A:      A protocol may only be used in a true emergency, or for biologicals or vaccines administered to individuals for the purpose of preventing diseases.  For all other situations, all orders must be patient-specific with well defined parameters for administration, and authorized by the prescriber prior to implementation.  The parameters to be used include: (1) description of the intended recipients, (2) drug name and strength, (3) specific instructions of how to administer the drug, (4) dosage, (4) frequency, and (5) a signature of the authorized prescriber.  The administration of drugs that are not patient-specific or authorized by the prescriber prior to implementation would be the unauthorized practice of medicine, which is a felony in this state.

Enforcing the appropriate use of protocols as described above is not intended to address or limit the practice of Certified Registered Nurse Anesthetists or Anesthesiologist Assistants administering anesthesia in accordance with statute and rule. This information is also not meant to disrupt the consultative agreement between pharmacist, physician and patient.

A:      For purposes of this rule, examples of "true emergencies" would be cases such as heart attacks, severe burns, cyanide poisonings, electrocutions, or severe asthmatic attacks  Examples of non-emergencies would be earaches, stomachaches, or infections.

A:      For purposes of this rule, examples of biologicals or vaccines administered to individuals for the purpose of preventing diseases would be flu vaccines, tetanus toxoids, hepatitis B vaccines, or PPD tuberculosis tests.  Note that vaccines such as typhoid oral vaccine that must be taken over a several day time period cannot be dispensed by a nurse who is not authorized to prescribe.  These drugs must be dispensed by an authorized prescriber to his or her own patients or by a pharmacist pursuant to a prescription.

A:         The protocol from the authorized prescriber must:

·         Specifically define the intended audience;

·         List the drug name and strength of the product; and

·         For the purposes of emergency protocols, give specific instructions on how to administer the drug, how much to administer, and how often the drug should be administered; for purposes of biologicals or vaccines, give specific instructions for the use of the drug.

In addition, the authorized prescriber must sign the protocol.  The authorized prescriber may have a more detailed protocol or may word the protocol any way the authorized prescriber wishes as long as it contains the required details noted above.

"EPINEPHRINE 1:1000.  When a patient has a severe allergic reaction or goes into anaphylactic shock as a result of an insect sting or a drug reaction, inject 0.3 ml SC.  If necessary, may repeat this dose every 10-15 minutes no more than two times until appropriate medical care can be sought or until symptoms subside."

"FLU VACCINE.  All patients, or patients at risk, will be offered the opportunity to receive this year's flu vaccine. The patient will first read and sign an information sheet which will be placed in the medical record.  Once the document is understood and signed, the patient will receive an injection 0.5ml IM of the flu vaccine.  All injections will be given in accordance with CDC guidelines."

A:      Pharmacy Board Rule 4729-5-01 O.A.C. addresses the adjustment or initiation of medications in inpatient settings through use of preprinted orders.  A preprinted order is defined as a patient-specific, definitive set of drug treatment directives to be administered to an individual patient who has been examined by a prescriber and for whom the prescriber has determined that the drug therapy is appropriate and safe when used pursuant to the conditions set forth in the order. Preprinted orders may be used only for inpatients.  Because the preprinted order is patient-specific and is prescribed by an authorized prescriber who has examined the patient, these are not protocols and are therefore appropriate for use in an inpatient facility.

A:      The Pharmacy Board defines "dispense" as "the final association of a drug with a particular patient pursuant to the prescription, drug order, or other lawful order of a prescriber and the professional judgment of and the responsibility for: interpreting, preparing, compounding, labeling, and packaging a specific drug." (4729-5-01 (B) O.A.C.) "Administer" is defined in the Revised Code as "the direct application of a drug, whether by injection, inhalation, ingestion, or any other means to a person or an animal." (3719.01(A) O.R.C.) To easily remember the difference between the two in practice, you may use this simplified distinction:  "Administration" means "here's a dose, take it NOW."  "Dispensing" means "here's a dose, take it LATER."  "Dispensing" is limited to pharmacists and authorized prescribers.  "Administration" may be performed by a nurse pursuant to the order of an authorized prescriber. 

A:      Yes, an authorized prescriber may have stock drugs available for his or her use only, or to have available to give a direct order to a health care professional for administration to a particular patient, employee, or student, including prescription drugs.  This occurs often in an occupational health or school setting.  These drugs must be documented on a list.  Prescription drugs in this list may include such items as antibiotics, non-steroidal anti-inflamatories (e.g. Naprosyn), and any other drug the authorized prescriber wishes to have available.  No prescription drug may be purchased or stored at a site unless it is on this drug list.  To store a drug at a site, an individual must be licensed to do so by the state Pharmacy Board.

A.             A qualifying statement must precede the list and the list must be signed and notarized by an authorized prescriber.

An example of documentation of a list of drugs to be regularly kept on the premises might be:

            "The drugs listed below will be purchased and stored at this facility for my use only or for use when I give a direct order to a health care professional to administer such drug to a specific patient."

                                                                                                        NDC number
   Drug Name                       Strength             Dosage Form         (on drug container)

A.         No, these drugs may not be administered using protocols, unless their use falls within one of the exceptions listed above.  The administration must be patient-specific and authorized by the prescriber prior to implementation.  To administer a listed drug using protocols would be the unauthorized practice of medicine, which is a felony in this state.

approved 2/12/2003