“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
While this is good news AT THE STATE LEVEL… but it does nothing to deal/stop with the actions of the DEA.
It would seem that the DEA has changed its practices and today Linda Cheek posted a article on a doctor and there is no mention of any DEATHS that were attached to the doctor’s practice https://doctorsofcourage.org/gilbert-ross-ghearing-md/
It would appear that the DEA is now looking at the GROSS NUMBER of controlled substances Rx written/dispense or the GROSS NUMBER of doses written/dispensed. Typically they report a LARGE NUMBER with maybe a date range but no number of pts involved nor the medical issues of those pts. Apparently they have done some data mining is some database that they can extract these numbers.
They presume from those large numbers that one or more Rxs were NOT FOR A VALID MEDICAL NEED which is a violation of the Controlled Substance Act and then if any are billing to Medicare or Medicaid. Then the doc is charged with Medicare/Medicaid fraud because billing for unnecessary medical services provide.
Recently DEA fined several CVS stores 535,000 for allegedly filling at total of 39 forged/fake C-II Rxs over a undisclosed time frame. This is almost $14,000 fine per forged Rx filled !
No one went to jail, no license was suspended for violating both the State practice act and CSA
Other than having one fake/forged Rx found by a pharmacist and turning it over to the DEA.. how else did they find the other fake Rxs other than do some data mining for the particular drug and particular prescriber and where they were filled and went to those particular store to look at those particular Rxs ?
To the best of my knowledge all state practice acts have parallel verbiage of the Federal Controlled Substance (CSA) act so if the DEA rolls into town and charges a prescriber with violating the CSA, boards will have little choice but to suspend the prescriber’s state license.
In the long term, this new law may end up being nothing more than a FEEL GOOD LAW and may end up being no more than a “paper tiger”
Drug Company Warned By FDA Over Illegal Online Sales
In a win for consumer safety, the FDA issued a warning letter to CanaRx, a pharmacy business based out of Ontario, Canada, for facilitating the illegal distribution of unapproved and misbranded drugs to American consumers.
The company would contract with public and private organizations, and get foreign physicians to rewrite employees’ prescriptions. They would then fulfill these with non-FDA approved drugs. NABP’s Pharmacy Verified Websites Program is one way consumers and health care providers can ensure the safety and legitimacy of pharmacy and pharmacy-related websites. Consumers who buy medicines from NABP-verified websites can be confident they are buying medicine from trustworthy, legitimate pharmacies. An easy way to know that a website has been verified by NABP is to look for the .pharmacy suffix at the end of the web address. A list of safe online pharmacies and related resources can be found on the Find a Safe Site section of www.safe.pharmacy.
FROM: The United States Food and Drug Administration
RE: Causing the Introduction of Unapproved and Misbranded Drugs into Interstate
Commerce
DATE: February 26, 2019
WARNING LETTER
The United States (U.S.) Food and Drug Administration (FDA) recently reviewed your websites listed at the bottom of this letter and determined that you and your affiliates cause the introduction of unapproved new drugs and misbranded drugs into interstate commerce in violation of sections 301(a), 301(d), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), and 355(a)]. While this letter refers to CanaRx Services Inc/CRX Intl (hereinafter CanaRx), the violations discussed apply to all entities conducting business by or on behalf of CanaRx. FDA requests that you immediately cease causing the distribution of violative drugs to U.S. consumers.
UNAPPROVED NEW DRUGS
CanaRx operates as a prescription drug provider that engages in activities to cause the introduction of unapproved new drugs from foreign sources into the United States in violation of the FD&C Act. Because these products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or affect the structure or function of the body, these products are drugs within the meaning of section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)]. These products are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No FDA-approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)].
Specifically, CanaRx contracts with public and private sector employers throughout the U.S. to provide select prescription drugs to employees. CanaRx acts as a broker between foreign pharmacies and the employer-sponsored health insurance plan to provide enrolled employees with prescription drugs. CanaRx accepts the employee’s U.S. prescription and facilitates its reissue under the direction of a foreign physician. The reissued prescription is subsequently filled by a pharmacy contracted by CanaRx in that foreign physician’s jurisdiction. The foreign pharmacy then ships the drug directly to the employee in the U.S. For each shipment, CanaRx uses the same templated invoice, which contains the standard disclaimer, “[d]epending on your country, our medications may appear to be different in size, shape or color.” Having this disclaimer in each invoice demonstrates that CanaRx has designed its business to operate in a manner that substitutes the FDA-approved drugs prescribed by the U.S. healthcare provider with unapproved drugs. This distribution scheme is particularly concerning, as employees are likely inclined to trust that they will receive safe and effective drugs through their employer’s “insurance” plan and may not question their legitimacy.
The substitution of FDA-approved prescription drugs with unapproved drugs poses significant health risks to U.S. consumers. For example, CanaRx offers certain drugs on its medication lists for which the FDA-approved version is subject to a Risk Evaluation and Mitigation Strategy (REMS) program, has a narrow therapeutic index, and/or is indicated to treat serious conditions such as HIV, cancer, or hepatitis. CanaRx also offers numerous maintenance medications that are indicated for conditions such as high blood pressure, high cholesterol, and acid reflux. Furthermore, the FDA-approved versions of several drugs listed on CanaRx’s medication lists have been subject to one or more recalls in the U.S. FDA has established processes to recall unsafe, substandard, and poor quality drugs within the legitimate U.S. drug supply chain. No such safeguards exist for unapproved drugs illegally distributed in the U.S. from foreign sources such as those provided through CanaRx. Therefore, many of the foreign versions of FDA-approved drugs substituted by CanaRx may also have been subject to recalls that were not carried out in the U.S. CanaRx’s operation does not appear to provide U.S. consumers with any protection or recourse should they receive or be harmed by drugs that may have been recalled in a foreign country.
In addition, several of the unapproved versions of FDA-approved drugs offered by CanaRx have different trade names and/or dosage amounts in their labeling than their FDA-approved counterparts. Such differences can cause patient confusion and lead to medication errors. Moreover, the substitution of FDA-approved prescription drugs with unapproved versions that may have substantially different risk profiles can pose serious health risks to consumers, especially in vulnerable patient populations that suffer from serious conditions such as HIV, cancer, or hepatitis. Unapproved drugs do not have the same assurance of safety and efficacy as drugs subject to FDA oversight and may be subpotent, superpotent, or adulterated with unknown active ingredients. Treatment with drugs that may be subpotent, superpotent, or adulterated in such vulnerable patient populations can lead to drug resistance and/or therapeutic failures, and jeopardize the effectiveness of alternative drug therapies on patient outcomes.
Examples of drugs offered on CanaRx’s medication lists and a general description of their respective indications are depicted in the table below. These include drugs that are for vulnerable patient populations with serious medical conditions. Such vulnerable patient populations may have received drugs subject to a recall or may have experienced medication errors due to receiving drugs with different dosages or risk profiles, which can lead to side effects that are life-threatening.
Baraclude (hepatitis)
Norvir (HIV)
CellCept (organ rejection)
Reyataz (HIV)
Foradil (asthma, COPD)
Stivarga (cancer)
Gilotrif (cancer)
Tegretol (epilepsy, nerve pain)
Gleevec (cancer)
Tracleer (pulmonary arterial hypertension)
Inlyta (cancer)
Truvada (HIV)
Invirase (HIV)
Zortress (organ rejection)
MISBRANDED DRUGS
Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a practitioner licensed by law to administer such drugs. Because CanaRx advises consumers that their U.S. prescriptions are being filled with less expensive, foreign approved drugs, CanaRx intends for these drugs to be used as prescription drugs. This is especially concerning considering that CanaRx offers drugs that have a narrow therapeutic index (NTI) on its medication lists. One such drug currently offered by CanaRx is Tegretol. Substituting an NTI drug without the U.S. prescriber’s direction poses significant health risks to patients. In particular, small differences in dose or blood concentration for NTI drugs may lead to serious therapeutic failures or adverse drug reactions that are life-threatening, or result in persistent or significant disability or incapacity.
A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). The drugs obtained through CanaRx are intended to treat conditions that are not amenable to self-diagnosis and treatment by persons who are not medical practitioners. Therefore, adequate directions for use cannot be written for these drugs, and they must qualify for one of the exemptions to section 502(f)(1) to avoid being misbranded. The exemption to section 502(f)(1) found at 21 CFR § 201.100 does not apply to unapproved new drugs because that exemption requires that such drugs bear “the labeling authorized by the approved new drug application.” Furthermore, unapproved new prescription drugs also do not qualify for the exemption set forth at 21 CFR 201.115, which also requires an approved new drug application (NDA) or active investigational new drug application (IND). Consequently, a prescription drug that is a new drug and has not been approved by FDA, or is not subject to an exemption from the premarketing approval requirements under the FD&C Act, cannot qualify for the exemptions to section 502(f)(1). Because none of the exemptions to section 502(f)(1) apply, these drugs are misbranded under section 502(f)(1).
These drugs are also misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)] because they fail to bear “adequate warnings against use…where [their] use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application….” This is particularly concerning because certain drugs offered by CanaRx are subject to REMS programs (e.g., Tracleer and CellCept). Specifically, the REMS program for Tracleer restricts distribution to minimize: the risk of fetal exposure and serious birth defects in female patients who are exposed to Tracleer and the risk of liver damage in patients who are exposed to Tracleer. Prescribers must order and review pregnancy tests prior to the initiation of treatment, monthly during treatment, and for one month after stopping treatment. In addition, prescribers must order and review liver function tests prior to the initiation of treatment and monthly during treatment. Furthermore, to comply with the REMS program for Tracleer, this drug must be mailed to patients from pharmacies certified in the REMS program. Pharmacies are also restricted from dispensing more than a 30-day supply and must verify the required testing prior to dispensing. The REMS for CellCept requires healthcare providers to report pregnancies to a registry and has an educational component regarding fetal toxicity. CanaRx is causing important safety measures that are put in place for the FDA-approved versions of these drugs to be bypassed.
By causing these products to be shipped to U.S. consumers, CanaRx is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
* * *
FDA is taking this action against CanaRx because of the risks posed by its conduct in facilitating the importation of unapproved new drugs and misbranded drugs to U.S. consumers. FDA’s regulation and oversight of the drug approval process protects consumers by requiring rigorous scientific standards for new drug approval, labeling review for accuracy and completeness, and manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. Unapproved new drugs and misbranded drugs do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight, and may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
Substituting an unapproved drug for the FDA-approved drug prescribed by a patient’s healthcare practitioner can negatively affect patient outcomes because the health care practitioner may unknowingly make subsequent treatment decisions based on the patient’s response to the unapproved drug. This can also cause potentially dangerous drug interactions with the patient’s other medications. In addition, sourcing drugs from uninspected, unregulated, and/or unknown supply chains can result in serious health consequences, especially in vulnerable patient populations, which may receive medications that are adulterated and are not shipped and/or stored properly.
This letter is not intended to identify all the ways in which your activities might be in violation of U.S. law. You should promptly cease causing the distribution of unapproved new drugs and misbranded drugs to U.S. consumers and correct all other violations of the FD&C Act. Failure to do so immediately may result in further regulatory action, including seizure or injunction without further notice.
Please notify this office in writing within 10 working days of receipt of this letter of any steps you have taken or will take to correct the violations set forth above and to prevent their recurrence. If the corrective action(s) cannot be completed within 10 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response, and any other inquiries concerning this letter, should be sent to FDA’s Internet Pharmacy Task Force at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.
Study: Oregon patients using physician-assisted suicide steadily increase
The number of patients using the nation’s first physician-aided suicide program, Oregon’s Death with Dignity Act, has continued to grow since voters first approved the law nearly two decades ago.
A new study shows a 12 percent yearly increase in lethal prescriptions from 1998 to 2013, with an unexplained jump of nearly 30 percent in 2015. The research doesn’t include 2016 numbers, which haven’t been released yet.
The growth reflects an increased awareness of the act among patients and physicians as more states adopt similar laws, said Dr. Charles Blanke, an Oregon Health & Science University oncologist and lead author of the study.
The study – one of the first detailed analyses of 18 years of Death with Dignity data – indicates the law is working as intended to give dying people a choice of how they want to die, Blanke said.
But it also shows too many people – 25 percent – said they were suffering too much pain, he said.
Blanke called that a tragedy, saying scientists must make sure patients aren’t killing themselves because they’re not getting help managing their pain.
Another tragedy: About 3 percent of patients used the law because the cost of chemotherapy was too high, the study found.
“What’s worse than that – literally nothing,” Blanke said.
Overall, 1,545 patients obtained a lethal prescription from 1998 through 2015. On average, 64 percent took the drugs. Almost all died but six people woke up and died later of natural causes.
The age range spanned 25 to 102 years, with a median of 71. Nearly 80 percent of the patients had cancer.
Most patients cited a decreased quality of life or loss of autonomy or dignity as reasons for using the law, according to the study, published Thursday in the Journal of the American Medical Association – JAMA Oncology.
Under the law, two physicians must certify that patients have a terminal illness and have only six months left to live. The physicians must determine that the patient is competent. If they have doubts, they can insist that the patient see a psychologist or psychiatrist.
Very few patients had a psychological consultation – only 5 percent.
Brian Johnson, a consultant for the California-based group, Seniors Against Suicide, and a former California commissioner on aging, said the study shows that patients were deeply depressed.
“This is a cry for help,” he said. “Suicide is the number one indicator of depression.”
Instead of writing a lethal prescription, the medical community should address the patient’s emotional state, he said.
“We don’t talk people off the edges of buildings in order to keep sidewalks clean,” Johnson said.
“We intervene in their lives because this individual is dealing with something they’ve never before dealt with.”
Blanke said research has shown that as many as three in four terminal patients are depressed.
“Either we’re missing depression,” Blanke said, “or it’s possible that physicians agree that depression is not enough to make a person incompetent to make such an important decision.”
The prescriptions – usually for 100 capsules of secobarbital that the patient must empty into water – aren’t cheap, ranging from $3,200 to $7,700 depending on the pharmacy. Another possibility involves a triple cocktail of much cheaper drugs and costs about $400 total, but it’s acidic and the patient stays in a coma for much longer.
The study showed that as a median, patients went into a coma within four minutes and died within 25 minutes.
The coma is like being anesthetized, said Blanke, chairman of SWOG, a worldwide network of scientists who conduct cancer trials. The blood pressure and pulse slow and the person doesn’t react to discomfort, indicating they’re not in pain, he said.
Almost all patients took the drugs at home, surrounded by loved ones. Physicians can’t administer the drugs and the law doesn’t require them to be there. In only 16 percent of cases, they were, the study shows.
Blanke has issued about 65 prescriptions since the law began. For years, he didn’t ask patients if they’d like him to be present but then realized they might. Since he’s asked, every patient has said yes. He’s attended about 30 deaths.
“It has a profound impact on the prescriber,” he said. “I find it quite moving. I end up being very close with the families.”
Blanke thinks more people would want their physician present but that doctors don’t ask.
Also, many physicians refuse to write Death with Dignity prescriptions, Blanke said, and won’t
even
refer patients to a doctor who supports the law.
Physicians at Providence Health & Services, a Catholic medical group, do not write prescriptions of lethal drugs, for example.
The study shows that physicians aren’t focusing lethal medications on disadvantaged people, an original concern about the law.
“Except for the 25 percent with poor pain control, the law is working nearly perfectly,” Blanke said.
He said the area is for research to help physicians better control pain, learn why one-third of patients don’t take the prescriptions and why some people experience a prolonged coma.
Five other states have laws supporting physician-assisted suicide. Another 25 are considering legislation, according to the advocate group, Death with Dignity.
The Oregon Catholic Conference, which represents the Archdiocese of Portland and the Diocese of Baker, expressed concern about the increase in patients.
“Assisted suicide laws make suicide socially acceptable,” it said in an email. “As a result, Oregon’s overall suicide rate is 41 percent higher than the national rate. Assisted suicide, like other forms of suicide, has negative effects on victims and families.”
The conference called on physicians to improve pain care for end-of-life patients.
The distances between the EPIDURAL area and the INTRATHECAL area is JUST MILLIMETERS. Anything injected into the intrathecal area (spinal fluid) has to be not only sterile, but also preservative free and a solution – as opposed to a suspension.
While injecting a corticosteroids in the epidural area is/can be troublesome.. it is when the person doing the injection inserts the needle just “a tad” to far and the medication gets injected into the intrathecal area is when “all hell breaks loose” for the pt and the pt ends up with adhesive arachnoiditis A very painful and IRREVERSIBLE condition.
It is stated that there are 10 million ESI’s given every year and 5% of the pts will end up with adhesive arachnoiditis Should this be considered a MALPRACTICE issue ? Could this be considered UNPROFESSIONAL CONDUCT by practitioners that are providing these treatments ?
Will this video shared with law firms give them enough ammunition to file lawsuits for personal injury ?
Would this video shared with members of Congress persuade them to get Medicare/Medicaid to stop paying for these procedures ?
Death of Columbine survivor Austin Eubanks renews discussion on opioid crisis
Greg Gutfeld and Kennedy and Eliz Mac Donald on Fox cable and Fox business are all PRO OPIATE but apparently the rest of the “talking head” are left to use their on air time to rant about their opiate phobias and biases
It is claimed that 10 million Epidural Spinal Injections (ESI) are given every year and 5% of the pts who get these ESI’s end up with Adhesive Arachnoiditis https://en.wikipedia.org/wiki/Arachnoiditis which is a very painful and irreversible condition. Generally caused by the practitioner inserting the needle a “bit to far” and end up injecting fluids into the spinal fluid.
The only medication(s) that can be safely injected into that the spinal fluids must be not only STERILE, but must also be PRESERVATIVE FREE and a SOLUTION – NOT A SUSPENSION.
The class of medications used in ESI’s – Cortisteroids – and particularly Methylprednisolone is ONLY STERILE, contains PRESERVATIVES and is a SUSPENSION.
That same class of medication is discouraged by both the FDA and the company that discovered/produces it – Pfizer – to be used in ESI’s.
These ESI’s at $1000 to $3000 a pop means that Medicare/Medicaid/Insurance is putting out 10’s of billions of dollars EVERY YEAR. Not to mention the untold number of pts that are added to the list of pts suffering with Adhesive Arachnoiditis and how many are not getting proper pain management for a disease caused by a careless healthcare professional ?
Pain clinics that “force” pts to get routine ESI’s with the promise of relief of pain for weeks or months and in reality the pt may only get relief for days or weeks, or requiring pts to get ESI’s at certain intervals because the “insurance will pay again”.. even though the relief of pain has left weeks/months ago.
Often pts are told that they must get ESI’s and/or other procedures that do not provide the promised relief in order for the prescriber to provide the pt with oral pain meds.
it was 60 billion in 2016 alone JUST FOR MEDICARE. Billing for medically unnecessary procedures is considered FRAUD.
Is it time for pts of these “needle jockey” pain clinics to start taking notes because some/many of you are going to get dismissed from the practice at some time in the future, often for nebulous or fabricated reasons. This is the time to BLOW THE WHISTLE… don’t call and file a complaint with Medicare, contact your Federal Senators or Representatives.
Successful whistler blower cases the whistle blower gets a percentage of what is recouped. If you have already been tossed out of the practice… why not try to get some revenge ?