Anarchy will Trump Opioid Manufacturing Limits

Share with others

Veterans Day is a reflective national holiday to honor those that severed in the US Military. These are the brave men and women that made personal sacrifices to ensure that all citizens, EVEN THOSE WITH CHRONIC PAIN SYNDROMES, are treated fairly and respectfully.  Yet, lawmakers and politicians have bastardized that unalienable right in an effort to gain popularity without consideration to The People.

I remind our readers that the Declaration of Independence states; “We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness.”

When arbitrarily setting limits on opioid manufacturing, if clinicians are willing to prescribe an alternative opioid that is available, it may be less desirable and more dangerous for their patient. Of equal concern is that as patients move from one opioid to another it raises the risk of accidental overdose and it also creates shortages of other opioids not on the list below. This will affect all patients whether they have chronic noncancer pain, acute pain, and end-of-life pain even in the hospice setting.

The very freedoms that our Veterans fought to preserve are being trampled on and trumped by Opioid Manufacturing Limits. As outlined HERE, citizens in pain have lost their independence, at times have NO LIFE to speak of, and NO LIBERTY because they are captivated by pain.

Here to sort out this new limit on controlled substance manufacturing are Drs. Lisa Dragic, Mena Raouf, and Erica Wegrzyn.  Each of these fine young clinicians should be commended for dedicating a year or more to caring for veterans.  This is what they had to say…

The Facts

In the United States two federal agencies oversee drug products, the US Food and Drug Administration (FDA) and the US Drug Enforcement Administration (DEA).1,2 The FDA is charged with protecting public health by ensuring safety and efficacy of medications.2 The DEA classifies drugs by their risk of abuse and medical benefit.3 Schedule I drugs, substances, or chemicals are defined as drugs with no currently acceptable medical use and have a high potential for abuse. Some examples of a schedule I medication would be marijuana, heroin, and lysergic acid diethylamide (LSD).2 Schedule II medications have a high potential for abuse, but do have an acceptable medical use. Some examples of schedule II medications include those such as hydromorphone or oxycodone. Under the Controlled Substance Act, the DEA regulates the production of all schedule I and schedule II drugs by establishing production quotas.

Quotas

Aggregate Production Quota (APQ) determines the total amount of controlled substances needed to meet an estimated medical, scientific, and research demands.1 This report determines the allowable manufacturing limits for each substance within the United States each year. In the 2015 Federal Register notice, the DEA increased the quotas of several opioids due to comments from the public expressing concern that there were insufficient amounts to provide for the estimated medical needs within the United States.3 Among those medications that saw an increase in production was hydromorphone at 7,000,000 grams, oxymorphone (for conversion) at 29,000,000 grams, and codeine (for sale) at 49,500,000 grams.3 While some medications and substances saw an increase in production, others medications such as amphetamines, tapentadol, and methadone saw a decrease.3 In 2015, the DEA allowed 37,500,000 grams of Amphetamine, a stimulant often used for Attention Deficit/Hyperactivity disorder (ADHD) and narcolepsy, to be manufactured.3 Down 13,000,000 grams from 2014. Tapentadol saw a 5,000,000 gram decrease in production from 2014 to 2015 and Methadone saw a 4,500,000 gram decrease without distinguishing between use as an analgesic or for opioid abuse disorder.3

2017 Quotas

On October 4th, 2016, the DEA announced its plan to reduce almost all Schedule II opioid medications manufacturing by nearly 25% or more for 2017.4,5 This established quota came after the DEA posted: “Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2017” on July 22, 2016.2 This proposal allowed for public comments for one month and received a total of 13 comments. Five comments were from DEA-registered manufacturers and four were non-DEA registered entities.2 Several of the commenters expressed concerned regarding the proposed decrease in production. One commenter requested “transparency in the process of setting aggregate production quotas.”2

After review of thirteen comments, 2016 manufacturing quotas, current 2016 sales and inventories, the DEA removed the additional 25% from the aggregate production quotas for 10 products including the following opioids; Hydromorphone, Levorphanol, and Opium tincture.

How does this compare to the 2015 Quota1-3?

Pharmacologic Class Drug Final 2015 Quotas (grams) Final 2016 Quotas (grams) Quota Change

(grams)

Opioids
Codeine (for sale)* 49,500,000 45,000,000 -4,500,000
Fentanyl 2,150,000 1,750,000 -400,000
Hydrocodone (for conversion)** 137,500 122,000 -15,500
Hydrocodone (for sale) 99,625,000 58,410,000 -41,215,000
Hydromorphone 7,000,000 5,140,800 -1,859,200
Methadone Intermediate 34,375,000 25,600,000 -8,775,000
Oxycodone (for conversion) 8,350,000 2,610,000 -5,740,000
Oxycodone (for sale) 137,500,000 108,510,000 -29,990,000
Oxymorphone (for conversion) 29,000,000 22,300,000 -6,700,000
CNS Stimulants
Amphetamine (for conversion) 21,875,000 12,000,000 -9,875,000
Lisdexamfetamine 29,750,000 19,000,000 -10,750,000
Methylphenidate 83,750,000 73,000,000 -10,750,000
Methamphetamine  2,061,375 1,539,100 -522,275

*For Sale: If you do not change the basic drug class

**For Conversion: If you change the basic drug class

Much of the reduction of these schedule medications is due in part to the removal of the 25% “buffer” that was added to protect against drug shortages from 2013-2016.2 Of the reductions listed, hydrocodone will take a 66% manufacturing cut and oxycodone a 46% cut, respectively. These manufacturing cuts went into effect as of October 5th, 2016.2


Need for better-established quotas

This wouldn’t be the first time the public and other agencies have criticized the APQ system for controlling production of controlled substances. In 2011 and 2012, the DEA received pressure from patients and legislatures to increase the quota of amphetamines.6,7 This was because many patients with  ADHD found it extremely difficult to obtain their medications. In response to this, the DEA increased manufacturing of amphetamines from 25.3 million grams to 49 million grams in 2014.1 The final quota for amphetamine manufacturing for 2017 is 42.4 million grams.2 Amphetamines isn’t the only medication class affected by drug shortages. From 2001 to 2013 there were an estimated 168 drug shortages, some of which lasted for nearly a year. Many of these reported shortages involved pain relievers.8

Drug shortages prevent both providers and patients access to essential medications for medical treatment. In efforts to gain control of these drug shortages, The FDA Safety and Innovation Act (FDASIA) required the FDA and the DEA to work together to increase the production of medications known to be experiencing a shortage; However, a report published by the U.S Government Accountability Office (GAO) showed that there is a need for better management of the quota process and coordination between the two agencies.8 The GAO report found that the DEA is lacking accuracy when it comes to the data in its Year-End Reporting and Quota Management System (YERS/QMS). In 2011, it was estimated that 44% of the YERS/QMS had errors and 10% in 2012.8 Additionally, the DEA states that it does not have set protocols, policies, training materials, or other documentation to manage this quota process.8 Due to the report findings, the GAO recommended that the DEA take actions to improve its management of the quota system. While the DEA did not agree or disagree, they raised multiple objections to the report produced by the GAO.

CDC Guidelines

The DEA has been under political pressure to reduce the supply of opioids.7,10 A letter was sent by a group of US Senators including Dick Durbin (IL) Sherrod Brown (OH), Edward Markey (MA), Amy Klobuchar (MN), Angus King (ME), and Joe Manchin (WV) to the DEA demanding a reduction in the opioid quotas. “We agree and believe efforts to halt this widespread epidemic will not be successful unless we use every tool at our disposal. We urge DEA to utilize its existing quota setting authority, to the fullest extent possible, to combat this epidemic“, the Senators stated in the letter. 10

The call for reductions of opioid production coincide with recent guidelines published by the CDC earlier this year. These guidelines focused on reducing opioids for chronic pain in efforts to combat the misuse and overdose of these medications.9 Although most of the reduction in opioid manufacturing is believed to be due to the removal of the 25% buffer, one can only wonder to what degree could the guidelines have influenced the DEA’s decision. For years, the DEA has experienced pressure to reduce the quota for opioid manufacturing. In fact, just this past summer a group of U.S senators urged the DEA to reduce the quota for opioid production.10 The DEA’s own press release cites the CDC guidelines recommendation for reducing opioid prescribing and states, “For years, DEA and others have been educating practitioners, pharmacists, manufacturers, and the public about the potential dangers of the misuse of opioid medications.”5 With the publication of the CDC guidelines and the DEA’s reduction of opioid production you can bet that legitimate patients suffering from chronic pain will find it hard to get the medications they need.  This could and will likely increase the risk of suicide among patients suffering from chronic pain and no doubt will fuel the black market for heroin, carfentanil increasing deaths, crime, infectious risks from illegal administration with needles, etc.

You may recall the infamous pharmacy crawl, following the crackdown on Florida pill mills in 2012, which forced legitimate pain patients with legal prescriptions for opioids to travel from one pharmacy, to another, and another in efforts to fill their prescription. 11,12 Eventually, some chronic pain patients turned to heroin and illicit substances.  While prescription drug overdoses may have declined in Florida, a noticeable rise in heroin and illicit fentanyl overdoses deaths was seen.13-14 History may be repeating itself here, and this time the impact could be greater and on a national level. The concern this time is not only a nationwide pharmacy crawl, but also institutions and hospitals unable to provide opioids to patients where use is indicated.

We are certainly not advocating for a wider opioid use.  There is no doubt that opioids are overprescribed but for a prudently selected subset of the population for whom other treatment options are not viable, opioids may be appropriate therapeutic options. However, efforts to curb addiction and drug abuse should not inflict greater harm on patients by limiting their access to pain relief and improved quality of life. The pendulum has swung too far and we hope the war against opioids does not continue to come at the expense of chronic pain patients.

History tells us that lawmaking around opioids is myopic at best, as outlined in Are State Lawmakers Calling for Suboptimal Physician Pain Education, which points out the ludicrous expectation that 3 hours of mixed education will qualify a medical provider to be an expert opioid prescriber.

Albert Einstein nailed it when defining insanity, “…doing the same thing over and over again and expecting different results.”  You can be sure that anarchy will #trump opioid manufacturing limits which became law on October 16, 2016.  We’ll see you back here to discuss the resultant panic on Veterans Day 2017.

As always, comments are welcome!


Below Left to Right: Drs. Lisa Dragic, Jeff Fudin, Mena Raouf.

Left to Right: Drs. Lisa Dragic, Jeff Fudin, Mena Raouf, Erica Wegrzyn

 

Dr. Dragic received her PharmD from Temple University School of Pharmacy and is currently a PGY1 pharmacy Resident at the Samuel S. Stratton VA Medical Center in Albany, NY, with a concentration in pain management and palliative care. Upon completion of the PGY1 residency, Dr. Dragic hopes to complete a PGY2 in Pain Management and Palliative care. Dr. Dragic aspires to be a leader in her chosen profession with focus on patient advocacy.

Dr. Raouf is a PGY-1 Pharmacy Resident at the VA Tennessee Valley Healthcare System. He received his PharmD from Albany College of Pharmacy and Health Sciences, with a concentration in nephrology. He completed an advance practice rotation in pain management under the mentorship of Dr. Jeffrey Fudin at the Stratton VA Medical Center, where he developed a strong interest in pain management and continued to volunteer thereafter as a student pharmacist. He has been involved in developing an automated software platform to assess pre-validated risk for opioid-induced respiratory depression to qualify patients for in-home naloxone. Following his PGY-1 residency training, Dr. Raouf hopes to pursue a PGY-2 in Pain Management.

 

10425387_10153363652926248_2898143228029211280_n

 

Left is Dr. Erica Wegrzyn. Dr. Erica Wegrzyn is currently completing a PGY-2 Pain and Palliative Care Residency
at the Stratton VA Medical Center, Albany NY. Dr. Wegrzyn received her PharmD from Western New England
University College of Pharmacy, Springfield MA and completed a PGY-1 residency at Maine General Medical Center, Augusta ME.
Prior to completing her PharmD, Dr. Wegrzyn also received her bachelors’ degrees in Biochemistry and Music (trombone) from Ithaca College.



 


References

  1. Gaffney A. Government Report Slams DEA for Oversight of Drug Production Quota System. 2016. Available at: Available at: http://www.raps.org/Regulatory-Focus/News/2015/05/07/22120/Government-Report-Slams-DEA-for-Oversight-of-Drug-Production-Quota-System/. Accessed October 10, 2016. Accessed October 7, 2016.
  2. Established Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2017. Federal Register. 2016. Available at: https://www.federalregister.gov/documents/2016/10/05/2016-23988/established-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances-and-assessment. Accessed October 7, 2016.
  3. Gaffney A. DEA Establishes Production Limits for Painkillers, With Some Drugs Set for Big Increases | RAPS. Rapsorg. 2016. Available at: http://www.raps.org/Regulatory-Focus/News/2014/09/05/20229/DEA-Establishes-Production-Limits-for-Painkillers-With-Some-Drugs-Set-for-Big-Increases/. Accessed October 7, 2016.
  4. DEA Reduces Opioid Manufacturing for 2017. Pharmacy Times. 2016. Available at: http://www.pharmacytimes.com/news/dea-reduces-opioid-manufacturing-for-2017. Accessed October 7, 2016.
  5. gov / Headquarters News Releases, 10/04/16. Deagov. 2016. Available at: https://www.dea.gov/divisions/hq/2016/hq100416.shtml. Accessed October 7, 2016.
  6. Harris G. F.D.A. Finds Short Supply of Attention Deficit Drugs. Nytimescom. 2014. Available at: http://www.nytimes.com/2012/01/01/health/policy/fda-is-finding-attention-drugs-in-short-supply.html?_r=2&hp. Accessed October 7, 2016.
  7. Anson PAnson P. DEA Cutting Opioid Supply in 2017. Pain News Network. 2016. Available at: http://www.painnewsnetwork.org/stories/2016/10/4/dea-cutting-opioid-supply-in-2017. Accessed October 7, 2016.
  8. Controlled Substances: DEA Needs to Better Manage Its Quota Process and Improve Coordination with FDA. Gaogov. 2016. Available at: http://www.gao.gov/products/GAO-15-494T. Accessed October 7, 2016.
  9. Dowell D, Haegerich T, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016.MMWR Recomm Rep. 2016;65(1):1-49. doi:10.15585/mmwr.rr6501e1er.
  10. Available at: http://www.painnewsnetwork.org/stories/2016/10/4/dea-cutting-opioid-supply-in-2017. Accessed October 7, 2016.
  11. Durbin Sends Letter to DEA Calling for Stricter Limits of Opioid Pills | U.S. Senator Dick Durbin of Illinois. Durbinsenategov. 2016. Available at: http://www.durbin.senate.gov/newsroom/press-releases/durbin-sends-letter-to-dea-calling-for-stricter-limits-of-opioid-pills-. Accessed October 7, 2016.
  12. State report shows Florida heroin deaths reached all-time high in 2014. Tampa Bay Times. 2016. Available at: http://www.tampabay.com/news/publicsafety/state-report-shows-florida-heroin-deaths-reached-all-time-high-in-2014/2247848. Accessed October 7, 2016.
  13. Anson PAnson P. Fentanyl Blamed for Half of Massachusetts Overdoses. Pain News Network. 2016. Available at: http://www.painnewsnetwork.org/stories/2016/5/10/fentanyl-blamed-for-half-of-massachusetts-overdoses. Accessed October 7, 2016.
  14. Anson PAnson P. Is ‘Malicious Actor’ Behind Fentanyl Overdoses?. Pain News Network. 2016. Available at: http://www.painnewsnetwork.org/stories/2016/8/8/is-malicious-actor-behind-fentanyl-overdoses. Accessed October 7, 2016.

 

 

 

 

 

 

 

 

 

8 thoughts on “Anarchy will Trump Opioid Manufacturing Limits

  1. My question is for Dr. Raouf. I live in the TN Valley (saw his position listed) outside of Bristol TN/Va.
    Could someone, for the love of God, point me in a direction to receive some humane pain care?If its in palliative or PM clinic I care not, be it in Western NC, NE TN, or SW VA, I am near to all. I have sarcoidosis(neuro involvement), MCTC, CVID, and due to steroid induced osteoporosis in my spine 5 fractured vertebtrae two almost completely collapsed (one >80% other >90%) which no surgeon will touch due to my meds and delicate nature of my spine. I was taking antibotics and antifungals while awaiting infusions of Ig just to keep me alive. I met w/a PM clinic I was a patient in good standing w/over 13yrs ago. I was not even seen by a doctor on my 1st visit but a NP who lectured me on the evils of methadone’s long term side effects. I was given up for dead a yr ago and he’s telling me I may lose testosterone this is insanity! IF I live to deal w/these problems I will be overjoyed because it will mean I am alive. These people are running scared but rather than man up they are taking the threats to cut people off and running w/the narrative of being CONCERNED! Western NC or SW Va or NE TN are all fine, anywhere w/in 100 miles would do, otherwise I am considering making monthly trips back to GA, it beats laying on a couch for life. I am incredibly active for my conditions IF I have what are not excessive amounts of opioid medications. Addicts are given 2-3 times as much for less than a stubbed toe. Please forward my request to the doctor my situation is becoming desperate.

  2. I always thought the dea was there to get criminals why have they been allowed for years to make a war on chronic pain patients???and to make it be ok for us to be discriminated against by pharmacies.

    1. Don’t believe what some in the dishonest media tell you about this. The pharmaceutical industry has spent millions to deceive you. The proof can be found in the simple expression, “follow the money.” Who stands to gain if the government ignores corrupt practitioners, rogue Internet pharmacies, and pill mills? The answer is obvious. Taking advantage of desperate pain patients to protect a multi-billion-dollar industry raises ethical questions with which we all should be concerned.

  3. WHY WONT ANYONE HELP TO STOP THESE EVIL IDIOTS already. Ppl got the dea to drop the kratom ban right away but we hace diagnosed medical issues n noone will help usml this is just sickening and evil. Why dobt they just do background checks on all patients and whoever hadls criminal drug charges Drop them that would solve all of this and make the true pain patients stop being forced to be discriminated against and suffer this is just unbelievable anyone can get away w doing this. If i could move out of this country i would have long ago. I have no help and dont make enough to survive on and forced to work oart time w all my physical issues AND STILL barely survive if they make me go through withdrawal EVERY MONTH or cut my meds again i won’t be able to wotk at all,.PLEASE FIND SOMEONE WHO HAS A BRAIN AND A HEART TO HELP US I AM SICK AND TIRED OF BEING PUNISHED and discriminated against FOR SOMETHING I NEVER ASKED FOR

  4. Jeff: Your guest bloggers have done a nice job in their research but their conclusions belie an unfamiliarity with some of the underlying systems in their study. In 1970, when Congress enacted the Controlled Substances Act, Section 826(a-f) established the requirements for setting annual quotas for the manufacture of Schedule I and II controlled substances. The Act directs that the quotas will be set “to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks.” (21 USC 826a)
    In 1931, an international treaty titled, “Limiting Manufacture and Regulating Distribution of Narcotic Drugs,” was put forth by the then-League of Nations’ Opium Advisory Commission to which the United States sent observers and in which the United States played an active role even though it was never a member of the League itself. This treaty set conditions for drug producing countries to estimate the needs and consumption levels of opioids and other drugs and to report these figures each year to the League. The purpose was to prevent diversion and abuse.
    Germany, at the time the world’s largest producer of codeine-based medications, argued that codeine was less addictive than morphine and heroin and deserved less international control. The negotiators finally arrived at a compromise that established two tiers or “schedules” that would show codeine products in the lower tier. The United States ratified this treaty on April 8, 1932. Under Article VI of our Constitution, the provisions set forth in the treaty became domestic law on that date.
    The League dissolved itself during World War II but its offices and functions were assumed by the newly constituted United Nations in 1945. In 1961, the UN promulgated a new treaty called the “Single Convention on Narcotic Drugs.” This treaty brought under a “single” agreement all previously executed drug treaties, including the 1931 treaty. The United States was a party to the 1961 Single Convention. The 1970 Controlled Substances Act, in part, was enacted by Congress to comply with the provisions in the Single Convention and those in previously executed drug treaties.
    Essentially, this is how both the drug quota and the drug scheduling laws were established (the original two schedules of the 1931 treaty were expanded to four in the 1961 treaty and the United States added an additional schedule in its 1970 domestic legislation).
    The Code of Federal Regulations sets forth the procedures for setting drug quotas.
    The relevant portions of the Code state the following:
    (a) The Administrator shall determine the total quantity of each basic class of controlled substance listed in Schedule I or II necessary to be manufactured during the following calendar year to provide for the estimated medical, scientific, research and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks.
    (b) In making his determinations, the Administrator shall consider the following factors:
    (1) Total net disposal of the class by all manufacturers during the current and 2 preceding years;
    (2) Trends in the national rate of net disposal of the class;
    (3) Total actual (or estimated) inventories of the class and of all substances manufactured from the class, and trends in inventory accumulation;
    (4) Projected demand for such class as indicated by procurement quotas requested pursuant to § 1303.12; and
    (5) Other factors affecting medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Administrator finds relevant, including changes in the currently accepted medical use in treatment with the class or the substances which are manufactured from it, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires. [highlighted emphasis added]
    As stated in Subsection (b)(1), the net disposal by the class of all manufacturers during the current and two preceding years must be taken into consideration by the DEA administrator in setting annual production quotas. According to the Automation and Consolidated Orders System (ARCOS), a database for collecting and collating orders and transactions involving certain controlled substances, the summaries of retail drug purchases (roughly equal to the disposal amount mentioned in (b)(1)) show that the aggregate production quotas for amphetamine, hydrocodone and oxycodone – the three drugs mentioned by your guest bloggers – are virtually identical to the disposal amounts recorded by ARCOS in 2014 and 2015. I’ve constructed two tables showing this and I’ve summed the various purchases made by specific business activities authorized to handle controlled substances at the retail level.

    2014 Summary for Retail Drug Purchases by Business Activity
    Amphetamine Hydrocodone Oxycodone
    Pharmacies 16,603,512.31 35,885,092.97 54,322,092.80
    Hospitals 443,382.20 1,777,385.64 2,920,699.61
    Practitioners 3,236.84 200,624.92 36,368.26
    Teaching Institutions 9.54 91.70 …
    Mid-Level Practitioners 27.15 5,025.33 3,286.14
    NTF 13.3 … …
    Totals 17,050,181.34 37,868,220.56 57,282,446.81

    2015 Summary for Retail Drug Purchases by Business Activity
    Amphetamine Hydrocodone Oxycodone
    Pharmacies 18,087,570.01 30,891,515.62 54,642,102.54
    Hospitals 470,126.00 1,890,137.82 2,881,725.22
    Practitioners 2,543.96 89,265.88 44,057.69
    Teaching Institutions 8.81 106.61 …
    Mid-Level Practitioners … 1,182.59 2,500.68
    NTF 16.73 36.32 …
    Totals 18,560,265.51 32,872,244.84 57,570,386.13

    I also need to add that the GAO report cited by the guest bloggers criticized the DEA for certain inefficiencies in the management of the quota program but not in the functional design of the program itself. Also, credit should be given the DEA for having instituted the “buffer” of 25% in 2013 when there was widespread belief that certain drug shortages were the result of DEA’s mishandling of the quota provisions.
    In the year or so following the addition of the buffer, DEA investigated and learned that the shortages of certain products was not connected to quota shortages but were the result of manufacturers deciding to favor certain products over others in their inventory. The DEA has no authority to tell a manufacturer, for example, to produce more of a branded generic over the branded product produced by the very same manufacturer. It must also be noted that manufacturers may ask DEA at any time for additional quota and records will show that upon a showing of need, DEA almost always will approve such increases.
    Earlier this year, recognizing that whatever drug shortages existed were not related to quotas, the DEA removed the 25% buffer and returned to the traditional levels and methods required by law to set quotas. I have taken the time to respond to this because I believe that it is important for people outside the regulatory environment to understand how and why regulations are made and how they are implemented. It does no one any good whatsoever to suggest that there are government villains conspiring to reduce needed medications that suffering patients rely on to maintain their functionality and quality of life. Indeed, the opening lines of the Controlled Substances Act attest to Congress’s finding that “Many of the drugs included within this subchapter [CSA] have a useful and legitimate medical purpose and are necessary to maintain the health and welfare of the American people.” (21 USC 801(1))
    Finally, I am not a mathematician by any stretch of the imagination, but I think the guest bloggers misstated the reduction or percentage of change in the quotas when they stated: “Of the reductions listed, hydrocodone will take a 66% manufacturing cut and oxycodone a 46% cut, respectively.”
    I used the formula, y2-y1/y1 X 100, and arrived at reductions for hydrocodone of 41.3 percent and for oxycodone of 23.8 percent. The hydrocodone reduction is probably related to the rescheduling of all hydrocodone products from Schedule III to Schedule II, thus reducing to some extent the volume of hydrocodone products being prescribed and refilled. The decrease in oxycodone comes close to the 25 percent buffer that, in retrospect, appears not to have been needed in the first place.
    Other than these comments and what they refer to, I found the work of your guest bloggers to be well-done and well-intentioned.

    1. John, As always your comments are incredibly insightful. It is great having a DEA expert on here that understands! I will be sure to review your comments with the team if they haven’t already seen them. Happy Veterans Day!

    2. UN Human Rights Council Special Report on Torture, and other cruel inhuman or degrading treatment. Opening: The present report focuses on certain forms of abuses in health-care settings that
      may cross a threshold of mistreatment that is tantamount to torture or cruel, inhuman or
      degrading treatment or punishment. It identifies THE POLICIES THAT PROMOTE THESE PRACTICES AND EXISTING PROTECTION GAPS. cont: (A/HRC/10/44 and Corr.1, para. 72).
      When the failure of States to take positive steps, or to REFRAIN FROM INTERFERING WITH HEALTH SERVICES, CONDEMNS PATIENTS TO UNNECESSARY SUFFERING FROM PAIN. STATES NOT ONLY FALL FOUL OF THE RIGHT TO HEALTH BUT MAY ALSO VIOLATE AN AFFIRMATIVE OBLIGATION UNDER THE PROHIBITION OF TORTURE AND ILL-TREATMENT.
      [sourced] for complete report see link below:
      http://www.ohchr.org/Documents/HRBodies/HRCouncil/RegularSession/Session22/A.HRC.22.53_English.pdf
      Denial of pain relief 86. The Special Rapporteur calls upon all States to:
      (a) Adopt a human rights-based approach to drug control as a matter of
      priority to PREVENT THE CONTINUING VIOLATIONS OF HUMAN RIGHTS STEMMING FROM THE CONTINUING VIOLATIONS OF RIGHTS FROM THE CURRENT APPROACHES TO CURTAILING SUPPLY AND DEMAND (A/65/255, para. 48). Ensure that
      national drug control laws recognize the indispensable nature of narcotic and
      psychotropic drugs for the relief of pain and suffering; review national legislation and
      administrative procedures to guarantee adequate availability of those medicines for
      legitimate medical uses;
      (b) ENSURE FULL ACCESS TO PALLIATIVE CARE AND OVERCOME REGULATORY and attitudinal OBSTACLES THAT RESTRICT AVAILABILITY TO ESSENTIAL PALLIATIVE CARE MEDICATIONS, ESPECIALLY ORAL MORPHINE. States should devise and implement
      policies that promote widespread understanding about the therapeutic usefulness of
      controlled substances and their rational use;

      I am going to be very frank w/your sir. You have obviously been too close to the agency to see the forest for the trees.How you can even mention Constitution and an unelected bureaucratic entity making regulations and quotas that are enforced as laws w/intimidation and persecution under vaguely set “norms” is utterly ridiculous. [For anyone not familiar w/the Constitution here is the beginning of Article VI which is referred to]:

      “This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, ANY THING IN THE CONSTITUTION OR LAWS OF ANY STATE TO THE CONTRARY NOTWITHSTANDING.

      The Universal Declaration of Human Rights in 1948 as well as the ADA aka the American w/Disabilities Act, The Bill of Rights, the AMA, and many other Congressional Acts, State Constitutions, INTL accords and treaties are believed to be optional when they interfere the abuse of continued bilking of the American people, all for an unnecessary layer of bureaucracy. Many are not aware of the HUNDREDS of such agencies which have no legitimate legal standing. The Constitution so often referred to, but rarely if ever illustrates its intent, which was of to have in writing a general contract for services, upon approval of its creators, the Independent Sovereign States and THEIR PEOPLE. Those same States that the govt now believes it has full power and authority over, as evidenced by the illegal appropriation of unauthorized powers. The DEA is simply one illegal agency whose brigands run roughshod over we the people. Every action that is legal for the US Govt to take is enumerated SPECIFICALLY in the Constitution that this man is referencing. NOTHING that isn’t explicitly written in the Enumerated powers is reserved for the STATES AND THE PEOPLE called the Reserved Powers and referenced in the 9th and 10th Amendments, more paper that is ignored in the massive centralization of power going on in the past 20-30 yrs. A bureaucratic coup if you will. A rule not by law, but by bureaucracy. It is the subtle nature of this lunacy that lulls the American people to sleep. They are waking up, like those brutalized by the DEA and wondering how on earth did we get here? Take for example Article III. It says that no Federal court can sit in permanence w/the exception of SCOTUS and is to be called to form by Congress for specific purposes ONLY. Do they adhere to this stipulation? NO, and it is illegal along w/up to 80% of what the central govt does. When will the American people have enough of this illegality? I think we are seeing signs that for many that time is NOW.

      Can someone tell me when and who decided we were to be ruled over by unelected bureaucratic agencies? THIS IS NOT REPRESENTATIVE GOVT!! Since the loss of their cash cow marijuana, the DEA have waged war on the least able to fight back, the disabled, the elderly, the incapacitated, all in a naked power grab to affect self preservation and nothing less. The loss of its main cash cow marijuana (civil seizures and asset forfeitures as well as appropriations) was brought about by the legal expression of the people and States in the form of Jefferson and Madison’s remedy for such Federal overreach; ostensibly by nullification, interposition, and Madison’s anti-commandeering doctrine. Just because 99% of the American public is too intimidated or distracted to speak out will not allow me to read such utter obfuscation and not respond to set the record straight.
      For those who would like to see more on how the States and we the people can fight off this Federal overreach into every facet of our lives see the 10th Amend Center and/or contact your STATE Representative (we cannot expect the Feds to limit their own power, to contract your US Congressman is futile. The DEA does not listen to their bosses aka CONGRESS nor State Courts as evidenced by its continued raids upon LEGAL STATE APPROVED MEDICAL MARIJUANA DISTRIBUTORS despite a call to discontinue using appropriations in this manner. http://tracking.tenthamendmentcenter.com/

      To even suggest that unelected appointed bureaucrats have ANY authority over we the people who are the creators of govt is propaganda illegally “legalized” by the Smith Mundt Modernization Act of 2012 which has led to the US media becoming so being inundated w/State govt created propaganda that had they been alive today would make Joseph Goebbles and the editors at Pravda jealous w/envy.

      The DEA company man above is either too brainwashed or is a disinformation agent seeking to substantiate false claims by the DEA that have been PROVEN false by many brave individual pharmacists, physicians, and patients RECORDED ON VIDEO, who have come forward and said the exact opposite of what this agent just stated. The DEA has NO credibility at this point and no legal standing other than that instituted by brute force and intimidation.

      The DEA has NO place in the medical field whatsoever. To go further,, they have no place in a legitimate American govt and have done more harm than good in their short, brutal, and illegal campaign against the American people. The whistle blowers and brave pharmacists and physicians have destroyed the very same narrative the DEA pushes, that the DEA has no role in the shortage of medications and their being almost unavailable to the very people who need them the most. The difference between the whistle blowers and the DEA is that they have nothing to gain. These actions have been taken because they possess certain attributes that most that work for the DEA lack. These attributes are sometimes referred to as MORALS, HONESTY, and INTEGRITY.

      They, and patients like myself w/nothing to lose, are simply attempting to return dignity,credibility, and respect to a health care system that is bankrupt of these at the moment. The bottom line is that patients are being left untreated due to intimidation by DEA agents that could be referred to as goons if it were not so insulting to goons.

Leave a Reply

Your email address will not be published.

This site uses Akismet to reduce spam. Learn how your comment data is processed.