Meds associated with Stevens-Johnson syndrome

Posted on September 28, 2018 by Pharmaciststeve

Pharmacists Mutual Insurance Company

RM Alert: Medication Misadventure – Stevens-Johnson Syndrome

Background

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are a group of hypersensitivity reactions that are very rare, serious and potentially fatal. Carbamazepine is the drug most commonly associated with the disease although some antiretroviral drugs, sulphonamides, penicillins, fluoroquinolones, and NSAIDs have also been known to cause the reaction.

The initial symptoms of the reaction are fever, muscle aches, and general weakness for one to three days. Subsequently, the skin develops painful open blisters. If the rash develops, the medication must be stopped immediately. Treatment is much like that of a burn victim including fluid replacement, infection prevention, and pain management. Treatment can last up to a year and many times permanent scaring results.

Lessons
• Carbamazepine is associated with Stevens-Johnson syndrome/toxic epidermal necrolysis in carriers of the human leucocyte antigen (HLA) B*1502 gene.
• The HLA B*1502 gene is most frequently found in Asian populations (Indians, Han Chinese, Thais and Malays). This population has a 10 times greater risk of developing SJS/TEN than Caucasians exposed to carbamazepine.
• The HLA A*3101 allele has been associated with reactions in Northern European populations.
• In 2007, the FDA recommended genetic screening of individuals of Asian ancestry prior to the start of carbamazepine.
Recommendations
• Ensure screening in genetically at-risk populations prior to initiating therapy.
• Review all signs and symptoms of SJS/TEN with all new prescriptions for carbamazepine.
Other insights

The increased use of carbamazepine, especially for control of pain, may be the reason for the increased incidence of SJS/TEN with it.

Awareness of such drugs implicated in life-threatening drug reactions will help physicians in preventing them by judicious use of the drugs.

For patients who are HLA-B*15:02 and HLA-A*31:01 positive, oxcarbazepine, phenytoin, fosphenytoin, eslicarbazepine acetate, and lamotrigine may also be associated with drug-associated cutaneous adverse reactions so these medications may need to be avoided as well.

For Tools & Resources to help you manage risk, members can access the Pharmacists Mutual Risk Management Center (RMC) from the Pharmacists Mutual Member Portal. Visit www.phmic.com, click on “My Account” & follow the on-screen prompts to set-up your free account.

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Opioid crisis impacting pet care

Posted on September 28, 2018 by Pharmaciststeve

LANCASTER, Pa. (WHTM) – Inside Pet Pantry of Lancaster County, there is a logbook for every time a doctor has to use opioids.

“We do use a lot of opioids such as fentanyl and some other things in hospital as anesthetic agents for these immediate operating times,” said Dr. Bryan Langlois, the clinic’s medical director.

Langlois is also the president of Pennsylvania’s Veterinary Medical Association. He said because of the opioid epidemic, drug companies are making less of the drugs and veterinarians are getting less of them.

“The human hospitals are getting the first crack at things,” he said. “We in the veterinary profession are left trying to get what we can.”

The issue is creating a supply and demand problem, which is turning into higher bills for pet care.

“Some prices are going to go up through distributors to be able to get those products,” Langlois said.

Prices aren’t skyrocketing, but some veterinarians are changing their protocols and seeking other options.

Langlois said that’s an issue because he believes opioids work best for pets.

“These drugs are some of the safest ones out there for us to do these procedures with,” he said. “We want to be able, for people’s pet safety, we want to provide the best and safest option that’s out

Where is PETA and ASCPA   aren’t they suppose to stand up for the abuse/mistreatment of animals.  Neither of these organizations have a DEA license.. thus the DEA has no lethal authority to threaten their existence – like they do prescribers who have DEA licenses if they stand up to the abuse by them.

ACLU   seems to also be reluctant to take a stand for the hundred of millions of chronic pain pts that are being denied adequate pain management.

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Time to get your flu shot – it is not all about just you

Posted on September 28, 2018 by Pharmaciststeve

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I Demand Justice !!!

Posted on September 28, 2018 by Pharmaciststeve

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FDA Offers Pharmacists Opioid Training

Posted on September 27, 2018 by Pharmaciststeve

FDA Offers Pharmacists Opioid Training

http://www.drugtopics.com/fda/fda-offers-pharmacists-opioid-training

The FDA’s new opioids Risk Evaluation and Mitigation Strategy (REMS) plan offers training to pharmacists and nurses for the first time, and adds new labeling for all opioids.

The agency’s final Opioid Analgesic REMS includes several measures to help better communicate the serious risks about the use of opioid painkillers to patients and health care professionals, including pharmacists.

Notably, the new REMS subjects immediate-release opioids analgesics—which account for around 90% of prescribed opioids—to a more stringent set of requirements as well as adds new labeling for all opioids, says FDA Commissioner Scott Gottlieb, MD, in a statement.

The new labeling includes information about REMS-compliant education in the Boxed Warning and Warnings and Precautions sections of labeling and strongly encourages providers to complete a REMS-compliant education program. The labeling also emphasizes to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists.

In addition, the expanded REMS requires that 347 opioid analgesics intended for outpatient use be subject to REMS, versus the 62 that were previously required.

The new REMS requires that the education for pharmacists, nurses, and other healthcare professionals cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain.

“Many people who become addicted to opioids will have their first exposure in the medical setting. Providers have a critical role to play in making sure these products are appropriately prescribed to patients,” Gottlieb says.

The FDA believes that all healthcare providers involved in the management of patients with pain should be educated about the safe use of opioids, “so that when they write or dispense a prescription for an opioid analgesic, or monitor patients receiving these medications, they can help ensure the proper product is selected for the patient and used with appropriate clinical oversight,” Lyndsay Meyer, an FDA spokesperson, tells Drug Topics.

The FDA’s goal is to reduce unnecessary and/or inappropriate exposure to opioids by making certain that prescribers are properly informed about appropriate prescribing recommendations, that providers understand how to identify abuse by individual patients, and know how to get patients with opioid use disorder into treatment, Meyer says.

“The crisis of opioid addiction is a public health tragedy of enormous proportions. The FDA’s goal is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of opioid analgesics, while maintaining patient access to pain medications,” she says.

Continuing education training under the modified REMS will be available to health care providers by March 2019.

There is no mandatory federal requirement that prescribers, pharmacists, or other healthcare professionals take the training provided through the REMS and completion of the training is not a precondition to prescribing opioid analgesics to patients, according to Meyer.

“However,” she adds, “the FDA’s Opioid Policy Steering Committee continues to consider whether there are circumstances when the FDA should require some form of mandatory education for healthcare providers and how the agency would pursue such a goal.”

This is a “can of worms”… The new REMS requires that the education for pharmacists, nurses, and other healthcare professionals cover broader information about appropriate pain management

If you notice that prescribers are not included in this statement, is the FDA trying to impose some reasoning on healthcare professionals that dispense and/or administer opiates to pts become the intermediary to “monitor” the prescribing of opiates to pts and perhaps become an “obstacle” between the prescriber and the pt  and the pt getting the opiates that have been prescribed to them ?

Could this be another “CDC guideline” type play by a federal agency since  There is no mandatory federal requirement that prescribers, pharmacists, or other healthcare professionals take the training provided through the REMS and completion of the training is not a precondition to prescribing opioid analgesics to patients, according to Meyer.

Is this something for the DEA to ‘hang their hat on” to go after prescribers and pharmacist that have not completed the course to accuse them of inappropriate “corresponding responsibility” because of their failure to take the course that is not mandatory ?

 

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DEA reschedules Epidiolex, marijuana-derived drug, paving the way for it to hit the market

Posted on September 27, 2018 by Pharmaciststeve

Epidiolex is the first FDA-approved drug that is derived from maijuana. DEA reschedules Epidiolex, marijuana-derived drug, paving the way for it to hit the market

  • The Food and Drug Administration in June approved Epidiolex, which is derived from cannabidiol, or CBD, a molecule contained in the marijuana plant.
  • This forced the DEA to consider how it would classify Epidiolex since marijuana is considered a schedule 1 drug, which it defines as having no currently accepted medical use and a high potential for abuse.

The Drug Enforcement Administration has rescheduled Epidiolex, paving the way for GW Pharmaceuticals to start selling the first FDA-approved drug derived from cannabis, but stopped short of reclassifying all cannabidiol products.

The Food and Drug Administration in June approved Epidiolex, which is derived from cannabidiol, or CBD, a molecule contained in the marijuana plant. This forced the DEA to consider how it would classify Epidiolex since marijuana is considered a schedule 1 drug, which it defines as having no currently accepted medical use and a high potential for abuse.

Epidiolex will be classified as a schedule 5 controlled substance, the lowest level, defined as those with a proven medical use and low potential for abuse. Other drugs in this category include some cough medicines containing codeine.

The drug is indicated to treat patients two years and older with Dravet Syndrome and Lennox-Gastaut Syndrome, rare forms of epilepsy that emerge during childhood and can be difficult to treat. It does not contain tetrahydrocannabinol, or THC, the psychoactive compound in cannabis that makes people high.

GW Pharma said it would “work hard” to make Epidiolex available within the next six weeks. Shares of GW Pharma rose 7 percent on the news.

“We are pleased that the DEA has placed EPIDIOLEX in the lowest restriction Schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” GW CEO Justin Gover said in a statement.

The rescheduling applies to CBD containing no more than 0.1 percent THC, in FDA-approved drug products. Though this allows GW Pharma to sell Epidiolex, it does not broadly apply to CBD.

So while oils and lotions are becoming wildly popular, they’re still schedule 1 drugs and therefore illegal under federal law, though the DEA typically does not pursue, or enforce the law against, individual users, a DEA spokeswoman told CNBC. Some states have legalized CBD and other marijuana products.

The DEA classifies marijuana as a schedule 1 drug, which it defines as having no currently accepted medical use and a high potential for abuse. Because CBD is a compound found in the marijuana plant, it is considered a schedule 1 drug and therefore illegal.

Coffee shops and other places selling CBD oil may be in line with state laws, depending on where they’re located, but they’re still skirting federal laws. And though the DEA may not pursue small-scale sellers, it may enforce those federal laws if consumer product conglomerates decide to enter the space.

Beverage giant Coca-Cola in September said although it has “no interest” in marijuana, it’s “closely watching the growth of non-psychoactive CBD as an ingredient in functional wellness beverages around the world.”

In announcing its approval of Epidiolex, the FDA was clear to distinguish that the drug contains purified CBD and the agency’s decision was not a broad approval of the substance. Commissioner Scott Gottlieb said the FDA remains “concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims.”

 

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CIAAG Calls for Pain management as Human Right to the United Nations

Posted on September 27, 2018 by Pharmaciststeve

Lauren Deluca, founding president of Chronic Illness Advocacy & Awareness Group (CIAAG), addressed the United Nations’ Commission on Narcotic Drugs today on the effects of the United States’ opioid crisis policies on chronic pain patients. CIAAG also proposed practical solutions to help monitor opioid use and ensure patients access to essential healthcare. Ms. Deluca warned, “Failure to protect patients’ rights to access essential medications and healthcare, will result in the loss of innocent lives through suicide, and inflate an already deadly issue into a human rights crisis.” Chronic Illness Advocacy & Awareness Group is working with Elected Officials and the patient community to help restore balance between protecting the public health from drug abuse and the safe, essential access to opioid analgesics for the chronically ill, older persons, and persons with disabilities. Learn more at CIAAG.net

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FOX6 in Milwaukee, Wisconsin coverage of pain-opiate protest

Posted on September 26, 2018 by Pharmaciststeve

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Corresponding responsibility or irresponsibility ?

Posted on September 26, 2018 by Pharmaciststeve

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Another example of a healthcare corporation taking away the professional discretion from their employed Pharmacists.  They use the “excuse”  of corresponding responsibility as justification for their actions.  Corresponding Responsibility is suppose to be a “two way street”… making sure that valid medications reach patients that need them and preventing the diversion of controlled substances.

Apparently some large corporations – like Walmart – that basically “dabble in providing healthcare”  have decided that they have the right to revoke the professional discretion of their employed Pharmacists and insert a corporate edict for them to follow.

Unfortunately, in this country we have a serious and growing Pharmacist surplus. Currently for ever TWO new pharmacists that we need, the pharmacy schools are graduating THREE. Some 5000 new pharmacists graduating every year looking for jobs that don’t exists. Pharmacists understand, don’t follow the corporate edict and you will be looking for a job.

Most/all boards of pharmacy have taken a similar stance..  their total focus seems to be on the prevention of diversion of controlled substances and those who have a valid medical necessity for controlled substance are just left to defend for themselves..

Since most of the 51 Boards of Pharmacy are “stacked” with non-practicing corporate Pharmacist and if you believe that these Pharmacists will stand up against the same corporations they work for…  you need a massive dose of REALITY.

The primary directive of the Boards of Pharmacy is to protect health/safety of the general public… and when individual pharmacists or healthcare corporations with pharmacies take the position that they are making a broad denial of care for certain pts… generally, the boards of pharmacy are as quiet as a “church mouse”

Generally speaking, independent pharmacies don’t “play games” with a pt’s necessary medications because you are dealing with the Pharmacist/owner and not a pharmacist that is being forced to walk in “lock-step” with their  corporate employers.

Here is a website that will help locate a independent pharmacy by zip code

http://www.ncpanet.org/home/find-your-local-pharmacy

 

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Nearly 500,000 people signed a petition to get LAST MAN STANDING back on the air

Posted on September 25, 2018 by Pharmaciststeve

Image result for last man standing tv show

https://en.wikipedia.org/wiki/Last_Man_Standing_(U.S._TV_series)

Nearly 500,000 people signed a petition to get the ABC cancelled show LAST MAN STANDING brought back after it was cancelled.

FOX has picked up the show returning this fall season…

I find it interesting that when there is a petition for something being done AGAINST – and can harm – the chronic pain community… MAYBE a couple of thousand will sign it.

I guess that getting a TV show’s cancellation reversed is more important.. since that 500,000 signatures is about 8%-10% of the typical number of viewers that watch the show in its last year on ABC than the chronic pain community standing up for themselves.

I have had chronic painers state that they don’t want to put their pain management at risk by taking a stand…  here is a NEWS FLASH !! you can’t keep your head low enough to avoid being noticed as a chronic painer !

 

 

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