Prison clinic pharmacy

What is a Prison Clinic Pharmacy according to Georgia Rule 480-8-.01?

• It is a portion of a prison correctional facility engaged in the distribution of drugs used in prevention, diagnosis, and treatment of injury, illness, and disease, and is registered with the Georgia State Board of Pharmacy under Chapter 26-4 of the O.C.G.A.

What license must a Prison Clinic Pharmacy hold?

• There must be a Director of Pharmacy Services.

What are Prison Clinic Pharmacies subject to, once licensed?

• They are subject to special prison clinic pharmacy regulations, but are exempt from certain other regulations and requirements.

How is an "inpatient" defined under this rule?

• An inpatient is an inmate confined to an infirmary bed in the custody of and assigned to a correctional institution (state, county, or municipal).

How is an "outpatient" defined under this rule?

• An outpatient is an inmate in the custody of and assigned to a correctional institution (state, county, or municipal) but not confined to an infirmary bed.

What is the "standard ward inventory" in a prison clinic pharmacy?

• It is a stock of legend drugs designated to be kept at specific locations within the prison clinic at all times, established by the Director of Pharmacy or their pharmacist designee in the best interest of patients.

Who is responsible for establishing and maintaining the list of standard ward inventory?

• The Director of Pharmacy or their pharmacist designee.

How should the use of standard ward inventory be approached?

• The use should be minimized

What must be maintained regarding the standard ward inventory?

• A copy of the list of items in the standard ward inventory must be kept by the Director of Pharmacy or their pharmacist designee.

Who is the Prison Clinic Administrator?

• The prison official responsible for the operation of the health care portion of the facility or institution.

Must all prison clinic pharmacies in Georgia be licensed?

• Yes, every prison clinic pharmacy in Georgia must be licensed by the Georgia State Board of Pharmacy.

How often must prison clinic pharmacies renew their license?

• Biennially, by June 30th of odd-numbered years.

What are some of the minimum information requirements for initial licensure or renewal of a prison clinic pharmacy?

• The Board requires:

• Name, business address, and telephone number of the licensee

• All trade/business names used

• Address and name(s) of the Prison Clinic Administrator

• Type of ownership (partnership, corporation, or sole proprietorship)

• Names of the owner(s) and/or operator(s)

What additional details are required if the ownership is a corporation?

• The name and title of each corporate officer and director, corporate names, state of incorporation, and name of the parent company, if any.

If a prison clinic pharmacy operates at more than one location, does each location need a separate license?

• Yes, each location must be separately licensed by the Georgia State Board of Pharmacy.

What is required before a prison clinic pharmacy license can be issued?

• An application must be filed with the Board, the fee paid, and a report from the GDNA Director confirming qualifications.

Are application fees for licensure refundable?

• No, application fees are non-refundable.

Can a prison clinic pharmacy license be transferred to another entity or person?

• No, licenses cannot be transferred or assigned; however, the Board may reassign a license to a successor entity upon request.

What must be done before changing the name, ownership, mode of operation, or location of a licensed pharmacy?

• The licensee must apply for approval from the Board using a Board-approved application and pay the required fee before the change.

When is a change of ownership considered to have occurred?

• When a transaction closes that changes the ownership information originally submitted to the Board.

What happens if a pharmacy fails to renew its license by September 1st of the odd-numbered year?

• The license lapses and cannot be renewed. Reinstatement requires a separate application and is at the discretion of the Board.

When must changes to previously submitted licensure information be reported to the Board?

• Prior to the change, unless otherwise required to be reported immediately.

What types of legal convictions can disqualify an applicant from obtaining a prison clinic pharmacy license?

• Convictions under Federal, State, or local laws related to:

• Drug samples

• Wholesale or retail drug distribution

• Distribution of controlled substances

• Any felony convictions under these laws.

Can the Board deny a license if the applicant provided false information?

• Yes, if the applicant furnished false or fraudulent material in any drug manufacturing or distribution application.

What past actions involving other licenses may affect eligibility for licensure?

• Suspension or revocation of any license currently or previously held by the applicant.

How does the Board evaluate an applicant's compliance history?

• By reviewing the applicant’s compliance with:

• Previously granted licenses

• Recordkeeping requirements for prison clinic pharmacies

• Making those records available to State Licensing Authorities and law enforcement.

Can the Board consider other factors beyond what is listed when deciding to issue a license?

• Yes, the Board can consider other factors or qualifications it deems relevant to public health and safety.

Does the Board reserve the right to deny a license for reasons beyond the listed criteria?

• Yes, the Board may deny a license if it determines that doing so is not in the best interest of the public.

Who is responsible for directing a prison clinic pharmacy in Georgia?

• A licensed pharmacist known as the Director of Pharmacy.

Must the Director of Pharmacy work full-time?

• No, the Director may work full-time or part-time based on the needs of the institution.

What are the responsibilities of the Director of Pharmacy?

• Responsible for:

• All activities of the pharmacy

• Ensuring compliance with Georgia Pharmacy Laws and Board regulations

  Supervising ancillary personnel and overall pharmacy operations

What must the Director do regarding ancillary personnel?

• The Director must:

• Ensure ancillary personnel are trained

• Develop written policies and procedures specifying duties

• Ensure they are personally and directly supervised by a pharmacist

• Ensure they are not assigned tasks reserved for licensed pharmacists

Can secretarial or clerical staff perform dispensing duties?

• No, they are only allowed to assist with record keeping, report submission, and administrative duties.

What does “personal and direct supervision” by the pharmacist require?

• The physical presence of a licensed pharmacist in the pharmacy.

Who must prepare written policies and procedures for drug provision when a registered pharmacist is not physically present?

• the director of pharmacy must do the written policies and procedures

How must access to drugs be controlled in the absence of a licensed pharmacist?

• Access must be through locked cabinets or enclosures located outside the pharmacy area, accessible only by specifically authorized personnel.

What must the Director of Pharmacy and the prison clinic committee develop regarding night cabinets?

• Inventory listings of drugs to be included in the night cabinets.

What labeling information is required on drugs stored in night cabinets?

• drug name

• lot number

• strength

• expiration date

What type and amount of drugs are allowed in night cabinets?

• only prepackaged drugs in amounts sufficient for immediate therapeutic requirements

What documentation is required whenever access to night cabinets is gained, especially for controlled substances?

• written physician’s orders proofs of use for controlled substances

How often must drugs in night cabinets be inventoried?

• no less than once per week

Who may access the pharmacy to obtain drugs not available in night cabinets during a pharmacist’s absence?

• one designated licensed medical staff member ( RN, LPN, or clinic associate) per 8 hour shift

What training must authorized medical staff receive before being allowed access to the pharmacy?

• thorough education and training by the director of pharmacy on access procedures, drug removal, records, and require policies

What must be recorded when a drug is removed from the pharmacy by authorized personnel?

Name of drug, strength, amount, date, time, and signature of the authorized medical staff member.

Where must the container from which the drug was removed be placed after removal?

• in a conspicuous location for review by the pharmacist coming on duty

What are emergency kits used for?

• to provide drugs required for immediate therapeutic needs when other authorized sources cannot supply them quickly enough

Who determines the drugs and quantities included in emergency kits?

• the director of pharmacy and the medical staff of the prison clinic jointly

How must emergency kits be stored?

• in limited access areas, sealed to prevent unauthorized access, and maintained to preserve the drugs

What must be labeled on the exterior of an emergency kit?

• at least once every 90 days

What must happen whenever an emergency kit is opened?

• the pharmacy must be notified and the kit must be restocked within a reasonable time, no later than the next pharmacist’s visit.

What action should be taken if an emergency kit is opened in an unauthorized manner?

• the pharmacy and other appropriate personnel of the facility must be notified

Who may remove drugs from emergency kits?

• only authorized medical personnel or pharmacists and only pursuant to a valid physicians order

What information should be available near emergency kits besides the kits themselves?

• Authoritative, current antidote information and the telephone number of the regional poison control center

What is the minimum floor space required for a prison clinic pharmacy?

• a minimum of 150 square feet

Who has direct control over the areas included in the minimum pharmacy space requirement?

• it is the director of pharmacy who has direct control

Name equipment required in the dispensing area of a prison clinic pharmacy

• refrigerator with thermometer

• sink with hot and cold running water

• graduates of assorted sizes

• two spatulas

• one pill counting tray

• typewriter/word processor/computer with label printer

• class A or equivalent weights

What should the refrigerator in the dispensing area have to ensure proper function?

• a thermometer for monitoring the temperature

What four areas must be included within the physical facilities of a prison clinic pharmacy?

• dispensing area

• storage and receiving area

• manufacturing and packaging area

• office space area

What must the Director of Pharmacy do to request a variance from the minimum equipment requirements?

• Submit a typed request to the Board including stated reasons for the variance.

When is a variance granted by the Board?

• Only when the Board judges there are sound reasons related to necessary or efficient delivery of health care.

Where must the Board’s variance approval letter be posted?

• Next to the Georgia Drugs and Narcotics Agency inspection report.

What minimum reference materials must a prison clinic pharmacy maintain?

• Copies or electronic access to the Georgia Pharmacy Practice Act, Georgia Controlled Substances Act, Rules of the Georgia State Board of Pharmacy, and current reference materials on drug interactions, patient counseling, compounding, pharmaceutical calculations, and generic substitution.

What additional reference materials should be available if IV solutions are prepared?

• Compatibility charts.

What information must be conspicuously displayed in the pharmacy?

• Current antidote information and the telephone number of a poison control center.

What conditions must be ensured for drug storage within the prison clinic pharmacy?

• Proper sanitation, temperature, light, ventilation, moisture control, segregation, and security.

When must drug storage cabinets and unit dose carts be locked?

• When the medication area is not attended by medical staff personnel.

What type of storage is preferable for Schedule II controlled drugs?

• An enclosed controlled room with limited access capable of showing forced entry.

What alternative storage is acceptable for Schedule II drugs if an enclosed controlled room is not available?

• A safe or metal cabinet that is adequately locked and permanently affixed to the structure.

What must be done when any area of the pharmacy is unattended?

• lock up the area

How must security be maintained for all areas occupied by the prison clinic pharmacy?

• Areas must be capable of being locked by key or combination to prevent unauthorized access.

Who designates which personnel have access to specific areas within the pharmacy?

• The Director of Pharmacy, in writing by name and specific area.

What laws and regulations must the security measures comply with?

• Federal and State laws and regulations.

Who is permitted to enter restricted areas within the pharmacy?

• Only those persons authorized in writing by the Director of Pharmacy.

The Director of Pharmacy is ultimately responsible for:

• Safe, efficient control and accountability of all drugs.

• Cooperation with other professional staff for ordering, administering, and accounting pharmaceutical materials.

What is defined as the drug distribution system in a prison clinic pharmacy?

• The entirety of the mechanism by which a practitioner's prescription drug order is executed, from the time the prescriber transmits the order until the drug is administered or delivered to the patient.

What must the pharmacy receive before dispensing the first dose of medication?

• A direct or mechanical copy of the physician’s order.

What information is required at minimum in the pharmacy-generated patient profile?

• Given and last name, DOC I.D. number, date of birth, sex, dorm or housing assignment, drug details (name, date dispensed, strength, dosage form, quantity, directions), identification of dispensing pharmacist, identification of controlled substances, selected medical data, and allergies/sensitivities.

How long must the patient profile be maintained?

• For at least two (2) years.

What is the maximum supply allowed for unit dose medication with prison clinic labeling?

• No more than a 7-day supply.

What is the maximum supply allowed for maintenance medication with retail labeling?

• No more than a 30-day supply.

Who participates in the development of the drug formulary for the prison clinic?

• The Director of Pharmacy participates.

What labeling information must be included on drugs dispensed for use inside the prison clinic?

• Brand or generic name, strength, lot number, and expiration date.

What additional labeling information is required for drugs dispensed to inmates housed outside the prison or on release?

• Prison clinic pharmacy name/address/phone, date and serial number, patient’s full name, drug name and strength, directions for use, prescribing practitioner’s name, controlled substance precautions, and other cautionary information.

Describe the approved method for destruction of non-controlled substances that are expired or discontinued in a prison facility.

• Inventory by a pharmacist and licensed healthcare professional or corrections officer, followed by secure storage and destruction on-site by designated staff, or transfer to a licensed reverse distributor.

What documentation is required when non-controlled drugs are destroyed on-site?

• A written record including date, time, personnel involved, and method of destruction, maintained for two years along with the inventory.

What are the approved methods for destruction of controlled substances in the prison clinic pharmacy?

• Destruction in a locked cabinet after inventory by pharmacist and licensed staff, with destruction witnessed by at least two witnesses and documented; or off-site destruction via licensed reverse distributor with documented transfer.

What form of inventory and accountability is required for Schedule II controlled substances?

• Perpetual inventory and proof of use forms.

What must a prescription drug order contain for inpatient drug use?

• Patient name and housing assignment, drug name and strength, directions for use, date, and physician's signature.

What additional information must be included on outpatient drug orders?

• Dispensing quantity, practitioner’s address, and DEA number if applicable.

What details must be documented on proof of use forms for controlled substances?

• Drug name, strength, dosage form, dose, ordering physician’s name, patient name and ID, date/time of administration, administering person’s signature, destruction documentation for unused portions, medication receipt with serial numbers, date medication was issued and return of proof of use.

Can computer hard copies be used for proof of use forms?

• Yes, if they meet all legal requirements.

What is the requirement for destruction of small quantities of controlled substances prepared for oral administration?

• Only the remainder of a single-dosage unit closest to the dose ordered can be destroyed on-premises.

Who must witness the destruction of controlled substances?

• At least two witnesses alongside the licensed pharmacist.

How long must inventory and destruction records be kept for both controlled and non-controlled substances?

• For at least two years.

What steps must the Director of Pharmacy take in case of a drug recall?

• Develop and implement a recall procedure to ensure all recalled drugs are returned for proper disposition.

What should be done immediately if a suspected adverse drug reaction occurs?

• Report it immediately to the ordering physician, pharmacy, and appropriate committee, and document it in the patient’s record.

What records must the Director of Pharmacy maintain and make available for inspection?

• Patient profiles, proof of use documents, adverse drug reaction reports, inventories (night cabinets, emergency kits, pharmacy stock), biennial controlled substances inventories, alcohol and flammables reports, and other required records.

What is the procedure for distributing drugs as standard ward inventory?

• Drugs may be distributed upon a signed requisition or inventory replacement system, administered only pursuant to physician’s orders, and recorded on patient profiles.

How often should a survey of standard ward inventory usage be performed?

• monthly

What is required for labeling drugs dispensed outside the prison clinic to inmates on leave or release?

• Name, address, and phone of the prison clinic pharmacy, date and serial number, full patient name, drug name and strength, directions, prescribing practitioner’s name, controlled substance precautions, and other cautionary info.