Published reports of independent testing by the FDA, state agencies, and others consistently show that compounded drugs fail to meet specifications at a considerably higher rate than FDA-approved drugs.
Pharmacy compounding involves the preparation of customized medications that are not commercially available for individual patients with specialized medical needs. Traditional pharmacy compounding is appropriate when done on a small scale by pharmacists who prepare the medication based on an individual prescription.
the regulatory oversight of pharmacy compounding is significantly less rigorous than that required for Food and Drug Administration (FDA)-approved drugs; as such, compounded drugs may pose additional risks to patients. Continue reading
Morphine pumps dangerous glitch – SFGate – San Francisco Chronicle
For thousands of chronic pain sufferers, the Medtronic implantable morphine pump has been a godsend.
The size of a hockey puck, the high-tech gadget is tucked surgically under the skin of the abdomen — primarily in injury and cancer patients — and drips morphine and other painkillers from a reservoir directly into the spine.
But a dangerous complication, once thought extremely rare, has now turned up in scores of patients.
An inflamed mass of tissue develops at the tip of the tube where the drug enters the spine.
These “granulomas” can grow to the size of a golf ball, compressing the spinal cord and causing paralysis — either suddenly or slowly, and often irreversibly. With mounting urgency, surgeons are attempting to pinpoint why this is happening.
One possible culprit: the use of unapproved drugs to refill the half-ounce reservoirs during monthly visits to the pain clinic.
It has become a common practice in pain management to refill the pump’s built-in tank with medicines made from scratch by community druggists known as “compounding pharmacists.”
As we know from the New England case where hundreds of patients were poisoned by non-sterile compounded drugs injected into their spines, this industry is not tightly regulated.
Doctors can order all kinds of exotic mixes to be compounded for injection into the spine through epidural injections or implanted pain pumps. Such creative compounding is NOT regulated like oral drugs, so it’s the “wild west” of pain management.
Instead of prescribing the FDA-approved morphine, known as Infumorph, doctors can order higher concentrations of compounded morphine, or mix it with other medications such as clonidine that enhance the painkiller’s effect.
Compounders — druggists who make up all kinds of medicine from bulk powders — also make the painkillers dilaudid and fentanyl for use in the pumps.
MAKING MONEY FROM MIXING
Mixing morphine for use in pumps is a lucrative business for both compounders and the doctors who buy it.
Less than $5 worth of powdered morphine is needed to refill the pump for a month. Reimbursements to physicians who refill the pumps can be as high as $1,000 a month, although Medicare will pay about $250 for eligible California patients.
But the number of reports of granuloma cases — most of which have been found in the past two years — has sent pain doctors and Minneapolis pump- maker Medtronic scrambling.
“The fact of the matter is we do not know with medical certainty what causes these granulomas,” said Scott Ward, president of Medtronic’s neurological and diabetes division
NUMBERS APPEAR TO GROW
The first pump granuloma case was reported in 1991. Most recently, 41 were identified in the journal Neurosurgery by Dr. Kim Burchiel of Oregon Health & Science University and Dr. Robert Coffey of Medtronic.
Burchiel confirmed that since the article was submitted a year ago, the number of cases has grown to at least 74
The inflammation may be a chemical irritation “related to the properties of morphine itself.”
PHARMACIST SEES RISKS
Pharmacist Sarah Sellers, a consultant to an FDA advisory committee on pharmacy compounding, has been a longtime critic of using compounded drugs to fill implantable pumps.
Because compounders make the refills from bulk, unsterile powders, Sellers said, there is a risk of contamination not only from processing chemicals, but also from organic debris that can slip through filters designed to strain out bacteria.
Nevertheless, pain doctors contacted by The Chronicle are skeptical that the use of compounded drugs is related to the growing number of pump-related paralyses.
Sellers said that compounded drugs simply shouldn’t be used in morphine pumps tied directly to the spine.
When we take a drug orally it is exposed to and broken down by our caustic digestive juices, which can mitigate sterility and pollution problems.
But when a drug is injected directly into the major highway of our whole nervous system, our body cannot defend itself against any impurities.
“There’s nothing in the scientific literature to support these drug mixtures,” she said. “They are experimenting with patients, and billing a lot of money for it.”
I have several posts explaining the dangers of epidural injections, but I’ve heard they can be very effective for a subset of patients. Here is an interview with a proponent of this treatment.
Q: What is an epidural steroid injection?
Dr. Richeimer: This procedure involves injection of corticosteroids into the epidural space around the spinal cord and nerves.
It is most often used to treat spinal disorders of the low back (lumbar spine), and also may be used to treat disorders in the neck (cervical spine).
Injections, Stimulation, Pain Pumps, and Other Treatments
For many people living with chronic pain, finding pain relief can be tough. A lot of trial and error is involved to find a pain treatment that works. Interventional pain management may help chronic pain patients cope with their pain.
what makes interventional pain management different is that it uses techniques, such as injections and radiofrequency rhizotomy, to directly [and invasively] address the source of your pain.
Some conditions interventional pain management techniques commonly treat include: Continue reading
Practitioners need to understand and educate their patients regarding the full scope of potential side effects that can occur when receiving epidural steroids.
Corticosteroids are a common component of nearly all therapeutic injections for pain management that physicians perform.
Whether they are used in a trigger-point injection performed by a primary care physician in an office or in a precision cervical epidural injection performed under fluoroscopic guidance, steroids have become one of the most commonly used injectable pain medications in the United States. Continue reading
The Multi-Society Pain Workgroup (MPW), representing more than 100,000 physicians and 15 medical societies, has commended the Washington State Health Care Authority’s Health Technology Clinical Committee (HTCC) for preserving access to spinal injection therapies for back pain.
These “pain specialists” are expecting more patients will be submitting themselves to more profitable (for doctors) and dangerous (for patients) invasive “interventional” procedures. Continue reading
So, What IS Pain Management? – National Pain Report | Dr. David Nagel | April 2, 2016
Even medical professionals struggle to agree with what pain management is, and that creates a big problem.
There is a perception that pain management is all about needles and opioids, a perception that is unfortunately based on what happens in the real world.
Needling and prescribing pay well, managing pain does not, so too often pain patients are needled and drugged in a piecemeal fashion with no attempt to look at the big picture of their lives. Continue reading
Unnecessary multiple epidural steroid injections delay surgery for massive lumbar disc: Case discussion and review | Surg Neurol Int. 2015 | Free Full Text PMC Article
From the Conclusions section:
Unfortunately, pain specialists (e.g., radiologists, anesthesiologists, and physiatrists), not specifically trained to perform neurological examinations or spinal surgery, are increasingly mismanaging spinal disease with ESI/variants.
Epidural steroid injections (ESI) in the lumbar spine are not effective over the long-term for resolving “surgical” lesions.
Here, we present a patient with a massive L2–L3 lumbar disk herniation whose surgery was delayed for 4 months by multiple unnecessary ESI, resulting in a cauda equina syndrome. Continue reading
This information is from a PPT slide show created by Terri Lewis, PhD, who has kindly given me permission to post it here:
Interventional pain procedures are increasing more rapidly than opioid prescribing
- Between 2000 and 2013, the use of Interventional Pain Management Procedures increased by 236%. About one half of these procedures were adhesiolysis procedures or epidurals and half were facet joint interventions and SI blocks.
- During this same time the number of opioid prescriptions dispensed by US retail pharmacies climbed 64%, from 126 million to 207 million (the max was in 2010 with 219 million).
While opioid prescriptions increased by 64%, interventional pain procedures increased by 236%. Continue reading
Over the past several years, we have sought to undersAdd Newtand the risk of serious neurologic events that occur after the epidural injection of glucocorticoids (corticosteroids) to manage radicular neck and back pain.
Between 1997 and 2014, a total of 90 serious and sometimes fatal neurologic events were reported to the FDA Adverse Event Reporting System (FAERS), including cases of paraplegia, quadriplegia, spinal cord infarction, and stroke.
Potential causes of these adverse events included technique-related problems such as intrathecal injection, epidural hematoma, direct spinal cord injury, and embolic infarction after inadvertent intraarterial injection.