CHAPTER 15
F425 - PHARMACY SERVICES
THE MEDICATION AUDIT TRAIL
(ORDERING, RECEIVING AND DISPOSITION OF MEDICATION)
NURSING HOME
THE PRESCRIPTION AUDIT TRAIL
I. Regulatory Overview
STATE
59A-4.112 Florida Nursing Home Regulations involving Pharmacy Services
1)The facility shall adopt procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals, to meet the needs of each resident.
2)The consultant pharmacist shall establish a system to accurately record the receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation.
3)The pharmacist shall determine that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled.
4)All controlled substances shall be disposed of in accordance with State and federal laws. All non-controlled substances may be destroyed in accordance with the facility’s policies and procedures. Records of the disposition of all substances shall be maintained in sufficient detail to enable an accurate reconciliation.
FEDERAL
F425 (Rev. 9/20/2006)
§483.60 Pharmacy Services (Complete regulation available in Section II of this manual)
The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in §483.75(h) of this part. permits, but only under the general supervision of a licensed nurse.
(a) Procedures. A facility must provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident.
(b) Service Consultation. The facility must employ or obtain the services of a licensed pharmacist who--
(1) Provides consultation on all aspects of the provision of pharmacy services in
the facility;
(2) Establishes a system of records of receipt and disposition of all controlled
drugs in sufficient detail to enable an accurate reconciliation; and
(3) Determines that drug records are in order and that an account of all
controlled drugs is maintained and periodically reconciled.
NURSING HOME
II. THE AUDIT TRAIL CONSISTS OF:
1) Records that show when medications were ordered.
a. Telephone Orders
b. Physician Orders (ex RX from outside prescriber)
c. Refill order sheets
d. copies of faxes at the Pharmacy
2) Delivery of Medication
a. documentation should show which nurse received the medication
b. copies of delivery documents (i.e. delivery logs or delivery manifests) should be
retained by the facility and the vendor Pharmacy
3) Administration of Medication
Doses administered are recorded on the facility’s medical records forms including:
a. the MAR (Medication Administration Record)
b. the PRN Sheet
c. the Treatment Sheet
4) Disposition of Medication
a. Documentation showing drug was destroyed in the facility (non-controls can be
destroyed on the nursing unit)
b. Documentation of controlled substances destruction showing disposition by the
Consultant Pharmacist, the D.O.N. and the Administrator or their designee
c. Documentation of medications released with a patient when they are discharged
d. Documentation of medications returned to the Pharmacy for credit.
III. THE GOAL OF THE AUDIT TRAIL
The audit trail should allow the Consultant Pharmacist to track a medication throughout the
Facility.
EX. 30 doses of Percocet ordered and delivered on 4/1/2007 by vendor pharmacy
Received by Nurse L. Smith LPN on 4/1/20073pm
MAR indicates 15 doses were administered between 4/1/2007 and 4/20/2007 (per MAR)
15 doses sent to the DON for destruction on 4/20/2007
15 doses actually destroyed by the Consultant Pharmacist on 5/30/2007
audit shows all doses are accounted for
NURSING HOME
Medication Orders in the Nursing Home
- Who can prescribe in the nursing home?
Anyone who can prescribe in Florida can also prescribe in the nursing home
- Identify prescribers who are problematic in the nursing home?
(1) Physician Assistants – Consultant must look at how P.A. orders are approved by
their Physician
(2) ARNP’s – prescribing or altering doses of controlled substance
NURSING HOME
- What is the process for ordering medications for a new admission?
- Hospital transfer
- Transfer from another facility
- Transfer from resident’s home
- The use of Telephone Orders vs In-house Orders
- What is the process for transferring orders from Nursing to Pharmacy personnel?
a. via phone
b. via fax
- Compare the new order process in the Nursing Home vs an ALF
- What makes an order “legal” in the nursing home?
- Specific Frequency (1 tab q4h)
- Route of administration
- Duration of therapy
- PRN orders must have reason for use
- The standard of practice requires the primary physician for each resident to renew orders every 30 days.
- Physician Order Sheet – signed and dated every 30 days.
Federal Indicators and state regulations do not require this process.
9. No medications can be administered without an order
NURSING HOME
FEDERAL PHYSICIAN REQUIREMENTS
F333 – Prescriber’s Orders –
The latest recapitulation of drug orders is sufficient for determining whether a valid
order exists provided the prescriber has signed the “recap” The signed “recap”, if the facility uses the “recap” system, and subsequent orders constitute a legal authorization to administer the drug.
F386 – Physician’s visits – The Physician must:
1) review the resident’s total program of care, including medications and treatments,
at each visit required by paragraph © of this section;
2) write, sign and date progress notes at each visit and
3) sign and date all orders
Under Guidance to surveyor: “There is no requirement for physician renewal of
orders”
F387 - Frequency of Physician visits
1) The resident must be seen by a physician at least once every 30 days for the first 90 days after admission, and at least once every 60 days thereafter
2) A physician visit is considered timely if it occurs not later than 10 days after the date the visit was required
F388 – At the option of the physician, required visits in SNF’s, after the initial visit, may alternate between personal visits by the physician and visits by a physician assistant, nurse practitioner or clinical nurse specialist in accordance with paragraph (e) of this section
REVISED FLORIDA PHARMACY REGULATIONS
64B16-27.1003 Transmission of Prescription Orders. Prescriptions may be transmitted from prescriber to dispenser in written form or by any means of communication. Prescriptions may be transmitted by facsimile systems as provided in Section 465.035, F.S., and federal law. Any direct transmission of prescriptions, including verbal, facsimile, telephonic or electronic data transmission, shall only be with the approval of the patient or patient’s agent. The pharmacist receiving any such transmitted prescription shall not participate in any system that the pharmacist knows or should have reason to know restricts the patient’s choice of pharmacy. The pharmacist shall take such measures necessary to ensure the validity of all prescriptions received. Specific Authority 465.005, 465.0155, 465.022 FS. Law Implemented 465.022, 465.026, 893.07 FS. History–New 11-18-07.
64B16-27.103 Oral Prescriptions and Copies.
(1) Only a pharmacist or registered pharmacy intern acting under the supervision of a pharmacist may, in the State of Florida, accept an oral prescription of any nature.
(2) Only a pharmacist or registered pharmacy intern acting under the supervision of a pharmacist may, in the State of Florida, prepare a copy of a prescription or read a prescription to any person for purposes of providing reference concerning treatment of the person or animal for whom the prescription was written, and when said copy is given a notation shall be made upon the prescription that a copy has been given, the date given, and to whom given.
Specific Authority 465.005, 465.0155, 465.014, 465.022 FS. Law Implemented 465.003(13), 465.014, 465.022, 893.07(1)(b) FS. History–Amended 5-19-72, Repromulgated 12-18-74, Formerly 21S-1.18, 21S-1.018, 21S-27.103, 61F10-27.103, Amended 9-19-94, Formerly 59X-27.103, Amended 10-15-01, 11-18-07.
Podiatric Residents
461.014(1)(f), Florida Statutes - Residency
(f) A person registered as a resident podiatric physician under this section may, in the normal course of his or her employment, prescribe medicinal drugs described in schedules set forth in chapter 893 and pursuant to s. 461.003(5) if:
The person prescribes such medicinal drugs through use of a Drug Enforcement Administration number issued to the hospital or teaching hospital by which the person is employed or at which the person's services are used;
1. The person is identified by a discrete suffix to the identification number issued to such hospital;
and
2. The use of the institutional identification number and individual suffixes conforms to the
requirements of the federal Drug Enforcement Administration.
NURSING HOME
Receiving Medications in the Nursing Home
1.Records of receiving a medication:
a.Who and when ordered?
b.Who and when received?
2.Record of source:
a.From the pharmacy?
b.From home?
c.Other?
3. Records of medication delivery (delivery log or delivery manifest) should be maintained
by the facility and vendor Pharmacy for at least 2 years.
These may be used during an AHCA investigation, a DEA investigation or a Medicaid
Audit
NURSING HOME
The Disposition of Medication in the Nursing Home
1. Methods of disposition
a.Proof of use (administered to resident as documented on the MAR)
b.Transfer of control drugs to the D.O.N. for Destruction
c.Waste (dropped doses or refused doses)
d.Returned to family or resident
e.Returned to the pharmacy for credit
f. Pilferage (will your audit trail catch missing meds??)
2. Discontinued Medications
a. When a drug order is discontinued the drug must be removed from the normal drug
storage area (i.e. drug cart) and placed in an area clearly marked for discontinued
medications
b. The facility policy will indicate whether the medication can be returned to pharmacy
for credit, destroyed in-house by nursing or if a controlled substance transferred to
the D.O.N. for destruction
c. The facility should have a standard format for logging in these discontinued
medications and identifying what happened to the remaining doses. (see sample
form)
d. The disposition records becomes part of the patient’s permanent chart
3. Discharge Medications in the Nursing Home
a. All medications of discharged residents must be removed from the nursing
drug cart in a “timely manner”.
b. Upon discharge, all medications may be sent home with the resident if so
ordered by the physician.
c. Under certain per diem contracts the meds may need to be returned to
Pharmacy unless the family or facility wishes to pay for the remaining
doses.
d. The disposition records becomes part of the patient’s permanent chart
NURSING HOMES
4. Compliance issues to be reviewed by the Consultant Pharmacist Monthly
a.Verbal orders not written in the chart
b. New orders were never sent to Pharmacy for processing
c. Discontinued orders still in use
d. Discontinued medications stored with active medications
e.Doctors signatures in place renewing orders in a timely manner (every 30 days)
f.Evidence of primary doctor involved in P.A. prescriptions and controlled
substances orders written by an ARNP
g. All orders have complete directions as described above
h. The audit trail from order (or reorder) to destruction is intact
NURSING HOME
THE RETURN OF UNIT DOSE MEDICATION TO THE PHARMACY
Note: This regulation does not address the type of facility that can return medications. The board has taken the position that only facilities with a Pharmacy license and a Consultant Pharmacist are allowed to return medications for credit.
This would prohibit ALF’s (without a Special ALF license), Group homes, ADT’s, FACT programs, Juvenile Detention Centers and Correctional facilities without an Institutional Modified license from returning medication even if they are in unit dosed packaging and stored centrally.
NURSING HOME
SAMPLE FORM
Discharge Drug List Form
Patient Name ______Room # ______
Physician ______
I certify that the following drugs have been delivered to and received by:
1.______
Signature of Charge NurseDate
I acknowledge that these medications are not currently packed in child resistant packaging and that I waive this special packaging requirement Yes ( ) No ( )
I request that these medications be repackaged by the Pharmacy in child resistant packaging prior to my receipt of this medication. Yes ( ) No ( )
2.______
Signature of Patient or Responsible PartyDate
PrescriptionNameQuantity
______
______
______
Drugs reviewed and evaluated by pharmacist:
3.______
Signature of PharmacistDate
4.Disposition of Drugs:
______
WMC-308
NURSING HOME
SAMPLE POLICY & METHODS
Medications to Resident on Discharge
POLICY:
It is the policy of this facility to send home the resident’s medications upon discharge if the physician orders it.
METHODS:
1.The physician must authorize the release of the medication and the nurse must document his request on the chart.
2.The nurse will complete and sign the disposition of medication form including the quantity sent with the patient and have the patient or another responsible person sign as receiving the medications. A copy of this form will be made a part of the patient’s chart.
3.Control drugs will also be included on the disposition form. Also the proof of use form for the control drug shall have a notation written on it by the nurse stating that these drugs have been returned to the patient and this form will also be signed by the person receiving the control drugs.
4.If the medication being sent with the patient does not have a safety closure package (i.e., unit dose packaging) the patient must state in writing that they request a non-complying package.
NURSING HOME
SAMPLE POLICY & METHODS
Ordering Drugs
POLICY:
Drugs are to be administered only upon the order of a person lawfully authorized to prescribe. All such orders are to be in writing and signed by the person giving the order. Each order is to specify the name and strength of the medication, the amount or duration of therapy, the dosage, the time or frequency of administration, the route if other than oral, and the site of the injection if so ordered.
There are to be no standing orders for medications or treatments. Telephone orders may only be given to a pharmacist or licensed nurse and are to be recorded immediately in the patient’s medical record and signed by the prescriber in a timely manner.
Unless otherwise specified by the prescriber or limited by automatic stop orders, drugs are to be prescribed for thirty (30) days, dispensed in thirty (30) day quantities. Daily drug order and receipt records are to be maintained on file in the facility for one (1) year.
METHODS:
1.9:00 AM medication nurse will be responsible for re-ordering all refill prescription except HS medications, and all new orders received during her shift (7-3).
2.The responsible charge nurse on each wing after 3:00 PM will order medications for new admissions, STAT orders, new orders received during that shift, and HS renewal orders.
3.When to order:
Prescriptions should be re-ordered when at least four (4) days medication supply remains. When making a pass only a four day supply of medication remains, place container on the side shelf for re-ordering when pass is completed. When a medication has been re-ordered it should be indicated on the Unit-Dose card in the space indicated. Always check storage bin before re-ordering. Medication dispensed in containers other than unit-dose cards, shall have a notation placed on the container that the medication has been re-ordered, the date, and the initials or name of the person re-ordering. Tape may be used to accomplish this.
4.A record of medications order transmitted to pharmacy will be kept on each wing. All new orders will be written on ASCO reorder form #M-1080 and a Xerox copy will be maintained in the medication room. All new or renewal order transmittals should be reordered on this form regardless of the pharmacy supplying the medication. For new prescriptions, the charge nurse at each station writes in the specifics of the prescription as per the information requested on the ASCO order form with the notable exception of the prescription number. For refill prescriptions of any kind, she merely peels off the re-order portion of the label on the Unit-Dose card and attaches it to the order being sure to specify whether it is:
a.Notification that is an order previously phoned in:
b.A request for a label change only.
When a peel off label is not affixed to a medication, the nurse will write all appropriate reorder information directly on the ASCO reorder form.
5.Upon receipt of prepared prescription from a pharmacy, the nurse receiving the medication will initial, date, and mark the order received on the previously completed ASCO order form where the original order to the pharmacy was written. These records shall be retained in an orderly and retrievable manner in each medication room. The 7-3 medication nurse shall check whether the previous day reorders have been delivered. The pharmacy should be notified on that shift if orders have not been received from the previous days orders and an incident report shall be fined with the director of nursing. The director of nursing shall report these incidents to the pharmacy consultant and the Pharmaceutical Services Committee.
6.ONLY a physician, a dentist, a podiatrist, an optometrist or an ARNP may prescribe drugs. All such orders are to be in writing and signed in writing by the person giving the order. For the purposes of these procedures, all prescription and non-prescription medications, vitamin and mineral supplements, intravenous and irrigating solutions, biologicals and vaccines, and alcohol-containing beverages are considered to be drugs.
7.EVERY drug order MUST specify all of the following:
a.The name of the medication
b.The strength of the medication, if any.
c.The dosage.
d.The time or frequency of administration.
e.The route of administration, if other than oral
f.The quantity or duration of therapy. (If not specified by the prescriber or limited by automatic stop orders, drugs are to be prescribed for thirty (30) days, dispensed in thirty (30) day quantities.
g.PRNs should specify the condition for which they are to be administered. For example, s needed for painor as needed for sleep.
8.Each new drug order is to be acknowledged by the charge nurse on duty at the time the order is received, or by the licensed nurse receiving the order, by entering the word noted, the nurse’s signature, and the time and date immediately below the order.
9.There are to be no standing orders for medications or treatments. Nurses may NOT accept standing orders from any physician for his/her patients in this facility.
10.The charge nurse on duty at the time the order is received, or the licensed nurse receiving the order is responsible for ALL the following: