Pharmaceutical services | NJ

PHARMACEUTICAL SERVICES

 

8:36-11.1       Qualifications of pharmacists

 

Each pharmacist shall be registered by the New Jersey State Board of Pharmacy, in accordance with N.J.A.C. 13:39.

 

8:36-11.2       Provision of pharmaceutical services

 

The assisted living residence, comprehensive personal care home, or assisted living program shall be capable of ensuring that pharmaceutical services are provided to residents in accordance with the prescriber’s orders, each resident’s health care plan, and in accordance with the rules of this chapter and all applicable State and Federal laws and regulations.

 

8:36-11.3       Supervision of medication administration

 

(a) If indicated in the resident’s health service plan or resident’s general service plan, a designated employee shall provide resident supervision of self- administration of medications in accordance with physicians’ orders. Any employee who has been designated to provide resident supervision of self- administration of medications shall have received training from the licensed professional nurse or the licensed pharmacist, and such training shall be documented.

 

1. The facility or program shall document the provision of training to each employee who has been designated to provide resident supervision of self- administration of medications;

 

2. The facility or program shall document any instance where medications are not taken in accordance with the prescriber’s orders; and

 

3. The facility shall keep a record of all prescribed medications for which the resident is receiving supervision of medication

 

8:36-11.4       Administration of medications

 

• Notwithstanding the definition of “health care service,” the administration of medication in accordance with N.J.A.C. 8:36-11.3 and this section, in and of itself, shall not be considered a health care

 

• All medications shall be administered by qualified personnel in accordance with prescriber orders, facility or program policy, manufacturer’s requirements, cautionary or accessory warnings, and all Federal and State laws and

 

8:36-11.5       Certified Medication Aide Program

 

• The administration of medications is within the scope of practice and remains the responsibility of the registered professional

 

• The registered professional nurse may choose to delegate the task of administering medications in accordance with N.J.A.C. 13:37-6.2 to certified medication aides, as defined in this

 

1. A unit-of-use/unit dose drug distribution system shall be developed and implemented whenever the administration of medication is delegated by the registered professional nurse to a certified medication aide;

 

1. Over-the-counter (OTC) solid and liquid dosage forms may be dispensed in a non unit-of-use or non unit-dose medication distribution

 

1. Prescription liquid medications (that is, conventional bottles, concentrates) may be dispensed in a non unit-of-use, non unit-dose, or conventional medication distribution

 

2. If an appropriate delegation is made, and in accordance with the facility’s policies and procedures and all applicable State and Federal laws and regulations, the certified medication aide may:

 

1. Administer medications through the routes of oral, ophthalmic, otic, inhalant, nasal, rectal, vaginal, topical, and by the percutaneous endoscopic gastrostomy (PEG) tube route of administration;

 

1. Administer any prescription or OTC medications as described in (b)1

above;

 

• Administer regularly scheduled medications, including prescription, OTC, and Schedule II-V medications;

1. Administer “prn” or as-needed prescription, OTC and Schedule II-V medications except that residents receiving the following medications shall be assessed by the registered professional nurse at least once every seven days:

 

• Residents receiving prn Schedule II narcotic analgesics;

 

• Residents receiving Schedule III-IV narcotic analgesics; and

 

• Residents receiving Schedule III-IV central nervous system agents;

 

1. Administer medications that have been dispensed by a pharmacy, in accordance with N.J.S.A. 45:14 et seq., N.J.S.A. 24:21 et seq., N.J.A.C. 13:39, and the requirements of this chapter; or

 

1. Administer experimental and/or research medications in accordance with 45 CFR Part 46, Protection of Human Subjects, incorporated herein by reference, as amended and

 

3. The certified medication aide shall not:

 

1. Administer any injection other than pre-drawn properly packaged and labeled insulin as described in (b)1 above;

 

1. Calculate a medication dosage;

 

• Pre-pour medications for more than one resident at a time;

 

1. Contact prescribers for changes in medication, to clarify an order, or contact the pharmacist for questions regarding a dispensed medication; or

 

1. Administer bolus doses of enteral feedings, or stop and/or start an existing enteral feeding pump or gravity-fed

 

4. The certified medication aide shall contact the registered professional nurse for any questions or clarification regarding medication

 

5. The delegating nurse shall review with the certified medication aide medication actions and untoward effects for each drug to be administered. Pertinent information about medications’ adverse effects, side effects, contraindications, and potential interactions shall be incorporated into the plan of care for each resident, with interventions to be implemented by the personal care assistant and other caregiving staff, and documented on the medication administration record (MAR).

 

6. At least weekly, a registered professional nurse shall review and sign off on any modifications or additions to the MAR that were made by the certified medication aide under the registered professional nurse’s

 

7. Registered professional nurses who participate in certified medication aide training shall attend a Department offered one-day Train-the-Trainer Medication Aide Workshop prior to providing such training to certified medication aides.

 

8. Registered pharmacists, who participate in certified medication aide training, shall attend a Department offered one-day Train-the-Trainer Medication Aide Workshop prior to providing such training to certified medication

 

9. The fee charged by the Department for a two-year approval of a medication aide training program shall be $100.00 and is non-refundable.

 

10. The facility shall keep a record of all prescription and non-prescription medications administered to each

 

• Each resident shall be identified prior to medication

 

• Medication prescribed for one resident shall not be administered to another resident. Borrowing shall not

 

• The registered professional nurse shall report medication errors and adverse drug reactions immediately to the prescriber, to the provider pharmacist and/or consultant pharmacist, and shall document the incident in the resident’s record.

 

• Medications shall be accurately administered and documented by properly authorized individuals, in accordance with prescribed

 

8:36-11.6       Designation of a pharmacist

 

(a) The facility or program shall designate a pharmacist who shall direct pharmaceutical services and provide consultation to the physician, facility, or program staff, and residents, as needed. The pharmacist shall assist the facility or program with, at a minimum, the following:

 

1. The training of employees;

 

2. Educating residents regarding medications;

 

3. Establishing policies and procedures which ensure safe and appropriate self-administration of medications;

 

4. Reviewing medication administration records on a quarterly basis; and

 

5. At least quarterly, inspecting all common areas of the facility or program where medications are stored or administered, documenting any problems and proposing solutions to these problems, and maintaining records of such inspections.

 

8:36-11.7       Storage and control of medications

 

• The administrator shall provide an appropriate and safe medication storage area, either in a common area or in the resident’s unit, for the storage of medications that are not self-administered by the residents. The storage area requirement may be satisfied through the use of a locked medication

 

1. The storage area shall be kept locked when not in

 

2. The storage area shall be used only for storage of medications and medical

 

3. The key to the storage area shall be kept on the person of the employee on duty who is responsible for resident

 

4. Each resident’s medications shall be kept separated within the storage area, with the exception of large volume medications which may be labeled and stored together in the storage

 

5. Medications shall be stored in accordance with manufacturer’s instructions, and/or extemporaneously applied pharmacy labels and/or directions, and/or United States Pharmacopoeia Drug Information (USP DI) Volume I, Drug Information for the Health Care Professional, 2005, incorporated herein by reference, as amended and supplemented and USP DI Volume II: Advice for the Patient, incorporated herein by reference, as amended and supplemented. USP DI Volume I: Drug Information for the Health Care Professional and USP DI Volume II: Advice for the Patient can be obtained by contacting Thomson- Micromedex, 6200 S. Syracuse Way, Suite 300, Greenwood Village, CO 80111, (303) 486-6400.

 

• All medications shall be kept in their original containers and shall be properly labeled and

 

1. The label of each resident’s prescription medication container shall be permanently affixed and contain the resident’s full name, prescriber’s name, prescription number, name and strength of medication, lot number, quantity, date of issue, expiration date, manufacturer’s name if generic, directions for use, and cautionary and/or accessory labels. Required information appearing on individually packaged medications or within an alternate medication delivery system need not be repeated on the

 

2. If a generic substitute is used, the drug shall be labeled according to

N.J.A.C. 8:71 and/or the provisions identified in the publication of the Office of Generic Drugs in the Office of Pharmaceutical Science of the Center for Drug Evaluation and Research of the United States Department of Health and Human

 

Services, “Approved Drug Products with Therapeutic Equivalence Evaluations,” 24th Edition, incorporated herein by reference, as amended and supplemented, commonly known as the “Orange Book.” The Orange Book can be obtained by contacting the Superintendent of Documents, Government Printing Office, P.O. Box 371954, Pittsburgh, PA 15250-7954, (202) 512-1800 or toll-free (866) 512- 1800, and is available on-line at http://www.fda.gov/cder/oranqe/default.htm and at http://www.fda.gov/cder/ob/default.htm.

 

3. All over-the-counter medications repackaged by the pharmacy shall be labeled with the name and strength of the medication, expiration date, lot number, date of issue, manufacturer’s name, and cautionary and/or accessory labels, in accordance with (a)5 Original manufacturer’s containers shall be labeled with at least the resident’s name, and the name label shall not obstruct any of the aforementioned information.

 

4. For non-liquid prescription medications, where a unit-of-use drug distribution system shall be used, each dose of medication shall be individually packaged in a hermetically sealed, tamper-proof container, and shall carry full manufacturer’s disclosure information on each discrete dose. Disclosure information shall include, but not be limited to, the following: product name and strength, lot number, expiration date, and manufacturer’s or distributor’s

 

5. If a customized resident medication package is utilized, it shall conform with the provisions of USP DI Volume Ill, Approved Drug Products and Legal Requirements, 2005, incorporated herein by reference, as amended and supplemented. USP DI Volume III, Approved Drug Products and Legal Requirements can be obtained by contacting Thomson-Micromedex, 6200 S. Syracuse Way, Suite 300, Greenwood Village, CO 80111, (303) 486-6400, under license granted by the United States Pharmacopeial Convention,

 

• Single use and disposable items shall not be

 

• No stock supply of medications shall be maintained, unless prior approval is obtained from the

 

• Discontinued or expired medications shall be destroyed within 30 days in the facility, or, if unopened and properly labeled, returned to the pharmacy for credit, if allowable, and in conformance with N.J.A.C. 13:39 and other State and Federal laws, codes, and

 

• All medication destruction in the facility shall be witnessed and documented by two individuals, each of whom shall be either the administrator, the registered professional nurse, the licensed practical nurse, or the provider or consultant pharmacist.

 

• The facility shall generate a crediting mechanism for medications dispensed in a unit-of-use medication distribution system, or other system that allows for the re-use of medications in accordance with all applicable State and Federal laws and regulations. The crediting system shall be monitored by the provider pharmacist and/or the consultant pharmacist and a facility representative.

 

• If the facility utilizes medications marked “sample,” the provider pharmacist and/or consultant pharmacist, and the registered professional nurse, shall develop a mechanism for the control and limitation of these medications, in accordance with N.J.A.C. 13:35 and 13:39.

 

• Medication containers and carts shall be kept clean, and handled properly to prevent damage to the contents, and to prevent injury and harm to staff and/or

 

• Needles and syringes shall be stored, used, and disposed of in accordance with N.J.S.A. 26:24-5.10 et seq. N.J.A.C. 8:43E-7, 7:26-3A, 29 CFR 1910.1930, and a record shall be maintained of the purchase, storage, and disposal of needles and

 

• Controlled dangerous substances shall be stored, and records shall be maintained, in accordance with the Controlled Dangerous Substances Acts,

N.J.S.A. 24:21-1 et seq. and all other Federal and State laws and regulations concerning the procurement, storage, dispensation, administration, and disposition of same.

 

• Any theft of Scheduled or Controlled Substances shall be reported to the New Jersey Department of Law and Public Safety, Division of Consumer Affairs, Enforcement Bureau of Professional Boards at (973) 504-6300, and/or to any other municipal, county, State, or Federal authority having jurisdiction over theft of such substances.