PHARMACY                                                                                                              29-02-004

PHARMACY CONTROLS

POLICY STATEMENT.

The Division of Veterans Healthcare Services (DVHS) requires that each of the New Jersey Veterans Memorial Homes (VMH) establish and implement a protocol for the control and oversight of the process of dispensing and administering medications and other pharmaceuticals to veterans home residents.

PURPOSE.

This policy and procedure shall serve to ensure that the process of dispensing and administering medications and other pharmaceuticals to veterans home residents is performed according to Federal and State statutes, laws, rules and regulations, and in accordance with currently accepted standards of professional practice.

PROCEDURE.

  1. New Jersey Veterans Memorial Homes

    1. The label of each resident’s individual medication container or package shall be labeled in accordance with the New Jersey State Board of Pharmacy regulations, which can be found at N.J.A.C. 13.39-5.9. These labels shall be permanently affixed, and shall contain the following information:

      1. The resident’s full name;

      2. The prescriber’s name;

      3. The prescription number;

      4. The name and strength of the drug;

      5. The quantity dispensed;

      6. The lot number;

      7. The date of issue;

      8. The expiration date;

      9. The manufacturer’s name, if generic;

      10. Cautionary and/or accessory labels.

      11. If a generic substitute is used, the drug shall be labeled according to the Drug Utilization Review Council Formulary, N.J.S.A. 24:6E-1 et seq., and N.J.A.C. 8:71.

      12. Required information appearing on individually packaged  drugs or within an alternate medication delivery system need not be repeated on the label;

      13. The name, address, and telephone number of the pharmacy.

  1. Unit Dose Drug Distribution System

    1. If a unit dose drug distribution system is utilized, the following requirements shall be met:

      1. Each resident shall have his or her own medication tray labeled with the resident’s name and location in the VMH;

      2. Each medication shall be individually wrapped and labeled with the generic or trade (brand) name and strength of the drug, the lot number or reference code, the expiration date, the dose, and the manufacturer’s name, and shall be ready for administration to the resident.

      3. Cautionary instructions shall appear on the resident’s record of medication, and the system shall include provisions for noting additional information, including but not limited to, special times or routes of administration and storage conditions.

      4. Delivery and exchange of resident medication trays shall occur promptly and, if a 24-hour unit-dose system is used, then at least one exchange of resident medication trays shall occur every 24 hours, including weekends and holidays.

      5. Both over-the-counter and prescription medications may be kept as stock. A limited amount of prescription medications may be kept as stock for the administration of stat (emergency) doses, lost doses, or doses not sent by the provider pharmacy. These medications shall be approved by the Pharmacy and Therapeutics Committee, monitored for accountability, and labeled to include drug name, drug strength, manufacturer’s name, lot number, expiration date, recommended dosage for over-the-counter medications, and applicable cautionary and/or accessory labels.

  1. The Consultant Pharmacist shall:
    1. Make monthly inspections of all areas in the VMH where medications are dispensed, administered, or stored.
    1. Periodically, as determined by the Quality Assurance program, observe a medication pass and review the crediting system.
    1. Document any problems and propose solutions to these problems.
  1. Pharmacy Controls
    1. The contents of emergency kits shall have been approved by the Pharmacy and Therapeutics Committee. Emergency kits shall be stored securely at each nursing unit, but not kept under lock and key, checked after each use, and checked at least monthly by the consultant pharmacist. Emergency kits shall not be accessible to residents, but shall be accessible to staff in a timely manner.
    1. All medications repackaged by the pharmacy shall be labeled with an expiration date, name and strength of drug, lot number, date of issue, manufacturer’s name if generic and cautionary and/or accessory labels, in accordance with N.J.A.C. 13:39-5.9, United States Pharmacopoeia (USP) requirements and applicable FDA regulations.
    1. The Pharmacy and Therapeutics Committee shall establish and enforce procedures for removal of discontinued, unused, expired, recalled, deteriorated, and unlabeled drugs and intravenous solutions and for removal of containers of medications with worn, illegible, damaged, incomplete or missing labels.
    1. All medications shall be stored in accordance with manufacturers’ and United States Pharmacopoeia (USP) requirements, and all medications shall be kept in locked storage areas.
    1. All medication destruction in the VMH shall be witnessed by at least two persons, each of whom shall be the consultant pharmacist, a registered professional nurse, or a licensed practical nurse. A record of each instance of drug destruction shall be maintained.
    1. Where allowable by law, the VMH shall generate a crediting mechanism for medications dispensed in a unit-of-use drug distribution system, or other system that allows for the re-use of medications.  The crediting system shall be monitored by the provider pharmacist and a VMH representative.
    1. The Pharmacy and Therapeutics Committee shall establish and enforce procedures for the inventory of controlled substances in accordance with law.
    1. Based on prescriber’s orders for medications, drug tests, diet and treatments, the VMH shall implement written methods and procedures for obtaining prescribed prescription medications and other pharmaceuticals from a pharmacy that has a permit from the New Jersey State Board of Pharmacy, in accordance with N.J.A.C. 13:39-4. The telephone number of the pharmacy and procedures for obtaining drugs shall be posted at each nursing unit.
    1. The VMH shall develop and implement a system whereby instructions for use are provided whenever medications are released to residents.  Instructions shall be written in a manner intended to promote proper storage, secure handling, and safe administration of medications released to residents. Documentation of released medications shall be entered into the resident’s medical record. See 29-02-004A.
    1. The VMH shall provide pharmaceutical services by contract with a provider pharmacy, 24 hours per day, seven days per week.
    1. If a resident obtains medications from a pharmacy that is not the VMH provider pharmacy, the following conditions shall be met:

      1. The outside pharmacy provider shall comply with all labeling requirements specified at N.J.A.C. 8:39-29.4(a).

      2. The VMH shall establish a plan for obtaining the resident’s medications on an emergency basis if the outside pharmacy is unable to provide the medications.

      3. If it is determined that a resident should not be allowed to obtain medications from an outside pharmacy, the VMH must submit documentation to the New Jersey Department of Health and Senior Services, prior to denying the request, demonstrating a significant risk to the health and safety of the resident as a result of this practice.

    1. Residents are strongly discouraged from keeping or storing medications in their rooms, or from using medications not prescribed by the assigned physician. 

    2. If the physician allows the resident to self-administer medications, “self-medication procedure” instructions shall be provided and must be followed.

  1. Controlled Dangerous Substances

    1. The Controlled Substances Act of 1970 replaces existing laws regarding labeling, handling, and accountability of narcotics, sedatives, stimulants, and other drugs with abuse potential.

    2. Controlled Dangerous Substance is abbreviated as CDS.

    3. The familiar classifications of narcotics, sedatives, etc., have been replaced by the following five “Schedules” indicating the potential for abuse:

      1. Schedule I – The substance: (1) has a high potential for abuse; and (2) has no accepted medical use in treatment in the Unites States; or (3) it lacks accepted safety for use in treatment under medical supervision (e.g. Heroin, Mescaline, Marihuana, etc.). (N.J.S.A. 24:21-5)

      2. Schedule II – The substance: (1) has a high potential for abuse; and (2) has currently accepted medical use in the United States with severe restrictions. In addition, (3) abuse of a Schedule II CDS may lead to psychic or physical dependence (e.g. Dilaudid, Morphine, Demerol, OxyContin, Seconal, etc.). (N.J.S.A. 24:21-6)

      3. Schedule III – The substance: (1) has a potential for abuse less than the substances listed in Schedules I and II; (2) has currently accepted medical use in treatment in the United States; and (3) abuse of a Schedule III CDS may lead to moderate or low physical dependence or high psychological dependence (e.g. Barbiturates, Tylenol or Aspirin w. Codeine, Paregoric, etc.). (N.J.S.A. 24:21-7)

      4. Schedule IV – The substance: (1) has low potential for abuse relative to the substances listed in Schedule III; (2) has currently accepted medical use in treatment in the United States; and (3) may lead to limited physical dependence or psychological dependence relative to the substances listed in Schedule III (e.g. Chloral Hydrate, Xanax, Valium, Ativan, etc.). (N.J.S.A. 24:21-8)

      5. Schedule V – The substance: (1) has low potential for abuse relative to the substances listed in Schedule IV; (2) has currently accepted medical use in treatment in the United States; and (3) has limited physical dependence or psychological dependence liability relative to the substances listed in Schedule IV (e.g. Cough Syrups w. Codeine, Lomotil, Parepectolin, etc.). (N.J.S.A. 24-21-8.1)

    4. Drugs listed in Schedule II, III, IV, and V of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 will not be accessible to other than licensed nursing, pharmacy, and medical personnel designated by the VMH.

    5. The Director of Nursing Services is designated by the VMH to be responsible for the control of such drugs.

    6. Controlled substances (CDS) ordered by the physician will be unit-dose, if available. Parental controlled substances will be sent in unit-dose form, if available.

    7. All non-unit-dose Schedule II CDS are to be stored under double lock and key, separate from all other medications.

    8. All non-unit-dose Schedule II, IV, and V CDS are to be stored under double lock and key, separate from all other medications.

    9. Record-keeping requirements for non-unit-dose CDS: (1) Separate records will be maintained on all controlled drugs (CDS). (2) This record will be in the form of a declining inventory record. (3) Such records will be accurately maintained and will include the:

      1. name of the resident

      2. name of the prescriber

      3. prescription number

      4. drug name

      5. form of the medication (tablet, injection, etc.)

      6. strength and dose of the CDS administered

      7. date and time of administration

      8. signature of the person administering the CDS

    10. Record-keeping requirements for unit-dose CDS: (1) Upon daily delivery of the unit-dose cassettes, the medication nurse will count all unit-dose CDS received, and record the amount received on the bottom of the Medication Administration Record (MAR). (2) Any discrepancy in this count will be immediately reported to the responsible nursing supervisor who will take the steps outlined in the next section.

  1. Controlled Dangerous Substances (CDS) Accounting Procedures
    1. All non-unit-dose CDS shall be counted at least three (3) times per day by at least two (2) licensed personnel who are legally authorized to administer medications.
    1. Each licensed personnel shall sign their name in the declining inventory record at the change of shift to acknowledge that they counted the CDS and that the count was correct.
    1. Any discrepancy in the count of the CDS is to be reported immediately to the responsible nursing supervisor, and a signed entry is recorded on the page where the discrepancy is found.
    1. The supervisor will initiate an inquiry as to whether or not the missing dose was administered or refused, the reason that the licensed personnel did not chart or record the CDS, and why the record was not updated as required. The inquiry will continue until the CDS is accounted for or it is determined that the CDS dose is missing.
    1. The consultant pharmacist shall be notified immediately if any discrepancy in the count is detected for any CDS, regardless of the classification.
    1. The consultant pharmacist shall make regular checks of the handling, storage, recording, and disposal procedures for CDS in the VMH.
    1. All unit-dose CDS shall be randomly checked by the consultant pharmacist on at least a monthly basis for control and compliance. Any discrepancy will be reported to the Director of Nursing Services for further action.
    1. All missing CDS must be reported to the VMH’s CEO or ACEO, to the Medical Director, and to the Director, Division of Veterans Healthcare Services for determination of appropriate action.
    1. All declining inventory records must be maintained in the office of the Director of Nursing Services for a period of two (2) years as a “Batch Log”.
  1. Disposition or Destruction of Unused or Discontinued CDS 
    1. All unused or discontinued CDS packaged in unit-dose counter packs, bingo cards, bottles, etc., will be collected by the licensed nurse in charge of the unit or shift, and transported to the Director of Nursing Services’ (DON) office, or another centrally located and secured location, where it can be received by the DON, the Assistant DON, or the Supervisor of Nursing Services (SONS).
    1. The declining inventory record for that specific CDS must be affixed to the package either with staples or a rubber-band.
    1. This process shall be completed for all nursing units throughout the VMH on an as-needed as well as a regularly scheduled basis.
    1. A count will be made by the nurse in charge and the DON/ADON or the SONS under the direct observation of the consultant pharmacist, to verify that the amount administered from the unit-dose counter pack, bingo card, or bottle corresponds to the amount recorded on the declining inventory record. Both nurses shall co-sign to verify accountability.
    1. Any discrepancy will be handled in the manner previously described.
    1. A Hazardous Waste Container or Sharps Container (hereafter called the Container) will be obtained.
    1. All CDS must be removed from the unit-dose packaging in the presence of the licensed nurse, the DON/ ADON or SONS, and the consultant pharmacist.
    1. All CDS pills will be crushed, and all CDS liquids will be removed from their containers, and all the crushed CDS pills and liquid CDS will be emptied into the Container.
    1. A small amount of water and some noxious substance such as old coffee grounds or cat litter will be added to the Container, and the Container will be shaken until the CDS and the water/cat litter forms a gelatinous, semi-solid mass. The Container shall then be sealed.
    1. Each declining inventory record must be signed by both nurses under the direct observation of the consultant pharmacist as the CDS are put into the Container for disposal, indicating the quantity destroyed and the date and time this was accomplished. Please see 29-02-004B.
    1. All empty packaging may be disposed of in the garbage. All empty syringes must be disposed of in a Sharps container, as per VMH policy.
    1. The Container will then be placed under double lock and key in a secured location in the VMH until the Medical Waste Company representative arrives for removal.
    1. The Medical Waste Company representative shall provide a duplicate of the receipt, and this duplicate receipt shall be sent to the Director of Nursing Services’ office for attachment to the Batch Logs that are maintained for each batch of CDS waste.

 

 

Revised:  July 2007
Revised:   March 2010
Revised:   January 2012