction.
  • 165,000 Americans died from overdosing on prescription opioids from 1999-2014, climbing from 3 deaths per 100,000 people to 9; the highest rates were seen among 25 to 54-year-old white Americans.

Clearly, sweeping changes were needed, and in response, new recommended guidelines for safer pain management were issued by the Centers for Disease Control (CDC) last spring, and received
strong endorsement from well-respected organizations including the American Academy of Pain Medicine and the American College of Physicians (ACP). According to ACP, the recommendations are “reasonable, based on the best available evidence, and find the right balance between educating about the hazards of opioids while recognizing special circumstances where such medications may be an important part of a treatment plan.” The recommendations specify best practices for dosage levels and usage, and raise awareness of the risks posed to all patients by the drugs. Please note that these are recommendations only and may be altered at the discretion of the physician treating you to fit your unique needs. These include:

  • Non-pharmacologic and non-opioid therapy are preferred for chronic pain. Opioid therapy should be used only if expected benefits for both pain and function are anticipated to outweigh risks.
  • If opioids are used, they should be combined with non-pharmacologic and non-opioid pharmacologic therapy, as appropriate.
  • Physicians should establish treatment goals with their patients before starting opioid therapy, including realistic and clinically meaningful goals for pain and function, and an ‘exit strategy’
    should the therapy need to be discontinued.
  • Use immediate-release opioids instead of extended-release/long-acting opioids.
  • Use the lowest effective dosage, and carefully reassess individual risks and benefits when increasing dosage to ≥50 morphine milligram equivalents per day.
  • Prescribe immediate-release opioids for acute pain in no greater quantity than needed for the expected duration of pain – three days or less will often be sufficient, more than seven days will
    rarely be needed.
  • A frank physician-patient discussion regarding the risks and benefits of opioids should take place before starting therapy. An evaluation of benefits and harms should be scheduled within one to four weeks of starting opioid therapy, and repeated at least every three months. If benefits do not outweigh harms of continued therapy, physicians should explore alternatives (see sidebar) with patients and work with them to gradually taper off to lower doses and ultimately discontinue use.

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Unlocking the Genetic Code: Spotlighting Pharmacogenomics

Hasson HW 2017 Summer FINAL 1

This is the first in a series exploring some of the most promising advances inspired by the Human Genome project. From the burgeoning field of pharmacogenomics to consumer genetic testing such as 23 and Me, the time from discovery to application is progressing rapidly. We’ll look at some of the latest thinking and its impact on personalizing medicine in the future.

To boil down a complex subject to its very human goal, pharmacogenomics means using genomics to get the right dose of the right drug to the right patient at the right time. There is tremendous variability in individual response to drugs, and a large percentage of adverse drug reactions may be due to genetic variables that are just beginning to be really understood.

It’s important to note that while significant progress has been made, the actual use of pharmacogenomics in primary care may be many years away and unlikely to impact the way in which your physician currently prescribes medications for you. However, as research continues to accumulate, the medical community is hopeful that this information will someday help guide prescription decision-making in a much more precise and personalized way.

Did You Know?

1957 – Dr. Arno Motulsky suggests that individual differences in drug efficacy and adverse drug reactions are at least partially attributable to genetic variations

2008 – The Food and Drug Administration releases a table listing genomic biomarkers with established roles in determining drug response

Sources: The National Human Genome Research Project, UptoDate, FDA.gov, JAMA

What we know now

Slightly different, but normal, variations in the human genetic code can yield proteins that work better or worse when they are metabolizing different types of drugs and other substances. Even small differences can have a major effect on a drug’s safety or effectiveness for an individual patient. Your drug-metabolizing enzymes may be set to act in a completely different way than a friend of similar height and weight because phenotypes range from ultrarapid and rapid metabolizers to normal, intermediate and poor metabolizers.
Consider this example from the National Institutes of Health: The liver enzyme known as CYP2D6 acts on 25 percent of all prescription drugs, including the pain reliever codeine. There are more than 160 versions of the CYP2D6 gene, and many of these vary by only a single difference in their DNA sequence. People who manufacture an overabundance of CYP2D6 enzyme molecules metabolize the drug very rapidly, and as a result, even a standard dose can be too much. Conversely, those who carry a CYP2D6 gene that results in a slowly metabolizing enzyme may not experience any pain relief. Armed with this kind of information, a physician may be able to prescribe different types of pain relievers for both of these patients.
The Food and Drug Administration now includes pharmacogenomic information on the labels of some medications, with details on risk for adverse events and side effects, effectiveness for people with specific genome variations, genotype-specific dosing and mechanisms of drug action (the specific biochemical interaction through which a drug substance produces its pharmacological effect). This may eventually help physicians make the right individual patient choices for drugs that include pain relievers, antidepressants, antivirals, statins and blood thinners.
A number of barriers, which includes the lack of clear, evidence-based guidelines, need to be overcome before personalized drug therapy becomes a routine component of mainstream medicine. For now, pharmacogenetics testing is successfully being used in treatment of specific genetically influenced tumors, and for certain medications for cystic fibrosis, inflammatory bowel disease and HIV…important first steps in this promising field.

Defining Terms

  • Pharmacogenomics: A field of research focused on understanding how genes affect individual responses to medications.
  • Pharmacogenetics: Sometimes used interchangeably with pharmacogenomics, it’s actually a subcategory that refers to the role of genetic variation on response to a drug; can be inherited through the germline or acquired as in a tumor.
  • Pharmacokinetics: How a drug moves through an individual’s body, from absorption and distribution through excretion. Blood and urine tests determine where a drug goes and how much of the drug or a breakdown product remains after the body processes it.

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Prescriptions: Take Exactly as Directed

HW Summer2014 Prescription 300x190

Look inside your medicine cabinet at your prescription bottles and ask: Have I read the label, stickered warnings and instructions? Have I discarded medications past their expiration dates? The Centers for Disease Control (CDC) reports that 80 percent of patients do not take their medications as prescribed. The prevalence of non-adherence to prescription directions has been cited as “America’s other drug problem” by the CDC. The agency estimates more than 125,000 people die annually from problems related to prescription medications, in part due to failure to read or follow label instructions. This number has the potential to increase dramatically over the next few decades, with the growing numbers of seniors, who are prescribed medication most frequently. Currently, 76 percent of Americans 60 and older use two or more prescription drugs, and by age 65, 42 percent take at least five medications weekly.

At every age, it is crucial to know the details about any medication prescribed to you. Consider these commonly asked questions, and you will understand why reading the fine print is essential.

Why do I need to finish an antibiotic? Probably the most common instance of non-compliance is taking fewer or partial doses of an antibiotic, which may allow the resistant bacteria to not only survive, but thrive. Taking a full course of antibiotics is the only way to kill all the harmful bacteria. Additionally, if the first course does not work, subsequent treatments may be more costly, with possible serious side effects.

What happens if I take more or less than prescribed? If you miss a dose, or take less because you feel better, the effectiveness may be reduced and can result in flare-ups of the condition—only if the prescription indicates ‘as needed’’ should you modify the dose. In most cases, experts advise returning to your regular medication schedule, but not to take two doses to make up for the dose you missed, as that can cause unintended side effects. Be careful not to take an extra over-the-counter pain relief pill (acetaminophen) for an intractable headache, as the narrow safety margin places many people “close to a toxic dose in the ordinary course of use,” according to the FDA.

Why do some medications need to be taken with food and others on an empty stomach? Stomach upset, a common side effect, can be lessened by taking a drug with meals, as indicated. For some medicines, the opposite is true, and ingesting food beforehand can delay or decrease absorption of the drug. If ‘take on an empty stomach’ is directed, take the medication first thing in the morning and wait 30 minutes before eating to give the body time to absorb it.

Why is the time of day important? Certain drugs are more effective or better tolerated with specific timing, according to new AARP research. Taking statins at bedtime is advised as cholesterol production in the liver is highest after midnight and lowest in the morning and early afternoon. Pain medications used for osteoarthritis are best swallowed four to six hours before the pain is anticipated to be at its worst. Asthma patients gain the most relief by taking oral medication in the mid-afternoon and inhaled steroids in late afternoon to prevent attacks most commonly experienced at night.

Why can’t I have alcohol with prescription medication? Consumption of alcohol when taking a prescription medication may cause nausea, headaches or fainting. It can also exacerbate medication’s effects, causing you to feel sleepy or lightheaded, and making it harder to concentrate and perform certain tasks.

Why can’t I drive or operate heavy machinery? Some drugs, like those for anti-anxiety, can dull alertness and slow reaction time, while stimulants can impair judgment. Common side effects of medication—drowsiness, dizziness, blurred vision, excitability—all point to the need to stay off the road.

Why should certain foods be avoided? Some medications may not work as well when taken with specific foods. For example, grapefruit contains a compound that affects the way a number of medications are metabolized by the liver and should be avoided or limited as indicated. When taking the frequently prescribed blood thinner warfarin (Coumadin), doctors recommend keeping your diet consistent, particularly with regard to your intake of leafy green vegetables which may impact blood levels.

Can I take drugs after the expiration date? Discard outdated drugs, which may not have full potency, particularly ones in solution or that require refrigeration. Take particular note of medications such as insulin, oral nitroglycerin, biologicals, blood products and epinephrine. Medications with preservatives, such as eye drops, may be unsafe past expiration, as bacterial growth can occur.

New technology can help, such as electronic pillboxes and smartphone apps, or simply use the tried and true pillbox.

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