Pee Dee Mental Health Center
Serving: Florence, Darlington, and Marion Counties

PEE DEE MENTAL HEALTH CENTER

Medical Directive
5-11-01

AREA:  Medical
SUBJECT:    Medication Control and Distribution
ORIGINAL ISSUE DATE:  01-08-01, Replaces Directive 96-32, 05-06-02
REVISION DATE:   01-09-06, 02-04-08, 09-25-08, 03-10-10

PURPOSE: 
To establish procedures for the storage, handling, and administration of medication at Pee Dee Mental Health Center in compliance with State and Federal regulations, and in consultation with a registered pharmacist.

RESPONSIBLE PERSONS:
Mental Health Center Executive Director/Medical Director, Assistant Medical Director, Medical Staff, and Nurses

PROCEDURES:
I.  Responsibilities
A.  Center Responsibilities:

  1. The Center will maintain a current South Carolina Board of Pharmacy Non-Dispensing Drug Outlet Permit at all locations where medications are stored and/or administered.
  2. Such Permits will be displayed in a conspicuous place in the permitted facility to allow for its examination by any interested party. The Center will promptly notify the Board of Pharmacy upon any change of the permit holder or the location of the permitted site or change in consultant RPh.
  3. In consultation with the Department of Mental Health, a S.C. licensed pharmacist will be designated and assigned the following responsibilities:

    1. Sign any new or renewal application for a non-dispensing drug outlet permit.
    2. Supervise all employees of the permit holder in so far as their duties relate to the procurement, storage, and distribution, administration, and disposal of medication.
    3. Facilitate drug recalls and the removal of outdated and adulterated drugs.
    4. Act as a drug information resource.
    5. Conduct monthly inspections of the drug storage room and document inspections on the medication storage area audit form.

B.  Medical Staff (M.D.s, Advanced Practice Nurses, etc.) responsibilities:

  1. Administration of psychoactive medication will occur only by prescription of a licensed D.O. or M.D., Clinical Nurse Specialist, Nurse Practitioner, or other medical staff with prescriptive authority.
  2. Medical staff may give verbal orders to registered nurses to telephone in prescriptions to pharmacy.  The medical staff’s verbal order will be recorded at time of receipt in the client’s medical record, signed and dated by the registered nurse receiving the order.  The medical staff member will sign the order as soon as possible, but no later than five (5) working days from the date of the order.
  3. Medical staff must assume responsibility for the storage, labeling, dispensing, distribution, and accountability of sample medications and medications provided by pharmaceutical manufacturers under their patient assistance (PA) programs.  After such medication has been appropriately labeled and corresponding log sheet entries made by the medical staff member, it may be held in a secure location in the secretarial area or medical staff/nurse’s office.  From there it can be handed to the client by any DMH clerical or clinical staff member.  The staff member will ensure that the log sheet is completed upon client pick-up, specifying dates of pick-up, client, and staff signatures.  Medical staff initiating the log will have already recorded the date prepared and the client name.  All medication not picked up within one week of release by the physician/medical staff member shall be returned to the physician/medical staff member.  See I.B.4. for labeling requirements.
  4. Medication given from stock bottles or otherwise removed from their original, sealed containers (as packaged by the original manufacturer or dispensed by a registered pharmacist) must be properly labeled by the physician to include:  the physician’s name, the date, the patient’s name, the drug’s name and strength and quantity (pills, capsules, milliliters, etc.), and directions for use, as well as the clinic’s name, address and phone number.
  5. All medications given to patients under PA programs must be logged in and out on a form or in a log book approved by the Medical Director.

C.        The provision of samples by Registered Nurses at Pee Dee Mental Health Center is possible if procedures are followed as listed in Appendix A.

II.  Storage of Medications:

  1. Medication held on premises shall be stored under proper conditions of sanitation, temperature, moisture, ventilation, sterilization and security, and will be maintained under lock and key at all times.
  2. Expiration dates of all sample and PA medications will be inspected periodically by the medical staff to ensure supplies have not exceeded their shelf-life.  Medications beyond their expiration date(s) may be destroyed by the medical staff.  Proper method of disposal is by environmentally approved incineration.  In the absence of an expiration date on the package, no medication will be kept longer than 90 days.  Expired medication must also be stored and separated from current medication, and delivered to the consulting pharmacist for disposal.
  3. Keys and entry into the drug storage area will be available only to nursing and medical staff, and consultant pharmacist.
  4. Keys to the area where sample and PA medications are kept will be maintained only by the medical staff.
  5. Sample and PA medications shall not be stored in the medication storage area, but shall be stored by the medical staff adhering to all legal requirements.  Medical staff may prescribe but will not accept, store, or dispense to patients any samples of controlled substances (e.g., benzodiazepines, opioids, amphetamines).  Samples by physicians are exempt from labeling requirements (see I.B.4., above), when they are left in the manufacturer’s original package, and when the medical staff member has given adequate verbal or written instructions for their use to the patient.  No records regarding the receipt of distribution of non-controlled sample medications are required, except in the individual client’s record when they are dispensed.  PA medications for individual patients must be logged in and out on a form or in a log approved by the Medical Director.
  6. Stock medication orders will be initiated by the designated licensed nurse in the Florence Office.  That Nurse will notify the Procurement Officer of the type and quantity needed.  The Procurement Officer will process the order through the SCDMH authorized distributor.  The stock shall be received, documentation completed, and stored in the Florence Office which may then be transported by the PDMHC courier in a secured container to satellite offices.
  7. Injectable medications will be received by the nurse, logged in on an inventory sheet and kept in medication storage area.  When used, it will be logged out.  Stock medication will be audited once a month and recorded on the inventory sheet.  Once signed out to a specific nurse, that nurse will keep a running log of each individual dose administered.  (See Attachment)  Once a multi-dose vial is opened, it should be initialed and properly dated by the nurse.  This vial expires 28 days from this date or as recommended by the manufacturer.
  8. Non-controlled injectable medications requiring refrigeration shall be stored in a refrigerator and maintained at the temperature between 36 to 46 degrees Fahrenheit.  This temperature shall be monitored and recorded weekly.  If stored in a multipurpose refrigerator, the medication must be kept separate by placing it inside a plastic covered storage container.  Controlled injectable medication (e.g., Ativan Inj.) must be stored under double locks:  either in a locked refrigerator dedicated to medications inside a locked room or inside a lockable box inside a locked refrigerator or locked room.
  9. Medications labeled “External Use Only” must be stored separately from internal and injectable medications.
  10. Doors to all medical cabinets and storage areas must be kept locked when not in use.
  11. When requested by the client, day treatment (e.g., PSR program) staff may secure the client’s prescribed medications for later use during the program’s hours of operation.  These medications must be under lock and key when not actually being distributed to the client.  Controlled substances must be under double lock and key

III.  Procedure for Non-Medical Staff to Assist Clients with Pill Minders:
In order to help ensure compliance and proper medical treatment, Pee Dee Mental Health Center will allow non-medical staff to aid those patients who might otherwise not take their medications as prescribed by helping them fill their weekly pill minders.  Elements of this service should include the following:

    1. Ensure the patient keeps medications in a secure place (e.g., not within the reach of children).
    2. Encourage the patient to keep all prescribed meds in their original containers (e.g., do not “refill” old script bottles with newly acquired medication).
    3. Count or estimate the remaining amount of each medication and check against the dispensing date.  Use this information to determine if the patient is taking the medication as directed, and if there is sufficient medication to last until the next refill or PMA.  Any significant discrepancies should be reported to the attending physician.
    4. Check all medications to be placed in pill minders against the current medication list in the patient’s chart.  If there is any discrepancy, even with regard to over-the-counter medication, the entire list must be reviewed in person or by telephone with the patient’s Center physician, or another Center physician, before any of the medication is placed in the patient’s pill minder.  Alternatively, this consultation may be done with a pharmacist who knows the patient’s current medication regimen.  Update the medication list in the chart based on this review.
    5. Do not physically place the medication in the pill minder.  Verbally direct the patient to do this, providing coaching and correction as needed.
    6. Assess the patient’s ability to perform this function alone.  Quiz, review, encourage, etc.  Unless the patient is severely compromised, or there are numerous incidents of deliberate noncompliance, there should come a point when he or she is no longer in need of this service.  It is recommended that independent use of the pill minder be stated as a goal in the patient’s ITP.

IV. Transportation of Medication:

Routine: Physicians and or Nurse Practitioners may transport medications, either PAP or sample medications, to and from various locations within Pee Dee Mental Health Center. This is a necessary practice that helps supply satellite locations with samples.

As needed: Case Managers and other staff may transport medications from one clinic or program to another such location or the client's residence or other natural environment for medication administration.

Method of Transportation: Medication shall remain in the same containers they originally came in unless a medical staff member puts aside a specified number (#) of pills or capsules in a properly labeled container. Medications should be labeled with client's name and date if they are intended for a specific client.

V.     Miscellaneous:

  1. Physician’s Desk Reference or other authoritative resource (either electronic or text) will be available to all clinicians during clinic hours.
  2. An antidote chart, conversion chart, and substitute chart will be kept in the medication storage area.
  3. Clients will be asked to sign a consent form for neuroleptic medication before a physician initially prescribes such medication.  This form will be renewed every two years and will be documented in the chart.  It will be the responsibility of the prescribing medical staff member to obtain this signed consent form whenever possible.
  4. Prescription pads will be kept under lock when not in use by the physician.
  5. Poison Control phone number(s) will be posted by each clinic telephone and on at least one bulletin board in each clinic.
  6. All required records will be kept readily retrievable for a period of two years.

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APPENDIX A

TITLE:           POLICY FOR PROVISION OF SAMPLES BY THE REGISTERED NURSE

PURPOSE:   To provide continuity of care to Center consumers who are unable to financially afford medications needed to effectively manage symptoms of mental illness and promote community tenure.

POLICY:        It is the policy of Pee Dee Mental Health Center to provide for our consumer complete clinical services, including medication services, within the scope of our function.

PROCEDURE:

  1. The physician must evaluate the appropriateness of medication monitoring.  The physician authorizes medication monitoring on the Individual Treatment Plan for the consumer.  Verbal or telephone orders for medication monitoring can be accepted by the registered nurse.  The registered nurse completes the medication monitoring sheet.
  2. Medication monitoring services are used for the purpose of fully assessing the consumer.  Medication monitoring will be performed by the registered nurse to determine 1) absence of side effects of the medication the consumer is presently being prescribed by the physician; 2) consumer understanding of the dosage, route, frequency and side effects of the medication presently prescribed; 3) education needed regarding the present medication the consumer is prescribed and 4) effectiveness of the medication prescribed.
  3. A standing order must be written by the physician in the medical record of the consumer on the PMO sheet, form C168B, allowing the registered nurse to provide sample medication to the consumer.  The registered nurse will not label any of the drug samples.  The consumer must have been evaluated previously by the physician and placed on sample medication at the previous psychiatric medical assessment (PMA) and this needs to be documented in a note on the PMO sheet, form C168B. 
  4. Registered nurses must have a verbal or written order by the physician to provide samples to the consumer.  In the absence of a physician, the registered nurse will have a standing order from the physician documented in the consumer’s medical chart that will allow the registered nurse to provide the sample medication.  The standing order must be renewed every six months.
  5. A copy of a preprinted direction sheet signed by the physician regarding the medication as to dosage, route, frequency, and side effects will be given by the registered nurse to the consumer when the sample medication is provided.  A copy of the direction sheet will also remain in the chart.  The registered nurse will document on a PMO sheet, form C168B, the name of the medication, dosage, route, frequency and number of samples provided to the consumer.  The physician must cosign the note within 24 hours.