Resources

Rescheduling Hydrocodone Combination Products: Addressing the Abuse of America’s Favorite Opioid

by John J. Coleman, MS, MA, PhD | April 10, 2015

Abstract

On October 6, 2014, hydrocodone combination products (HCPs) became Schedule II controlled substances in the U.S. For more than three decades, HCPs had been designated Schedule III drugs by the Controlled Substances Act (CSA), meaning that federal and state controls were less stringent than those for Schedule II drugs. Beginning in the 1990s, however, the abuse and diversion of prescription opioids, including HCPs, increased dramatically. In this review we focus on HCPs, a category of opioids prescribed more frequently than all other medicinal opioids combined. We discuss the origin of drug scheduling and the history of the complicated regulatory process used by the government to schedule HCPs. The scope of the HCP abuse problem is described, along with a discussion of public concerns and comments addressed in the Drug Enforcement Administration’s (DEA) Final Rule designating HCPs Schedule II controlled substances.

Introduction

Hydrocodone is an important and popular antitussive and narcotic analgesic agent. In 1970, Congress placed hydrocodone in Schedule II (also known as “C-II”) of the CSA, a classification reserved for medications with a high potential for abuse, a currently accepted medical use in treatment in the U.S. or a currently accepted medical use with severe restrictions, and the abuse of which may lead to severe psychological or physical dependence.1

Congress permitted limited doses of six C-II drugs, including hydrocodone, to be listed in Schedule III, a less restrictive category reserved for drugs with abuse potential less than that of drugs in Schedule I and II.a To qualify, a hydrocodone-containing formulation must contain “not more than 300 milligrams…per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium …” [or] “… with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.” 1b

In 2010, the United Nations estimated the global production of hydrocodone to be 36.3 tons, of which the U.S. reportedly consumed more than 99 percent.3 Between 1998 and 2012, the U.S. production of HCPs increased more than four-fold, from 15,359 kgs to 63,338 kgs.4 Each year, HCPs are prescribed and dispensed more than all other medicinal opioids combined.c

In 2013, HCPs earned more than $1 billion in generic drug sales, second only to methylphenidate ER ($1.4 billion). In the same year, HCPs led all generic drugs in total number of prescriptions dispensed (137 million), with Lisinopril (99 million), a blood pressure medication, and Simvastatin (89 million), a lipid lowering medication, coming in a distant second and third, respectively.4, 6

In retrospect, Congress underestimated the abuse potential of HCPs. By 1991, a sampling of hospital emergency department (ED) admissions revealed 5,089 episodes in which C-III hydrocodone was mentioned; this was 27.2 percent higher than the number of episodes involving C-II oxycodone (4,001 mentions).d, 7

In 2004, a similar survey of ED admissions produced significantly higher figures for both hydrocodone (46,536 mentions) and oxycodone (51,418 mentions). By 2011, these figures more than doubled for hydrocodone (108.9%, 97,183 mentions), and more than tripled for oxycodone (240.8%, 175,229 mentions).e, 8

The Centers for Disease Control and Prevention (CDC) reports that in 2010, there were 16,651 deaths involving overdoses of “opioid drugs primarily containing oxycodone, hydrocodone, or methadone.”4 Although figures for individual opioids were not reported, the role of HCPs appears significant in this statistic.

Welcoming the Decade of Pain Control and Research

By the mid-1990s, it was apparent that the abuse of prescription opioids, notably HCPs and oxycodone products, was increasing. The increase in oxycodone abuse coincided with the introduction of an oral extended release form of the drug approved by the FDA in late 1995 and marketed aggressively beginning in early 1996.

At the same time, there was a growing consensus in the healthcare industry that new formulations and improved standards of care were needed for millions of undertreated chronic pain patients. In 2000, at a conference sponsored by the Joint Commission on Accreditation of Healthcare Organizations and the American Pain Society, pain was defined as a “patient’s rights” issue, to be attended to, when necessary, as a “fifth vital sign,” joined in prominence with the four other vital signs of life: blood pressure, pulse, temperature, and respiratory rate.9

Congress wasted no time in declaring the decade beginning January 1, 2001, as the Decade of Pain Control and Research.10 It was, in part, a recognition that addressing chronic pain not only is a matter of public health, but also a necessity to ensure and maintain a healthy economy. Today, unmitigated chronic pain is estimated to cost the U.S. economy between $560 billion and $635 billion per year.11

The Epidemic of Prescription Drug Abuse: Ignoring Early Warning Signs

Before and during the Decade of Pain Control and Research red flags, such as the alarming increase in opioid-related ED admissions, were ignored or their importance minimized. In 2002, the government halted its collection of drug abuse data from EDs after concluding that its key database, the Drug Abuse Warning Network (DAWN), was unreliable.12 A year later, this database was relaunched with a new methodology designed to improve the tracking of prescription drug abuse. Even so, by 2011, rather than praising the accomplishments of the Decade of Pain Control and Research, the government instead was warning of an epidemic of prescription opioid overdoses.13, 14

The Private Sector Sounds the Initial Call for Tighter Controls on HCPs

In January 1999, Ronald J. Dougherty, M.D., FAAFP, ASAM, an addiction medicine specialist, submitted a “citizen’s petition” to the DEA, asking the agency “to initiate proceedings for the addition of Hydrocodone (Vicodin/Lortab) to a Schedule II status throughout the United States.”15 The petition was filed pursuant to a provision in the CSA permitting “any interested party” to request the “issuance, amendment, or repeal” of rules, among other things, pertaining to the scheduling of controlled substances.16

On July 28, 2004, as required by the CSA, the DEA forwarded Dr. Dougherty’s request, along with an 85-page detailed “eight-factor analysis,” to the Department of Health and Human Services (DHHS), asking for a scientific and medical evaluation and recommendation to reschedule HCPs to C-II.f In a cover letter to the Acting Assistant Secretary for Health, DEA Administrator Karen P. Tandy agreed with Dr. Dougherty’s request, adding, “Despite their obvious utility in medical practice … hydrocodone products are among the most popular pharmaceutical drugs associated with drug diversion, trafficking, abuse, and addiction.”18 

In 2008, the Assistant Secretary for Health rejected the DEA’s request.5 The following year, the DEA renewed its request and offered additional supporting data.4 There is no public record of a response. 4

On July 9, 2012, President Barack Obama signed into law the Food and Drug Administration Safety and Innovation Act that, among other things, directed the FDA to hold a public meeting to “solicit advice and recommendations” on the control of HCPs.4 A meeting of the FDA’s Drug Safety and Risk Management Advisory Committee was convened for this purpose on January 24-25, 2013.

FDA provided each member of the committee with a 363-page briefing document largely refuting the DEA’s analysis and concluding “that there is insufficient evidence to support DEA’s finding that combination hydrocodone-containing products have a similar potential for abuse to oxycodone products.”5 In its analysis, the DEA had used C-II oxycodone as a comparator drug.

Despite the FDA’s advice, on January 25, 2013, the Committee voted 19 to 10 to place HCPs in Schedule II.4 Although not bound by the Committee’s decision, the DHHS nonetheless reversed its previous position and on December 16, 2013, provided the DEA with a recommendation to “upschedule” HCPs. 4

DEA followed with a Notice of Proposed Rulemaking (NPRM) in February 2014 announcing the agency’s intention to reschedule HCPs from C-III to C-II.19 After an obligatory public comment period, the DEA published a 22-page Final Rule on August 22, 2014 rescheduling HCPs, effective October 6, 2014.4

Concerns of HCP Rescheduling Action Expressed by Public Commenters

The Final Rule provides legal and logistical guidance and addresses some of the 573 public comments submitted in response to the NPRM. Of the 573 comments, 298 (52%) supported, or supported with qualification, the proposed rescheduling action, while 235 (41%) were opposed and 40 (7%) did not take a definitive position. The DEA identified five groups of commenters: the general public (44%; 250 comments); pharmacists and pharmacy students (21%; 122 comments); physicians (13%; 73 comments); ultimate users (6%; 35 comments); and mid-level practitioners (5%; 31 comments).

Some of the comments received and responded to by the DEA in its Final Rule are instructive and may assist practitioners, pharmacists, and patients in understanding the legal and clinical implications of rescheduling HCPs. They are synopsized below as categorized in the Final Rule by the DEA.

  1. Requirements Applicable to Prescriptions: Nineteen commenters opposed rescheduling HCPs because in some jurisdictions mid-level practitioners (e.g., physician assistants, nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists, etc.) are not authorized to prescribe C-II drugs.

    DEA noted that the authority to allow mid-level practitioners to prescribe C-II drugs is beyond the scope of DEA’s authority and is up to individual states to decide.g
  2. Transmittal Method of HCP Prescriptions as C-II Controlled Substances: Multiple commenters raised the issue of prescribers not being able to “call-in” oral prescriptions for C-II drugs especially during off-hours and emergencies.

    DEA reminded commenters that in emergency situations, authorized prescribers can “call-in” C-II prescriptions and pharmacies can dispense C-II drugs without a signed written prescription, as permitted by the Code of Federal Regulations (CFR).hThe quantity of drug prescribed and dispensed is limited to the amount deemed adequate to treat the patient during the emergency period.

    Some of the same commenters mentioned the need in their jurisdictions (TX and CA) to use triplicate forms for prescribing C-II drugs, stating that this requirement posed an obstacle to emergency prescribing of C-II drugs.

    DEA noted that its Final Rule and the CFR do not override state laws that, as in this instance, may be stricter than federal regulations.
  3. Quantity and Frequency of Fills and Refills for C-II HCPs: Pharmacists, prescribers, and ultimate users expressed concerns about being unable to refill prescriptions automatically for C-II HCPs, as well as being restricted in some jurisdictions to providing no more than a 30-day supply of C-II drugs at a time.

    DEA stated that although the CSA generally imposes no specific limit on the quantity of a drug that may be prescribed in a single prescription, or the duration of treatment intended for a single prescription, some States and individual prescription benefit providers do impose such limits on C-II controlled substances. DEA added that a practitioner may issue multiple C-II prescriptions in order to provide up to a 90-day supply of medication in accordance with instructions contained in the CFR.i Federal approval for doing this, however, is contingent upon the practice being allowed by state law.21

  4. Patient Access to Medicine: Commenters were concerned about the need for increased provider visits and related costs for C-II HCPs. They expressed concern that this might result in doctors selecting less effective alternative (i.e., non C-II) medications.

    DEA noted that these factors, although important, are not relevant to the determination of a drug’s control. The DEA noted that other C-II drugs are widely prescribed by doctors and that the choice of which medication is appropriate for a patient should not be influenced by a drug’s schedule.
  5. Impact of Criminal Action: Some commenters were concerned that rescheduling HCPs would deter practitioners from properly treating pain for fear of facing criminal investigation and prosecution.

    DEA noted that the CSA requires that every prescription issued for a controlled substance be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. These requirements, the agency stated, do not interfere with the legitimate practice of medicine nor should they cause practitioners to be deterred from prescribing appropriate medications for their patients.
  6. Impact on Drug Availability: Commenters expressed concern that wholesalers would limit distribution of HCPs to community pharmacies if they were rescheduled, causing shortages and difficulties for patients needing to fill prescriptions.

    DEA noted that it does not limit the quantity of drugs that can be distributed to a community pharmacy – or any pharmacy. The regulations, however, impose requirements on distributors to operate systems to disclose suspicious orders received from customers (hospitals, retail pharmacies, buying groups, etc.). DEA noted that 109,632 registrants placed orders for C-I or C-II drugs in 2013. These orders represented approximately 50 million individual transactions. Adding HCPs to this list, according to DEA, will not pose a problem for distributors or their customers.

  7. Shift to the Black Market: Several commenters stated that rescheduling HCPs would limit their availability and drive people to buy drugs, including heroin, on the street or black market.

    DEA discounted this theory, stating that there are many C-II drugs readily available for legitimate medical use and no one is forced to buy them on the black market.

  8. Impacts on Unique Populations: Several commenters expressed concern that patients suffering from chronic pain, cancer, rare diseases, chronic and end-stage renal failure, dental, and surgical post-op pain could face difficulty in obtaining their medication if HCPs are rescheduled.

    DEA noted that scheduling decisions are based on a substance’s estimated abuse, its potential for psychological and physical dependence, and whether the substance has a currently accepted medical use in the U.S. The statute does not authorize the DEA to schedule or reschedule a drug based on characteristics and circumstances of the populations that it is intended to treat.
  9. Impact of Rescheduling HCPs on Long-Term Care Facilities (LTCFs): Many commenters, including two U.S. Senators, expressed concern about patients in LTCFs who might not have quick access to rescheduled HCPs, when needed. This, they said, would be problematic because most LTCFs do not have a physician on site.

    DEA restated the legal criteria used for drug scheduling and noted that it has issued special rules to accommodate the unique circumstances of LTCF residents. A prescription for a C-II controlled substance for an LTCF patient may be transmitted via facsimile by the practitioner or practitioner’s agent to the dispensing pharmacy. Also, a prescription for a C-II controlled substance issued for a LTCF patient may be filled in partial quantities, to include individual dosage units. In addition, emergency C-II oral prescribing provisions, discussed above, apply equally to patients in LTCFs.
  10. Responsibilities of Pharmacists: Pharmacy commenters expressed concern that rescheduling HCPs would increase their administrative burden by requiring separate records for C-II prescriptions and biennial inventories. j

    DEA noted that the processes and procedures associated with dispensing controlled substances are not relevant to the criteria that it must consider when evaluating a drug for scheduling or when choosing which schedule would be the most appropriate.

Besides the above, comments pertaining to narrower administrative issues and concerns were addressed in the DEA’s Final Rule.

Discussion

The concept of drug “schedules” traces its origin to a 1931 League of Nations conference on the control of manufactured drugs. At the time, Germany manufactured most of the world’s codeine products and opposed a unitary control schema on the grounds that certain products, specifically codeine cough medications, had lower abuse liability than morphine or heroin. Delegates agreed on a two-tier plan that designated codeine products in the lower, less regulated, tier or schedule.23 

In 1961, the United Nations (successor to the League) proposed a new drug treaty (1961 Single Convention on Narcotic Drugs) that, among other things, expanded drug schedules from two to four to accommodate new classes of products introduced since the 1931 treaty.24 Signatories (including the U.S.) agreed to enact domestic legislation, if necessary, to comply with the treaty.25

Passage of the 1970 CSA satisfied this obligation and was so acknowledged in the Act’s introductory provisions: “The United States is a party to the Single Convention on Narcotic Drugs, 1961, and other international conventions designed to establish effective control over international and domestic traffic in controlled substances.”26

Whereas the 1961 treaty contained four schedules, the CSA included an additional schedule (C-I) for drugs and other substances that are not approved in the U.S. for medical use (e.g., LSD, marihuana, heroin, PCP, etc.). Although Schedule I and II drugs have the same abuse potential, they differ in that Schedule II drugs are FDA-approved for medical use “with severe restrictions.”27 

Some of the severe restrictions reserved for Schedule II drugs have been discussed in this paper. Of the thousands of pharmaceutical drugs approved by the FDA for medical use, only about 250 are scheduled under the CSA. Of this number, about 20 (~8%) are misused at high enough levels to threaten public health, as measured, for example, by hospital ED admissions. Opioids, led by oxycodone and hydrocodone, comprise 50 percent of the drugs in this top 20 list. k, 28

Epidemiologists with the CDC have compared the volume of opioids prescribed for medical use (as measured by their sales) with annual mortality rates attributed to their abuse, finding a close – almost parallel – correlation.30 Johnson and colleagues (2014) studied a similar phenomenon in Florida after legislation to address the proliferation of pill mills was enacted in 2011.31 After July 1, 2011, Florida law prohibited physicians from dispensing C-II and C-III drugs from their offices. Two months later, the new law required pharmacists to report dispensing data for controlled substances to the state’s prescription drug monitoring program.31

TThe effect of these changes was remarkable. Between 2010 and 2012 (the year before and the year after the new law), overdose deaths in Florida attributed to HCPs declined 22.2 percent (from 315 to 245), while the prescribing rate of HCPs per 100,000 population declined 9.7 percent. Findings for oxycodone were even more impressive. Between 2010 and 2012, overdose deaths attributed to oxycodone declined 51.5 percent (from 1,516 to 735), while the prescribing rate of oxycodone per 100,000 population declined 24 percent.31

To be sure, these life-saving accomplishments did not occur without controversy. In their findings, Johnson and colleagues noted that “the data sources available for this investigation did not permit any assessment of potential unintended consequences of these policy changes, such as reduction of access to pain medications for legitimate prescribing indications.”31

Since the changes in Florida some chronic pain patients previously treated at now defunct pill mills have reported difficulty in obtaining care from traditional practitioners fearful of accepting them as patients. When and if they have been accepted, the new providers often have been reluctant to maintain the former pill mill patients on the high-dose opioid regimens previously prescribed for them. In addition, there have been media accounts of pharmacists either refusing to carry certain high-risk drugs or simply rejecting new patients presenting valid prescriptions for them.32,33 Complaints of a similar nature have surfaced in other states where similar drug controls have been adopted.

These concerns have been heard in the halls of Congress. On September 18, 2014, a bill titled “Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014,” was introduced by Senator Orrin G. Hatch (R-UT) and co-sponsored by Senators Rand Paul (R-KY) and Sheldon Whitehouse (D-RI). This bill would require a report by government officials, including the Administrator of the DEA and the Commissioner of the FDA that, among other things, would identify regulatory obstacles to legitimate patient access to controlled substances.34 Although this bill expired with the close of the 113th Congress, it was re-introduced by Senators Hatch and Whitehouse as S.483 on February 12, 2015. A companion bill, H.R.471, was introduced in the House by Representative Tom Marino (R-PA) on January 22, 2015.35

Although it is too early to evaluate the public health effects of the recent rescheduling of HCPs, the above-described Florida study suggests a probable reduction in the volume of HCPs being prescribed and dispensed along with a corresponding reduction in morbidity and mortality attributed to their misuse. Additionally, we may expect at the outset some unintended consequences in the form of reduced access to HCPs for legitimate prescribing indications. How well the nation’s healthcare system manages this ultimately will determine the soundness of this important regulatory change.

Conflict of Interest Statement: The views, opinions, and analyses presented in this paper unless otherwise stated are those of the author, John J. Coleman, PhD, a retired senior executive of the DEA, and current President of Prescription Drug Research Center, LLC, 134 N. LaSalle Street, Chicago, IL 60602. Dr. Coleman also is President of the Board of Directors of Drug Watch International, Inc., a 501c3 non-profit organization of volunteers dedicated to preventing drug abuse through education and awareness. Dr. Coleman has received no financial assistance or editorial guidance for writing this report.

John J. Coleman, PhD

John J. Coleman, PhD, is a retired DEA Special Agent who served more than three decades with the agency beginning as an undercover agent working the streets of New York City. During the French Connection era he was posted as a Narcotics Attaché at the American Embassy in Paris, France. Over the course of his career he was in charge of DEA offices in Marseille (France), Chicago (second-in-command), Boston, Newark, and the DEA training division at the FBI Academy in Quantico, VA. From 1991 to 1994, Dr. Coleman served as DEA’s Assistant Administrator for Operations, in charge of all law enforcement operations of the agency, including those of the Office of Diversion Control that oversees more than 1.5 million DEA-registrants. Besides manufacturers and distributors of controlled substances, DEA registrants include practitioners and pharmacies authorized by the agency to prescribe and dispense controlled substances. Dr. Coleman is president of Prescription Drug Research Center LLC, 134 N. LaSalle Street, Chicago, IL 60602, a consultancy firm. Also, Dr. Coleman is the elected president of the board of directors of Drug Watch International, Inc., a 501c3 organization dedicated to preventing drug abuse through education and awareness. Dr. Coleman is a graduate of Iona College, has a business degree from the National College of Education, a master’s degree in criminal justice from Rutgers University, and a doctoral degree in public policy from George Mason University. He is a graduate of the FBI National Executive Institute and completed the Senior Managers in Government program at Harvard University’s JFK School of Government.

Notes 


a. Schedule I drugs are not approved for medical use.

b. Between passage of the 1970 CSA and 2013, only immediate-release hydrocodone combination products were available in the U.S. On October 25, 2013, the Food and Drug Administration (FDA) approved Zohydro ER® (Zogenix, Inc., CA), the first extended release single entity form of hydrocodone.2

c. An FDA comparison of prescription dispensing volumes for hydrocodone and several comparator drugs in 2011 estimated 130.7 million prescriptions for hydrocodone analgesic products (66% of a total of 198 million prescriptions in the sampling frame), 57 million prescriptions for oxycodone products (28.8%), 7.6 million prescriptions for morphine sulfate products (3.9%), and 2.7 million prescriptions for hydromorphone products (1.4%).5

d. This survey (Drug Abuse Warning Network) does not distinguish between single entity products and combination products. Prior to October 2013 and the approval of a single entity C-II product, hydrocodone was commercially available in the U.S. only in combination products meeting C-III scheduling criteria.

e. The methodology used for these government surveys changed in 2002, so direct comparisons between data for 1991 and 2004 (and later) cannot be made. Nonetheless, contemporaneous drug scheduling decisions were made, and continue to be made, using these data.

f. Although the CSA provides authority for the Attorney General (delegated to the DEA) to schedule, reschedule, or remove from schedules controlled substances, this can be done only with a concurring recommendation from the Secretary of DHHS (delegated to the Assistant Secretary of Health).17

g. Mid-level practitioners are eligible to apply for DEA registrations that match their level of state approval for prescribing controlled substances.20

h. 21 CFR 1306.11(d).

i. 21 CFR 1306.12

j. Registrants, including dispensers, are required to perform an initial and close of business inventory of controlled substances as well as a biennial (every two years) inventory while in business. They must maintain a written record at the registered location in case of a DEA audit. For dispensers, the regulation requires an exact count or measure for C-I or C-II controlled substances. For substances in Schedules III, IV or V, an estimated count or measure can be made unless a container holds more than 1,000 tablets or capsules in which case an exact count must be taken.22

k. Ten opioids within the top 20 drugs in 2009 mentioned in hospital emergency department admissions for abuse/misuse (frequency of ED mentions): Oxycodone (175,949); Hydrocodone (104,490); Methadone (70,637); Morphine (34,282); Fentanyl (22,143); Buprenorphine (17,546); Hydromorphone (15,582); Propoxyphene (11,515); Codeine (9,018); and Meperidine (1,367). 8,28(Notes: a) Propoxyphene was removed from the U.S. market in November 2010;29 b) ED mentions of fentanyl include both pharmaceutical and non-pharmaceutical illicit fentanyl and fentanyl analogs.)

References cited 


1.            Controlled Substances Act. 21 United States Code, Sect. 812: Schedules of controlled substances (Public Law 91–513, 84 Stat. 1236). Washington, D.C.: GPO; 1970.

2.            Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. 2014; http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=202880&TABLE1=OB_Rx. Accessed January 22, 2015.

3.            United Nations International Narcotic Control Board (INCB). Narcotic Drugs: Estimated World Requirements for 2012 and Statistics for 2010. 2012; https://www.incb.org/documents/Narcotic-Drugs/Technical-Publications/2011/Part_FOUR_Comments_NAR-Report-2011_English.pdf. Accessed January 9, 2015.

4.            Drug Enforcement Administration. Federal Register (79 FR 49661): Schedules of controlled substances: Rescheduling of hydrocodone combination products from Schedule III to Schedule II; Final Rule. 2014; http://www.ncbi.nlm.nih.gov/pubmed/25167591. Accessed January 12, 2015.

5.            Food and Drug Administration. FDA Briefing Document: Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting, October 29-30, 2012 (postponed to January 29-30, 2013). 2012; http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/ucm334275.htm. Accessed January 9, 2015.

6.            Pharmacy Times. Top Drugs of 2013. 2014; http://www.pharmacytimes.com. Accessed January 12, 2015.

7.            U.S. Department of Health and Human Services, Alcohol, Drug Abuse, and Mental Health Administration, National Institute on Drug Abuse. Statistical Series No. 11-A; Annual Emergency Room Data (from the Drug Abuse Warning Network). Rockville, MD: GPO; 1991.

8.            U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Office of Applied Studies. Drug Abuse Warning Network (DAWN) National & Metro Tables, 2004-2011 ("All misuse and abuse"). 2013; http://www.samhsa.gov/data/DAWN.aspx#DAWN Accessed January 12, 2015.

9.            Phillips DM. JCAHO pain management standards are unveiled. Joint Commission on Accreditation of Healthcare Organizations. Jama. 2000;284(4):428-429.

10.          Victims of Trafficking and Violence Protection Act of 2000, Title VI, Sec. 1603: Decade of pain control and research; H.R. 3244 (Public Law No: 106-386 ), (2000).

11.          Lynn R. Webster, MD. VA Announcement a New Front in Fight Against Chronic Pain Among Veterans. Pain Medicine News. 2015;13(1).

12.          Substance Abuse and Mental Health Services Administration, Office of Applied Studies. Drug Abuse Warning Network: Development of a New Design (Methodology Report). DAWN Series M-4, DHHS Publication No. (SMA) 02-3754, Rockville, MD, 20847. 2002; http://archive.samhsa.gov/data/dawn/dawninfo/pubs/new-design.pdf. Accessed January 24, 2015.

13.          Centers for Disease Control and Prevention. Prescription painkiller overdoses at epidemic levels. 2011; http://www.cdc.gov/media/releases/2011/p1101_flu_pain_killer_overdose.html. Accessed January 23, 2015.

14.          Executive Office of the President, Office of National Drug Control Policy. Epidemic: Responding to America's Prescription Drug Abuse Crisis. 2011; http://www.whitehouse.gov/sites/default/files/ondcp/policy-and-research/rx_abuse_plan.pdf. Accessed January 21, 2015.

15.          Dougherty R. Citizen's Petition filed with DEA on Jan 4, 1999 to initiate proceedings for the addition of Hydrocodone (Vicodin/Lortab) to a Schedule II status throughout the United States (unpublished file in possesion of John J. Coleman). 2008.

16.          Controlled Substances Act, Title 21, United States Code, Sec. 811, Authority and criteria for classification of substances. 1970; http://uscode.house.gov/search/criteria.shtml. Accessed January 17, 2015.

17.          Controlled Substances Act, Title 21, United States Code, Sec. 811(b), Evaluation of drugs and other substances. 1970; http://uscode.house.gov/search/criteria.shtml. Accessed January 21, 2015.

18.          Karen P. Tandy, Administrator, Drug Enforcement Administration. Letter with attached analysis report to Cristina V. Beato, M.D., Acting Assistant Secretary of Health, DHHS, Washington, D.C. 20201 (Unpublished; obtained from DEA by John J. Coleman on 10/17/2014, via Freedom of Information Act). 2004.

19.          Drug Enforcement Administration. Federal Register; Notice of proposed rulemaking (79 FR 11037): Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II. 2014; http://www.gpo.gov/fdsys/pkg/FR-2014-02-27/pdf/2014-04333.pdf. Accessed January 12, 2015.

20.          Code of Federal Regulations. 21 CFR 1301.01: Definitions relating to controlled substances: Mid-level practitioner. 2014; http://www.gpo.gov/fdsys/pkg/CFR-2014-title21-vol9/pdf/CFR-2014-title21-vol9-chapII.pdf. Accessed January 22, 2015.

21.          Code of Federal Regulations. 21 CFR 1306.12, Refilling prescriptions; issuance of multiple prescriptions. 2014; http://www.gpo.gov/fdsys/pkg/CFR-2014-title21-vol9/xml/CFR-2014-title21-vol9-part1306.xml. Accessed January 13, 2015.

22.          Code of Federal Regulations. 21 CFR 1304.11 Inventory requirements. 2014; http://www.gpo.gov/fdsys/pkg/CFR-2014-title21-vol9/pdf/CFR-2014-title21-vol9-chapII.pdf. Accessed January 21, 2015.

23.          McAllister WB. Drug Diplomacy in the Twentieth Century: An International History. London & New York: Routledge Press; 2000.

24.          United Nations. The International Drug Control Conventions; Schedules of the Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol, as of 25 September 2013. 2013; https://www.unodc.org/documents/commissions/CND/Int_Drug_Control_Conventions/1961_Schedules/ST-CND-1-Add1_E.pdf. Accessed January 14, 2015.

25.          United Nations. Single Convention on Narcotic Drugs of 1961. 2013; https://www.unodc.org/pdf/convention_1961_en.pdf. Accessed January 14, 2015.

26.          Controlled Substances Act. 21 USC § 801. Congressional findings and declarations: controlled substances. 1970; http://uscode.house.gov/search/criteria.shtml. Accessed January 14, 2015.

27.          Controlled Substances Act. Title 21, United States Code, § 812(b)(II)(B); Schedules of controlled substances. 1970; http://uscode.house.gov/search/criteria.shtml. Accessed January 16, 2015.

28.          Coleman JJ. The supply chain of medicinal controlled substances: addressing the Achilles heel of drug diversion. Journal of pain & palliative care pharmacotherapy. 2012;26(3):233-250.

29.          National Institutes of Health, U.S. National Library of Medicine, MedlinePlus. Propoxyphene. 2011; http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682325.html. Accessed January 18, 2015.

30.          Paulozzi LJ, Weisler RH, Patkar AA. A national epidemic of unintentional prescription opioid overdose deaths: how physicians can help control it. The Journal of clinical psychiatry. 2011;72(5):589-592.

31.          Johnson H, Paulozzi L, Porucznik C, et al. Decline in drug overdose deaths after state policy changes - Florida, 2010-2012. MMWR. Morbidity and mortality weekly report. 2014;63(26):569-574.

32.          Liz Freeman. Pill mill fallout: Legitimate patients have trouble getting pain meds. Naples Daily News 2014; http://www.naplesnews.com/news/local-news/pill-mill-fallout-legitimate-patients-have-trouble-getting-pain-meds_31951071. Accessed January 24, 2015.

33.          Shannon Behnken, WFLA News Channel 8, Tampa, FL. More chronic pain patients say they're denied medication. 2014; http://www.wfla.com/story/25539482/more-chronic-pain-patients-say-theyre-denied-their-medication. Accessed January 24, 2015.

34.          U.S. Senate, Committee on Health, Education, Labor, and Pensions. S.2862: Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 (Introduced on 9/18/2014 by Senator Orrin G. Hatch of Utah). 2014; http://thomas.loc.gov/cgi-bin/query/z?c113:S.2862:. Accessed January 19, 2015.

35.          The Library of Congress, Thomas Legislative Information Database. Legislation in Current Congress. 2015; http://thomas.loc.gov/home/thomas.php. Accessed February 13, 2015.

 

7 comments

Leave a comment
  1. Amol Feb 19, 2019 - 01:25 AM
    Thanks, you guys that is a great explanation. keep up the good work in your granite blog.Mobile app Development Company in Noida
  2. stephen e. hansen May 05, 2018 - 06:02 PM

    pretty sorry collection of comments by drug addicts here.

     

  3. James Christopher Hill Jun 28, 2016 - 06:07 PM

    Cool link, Thank you Donni! Good research.  It's obvious there is a nefarious reason behind the control of these medicines.  If the FDA and the DEA along with the DHHS really cared about people overall, they would see that the rescheduling would hurt and possibly kill thousand while hurting millions and destroying any quality of life they might have just to "save" the few thousand per year of overdoses.  Have they ever done extreme research into the od's in the ER and found concomitant use of other drugs or alcohol mixed in the patient's system?  This will be bad.  A friend of a friend was shot and killed for drugs that he might have carried with him.  Horrible.

  4. Jane Doe Oct 21, 2015 - 02:17 PM
    What has not been addressed is the critical fact of acetaminophen being forced upon users of many narcotics. Personally I fear that the Tylenol will catch up my liver and kidneys long before the narcotic. My Dr's continued response to this? "Yes, that's a concern". No doubt it's in the best interest of makers of acetaminophen to continue this practice.
  5. Donni Sep 28, 2015 - 05:45 PM

    PS - Well said, James Christopher! 

  6. Donni Sep 28, 2015 - 05:37 PM

    If you did your homework, you would dig a little deeper into the nefarious agenda as to why hydrocodone has been rescheduled. A leaked document by the Aquarius Group - states very clearly why they do not want the public to have access to opioids. They are brainwashing blockers, same as THC (marijuana). So, with the fake and failing 'war on drugs' - really? Is that why we have troops guarding the poppy fields in Afghanistan? Anyway - I will leave a link and you can read the document yourself. It is evil, but I learned something. http://www.stopthecrime.net/COMM%2012%20BRIEFING001%20%281%29.pdf - scroll ahead to Pg 46 of the document - it is all in black and white. It is time to repeal this - there are many chronic pain sufferers who are suffering, turning to the streets, or committing suicide. Like the powers that be really care, isn't depopulation their agenda? So we know the 'overdose' and 'addiction' excuse doesn't work anymore. America is waking up.      

  7. James Christopher Hill Jun 11, 2015 - 08:42 PM

    Rescheduling the Hydrocodone from III to II is a knee-jerk reaction and will cause crime to skyrocket.  America is not "addicted" to HC, American's if they are addictive personalities will become addicted to anything bad for them, alcohol, cigarettes, video games, salts, sugar, fats.  Since when did the FDA turn into the DEA?  At the same day they passed a pass for a super Vicodin with 8 TIMES the amount of opioid.  Makes no sense except now the people who really need the drug will have to see the doctor every month, paying more money for each visit, taking away the PCP's time from other patients especially when most can't even ride in a car as my brother simply can't due to a severely bad back as he has been in constant pain for 18 years.  Yea, sure some people overdose or sell the drugs for profit, but why should a grown human who is responsible (which is the majority of people in America) suffer for the sins of the few.  We are losing more and more everyday the control of our own bodies while the general Dr's are getting more and more scared and frustrated with the new laws being passed.  They addressed the main problem which was to lower the acetaminophen in the pills, but they just went overboard. This law NEEDS to be repealed.  I bet for sure the people who passed these laws have no problem getting their hands on the drug if they need it.  This is personal for me as my mother was denied pain meds while on a bad back, so needless to say she turned into an abusive raging alcoholic to kill her pain.  Well done FDA!  (sarcasm).  We have protocols in place already to detect addiction and will not allow a refill when they "run out" early.  So why change the law? They want to fill up the prisons with non-violent offenders since prisons are now privatized using our tax payer dollars turning addicted people into criminals instead of treating the addiction.  Most responsible Dr.s monitor the patient's dosage carefully and America is NOT addicted as much as the media says they are.  Everything, even water has risks. It's up to the Dr and the patient to decide, not the FDA who is obviously being paid of by big drug companies to sell very serious side effect medications that are way more costly and dangerous to the human in every aspect.  Repeal the law.  Now!  It's only a money maker for the drug companies and the insurance companies.  The DEA or the government does not "care" about the people's well being anymore - it's obvious.  People need to have control over their own bodies and lives.  If they are addicted, the old way would have caught the addiction faster, now they won't be able to as effectively as we have removed more power from our Doctors and given the power over to the DEA and FDA which obviously do not know what they are doing except take money from the taxpayer faster.  Crime will skyrocket as more people will "steal" or buy from a dealer the drug rather than get real help from their PCP.  America is quickly becoming a police state more and more and I feel sorry for the younger generation and especially now for the people living in constant pain.  This will NOT solve the addiction problem, but only exacerbate it!  Did we not learn from prohibition? Guess not.

     

    Leave a comment