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The following procedure is for the proper procurement, storage, record keeping, labeling and handling of drugs and/or devices by authorized agents or employees of the Georgia Department of Department of Community Health, Division of Public Health and the County Boards of Health. Licensed Pharmacist: Print name Signature Date Licensed Physician: Print name Signature Date Drug Dispensing Procedure 4. 1 Division of Public Health Standard Nurse Protocols for Registered Professional Nurses for 2010

DRUG DISPENSING PROCEDURE All registered professional nurses or physician’s assistants who dispense dangerous drugs and/or devices under the authority of an order issued in conformity with a standard nurse protocol or job description and as an agent or employee of the Division of Public Health of the Department of Community Health or any county board of health, shall meet the same standards and comply with all record-keeping, labeling, packaging, storage and all other requirements for the dispensing of drugs imposed upon pharmacists and pharmacies with regard to such drugs and/or devices, as outlined by the following dispensing procedure: A.

DEFINITIONS For the purpose of this dispensing procedure, the following definitions apply: 1. Administer or Administration Administer or administration means to give a unit dose of any drug or to perform any medical treatment or diagnostic study. O. C. G. A. § 43-34-23(a)(1) (formerly § 43-34-26. 1). Dangerous Drug Dangerous Drug means any dangerous drug as defined in O. C. G. A. § 16-1371, but does not include any controlled substance or Schedule I controlled substance. Dangerous drugs are required to bear upon the package, the words “Caution Federal Law Prohibits Dispensing Without Prescription”, “Rx only,” or words of like import.

These drugs may also be referred to as “Legend” drugs. See also O. C. G. A. § 43-34-23(a)(3) (formerly § 43-34-26. 1). Device Device means an instrument, apparatus, contrivance or other similar or related article, including any component part or accessory, which is required under federal law to bear the label, “Caution: federal or state law requires dispensing by or on the order of a physician” or “Rx only. ” O. C. G. A. § 26-4-5(9). Dispense Dispense means the delivery of a drug or device to a patient, patient’s caregiver, or patient’s gent pursuant to a lawful order of a practitioner in a suitable container appropriately labeled (see section F, labeling and appropriate containers) for subsequent administration to, or use by, a patient. O. C. G. A. § 26-4-5(10). Dispensing Procedure Dispensing Procedure means a written document signed by a licensed pharmacist and a licensed physician that establishes the appropriate manner under which drugs may be dispensed pursuant to O. C. G. A. § 43-34-23(a)(4) (formerly § 43-34-26. 1). Drug Dispensing Procedure 4. 2 2. 3. 4. 5.

Division of Public Health Standard Nurse Protocols for Registered Professional Nurses for 2010 6. Distribute Distribute means the delivery of a drug or device other than by administering or dispensing. O. C. G. A. § 26-4-5(11). Nurse Nurse means a person who is a registered professional nurse licensed as such under O. C. G. A. § 43-34-23(a)(6) (formerly § 43-34-26. 1). Nurse Protocol Nurse protocol means a written document mutually agreed upon and signed by a nurse and a licensed physician, by which, the physician delegates to that nurse the authority to perform certain medical acts pursuant to subsection (b) of O.

C. G. A. § 43-34-23 (formerly § 43-34-26. 1). These acts shall include, without being limited to, the administering and ordering of any drug. O. C. G. A. § 43-3423(a)(7). Job Description Job Description means a document signed by a licensed physician and describing the duties which may be performed by a physician’s assistant. By this document the physician delegates to that physician’s assistant the authorization to perform certain medical acts pursuant to subsection (b) of O. C. G. A. § 43-34-23 (formerly § 43-34-26. ) and which acts shall include, without being limited to, the administering and ordering of any drug. O. C. G. A. § 43-34-23(a)(5. 1) (formerly § 43-34-26. 1). Order Order means to select a drug, medical treatment or diagnostic study through physician delegation in accordance with a nurse protocol or a physician’s assistant’s job description. Ordering under such delegation shall not be construed to be prescribing, which act can only be performed by the physician, nor shall ordering of a drug be construed to authorize the issuance of a written prescription.

O. C. G. A. § 43-34-23(a)(8) (formerly § 43-34-26. 1). Practitioner or Practitioner of the Healing Arts Practitioner or Practitioner of the Healing Arts means a physician, dentist, podiatrist or veterinarian, and shall include any other person licensed under the laws of Georgia to use, mix, prepare, dispense, prescribe and administer drugs in connection with medical treatment to the extent provided by the laws of Georgia. O. C. G. A. § 26-4-5(33).

Prescription Drug Order Prescription Drug Order means a lawful order of a practitioner for a drug or device for a specific patient; such order includes an electronic visual image prescription drug order and an electronic data prescription drug order. O. C. G. A. § 26-4-5(36). Drug Dispensing Procedure 4. 3 7. 8. 9. 10. 11. 12. Division of Public Health Standard Nurse Protocols for Registered Professional Nurses for 2010 B. GENERAL REQUIREMENTS Although the Division of Public Health and the county boards of health may stock drugs and related supplies which are not considered dangerous drugs (e. . , ferrous sulfate tablets, reagent strips), the storage, record keeping and inventory control requirements shall apply to all drugs and related items. All biologicals (vaccines and diluents) must be handled and stored according to the storage and handling guidelines located in the Georgia Immunization Program Manual. The manual may be accessed on line at http://health. state. ga. us/publications/manuals. asp. A current drug reference book should be available in all health departments and/or health centers. At a minimum, Drug Facts and Comparisons [eFacts and Comparisons], American Hospital Formulary Service or Lexi-Comp Drug Information Handbook. ) All drugs or devices which bear, or are required to bear, upon the package, the words “Caution, Federal Law Prohibits Dispensing Without Prescription”, “Rx only” or words of like import, shall be issued pursuant to one of the following: 1. 2. A prescription from a licensed practitioner authorized to prescribe. An order issued in conformity with a nurse protocol or job description.

A registered professional nurse or physician’s assistant is only authorized to dispense pursuant to an order issued in conformity with a standard nurse protocol or job description, not a prescription or an order written on a chart or phoned in by a physician. C. DRUG STORAGE AND RECORD KEEPING 1. All drugs shall be stored in designated areas within the facility that are sufficient to insure the proper sanitation, temperature, light, ventilation, moisture control, segregation and security. These conditions must also be considered when drugs are being distributed/transported from one area/facility to another area/facility. a.

All drugs requiring refrigeration must be stored in a refrigerator designated for drug use. The refrigerator and/or freezer must have a thermometer and the temperature must be checked and recorded on a routine basis to insure the proper temperature range specified for those particular drugs. Store drugs for external use apart from drugs for internal use or injection (segregate at least by using different shelving or bins). b. Drug Dispensing Procedure 4. 4 Division of Public Health Standard Nurse Protocols for Registered Professional Nurses for 2010 2. All drugs shall be stored in a secured area (under lock and key when not in actual use).

Access to drugs should be only to specifically authorized personnel, as indicated by written policy and procedure, and the area should be sufficiently secure to deny access to unauthorized persons. Whenever more than one authorized person has access to drugs from a common inventory, one person shall be designated “in charge” of said inventory. All authorized persons “in charge” shall ensure that a complete and accurate record of all drugs on hand, received, dispensed, issued, removed or otherwise disposed of, has been kept in accordance with the record-keeping requirements of the Board of Pharmacy.

This system of accountability must exist for all drugs and include at a minimum, the name of drug and strength, the amount of drug, the date and signature of authorized persons or other information as indicated by written policy and procedure for drug accountability. 3. Required documentation on a Drug Dispensing Sign-out Sheet when a drug is dispensed pursuant to an order issued in conformity with a nurse protocol includes: a. b. c. d. e. f. Name and strength of drug dispensed. Quantity dispensed. Date dispensed. Record of nurse dispensing. Name of patient.

Lot number and expiration date, per legal requirements. 4. A running inventory of drugs received, and drugs removed, from designated storage areas must be verified by actual count on a monthly basis. Districts that contract for local retail or hospital pharmacy services must ensure that a list of state supplied drugs dispensed from the pharmacy location to public health clients is forwarded to appropriate district staff or state program on a monthly basis (e. g. , SHAPP). All records pertaining to drug accountability (from ordering and receipt of drug to actual patient administration) must be kept on file.

The Georgia Drugs and Narcotics Agency and its inspectors shall have the authority to conduct inspections or audits on all drugs received and/or disposed of by an agent or employee of the Division of Public Health of the Department of Community Health or any county board of health. Prescriptions and/or orders issued in conformity with a standard nurse protocol shall be kept on file for a minimum period of two (2) years from the date they are filled. Refer to the Public Health Record Retention Policy for specific program requirements that may be more stringent. Drug Dispensing Procedure 4. 5. 6. Division of Public Health Standard Nurse Protocols for Registered Professional Nurses for 2010 7. No health center in which drugs are handled shall operate in any manner or dispense any drugs under unclean, unsanitary, overcrowded, unhealthful conditions or under any condition that endangers the health, safety or welfare of the public. All drugs shall be kept beyond the normal reach of small children. Drug samples are forbidden in public health facilities unless a written procedure has been established for their use by a licensed physician and a licensed pharmacist. . D. OUTDATED, DETERIORATED, RETURNED AND RECALLED DRUGS 1. Examine drug stock at regular intervals of not more than six (6) months duration and remove from stock all outdated and deteriorated drugs. Stock must be rotated so the shortest dated stock will be used first. No outdated or deteriorated drug may be kept in stock for patient use. Under no circumstance shall any drug be dispensed or administered that bears a date of expiration that has been reached or that is in a deteriorated condition. Remove all outdated, deteriorated, unused or overstocked drugs from inventory.

The district pharmacist or district/county drug coordinator will be responsible for compiling and sending the required documentation to the drug manufacturer, drug wholesaler or the reverse drug distributor (i. e. , Guaranteed Returns) for handling the drugs appropriately. For any drug purchased through the State Office of Pharmacy, prior notification and a copy of the prepared documentations is required to be sent to the State Office of Pharmacy. The proper documentation should be kept on file for a minimum of two (2) years.

Information on drugs purchased or supplied with state or federal funds must be submitted upon request. Documentation should include the following: a. b. c. d. Name and strength of the drug, expiration date, lot number, unit or size and quantity of drug returned. The name and street address of the clinic/county/district returning drugs. The date of the return. The reason the drug is being returned (e. g. , out-of-date, deteriorated, discontinued, unused, overstocked). 2. Depending on the drug and/or the contract, an exchange for fresh stock, a return for credit or a return for “destruction only” may occur. 3.

The District/County Drug Coordinator or the District Pharmacist shall ensure that any drugs/vaccines at the district level requiring destruction shall be destroyed in accordance with current pharmacy rules and regulations that apply to non-controlled substances. A record of the destruction should be kept on file for a minimum of two (2) years and a copy sent to the Pharmacy Director of the Division of Public Health with the following information: a. Name and strength of the drug, expiration date, lot number, Drug Dispensing Procedure 4. 6 Division of Public Health Standard Nurse Protocols for Registered Professional Nurses for 2010 . c. d. e. manufacturer, and quantity destroyed. The name, address and organizational code of the district. The date the drug was destroyed. The reason the drug is being destroyed. The name and title of the person, in print and signature, destroying the product. 4. Drug Recalls If a drug recall for pharmaceutical supplies purchased by the Office of Pharmacy is issued by a manufacturer or other authorized agency, the district pharmacist or drug coordinator will be notified of the procedure to follow to insure that all recalled public health issued drugs are removed from stock at the state, district and county level.

For pharmaceutical supplies purchased by the district or county, the district pharmacist or drug coordinator would work with the drug manufacturer or wholesaler and pull any recalled drugs. See the Georgia Immunization Program Manual, Storage and Handling Guidelines regarding the disposition of outdated, expired or wasted vaccines. The manual is located at http://health. state. ga. us/publications/manuals. asp. 5. E. INVENTORY 1. Annual Inventory An inventory of all drugs and/or devices in each health district must be taken at the end of each fiscal year for auditing purposes.

This inventory must include all drugs purchased for use in public health whether these drugs are located in the district, the county health department or a local retail or hospital pharmacy. The completed annual inventory form must be maintained on file at the district level for a period of two (2) years. Inventory information on drugs purchased or supplied with state or federal funds must be submitted upon request. Each health district should maintain a supply of drugs on hand within the district, adequate to supply the needs of the district, but not to exceed a three (3) months’ supply.

Inventory levels for each drug should be established, and then reviewed and adjusted on a routine basis to maintain proper inventory control. Vaccine inventory must be documented and managed in the Georgia Registry of Immunization Transactions and Services (GRITS). 2. 3. Drug Dispensing Procedure 4. 7 Division of Public Health Standard Nurse Protocols for Registered Professional Nurses for 2010 F. LABELING AND APPROPRIATE CONTAINERS 1. All drugs and/or devices for use in the health department shall be in appropriate containers (manufacturer’s original package or prescription vial), including the use of: a. . c. Child-proof containers. Light-resistant and moisture-proof containers. Adequately-labeled containers to identify, at a minimum, the brand name or generic name, strength, lot number and expiration date. 2. Any drug and/or device issued or dispensed to the client for self- administration shall be in appropriate containers (manufacturer’s original package or light resistant prescription vial, both with child-proof caps, unless a waiver is on file for non-safety caps) and labeled with the following information: a. b. c. d. e. f. g. h. i.

Name, address and telephone number of the health district, health department or health center. Date and identifying serial number (at minimum, the three (3) digit county code and any other necessary identifying numbers). Full name of the client. Name of the drug (brand or generic) and strength. Name of drug manufacturer (optional). Directions for use to the patient. Name of practitioner, delegating physician or initials of DHR. The expiration date of the drug. Such other accessory cautionary information as may be required or desirable for proper use and safety to the client. . All drugs must be identified up to the point of administration to, or use by, the client. Therefore, the nurse should READ LABELS THREE TIMES -a. When the drug is selected from the storage area. b. When preparing, labeling, dispensing or administering the product. c. When returning the original container or package to the storage area, or discarding it. 4. The contents and the label of every drug must be verified by the licensed individual authorized to dispense, issue or administer drugs before each drug is given to the client. G.

CLIENT COUNSELING COMPONENTS The following client counseling components are a requirement of the Omnibus Budget Reconciliation Act of 1990, and the Georgia State Board of Pharmacy Rules and Regulations. The purpose, in part, is to enhance the public health and welfare by Drug Dispensing Procedure 4. 8 Division of Public Health Standard Nurse Protocols for Registered Professional Nurses for 2010 requiring that consultation be offered to clients regarding their medications and various conditions that could affect or be affected by the use of those medications. 1. Client Records a.

A client record system shall be maintained for clients for whom Prescription Drug Orders are dispensed or for whom drugs are dispensed under the authority of a nurse protocol or job description. The client record system shall provide for the immediate retrieval of information necessary for the nurse or physician’s assistant to identify previously dispensed drugs. Such client’s record shall contain, at a minimum: 1) 2) 3) 4) b. Full name of the client for whom the drug is intended, Date of birth, Client’s gender/sex, Address of the client (and telephone number if available).

Unless the client or the client’s agent refuses such information, the nurse or physician’s assistant dispensing under the authority of a nurse protocol or job description shall make a reasonable effort to obtain from the client or client’s agent and record: 1) 2) 3) Any known allergies, drug reactions or idiosyncrasies; Chronic conditions or disease states of the client; The identity of any other drugs, including over-the-counter drugs, or medical devices currently used by the client. c.

The nurse or physician’s assistant dispensing under the authority of the standard nurse protocol or job description shall make a reasonable effort to obtain, record and maintain a list or record of all drug orders obtained by the client at the site where the drug was dispensed within the preceding two (2) years, showing the following information: 1) 2) 3) 4) Name and strength of the drug. Quantity and date dispensed. Name of the nurse or physician’s assistant ordering and dispensing the drug.

Comments from the nurse or physician’s assistant relevant to the individual’s drug therapy, including any other information peculiar to the specific client or drug. d. A client record shall be maintained for a period of not less than two (2) years from the date of the last entry in the profile record. Drug Dispensing Procedure 4. 9 Division of Public Health Standard Nurse Protocols for Registered Professional Nurses for 2010 2.

Prospective Drug Review For the purpose of promoting therapeutic appropriateness, before ordering a drug(s) from a nurse protocol or job description and before dispensing any such drug(s), the nurse or physician’s assistant shall, at a minimum, review the client’s records and each drug(s) ordered to identify: a. b. c. d. e. f. g. Drug over-utilization or under-utilization. Therapeutic duplications. Drug-disease contraindications. Drug-drug interactions. Incorrect dosage, dosage form or duration of therapy. Drug-allergy interaction(s). Clinical abuse or misuse.

Upon recognizing any of the above, the nurse or physician’s assistant ordering the drug shall take appropriate steps to avoid or resolve the problem including, if necessary, consultation with the delegating physician. 3. Client Counseling a. Before dispensing a drug and/or device which has been ordered under the authority of a nurse protocol or job description, and following a review of the client’s record, the nurse or physician’s assistant shall personally offer to discuss matters which will enhance or optimize drug therapy with each client, or caregiver of such client.

Such discussion shall include appropriate elements of client counseling, based on the professional judgment of the nurse or physician’s assistant. Such elements may include but are not limited to the following: 1) 2) 3) 4) 5) The name, strength and description of the drug. The dosage form, dose, route of administration and duration of drug therapy. Intended use of the drug and expected action or result. Any special directions and precautions for preparation, administration and use by the client. Common, severe side effects, adverse effects or interactions, and therapeutic contraindications hat may be encountered, including their avoidance, and the action required if they occur. Techniques for self-monitoring drug therapy. The proper storage of the drug. Follow-up information regarding the need for continued drug therapy, if applicable. Action to be taken in the event of a missed dose. Comments relevant to the individual’s drug therapy, including any other information peculiar to the specific client or drug. Drug Dispensing Procedure 4. 10 6) 7) 8) 9) 10) Division of Public Health Standard Nurse Protocols for Registered Professional Nurses for 2010 . Additional forms of client information may be used to supplement verbal client counseling when appropriate or available. NOTE: The above procedures apply to all drugs and devices within the district, whether purchased through state or local funds. The Pharmacy Director for the Division of Public Health, or a qualified designee, will make periodic on-site visits to health districts and/or local health departments to provide technical assistance and review drug use, storage and handling. H. ADDITIONAL INFORMATION 1.

The Food and Drug Administration The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR is reserved for rules of the Food and Drug Administration. Each title (or volume) of the CFR is revised once each calendar year. A revised Title 21 is issued on approximately April 1st of each year. CFR 21 is downloaded from the files of the Government Printing Office (GPO) and contains the most recent revision.

The CFR at GPO, both current and historical, can also be searched directly at http://www. access. gpo. gov/nara/cfr/index. html. a. To report non-emergencies about medical products: medicines, medical devices, blood products, biologics, and special nutritionals: The FDA’s MedWatch program allows healthcare professionals and consumers to voluntarily report serious problems that they suspect are associated with the drugs and medical devices they prescribe, dispense or use. These problems include serious adverse reactions and events, product quality problems and product use errors.

Reporting can be done online, by phone, or by submitting the MedWatch 3500 form by mail or fax. Visit the MedWatch site, http://www. fda. gov/medwatch/, for more details. b. To report non-emergencies about vaccines: Adverse reactions and other problems related to vaccines should be reported to the Vaccine Adverse Event Reporting System, which is maintained by FDA and the Centers for Disease Control and Prevention. The vaccine reporting form may be found at http://vaers. hhs. gov; a copy of the form may also be obtained by calling 1-800-822-7967 or at the FDA website, http://www. da. gov/. Drug Dispensing Procedure 4. 11 Division of Public Health Standard Nurse Protocols for Registered Professional Nurses for 2010 2. To report accidental poisonings: Georgia Poison Center 80 Jesse Hill Drive, SE PO Box 26066 Atlanta, GA 30335-3801 Emergency Phone: 1-800-222-1222 TTY/TDD: (404) 616-9287 Administrative Phone: (404) 616-9237 FAX: (404) 616-6657 (administrative) or (404) 616-9288 (Poison Control Center) Website: www. georgiapoisoncenter. org Drug Dispensing Procedure 4. 12

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