Pain Medicine News - Abuse-Deterrent Labeling Approved for Reformulated OxyContin

Pain Medicine News - Abuse-Deterrent Labeling Approved for Reformulated OxyContin

Abuse-Deterrent Labeling Approved for Reformulated OxyContin

The FDA has approved updated labeling for reformulated OxyContin (oxycodone hydrochloride controlled-release, Purdue) tablets, effectively putting a nail in the coffin for potential generic opioid formulations that do not have abuse-deterrent properties.
   The new labeling states that reformulated OxyContin is imbued with “physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting),” according to a press release from the FDA announcing the approval.
   The FDA further announced that the reformulated OxyContin is therapeutically equivalent to original OxyContin, which ceased delivery to pharmacies in August 2010 due to safety concerns (the abuse-deterrent version of the agent was introduced in April 2010). The agency added that given that the original version’s higher risk for some forms of abuse and misuse “the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness.” Thus, the FDA stated at the time of the new approved labeling it would not consider for approval new drug applications for generic agents based on the approval of the original, discontinued version of OxyContin.

   OxyContin was approved by FDA in its original form in 1995. The original formulation went off patent on April 16.

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Transdermal PCA in Acute Postoperative Pain Management

http://www.painmedicinenews.com/ViewArticle.aspx?d=Special+Reports&d_id=94&i=March+2013&i_id=935&a_id=22676

Transdermal PCA in Acute Postoperative Pain Management: A Critical Evaluation of the Investigational IONSYS System

	REPORT Transdermal PCA in Acute Postoperative Pain Management: A Critical Evaluation of the Investigational IONSYS System Acute postoperative pain con- tinues to be undertreated, with up to 75% of patients in the United States failing to receive adequate postoperative pain relief.1,2 Postoperative pain man- agement was revolutionized with the introduction of patient-con- trolled analgesia (PCA) using IV or epidural delivery routes more than 20 years ago.3 Opioids are the primary treatment for acute pain management,4 either alone or increasingly as part of a multi- modal analgesic strategy—char- acterized by administration of 2 Chair Eugene R. Viscusi, MD Professor of Anesthesiology Director, Acute Pain Management Thomas Jefferson University Philadelphia, Pennsylvania Faculty John Fanikos, RPh, MBA Director of Pharmacy Business Brigham and Women’s Hospital Boston, Massachusetts Michael H. Huo, MD Despite advances in pain man- agement technology, the advent of acute pain services, and pro- fessional practice guidelines aimed at improving postoperative pain management, inadequacies and treatment gaps still exist, and improvement remains a priority.7 An analgesic intervention that might help to mitigate clini- cian concern is the fentanyl ion- tophoretic transdermal system (IONSYS), a credit card–sized, self-contained, and prepro- grammed investigational product candidate intended to provide
	or more drugs (eg, opioid and nonopioid analgesics, used in combination) that act by different mechanisms, and along differ- ent pain pathways—an approach that is recommended by the American Society of Anesthesi- ologists (ASA) and the American existing PCA modalities have limitations that include inva- sive access, challenges in titration of analgesic effect, cumbersome pump technologies, impaired patient mobil- ity, and limited drug preparations that have been associ- ated with programming, medication, and dosing errors. pain relief for adult inpatients requiring opioids following sur- gery.8 It is a needle-free system that is applied to the skin on the upper arm or chest.8 A generally imperceptible electrical current then delivers a small dose of fen- tanyl directly through the skin and into the systemic cir- culation. The FDA approved IONSYS in 2006; however, it was never launched in the United States due to required changes in manufacturing. The enhanced design will be reviewed by the FDA in the near future for use in patients with moderate to severe postoperative pain. Professor Department of Orthopedic Surgery UT Southwestern Medical Center Dallas, Texas Pain Society.5,6 However, More from Link above

Pain Medicine News - Study Warns of Dearth of US Neurologists

Pain Medicine News - Study Warns of Dearth of US Neurologists

Americans who need to see a neurologist may face longer wait times or have more difficulty finding one, reported a new study published in the April 17, 2013, online issue ofNeurology^®, the medical journal of theAmerican Academy of Neurology(AAN). The findings are being released as nearly 150 neurologists will meet on Capitol Hill on Tuesday, April 23 to encourage Congress to protect patients’ access to neurologists.

“We want Congress to act now to help alleviate this shortage,” said Timothy A. Pedley, MD, FAAN, president of the AAN, the world’s largest association of neurologists. “Neurologists are the physicians best suited to care for the one in six people currently affected by neurologic disease. It is therefore vital that they have access to neurologists who are specially trained in treating brain diseases.”

More in link above 

Rare Disease Legislative Advocates

https://www.facebook.com/Rare.Disease.Legislative.Advocates?fref=ts

Rare Disease Legislative Advocates

Clearing house for all Rare Disease Legislation Legislative Action Center – Online tools to write your Congress Member Latest news from the Rare Disease Congressional Caucuswww.RareDiseaseLegislativeAdvocates.org

Does Weather Affect Joint Pain

http://www.webmd.com/pain-management/features/weather_and_pain?page=2

Does Weather Affect Joint Pain?

How the weather can affect joint pain, and what to do about it.

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How Might Weather Cause Pain? continued...

But barometric pressure often drops before bad weather sets in. This lower air pressure pushes less against the body, allowing tissues to expand -- and those expanded tissues can put pressure on the joint. "It's very microscopic and we can hardly notice, except that we have these sensations," Jamison says.

Furthermore, when people have chronic pain, sometimes nerves can become more sensitized because of injury, inflammation, scarring, or adhesions, Jamison says.

"For whatever reason, the nerves are just hypersensitive, and they just keep firing, based on what you do -- or not for any reason at all. But if there's some expansion internally -- in other words, the body can either expand or contract based on outside pressure changes -- then that's going to affect how pain is signaled."

Nevertheless, the link between pain and weather changes remains hypothetical; research has come to mixed conclusions, Jamison says. "All the results are not very clean, meaning there are people who say that weather doesn't affect their pain."

Borenstein agrees that there's no consensus, but he finds barometric pressure a likely explanation because it does affect people's bodies.

"It's not metaphysical; it's actually physical. It's the same kind of thing that you have with people who go up in a plane or [astronauts]," he says. "They are creatures of the atmosphere."

At higher altitudes, there's less barometric pressure and our bodies react accordingly, Borenstein says. "When there's less pressure, we expand," he says. For example, he notes, even though plane cabins are pressurized, our feet often swell during a flight, but not while we're seated at our desks for similar amounts of time at sea level.

Should You Move to Florida or Arizona?

It's a question that doctors hear all the time from arthritis patients.

"People with chronic pain, if they can't get out as much -- and it's so cold all the time or rainy or snowy -- then they think, ‘Boy, I'd like to go some place where the weather isn't quite so dramatic,'" Jamison says of his patients in Boston.

Though he doesn't advise against moving to warmer climes, he does try to offer realistic expectations. "There's no heaven on earth," he says. "If you have awful back or neck pain ... there's a good chance that that pain will travel with you."

In fact, in Jamison's research, people from San Diego reported the greatest sensitivity to weather changes -- a surprise finding, considering that it had the warmest climate, compared to Nashville and the two Massachusetts cities.

San Diegans in his study noticed pain even with small changes in weather. "You think of San Diego and the temperature is always mild -- it never gets too cold or particularly too hot -- but with just a small change, people with pain still reported that they could detect it," Jamison says. "I think as mammals, we kind of adjust to our climate."

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Use of Opioids for the Treatment of Chronic Pain (Feb 2013)

Use of Opioids for the Treatment of Chronic Pain A statement from the American Academy of Pain Medicine
Proper management of pain is a high priority in the United States.
According to the recent Institute of Medicine Report on Pain, 100 million Americans suffer from pain. Treatment of pain costs the United States more than half a trillion dollars per year. Pain is one of the most common reasons people consult a physician. Yet it frequently is inappropriately treated.
In the last several years, health-policymakers, health professionals, regulators, and the public have become increasingly interested in the provision of better pain therapy and in the reduction of drug diversion and addiction. However, there is currently no nationally accepted consensus for the treatment of chronic pain not due to cancer. Moreover, the economic and social costs of chronic pain are substantial.
Federal and State laws and policies about opioid use are currently undergoing revision. The trend is to adopt laws and guidelines that specifically recognize the use of opioids to treat intractable pain. These statements serve as indicators of increased public awareness of the sequelae of undertreated pain and help clarify that the use of opioids for the relief of chronic pain is a legitimate medical practice.
Due to concerns about drug misuse, diversion and addiction, and regulatory scrutiny, physicians may want guidance as to what principles should generally be followed when prescribing opioids for chronic or recurrent pain states. Regulators have also expressed a need for guidelines to help them to distinguish legitimate medical practice from questionable practice and to allow them to appropriately concentrate investigative, educational, and disciplinary efforts, while not interfering with legitimate medical care.
The American Academy of Pain Medicine offers these Statements on the Use of Opioids for the Treatment of Chronic Pain:

I.

Legislation and Regulatory Policies Should Limit Inappropriate Prescribing But Should Not Discourage Or Prevent Prescription Of Opioids Where Medically Indicated And Appropriately Managed.
The United States is in a critical phase of national and state policy development with respect to the use of opioids in pain treatment. There has been recent interest in this issue in both the United States Senate and the House of Representatives. State legislatures have enacted laws intended to reduce the prevalence of “pill mills” which have led to overprescribing of opioids with little to no medical necessity.

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II.

AAPM supports legislative actions which limit inappropriate prescribing while, at the same time, allow access for patients who suffer from moderate to severe pain. The purpose of laws that govern controlled substances and professional conduct is to protect the public. Thus, we believe that federal and state policies should be directed at reducing the problem of improper drug diversion and abuse while, at the same time, allowing appropriate medical treatment.
AAPM does not advocate the imprudent use of opioids. However, if a practitioner responsibly decides to treat chronic pain with opioids, we offer this document as a guide to the judicious use of these drugs in the course of medical practice.
Prescription Of Opioids For Chronic, Intractable Pain Is Appropriate When More Conservative Methods Are Ineffective And The Treatment Plan Is Reasonably Designed To Avoid Diversion, Addiction, And Other Adverse Effects.
AAPM believes that pain should be diagnosed and treated in a comprehensive, systematic, collaborative, patient-centered fashion. Many strategies and options exist to treat and to manage chronic pain. Since chronic pain may have myriad causes and perpetuating factors, treatment strategies and options include interventional techniques, cognitive and behavioral methods, rehabilitation approaches, and the use of medications, including, where medically indicated, opioids.
In many cases, there is no cure for chronic pain. Therefore, treatment goals and clinical focus include pharmacologic and non-pharmacologic methods to improve the management of pain, improve quality of life, and decrease suffering. AAPM advocates a collaborative approach which includes biological, psychological, and social interventions in order to improve pain control and psychosocial functioning.
Chronic opioid therapy (COT) should be reserved for those who have intractable chronic pain that is not adequately managed with more conservative or interventional methods. AAPM does not advocate opioids as a first-line therapy, but we believe that these medications may be useful if prescribed in a judicious manner as part of a logical progression of treatment. Of course, the physician must prescribe in a manner calculated to avoid addiction, diversion, respiratory depression, dependence, and other adverse effects. We also believe that responsible prescription of opioids should not be inhibited by fear of criminal prosecution or regulatory action.
Physicians Should Be Sensitive To And Seek To Minimize The Risks Of Addiction, Respiratory Depression And Other Adverse Effects, Tolerance, And Diversion. However, Some Commonly Held Assumptions About These Issues Need To Be Reviewed.
Addiction: Addiction is a neurobiological, compulsive disorder in which an individual becomes preoccupied with obtaining and using a substance-- and experiences a lack of control over using that substance -- despite continued use that results in a decreased quality of life and significant adverse consequences. Addiction is a serious problem that should be considered as a possibility in all patients receiving opioids. Physicians should act responsibly to reduce the risks of addiction. However, misunderstanding of addiction and mislabeling of patients as addicts may result in unnecessary withholding of opioid medications. In all cases, the physician must balance the possibility of addiction against the benefits of the therapy – striving always to reduce the risk of the former. In some cases, however, treatment by an addiction medicine specialist may be indicated.

III.

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IV.

Respiratory depression and other adverse effects: Fear of inducing respiratory depression is often cited as a factor that limits the use of opioids in pain management. While respiratory depression can occur with patients taking opioids, this risk can generally be minimized if certain precautions are followed. For instance, concomitant use of other neuro-depressive drugs, such as benzodiazepines and alcohol, should be viewed with great caution, since the combination of these drugs has been shown to increase the risk of serious adverse events. In addition, caution with dosing and titrations is indicated for patients with underlying diagnoses such as sleep apnea or end-stage respiratory disease due to the increased risk of cardio-respiratory events. There is emerging data suggesting that COT can be associated with central sleep apnea, although the details of the association are not well understood. Finally, patients do not develop complete tolerance to the respiratory depressant effects of opioids and the risk of respiratory depression increases as dose increases, regardless of how long one is on opioids. Additionally, people on COT who develop respiratory infections or asthmatic attacks may be at risk of hypoxia. Dose decreases during these events should be considered.
Tolerance: It was previously thought that the development of analgesic tolerance limited the ability to use opioids effectively on a long-term basis for pain management. Tolerance, or decreasing pain relief with the same dosage over time, has not proven to be a significant impediment to long-term opioid use. Experience with treating cancer pain has shown that what initially appears to be tolerance is usually progression of the disease. In the noncancer patient, the failure to respond to increasing doses of opioids should be evaluated very carefully. The possibilities include tolerance, disease progression, non-opioid responsive pain syndromes, and opioid-induced hyperalgesia.
Diversion: Diversion of controlled substances should be a concern of every health professional. Attention to patterns of prescription requests and the prescribing of opioids as part of an ongoing relationship between a patient and a healthcare provider can decrease the risk of diversion. Urine and/or blood drug screening, frequent follow up and patient contact, and pill counts are some commonly used clinical interventions that may be helpful in ruling out the issue of diversion. Periodic review of state prescription monitoring program databases, where available, is also a useful tool to monitor compliance and adequacy of communication.
Opioids Should Be Prescribed Only After A Thorough Evaluation Of The Patient, Consideration Of Alternatives, Development Of A Treatment Plan Tailored To The Needs Of The Patient And Minimization of Adverse Effects, And On-Going Monitoring And Documentation.
AAPM believes that guidelines for prescribing opioids should be an extension of the basic principles of good professional practice.
Evaluation of the patient: Evaluation should initially include a pain history and assessment of the impact of pain on the patient, a directed physical examination, a review of previous diagnostic studies, a review of previous treatments, a drug history, and an assessment of coexisting diseases or conditions. When appropriate, the patient should undergo a baseline drug screening exam.
Treatment plan: Treatment planning should be tailored to both the individual and the presenting problem. Consideration should be given to different treatment modalities, such as an

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© 2013 American Academy of Pain Medicine - Approved February 2013

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© 2013 American Academy of Pain Medicine - Approved February 2013

interventional approach, a formal pain rehabilitation program, the use of physical medicine and psychological and behavioral strategies, or the use of medications, depending upon the physical and psychosocial impairment related to the pain. Opioids should be prescribed only if the physician reasonably concludes that other treatment modalities will be inadequate to address the patient’s pain. If a trial of opioids is selected, the physician should ensure that the patient or the patient’s guardian is informed of the risks and benefits of COT and the conditions under which opioids will be prescribed. AAPM has recently updated its guidance for the proper consent for the use of opioids. A trial of opioids implies setting expectations that the medications will be prescribed for a short period of time. Continued use will be contingent upon demonstrated improvement in analgesia, physical function and quality of life – and absence of significant adverse events and maladaptive behaviors.
Consultation as needed: Consultation with a Pain Medicine or other specialist may be warranted, depending on the expertise of the practitioner and the complexity of the presenting problem. The management of pain in patients with a history of addiction or a comorbid psychiatric disorder requires special consideration.
Periodic review of treatment efficacy: Review of treatment efficacy should occur frequently to assess the functional status of the patient, continued analgesia, adverse effects, quality of life, and indications of medication misuse. Monitoring of compliance is a critical aspect of chronic opioid prescribing, using such tools as random urine drug screening, pill counts, and where available, review of prescription monitoring data base reports. Close follow-up and reexamination is warranted to assess the nature of the pain complaint and to ensure that opioid therapy is still indicated. Attention should be given to the possibility of a decrease in global function or quality of life as a result of opioid use.
Documentation: Documentation is essential for supporting the evaluation, the reason for opioid prescribing, the overall pain management treatment plan, any consultations received, and periodic review of the status of the patient. 

Drs Neurosurgeon 's Worldwide

Tuesday, 24 July 2012

Drs Neurosurgeon 's Worldwide

Dr's NS, treating Tarlov Cyst Patients Worldwide

Feigenbaum, Frank, M.D. (Neurosurgeon) Main Office: 9080 Harry Hines Blvd, Ste 210, Dallas, Texas 75235

Phone             (214) 351-8450        /  Fax (214) 351-8451
Satellite Office: 12330 Metcalf Ave, Ste 500B, Overland Park, KS 66213

Midwest Neurosurgery Associates, PC 
6420 Prospect Ave., Suite T411 
Kansas City, MO 64132 
Phone:             816/363-2500       
Fax: 816/363-8741 
Link to Dr. Feigenbaum's website: http://www.frankfeigenbaum.com 

Patient Support Group, 

tarlovcystsurvival @yahoogroups.com  New Members Welcome,

Research Medical Center Kansas City, MO./Tarlov Cyst Institute 

Henderson, Fraser C. Sr. M.D. (Neurosurgeon) 
The Metropolitan Neurosurgical Group, LLC 
7830 Old Georgetown Rd 
Bethesda, MD 20814-2432 
Phone             301/654-9390       
Fax: 301/654-9394 
Note: To seek a consultation with Dr. Henderson, you will need to make an appointment with his office to see him. Please do NOT mail your MRIs and medical information to him requesting a consultation. 


Kathuria, Sudhir, M.D. (Interventional Neuroradiologist) 
Johns Hopkins Medical Institute 
Department of Interventional Neuroradiology 
600 N. Wolfe Street 
Radiology B-100 
Baltimore, MD 21287 
Phone:             410/955-8525       
Fax: 410/614-8238 

Long, Donlin ,M.D. (Neurosurgeon) 

Joppa Green II 2328 West Joppa Road 
Suite 103 
Lutherville Maryland 21093 
Phone:             410-828-7513       

Link to Dr. Long's website: www.donlinlong.com 

Note: Dr. Long retired from clinical practice at Johns Hopkins Medical Institute effe. His new practice will focus on spinal diseases, which are painful, including patients with perineural cysts. He will not be actively involved with surgery for Tarlov cysts but will refer surgical patients to active surgeons. 

Although Tarlov cyst surgery is no longer being performed at Johns Hopkins Hospital, the aspiration & fibrin glue injection procedure is still being performed at JHH by Dr. Sudhir Kathuria, Interventional Neuroradiologist (contact information above) 



Schrot, Rudolph J., MD (Neurosurgeon) 
Assistant Professor 
Department of Neurological Surgery 
University of California at Davis 
4860 Y Street, Suite 3740 
Sacramento, CA 95817 
Phone:             916-734-6511       
*This phone number is a direct line to Robert Dillman, Admin. Asst. to Dr. Schrot 
If you reach a message machine, please leave your name, contact number, and that you are a Tarlov cyst patient; 
Mr. Dillman will return your phone call. 
Fax: 916-703-5368 




Canada 
Murphy, Kieran M.D. MB FRCPC FSIR (Interventional Neuroradiologist) 
Vice Chair Deputy Chief Medical Imaging 

University of Toronto 
399 Bathurst Street 
Toronto, Ontario M5T 2S8 
Canada 
Phone:             416-603-5800       Ext. 2393 
Fax: 416-603-4257 

the aspiration & fibrin glue injection procedure for Tarlov cysts treatment is postponed until further final approval of the Research Ethics Board. 

Please do not send MRIs for consultative review or request a consultation with Dr. Murphy until final approval is received. 


Europe 
NOTE: Phone numbers to Europe are complete with International codes/country codes/city codes. 

France 
Maitrot, Daniel M., M.D. (Neurosurgeon) 
Department of Neurosurgery, Faculty of Medicine 
The Université Louis Pasteur 
67098 Strasbourg CEDEX, Strasbourg, France 
Phone: 011 33 388.12.76.14 and 15 
Zollner, Georges, M.D. (Interventional Neuroradiologist) 
Department of Neuroradiology 
The Université Louis Pasteur 
67098 Strasbourg CEDEX, Strasbourg, France 
********** 
Italy 
Marcettini, Paolo, M.D. (Neurologist with specialty in Pain Management) 
dell' Ospedale San Raffaele di Milano 
Milan, Italy 
Phone: 011 39.02.2643.3206 

Brazil 
Arantes, Aluizio, M.D. 
Belo Horizonte 
Brazil