15.1

CHAPTER 15

F425 - PHARMACY SERVICES THE MEDICATION AUDIT TRAIL

(ORDERING, RECEIVING AND DISPOSITION OF MEDICATION)

15.2

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.

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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 e. Record Retention Requirements (BOP 64B16.28.140) has recently changed from

2 years to 4 years (see page 15.11)

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 4/1/2012 by vendor pharmacy Received by Nurse L. Smith LPN on 4/1/2012 3pm MAR indicates 15 doses were administered between 4/1/2012 and 4/20/2012 (per MAR) 15 doses sent to the DON for destruction on 4/20/2012 15 doses actually destroyed by the Consultant Pharmacist on 5/30/2012 audit shows all doses are accounted for

15.4

NURSING HOME Medication Orders in the Nursing Home

1. Who can prescribe in the nursing home? Anyone who can prescribe in Florida can also prescribe in the nursing home

2. 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

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NURSING HOME

3. What is the process for ordering medications for a new admission?

a. Hospital transfer b. Transfer from another facility c. Transfer from resident’s home

4. The use of Telephone Orders vs In-house Orders

5. What is the process for transferring orders from Nursing to Pharmacy personnel? a. via phone b. via fax

6. Compare the new order process in the Nursing Home vs an ALF

7. What makes an order “legal” in the nursing home? a. Specific Frequency (1 tab q4h) b. Route of administration c. Duration of therapy d. PRN orders must have reason for use

8. The standard of practice requires the primary physician for each resident to renew orders

every 30 days. a. 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

15.6

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

15.7

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.

15.8

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

SAMPLE OF A DELIVERY LOG

Quality Care Pharmacy 6499 38th Ave N

St.Petersburg Fl 33710

Shady Rest Nursing Home 8/1/2012 11440 49th Street N Clearwater Florida 8/1/2012 Rx 711000 Mary Smith Furosemide 40mg #30 8/1/2012 Rx 711001 Mary Smith Ibuprofen 400mg #30 8/1/2012 Rx 711002 Mary Smith Slow K 8meq #30 8/1/2012 Rx 683722 Tom Jensen Isosorbide Mononitrate ER 60mg #30 8/1/2012 Rx 711009 Gus Adams Phenytoin ER 100mg #30 __________________________________ ______________________ Nurse Signature Date

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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

15.10

Federal Register/Vol. 75, No. 173/Wednesday, September 8, 2010/Notices54627

ENVIRONMENTAL PROTECTION AGENCY

[Frl-9197-7]

Best management practices for unused pharmaceuticals at health care facilities

AGENCY: ENVIRONMENTAL PROTECTION AGENCY (EPA). Action: notice.

Summary: EPA is requesting public comments on a draft guidance document entitled, best management practices for unused pharmaceuticals at health care facilities. The guidance is targeted at hospitals, medical clinics, doctors’ offices, long-term care facilities and veterinary facilities. EPA expects that this document will help reduce the amount of pharmaceuticals that are discharged to water bodies.

Dates: EPA requests comments on or before November 8, 2010. Comments received after this date may not be Incorporated into the final guidance document.

Addresses: EPA prefers receiving comments by e-mail. Please send e-mail comments to unusedpharms@epa.gov and include your name and Organizational affiliation, if any. You may also send comments by postal mail to Meghan Hessenauer, engineering and analysis division (4303t), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, dc 20460.

For further information contact: Meghan Hessenauer, engineering and analysis division, telephone: 202-566-1040; e-mail: Hessenauer.meghan@epa.gov.

Supplementary information: Pharmaceuticals are being discovered in our nation’s waters at very low concentrations. EPA has been studying unused pharmaceutical disposal practices at health care facilities, prompted by the concern that large amounts of pharmaceuticals are being flushed or disposed of down the drain, ultimately ending up in rivers, streams and coastal waters.

The agency has drafted a guidance document for health care facilities, which describes:

1. Techniques for reducing or Avoiding pharmaceutical waste; 2. Practices for identifying and managing types of unused pharmaceuticals; and applicable disposal regulations. The guidance is targeted at hospitals, medical clinics, doctors’ offices, long-term care facilities and veterinary facilities. 3. EPA expects that this document will help reduce the amount of pharmaceuticals that are discharged to water bodies. The document is available on EPA’s Web site

http://water.epa.gov/scitech/wastetech/guide/unusedpharms_index.cfm. EPA has visited many facilities and consulted with organizations in the health care industry, as

well as federal, state and local government agencies. EPA continues to solicit recommendations from a wide range of stakeholders and welcomes comments on the draft document. We plan to publish a final version of the document in late 2010.

Dated: September 1, 2010.Ephraim S. King, Director, Office of Science and Technology. [FR Doc. 2010-22325 Filed 9-7-10; 8:45 am]

15.11

64B16-28.140 Record Maintenance Systems for All Pharmacy Permits. (1) Requirements for records maintained in a data processing system. (a) The pharmacy must comply with the provisions of 21 C.F.R. Section 1304.04 (a regulation of the Federal Drug

Enforcement Administration), which is hereby incorporated by reference as of March 1, 1998, when such is applicable to operate such a data processing system if any controlled substances (as that term is used in Ch. 893, F.S.) are dispensed from the pharmacy.

(b) Any pharmacy using a data processing system must meet the requirements of 21 C.F.R. Section 1306.22, which is hereby incorporated by reference as of March 1, 1998.

(c) If a pharmacy’s data processing system is not in compliance with this subsection, the pharmacy must maintain a manual recordkeeping system as specified in Rule 64B16-27.800, F.A.C., and Section 893.07, F.S.

(d) Original prescriptions, including prescriptions received as provided for in Rule 64B16-28.1003, F.A.C., Transmission of Prescription Orders, shall be reduced to a hard copy if not received in written form. All original prescriptions shall be retained for a period of not less than four (4) years from date of last filling. To the extent authorized by 21 C.F.R. Section 1304.04, a pharmacy may, in lieu of retaining the actual original prescriptions, use an electronic imaging recordkeeping system, provided such system is capable of capturing, storing, and reproducing the exact image of the prescription, including the reverse side of the prescription if necessary, and that such image be retained for a period of no less than four (4) years from the date of last filling.

(e) Original prescriptions shall be maintained in a two or three file system as specified in 21 C.F.R. 1304.04(h). (f) Requirements for back-up systems. 1. The pharmacy shall maintain a back-up copy of information stored in the data processing system using disk, tape

or other electronic back-up system and update this back-up copy on a regular basis, at least weekly, to assure that data is not lost due to system failure.

2. Data processing systems shall have a workable (electronic) data retention system which can produce an audit trail of drug usage for the preceding four (4) years as specified in Rule 64B16-27.800, F.A.C.

(g) Change or discontinuance of a data processing system. 1. Records of dispensing. A pharmacy that changes or discontinues use of a data processing system must: a. Transfer the records of dispensing to the new data processing system; or b. Purge the records of dispensing to a printout which contains the same information required on the daily printout

as specified in paragraph (3)(b) of this section. The information on this hard-copy printout shall be sorted and printed by prescription number and list each dispensing for this prescription chronologically.

2. Other records. A pharmacy that changes or discontinues use of a data processing system must: a. Transfer the records to the new data processing system; or b. Purge the records to a printout which contains all of the information required on the original document. 3. Maintenance of purged records. Information purged from a data processing system must be maintained by the

pharmacy for four (4) years from the date of initial entry into the data processing system. (h) Loss of Data. The prescription department manager shall report to the Board in writing any significant loss of

information from the data processing system within 10 days of discovery of the loss. (2) All transfers of prescriptions must be strictly in accordance with the provisions of Section 465.026, F.S., and

Rule 64B16-27.105, F.A.C. (3) Records of dispensing. (a) Each time a prescription drug order is filled or refilled, a record of such dispensing shall be entered into the data

processing system.

15.12

(b) The data processing system shall have the capacity to produce a daily hard-copy printout of all original prescriptions dispensed and refilled. This hard copy printout shall contain the following information:

1. Unique identification number of the prescription; 2. Date of dispensing; 3. Patient name; 4. Prescribing practitioner’s name; 5. Name and strength of the drug product actually dispensed, if generic name, the brand name or manufacturer of

drug dispensed; 6. Quantity dispensed; 7. Initials or an identification code of the dispensing pharmacist; and 8. If not immediately retrievable via CRT display, the following shall also be included on the hard-copy printout: a. Patient’s address; b. Prescribing practitioner’s address; c. Practitioner’s DEA registration number, if the prescription drug order is for a controlled substance. d. Quantity prescribed, if different from the quantity dispensed; e. Date of issuance of the prescription drug order, if different from the date of dispensing; and f. Total number of refills dispensed to date for that prescription drug order. (c) The daily hard-copy printout shall be produced within 72 hours of the date on which the prescription drug

orders were dispensed and shall be maintained in a separate file at the pharmacy. Records of controlled substances shall be readily retrievable from records of non-controlled substances.

(d) Each individual pharmacist who dispenses or refills a prescription drug order shall verify that the data indicated on the daily hard-copy printout is correct, by dating and signing such document in the same manner as signing a check or legal document (e.g., J.H. Smith, or John H. Smith) within seven days from the date of dispensing.

(e) In lieu of producing the printout described in paragraphs (b) and (c) of this section, the pharmacy shall maintain a log book in which each individual pharmacist using the data processing system shall sign a statement each day, attesting to the fact that the information entered into the data processing system that day has been reviewed by him or her and is correct as entered. Such log book shall be maintained at the pharmacy employing such a system for a period of four (4) years after the date of dispensing provided, however, that the data processing system can produce the hard-copy printout on demand by an authorized agent of the Department of Health. If no printer is available on site, the hard-copy printout shall be available within 48 hours with a certification by the individual providing the printout, which states that the printout is true and correct as of the date of entry and such information has not been altered, amended or modified.

(f) The prescription department manager and the permit holder are responsible for the proper maintenance of such records and responsible that such data processing system can produce the records outlined in this section and that such system is in compliance with this subsection.

(g) Failure to provide the records set out in this section, either on site or within 48 hours for whatever reason, constitutes failure to keep and maintain records.

(h) In the event that a pharmacy which uses a data processing system experiences system downtime, the following is applicable;

1. An auxiliary procedure shall ensure that refills are authorized by the original prescription drug order and that the maximum number of refills has not been exceeded or that authorization from the prescribing practitioner has been obtained prior to dispensing a refill; and

2. All of the appropriate data shall be retained for on-line data entry as soon as the system is available for use again. (4) Compounding records. A written record shall be maintained for each batch/sub-batch of a compounded product

under the provisions of Rule 64B16-27.700, F.A.C. This record shall include: (a) Date of compounding.

15.13

(b) Control number for each batch/sub-batch of a compounded product. This may be the manufacture’s lot number

or new numbers assigned by the pharmacist. If the number is assigned by the pharmacist, the pharmacist shall also record the original manufacture’s lot number and expiration dates. If the original numbers and expiration dates are not known, the pharmacy shall record the source and acquisition date of the component.

(c) A complete formula for the compounded product maintained in a readily retrievable form including methodology and necessary equipment.

(d) A signature or initials of the pharmacist or pharmacy technician performing the compounding. (e) A signature or initials of the pharmacist responsible for supervising pharmacy technicians involved in the

compounding process. (f) The name(s) of the manufacturer(s) of the raw materials used. (g) The quantity in units of finished products or grams of raw materials. (h) The package size and number of units prepared. (i) The name of the patient who received the particular compounded product. (5) Authorization of additional refills. Practitioner authorization for additional refills of a prescription drug order

shall be noted as follows: (a) On the daily hard-copy printout; or (b) Via the CRT display. (6) Any other records, policy and procedure manuals, or reference materials which are not specifically required by

statute or rule to be kept in a hard copy may be kept in a readily retrievable data processing system which complies with the provisions of subparagraph (1)(f)1.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.003(14), 465.022, 465.026, 465.035, 893.07 FS. History–New 3-

16-94, Formerly 61F10-28.140, Amended 3-12-97, 6-4-97, Formerly 59X-28.140, Amended 10-29-97, 6-15-98, 11-11-98, 10-15-01,

3-24-14.

15.14

NURSING HOME

Extracted from: Nursing Homes - Clarification of Guidance related to Medication Errors and Pharmacy Services - CMS November 2012

B. Fentanyl Patches

Tag F431- Service Consultation requires a licensed pharmacist, who is employed by or provides services to a facility, to establish a system of records of receipt and disposition of all controlled medications. The system should enable periodic, accurate reconciliation and accounting of all controlled drugs. Fentanyl transdermal patches are a controlled substance commonly used in nursing homes for pain medication. These patches present a unique situation given the multiple boxed warnings, the potential for abuse, misuse and diversion, and the substantial amount of fentanyl remaining in the patch after use. The facility’s policies must address safe and secure storage, limited access and reconciliation of controlled substances in order to minimize loss or diversion, and provide for safe handling, distribution and disposition of the medications. One benefit of the patch is the continuous delivery of fentanyl over 72 hours. This slow-release of fentanyl from the transdermal reservoir allows for more consistent pain control in patients with chronic pain. This unique delivery system, however, is not impervious to diversion, even after the fentanyl patch has been used, removed and/or disposed. One study determined that even after three days of use, 28 to 84.4% of the original fentanyl dose was still present in the patch. The study noted that the dose remaining in the patch was within the limits of a lethal fentanyl dose.7

The remaining fentanyl in a used patch is a potential vehicle of abuse and accidental overdose and warrants implementation of adequate disposal policies. Fentanyl products contain several boxed warnings related to potential abuse, misuse, and diversion, and specifically, the contraindication of fentanyl transdermal patch use in individuals who are not opioid tolerant. Staff should dispose of fentanyl patches in the same manner as wasting of any other controlled substances, particularly because the active ingredient is still accessible. Wasting must involve a secure and safe method, so diversion and/or accidental exposure are minimized. Tag F425 requires the facility’s procedures to address the disposition of all medications. This includes but is not limited to:

15.15

• Timely identification and removal of medications from the current supply of medications for disposition;

• Identification of storage method for medications awaiting final disposition; • Control and accountability of medications awaiting final disposition; • Documentation of actual disposition for both full dose and any

other remaining partial dose; and • A method of disposition consistent with applicable state and

Federal requirements, local ordinances, and standards of practice.

Survey Implications: If surveyors identify misuse or diversion of a controlled substance, they should consider and investigate these requirements:

• F309 - Quality of care, for evidence and/or potential outcomes, such as unrelieved pain. For example, evidence that on a particular shift, or when a particular staff member is working, that the resident’s pain symptoms are not relieved to the extent possible but the pain symptoms are met to the extent possible on other shifts; • F425 - Pharmacy Services, for policies for safeguarding and access, monitoring, administration, documentation, reconciliation and destruction of controlled substances; • F431 - Pharmacy service consultation, for drug records and reconciliation of controlled drugs; • F514 - Clinical Records, accuracy of medical record and for the documentation of the administration of the medication and outcomes; or • F520 - Quality assessment and assurance, for how the QAA committee monitors the administration, reconciliation and disposition of controlled substances in the facility.

In addition, if the investigation identifies diversion of a resident’s medication, the surveyor must review for F224- Misappropriation of Resident’s Property. If it is determined that a resident’s medications were diverted for staff use, the State Agency must make referrals to appropriate agencies, such as local law enforcement; Drug Enforcement Administration; State Board of Nursing; State Board of Pharmacy; and possibly the State licensure Board for Nursing Home Administrators.

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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

15.17

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.

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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 Nurse Date 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 Party Date Prescription Name Quantity ______________________________________________________________________________________________________________________________________________________ _________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ___________________________________________________________________________ Drugs reviewed and evaluated by pharmacist: 3. _____________________________________________________________________

Signature of Pharmacist Date 4. Disposition of Drugs: ____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ WMC-308

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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.

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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.

15.21

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.

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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:

a. Telephoning the new order into the pharmacy exactly as prescribed, and as soon

as possible after receiving and noting it on the physician’s order sheet. Each medication prescribed for a patient MUST be ordered and must be available for use regardless of how infrequently it may be used. Stat orders and orders for emergency drugs not in the emergency drug supply MUST be telephoned into the pharmacy immediately upon receiving them. ONLY a licensed nurse or pharmacist may telephone medication orders to the pharmacy.

b. Entering each newly prescribed medication in the daily drug order and

receipt record and indicating in the record that the medication order has been telephoned to the pharmacy.

c. Entering each newly prescribed medication on the patient’s current

Medication administration record. When a new order changes the dosage or dosage interval of an already prescribed medication, the previous entry on the patient’s current medication administration record is discontinued by writing “Dc” and the date following the last documented administration. The new order is then to be entered in the space designated for medication names and directions.

11. Daily drug order and receipt records and medication re-order forms are to originate

at each nursing station. Medication orders from different nursing stations are not to be listed on the same order sheet. Each daily drug order and receipt record and medication reorder form is to be clearly marked as to the station from which the orders originate, and are to be delivered.

12. Each newly prescribed and re-ordered medication must be entered on that nursing

station’s daily drug order and receipt record. The nurse making the entry is to include all of the following information and initial the entry:

a. The date ordered.

b. Whether the order is a new order or a re-order.

c. The patient’s name.

d. The name of the drug and the strength, if any, or the prescription number, if it

is a re-order.

e. The directions for use.

f. The prescriber’s name.

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g. The name of the pharmacy, if other than the usual pharmacy. If the patient or his/her responsible party request the medication be ordered by telephone from a pharmacy of their choice, in accordance with the procedures for ordering drugs from other pharmacies, the entry may be made on the same daily drug order and receipt record. The nurse making the entry must, however, mark the pharmacy’s name prominently on the entry line.

The original (top) copy of the daily drug order and receipt record is to be forwarded to the pharmacy and the carbon is to be kept as a record of what was ordered. The pharmacy is to return the original with the re-ordered medications and in accordance with the procedures for receiving drugs, the original and the carbon are to be stapled together and the completed record filed at the business office in the log designated for that purpose. The billing clerk is responsible for maintaining a log of completed daily drug order and receipt records on file for one (1) year.

13. There are only four (4) kinds of drug orders. They are:

a. New, handwritten orders, entered on a physician’s order sheet and signed by

the prescriber.

b. New orders, received verbally over the telephone or received verbally in person, such as when the prescriber is leaving the facility.

c. New, signed orders on a transfer sheet from a hospital or other health care

facility.

d. Drug re-orders.

14. In addition to the standard procedures for ordering drugs, the following procedures apply to:

NEW HANDWRITTEN ORDERS, ENTERED ON A PHYSICIAN’S ORDER SHEET AND SIGNED BY THE PRESCRIBER.

a. The director of nursing services is responsible for instructing ALL Nursing

and administrative staff to inform the director of nursing and/or all charge nurse(s) when any physician enters the building.

b. The charge nurse on duty at the time the order is received is responsible for

clarifying the order BEFORE the physician leaves the nursing station.

c. The nurse receiving the order is responsible for sending the pharmacy a transcription of the physician’s order each time he/she is in facility and signs an order for medications.

15. In addition to the standard procedures for ordering drugs, the following procedures

apply to:

NEW ORDERS RECEIVED VERBALLY OVER THE TELEPHONE OR IN PERSON

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a. Verbal orders for medications are to be handled in the same manner whether

received over the telephone or in person such as when the physician is leaving the facility. Only a licensed nurse or registered health care practitioner in the course of their responsibility may receive a verbal order for a drug. The practitioner receiving the order should enter the order into chart and other entries for the medication record keeping system, including physicians orders, a telephone order verification form (when applicable), the MAR and the monthly update record.

b. The licensed practitioner receiving the verbal order is required to enter each

medication ordered on a telephone order form:

Copy of Telephone Order Form in this space

The telephone order form is a three-part NCR (carbonless) form. The original copy of the form must be mailed to the prescriber for signing. The second duplicate copy is to be taped on the page designated for that purpose located just behind the physician’s order sheet in the patient’s chart. The third copy is placed in the consultant pharmacist mail box. When the signed copies are returned to the facility by the doctor, the original is to be taped in the patient’s chart replacing the duplicate second copy which may be discarded. When the physician signs the charted order at the time of his next visit, the signed, original telephone order may be discarded.

c. Verbal orders for Schedule II drugs are permitted only in the case of a bona

fide emergency situation. 16. In addition to the standard procedures for ordering drugs, the following procedures

apply to:

NEW, SIGNED ORDERS, ON A TRANSFER SHEET FROM A HOSPITAL OR OTHER HEALTH CARE FACILITY.

a. When a transfer sheet containing medication orders (1) bears a physician’s

signature, and (2) indicates the medication(s) is to be continued in this facility, the charge nurse on duty at the time the order is received, or the licensed nurse receiving the order, is responsible for verifying the order over the telephone with the patient’s physician before drugs are administered. The

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nurse is responsible for documenting the telephone verification on the admission orders by entering the phrase, Admission orders verified per telephone, the nurse’s signature, the time and date.

b. Where NO physician’s signature appears on the transfer sheet, admission

orders must be verified over the telephone with the patient’s physician before drugs are administered, and then signed by the patient’s physician within forty-eight (48) hours according to the procedures for a telephone order.

17. In addition to the standard procedures for ordering drugs, the following procedures

apply to:

DRUG RE-ORDERS

a. Each medication prescribed for a patient must be available for use at least twenty four (24) hours in advance of exhausting the supply on hand regardless of how infrequently it may be used. Routinely administered drugs are to be re-ordered three (3) to four (4) days before the last dose on hand is expected to be given.

b. Re-orders can be made by removing the special peel-off label from the

medication container and placing it in the space provided on the medication re-order form.

c. The nurse re-ordering the medication is responsible for identifying any error

which appears on the label, or noting any change in directions for use which have occurred since the medication was originally dispensed.

d. In the event the special peel-off label from the container is not available, re-

orders can be made by entering the patient’s name, prescription number, name and strength of the medication, current directions for use, and the physician’s name in the spaces provided on the daily drug order and receipt record, and indicating it is a re-order without a reorder label.

e. Regardless of whether the peel-off label is available, all re-ordered

medications must be entered on that nursing station’s daily drug order and receipt record. This is the only permanent record of re-ordered drugs kept in the facility and it must be kept for each re-ordered medication.

f. When the medication re-order form and the daily drug order and receipt

record are completed, they are to be placed in the pharmacy pick up basket for pick up by the pharmacy messenger service at the next regularly scheduled pick up and delivery.

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NURSING HOME

SAMPLE POLICY & METHODS

New Orders to Begin on Arrival POLICY:

It is the policy of this facility to provide residents with new medication orders in a timely manner.

METHODS:

1. Nurses receiving medication orders from the physician shall determine how quickly the medication should be started.

2. If the order is of a STAT nature, to begin immediately, the pharmacy shall

immediately be notified and asked to provide the drug as quickly as possible.

3. If the order is of a routine nature, the medication shall be ordered from the pharmacy using the usual procedures for ordering.

4. All routine new orders shall be written to include the phrase may begin on arrival.

5. The routine order shall be administered as soon as received if appropriate with the

directions.

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NURSING HOME

SAMPLE POLICY & METHODS

Receiving Drugs

POLICY:

Medications are to be received from the issuing pharmacy on a prompt and timely basis. For each medication ordered, a record is to be maintained by the licensed nursing staff showing the name of the patient, the drug’s name and strength, the quantity ordered and received, the date ordered and received, and the name of the issuing pharmacy. The record is to be maintained on file in the facility for one (1) year.

State Survey Manual

59A-4.112 (3) 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.

59A-4.112 (4) The pharmacist shall determine that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled.

59A-4.112 (7) 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.

METHODS:

1. Prompt and timely availability is interpreted as follows:

a. All new drug orders are to be received and available for administration on the day they are ordered by the physician unless the drug would not usually be started until the next day, in which case it is to be received before the first dose would ordinarily be administered.

b. Drugs ordered from the pharmacy during their regularly scheduled business

hours on an emergency or stat basis should be received and administered within one (1) hour.

c. Drugs ordered from the pharmacy after their regularly scheduled business

Hours on an emergency or stat basis are to be received and administered not more than two (2) hours after the order is received from the prescriber.

d. The reason(s) for deviating from the above procedures should be documented

in the patient’s chart.

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2. Medication delivered to the facility from any pharmacy must be received by a

licensed nurse.

3. The receipt of each medication is to be recorded on the original or copy of the daily drug order and receipt record. The licensed nurse checking in the medication is to record the quantity of the medication received, and date and initial the record, thereby documenting that the medication was received.

4. If an ordered medication is not received and there is no explanation from the

pharmacy, the pharmacy is to be contacted by telephone as soon as possible to determine why the medication was not sent.

5. The licensed nurse receiving the medication is responsible for verifying medication

received and the directions for use with the medication ordered and with the physician’s order in the patient’s medical record.

6. Disposition of Orders Once Received: To put an order away, first determine via the

pharmacy order book if it is a new or a refill prescription, and if refill, what kind. If it is new, place one card in each dosage drawer.

Example: If medication is given QID, and if you are using a time pass method, place one card in each of the 9:00, 1:00, 5:00, and 9:00 bins in front of that patient’s divider card.

On refills, place the entire prescription in a storage bin under that Patient’s name (or immediately behind the correct patient’s in use card in the medication bins) and leave there until old card in the dosage bin is utilized. Once again: ALWAYS CHECK STORAGE BIN BEFORE RE-ORDERING.

If the refill is a PRN box replacement, you will want to immediately put it in the PRN box.

When a card on a pass is emptied and the cart is returned to the nursing station the storage bin should be immediately checked for a replacement medication card or an emergency re-order should be made (for delivery the next day).

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NURSING HOME

SAMPLE POLICY & METHODS

Ordering and Receiving Drugs from Other Pharmacies

POLICY:

Medications brought into the facility by or with the patient or by the patient’s family are to be used only upon a written order by the patient’s physician and only when the contents of the medication container are known to be consistent with that which appears on its label.

Patients or their responsible parties, who want to purchase medications from a pharmacy other than the facility’s contractual pharmacy supplier, may do so provided:

(1) They and their pharmacist sign a notice of intent to purchase medications

from an outside pharmacy; and

(2) They and their pharmacy adhere to the facility’s policies and procedures for drug labeling, packaging, prompt and timely delivery of medication, emergency service, drug regimen review, etc.

The facility retains the right to terminate the agreement for cause and, in the event of an emergency, to order any drug, medication, or related supply for the patient from the facility’s regular pharmacy supplier.

METHODS:

1. Medications brought into the facility by or with the patient or by the patient’s family are to be used only if ALL of the following conditions are met:

a. The drug has been ordered by the patient’s physician and the order entered in

the patient’s medical record.

b. The medication container or prescription vial is clearly and properly labeled in accordance with the facility’s procedures for drug labeling.

c. The contents of the container or prescription vial have been examined and

positively identified after its arrival in the facility by a physician or a pharmacist, unless the medication has come directly from another health care facility. For example, discharge medications from an acute hospital which have come in the ambulance with the patient or those delivered directly by an outside pharmacy need not be identified by the physician or pharmacist unless the nurse has reason to question the contents.

2. If the patient’s physician is not available to identify the contents of medication

brought into the facility by the patient or member of the family, the medication is to be entered on the daily drug order and receipt record and the words verify contents written. The medication is then to be sent to the pharmacy for identification with the regularly scheduled pick-up.

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3. Patients or their responsible parties who want to purchase medication from a pharmacy other than the facility’s contractual pharmacy supplier may do so provided: a. The patient or their responsible party and their pharmacist sign a notice of

intent to purchase medications from an outside pharmacy.

b. The patient or their responsible party and their pharmacy adhere to the terms of the notice, and the facility’s policies and procedures for drug labeling, packaging, prompt and timely delivery of medication, emergency service, drug regimen review, etc.

4. When the patient or their responsible party indicate that they wish to purchase drugs

from a pharmacy other than the facility’s regular pharmacy supplier, the administrator, billing clerk, or the charge nurse on duty at the time is to provide them with a copy of the notice of intent to purchase medications from an outside pharmacy. A supply of notices is stored at the nursing station and the business office. A copy of all relevant policies and procedures is to be provided to the outside pharmacy upon request. The completed and signed copy of the notice is to be maintained in the Patient’s medical record.

5. When the completed and signed copy of the notice is received and placed in the

patient’s chart, the charge nurse on duty at the time is to mark the patient’s current medication administration record and drug storage box with the name of the outside pharmacy to indicate the proper order source. Thereafter, drug orders are to be telephoned to the outside pharmacy, and each order is to be entered in the daily drug order and receipt record, prominently indicating the name of the outside pharmacy.

6. In order to avoid delays associated with verifying the contents of medications, all

drugs and related supplies ordered from an outside pharmacy are to be shipped directly from the pharmacy to the nursing station. Shipment may be carried ONLY by: a. A licensed pharmacist; b. An agent of the pharmacy; c. An independent bonded delivery; d. A licensed physician; e. Parcel delivery; or f. The patient’s responsible party (or delegated family member). Medication delivered in any other way must be verified by the regular pharmacy. Under no circumstances shall medications, whether prescription or non-prescription be brought to the patient’s bedside.

7. If a situation occurs where the delivery of the patient’s medication from the outside

pharmacy is delayed or uncertain, the medication nurse is to order by telephone a seven (7) day supply of all drugs needed for administration from the regular pharmacy. If this is done, the nurse placing the order is to notify the billing clerk of the situation for clarification in the next billing.

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