E-News Archive Index

APS E-News
September 13, 2005
Allen Lebovits, PhD, Editor

Visit the Online Store.

Browse the Publications Brochure.

In This Issue:

September Is Pain Awareness Month

Pain Bill Gathers Momentum in Congress

APS President Urges Member Involvement in Grassroots Lobbying

APS Joins Pain Awareness Month Activities

Fear of Government Scrutiny Forces Physicians to Short-Change Patients on Their Pain Medication

DEA Clarification of Existing Requirements Under the Controlled Substances Act for Prescribing Schedule II Controlled Substances

APS 25th Annual Scientific Meeting Call for Papers and Posters

Share Pain Awareness Month E-News with a Colleague!

Send Us Your Stories

September Is Pain Awareness Month

Dear Fellow APS Members,

After 2 years of valuable exposure in the previous session of Congress, the Pain Care Policy Act, now known as HR 1020, has been referred for consideration by the House Energy and Commerce Subcommittee on Health. A hearing on the bill may occur as early as September, according to Robert Saner, legislative counsel for the Pain Care Coalition (PCC). PCC includes APS, the American Academy of Pain Medicine, the American Headache Society, and the American Society of Anesthesiology.

"We're glad the bill is moving to the hearing stage, but we'd like to have a better balance of Republican and Democratic cosponsors, especially from the Energy and Commerce Committee's Subcommittee on Health, to increase our chances for prompt, favorable action," said Saner. The measure currently has 20 cosponsors, of which six are Republicans. The lead sponsor is Representative Mike Rogers, a Republican from Lansing, MI.

"Given the lack of a strong constituency around pain issues both in Washington and at the grassroots level, the focus of activity will continue to be on recruiting additional cosponsors," said Saner. "A strong showing of support from the home district is effective in making your issue a top-of-mind concern for any member of Congress. For this to be successful, we must flood Capitol Hill with letters asking for support and explaining the importance of good pain care to patients, families, employers, and communities."

The Democratic cosponsors are Representatives Cummings (MD), Frank (MA), Inslee (WA), Kucinich (OH), McGovern (MA), Murtha, (PA), Nadler (NY), Payne (NJ), Price (NC), Ruppersberger (MD), Slaughter (NY), Stark (CA), Wexler (FL), and Woolsey (CA).

In addition to lead sponsor Rogers, the cosponsoring Republicans are Representatives Bachus (AL), Conaway (TX), Norwood (GA), Platts (PA), Schwarz (MI), and Tiberi (OH).

HR 1020 Provisions

HR 1020 would allocate $60 million to establish a National Center for Pain and Palliative Care Research at National Institutes of Health (NIH) and establish six regional pain centers. Other provisions will

• Establish a White House Conference on Pain to raise awareness of pain as a significant national health problem and identify barriers to appropriate pain care.
• Create a pain and palliative care research and quality program within the Agency for Health Care Quality and Research.
• Ensure that American military personnel and veterans receive appropriate pain care services at VA healthcare facilities.
• Ensure that patients enrolled in Medicare managed care plans receive appropriate pain care.
• Authorize a public awareness campaign by HHS to educate patients, families, and other caregivers on pain care.

APS Members Visit Capitol Hill for Pain Awareness Month

To support the lobbying effort for passage of HR 1020, APS representatives will visit Capitol Hill this month to meet with House members and staff on the Energy and Commerce Subcommittee on Health, which is expected to hold a hearing on the bill in September.

In addition to the Hill visits, a separate APS delegation will meet with officials of the NIH to review various provisions of the pain bill.

The APS Hill visits are being coordinated with a broader lobbying effort sponsored by Partners for Understanding Pain, a national consortium of pain advocacy groups and professional societies led by the American Chronic Pain Association. On September 14, Partners' member organizations will send representatives to the Washington and local district offices of House members to urge support for HR 1020.

APS President Urges Member Involvement in Grassroots Lobbying

The reintroduction this year of HR 1863, now HR 1020, The National Pain Care Policy Act of 2005, has generated great enthusiasm within the pain community, but APS President Dennis Turk cautions that the bill faces a long and arduous trek through Congress before it becomes law.

"The bill has received some great exposure and attention in Washington and has 20 cosponsors in the House," said Turk. "Now that the bill is under subcommittee consideration it's imperative we add as many cosponsors as possible through effective pressure at the grassroots level by asking our APS colleagues to write, e-mail, and call their local representatives. If we are successful in adding an impressive number of cosponsors, it can expedite consideration of the pain bill," he added.

APS has developed a boilerplate letter and background information to assist individual members in contacting their representatives. In addition, APS has developed other resources to help members generate local media coverage and supportive editorials.

"House members and their assistants pay close attention to editorial opinions published in daily and weekly newspapers within their districts," said Turk. "Grassroots publicity, therefore, can be very influential in shaping a legislator's views on a particular issue."

APS members who want to help generate favorable news coverage for the pain bill in their communities should contact APS Public Relations Consultant Chuck Weber at cpweber@weberpr.com.

"We encourage every APS member to become as active as possible in generating support for the pain bill," said Turk. "With strong member involvement at the grassroots, APS will be a very influential and powerful player in the ongoing effort to secure passage of this critical legislation."

APS Joins Pain Awareness Month Activities

Every year, the APS John and Emma Bonica Award recognizes contributions by an individual or organization through public education, public service, or other vehicles that communicate information about pain. The 2005 award recipient is Penny Cowan, director of the American Chronic Pain Association and leader of Partners for Understanding Pain, a consortium of pain advocacy organizations. Its mission is to create greater understanding that pain is a serious public health problem and to offer a comprehensive network of resources for those affected by persistent pain. APS is a member of the consortium and again this year APS joins Cowan and her supporters in commemorating Pain Awareness Month.

"Penny Cowan is a tireless advocate for people with pain," said APS President Dennis Turk. "She has dedicated her life to spreading the message that pain patients have responsibility for their care and should play a key role on the treatment team."

In 2004, Turk was the keynote speaker at the Partners annual convention in Washington, DC. He told the group that the Decade of Pain Control and Research offers APS and other professional and patient groups a unique opportunity to push an aggressive agenda in Congress and at NIH for policy reforms and increased research funding. He said that passage of the pain bill will mark the first time that pain care and research will be funded on its own rather than being considered only as a complication of cancer and other diseases.

"Although the Decade of Pain has yielded beneficial achievements thus far, the pain community has a long way to go to achieve a meaningful level of public awareness about pain and pain management to help shift the tide toward expanded pain research and improved access to quality care," said Turk. "For this reason, APS is pleased to join Partners for Understanding Pain in commemorating Pain Awareness Month to help educate the public and move the needle of public opinion in ways beneficial to pain patients, clinicians and researchers."

Fear of Government Scrutiny Forces Physicians to Short-Change Patients on Their Pain Medication

In his Decade of Pain Lecture at the 2005 APS Scientific Conference, David Joranson, senior scientific director of the Pain and Policy Studies Group (PPSG) of the University of Wisconsin's Comprehensive Cancer Center, told APS members that state and federal regulatory efforts to curb opioid diversion should not interfere with patient care. He reported that fear of governmental scrutiny—fueled by the media and its misconception that prescribed opioid analgesics account for skyrocketing substance abuse—is forcing physicians to under-prescribe needed pain medications.

"I can remember when media coverage focused on the under-treatment of pain," he said. "Somewhere along the line that shifted to a war on pain killers, casting prescription opioids as the new villain in the war on drugs."

Joranson cited three recent national surveys showing a trend for physicians to reduce doses or prescribe fewer opioids to avoid investigation by their state medical boards. He urged APS members to look for opportunities to build an understanding among federal and state regulators that the causes of increased abuse, especially criminal diversion, should be studied much more thoroughly.

"'Diversion'—the movement of opioids from licit to the illicit channels—is the key word," he said, "and the sources of diversion should be addressed directly, without interfering with medical practice. Controlled substance status is not intended to diminish medical use of opioids." He added that the source and the amount of criminal activities are what really matters.

"Drugs don't divert themselves," said Joranson, citing diversion's many sources—pill mills, shopper prescription fraud, patients, theft, and the Internet. Theft of trucks alone accounts for hundreds of thousands of analgesic units a year, he noted.

In a recent 3-year-period, there were 2,494 thefts of Oxycontin, including 631 armed robberies and 707 night break-ins, accounting for 1,369,667 dosage units, according to the Drug Enforcement Administration (DEA), which made pharmacy theft a federal crime in 1984.

Joranson also reported that from 2000 to 2003, 16 states improved their pain policies. At the national level, his Pain and Policy Studies Group is pressing the DEA to stop sending messages of fear to physicians and to clarify what constitutes unlawful physician conduct.

DEA Clarification of Existing Requirements Under the Controlled Substances Act for Prescribing Schedule II Controlled Substances

On January 18, 2005, the Department of Justice Drug Enforcement Administration (DEA) published a solicitation of comments on the subject of dispensing controlled substances for the treatment of pain in the Federal Register. Many of the comments that the agency received indicated a need for clarification of certain aspects of the prescription requirements for schedule II controlled substances. On August 26, 2005, the DEA issued the following clarifications to the Controlled Substances Act (CSA) and DEA regulations:

1. As the Interim Policy Statement states, "For a physician to prepare multiple prescriptions [for a schedule II controlled substance] on the same day with instructions to fill on different dates is tantamount to writing a prescription authorizing refills of a schedule II controlled substance." To do so conflicts with the provision of the CSA which provides: "No prescription for a controlled substance in schedule II may be refilled."

2. Many of the comments that DEA received were from patients who said they have been receiving prescriptions for schedule II controlled substances for several years (for example, for the treatment of severe pain or attention deficit hyperactivity disorder) and have gotten into a routine of seeing their physician once every 3 months. Many who made comments were under the mistaken impression that, because of the Interim Policy Statement, they now must begin seeing their physician every month. The Interim Policy did not state that such patients must visit their physician's office every month to pick up a new prescription. There is no such requirement. What is required, in each instance where a physician issues a prescription for any controlled substance, is that the physician properly determine that there is a legitimate medical purpose for the patient to be prescribed that controlled substance and that the physician be acting in the usual course of professional practice. 21 CFR 1306.04(a); United States v. Moore, 423 U.S. 122 (1975).

At the same time, schedule II controlled substances, by definition, have the highest potential for abuse, and are the most likely to cause dependence, of all the controlled substances that have an approved medical use. 21 U.S.C. 812(b). Physicians must, therefore, use the utmost care in determining whether their patients for whom they are prescribing schedule II controlled substances should be seen in person each time a prescription is issued or whether seeing the patient in person at somewhat less frequent intervals is consistent with sound medical practice and appropriate safeguards against diversion and misuse. Physicians must also abide by any requirements imposed by their state medical boards with respect to proper prescribing practices and what constitutes a bona fide physician-patient relationship. 21 U.S.C. 823(f)(1), (4).

3. Under the circumstances in which a physician (who regularly sees a patient) issues a prescription for a schedule II controlled substance for a legitimate medical purpose without seeing the patient in person, the physician may mail the prescription to the patient or pharmacy. In addition, as the DEA regulations state: "A prescription for a schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted [elsewhere in this section of the regulations]." 21 CFR 1306.11(a). Thus, as this provision of the regulations provides, faxing may be used to facilitate the filling of a schedule II prescription, but only if the pharmacy receives the original written, signed prescription prior to dispensing the drug to the patient.

4. The CSA and DEA regulations contain no specific limit on the number of days' worth of a schedule II controlled substance that a physician may authorize per prescription. Some states, however, do impose specific limits on the amount of a schedule II controlled substance that may be prescribed. Any limitations imposed by state law apply in addition to the corresponding requirements under Federal law, so long as the state requirements do not conflict with or contravene the Federal requirements. 21 U.S.C. 903. Again, the essential requirement under Federal law is that the prescription for a controlled substance be issued for a legitimate medical purpose in the usual course of professional practice. In addition, physicians and pharmacies have a duty as DEA registrants to ensure that their prescribing and dispensing of controlled substances occur in a manner consistent with effective controls against diversion and misuse, taking into account the nature of the drug being prescribed. 21 U.S.C. 823(f). Finally, as stated in the Solicitation of Comments, once DEA has completed its review of the comments, the agency plans to issue a new Federal Register document, which will provide a recitation of the pertinent legal principles relating to the dispensing of controlled substances for the treatment of pain.

For more information, contact Patricia M. Good, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC, 202/307-7297.

APS 25th Annual Scientific Meeting Call for Papers and Posters

The APS Scientific Program Committee invites the submission of proposals for papers and posters to be presented at the APS 25th Annual Scientific Meeting, May 3–6, 2006, in San Antonio, TX.

The online submission system opened on September 12, 2005, and will remain open until November 4, 2005.

Review the submission guidelines or apply online and share your knowledge and research with your colleagues.

Paper and poster submissions will be reviewed and rated by members of the APS Scientific Program Committee who have expertise in the research or clinical area of the submission. Each submission will be reviewed for its scientific or clinical importance, ethical practice, and study design.

APS invites all primary authors of posters accepted for presentation at the 2005 Society for Neuroscience meeting to present their work at the APS Annual Scientific Meeting in San Antonio in 2006. (This invitation does not apply to paper presentations.)

First authors on paper or poster submissions will be notified in January 2006 (by mail) of their abstract's acceptance or rejection.

Share Pain Awareness Month E-News with a Colleague!

Although APS E-News is a benefit of APS membership, we invite you to forward the next four issues to your colleagues. These issues cover not only Pain Awareness Month but also provide information about APS and the important work it does to advance pain-related research, education, treatment, and professional practice.

If you know someone who may be interested in learning more about Pain Awareness Month or joining our network of more than 3,200 basic and clinical scientists, practicing clinicians, policy analysts, and others working to elevate the standards of pain care, simply click Forward to a Colleague and insert the e-mail address. As APS grows, so does its effectiveness in influencing patient care and its ability to provide an outstanding array of benefits.

Has this special edition of APS E-News been forwarded to you? Would you like to learn more about APS and the other benefits of membership? Click here.

Send Us Your Stories

Do you have a story that you would like to share about something that you or your colleagues are doing to commemorate Pain Awareness Month? If so, e-mail Managing Editor Deborah Pinkston at dpinkston@amctec.com and share your story.