Section 856IAC1-28.1-1. Definitions

   In addition to the definitions in IC 25-26-13-2 and for purposes of this rule, the following definitions apply throughout this rule:

(1) "Cabinet" includes a mechanical storage device for dispensing drugs. The term means a locked or secured enclosure located outside the pharmacy licensed area:

(A) to which only specifically authorized personnel may obtain access by key or combination available only to those authorized persons by:

(i) security code;

(ii) password; or

(iii) other method of positively identifying an individual; and

(B) that is sufficiently secure to deny access to unauthorized persons.

(2) "Cognitive services" means those acts and operations related to a patient's drug therapy that are judgmental in nature, based on knowledge, and derived from empirical factual information.

(3) "Consultant pharmacist" means a pharmacist licensed pursuant to IC 25-26-13-11 and who engages in the practice of pharmacy in or for long term care facility or other residential patients, other than as a supplying pharmacist.

(4) "Consulting" means the provision of nonsupply related cognitive services that include, but are not necessarily limited to, the following:

(A) Drug regimen review as defined in IC 25-26-13-2.

(B) Provision of advice and counsel on drugs, the selection and use thereof to the facility, the patients therein, the health care providers of the facility regarding the appropriateness, use, storage, handling, administration, and disposal of drugs within the facility.

(C) Participation in the development of policies and procedures for drug therapy within the institution, including storage, handling, administration, and disposing of drugs and devices.

(D) Assuring the compliance with all applicable laws, rules, and regulations.

(E) Provision of educational and drug information sources for the education and training of the facility health care professionals.

(F) Accepting responsibility for the implementation and performance of review of quality-related or sentinel events as defined in this rule.

(5) "Emergency drugs" means those drugs that:

(A) may be required to meet the immediate therapeutic needs of patients; and

(B) are not available from any other authorized source in sufficient time to prevent risk of harm to patients by delay resulting from obtaining such drugs from other sources.

(6) "Institutional facility" means any health care facility whose primary purpose is to provide a physical environment for patients to obtain health care services, except those places where practitioners, as defined by IC 16-42-19-5, who are duly licensed, engage in private practice and pharmacies licensed under IC 25-26-13-17.

(7) "Institutional pharmacy" means that portion of an institutional facility where pharmacy is practiced and is:

(A) the location of the selection, compounding, production, sale, storage, and distribution of drugs, devices, and investigational or new drugs used in the diagnosis and treatment of injury, illness, and disease pursuant to drug orders and prescriptions by practitioners; and

(B) licensed with the board under IC 25-6-3-7.

(8) "Performance improvement program" means a continuous, systematic review of key medication use processes to identify, evaluate, and improve medication use and patient care.

(9) "Pharmacist in charge" (by whatever title, for example, "pharmacy manager", "pharmacy director", or "director of pharmacy") means the pharmacist who directs the activities of the institutional pharmacy and who is, as such, responsible for:

(A) all activities of the institutional pharmacy; and

(B) meeting the requirements of:

(i) IC 25-26-13;

(ii) the rules of the board; and

(iii) any federal requirements pertaining to institutional pharmacies.

The qualifying pharmacist may, depending on the circumstances, also be the pharmacist in charge, though the pharmacist in charge is not required to be the qualifying pharmacist.

(10) "Policy and procedure manual" means a written document containing the agreed-to institutional rules of operation and methodology for the effective delivery of pharmacy services.

(11) "Qualifying pharmacist" means the pharmacist who accepts responsibility for the operation of a pharmacy as defined in IC 25-26-13-2 and whose name is listed on the pharmacy permit granted under IC 25-26-13-17.

(12) "Quality-related event" means the inappropriate provision of pharmaceutical services whether or not resulting in an adverse health incident, including the following:

(A) A variation from the practitioner's order, including, but not limited to, the following:

(i) Dispensing an incorrect drug.

(ii) Dispensing an incorrect drug strength.

(iii) Dispensing an incorrect dosage form.

(iv) Dispensing a drug to a wrong patient.

(v) Providing inadequate or incorrect packaging, labeling, or directions.

(vi) Failing to provide an ordered drug.

(B) A failure to identify and manage:

(i) overutilization or underutilization;

(ii) therapeutic duplication;

(iii) drug-disease contraindications;

(iv) drug-drug interactions;

(v) incorrect drug dosage or duration of therapy;

(vi) drug-allergy interactions; or

(vii) clinical abuse and/or misuse.

(13) "Reversible condition" means a condition that requires intervention to resolve in a reasonable time.

(14) "Sentinel event" means an unexpected occurrence involving serious adverse effect, such as disability, life threatening condition, prolonged hospitalization, or death in a patient resulting from medication use.

(15) "Supplying pharmacist" means that pharmacist licensed in the state where the pharmacist is practicing and who is practicing in a supplying pharmacy (as defined in this rule) and who accepts responsibility for all aspects the drugs and devices sold (as defined in IC 25-26-13-2) or dispensed to a facility.

(16) "Supplying pharmacy" means a pharmacy licensed in the state where the pharmacy is located and which provides drugs and devices to patients in long term care or other facilities where patients reside.

(17) "Temporary condition" means a condition that resolves in a reasonable time without intervention.

(Indiana Board of Pharmacy; 856 IAC 1-28.1-1; filed Dec 26, 2001, 2:44 p.m.: 25 IR 1636; readopted filed Sep 26, 2008, 10:55 a.m.: 20081015-IR-856080346RFA; readopted filed Dec 1, 2014, 8:33 a.m.: 20141231-IR-856140392RFA)