title 480 GA law chapter 11- 22 Flashcards

chapt 12 specialty pharmacies

In order to qualify for specialty pharmacy practice certification,and ce. A person who has already passed the examination and meets all requirements may make application to the Board on a form approved by the Board and

Licensed pharmacist who have a specialty pharmacy practice certification must complete a minimum of ------hours of continuing education in each specific area of specialty during each biennium renewal period

A remote order entry pharmacist shall mean a pharmacist who is licensed to practice pharmacy in the State of Georgia, who is at a remote location located within the United States, who is an employee or contractor of a pharmacy licensed in this state or that holds a nonresident pharmacy permit issued pursuant to Code Section 26-4-114.1, and who is under contract with or employed by the hospital to review and enter patient specific prescription drug orders for hospital patients when the hospital pharmacy is closed.

All hospital pharmacies shall renew --------of each -----with the Georgia State Board of Pharmacy; certificates of registration shall be issued only to those hospital pharmacies which comply with the provisions of O.C.G.A. § 26-4-110, and with these Rules and Regulations.

When a licensed pharmacist is not physically present in the hospital and the pharmacy is -----, written policies and procedures shall be prepared in advance by the Director of Pharmacy for the provision of drugs to the medical staff and other authorized personnel of the hospital by use of ----- and/or by access to the pharmacy. The policies and procedures may include the use of -----to ensure that in-patient needs are met at the hospital when a licensed pharmacist is not physically present. All policies and procedures providing for the use of night cabinets and/or access to the pharmacy when a licensed pharmacist is not physically present shall be made available to the Georgia State Board of Pharmacy, its designee, or a representative of the Georgia Drugs and Narcotics Agency (GDNA), upon request.

when is A hospital pharmacy shall be authorized to utilize remote order entry when. Select 3 choices

The remote entry pharmacist shall maintain records of any and all records entered for the hospital for a minimum of ----years, and such records shall be readily available for inspection, copying by, or production of upon request by the Board, its designee, or a representative for the Georgia Drugs and Narcotics Agency (GDNA), upon request

Access to drugs, in the absence of a licensed pharmacist, shall be by locked cabinet(s) or other enclosure(s) constructed and located outside of the pharmacy area to which only specifically authorized personnel as indicated by written policies and procedures may obtain access by key or combination, and which is sufficiently secure to deny access to unauthorized persons.

Night cabinets: Only ------ drugs ( hint packaged or pre packaged?) are available therein, in amounts sufficient for immediate therapeutic requirements

All drugs therein are inventoried no less than ------per week.

whenever a drug is not available from floor supplies or night cabinets, and such drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized,what can be done?

When a nurse accesses drugs directly from the closed pharmacy, the nurse must:

Emergency kit/crash cart drugs are those drugs which may be required to meet the immediate therapeutic needs of patients and which are not available from any other authorized source in sufficient time to prevent risk of harm to patients;

how are emergency kits stored

how are emergency kits labeled exterior?

how are emergency kits labeled interior?

Each emergency kit/crash cart shall be opened and its contents inspected by a pharmacist at least once every ------days. Upon completion of inspection, the emergency kit/crash cart shall be re-sealed;

A hospital pharmacy shall have within the hospital which it serves, sufficient floor space allocated to it to insure that drugs are prepared in sanitary, well-lighted and enclosed places, and which meet the other requirements of this section and the Georgia Pharmacy Laws. The hospital pharmacy space requirements should be a minimum of ------ per hospital bed, which includes all areas assigned and under the direct control of the Director of Pharmacy.

all drugs dispensed by a hospital pharmacy to patients about to be discharged or on leave of absence shall be labeled with the following information:

Destruction of controlled substances:

Any portions of controlled substances discontinued and taken from a medication delivery device shall be destroyed by a----- or a ------and ----- The two persons witnessing the destruction must sign the destruction record at the time of destruction. The destruction record shall be returned to the pharmacy and must be signed by the pharmacist who is ultimately responsible for the accuracy of the information contained therein.

discontinued non-controlled substances dispensed to hospital patients shall be returned to the pharmacy and evaluated by the ----- to assure the integrity of the medication.

if the drugs are to be transferred to a reverse distributor with a current license issued by the Board, a record of the following must be maintained by the hospital pharmacy for a minimum of -----years

A securely attached wooden or metal cabinet within a locked limited-access area shall be used to store the drugs until the drugs are destroyed. When controlled drugs are discontinued or the patient expires, what should happen?

Prescription drug orders for drugs, devices or materials for use by in-patients. Prescription drugs orders for use by in-patients shall, at a minimum, contain:

drugs from outside sources:

Such drugs shall not be administered unless they can be precisely identified.

Medications received from an outside source, but not to be administered, can they be stored in pt room?

Inspections is conducted --------.The Director of Pharmacy shall no less than once per month, personally or by qualified designee, inspect all matters within his/her jurisdiction and responsibility and make appropriate written records of such inspections. Such inspections shall, at a minimum, verify that

The Board of Pharmacy inspections shall be conducted by representatives of the Georgia Drugs and Narcotics Agency (GDNA) no less than once every ----- years.

chapter 14: DRUGS AND NARCOTICS AGENCY CLASSIFICATIONS AND MINIMUM REQUIREMENTS FOR SPECIAL AGENTS AND DEPUTY DIRECTOR

A GDNA Special Agent shall be a graduate of a recognized school or college of pharmacy and hold a current pharmacist license issued by the Georgia State Board of Pharmacy (Board). Additionally, to qualify as a GDNA Special Agent, the applicant shall have

chapter 15 PHARMACY TECHNICIANS AND OTHER PHARMACY PERSONNEL

a registered pharmacy technician who has either successfully passed a certification program approved by the Board, or has successfully passed an employer's training and assessment program approved by the Board, or has been certified by either the Pharmacy Technician Certification Board (PTCB) or any other nationally recognized certifying body approved by the Boar

In order to be registered as a Pharmacy Technician in this State, an applicant shall:

On and after July 1, 2023, as a requirement for the biennial renewal of his/her registration, a pharmacy technician must complete not less than----- hours of approved continuing education.

The pharmacist to registered pharmacy technician ratio shall not exceed one pharmacist providing direct supervision of four registered pharmacy technicians in accordance with the certification requirements below

.1.Any time during which a pharmacist is directly supervising ---or---- technicians, no certification is required.

2.Any time during which a pharmacist is directly supervising ---- technicians, at least --- must be certified

3.Any time during which a pharmacist is directly supervising---- technicians, at least two must be certified

.(i)Have successfully passed a certification program approved by the Board of Pharmacy;(ii)Have successfully passed an employer's training and assessment program which has been approved by the Board of Pharmacy; or(iii)Have been certified by the Pharmacy Technician Certification Board.

In addition to the utilization of ----registered pharmacy technicians as outlined in subsection (e), a pharmacist may be assisted by and directly supervise at the same time one (1) pharmacy intern, one (1) pharmacy extern, and one (1) pharmacy observer.

Duties or Functions Prohibited from Being Performed by a Registered Pharmacy Technician: prohibited or not questions as followed below

Acceptance of telephoned or other oral prescriptions

Transfers of prescription drug orders from another pharmacy or transfers of a prescription drug order to another pharmacy

Patient counseling

Receiving information or providing information about a prescription drug order

Making the determination as to whether to refill the prescription drug order

Certification of a filled and finished prescription drug order

Weighing or measuring active ingredients without a mechanism of verification

Compounding of medication without a mechanism of verification;

Giving a completed prescription to the patient requesting same without the label and contents and the label being verified by a pharmacist.

Reconstitution of prefabricated medication without a mechanism of verification

Verification of the constituents of final IV admixtures for accuracy, efficacy, and patient utilization

Enter of order on patient medication profiles without verification by a pharmacist

Provision of drug information that has not been prepared or approved by the pharmacist

Review of the patient record for therapeutic appropriateness

chapter 16 MISCELLANEOUS GUIDELINES FOR PHARMACISTS

Any pharmacist having knowledge that a pharmacist or drug store owner allows or encourages any unlicensed person to illegally fill prescriptions or practice pharmacy while impaired shall report such action within------ days to the Director of the Georgia Drugs and Narcotics Agency (GDNA) and upon his failure to report such acts to the director, which shall be grounds for sanctions on such licensed person's license.

It shall be unlawful, and a violation of these rules, for any licensed pharmacist or pharmacy licensed under O.C.G.A. 26-4 to accept for refund purposes, or otherwise, any unused portion of a drug which has been previously dispensed via a prescription drug order and delivered to the patient or patient's caregiver, except ----

Nothing in this Rule shall be meant to be in conflict with Board Rule 480-10-. 17, which allow a pharmacy to receive unused, manufacturer's unit-dose packaged drugs from a Medicaid patient residing in a long term care facility. rule 480:10-17 says:

Within ----days following any damage by fire and/or water to a building or storage area in which any of the above said items are stored or retained, written notice shall be forwarded to the Director of the Georgia Drugs and Narcotics Agency (GDNA) at his office, by the person or his agent with custody or control of the said items informing the Director of the GDNA of the circumstances and requesting an immediate inspection of said items.

The theft, loss, or the discovery of unaccounted for controlled substances, within ---- days of its discovery, must be reported to the GDNA

A written report must be made regarding any theft or significant loss, as defined under 21 C.F.R. 1301.76, of controlled substances by completing a DEA Form ---- and submitted to the Drug Enforcement Administration, with a copy to the GDNA.

The report shall include the following information:

skipped chapter 17,18

A licensed pharmacist, or intern acting under the immediate and direct supervision of a licensed pharmacist, may sell, dispense or otherwise dispose of without prescription not more than-----dosage units of an exempted non-pseudoephedrine Schedule V controlled substance within any ---hour period of time, but only:

No person shall obtain or attempt to obtain, in any 48-hour period of time, more than -------dosage units of a Schedule V controlled substance.

Before the sale of any non-pseudoephedrine Schedule V Controlled Substance without a prescription, a licensed pharmacist should first determine whether or not the product to be sold is packaged in a container with not more than 4 ounces or 32 dosage units of the drug, and whether the label provided by the product manufacturer contains a Federal Caution or Warning.

A registered pharmacist or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist may sell, dispense or otherwise dispose of without prescription not more than ----grams every 24 hours, or a maximum of ------ grams every 30 days, to each customer of a pseudoephedrine containing drug product, but only

For electronic logbooks used to record patient information for the sale of an exempt Schedule V pseudoephedrine containing

All logbooks must be retained for a minimum period of ---- years from the date of the last recorded sale.

Any drug product containing pseudoephedrine which comes in a container packaged by the its manufacturer with and its label contains a Federal Caution or Rx Only indication, this product is not an exempt narcotic under this rule and cannot be sold as an ----drug product and can only be dispensed by a pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist upon receipt of a prescription issued by a licensed practitioner.

chapter 21 RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES

FINISH UP

Each retail pharmacy providing home health care services shall have a designated area for preparing compounded, sterile parenteral products. This area shall be physically separate from other areas and should be designed to avoid unnecessary traffic and airflow disturbances. The minimum space shall be ---- square feet. It shall be used only for the preparation of specialty products. It shall be of sufficient size to accommodate a laminar airflow hood and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation, and security.

22 REQUIREMENTS OF A PRESCRIPTION UNDER ORDER

A hard copy prescription drug order for any Schedule ____ controlled substance must be on security paper.

Practitioners not registered with the DEA, but affiliated with hospitals or other institutions, shall include

can a C-II prescription drug order, meeting the requirements of be transmitted by the practitioner or the practitioner's agent, to a pharmacy via facsimile machine or equipment?

Prior to the practitioner's agent transmitting such schedule II (C-II) prescription via facsimile machine, the C-II prescription drug order, meeting the requirements of may be transmitted by the practitioner or the practitioner's agent, but not the -----or -------agent, to a pharmacy via facsimile machine or equipment

Upon dispensing a schedule II (C-II) drug, the pharmacist shall physically sign his or her name on either the face or rear of the schedule II (C-II) prescription drug order in such a manner that the signature does not cover any information required by this chapter. I

pharmacist may dispense a schedule II (C-II) controlled substance only upon receiving oral authorization of the prescribing practitioner given what conditions:

In C2 emergency prescriptions what should pharmacist do if pharmacist doesnt know the provider or prescriber?

A prescription drug order for a terminally ill patient, prepared in accordance with Rule 480- 22-.03 written for a Schedule II Controlled Substance as defined by O.C.G.A. § 16-13-26, may be transmitted in what means?

terminal ill pt: Prior to the prescribing practitioner's agent transmitting such Schedule II Controlled Substance prescription via facsimile machine,------ and _______for the prescribing practitioner must be included in the face of prescription. The information may be used for verification of the prescription

LTCF: A prescription drug order prepared in accordance with Rule 480-22-.04 written for any C-II substance for a resident of Long Term Care Facility (LTCF) may be transmitted directly by the prescribing practitioner or the practitioner's agent, but not the patient or the patient's agent, to the dispensing pharmacy by facsimile machine or equipment.

The practitioner, practitioner's agent, or pharmacist will note on the prescription drug order that the patient is a LTCF patient by writing ---- on the face of the prescription

In addition to the term LTCF being noted on the face of the prescription, whenever a practitioner's agent transmits or a pharmacist receives such a prescription, -----,-------,-------must be included on the face of the prescription. This information may be used for verification of the prescription drug order.

CIIs After transmission of the original prescription, the pharmacist should suggest that the practitioner mark "----across the face of the prescription, and that it be maintained by the practitioner in the patient's medical record

The practitioner or practitioner's agent will note on the prescription drug order that the patient is a hospice patient by writing -----on the face of the prescription.

Whenever a pharmacist receives a prescription for a C-II controlled substance, and either the quantity of the drug to be dispensed or the strength of the drug to be dispensed has not been included by the prescribing practitioner, or when the strength of the prescribed drug is not immediately available, in order to dispense this drug, the pharmacist must perform the following:

When contacting the practionioner determine what three things:

Regarding the information provided by the practitioner, the pharmacist must write the missing quantity, the missing strength, or the changed quantity and strength of the prescribed drug on the face of the prescription along with the-------

The refilling of a prescription for a schedule------controlled substance is prohibited.

is The partial filling of a schedule II (C-II) prescription drug order permissible?

the remaining portion of the prescription drug order may be filled within ---- hours of the first partial filling.

A prescription drug order for a schedule II (C-II) controlled substance written for a patient in a Long Term Care Facility (LTCF), a hospice patient, or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities.

No partial fill for any one except ?

For each partial filling, the dispensing pharmacist shall record on the back of the prescription drug order (or on another appropriate record, uniformly maintained, and readily retrievable)

The total quantity of a schedule II (C-II) controlled substance dispensed in all partial fillings may not exceed the total quantity prescribed. Such C-II prescription drug orders may be partially filled for a period not to exceed ----days from the dispensing date or sooner if the medication is discontinued.

Upon dispensing a C-III, IV, or V controlled substance, the dispensing pharmacist shall ensure that his or her initials, the dispensing date, and the prescription serial number appear on the face of or the rear of each such prescription. Nothing shall prohibit the use of a computer-generated label to fulfill the requirements of this paragraph and/or the requirements of this Rule

Prescription drug orders for schedule C-III, IV, or V controlled substances shall be maintained either in a separate prescription drug order file for such C-III, IV, or V drug orders only or in such a form that they are readily retrievable from the other prescription drug orders of the pharmacy.

No prescription drug order for a C-III, IV, or V controlled substance shall be filled or refilled more than----- months after the date on which such prescription drug order was issued by the prescribing practitioner and no such prescription drug order may be authorized to be refilled for the quantity prescribed more than -----

The date of each refilling of a prescription drug order shall be entered on the back of the prescription drug order or in a computerized record system, with which all documents must be uniformly maintained and readily retrievable.

The prescribing practitioner may authorize additional refills of the original C-III, IV or V controlled substance prescription drug order through an oral refill authorization transmitted directly to the pharmacist or pharmacy intern/extern working under the direct supervision of a licensed pharmacist provided the following conditions are met

An automated data processing (ADP) or computerized system may be used for the storage and retrieval of refill information for prescription drug orders for C-III, IV or V substances,

The partial filling of a C-III, IV, or V prescription drug order is permissible, subject to the following requirements:

A pharmacist filling a prescription drug order for a C-II, III, IV or V substance shall affix to the package a label showing the following:

The transfer of original prescription drug order information for a C-III, IV, or V substance for the purpose of refill dispensing is permissible between pharmacies ----- time only.

However, pharmacies electronically sharing a real-time, online computerized database may transfer the prescription drug order information as many times as there are authorized refills, up to the maximum of -----times, if it is within------months from the date of issuance.

The transferring pharmacist or pharmacy intern/extern shall record the following information in either real time or at the first opportunity after the transfer:

The pharmacist or pharmacy intern/extern receiving the transferred prescription drug order information shall reduce it to writing and record the following information:

a physician assistant (PA) licensed by the Georgia Composite Medical Board is permitted to issue a prescription drug order or orders for any dangerous drugs, as defined in O.C.G.A. § 16-13-71, or for any Schedule ----,-----,-----Controlled substance without the co-signature of a supervising physician under the following conditions:

A physician assistant

No prescription drug order issued by a PA can be used to authorize refills more than------ months past the date of the original drug order.

The prescription drug order must include the following:

(i)The name, address, and telephone number of the supervising physician and the PA;

(ii)The patient's name and address;

(iii)The drug name, strength and quantity prescribed;

(iv)The directions to the patient with regard to taking the drug;

(v)The number of authorized refills, if any; and

(vi)If applicable, the DEA permit number of the PA.

If the prescription is transmitted by facsimile or computer, the prescription shall include:

(i)The complete name and address of the supervising physician and the PA;

(ii)In the case of a prescription drug order for a controlled substance, the DEA registration number of the PA;

(iii)The telephone number of the PA for verbal confirmation;

(iv)The name and address of the patient;

(v)The time and date of the transmission;

(vi)The full name of the person transmitting the order;

(vii)The drug name, strength and quantity prescribed;

(viii)The directions to the patient with regard to taking the drug;(ix)The number of authorized refills, if any; and(x)The signature of the PA as provided in Rule 480-27-.02(2) or, in the case of a controlled substances prescription, in accordance with 21 C.F.R. 1301.22.

An advanced practice registered nurse (APRN) who is recognized by the Georgia Board of Nursing as having met the requirements to engage in advanced nursing practice, and whose registered nurse license and advanced practice registered nurse license are in good standing with the Georgia Board of Nursing, is permitted to issue a prescription drug order or orders for any dangerous drugs, O.C.G.A. § 16-13-71except for drugs intended to cause an abortion to occur pharmacologically, or for any Schedule---,----,-----controlled substance without the co-signature of a delegating physician under the following conditions:

o prescription drug order issued by an APRN can be used to authorize refills more than -------months past the date of the original drug order unless the prescription drug order is for --------

A pharmacist shall presume that a prescription drug order issued by a PA or APRN was issued by a PA or APRN duly licensed and qualified under Title 43, Chapter 34 to prescribe pharmaceutical agents.

Any practitioner receiving, maintaining, and dispensing professional drug samples shall maintain records of all drug samples requested and received, along with a complete list of the specific number and dosage of each professional drug sample and medication dispensed by the practitioner and the person to whom the drug samples were dispensed; Such records must be maintained for a minimum of two years by the practitioner at each facility or office location where professional drug samples are received, maintained, and dispensed.

Ophthalmic topical products may be refilled without authorization from a practitioner to prevent unintended interruptions in drug therapy provided that:

(1)The original prescription order contains valid refills;

(2)Refills occur at ----percent or greater of the predicted days of use; and

(3)Refills are purchased through retail and/or mail order pharmacies.