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

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)

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.

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.

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)

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

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

Revised July 15, 2016

Pharmacy Issues

Revised July 15, 2016

Consumer Resources

Consumers can visit the following websites to learn more about prescription controlled substance abuse:

Recent Articles
Legislative News Articles
Prescribing [02/27/2017]
Licensing [02/27/2017]
Bills [03/21/2016]
Morgue [03/21/2016]
Pharmacy [02/22/2016]
Pharmacy [02/08/2016]
Pharmacy [01/25/2016]
Introduction [05/04/2015]
Pharmacy [05/04/2015]
Morgue [05/04/2015]
Pharmacy [04/20/2015]
Medicaid [04/06/2015]
Medicaid [02/23/2015]
Medicaid [02/09/2015]
Introduction [02/09/2015]
Public Policy Articles
PHARMACEUTICALS [01/01/2017]
METHADONE [01/01/2017]
MEDICAL MARIJUANA [01/01/2017]
INSPECT [01/01/2017]