6.1 Collaborative Pharmacy Practice, Drug Therapy Management & Administration of Drugs

6.1 Collaborative Pharmacy Practice, Drug Therapy Management & Administration of Drugs

Blueprint item 2.2 covers the conditions under which pharmacists and other staff take part in "the administration of drugs in the management of patients' therapy." In Utah this covers four tools: collaborative practice agreements, drug therapy management (DTM), drug administration, and device prescribing. Pharmacist prescribing under public-health guidance is covered in Sections 6.2 and 6.3.

Collaborative pharmacy practice

The Pharmacy Practice Act defines the key terms:

• Collaborative pharmacy practice: a practice in which one or more pharmacists have agreed, on a voluntary basis, to work with one or more practitioners under protocol, so the pharmacist may perform certain pharmaceutical care functions the practitioners authorize, under specified conditions or limits (§ 58-17b-102(16)).
• Collaborative pharmacy practice agreement: a written and signed agreement between one or more pharmacists and one or more practitioners that provides for collaborative practice "for the purpose of drug therapy management of patients, initiating therapy, and prevention of disease" (§ 58-17b-102(17)).
• The practice of pharmacy includes collaborative practice under an agreement (§ 58-17b-102(58)(b)). A prescription includes an order issued "by collaborative pharmacy practice agreement" (§ 58-17b-102(63)).

Utah's statute and rule do not prescribe a detailed form for the agreement, a fixed review interval, or an insurance requirement. What they require is that the agreement be written and signed, be voluntary, and operate under protocol within limits the practitioner may lawfully delegate. The agreement cannot give the pharmacist more authority than the collaborating practitioner has. A pharmacy applying for a Class D license must describe any collaborative practice arrangements in its protocol (§ 58-17b-306(2)(f)).

Drug therapy management (R156-17b-611(1))

Decisions involving DTM "shall be made in the best interest of the patient." DTM may include:

1. implementing, modifying, and managing drug therapy according to the collaborative agreement;
2. collecting and reviewing patient histories;
3. obtaining and checking vital signs (pulse, temperature, blood pressure, respiration);
4. ordering and evaluating laboratory tests directly related to drug therapy, when done under approved protocols for the practice setting; and
5. other patient-care services allowed by rule.

Administration of drugs

Administration is part of the practice of pharmacy when it is done under a lawful order of a practitioner (when one is required) and under written guidelines or protocols. For inpatients, those protocols are set by the facility. For outpatients, when the pharmacist alone administers, they must be approved by DOPL with the board and, when appropriate, the Medical Licensing Board (§ 58-17b-102(58)(c)).

Training (R156-17b-621)

Before administering a prescription drug or device, a pharmacist or intern must complete:

• current Basic Life Support (BLS) certification;
• for injectables, didactic and practical training in administering injectable drugs;
• training on the specific drug or device being administered;
• for vaccines, current ACIP guidelines; and
• training in management of an anaphylactic reaction.

A technician who administers needs the BLS, injection, and anaphylaxis training. Acceptable training sources include ACPE-approved programs, college of pharmacy or ASHP-accredited technician curricula, health department programs, and other board-recognized providers. Each person who administers must keep documentation of the training and complete two hours of related CE each renewal cycle (R156-17b-621(4); R156-17b-309).

Administering without appropriate training, without a physician's order when the law requires one, or contrary to a practitioner's written guidelines or protocol is unprofessional conduct (§ 58-17b-502(1)(i)).

Long-acting injectables and naloxone (§ 58-17b-625; R156-17b-621a)

A pharmacist may administer naloxone or a long-acting injectable (for example, a long-acting antipsychotic or buprenorphine formulation) intramuscularly only if the pharmacist:

1. has completed current BLS and an ACPE-accredited training program for intramuscular long-acting injectables, and keeps documentation;
2. administers the drug at a clinic or community pharmacy as DOPL defines those terms (a Class B pharmacy or qualifying outpatient facility, or a Class A pharmacy); and
3. is directed by the physician who issues the prescription to administer it.

Pharmacist prescribing of devices (§ 58-17b-610.8; R156-17b-612a)

For nebulizers, spacers for nebulizers or inhalers, and diabetic supplies:

• A written prescription, or a written record of the patient's current diagnosis or treatment protocol on file at the pharmacy, counts as a prescription for the device.
• A pharmacist may prescribe one of these devices when it is not covered by the document on file and the pharmacist decides it is necessary for appropriate delivery of the prescribed drug. The prescribing practitioner on the underlying document is treated as the device's prescriber.
• The pharmacist determines the dispense quantity, directions, and refills, and dispenses from a Class A or B pharmacy.
• The pharmacist must notify the prescribing practitioner within five business days, in writing, electronically, or by phone, giving the pharmacy name and phone number, patient, quantity, directions, and refills.

A pharmacist may also dispense a therapeutic equivalent when filling a prescription for a glucometer, test strips, lancets, syringes, needles, or other designated diabetes supplies (§ 58-17b-608.2(7); R156-17b-612b(2)).

Public health prescriptions (§ 58-17b-620)

To treat a reportable disease or a non-emergency condition that directly affects public health, a health department may use special procedures for non-controlled drugs. These cover STI treatment, fluoride, travel immunizations, latent TB treatment, and other preventive treatment at clinics or temporary sites. A physician may sign serially numbered prescriptions without the patient's name, address, and date, and a health department registered nurse completes them under standing written orders and an approved protocol. A prescriber may also write prescriptions for a patient's contacts without a face-to-face exam. A health department nurse may dispense prepackaged STI drugs under R156-17b-628.

Exam traps

• A verbal "manage her warfarin" instruction is not a collaborative practice agreement. The agreement must be written and signed.
• Collaborative practice does not let a pharmacist make independent diagnoses outside the protocol.
• Vaccines follow a separate protocol (Section 6.4). Long-acting injectables and naloxone IM require the training, setting, and physician-direction conditions of § 58-17b-625.