6/14/2017. I have no actual or potential conflict of interest in relation to this program/presentation.

Transcription

1 Sheila Weix MSN, RN, CARN smw June I have no actual or potential conflict of interest in relation to this program/presentation. I am not A recipient of grant or research funds from any company A member of any company s speaker bureau A consultant for any company A major shareholder for any company smw June Registered Nurse Addiction professional - CARN In practice since the early 1980s Experience in both private and public systems Medical/surgical acute care background followed by work in inpatient detoxification, and full continuum of substance use disorder treatment services The opinions expressed are those of the speaker Questions are encouraged, although answers may be deferred smw June

2 Describe the marketing methods and research that lead to the increased use of prescription drugs for chronic pain management Understand the new protocols, prescriber-access databases and education efforts that have been created and disseminated to assist in reduction of prescribed opioid medication misuse and dependency Identify individual and community actions that can make a difference smw June Promotion and marketing of OxyContin by Purdue Pharma Introduced in 1996: Medication did NOT have significant advantages over other opioids 1996 sales $48 million $48,000, sales $1.1 BILLION $1,100,000,000 HOW: Aggressive campaign to promote opioids in general and OxyContin in particular 2001: $200 million to market and promote OxyContin Successfully impacted prescribing, standards of care, patient expectations and measurements of quality smw June Perdue Pharma is owned by the Sackler family Brothers Arthur, Mortimer and Raymond purchased a small pharmaceutical company in New York in 1952 All three brothers were practicing psychiatrists Arthur was highly successful in medical advertising Listed in the Medical Advertising Hall of Fame Wrote papers that helped Valium become the first $100 million drug 1987 the company began working with pain medications Modified Oxycodone (WWI era German med) for time release Forbes 2015 Richest Families: estimated $14 Billion Forbes 7/2015 smw June

3 1986 paper: 38 cases concluded opioid therapy safe and humane for non-malignant pain and no history of drug abuse 1990s: One of the Directors of the American Pain Foundation and President of the American Pain Society Identified the epidemic of untreated pain Campaigned for pain as the fifth vital sign Many lectures identifying the risk of addiction with the use of opioids for pain at <1% 1980 Porter & Jick letter to NEJM: Hospitalized acute care patients $$ Research support, consultant fees and honorariums: Perdue, Cephalon smw June : Company conducted more than 40 national painmanagement and speaker training conferences >5000 doctors, nurses and pharmacists attended Resorts in Florida, Arizona and California All-expense paid Recruited and trained for Purdue s national speaker bureau Aggressive sales force Prescriber profiles: database of prescribing profiles Targeted the highest prescribers Identified those with high numbers of chronic pain patients Direct contact with large incentives for sales people ($40 million in bonuses in 2001) smw June Targeting of primary care physicians Offering coupons for free initial 7-30 day supply Focused on non-malignant pain (10 fold increase in Rx from 1997 to 2002 while cancer pain Rx increased only 4x) Disinformation Risk of addiction <1% (Studies 0% to 50% depending on criteria and subpopulation) Marketing directly to providers and patients without FDA review >20,000 pain-related education programs funded by Purdue July 2002 Blurring of education and marketing smw June

4 1996 APS & AAPM landmark consensus little risk of addiction or overdose in pain patients Pseudo-addiction Pain patients cannot become addicted 5 th Vital Sign entirely subjective What is your pain rating? Was your pain treated? Patient right to pain control Pain-free expectation versus functional emphasis Discounting/exclusion of interventions that are not a medication Failure to provide opioid Rx for chronic pain could be interpreted as a failure to treat with possible implications for the provider smw June Veteran s Administration adopts the pain as 5 th vital sign as part of national pain management strategy 1998 Federation of State Medical Boards recommended policy reassuring providers that regulatory action would not be taken for Rx large amounts of narcotics in the course of medical tx: Purdue Pharma executive helped in the production of the policy 2001 Joint Commission Pain standards JC publishes a guide sponsored by Purdue Pharma Patient satisfaction surveys: Process and consultation CMS value based pay program using patient surveys that include scoring of satisfaction with pain management. Patient satisfaction 30% weight Administrators held providers responsible for patient satisfaction with impact on pay and bonuses FDA: one half of budget based on User Fees paid by pharmaceutical companies Pharmaceutical employees and consultants on multiple advisory groups with input at multiple levels, including voice of the patient If patient began exhibiting addiction behaviors, could be labeled as drug-seeking and pushed out of healthcare into legal or social systems: patient failure smw June Role of respected expert throughout this time 2004 Rebuttal letter in response to expert testimony in trial of provider Reference to high dose opioid therapy as an indication of drug abuse as untrue. The high dose may be needed to control pain and such use is in the scope of medicine. The expert identified morphine at a dose of 195mg/day as a high dose. Dr. P. labeled this as without foundation in the medical literature and absurd. Disagreement with the expert testimony that opioid treatment of an individual with known addiction is medically wrong and worsens the addiction. Dr. P. supported the approach of relief through careful opioid therapy. smw June

5 Approach to pain changed with increases in all opioids being prescribed in this country opioids become an accepted/expected part of care for almost everything Opioid prescribing patterns have had regional variations with increasing diversion, opioid abuse and overdose deaths following the prescribing patterns % increase in sales in 4 years!! By 2010 $3.1 billion or 30 percent of the painkiller market sale of Rx painkillers quadrupled and overdoses quadrupled Overall amount of pain reported by Americans has NOT changed!! smw June million Americans with a SUD in 2015, 2 million had a SUD involving Rx pain relievers and 591,000 had a SUD involving heroin Drug overdose is the leading cause of accidental death in the U.S. with 52,404 lethal drug overdoses in ,101 related to Rx drugs; 12,990 overdose deaths related to heroin x increase in OD deaths; x increase in Rx pain relievers; x SUD tx admissions 4 of 5 heroin users started out with Rx painkillers million Rx written for opioids: more than enough for every adult American to have their own bottle of pills smw June May 2007 Purdue settlement with 26 states $19.5 million and ending of some of the most controversial sales techniques including bonuses for OxyContin sales May 2007 Purdue and three top executives plead guilty to criminal charges for misbranding by claiming less addictive and less subject to abuse and diversion than other opioids $634 million in fines and other fees December 2015 Kentucky lawsuit settled for $24 million January 2017 Everett, Washington filed suit against Purdue Pharma claiming the company knew its drugs were being diverted and did nothing to stop it May 2017 Perdue settles Canadian lawsuit for $20 million smw June

6 2012 interview in the Wall Street Journal: erred in overstating the drugs benefits and glossing over the risks 2010 interview: lectures in the 1980s and 1990s about addiction that weren t true Disclosed relationships with more than a dozen companies, most of which produce opioid painkillers Dr. P. denied that these financial relationships biased any of his lectures or publications Dr. Portenoy is now included in a number of the lawsuits that have been filed in terms of misrepresentation of the risks and benefits of the medication smw June CDC prescribing guidelines Wisconsin Medical Examining Board Opioid Prescribing Guidelines Provider education requirements PDMP Complete reassessment of how we approach pain Patient education Community education smw June Opioids NOT 1 st line Establish goals for pain & function Discuss risks & benefits Use immediate-release opioids when starting Use the lowest effective dose Rx short durations for acute pain 3-7 days Evaluate benefits & harms frequently Use strategies to mitigate risk: naloxone if hx of OD or >50 MME/day PDMP review Urine drug testing Avoid opioids AND benzos Offer treatment for opioid use disorder smw June

7 NEW CONTINUING MEDICAL EDUCATION REQUIREMENT IN EFFECT IN THE CURRENT BIENNIUM Medical Examining Board Issues Emergency Rule Regarding Opioid Prescribing Continuing Medical Education On November 10, 2016, the Wisconsin Medical Examining Board s (MEB) emergency rule relating to continuing medical education (CME) on its opioid prescribing guideline became effective. The rule requires two CME credits per biennium for at minimum the next two times you will renew your license. The courses will relate to the guideline, which was issued by the MEB in July The requirement is one component of a comprehensive statewide strategy to address prescription drug abuse in the best interest of public health and safety. This emergency rule does not require additional hours of CME. The new two credit requirement is part of the 30 credit total, not an addition to the total. The purpose of the rule is to require that a portion of the CME requirement relates specifically to the opioid prescribing guideline. smw June What is the new requirement? Beginning April 1, 2017, prescribers will be required to review patient records in the WI epdmp prior to issuing most controlled substance prescription orders to their patients. This requirement is for all controlled substance prescriptions unless any of the exceptions apply; the law does not provide an exception based on the schedule of the drug. The exceptions to the requirement to review are: patients receiving hospice care, prescriptions intended to last the patient 3 days or less that are not subject to refill, drugs that are administered directly to the patient, emergency situations that prevent the practitioner from reviewing epdmp records, and technological failures. smw June Partner with the patient: his or her journey Focus on function and goals, not pain number Recognize pain as having purpose and function Recognize the true risks and benefits of opioid treatment Understand the chronic pain is by definition chronic, pain-free may not ever be a goal for some people Recognize and support holistic approaches that emphasize improvement in quality of life Consider alternative therapies consistent with the individual s needs and beliefs Recognize when addiction may be present and refer to needed care smw June

8 Clarify the meaning of good care True risk/benefit discussion including addiction risks Non-opioid alternatives (NSAID, acetaminophen, heat, ice, rest) When needed, expect the lowest dose of opioids for the least amount of time Particular attention to prescribing of opioids for minors (parental role) Dispose of any unused medications If addiction is suspected, will approach directly in nonjudgmental manner to assist the patient to access needed assistance smw June How pain management has changed: there is no magic pill Risks of opioid use Parental education regarding opioid prescribing for minors Rx drug collections Addiction as a brain disease and recovery is possible smw June Dreamland: The True Tale of America's Opiate Epidemic by Sam Quinones OxyContin commercial: OxyContin Poster Children: 15 Years Later Opioids: Last Week Tonight with John Oliver (Caution: does include adult language. HBO broadcast) smw June

9 Change is slow. Opioid treatment of pain was a part of medical education for the past two decades Public TV documentary on pain treatment The Painful Truth : depicts overreaction to opioid overdoses and provides the plight of patients struggling to find effective treatment for chronic pain. Producer: Dr. Lynn Webster who has been an advisor, consultant and recipient of research money from pharmaceutical companies who make opioid pain medications. The connection is not identified in the documentary. Dr. Webster is named as a defendant on some of the opioid lawsuits smw June CDC Prescribing Guidelines: Wisconsin Medical Examining Board Opioid Prescribing Guidelines: esources/meb/meb_guidelines.pdf smw June ASAM Opioid Addiction 2016 Facts & Figures Armstrong, D. TV documentary on pain treatment funded by doctor with industry ties. CBS News Kentucky settles lawsuit with OxyContin maker for $24 million Gosk, S. and Douglas, D. Oxycontin maker Purdue Pharma hit with unprecedented lawsuit by Washington city smw June

10 Hirsch, R., MD the opioid epidemic: it s time to place blame where it belongs Howlett, K. Purdue Pharma agrees to settle OxyContin classaction suit Dk5NzE%3D Jacobs, H. This one-paragraph letter may have launched the opioid epidemic Meier, B. In guilty plea, OxyContin maker to pay $600 million smw June Morrell, A. The OxyContin clan: the $14 billion newcomer to Forbes 2015 list of richest U.S. families Poison Review The money and influence behind Pain as the Fifth Vital Sign Van Zee, A. The promotion and marketing of OxyContin: commercial triumph, public health tragedy. Am J Public Health. 2009;99: doi: /AJPH smw June