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February 6, 2008

Public Act 95-0442: Expanded Reporting Requirements for Pharmacies Dispensing Controlled Substances

TO: Chief Executive Officers, Member Institutions

Introduction
Illinois has long history of health care providers working with law enforcement to discourage the illegal use of drugs. Since 1986, Illinois physicians prescribing, or pharmacies dispensing, Schedule II controlled substances to patients have had to report patient-specific information to the Illinois Prescription Monitoring Program, provided the medications were not dispensed to patients receiving care in a hospital licensed under the Hospital Licensing Act. Over time, the state’s monitoring program evolved to eliminate physician reporting requirements, placing those responsibilities solely upon pharmacies filling prescriptions.

In accordance with federal initiatives to better assist law enforcement and the medical community in addressing and preventing illegal activity, SB 30, a bipartisan initiative, was introduced during the 2007 session and was passed unanimously by the General Assembly in May. Governor Blagojevich signed the bill into law last August, effectively building on existing state reporting requirements of controlled II substances. As of January 1, 2008 the revised law requires pharmacies to report Schedule II-V controlled substances dispensed by prescription. The data required for Schedule III-V controlled substances is the same data previously reported for dispensation of Schedule II substances.

In addition, the revised Controlled Substance Act (720 ILCS 570) expands the state’s confidential data repository containing the reportable information and adds a real-time inquiry system "to assist the medical community in its goal of effective clinical practice and to prevent patients from diverting or abusing medications." (720 ILCS 570/318 (j)). The Department of Human Services manages this confidential database containing patient-specific information for prescribers and pharmacists which may be accessed at https://ilpmp.org.

Exempted Activity
For the purposes of this Act, the medication order for a controlled substance generated by a physician’s order on a patient’s chart in the hospital setting differs from a written prescription for the same medication handed from a doctor or other prescriber to his/her patient. When pharmacies licensed under the Hospital Licensing Act dispense and administer controlled substances generated from a physician’s order sheet as part of the patient’s chart, and not from a written prescription, they are exempt from the reporting requirements as long as the controlled substance is noted on the patient’s record, signed by the prescriber, dated, and the name and quantity of controlled substance is recorded. (720 ILCS 570/313 (a)). This exemption extends to those hospital departments and services that also fall under the Hospital Licensing Act, e.g. the emergency room, oncology or radiology areas. Therefore, controlled II-V substances for short 1-2 day supplies that are filled from the hospital’s inventory and noted in the patient’s record do not require reporting under the revised law.

Operational Impact
Unless the medication activity falls within the exemption outlined above, a hospital pharmacy dispensing controlled substances in conjunction with a written prescription provided, for example, to a patient upon discharge or physician office visit, must report to the Illinois Prescription Monitoring Program. The reporting mandate also includes every written prescription for a Schedule II through V controlled substance that a hospital employee, physician, or staff family member may present to the hospital pharmacy for filling.

Reporting Process:
Again, the major change to the Act requires prescription data previously required for Schedule II controlled substances to now be collected and reported for Schedules III-V (720 ILCS 570/321). Otherwise, the state’s reporting process established for Schedule II controlled substances remains exactly the same:

Additional Information
The following resources may be helpful to assist your hospital’s implementation efforts and all are available from IHA’s web site (click here):

IHA expresses appreciation to the staff of the Illinois Council of Health-System Pharmacists (ICHP) for their collaboration and review with this update. Please contact me directly at bmcarte@ihastaff.org or (630) 276-5843 or Scott Meyers, RPh, Executive Vice President, ICHP, at 815/227-9292 with any additional questions or concerns.