Tighter Restrictions Recommended for Vicodin and Hydrocodone Products

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Last Updated: 03 January 2016 03 January 2016

An advisory panel set up by the Food and Drug Administration (FDA) voted on Friday, January 25, 2013 for tighter restrictions to be placed on Vicodin and other hydrocodone products.

Vicodin/ hydrocodone products are currently classified by the U.S. Department of Justice Drug Enforcement Agency (DEA) as Schedule III Controlled Substances, a category of drugs considered to have a lesser potential for abuse than those in Schedule I and II.

Physicians can prescribe medications from the Schedule III category using one of several acceptable methods: written, oral (by phone), or by fax and this medication can be refilled 5 times within a 6 month period.

In contrast, prescriptions for Schedule II medications must be written out, one for each month, and with no refills. Physicians must follow additional rules, limits and reporting regulations as well as the pharmacies that dispense controlled drugs (in how these drugs are stored, record keeping, and notification protocols).

The DEA claims Vicodin/hydrocodone products are now the most frequently abused painkillers in the U.S., caused by fairly lax prescribing practices of Schedule III drugs. This agency asked the FDA to convene a panel to review and make recommendations about the reclassification of these specific pain medications. The majority of the panel viewed Vicodin/hydrocodone as being pharmacologically comparable to opioids and having similar potential for abuse, therefore, they recommended reclassification of these pain medications as Schedule II controlled substances (along with opioids).

Conflict of opinion surrounds this recommendation for tighter prescribing restrictions. Some members of the medical community, pain medicine societies, and advocates believe this change will cause undue hardship for patients.

Addiction specialists feel the extensive use and accessibility of these particular painkillers increases the risk of overdose, addiction and/or abuse, including by people who use them for non-medical reasons and who may steal them or obtain them illegally from drug dealers.

While the FDA has not yet made a decision as to whether it will adopt these recommendations, it is important to realize this is not a new development.

The debate and push (by way of public petitions) to have hydrocodone /hydrocodone-combination products be placed under the more restrictive category of Schedule II substances has been going on since 1999. A few months earlier, a leading national newspaper ran a story about tactics used by the DEA to crack down on the growing problem of painkiller use/abuse such as arresting doctors who were overprescribing these drugs and closing down pharmacies that dispensed too many painkillers or were charged with other violations.

Wholesalers have also been targeted (i.e., referred to as the “middlemen” between pharmaceutical companies and pharmacies) for sending large shipments of controlled substances to certain pharmacies or locations or being charged with failure to report suspicious shipments to the DEA—some distributors have lost their licenses as a result and others have restricted or terminated shipments to pharmacies that could pose a threat to them.

This problem appears to be worse in some states (like Florida, known for its “pill mills”) forcing patients to travel extensively in search of a pharmacy that would fill their prescription. While prescription drug abuse has increased substantially over the past 10 to 15 years, access to pain medication/ pain management needs to be protected for people who legitimately suffer from chronic pain.

The White House, Office of the National Drug Control Policy issued a Press Release on October 1, 2012 which describes a new program they will offer, White House Drug Policy Office and National Institute on Drug Abuse Unveil New Training Materials to Combat National Prescription Drug Abuse Epidemic. This program is created for physicians, medical interns and residents so they can learn how to properly prescribe pain medications and address prescription drug abuse. This initiative is sponsored by the National Institute on Drug Abuse (NIDA) which also allows participating healthcare professionals to earn continuing medical education (CME) credits.

For more information

“FDA Panel Votes for Tighter Controls on Vicodin” by Kristina Fiore (MedPage Today) published on January 25, 2013, available at: http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/37024

“F.D.A. Panel Votes to Restrict Drugs Like Vicodin” by Sabrina Tavernise (New York Times) published on January 25, 2013, available at: http://www.nytimes.com/2013/01/26/health/fda-vote-on-restricting-hydrocodone-products-vicodin.html

“A New Painkiller Crackdown Targets Drug Distributors,” by Barry Meier (New York Times ) published on October 17, 2012 available at:  http://www.nytimes.com/2012/10/18/business/to-fight-prescription-painkiller-abuse-dea-targets-distributors.html

“White House Drug Policy Office and National Institute on Drug Abuse Unveil New Training Materials to Combat National Prescription Drug Abuse Epidemic,”— Press Release issued on October 1, 2012, that can be viewed at:  http://www.whitehouse.gov/ondcp/news-releases-remarks/ondcp-nida-announce-new-elearning-tools-combat-rx-drug-abuse

Insights about FM and chronic pain

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Last Updated: 03 January 2016 03 January 2016

Studies and articles, published in 2012, that can help patients to better understand and manage their pain

[These are still relevant in 2015—Ed.]

"Anatomy of an Epidemic: The Opioid Movie" (MEDPAGE Today, 09/09/2012) John Fauber, Milwaukee Journal Sentinel/Medpage Today and Ellen Gabler, Milwaukee Journal Sentinel co-author an investigative report into the rapid rise of prescription painkiller sales over the past decade. A promotional video created by a leading pharmaceutical company in 1998 may have persuaded some doctors to prescribe their products (OxyContin, in particular). This article takes a second look at the use of opioid analgesics.

"Brain Activity Reflects Pain in Fibromyalgia"(this report is part of a 12-month Clinical Context series)(MedPage Today) Functional MRI was used to measure resting brain activity and connectivity and may provide an objective measure of pain in FM patients.

"Explaining Fibromyalgia to Others" by Kristin Thorson (Fibromyalgia Network, free article posted on 08/29/2012) This article looks at the challenges in trying to describe pain and symptoms of FM to other people.

"Fibromyalgia and the Brain: New Clues Reveal How Pain and Therapies are Processed" (American College of Rheumatology (ACR)) Research presented by Richard E. Harris, PhD, University of Michigan, Ann Arbor, MI, during the ACR 2012 Annual Meeting which examines the involvement of the µ-opioid system in the pathogenesis of Fibromyalgia and might explain patients’ response to certain analgesics.

Fibromyalgia: Current Status - Roland Staud, MD (National ME/FM Action Network, Canada) An informative 39 minute video featuring Dr. Staud, a pain specialist and professor at the University of Florida College of Medicine, and author of "Fibromyalgia For Dummies".

"Introducing 'Understanding UDT in Pain Care'" (Pain-Topics.org - News/Research Updates, article published 08/27/2012) Stewart B. Leavitt, MA, PhD and Gary M. Reisfield, MA conduct a review of the "Clinical Complexities and Medical Mandates" (Part 1) surrounding urine drug testing (UDT) of patients in a pain management setting. Though they recognize UDT as an important part of patient monitoring, they also point out that "when UDT is motivated by fear and coercion, rather than diagnostic and therapeutic objectives, it can be offensive or intimidating to patients and misunderstood or misused by practitioners."

"Is the Deficit in Pain Inhibition in Fibromyalgia Influenced by Sleep Impairments?"(Bentham Open) Full access article (free) to a Canadian study evaluating sleep problems in Fibromyalgia, published in The Open Rheumatology Journal, 2012, 6, 296-302. This study found a relationship between inhibitory conditioned pain modulation (ICPM) efficacy and sleep quality, more precisely sleep effectiveness, in a significantly large sample of patients with Fibromyalgia (FM). This study also suggests the association between sleep problems/impaired sleep and ICPM may be closely linked to FM pathophysiology.

"My Pain Diary: Chronic Pain Management v1.982 for iPhone Now Available" (PRWeb, Jan. 19, 2012)  A new app now available for iPhone and iPod Touch offers a convenient/ effective way for patients to record, report, and manage their chronic pain conditions.

“New Understanding of Chronic Pain” Although this Science Daily article does not directly discuss ME/CFS or fibromyalgia, it  points out how metabolites can give direct indication of disease biochemistry and lead to potential treatments for chronic pain (which is present in ME/CFS and FM).

"Opioids on Trial, But Where's the Evidence?" (Pain-Topics.org - News/Research Updates, article posted 08/08/2012) Stewart B. Leavitt, MA, PhD takes a critical look at how some Congressional Caucus members may influence decisions made on use of opioid analgesics for chronic noncancer pain (i.e., by limiting dose, length of treatment, and other restrictions) without balanced review of medical evidence.

PainEDU.org  is a site which is a wealth of information concerning pain for patients and providers. Be sure to check out the extensive interactive and non-interactive sources provided on their "Tools" page (click on "Tools" located along the top menu bar).

Pain Pathways magazine (http://www.painpathways.org/) was created by Dr. Richard Rauck, in 2008 as a resource for people living with pain or those caring for others in pain. Several recent articles worth checking out are the following:

"7 Steps to Maintaining Healthy Relationships When You’re in Pain" Very timely and sound advice by Kevin E. Wilson, Ph.D., clinical faculty member of the Wake Forest University School of Medicine’s Pain Fellowship Program on the toll that chronic pain and health problems take on our relationships and what we can do.

"Making the Most of Your Doctor Visit"  This article reviews tools (like charts and pain logs) that can help patients record and monitor their pain— these are provided by the American Chronic Pain Association (ACPA).

"Guided Imagery: A Valuable Tool for Managing Pain"  An overview of a technique that can help patients manage their pain (ways to shift one's focus away from pain) and be incorporated into their daily routine.

"Top 5 Drugs That Can Cause Pain" by Dr. Christina Lasich (HealthCentral, 08/06/2012) Review of medications used to relieve pain which may actually generate pain (i.e., such as over-the-counter (OTC) non-steroidal anti-inflammatory drugs, those containing caffeine as well as several prescription drugs).

Fibromyalgia studies 2012

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Last Updated: 08 November 2015 08 November 2015

This is a recap of studies and relevant articles on Fibromyalgia which were published during 2012 (formerly posted on our News around the Web page).

"Working Memory Impairment in Fibromyalgia Patients Associated with Altered Frontoparietal Memory Network" (PLoS One) A study conducted by Korean researchers using functional magnetic resonance imaging (fMRI) to demonstrate differences in working memory between FM patients and healthy subjects.

“Cardiac autonomic impairment and chronotropic incompetence in fibromyalgia”
(da Cunha Ribeiro et al, Arthritis Research & Therapy 2011, 13:R190 doi:10.1186/ar3519) Research by a team of rheumatologists at University of Sao Paulo School of Medicine, Brazil, that found some patients with FM experienced various cardiac irregularities in response to exercise.

“Autonomic dysfunction in women with fibromyalgia” — an editorial in response to the article published by Ribeiro and colleagues in Arthritis Research & Therapy, supporting the finding of autonomic dysfunction at rest in FM patients.

Research on Fibromyalgia Skin Sensitivities (Fibromyalgia Network) Researchers provide answers about what might be causing itchy or burning sensations and other skin sensitivities frequently experienced in FM.

New Device Cuts Fibromyalgia Pain in Pilot Study (Clinical Psychiatry News Digital Network) Results from a small pilot study of FM patients who were treated with an investigational transcranial stimulation device designed to target a region deep in the brain linked to chronic pain.

Developments in Fibromyalgia Treatments 2012

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Last Updated: 03 January 2016 03 January 2016

This group of articles, published in 2012 at various sources, evaluates status of commonly prescribed recommendations and treatments for Fibromyalgia.

"Fibro Doctors Chose Pfizer Over You "(Fibromyalgia Network, posted May 30, 2012) An editorial by Kristin Thorson, founder and editor of the Fibromyalgia Network, on the FibroCollaborative Roadmap for Change program. Disclaimer: This editorial is being provided as a source of information. The opinions expressed are those of the author and do not necessarily state or reflect the views of Massachusetts CFIDS/ME & FM Association.

"Fibro Out-of-Control?" (One of the free, sample articles available at Fibromyalgia Network) Dr. Charles Lapp and Dr. Carol Beals explain why FM symptoms get worse and offer ways to tackle.

"Increase in Diagnosis Rates and Penetration into New Markets Drives the Global Fibromyalgia Therapeutics Market, According to New Report by Global Industry Analysts, Inc." (PR Web) An article that takes a look at unmet medical needs for Fibromyalgia from a business standpoint.

"Low-Dose Naltrexone for Autoimmune Diseases and Fibromyalgia? The Unfinished Story" (ProHealth, Dec. 21, 2011)

“Milnacipran Beneficial for Fibromyalgia in Patients With Inadequate Response to Duloxetine” (Monthly Prescribing Reference (MPR)   Review of two FM-specific medications (i.e., milnacipran (brand name, Savella) and duloxetine (brand name, Cymbalta) that includes study observations/ recommendations made by Dr. Lucinda Bateman at The Fatigue Consultation Clinic in Salt Lake City, UT.

"Omega-3 Trial Suggests 'a Nutritional Supplement Might Actually Make a Difference in Aging'" (ProHealth) An interesting article examining some of the benefits of supplemental omega-3 fatty acids as shown in a trial, "Omega-3 fatty acids, oxidative stress, and leukocyte telomere length: A randomized controlled trial," by Kiecolt-Glaser JK, et al. Ohio State University College of Medicine and College of Public Health; University of California, San Francisco, CA, published in Brain, Behavior, and Immunity, Sept. 23, 2012.

A study of 1555 FM Patients provides valuable insight on longitudinal outcome of FM

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Last Updated: 08 November 2015 08 November 2015

The Journal of Rheumatology, July 2011 issue, published a comprehensive study that examined symptoms in 1,155 Fibromyalgia (FM) patients (i.e. their severity and overall change or stability) on a semi-annual basis for up to 11 years. Initially all patients satisfied the American College of Rheumatology preliminary 2010 FM criteria modified for survey research.

The study revealed, amongst other things, that variability of symptoms caused 44% of patients to fail to meet FM criteria at least once over the study period.

The researchers found that about 10% of patients had substantial improvement and about 15% had moderate improvement of pain over the study period.

Overall, FM severity worsened in 35.9% and pain in 38.6%. This study could help physicians and patients to develop more realistic expectations about the course of FM.

View the abstract and find out how to access the full text article.