Memorandum

To: Clinical Nurse Specialists and Nurse Practitioners

CC: Certified Registered Nurse Anesthesists

From: Tracy Klein, RN, MS, FNP

Advanced Practice Consultant

Date: 8/19/08

Re: Board Updates

Administrative Rule Changes

The Board adopted several comprehensive changes to the Nurse Practice Act at its June 18^th meeting. Newly revised regulations are posted on the Board’s website at www.oregon.gov/OSBN. As a reminder, draft regulations are posted for input and are heard at a minimum of two Board meetings before adoption. Please use the website as a primary resource for the latest information. The Board is also looking at the possibility of offering a list serve option to sign up for updates related to CNS, CRNA, CNM and NP issues and regulations.

Newly updated sections are:

§ Division 21 Rules Regarding the Standards for the Approval of Educational Programs in Nursing Preparing Candidates for Licensure as Practical or Registered Nurses (complete overview and revision)

§ Division 45 Standards and Scope of Practice for the Licensed Practical Nurse and Registered Nurse (complete overview and revision)

§ Division 56 Rules Regarding Clinical Nurse Specialist and Nurse Practitioner Authority to Prescribe and Dispense ( revision of specific sections removing the Formulary requirement and clarifying standards for prescribing/dispensing)

Patient Records

The Board has recently been contacted by a number of patients who are unable to locate their medical records when care was provided by a Nurse Practitioner. The Nurse Practice Act requires notification of the Board within 30 days of any change in practice address or setting whether or not direct patient care is provided. (OAR 851-050-0010). The Board and patients must be informed when a practice is closed regarding where medical records are stored and how they may be accessed. Please see the Board’s Patient Abandonment policy for further details regarding notification and discharge of patients from your care: http://www.oregon.gov/OSBN/pdfs/policies/abandon.pdf. Additional regulations regarding closure of practice and patient obligations may be found in the newly revised Division 45.

Formulary Update

The requirement for Oregon Nurse Prescribers to use a Board approved Formulary was officially removed from regulations on June 18, 2009. The Board adopted a set of standards which defines continuing expectations for prescribers including safety, congruence with scope of practice, and FDA approval for drugs prescribed with the exception of Institutional Review Board approved medical trials.

Clinical Nurse Specialists and Nurse Practitioners with prescriptive authority may prescribe:

§ Limited Access Drugs- Sometimes known as “expanded access” drugs, these are approved by the FDA for patient access before final FDA trials are completed. FDA approval for limited or expanded access must already be granted for a Nurse Prescriber or Clinical Nurse Specialist to prescribe, dispense, or procure these drugs.

§ Over the Counter Drugs- Occasionally a prescription is required in order for an over the counter medication to be covered by insurance. This is acceptable to the Board provided that the prescription is congruent with the diagnosis or indication.

§ Appliances and Devices- Examples of appliances and devices include blood glucose meters, CPAP devices, and breast pumps. Clinical Nurse Specialists without prescriptive authority may order durable medical equipment (see Division 54 for specific rule language).

§ Orphan Drugs- These are drugs approved for rare diseases or conditions which are not able to be mass marketed. According to the FDA “The orphan designation process is the mechanism by which sponsors of drugs and biologics for rare diseases may qualify for incentives of the Orphan Drug Act such as tax credits and marketing exclusivity” (http://www.fda.gov/orphan/grants/faq.htm).

§ Investigational Drugs Distributed through an Institutional Review Board (IRB) Approved Medical Trial- The FDA’s Center for Drug Evaluation and Research (CDER) approves applications for investigational new drugs. If a nurse prescriber is participating in an IRB approved trial he or she may now be designated to prescribe, dispense, and procure the drug if permitted by IRB, facility, and federal law or policy. See http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm for more details regarding this process.

Please see Division 56 of the Nurse Practice Act for more specific detail regarding prescribing and dispensing laws in Oregon.