Prescribing Controlled Substances

With increasing public and regulatory attention on the dangers of controlled substances, the need for physician vigilance is greater than ever. This webpage is intended to provide physicians with resources on these issues.

Disclaimer: This webpage is intended to be a resource. It is NOT intended to be comprehensive or to be legal advice. Physicians should always consult with their medical malpractice insurance company for risk management advice and with their private health care attorney for legal advice.

General Information

New restrictions on opioid prescribing begin July 1, 2017, include several exceptions

The Opioid Epidemic: By the Numbers

Advance Directive for Addiction in Remission and to Ensure Continued Recovery form

Indiana Opioid Pain Management Prescribing Requirements Final Rule (Updated Oct. 25, 2016)

Indiana Opioid Pain Management Prescribing Final Rule Summary (Updated Oct. 25, 2016)

Comparison of CDC guidelines to Indiana Prescribing Rule

Office of the Indiana Attorney General – www.in.gov/bitterpill

ISMA public policy on drug abuse

Controlled Substance Resources (not comprehensive)

Click on a topic to view available resources.

Indiana Prescribing Laws	Indiana Opioid Pain Management Prescribing Requirements Final Rule (Updated Oct. 25, 2016) Indiana Opioid Pain Management Prescribing Final Rule Summary (Updated Oct. 25, 2016) Health Professions Standards of Practice and Disciplinary Sanctions: I.C. § 25-1-9-4 & - 9. Indiana Controlled Substance Registration (CSR): I.C. § 35-48-3(b) and 856 I.A.C. 2-3-4. Prescribing to Persons Not Seen By Physician: 844 I.A.C. 5-4-1. Assisting an Addict: A physician is subject to disciplinary sanctions if the physician "knowingly prescribed, sold, or administered any drug classified as a narcotic, addicting, or dangerous drug to a habitue or addict.” I.C. § 25-1-9-4(a)(9). Recordkeeping: Any person registered to manufacture, distribute, or dispense controlled substances "shall keep records and maintain inventories in conformance with record-keeping and inventory requirements of federal law and with any additional rules the board issues." I.C. § 35-48-3-7. Controlled Substance Schedules: I.C. § 35-48-2 et seq. and 856 I.A.C. 2-2-1 et seq. (Note: Federal law schedules can differ). Criminal Penalties for Sale and Possession of Controlled Substances: I.C. § 35-48-4-1et seq. Revised July 15, 2016
Federal Prescribing Laws	AMA: DEA Final Rule Rescheduling Hydrocodone Combination Products (Sept. 11, 2014) Federal Standard: "Valid prescription” means a "prescription that is issued for a legitimate medical purpose in the usual course of professional practice by: (i) a practitioner who has conducted at least one in-person medical evaluation of the patient; or (ii) a covering practitioner.” 21 U.S.C. § 829(e)(2)(A). Drug Enforcement Administration Controlled Substance Registration: 21 U.S.C. § 822. The DEA Practitioner's Manual provides information on a practitioner's obligations under the Federal Controlled Substances Act. DEA Final Rule on Using Authorized Agents to Communicate Controlled Substance Prescriptions to Pharmacies (Oct. 6, 2010) ISMA Reports article: "The ISMA Explains DEA Policy for Prescribing Controlled Substances” (Dec. 6, 2010) DEA Policy Statement on Dispensing Controlled Substances for the Treatment of Pain (Sept. 6, 2006) DEA Final Rule on the issuance of multiple prescriptions for Schedule II controlled substances DEA FAQs on the Issuance of Multiple Prescriptions for Schedule II Controlled Substances
INSPECT	Physicians were given access to INSPECT in 2007 for the first time as a result of ISMA's advocacy efforts. As of Dec. 15, 2013, doctors are required to consult INSPECT as part of chronic opioid pain management treatment. Indiana Law on INSPECT: When physicians are allowed to check INSPECT and limitations on disclosing INSPECT reports. IC 35-48-7 et seq. Reporting to Law Enforcement: IC 35-48-7-11.1(n) - (Indiana law permits physicians to report patients to law enforcement. However, federal law does not mirror state law, so physicians must still determine if any such report is permissible under HIPAA). Registration and more information: See INSPECT home page and INSPECT login site. ISMA Reports Newsletter Articles "Changes to INSPECT law" (July 5, 2016) "ISMA Legal Staff Shares BIG News about Reporting INSPECT Patients” (May 3, 2010) "Here's News about INSPECT: Patient Alerts, More Changes Coming” (Sept. 20, 2010) "INSPECT Helps you Manage Patients with Controlled Substance Prescriptions” (Jan. 7, 2013) "Pain Management Physicians Offer Tips to Help Your Patients” (June 24, 2013) Revised July 15, 2016
Rx Pulse articles	Rx Pulse columns are provided to keep physician members informed about the changing environment surrounding controlled substance prescribing. Are you part of the solution to our public health crisis? (Oct 10, 2016) AMA House takes action regarding pain (July 13, 2016) Comprehensive integrated opioid treatment (July 5, 2016) Four years and still questions: Why? Oh Why? (May 9, 2016) Non-pharmacologic treatment of chronic pain (March 23, 2016) Are you on board with this Black Box Warning and petition? (March 15, 2016) Physicians leading the fight against opioid crisis (Feb. 24, 2016) Attorney General Greg Zoeller discusses Indiana's opioid epidemic (Jan. 19, 2016) Changing the pain management culture at the Indianapolis VA (Dec. 18, 2015) Painting Indiana with Suboxone - The opioid medication crisis (Oct. 13, 2015) New law allows you to prescribe naloxone to prevent accidental deaths (Sept. 8, 2015) A dialogue on the opioid abuse epidemic with the new U.S. Attorney (Aug. 24, 2015) What to do when the DEA visits and demands you surrender your registration (Aug. 10, 2015) Your ISMA expands its controlled substance prescribing education with Rx Pulse (Aug. 10, 2015) Revised Oct. 14, 2016
Prescription Pads	Definition of "Prescription”: IC § 25-26-13-2. Controlled Substance Prescription Requirements: IC 35-48-3-9 and 856 IAC 2-6-4(a). Also see the Indiana Board of Pharmacy website. Controlled Substance Prescription Pad Requirements: 856 IAC 1-34-2 and Indiana Board of Pharmacy website.
Schedule II	DEA Final Rule on the issuance of multiple prescriptions for Schedule II controlled substances DEA FAQs on the Issuance of Multiple Prescriptions for Schedule II Controlled Substances Indiana: See Indiana Board of Pharmacy website
Tramadol	Tramadol has been a Controlled Substance Schedule IV drug in Indiana as of April 23, 2015 (HB1184) e-Reports, Proposed legislation would make tramadol a controlled substance (Jan. 26, 2015) e-Reports, Tramadol as a scheduled drug changes how you prescribe it (Aug. 25, 2014) Federal Register, Schedules of Controlled Substances: Placement of Tramadol Into Schedule IV (July 7, 2014) Revised July 15, 2016
Weight Loss Treatment	State Laws: Treatment for Weight Reduction or to Control Obesity: IC 35-48-3-11 and 844 IAC 5-2-20. ISMA Reports article, "The ISMA Cautions you about Prescribing Weight Loss Medications” (Oct. 22, 2012)
Drug Samples	State Law: Definition and anctions for selling and delivering drug samples after expiration dates. I.C. § 16-42-21-4 Federal Law: Multiple Federal regulations on drug samples. 21 C.F.R. § 203 Revised July 15, 2016
Physician Discipline/Enforcement Cases	ISMA Reports articles "Efforts Escalate to Curb Inappropriate Prescribing” (Dec. 17, 2012) "State Suspends Physician's Medical License for Pre-signing Prescription Pads” (March 18, 2013)
Loss/Theft	Federal Law: DEA requirement for reporting loss or theft of Controlled Substances – 21 C.F.R. § 1301.76(b) DEA Form 106 for Reporting Theft or Significant Loss of Controlled Substances Indiana Law: Duty to Report: 856 IAC 2-3-35(b) Indiana Board of Pharmacy Reporting Revised July 15, 2016
Pain Management/Opioid Therapy Guidelines	Indiana Controlled Substance Prescribing Rules (adopted Oct. 24, 2013) Federation of State Medical Boards, "Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain ” (July 2013) Federation of State Medical Boards, "Responsible Opioid Prescribing: A Clinician's Guide,” Dr. Scott Fishman, MD, (2012) American Pain Society, "Clinical Guidelines for Use of Chronic Opioid Therapy in Noncancer Pain,” (2009) Veterans Affairs/Department of Defense, "Management of Opioid Therapy for Chronic Pain,” (2010)
Addiction	Screening Tools Indiana Attorney General – Advance Directive for Addiction in Remission and to Ensure Continued Recovery National Institute on Drug Abuse: Clinician's Screening Tool for Drug Use in General Medical Settings: www.drugabuse.gov/nidamed-medical-health-professionals. Referrals Visit http://www.in.gov/bitterpill/ for referral resources, screening tools and other information relating to prescription drug abuse in Indiana. SAMHSA: Search for drug and alcohol abuse treatment or mental health facilities and programs in your area at http://findtreatment.samhsa.gov. You may also contact the SAMHSA Treatment Referral Helpline at (800) 662-4357 for referral services. Indiana FSSA: For a 24-hour hotline providing referral information for addiction treatment centers, contact the Indiana Family and Social Services Administration (FSSA) Division of Mental Health and Addiction (DMHA) at (800) 662-4357. Physicians: The ISMA Physician Directory can help you find specialists in addiction medicine, addiction psychiatry, pain management and more. Search by specialty and geographic location at www.ismanet.org/directory/index.htm. Revised July 15, 2016
ISMA eReports Articles	ISMA Reports, "Preventing Iatrogenic Relapse" (April 11, 2016) Revised July 15, 2016
Pharmacy Issues	DEA: Pharmacist corresponding responsibility, "Pharmacist's Manual Section IX – Valid Prescription Requirements” (see "Corresponding Responsibility” section) Indiana Law: Pharmacist's professional judgement and immunity IC 25-26-13-16. ISMA Reports, "Organizations Collaborate for Responsible Prescribing, Dispensing of Controlled Substances” (Feb. 24, 2014) ISMA Reports, "Pharmacies Creating Barriers for Patients Filling Controlled Substance Prescriptions” (April 29, 2013) Indiana Board of Pharmacy, Corresponding Responsibility Guidance Document (March 10, 2014) Revised July 15, 2016
Consumer Resources	Consumers can visit the following websites to learn more about prescription controlled substance abuse: www.in.gov/bitterpill www.justthinktwice.com www.getsmartaboutdrugs.com www.dea.gov