title 480 GA law chapter 24 - Flashcards


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1

________ is a pharmacist licensed to engage in the practice of pharmacy in this state who is responsible for developing, coordinating, and supervising pharmaceutical services in the nursing facility. These services shall include, at a minimum, review of each patient's drug regimen monthly and report of any irregularities to the Medical Director and Administrator of the nursing facility, written reports of pharmaceutical services, and monitoring of established policies and procedures for medication handling and storage.

Consultant Pharmacist.

2

--------is a pharmacist licensed to engage in the practice of pharmacy in this state who is responsible for supervising the proper dispensing and delivery of drugs to a nursing facility. These services shall include, at a minimum, proper drug labeling, storage, transport, and record keeping in compliance with all federal, state and local laws and regulations.

vendor pharmacist

3

Dispensing of all drugs to the facility shall be pursuant to a legal prescription drug order for an individual patients. are standing orders allowed?

Standing medication orders shall not be allowed

4

For use inside the facility, all drugs dispensed shall be dispensed in appropriate containers, as defined by the Food and Drug Administration and the Consumer Protection Agency, and adequately labeled with the following information:

a)Name, address, and telephone number of the pharmacy;

(b)Date of issuance and identifying serial number;

(c)Full name of patient;

(d)Brand and/or generic name of drug, strength, and quantity dispensed;(e)Directions for use, which may be placed on the container label or on a Medication Administration Record available and consulted at the time of the administration of each dose, provided, however, that both methods may be utilized inside a single facility;

(f)Name of physician prescribing;

(g)Required precautionary information regarding controlled substances

;(h)Such other and further accessory cautionary information as may be required or desirable for proper use and absolute safety to the patient; and

(i)Expiration date.

5

Doses of solid oral medications dispensed are pharmacy-prepared or manufacturer-prepared in individually packaged and sealed doses which are identifiable and properly labeled to include, at a minimum:

1.Brand and/or generic name of the drug;

2.Strength;

3.Lot number; and

4.Expiration date.

6

Doses of medication for individual patients are placed into individual patient containers, bins, compartments, or drawers and whenever possible, are subdivided by dose and administration time and not to exceed a -----hour supply. Drug distribution systems which exceed a -----hour supply must follow labeling requirements of

72

72

7

is partial filling of CII allowed?

yes

8

Partial filling of Schedule II drugs will be allowed but limited to------ days only.

60

9

Emergency kits may be placed in licensed nursing homes by the pharmacy of the consultant or vendor pharmacist provided the following guidelines are met:

A record of the drugs to be kept in an emergency drug kit be kept in the nursing home and the provider pharmacy

10

Drugs shall not be accessed for use from the emergency drug kit in an emergency situation without a new prescription drug order from a licensed practitioner. A valid, signed prescription drug order for any such drug must be issued to the vendor pharmacy, supplying the emergency drug kit, within ---- hours of the drug being taken from the kit.

72

Emergency drug kits shall be stored in limited access areas and sealed to prevent unauthorized access and to insure a proper environment for preservation of the drugs therein. The provider pharmacy shall develop a method to readily determine if an emergency drug kit has been accessed without authorization;

11

An emergency drug kit must be inventoried at least ----- a month by a pharmacist from the provider pharmacy and sign a card attached to the kit indicating the date it was inspected. The provider pharmacy must maintain an adequate record of such inspections.

once

12

The provider pharmacy must apply on an individual basis to the Board, in care of the ----- Director, for approval to place an emergency drug kit in each individual nursing home and a copy of this approval will be kept on file in both the nursing home and the provider pharmacy.

GDNA

Upon recommendation by the GDNA Director, the Board may revoke the approval for an emergency drug kit in any nursing home where abuse or misuse of drugs from the emergency drug kit is used for any purpose other than emergency purposes;

13

The exterior of an emergency drug kit shall be labeled so as to clearly and unmistakably indicate that it is an emergency drug kit and is for "------

EMERGENCY USE ONLY"

14

Proof of use of Schedule II, III, IV and V controlled substances and such other drugs as may be specified by the appropriate committee of the facility, shall be upon proof of use forms which shall specify at a minimum:

1.Name and strength of the drug;

2.Dose and route of administration for the drug;

3.Name of ordering prescriber;

4.Name of patient;

5.Date and time of administration to patient;

6.Signature and title of individual administering, the medication; and

7. Documentation of destruction of all unused portions of single doses shall include signature verifications of two licensed authorized personnel.

15

Make periodic inspections, which shall occur at least every----- days, of drugs and medication records kept within the facility. A written report of inspection shall be maintained at the facility; and,

30

16

When non-controlled drugs are expired, discontinued from use or the patient for whom they were ordered is no longer a patient, the drugs shall be immediately removed from the active stock and inventoried by ----people who shall be licensed either as a pharmacists, a nurses, or a licensed practical nurses. The completed inventory record shall be signed and dated by these -----individuals. The original inventory record shall be maintained by the facility for two years, and a copy shall be kept with the drugs until their final disposition.

2

2

17

When controlled drugs are expired, discontinued from use or the patient for whom they are ordered is no longer a patient, the medication shall be removed from the active stock immediately and inventoried and verified by two people who shall be licensed either as a pharmacist, a nurse, or a licensed practical nurse.

The completed inventory record shall be signed and dated by those two individuals. An inventory form will be established by the pharmacist, which must include the following data:

1.Date of discontinuance or inventory date;

2.Name of patient;

3.Name of issuing pharmacy;

4.Identifying serial numbers of the prescriptions;

5.Name and strength of drug; and

6.Quantities of drugs in containers when inventoried.

18

On-site destruction can be as follows:

Three licensed professionals or law enforcement officers, one of whom must be a pharmacist, must witness the destruction of these drugs.

The consultant or vendor pharmacist will notify the GDNA as to the date and time the destruction will take place at least two weeks prior to destruction at the facility. (Please note that the consultant may set up a specific schedule of destruction - an example would be the first Tuesday in each month at 10:00 a.m.)

19

Hospice Emergency Drug Kits

Drugs shall not be accessed for use from the emergency drug kit in an emergency situation without a new prescription drug order from a licensed practitioner. A valid, signed prescription drug order for any such drug must be issued to the vendor pharmacy, supplying the emergency drug kit, within ----- hours of the drug being taken from the kit.

72

20

A record of all controlled substance drugs received and disposed of by a dispensing practitioner must be maintained. All invoices of Schedule II controlled substances must be kept or maintained in a separate file. All invoices for Schedule III, IV or V controlled substances must be kept in or maintained in a separate file, provided that these invoices may be filed with other invoices only if the letter----- is stamped on each invoice of Schedule III, IV or V controlled substances so that such invoice shall be easily accessible and retrievable.

"C" in red ink

21

An inventory of all controlled substances must be maintained separately and taken ----- or ---- from the day of the last inventory, of every odd-numbered year.

biennially on May 1st, or two (2) years

22

filing

A practitioner can maintain three separate files;

one for all Schedule II controlled substances dispensed, one for all Schedule III, IV and V controlled substances dispensed, and one for all dangerous drugs dispensed,

23

A practitioner can maintain two files,

one for Schedule II controlled substances dispensed and one for all other drugs dispensed. If this method is utilized, the prescriptions for Schedule III, IV and V controlled substances must be stamped with the letter "C" in red ink, not less than one inch high, in the lower right-hand corner, so that such records are easily accessible and retrievable, or

24

A practitioner can maintain two files; one for all controlled substance drugs dispensed and one for all dangerous drugs dispensed. If this method is utilized,

the prescriptions for Schedule III, IV and V controlled substances must be stamped with the letter "C" in red ink, not less than one inch high, in the lower right-hand corner so that such records are easily accessible and retrievable.

25

A loss or theft of any controlled substance drugs must, within----hours of discovery, be reported to the GDNA.(2)A written report must be made regard any theft of 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.

48

106

26

Prospective Drug Review.1.A pharmacist shall review the patient record and each Prescription presented for Dispensing for purposes of promoting therapeutic appropriateness by identifying

:(i)over-utilization or under-utilization;(ii)therapeutic duplications;(iii)drug-disease contraindications;(iv)Drug-Drug interactions;(v)incorrect Drug dosage or duration of Drug treatment;(vi)Drug-allergy interactions;(vii)clinical abuse/misuse.

27

Patient Counseling, as described above and defined in the Act, shall not be required for

the following

28

is counseling required for in-patients of a hospital or institution where other licensed health care professionals are authorized to administer the drug(s)

no

29

is counseling required for patients receiving drugs from the Georgia Department of Human Resources Division of Public Health; provided however, that pharmacists who provide medications to patients in accordance with Section 43-34-26.1 of the Official Code of Georgia Annotated shall include in all dispensing procedures a written process whereby the patient or the caregiver of such patient is provided with the information contained in Chapter 480-31 of the Rules of the Georgia State Board of Pharmacy.

no

30

is counselling required for refills of prescription drug orders for which, in the professional judgment of the Pharmacist, appropriate counseling has taken place or has been declined. The need for counseling on refills resides in the professional judgment of the dispensing Pharmacist.

no

31

A Pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses such consultation.

true

32

chapter 33 Outpatient clinic pharmacies

ch 33

33

When a licensed pharmacist is not physically present in the clinic pharmacy, written policies and procedures shall be prepared in advance by the pharmacist-in-charge for the provision of drugs to the medical staff and other authorized licensed personnel of the clinic by use of after hours cabinets or containers and/or by access to the pharmacy.

...

34

Access to pharmacy : Whenever any drug is not available from standard ward inventories or after hours cabinet(s), container(s) or enclosure(s) and such drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, such drug may be obtained from the pharmacy pursuant to the practitioner's order and the requirements of this subsection

One licensed health care professional as designated in the policies and procedures may have access to the pharmacy and may remove drugs therefrom.

35

An outpatient clinic pharmacy shall have within the clinic 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 outpatient clinic pharmacy space requirements shall be a minimum of ----square feet. Such space shall include all areas which are assigned and under the direct control of the pharmacist-in-charge

150

36

Copies of and/or electronic access to current reference materials appropriate to the individual pharmacy practice. These reference materials shall be authoritative on at least the topics of drug interactions; patient counseling; compounding and pharmaceutical calculations; and generic substitution.

Graduates of assorted sizes;

Two mortars and pestles of assorted sizes

.Two spatulas;

One oral solid counting tray;

.Ointment slab, tile or ointment paper pad;

Typewriter, word processor or computer with label printer; and

.Any other equipment necessary for a specialized practice setting where such a specialized practice takes place.

The telephone number of a poison control center.

Adequate supply of drugs most commonly prescribed.

Assorted sizes and types of appropriate dispensing containers.

The Georgia Pharmacy Practice Act,The Georgia Controlled Substances Act/Dangerous Drug Act, Official Rules of the Georgia State Board of Pharmacy

Refrigerator in operating condition and a thermometer;

Class A Balance with an assortment of metric weights or a Class I or II Electronic Balance;

.Sink in working condition with both hot and cold running water.

37

The compounding, admixture, and quality control of large volume parenterals is the responsibility of a pharmacist and shall be prepared under a laminar flow hood within the pharmacy. Other licensed healthcare professionals who are authorized by law to prepare or administer large volume parenterals must have special training to do so.

These functions of compounding shall be done primarily by the pharmacy department with exceptions allowed for specialty-care areas, emergency situations, and during unattended hours of the pharmacy department. The pharmacist-in-charge shall be responsible for providing written guidelines and for approving the procedure to assure that all pharmaceutical requirements are met when any part of the above functions (preparing, sterilizing and labeling parenteral medications and solutions) is performed within the clinic by other licensed healthcare professionals who are authorized by law to prepare parenteral medications and solutions.

38

In outpatient clinic pharmacies

The pharmacist-in-charge shall establish procedures relating to medications brought into the clinic. Such drugs shall not be administered unless they can be precisely identified. Administration shall be pursuant to an authorized practitioner's prescription drug order only.

If such medications are not to be administered, the medication shall be returned to an adult member of the patient's immediate family or stored by the pharmacy and returned to the patient at the time of his/her departure from the clinic.

39

The Pharmacist in Charge of each Low THC Pharmacy Dispensary shall cause examination of the stock of the prescription department of that Pharmacy, by persons qualified to do so, and shall cause to be removed from stock all outdated and deteriorated Low THC Products, and such shall be done at regular intervals of not more than ------- months duration, and under no circumstances will any Low THC Pharmacy Dispensary or Pharmacist permit any Low THC Product to be dispensed which bears a date of expiration which has been reached, or any Low THC Product which is in a deteriorated condition.

6

40

chapter 51

51

41

A practitioner of the healing arts may instruct the pharmacist not to substitute an interchangeable biological product in lieu of a prescribed biological product by including the words -------" in the body of the prescription.

"brand necessary

42

Within ------excluding weekends and holidays, following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the specific product provided to the patient, including the name of the biological product and the manufacturer.

forty-eight (48) hours,

43

chapter 37 REMOTE AUTOMATED MEDICATION SYSTEMS

37

44

No more than a -----day supply of each individual medication may be stocked in a RAMS at one time.

30

All drugs in a RAMS must inventoried no less than once every 30 days and documentation must be maintained of the inventories including the removal of any discontinued/out of date medications

45

All drugs in a RAMS must inventoried no less than once every 30 days. All controlled substances drugs in a RAMS must inventoried no less than once every ---- days. A system of accountability must exist for all drugs contained in a RAMS.

7

Any discrepancies or deficiencies noted shall be corrected and written notice filed with GDNA within 30 days after receipt of the inspection notice.

46

PDMP - PRescribers

A prescriber is required to check the PDMP before writing a prescription for the first time for:

  • Benzodiazepines
  • Opiate drugs or cocaine derivatives listed in Schedule II

47

Thereafter, if the prescription continues, the prescriber should check the PDMP at least every ---- days.

90

48

For Pharmacists and Pharmacies

As of July 1, 2017, prescription information for Schedule II, III, IV, V substances must be entered into the Georgia PDMP within ---- hours after the prescription is dispensed. This means reports will be made daily rather than weekly. Pharmacies are required to file a “------” for the days that the pharmacy is closed or if there were no prescriptions filled for Schedule II, III, IV, or V drugs.

24

zero report

49

dispensers will be required to enter prescription information for Schedule II, III, IV, V controlled substances within---- hours.

24