Pharmacy Operations

What is the relationship between a pharmacy’s state permit and DEA registration?

A pharmacy must generally have an active state pharmacy permit at its physical location before obtaining or maintaining DEA registration.

Loss of the state permit generally means loss of DEA registration.

Some states also require a separate state controlled-substance registration.

What is generally required when a pharmacy mails prescriptions to another state?

The pharmacy usually must:

• Maintain an active permit in its home state

• Obtain a nonresident/out-of-state pharmacy permit in the patient’s state

• Follow applicable dispensing laws of the patient’s state

• Report discipline against its home-state permit

Remote pharmacists may also need individual licensure in the patient’s state.

What pharmacy changes commonly require notification to the board?

Memorize:

• Pharmacy name

• Address

• Pharmacist-in-charge

• Ownership

• Permanent or temporary closure

A change of ownership commonly requires a new pharmacy permit, rather than merely transferring the old permit.

What special restrictions may apply to a pharmacist-in-charge?

States may require the PIC to:

• Work a minimum number of hours each week

• Be physically present a specified amount of time

• Serve as PIC for only a limited number of pharmacies

• Complete an inventory when beginning or ending as PIC

The PIC is ultimately responsible for pharmacy operations and compliance.

Can one building contain more than one separately permitted pharmacy?

Yes.

A board may require separate permits for distinct pharmacy operations at the same location, such as:

• Hospital inpatient pharmacy

• Hospital outpatient pharmacy

• Specialty or limited-service pharmacy

What is a limited pharmacy permit?

A permit authorizing only specified pharmacy services, such as operating an automated dispensing system in an LTCF.

A limited pharmacy may require:

• Periodic pharmacist inspections

• A consultant pharmacist

• Restricted services rather than full community-pharmacy operations

What are the major requirements for pharmacy records?

Records must be:

• Accurate

• Retained for the required period

• Readily retrievable

• Protected from unauthorized access

• Available for inspection

Records are generally confidential and are not public records.

What must pharmacy computer systems document?

The system should identify the person who performed each activity, such as:

• Data entry

• Prescription processing

• Final verification

• Dispensing

• Vaccine administration

Some states require a pharmacist to sign or attest to the electronic record at the end of the day.

How does a central-fill prescription move through the system?

1. Originating pharmacy receives the prescription.

2. It transmits the prescription to the central-fill pharmacy.

3. Central fill prepares and labels the medication.

4. Central fill returns it to the originating pharmacy.

5. Originating pharmacy dispenses and counsels the patient.

Memory hook: Central fill fills; originating pharmacy faces the patient.

Who performs counseling and delivery in a central-fill arrangement?

The originating pharmacy generally:

• Dispenses the prescription to the patient

• Provides counseling

• Maintains patient interaction

The central-fill pharmacy generally does not deliver directly to the patient.

Records and labels must identify where the prescription was filled.

What is the key dividing line for pharmacy-technician duties?

Technicians may perform technical tasks under pharmacist supervision, but generally may not independently perform tasks requiring professional judgment.

Generally prohibited:

• Counseling

• Clinical decision-making

• Drug-utilization review

• Final verification

• Resolving clinical problems independently

What requirements may states impose on pharmacy technicians?

Memorize:

• Registration or license

• Training program

• Certification, such as PTCB or ExCPT

• Continuing education

• Minimum age

• High-school diploma or GED

• Background check

States may create multiple technician levels with different scopes of practice.

What is the pharmacist-to-technician ratio?

The maximum number of technicians one pharmacist may supervise at one time.

The ratio varies by state and may depend on:

• Technician certification

• Technician training

• Practice setting

• Presence of interns or other pharmacists

How is a pharmacy clerk different from a technician?

A clerk performs limited administrative tasks, such as:

• Operating the register

• Answering phones

• Filing

• Directing patients

A clerk generally may not perform prescription-processing or dispensing tasks unless registered and authorized as a technician.

What may a pharmacy intern generally do?

Under pharmacist supervision, an intern may often perform pharmacist functions, including:

• Receiving prescriptions by telephone

• Transferring prescriptions

• Counseling patients

• Administering immunizations

• Reviewing patient information

Unless specifically prohibited by state law.

What special rules apply to pharmacy interns?

• Must work under pharmacist supervision

• Records may need both the intern’s and pharmacist’s identities

• Must maintain active intern registration

• A student on leave may lose active intern status

• A student without active intern status may need technician registration to continue working

What is the major controlled-substance difference between a hospital and an unregistered LTCF?

Hospital	Unregistered LTCF
May use medication or chart orders	Generally requires patient-specific prescriptions
Usually has its own DEA registration	Usually does not have DEA registration
May maintain controlled-substance stock	Cannot maintain general controlled-substance stock under its own authority

What are the major federal rules for an automated dispensing device in an LTCF?

• nstalled and controlled by a DEA-registered retail pharmacy

• Pharmacy obtains a separate DEA registration for the LTCF device location

• LTCF itself does not necessarily need DEA registration

• Medication is released in single doses

• A patient-specific prescription is required

• Authorized LTCF staff may access the device

What may an authorized LTCF nurse or employee communicate to a pharmacy?

With appropriate authorization, the agent may:

• Prepare a written prescription for the practitioner’s signature

• Call in Schedule III–V prescriptions

• Transmit faxed prescriptions, including permitted Schedule II faxes

The agent may not communicate an emergency oral Schedule II prescription. The practitioner must personally communicate it.

What special rules should be memorized for LTCF emergency kits and nuclear pharmacies?

LTCF emergency kits

• A DEA-registered pharmacy may place a controlled-substance emergency kit in a nonregistered LTCF.

• The kit remains under the pharmacy’s control and registration.

• Required prescription or authorization must be received before release.

• State law may regulate contents, access, security and records.

Nuclear pharmacies

May require:

• Separate nuclear-regulatory registration

• Specially trained or authorized nuclear pharmacist

• Radiation security and handling procedures

• Special storage, packaging and labeling

• Specialized facilities and policies