Safe Prescribing: Protecting Kids While Controlling Costs

1. Safe Prescribing:Protecting Kids While Controlling Costs Ann Woloson Executive Director, Prescription Policy Choices National Conference of State Legislatures Annual Meeting July 24, 2009Philadelphia, PA

2. Prescription Policy Choices • Nonprofit, nonpartisan 501(c)(3) educational and public policy organization providing objective research, information and expertise on prescription drug policy to expand access to safe, effective and affordable prescription drugs • Foundation and Consumer Advocacy Group funding: Nathan Cummings Foundation, Endowment for Health, Maine Health Access Foundation, Bingham Program, Consumers Union, Sadie and Harry Davis, Maine Community Foundation

3. Safe Prescribing: Protecting Kids While Controlling Costs • Banning Predatory Marketing to Minors • Psyche Drugs and Kids: Off-label Use in Kids Questioned • Academic Detailing / Prescriber Education / Evidence-based prescribing

4. Banning Predatory Marketing to Minors Pharmaceutical Executive (PE) (pharmaceutical trade journal) July, 2008 reported: • Online ads will amount to $30 billion

5. PE, August, 2008 reported Minors Targeted via Internet and MySpace

6. Example: NuvaRing(birth control) internet ad links viewers to “Sign up for your Daily Horoscope”

7. Differin (acne cream) Offers Free Samples if You Give Them Your Name, Address, etc.

8. Online Patient Compliance Programs used to boost sales and direct consumers to specific products, some offer awards, etc. • Serano’s growth hormone website (www.coollearnings.com) offered kids free downloads for answering a quiz correctly / free gifts to be mailed to your home (lunch boxes, art packs, etc) • Gardasil used text-messaging to remind girls they need all three doses of vaccine

9. Unintentional Consequences: • Personal or health care related information collected, stored, shared, and used over time for marketing purposes • Children steered toward drugs that may be unnecessary, are more expensive, no more effective and sometimes less safe than other products on the market

10. Maine Public Law 2009, Chapter 230An Act to Prevent Predatory Marketing of Minors • Bans the unlawful collection and use of health related or personal information for marketing purposes from minors without first obtaining parental (or guardian) consent • Violations considered unfair trade practices – Attorney General may establish procedures for receiving and investigating complains of violations • Provides Civil penalties for Civil violations and federal law application (Children’s Online Privacy Protection Act of 1998)

11. Safe Prescribing: Protecting Kids While Controlling Costs Related Issues: • Kids and Psyche Drugs • Academic Detailing / Prescriber Education

12. Kids and Psyche Drugs Prescribing psyche medications to children in the US has increased dramatically: • In less than a ten-year period, the use of potent psychotropic medication in children and adolescents grew by five-fold.

13. Us Kids Take More Psychopathic Drugs than Europeans

14. Younger Children are Being Prescribed Psychotropic Medications Some children as young as just one year-old, are being prescribed these medication at increasing rates. • Behaviors once considered “normal” – a baby “not sleeping through the night” or a toddler going through “the terrible twos” are now being diagnosed and medicated as “sleep resistant” or “oppositional-defiant, with mood swings.”

15. Medicaid and Foster Care • Pediatrics, 2008: Youth in foster care covered by Medicaid insurance receive psychotropic medication at a rate greater than 3 times than other Medicaid-insured youth… even though such treatment lacks substantive evidence as to its effectiveness and safety. • Increase in Medicaid expenditures for atypical antipsychotics: 21% growth rate was seen in costs and growth in utilization between 2000 and 2007

16. Risks: While only a handful of these drugs are approved by the FDA for use in children, many taken by children are “adult” medications prescribed for off-label usage. Kids exposed to side effects: • Weight Gain and High Blood Sugar (Diabetes) • Cardiovascular Disorders • Suicidal Thoughts

17. Safer and Effective Prescribing of Psyche Drugs to Kids • FDA’s black-box warning (10/04) describing possible suicide risk(s) in children: • Following the release of information about safety risks and the inclusion of the black-box warning, studies found substantial declines in the use of antidepressants among both children and adults • Florida Medicaid: requires approval before prescribing to young children (5 and under): • Prescriptions written for the drugs dropped by nearly 75% - no major outcry from doctors • Agency of Health Research and Quality (AHRQ) study: • 16 states collecting common data re: prescribing of AAPs to kids to understand variations in prescribing patterns and evaluate gaps in therapy and best practices for reducing AAP prescribing practices.

18. Academic Detailing • Also known as prescriber education and outreach • Practice of sending highly-trained clinicians to prescribers’ practices to discuss objective, non-commercial, evidence-based information on effectiveness, risks and cost-effectiveness of commonly used drugs • Free of commercial conflicts of interest

19. Drug Industry Sales Strategy:Gimme an Rx! Cheerleaders Pep Up Drug Sales By STEPHANIE SAUL Published: November 28, 2005, New York Times As an ambitious college student, Cassie Napier had all the right moves- flips, tumbles an ever-flashing America's sweetheart smile - to prepare for her job after graduation. She became a drug saleswoman.

20. In Contrast… Academic Detailing uses trained clinicians (Pharmacist, Doctors, Physician Assistants and Nurses) to provide Up-To-Date -evidence -based information.

21. Existing Prescriber Education Programs • US: Pennsylvania: since 2005, administered by the Independent Drug Information Service (iDiS) / Harvard Medical School for PA’s elderly drug assistant program (PACE); www.RxFacts.org Vermont: since 1999; housed in U VT’s College of Medicine Office of Primary Care South Carolina: since 2007, U SC School of Pharmacy • Worldwide: Australia (DATIS), Canada & Europe

22. Emerging Prescriber Education Programs • Maine: passed legislation in 2007 funding the program through pharmaceutical manufacturer fees • New Hampshire: passed enabling legislation in 2008 • New York: 2008 legislation appropriated general funds to Dept. of Health • Massachusetts: 2008 legislation appropriated general funds to the Dept. of Public Health • Washington, DC: 2008 SafeRx legislation

23. Current Prescriber Education Legislation • California: SB 341 cleared the Senate Health Committee and will be held over until Jan. • Minnesota: SF 895 is alive, held over until Feb. • New Mexico & Maryland: Studies

24. Federal Prescriber Education Bill • IDEA – the Independent Drug Education and Outreach Act of 2009 (S 767; HR 1859) • Sponsors: Kohl (D-WI) & Waxman (D-CA) • A two-pronged federal grant program for: • Development of educational materials • Dissemination of educational materials through prescriber education/academic detailing • States would be eligible to apply

25. Contact: Ann Woloson awoloson@policychoices.org