The National School Nurse Association Position Statement on Research Medication in the School Setting
By Lorinda L. Dishington, RN, BSN
This NASN position statement was adopted in June 2001 in order to provide school nurses with a resource for dealing with medications that do not fall within the Food and Drug Administration (FDA) guidelines. While this is not a common, everyday occurrence for most school nurses, the issue does occasionally arise and the school nurse must be familiar with the NASN position statement.
Research medications fall into two categories: experimental medications and off-label medications. Experimental medications are usually part of a clinical trial, meaning they are part of a formal study to determine the safety and efficacy of the medication, but are not yet FDA approved. The example cited by the NASN is a cancer drug being taken by a student as part of a clinical trial.
Off-label medications, on the other hand, are FDA approved, but are prescribed for purposes other than the approved legal use. Examples of off-label medications may include medications that are typically prescribed for adults, but are instead prescribed for a child, medication that is prescribed in an alternate dose or route, or medication that is used to treat a particular medical condition, but is instead being used for a different medical condition.
The NASN position statement supports the idea that school nurses must have age-appropriate medication information that has been verified through clinical trials and must ensure that students receive both safe and effective drugs. The position statement also mention that courts have upheld the nurse's refusal to administer a medication that exceeds the amount published in a standard medication reference guide such as the Physician's Desk Reference.
The official NASN recommendation is "that school districts develop policies and procedures to address staff handling and administration of experimental or off-label medications, if medically necessary during school hours, with student safety as the primary consideration" (2001). In addition, each situation should be evaluated on a case-by-case basis by both the school nurse and the licensed prescriber of the medication.
When dealing with experimental medication, the nurse should obtain a copy of the written protocol, a consent form signed by the parental or guardian, description of the study that includes the potential benefits and risks, the signs and symptoms of adverse reactions, and contact information for the members of the research team. In the case of off-label medications, the nurse should obtain adequate and reliable information that supports the safety and efficacy of administrating the drug in school.
In the Massachusetts, medication administration in school is governed by the Massachusetts Department of Public Health (1996), and they define an Investigational New Drug as "any medication with an approved investigational new drug (IND) application on file with the Food and Drug Administration (FDA) which is being scientifically tested and clinically evaluated to determine its efficacy, safety and side effects and which has not yet received FDA approval." Investigational New Drugs may be administered by the school nurse provided that there is a written order by a licensed prescriber, written consent by the parent or guardian, and a pharmacy labeled container is available.
References
Massachusetts Department of Public Health. (1996). 105 CMR 210.00: the administration of prescription medications in public and private schools. Retrieved June 26, 2006 from http://www.mass.gov/dph/regs/reg105cmr210.pdf.
National Association of School Nurses. (2001). Position statement: research medications in the school setting. Retrieved June 26, 2006 from http://www.nasn.org/Default.aspx?tabid=244.