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PHARMACY POLICIES AND PROCEDURES

November 2011

PHARMACY

POLICIES AND PROCEDURES

Table of Contents

Please Note! Clicking on a title will

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Accutane Prescriptions

Addition of Supplemental Medication to IV Solutions

Athlete Prescription Pick-up by ND Athletic Trainers

Athletic Trainer Med Bag

Communication of Pharmaceutical Information to Staff

Comptom, JACC, and Stadium First Aid Rooms

Confidentiality

Controlled Drug Inventory

Controlled Drug Prescriptions

Controlled Drugs for Inpatient Unit

Controlled Substances-Indiana and DEA Licenses and Registrations

Department Requisitions

Drug Samples

Eligible Populations for Pharmacy Services

Emergency Kits

Employee Purchase of Medication

Expiration Date for Reconstituted Medicinals

Expiration of Multi-Dose Injectable Vials

Expired Drugs

First Aid Kits

Inspect Report of Controlled Drugs

Inventory of Drugs and Supplies

Investigational Drugs

Isoniazid Prescriptions

Loan and Borrow Procedure

Maintaining Prescriptions and Prescription Records

Medication Charges and Management of Student, Departmental and Workman's Compensation Accounts

Medications Stored in the Training Rooms

Monitoring Medication Dispensing from Inpatient Unit and Triage

Narcotic Counts in Inpatient Unit

Normal and Customary Supply of Drugs

Patient Counseling

Patients Own Medication

Performance Improvement for Pharmacy

Pharmaceutical Utilization

Pharmacist Responsibilities

Pharmacy Computer Backup

Pharmacy Technician Responsibilities

Physician Medical Bag

Poison Control-Antidote Information

Prepackaged Medications and Records

Prescribing and Dispensing of Medications for ADHD

Prescription Pads

Prescription Sign-Out

Prescriptions for Varsity Athletes

Procurement Standards of Pharmaceuticals

Professional Judgment

Pseudoephedrine Purchases

Purchase Order and Invoice Processing

Rabies Exposure Vaccine Rabies Immune Globulin

Recalled Drugs

Refrigerator Alarms

Restricted Meds

Scope of Service

Security for the Pharmacy

Valid Prescription and Medication Orders

As of 11/21/2011

SUBJECT: ACCUTANE PRESCRIPTIONS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE: Fill prescriptions for Accutane (tretinoin) for patients enrolled in the Ipledge Program. PROCEDURE AND/OR GUIDELINES When a prescription is received for Accutane (tretinoin) from a patient, the pharmacist logs into the Ipledge website, entering the Ipledge number and birthdate of the patient. The pharmacist follows the prompts of the system. To gain authorization to fill a prescription the pharmacist enters the NDC# of the product, quantity and days supply, and an approval number (RAM#) and expiration date are generated. This information is written on the face of the prescription, entered in QS1 and the prescription is filled. An expiration date sticker is attached to the prescription bag and If the prescription is not picked up by this date, the medication may not be dispensed to the patient. ANNUAL REVIEW

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Date Issued Approved by: ______________________________________ Office of Student Affairs ______________________________________ Director, University Health Services ______________________________________ Medical Director ______________________________________ Chief Pharmacist

SUBJECT: ADDITION OF SUPPLEMENTAL MEDICATION TO INTRAVENOUS SOLUTIONS POLICY Administer IV solutions that are sterile and are physically and chemically compatible. PURPOSE Make available a system for providing sterile and chemically and physically compatible intravenous solutions when necessary. PROCEDURE and/or GUIDELINES The Pharmacy provides medications for addition to an intravenous solution only where there is a closed system, e.g. a commercially available preparation or an “advantage” system. For any other preparation requiring the addition of medication to an IV solution, a home care IV pharmacy will be consulted, e.g. Memorial Homecare Pharmacy, a JAACO accredited facility. Their phone number is 647-8675 and fax number is 273-5604. The central intake number for insurance approval is 647-8602. They are open Monday through Friday 8am to 5pm and have a pharmacist on call 24/7. They can provide medication and delivery generally within a four-hour window. Annual Review


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Issued Approved by: ______________________________________ Office of Student Affairs ______________________________________ Director, University Health Services ______________________________________ Medical Director ______________________________________ Director, Sports Medicine ______________________________________ Chief Pharmacist

SUBJECT: ATHLETE PRESCRIPTION PICK-UP BY NOTRE DAME TRAINERS POLICY: Notre Dame athletic trainers may pick up prescriptions for athletes with the athlete’s

permission. PURPOSE: To ensure an athlete has timely access to prescriptions when athletic/academic demands

prevent dispensing directly to the athlete during normal business hours. PROCEDURE and/or GUIDELINES:

Athletic trainers may pick up prescriptions for athletes with the athlete’s permission during normal business hours. A “student” trainer may pick up and sign for prescriptions by the direction of the athletic trainer. Only adult, non-student athletic trainers, may pick up prescriptions for controlled drugs and only with a valid driver’s license. The bagged prescription is placed inside another bag and sealed to protect confidentiality. (The sign-out receipt does not include the name of the patient/athlete.) Picked up prescriptions will be secured in the office or in the exam room of the training room (Compton, Guglielmino, or JACC) until the patient/athlete can accept the filled prescription.

Athlete’s Prescriptions Picked up By Athletic Trainers Athletes may call the Pharmacy if they have questions concerning their medication.

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Issued Approved by: ______________________________________ Office of Student Affairs ______________________________________ Director, University Health Services ______________________________________ Medical Director ______________________________________ Chief Pharmacist

SUBJECT: ATHLETIC TRAINER’S MEDICAL BAG POLICY Athletic trainers who travel with a team may carry over-the-counter medications and with

permission from the Athletic Department Medical Director, specific prescription medications, for the purpose of athlete self-treatment.

PURPOSE Make available medications that may be useful or necessary for the self-treatment of an

athlete during travel. PROCEDURE and/or GUIDELINES

The Pharmacy may provide athletic trainers with a supply of OTC medications. These medications may include, but are not limited to OTC NSAIDS, antihistamines, or antacids.

The Pharmacy may also provide certain prescription medications for athlete’s self-treatment with the permission of the Medical Director for the Athletic Department. These medications may include, but are not limited to an EpiPen or an albuterol inhaler.

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SUBJECT: COMMUNICATION OF PHARMACEUTICAL INFORMATION TO STAFF AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To communicated to UHS staff up to date information as new therapies and pharmaceutical products are developed,

PROCEDURE AND/OR GUIDELINES:

Information is relayed through the Vital Signs newsletter and the UHS Pharmacy newsletter. More urgent changes or questions about pharmaceuticals are posted in nursing areas and in the Clinical Services Communication book by pharmacy staff. Information is also shared verbally or by email to physicians as information becomes available.

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SUBJECT: COMPTON, JOYCE CENTER, AND STADIUM FIRST AID ROOMS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE: To provide medications and supplies to the first aid rooms located in the Compton,

JACC, and the Stadium.

PROCEDURE AND/OR GUIDELINES: 1. During football season, the Spring Game, Graduation or other Stadium

event, the three first aid rooms in the Stadium are stocked with medical supplies and over-the-counter medications.. Each room receives a tote box containing a small supply of prescription medications. Each room also receives a locked box containing a small supply of controlled drugs. All medications are dispensed by trained medical personnel under the direction of physicians to Stadium guests. The pharmacist prepares the supplies and tote boxes and delivers them to each room before each home football game, the Spring Game, Graduation or Stadium event. These cabinets, as well as the locked box, are locked and may be accessed only by the Pharmacist and licensed personnel working in each room. After each event and at the end of the season these supplies are placed in storage within the Pharmacy.

2. The first aid room in the Compton and the Joyce Center is maintained by

the pharmacist weekly with OTC medications and basic medical supplies during the academic year and monthly during the summer or as needed. Supplies are provided for first aid personnel to treat guests.

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March 2011 Issued Approved by: ______________________________________ Assistant Vice President, Student Affairs ______________________________________ Director, University Health Services ______________________________________ Medical Director ______________________________________ Chief Pharmacist

SUBJECT: CONFIDENTIALITY POLICY

To hold strict confidentiality standards as relate to prescriptions, drug orders, and patient information.

PURPOSE

Confidentiality of patient information is mandated except under a criminal investigation under Indiana statute IC 25-26-13-15.

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SUBJECT: CONTROLLED DRUGS INVENTORY AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE: A record of an annual inventory of all controlled drugs in the Pharmacy is taken to comply with Indiana and Federal law. This inventory is made available to the Indiana Pharmacy inspector upon request. A running inventory is kept of CII drugs (Schedule II), as well. PROCEDURE AND/OR GUIDELINES: Once a year an inventory of all controlled drugs is made. (Schedules II, III, IV and V) A dated and signed copy of this inventory is maintained in the Controlled Drug binder. In addition, a perpetual (running) inventory is kept of all additions (purchases) and withdrawals (dispensing or outdated) of Schedule II drugs. This inventory is maintained in the Controlled Drug binder. Purchases of Schedule II drugs are made on either a triplicate #222 or electronic #222 DEA (CSOS) form from AmerisourceBergen. Invoices for Schedule II purchases are attached to the corresponding #222 and filed. Copies of invoices for Schedule III-V purchases are filed separately. Schedule II drugs are stored in a locked cabinet in the pharmacy and Schedules III, IV and V are distributed among the regular stock. Prescription records for Schedule II (200….) are filed separately from Schedule III-V (400….). A daily “Controlled Drug Report” is made through QS1. It is checked with the daily prescriptions, signed by the pharmacist and filed. Loss or theft of any controlled drug is to be reported on DEA form 106 and to law enforcement. Outdated drugs are removed from stock and returned for credit or disposal to a licensed drug return company on a triplicate #222 DEA form. Invoices for controlled drugs dispensed to the athletic department (training rooms, physician medical bags)

are maintained in a separate file. Furthermore, prepackaged drugs for the Inpatient Unit or Stadium First Aid Rooms will be dispensed through QS1 and recorded in the “Prepackaged Log.” All records are maintained for a minimum of three years. FORMS or REFERENCES: Federal code Section 1304.11 DEA Form #222 DEA Form #106 ANNUAL REVIEW


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SUBJECT: CONTROLLED DRUG PRESCRIPTIONS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To legally fill prescriptions for controlled drugs (CII through CV) according to state and federal statutes.


Prescriptions for CII through CV prescription medications are filled in accordance with Indiana statutes 856 IAC 2-6 -1 through 17 and federal statutes, summarized in the DEA Pharmacist’s Manual, 2010 edition, Section IX-Valid Prescription Requirements, pages 28-35 and Section X-Dispensing Requirements, pages 36-39. Non-prescription CV drugs and syringes/hypodermic needles are dispensed only with a prescription.

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SUBJECT: CONTROLLED DRUGS FOR INPATIENT UNIT AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To provide a limited supply of controlled drugs for patients admitted to the Inpatient unit.

. PROCEDURE AND/OR GUIDELINES:

The Pharmacy provides a unit-dosed supply of some controlled drugs to the Inpatient unit for dispensing to patients admitted to the Inpatient unit with a physician’s order. These medications are generally limited to pain, cough, and anxiety/seizure medications. These medications are dispensed in a “unit dose” container as a “prescription” with all of the labeling and documentation of a prepackaged medication (see Pharmacy Procedure, “Prepackaged Medications and Records”) with an accompanying sign-out sheet. Inventory of these medications is maintained according to Pharmacy Procedure, “Narcotic Counts in Inpatient Unit”.

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SUBJECT: CONTROLLED SUBSTANCES—INDIANA AND DEA LICENSES AND

REGISTRATION AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

University of Notre Dame Pharmacy is a registered dispenser of controlled substances. The registration covers the Pharmacy and the Health Center.

PROCEDURE AND/OR GUIDELINES

Appropriate license applications are filed and associated fees are paid bienially to maintain an Indiana Controlled Drug license (IC 35-48-3-3) and every three years for renewal of the DEA (federal) license in order to purchase and dispense controlled drugs (CII through CV).

FORMS or REFERENCES:

DEA Form 224A Indiana CSR

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SUBJECT: DEPARTMENT REQUISITIONS PURPOSE

To provide necessary supplies to campus departments for departmental use only. POLICY

Various departments within the University may request medications and medical supplies that may be supplied by the Pharmacy.

PROCEDURE and/or GUIDELINES

A written, faxed or verbal request may be made to the pharmacy for medications or medical supplies. The request would include the date, name of the department, person making the request, FOAPAL number and description of items requested. These requests may include but are not limited to first aid kits and replacement supplies, supplies for the Fire Department, Athletic Training rooms, and first aid rooms in the JACC and Stadium.

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Date Revised Approved by: ______________________________________ Office of Student Affairs ______________________________________ Director, University Health Services ______________________________________ Medical Director ______________________________________ Chief Pharmacist

SUBJECT: DRUG SAMPLES POLICY Drug samples supplied to UHS physicians are stored in a separate and locked

cabinet/closet. Receiving, distribution, appropriate documentation and destruction are performed by the physician or the physician’s agent according to Indiana statute IC 16-42-21

PURPOSE Provide for the legal distribution of drug samples. PROCEDURE and/or GUIDELINES

If a pharmaceutical representative wishes to provide medication samples to the Health Center, a physician signs for the samples and that physician is responsible for storing, distributing to a patient and documenting the sample given, lot number and expiration date in the patient chart. As samples expire, they are discarded appropriately. These functions may be assigned to the physician’s agent, e.g. nurse, upon the physician’s direction.

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SUBJECT: ELIGIBLE POPULATIONS FOR PHARMACY SERVICES PURPOSE To provide pharmacy services to students, injured employees, religious and guests of the University. POLICY University Health Services Pharmacy will provide services to all registered students. University employees who sustain injury in the course of their employment may use the services of the University Health Center Pharmacy. All Holy Cross Religious and other Religious employed by the University may utilize pharmacy services. Guests on campus needing emergency pharmaceutical assistance may request service of the University Pharmacy during normal operational hours. PROCEDURE and/or GUIDELINES University-approved prescriptions and over-the-counter medications and medical supplies may be purchased by cash or check. University students and religious may have charges placed on their student account or University account, respectively. Prescriptions and supplies for injured employees are billed to Risk Management. Guests will pay by cash or check. The Pharmacy extends prescription services to students for one week after graduation.

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SUBJECT: EMERGENCY KITS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To provide first aid during campus events, various kits are used by physicians or nurses or trained first aid personnel under the supervision of a physician.


Various emergency kits are stored in the Pharmacy for university events, including but not limited to Stadium First Aid rooms (Football), Bookstore Basketball, Bengal Bouts, and Graduation. These kits are updated as needed prior to the event. Outdated medications and supplies are removed, the container is cleaned and re-supplied by the pharmacist. A charge is made to the event or department that uses the box. Once the event is over, the box is returned to the Pharmacy for storage.

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SUBJECT: EMPLOYEE PURCHASES OF MEDICATION PURPOSE

University employees except those defined in Policy and Procedures “Eligible Populations for Pharmacy Services” and “Scope of Service” are not eligible for services at the Pharmacy

POLICY

University employees may not purchase prescription medications or over-the-counter medications from the UHS Pharmacy.

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University employees are referred to off-campus pharmacies for prescription filling and purchase of OTC medications.

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SUBJECT: EXPIRATION DATE FOR RECONSTITUTED MEDICINALS AUTHORIZATION: Chief Pharmacist DATE: March 2011:

PURPOSE:

To ensure that reconstituted medicinals are properly mixed, stored and discarded before deterioration per the manufacturer's recommendation.

PROCEDURE AND/OR GUIDELINES

Any medicinal product for oral or parenteral use manufactured in the powdered state which is reconstituted by University Health Services personnel shall receive an expiration date consistent with the recommendations of the manufacturer. Any such medication shall be labeled with the expiration date and stored under the conditions recommended by the manufacturer. It is appropriately discarded by the date of expiration.

FORMS or REFERENCES:

Package insert Facts and Comparisons

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SUBJECT: EXPIRATION OF MULTI-DOSE INJECTABLE VIALS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To ensure sterility and stability of injectable multi-dose vials (containing preservative).


Medication dispensed from a multiple dose vial (MDV) is withdrawn according to USP 797 standards or those of the manufacturer and a label denoting the date of first entry of the vial is placed on the vial. The vial is stored appropriately, e.g. room temperature or refrigerated. The vial is discarded 28 days after the initial entry or according to the manufacturer’s recommendation and USP 797 (Compounding of Sterile Products).

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SUBJECT: EXPIRED DRUGS AUTHORIZATION: Chief Pharmacist DATE: March 2011 ____________________________________________________________________________________

PURPOSE: To remove outdated medication from stock. PROCEDURE AND/OR GUIDELINES:

At the beginning of each calendar year, all stock within the Pharmacy, the Training Rooms and the JACC First Aid Room is stickered with a month of expiration, if expiring within that calendar year. As new stock is added, it is also stickered if it expires within that calendar year. At the beginning of each month, the stickered, expired medications are removed

from stock within the Pharmacy, first aid rooms (Compton, JACC and Stadium) and training rooms

(Compton, Guglielmino and JACC) by a pharmacist. A nurse routinely (monthly) checks all other

areas of the Health Center for expired medications and supplies. Expired drugs or supplies are all returned to the pharmacy for disposition by the pharmacist. This may include return to the manufacturer or wholesaler or for credit or destruction by a return processing company on a regular basis. Prescription labels indicate the expiration date of the medication. QS1 defers to one year from date of fill. If medication expires prior to that date, a “correct” expiration date is applied to the prescription label. Controlled drugs are returned for credit or destruction to a return processing company as described in the DEA Pharmacist’s Manual, 2010 edition, Section !V-Transfer or Disposal of Controlled Substances, page 13.

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SUBJECT: FIRST AID KITS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

Provide basic first aid kits to residence halls and university departments. PROCEDURE AND/OR GUIDELINES:

Risk Management approved a list of supplies and medications to be included in a basic first aid kit for use in residence halls and in university departments.

The Pharmacy provides a small lunch-box sized kit with the additional items added per Risk Management and the kit is checked for completeness. A list of contents is taped to the back of the box. An expiration date is placed on the front of the box and a tamper seal, signed by the pharmacist and the pharmacy technician who prepared the kit, is affixed.

First aid kits are supplied at no charge to residence halls as part of the health services fee charged to students.

University departments are charged for a kit.

Kits are to be checked regularly for missing or out-dated supplies by the department or for a fee by the Pharmacy. Additional supplies may be ordered from the Pharmacy for a minimal fee.

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SUBJECT: INSPECT REPORT OF CONTROLLED DRUGS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To ubmit the required "Inspect" report of controlled drugs dispensed by the pharmacy to the state at least every 7 days as prescribed by Indiana law (IC 35-48-7-8.1).


A list of all controlled drugs in generated in QS1 and uploaded to the PMP website in the ASAP 2007 format. A recheck of the transmission is made with 24 hours to check and correct any errors. A hard copy of the report is maintained in an Inspect binder.

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SUBJECT: INVENTORY OF DRUGS AND SUPPLIES AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To take a yearly physical inventory of all medication and supplies of those items ordered and managed by pharmacy staff.


A physical inventory of the Pharmacy is taken yearly by a company that specializes in pharmacy inventories (Abacus). They provide a alphabetized, itemized and notarized list of all items in stock—including AWP and cost. A copy of the inventory is maintained inside the Controlled Drug binder.

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SUBJECT: INVESTIGATIONAL DRUGS POLICY University Health Services is not part of an institution review board and as such will not take part in any clinical trials nor dispense any investigational drugs. ANNUAL REVIEW


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Date Issued Date Revised Approved by: ______________________________________ Office of Student Affairs ______________________________________ Director, University Health Services ______________________________________ Medical Director ______________________________________ Chief Pharmacist

SUBJECT: ISONIAZID PRESCRIPTIONS PURPOSE

To provide the isoniazid and vitamin B6 for six to nine months to minimize the probability of converting to active tuberculosis.

POLICY

Provide isoniazid and vitamin B6 and monitor treatment for those students who test positive for tuberculosis exposure.

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1. The TB nurse counsels each patient who qualifies for treatment.

2. The nurse provides a log sheet for each student who chooses to participate. Log sheets for all patients are maintained in a notebook that stays with the prescriptions in the prescription cart.

3. The pharmacist enters each student’s prescriptions for isoniazid (INH) and vitamin

B6 into QS1 and fills them monthly. The lot number and expiration are recorded for each refill on the patient log sheet.

4. During the first visit to the pharmacy, the patient is counseled by the pharmacist about taking the medication, side effects and picking up refills.

5. Each time the prescription is picked up from the pharmacy the date is recorded on

the log sheet and any side effects or questions are noted and followed up as necessary.

6. The TB nurse monitors the logbook monthly for compliance and provides certificates of completion to the student.

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SUBJECT: LOAN AND BORROW PROCEDURE PURPOSE

Ensure an adequate supply of necessary pharmaceuticals and supplies for UHS patients. POLICY

When a prescription is received by the pharmacy or a need arises within the Health Center for a product that is out of stock, that product may be borrowed (returned in kind) or purchased from another pharmacy (retail or hospital).

PROCEDURE and/or GUIDELINES If a medication or supply is required at the Health Center, which cannot be supplied by the

Wholesaler or until the following business day, the pharmacist on duty may do the following: 1. Request an emergency delivery from the wholesaler.

2. If a wholesaler delivery is not possible, the pharmacist may contact the following pharmacies to arrange to purchase (charge or petty cash) or borrow the medication or supply: CVS @ SR23 and Ironwood (273-0080) CVS @ Ironwood and Edison (472-3234) Memorial Hospital (647-7404) Kenny

LOAN AND BORROW PROCEDURE

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SUBJECT: MAINTAINING PRESCRIPTIONS AND PRESCRIPTION RECORDS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To maintain prescriptions and all records associated with filling prescriptions and dispensing medications in accordance with Indiana law.


Hard copies of prescriptions are filed in the Pharmacy and maintained for a period of at least two years. (IC 25-26-13-25). Hard copies of controlled drug prescriptions are filed in a two separate files, CII and CIII through CV, (DEA Pharmacists Manual, Prescription Records, 2010 Edition, page 20.) Hard copies of controlled drug prescriptions are filed in the Pharmacy and maintained for a period of at least two years (DEA Pharmacists Manual, Electronic Recordkeeping of Schedules III-IV PrescriptIon Information, 2010 Edition, page 34.) Daily dispensing records are maintained for a period of at least five years (856 IAC 1-29-3). Pseudoephedrine/Ephedrine dispensing logs are maintained for a period of at least two years (IC 35-48-4-14.7) Other records involving purchases of medication and billing are maintained for a minimum of two years. All records are stored within the Pharmacy file cabinets or in the adjoining medical storage room.

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SUBJECT: MEDICATION CHARGES AND MANAGEMENT OF STUDENT,

DEPARTMENTAL AND WORKER'S COMPENSATION ACCOUNTS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE: To provide for billing of medications and supplies to students and Risk Management. PROCEDURE AND/OR GUIDELINES:

Designated front office staff enter charges into Medicat for after-hours treatment from Triage or Inpatient Unit to the student account. Pharmacy personnel enter pharmacy charges into Medicat for OTCs and supplies purchased from the Pharmacy during business hours. Prescriptions are billed automatically through the QS1/Medicat interface to Medicat. Charges for varsity athletes that cannot be paid by the Athletic Department are charged into Medicat by Pharmacy personnel. The Health Services front office down-loads all charges periodically from Medicat to Student Accounts.

Department charges are billed when they are received with a FOAPAL number. Workers’ compensation charges are printed monthly on hard copy and sent to Risk Management. An electronic report of school-sponsored student insurance charges is generated monthly in QS1 and sent to Aetna. Claims for school-sponsored insurance (Aetna) are reconciled by the UHS business office. Rejected claims are charged to the student account.

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Revised Date Approved by: ______________________________________ Office of Student Affairs ______________________________________ Director, University Health Services ______________________________________ Medical Director ______________________________________ Chief Pharmacist

SUBJECT: MEDICATIONS STORED IN THE COMPTON, GUGLIELMINO, AND JACC TRAINING ROOMS PURPOSE To make available those medications that may be useful or necessary treating athletes. POLICY

Medications are stored in the training rooms for physician dispensing to athletes from the training rooms and if necessary on the field.


Physicians write or phone prescriptions to the Pharmacy for most medication dispensed to athletes. The athlete picks up the prescription from the Pharmacy with appropriate identification. Alternately, an athletic trainer may pick up the medication from the Pharmacy for an athlete, with the athlete’s permission and with appropriate identification, if necessary. The Pharmacy provides a limited supply of appropriate medications for physician dispensing from the training rooms. These medications are stored in locked cabinets within the training rooms. Only physicians and the pharmacist have access to a key to these cabinets. Physician dispensing from the training rooms is limited to a maximum 72-hour supply and is documented on the Training Room Medication Log. The training room medication room is locked when not in use. The training room at the Guglielmino is also alarmed when closed. The training room in the JACC is located next to the ND Security Police station with video monitoring. Physicians do not bring samples to the training rooms for dispensing to athletes.

MEDICATIONS STORED IN THE JACC AND GUGLIELMINO TRAINING ROOMS

The Pharmacy also provides medications and medical supplies to several portable medical cases for use on the athletic field. These cases are stored within the training rooms in locked cabinets, accessible only to the physicians and the pharmacist. When these cases are transported to the field, they are constantly under the direct control of the physician. Medications are for urgent treatment on the practice field or during an athletic event and are administered by licensed medical personnel. These medications may include but are not limited to controlled drugs. Documentation of any item removed from the box is made on the Training Room Medication Log, listing the date, patient, medication, quantity dispensed and signed by the attending physician.

ANNUAL REVIEW


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SUBJECT: MONITORING MEDICATION DISPENSING FROM INPATIENT UNIT AND

TRIAGE AUTHORIZATION: Chief Pharmacist

DATE: March 2011

PURPOSE:

To provide medications and monitor dispensing from the Inpatient unit and Triage, when the Pharmacy is closed according to Indiana statute 856 IAC 1-28.1-7.


The Pharmacy provides a limited supply of prescription medications to the Inpatient unit for dispensing with a physician’s order to those students admitted to that unit. Similarly, the Pharmacy provides a limited supply of prescription medications to Triage for dispensing with a physician’s order to those students seen when the Pharmacy is closed. Nursing personnel chart all doses given in the patient chart and on an inventory sheet for the date dispensed. The pharmacist makes a daily check of drug orders from this inventory sheet, controlled drug inventory sheets, patient charts and medication sheets to monitor dispensing of medication. The pharmacist makes note of this information on a log maintained in the two units with the date, time, comments and signature.

ANNUAL REVIEW


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SUBJECT: NARCOTIC COUNTS IN INPATIENT UNITS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To maintain an exact inventory and dispensing record of controlled drugs dispensed at the Health Center.


Controlled drugs are kept in double locked cabinets in the Inpatient Unit. Two nurses (or a nurse and a pharmacist) count controlled drugs, verify with the logged inventory and sign the log book. This is done every shift during the academic year and daily during the summer. Signature logs and inventory sheets are returned to the Pharmacy for storage at the end of each month and when more medication is required, respectively.

ANNUAL REVIEW


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SUBJECT: NORMAL AND CUSTOMARY SUPPLY OF DRUGS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To maintain an adequate supply of medications, vaccines and supplies for the needs of Pharmacy, Health Center and those areas it supplies.


Place orders as needed from appropriate vendors in a timely manner to supply the needs of the Pharmacy, Health Center and and those areas it supplies, e.g. first aid rooms, training rooms.

ANNUAL REVIEW


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SUBJECT: PATIENT COUNSELING AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To offer information to patients regarding the appropriate use of their medication. PROCEDURE AND/OR GUIDELINES:

Patient profiles are maintained in QS1 with demographic information as well as drug allergies, adverse reactions and known disease states in accordance with Indiana statute 856 IAC 1-33-3. Written information in the form of handouts and medication guides and verbal counseling is offered to patients on the appropriate use of their medication in accordance with Indiana statue 856 IAC 1-33-1 through 2. Documentation that patient counseling was given or refused is made on the prescription sign out log when the prescription is picked up from the pharmacy.

ANNUAL REVIEW


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SUBJECT: PATIENT’S OWN MEDICATION PURPOSE

To provide medication with a physician’s order to patients staying in the Inpatient unit. POLICY

Patients staying in the Inpatient unit may receive medicaton supplied through the pharmacy. The patient may also take their own medication according to Indiana statute 856 IAC 1-28.1-14.


Medication is provided to Inpatient patients by physician order. The nurse who administers medication to a patient, whether from the patient’s own supply or from the Pharmacy provided supply, witnesses and documents the administration. All medication is stored appropriately and securely in the nurse’s station. Once a student leaves the Inpatient unit, their own medication is sent with them.

ANNUAL REVIEW


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SUBJECT: PERFORMANCE IMPROVEMENT FOR PHARMACY POLICY: University Health Services provides for annual performance reviews and supports quality

assurance improvement activities. PURPOSE: To fulfill Indiana statute 856 IAC 1-28,1-11ch requires that a performance review process be in

place to address issues of performance improvement, sentinel events, corrective and avoidance measures, review, records and documentation.

PROCEDURE AND GUIDELINES: See UHS Administrative Policies and Procedures: Performance Management, Adverse Events ANNUAL REVIEW


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Pharmacist Peer Review Check-List

Always Often Sometimes Rarely Never N/A

Open/close Pharmacy—

Unlock/lock and disarm/arm

alarm. Pharmacy

locked/alarmed if pharmacist

out of pharmacy

Wear name tag

Refrigerator--check

temperature twice a day

QS1 Backup—check and

verify daily

QS1—sign on

Medicat—sign on

Pharmacy email—sign on,

retrieve messages

Phone—answer with name,

your name, title and “may I

help you”

Voicemail—change

messages, retrieve messages

Student ID—retrieve patient

profile in QS1

Patient demographics—

allergies, birthdate, insurance,

other medications & drug

interactions

Insurance & Billing—

explain policies

Drivers license/passport—

controlled drug Rxs/ PSE

purchases

Prescription—enter

accurately into QS1

Controlled Rxs—verify the

physician’s DEA# with

formula

Controlled Rxs—verify

validity for

unknown/suspicious

physicians with physician or

his agent, e.g. call back


Phoned prescriptions—read

back the phoned prescription

Pharmacy Technician Peer Review Check-List

5

Always

4

Almost

Always

3

Sometimes

2

Rarely

1

Never

Wear name tag

Sign on--QS1, Medicat, pharmacy

email

Phone-- Answer phone with

pharmacy name, your name, title and

“may I help you”, retrieve voicemail

messages

Student ID--to bring up patient

profile on QS1

Patient demographics--allergies,

birtthdate, insurance

Insurance & Billing—explain

policies

Drivers license/passport—controlled

drug Rxs/ PSE purchases

Prescription—enter accurately into

QS1

Refill Rxs--bring up prescription from

patient profile or Rx number if

available

Verify Correct Rx—stock product

NDC code matches NDC code on

label, double check label with Rx,

double check label with stock bottle

Expiration date—check on stock

bottle

Phoned or faxed Rxs—contact

patient by phone or email

Rx log—patient or agent sign,

document counseling/refusal

Billing—correctly bill student

accounts for Rxs & OTCs and

departmental charges

5

Always

4

Almost

Always

3

Sometimes

2

Rarely

1

Never

Ordering medications—log on to

Amerisouce website, create and

transmit order, check in and shelve

Vaccines—log on to manufacturer

website, create and transmit order,

check in and refrigerate

Medical Supplies— log on to

Amerisouce website, create and

transmit order, check in and shelve

Seek--availability/pricing and

purchase of medical

supplies/hardware, maintain product

manuals

Blanket accounts—set up annually

Payment of all invoices--through

Procurement, maintain billing records

Short dated products—sticker with

out-date month within the calendar

year

Collect and sort--outdates and

returns for return to Amerisource,

Gemco or for destruction

C3-C5 and PSE drugs—file a copy

of the invoice for purchase and for

sale

PSE—sign out using NPlex system

Prepackaged medications—record

date prepared, destination, Rx#, name

of medication, quantity, manufacturer,

manufacturer lot# and expiration date,

initials in log binder

Medical supply room—maintain

inventory

Inpatient unit/Triage—provide

supplies

First aid kits for

departments/residence halls—

prepare and bill

License—fulfills continuing ed and

retains current Indiana pharmacy

technician license

10/24/11/bc

to physician or agent, name

of agent, date, RPh initials.

address, phone #, DEA#

reduce to writing ASAP

Refill Rxs--bring up

prescription from patient

profile or Rx number if

available

Faxed Rxs—Rx states “valid

by facsimile only” or call

physician’s office to verify

and document faxing in order

to fill

Verify Correct Rx—stock

product NDC code matches

NDC code on label, double

check label with Rx, double

check label with stock bottle

Expiration date—override

on Rx label if less than 1 year

on stock bottle

Counting—double count C2-

C5 meds

ADHD letter—maintain

verification letter on file for

non-ND physicians

C2 Rxs face—sign off face

of Rx with date, signature of

RPh & quantity dispensed

C2 Rx inventory—sign out

Rx into inventory log book

Compounded Rxs—

calculate ingredients and

double check, collect and

double check ingredients,

compound in the prescribed

manner & order to produce

an accurate and aesthetically

acceptable product, assign

label with an expiration date

according to USP 795,

document all processes and a

copy of the label are

produced and maintained in

the compounding log book

according to USP 795


Phoned or faxed Rxs—

contact patient by phone or

email

Counseling-- what MD told

about Rx, say name, dose and

directions, how to take, how

long, missed doses, pertinent

side effects, any questions,

etc.

Patient information--

provide med guide where

required, patient handouts

and itemized receipt

Rx log—patient or agent

sign, document

counseling/refusal

Ordering—log on to

wholesaler, vaccine

manufacturer website &

create & transmit order,

For ordering vaccines—log

on to manufacturer website,

create and transmit order

Influenza vaccine—book &

receive annually

Receiving--check

medications & vaccines with

invoice and sticker, sticker, &

check expiration date, sticker

out-date month for short

dates

Outdates--sticker all

medications in January for out-

date for the year with month of

expiration, remove out-dated

medications from stock

monthly, collect outdates for

return or for destruction


C2 drug orders—order on

CSOS/ DEA#222 hard copy,

receive & document in CSOS

or DEA#222, attach copy of

invoice, log into inventory &

file #222

C3-C5 & PSE drugs—file a

copy of the invoice

PSE—sign out using NPlex

system or by Rx

Prepackaged medications—

date prepared, destination,

Rx#, name of medication,

quantity, manufacturer,

manufacturer lot# and

expiration date, initials/log

Recalls—check stock for any

recalled medications or

supplies & remove from

stock and return as indicated,

recall document is dated,

noted if in stock, initialed and

filed, prepare list of possible

consumers and notify in

writing/email if possible if to

consumer level

Inpatient unit—stock &

monitor dispensing of

medications daily

Training rooms-- remove

outdated & replace stock

First aid rooms—remove

outdated & replace stock

Physician medical bags--

remove outdated & replace

stock

Bengal Bouts—prepare

supplies

Bookstore Basketball—

prepare supplies

Bowl Game—prepare

supplies

Inspect Report—prepare

weekly, transmit, verify &

correct


Prescription log—run daily

Controlled drug log—run

daily

Controlled drug inventory--

yearly

Monthly reports

Monthly price updates

Monthly insurance (Aetna)

report—prepare & transmit

QS1 updates—as needed

Monthly pharmacy report

Yearly pharmacy report

Refrigerator alarm system--

monthly check at service

panel with all enabled Health

Center refrigerators

License—fulfills continuing

ed and retains current Indiana

pharmacy license

Pharmacy license—obtains

and displays Indiana

pharmacy license, Indiana

controlled drug license, DEA

license

10/18/11 bc

Monthly Check of 3 Rxs

C2 Rx Jan Feb Mar Apr May June July Aug Sept Oct Nov Dec

RX#

Name

Dates

written/filled

Drug/NDC

Sig

Refills

MD verified

Allergies

Checked by

RPh

Inventoried

Comments

C3-5 Rx Jan Feb Mar Apr May June July Aug Sept Oct Nov Dec

RX#

Name

Dates

written/filled

Drug/NDC

Sig

Refills

MD verified

Allergies

Checked by

RPh

Comments

Non-Controlled Rx Jan Feb Mar Apr May June July Aug Sept Oct Nov Dec

RX#

Name

Dates

written/filled

Drug/NDC

Sig

Refills

MD verified

Allergies

Checked by

RPh

Comments

10-24-11/bc

March 2011

Date Revised Approved by: ______________________________________ Office of, Student Affairs ______________________________________ Director, University Health Services ______________________________________ Medical Director ______________________________________ Chief Pharmacist

SUBJECT: PHARMACEUTICAL UTILIZATION POLICY To outline specific procedures concerning appropriate uses of drugs for Health Center

patients. PURPOSE Ensure safe and appropriate uses of drugs according to documentation. PROCEDURE and/or GUIDELINES

1. The basic indication for the use of drugs at UHS shall be those indicated on the package insert as permitted by the Federal Drug Administration (FDA). 2. Further indications for the use of drugs other than those approved by the FDA shall be permitted at UHS by the Medical Staff:

a) When recognized authorities and reference sources state that such use is indicated; and/or

b) When the known pharmacodynamics of the drug in question would recommend the use of preparation and at the same time, know that deleterious effects of the drug are minimal and are outweighed by the possible beneficial effects.

3. UHS will maintain references which address the use of approved drugs for non-approved indications by the FDA. These references will be used by the UHS pharmacy in its ongoing monitoring of pharmaceutical usages within UHS.

PHARMACEUTICAL UTILIZATION

ANNUAL REVIEW


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SUBJECT: PHARMACIST RESPONSIBILITIES AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To outline the legal and ethical responsibilities of the pharmacist. PROCEDURE AND/OR GUIDELINES:

The pharmacist fulfills all the duties of a pharmacist in an institutional (Type II) pharmacy as outlined in Indiana statute 856 IAC 1-28.1-7. The pharmacist wears a name tag, identifiying herself as a pharmacist and she verbally identifies herself as a pharmacist.

ANNUAL REVIEW


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SUBJECT: PHARMACY COMPUTER (QS1) BACKUP AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To assure that prescription electronic data is safely stored and maintained. EQUIPMENT/SUPPLIES:

QS1 computer terminal, external hard drive PROCEDURE AND/OR GUIDELINES:

The pharmacy computer (QS1) has been formatted for automatic nightly backup to an external drive seven days a week. Each morning the logs, "backup" and "verify" are checked to make certain that there are no errors or problems with the hard drive.

A hardcopy daily record of prescriptions filled is run at the end of each day as an additional backup. These records are maintained for a minumum of five years in accordance with Indiana statute IAC 1-29-3.

ANNUAL REVIEW


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SUBJECT: PHARMACY TECHNICIAN RESPONSIBILITIES AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To outline the legal responsibilities of the pharmacy technician as well as those spelled out in her job description.


The pharmacy technician fulfills all the qualifications for licensure and maintaining a license (856 IAC 1-35-4 through 7 and IC 25-26-19-1 through 9), abides by the purpose and scope of the duties she may and or may not perform. The pharmacy technician identifies herself verbally and with a nametag as a pharmacy technician. The pharmacy technician also fulfills those “non-pharmacy” functions, e.g. billing, as spelled out in her job description.

ANNUAL REVIEW


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SUBJECT: PHYSICIAN MEDICAL BAG AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To provide medications and supplies to physicians who treat athletes on the field or court.


Each physician who attends student athletic events is supplied with a medical bag containing the drugs and supplies necessary to provide no more than a 72-hour supply of medication. The pharmacist checks these bags at least twice a year and as needed for replacement of outdated or additional supplies. Charges for these medications/supplies are made to the individual sport.

ANNUAL REVIEW


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SUBJECT: POISON CONTROL/ANTIDOTE INFORMATION AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To provide antidote information and care for suspected poisonings or overdoses. PROCEDURE AND/OR GUIDELINES:

Refer to Risk Management, Policies and Procedures for “Poisonings”. ANNUAL REVIEW


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SUBJECT: PRE-PACKAGED MEDICATIONS AND RECORDS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To prepare and maintain in the pharmacy supplies of medications and their dispensing records that are repackaged for use at the Health Center in the inpatient unit and Triage, as well as medications repacked for distribution from the two athletic training rooms.


The pharmacist repackages medication as a filled prescription (QS1) in compliance with Indiana statute 856 IAC 1-21-1. The label contains the following information: a prescription number that will act as a lot number, the area that it will be dispensed to, e.g. Inpatient Unit, date of fill, name of the medication, expiration date or “date not to be used after” (1 year from the dispensing date or the expiration date from the stock bottle--whichever comes first), name and dose of medication, brand and generic name and ingredients, if applicable, quantity dispensed, NDC# from the stock bottle and name of physician in charge. This information is recorded in a "prepackage" log book, which is maintained in the pharmacy.

ANNUAL REVIEW


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March 2011 Date Revised Approved by: ______________________________________ Office of Student Affairs ______________________________________ Director, University Health Services ______________________________________ Medical Director ______________________________________ Chief Pharmacist

SUBJECT: PRESCRIBING AND DISPENSING OF MEDICATIONS FOR ADHD PURPOSE

To provide medications to students who have a documented diagnosis of ADHD within the legal and ethical bounds of filling CII prescriptions.

POLICY

All patients who wish to have prescriptions written for medication for ADHD (CII) by University Health Services physicians must undergo testing or show proof of testing, meet with a UHS physician at least once a year and sign a yearly contract with the Health Center physicians agreeing to their conditions for obtaining these prescriptions. All records are maintained in the patient chart. Prescriptions for these medications may also be filled from physicians outside of the Health Center using diligent discretion of validity as described by Indiana and federal law (CSA 21 USC, 829).


Students may request a new prescription from a Health Center physician through the Pharmacy if they have had prescriptions written for them in the past by a Health Center physician and have fulfilled their obligations of providing records, seeing the physician and signing a contract. The request is attached to the patient chart and forwarded to the physician. The nurse will present the Pharmacy with a new prescription for filling. Students who have prescriptions for CII medications written by physicians outside of the Health

Center must provide a new prescription each time. The pharmacist has the obligation to inquire as to the validity of any prescription she deems necessary by calling the physician's office to verify the prescription before filling. Prescriptions must be written on appropriate prescription blanks and must be written entirely in the physician's hand or electronically printed and signed by the physician.

ANNUAL REVIEW


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SUBJECT: PRESCRIPTION PADS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To provide prescription pads to the physicians in the Health Center and Counseling Center and maintain their security.


Consecutively numbered prescription pads are ordered for the Health Center and Counseling Center physicians. Security pads, which fulfill the requirements of Indiana statute 856 IAC 1-34-2, are provided for writing controlled drugs. Duplicate prescription pads are supplied for writing all other prescriptions. The copy is maintained in the patient chart. Upon request, prescription pads are signed out to a physician by pharmacy staff in a designated log book. The date issued, person issued to, place issued to and issuer are recorded in the log with the numbered Rx pad(s). If a pad is stolen, it may then be traced to its origin. Furthermore, as a matter of daily routine, offices, exam rooms, and treatment rooms are monitored for securing prescription pads from theft. If a prescription pad is left out, it is secured and the responsible party is reminded in writing.

ANNUAL REVIEW


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SUBJECT: PRESCRIPTION SIGN-OUT

AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To provide documentation of receipt of prescriptions. PROCEDURE AND/OR GUIDELINES:

Each prescription received by a patient signs a prescription receipt on a log retained in the Pharmacy. The log is dated and initialed by the pharmacist or pharmacy technician who dispenses the medication. A notation is made whether consultation was provided to the patient or refused. If the prescription is a controlled drug, the receipt will also include a state or federal ID. Each person picking up a prescription for a controlled drug must present valid state or federal ID. A patient may request that another individual pick up a prescription for him/her, but he/she must provide name of the individual and present appropriate ID. Log pages are filed in a monthly folder, which is maintained with other Pharmacy records.

ANNUAL REVIEW


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SUBJECT: PRESCRIPTIONS FOR VARSITY ATHLETES PURPOSE To provide medications to students athletes where there is a need to allow the athlete to

perform in his/her sport. POLICY The athletic department may pay for prescriptions for varsity athletes under certain

conditions as prescribed by the NCAA. PROCEDURE and/or GUIDELINES

Students identify themselves as varsity athletes to the pharmacist. Prescriptions for these students are not billed directly to their student account when they are filled. At the end of each month, a list of these prescriptions is provided to the head athletic trainer to determine which medications are eligible for payment. A journal entry from the Athletic Department to the Health Center reimburses the Pharmacy for eligible charges. Non-eligible charges are billed to the student account.

ANNUAL REVIEW


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SUBJECT: PROCUREMENT STANDARDS OF PHARMACEUTICALS PURPOSE

To ensure compliance with regulatory and legal requirements and to ensure the integrity and appropriateness of pharmaceuticals used or administered, all such items must be reviewed and authorized for use by a licensed pharmacist.

POLICY

All pharmaceuticals used or administered by University Health Services shall be retained and dispensed from the Pharmacy according to Indiana statute 856 IAC 1-28.1-7.


The chief pharmacist shall be responsible for specifications as to quality, quantity and source of supply of all pharmaceuticals, biologicals and chemicals used in the diagnosis and/or treatment of patients of University Health Services.

ANNUAL REVIEW


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March 2011


SUBJECT: PROFESSIONAL JUDGMENT PURPOSE

The pharmacist always exercises professional judgment when choosing to fill or not fill a prescription, taking into consideration the best interest of the patient and the legality of the prescription as stated in Indiana statute IC 25-26-13-16.

POLICY

The pharmacist exercises professional judgment in honoring or refusing to honor a prescription.

ANNUAL REVIEW


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SUBJECT: PSEUDOEPHEDRINE PURCHASES AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE: To comply with Indiana law (IC 35-48-4-14.7) and federal laws (Combat

Methamphetamine Epidemic Act of 2005) regarding purchase and sale of products containing pseudoephedrine and ephedrine.


Pharmacy personnel have fulfilled the “Self-Certification” requirement of CMEA and the certificate is posted in the Pharmacy. All OTC pseudoephedrine products are stored behind the pharmacy counter. A sign is posted in the Pharmacy regarding sale of pseudoephedrine products, according to Indiana law. Purchasers must present valid official state or federal ID and must be eighteen years old. OTC purchases are entered in the Indiana database (NPLEx by January 1, 2012), mandated by the aforementioned Indiana law. Signatures are maintained in an accompanying signature log. A monthly printout of purchases is filed in the Pharmacy. Students without ID may present a written prescription from the physician. A supply of a single-dose of pseudoephedrine, either 2x30mg tablets or 1 Mucinex D (60mg), labeled for use, is available from the Triage nurse for dispensing when the Pharmacy is closed. A log sheet accompanies this supply for signing out each dose given.

ANNUAL REVIEW


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SUBJECT: PURCHASE ORDER AND INVOICE PROCESSING AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To document the procedure for purchasing medications and supplies for the Pharmacy and the Health Center.


All purchases (except petty cash purchases) are made by one or two processes through Procurement. 1. Blanket accounts are set up at the beginning of each fiscal year with Procurement for the expected purchases of frequently used, direct purchase and expected charges. These purchasers include AmerisourceBergen (wholesaler), Moore Medical and DeKroyft (medical supplies and equipment), Sanofi Pasteur, GSK and Merck (vaccines) and QS1 (phamacy software). 2. Other purchases are made through the BuyND system with purchase orders for less frequently used products. Purchases over $500 require approval of Pharmacist, Health Center Director and directors at Student Affairs. All payments are made through Procurement.

AUTHORIZED PERSONS:

Pharmacist, Pharmacy Technician or Agent ANNUAL REVIEW


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SUBJECT: RABIES EXPOSURE- VACCINE AND RABIES IMMUNE GLOBULIN AUTHORIZATION: Chief Pharmacist

DATE: March 2011

PURPOSE:

To administer rabies vaccine and immune globulin for a possible rabies exposure. PROCEDURE AND/OR GUIDELINES:

If appropriate to treat exposed patient at Health Center, the following procedure may be followed: 1. Calculate the dose of rabies immune globulin (Imogam) required, 0.06ml x wt (lb)=dose (ml). 2. Call Memorial Hospital Pharmacy (647-7405 or 647-7548) to borrow the Imogam. Arrange for a pick up from the Hospital. 3. Call Sanofi Pasteur (1-800-vaccine) to receive next day delivery for replacement of Imogam to the Hospital. 4. Several doses of Imovax or Rabavert (rabies vaccine) are available at the Health Center for the commencement of immunization according to CDC guidelines.

ANNUAL REVIEW


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SUBJECT: RECALLED DRUGS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To dispose of recalled drugs. PROCEDURE AND/OR GUIDELINES:

Notification of drug recall may be made through several sources, including but not limited to, local and national media, wholesaler, FDA website, or manufacturer. For any level of product recall or withdrawal by the FDA, the Pharmacy will act immediately. Existing stock is examined in the Pharmacy and in all areas of the Health Center and campus for recalled products or lot numbers. If a recalled product is found, it is removed from stock and returned to the appropriate agency per the recall letter instructions. Copies of recall documentation are initialed, dated and filed for at least two years. If the product is recalled at the consumer level, every effort will be made to track down and notify patients who may be affected of the recall. If no stock exists, this is noted on the letter of recall and is initialed, dated, and filed for at least two years.

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SUBJECT: REFRIGERATOR ALARMS AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To ensure the functioning of refrigerators within the Health Center where pharmaceuticals, medications and allergy serums are stored.


There are seven refrigerator zones within the Health Center that are equipped with the Sensor 800 alarm system. The handbook for this system is stored in the Pharmacy for ready retrieval. The various zones are listed in the chart below with their assigned temperature ranges.

Zone Location Refrigerator/Freezer Low High

1 105-Travel Refrigerator 34 48

2 107-Pharmacy Refrigerator 34 48

3 107-Pharmacy Freezer -20 6

4 118-Triage Refrigerator 34 48

5 128-Allergy Refrigerator 34 48

6 128-Allergy Freezer -20 6

7* 230B-Inpatient Refrigerator 34 48

*inactivated A log for checking the functioning of the system is posted near the keypad (across from the Health Center front desk). A check of the system—the current temperature from the keypad and from actual refrigerator thermometer readings is done at least monthly.

Furthermore, a system for alerting personnel to a refrigerator zone being out of range is in place. The alerting sequence is as follows:

Alarm Sequence Calls Phone#

Keypad Alarm Keypad

Health Center Health Center Front Desk 631-7567

1 Betsy Creary RPh 288-0161 (home)

2 Betsy Creary RPh 850-2864 (cell)

3 Ruthann Heberle RN 271-0990 (home)

4 Ruthann Heberle RN 274-1587 (cell)

5 Mary Ellen McCaslin RN 219-363-9613 (cell)

6 Annie Kleva RN 269-782-9613 (home)

7 Annie Kleva RN 276-8785 (cell)

Alarm response is as follows: Alarm will first sound at the control panel, across from the front desk. Press ALARM CANCEL button on keypad to acknowledge. Attend to alarmed zone if necessary. If not responded to: Alarm will call 631-7567 at front desk. Press 5-5-5 on telephone keypad to acknowledge. Attend to armed zone if necessary. If not responded to: Alarm will begin to call responder list phone numbers from 1 to 7 until someone responds to the alarm. Press 5-5-5 on telephone keypad to acknowledge. Attend to armed zone if necessary. Responding to an alarm may involve simply responding to the alarm and/or it may involve moving vaccines and medication to another refrigerator and requiring repair of a refrigerator. If it is necessary to access the Pharmacy to attend to a refrigerator alarm, the nurse supervisor or her agent and security will enter the Pharmacy as described in Pharmacy Policy and Procedure, “Security in the Pharmacy”. Each responder has a card containing this information and it is also posted by the alarm keypad and by the front desk phone.

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March 2011


SUBJECT: RESTRICTED MEDICATIONS POLICY

University Health Services Pharmacy is owned and operated by the University of Notre Dame and certain medications have been determined to be restricted and subject to assessment by UHS physicians.

Birth control devices and medications: Under certain circumstances, medication that is normally used for birth control may also be prescribed for other medical purposes. Students requiring these medications/devices must permit verbal or written documentation of their diagnosis from their physician in order to fill the prescription. Documentation of the diagnosis is maintained in the patient chart.

PURPOSE

Provide medications to students for documented diagnoses according to the philosophy and standards of the University.


The pharmacist informs the student of the University policy on birth control. With the student’s

permission the pharmacist contacts the physician's office to verify a medical diagnosis. The medical diagnosis is written on the prescription and a photocopy of the prescription is placed in the student chart.

ANNUAL REVIEW


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March 2011


SUBJECT: PRESCRIPTIONS FOR VARSITY ATHLETES POLICY

The athletic department may pay for prescriptions for varsity athletes under certain conditions as prescribed by the NCAA.

PURPOSE

Provide medications to student athletes where there is a need to allow the athlete to perform in his/her sport.


Students identify themselves as varsity athletes to the pharmacist. Prescriptions for these students are not billed directly to their student account when they are filled. At the end of each month, a list of these prescriptions is provided to the head athletic trainer to determine which medications are eligible for payment. A journal entry from the Athletic Department to the Health Center reimburses the Pharmacy for eligible charges. Non-eligible charges are billed to the student account.

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March 2011 Date Revised Approved by: ______________________________________ Office of Student Affairs ______________________________________ Director, University Health Services ______________________________________ Medical Director ______________________________________ Chief Pharmacist

SUBJECT: SCOPE OF SERVICE POLICY

University Health Services Pharmacy is licensed as a Type II Pharmacy as defined in Indiana statute IC 25-26-13-17. As such, service includes inpatient dispensing to students admitted to inpatient services at University Health Services; outpatient services to defined populations (see Policy & Procedure for “Eligible Populations for Pharmacy Services”); stocking of first aid supplies throughout campus, and pharmaceutical services to the Athletic Department under the direction of University Health Services physicians.

ANNUAL REVIEW


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March 2011

Date Issued Approved by: ______________________________________ Office of Student Affairs ______________________________________ Director, University Health Services ______________________________________ Medical Director ______________________________________ Chief Pharmacist

SUBJECT: SECURITY FOR THE PHARMACY POLICY

Only the pharmacists and a nurse supervisor or her designated nurse agent have access to a key to the Pharmacy as described in Indiana statute 856 1-28.1-8.

PURPOSE

A nurse supervisor or her designated agent (nurse) may enter the pharmacy for retrieval of a medication or to attend to a refrigerator or burglar alarm.


If it is necessary for the nurse supervisor (or her agent) to attend to a burglar alarm, a refrigerator alarm or retrieve a medication, she will call Notre Dame Security (1-5555) to accompany her and to disengage and reset the alarm. If the burglar alarm is activated, the pharmacist, nurse supervisor or her agent will unlock the door, but Notre Dame Security will enter the Pharmacy first to secure the premises. A refrigerator alarm may require that the pharmacist, nurse supervisor or her agent move refrigerated items to another refrigerator. If it is necessary for a medication to be taken from the Pharmacy, documentation of medication taken, including a physician’s order are made and the pharmacist reviews this process within 24 hours according to the above statute.

Whenever entry is made into the Pharmacy during non-business hours, the time, date, purpose and signature are made into the entry log, located next to the refrigerator.

SECURITY FOR THE PHARMACY

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SUBJECT: VALID PRESCRIPTION AND MEDICATION ORDERS

AUTHORIZATION: Chief Pharmacist DATE: March 2011

PURPOSE:

To verify the validity and accuracy of prescription and medication orders. PROCEDURE AND/OR GUIDELINES:

Valid prescriptions are those prescriptions that meet all state and federal requirements (Section IX-Valid Prescription Requirements, DEA Pharmacist’s Manual, 2010 Edition, page 28 and 29, Indiana codes 856 IAC 2-6, 856 IAC 1-28.1-7, and IC-16-42-3-6). These orders may be written on valid and appropriate prescription blanks, faxed copies, or they may be communicated orally to a registered pharmacist. The pharmacist receiving the order will immediately reduce all information onto a readily accessible instrument (paper or computer). (Schedule II prescriptions may not be faxed or communicated orally to the pharmacist.) It is the responsibility of the dispensing pharmacist to verify the identity of the transmitting or writing party by legal identifiable methods, which include but are not limited to the following:

1. Physician or physician's office - name, address, phone number, DEA number of physician and identity of person making the call or from a written prescription. 2. Faxed prescriptions - Must state on the prescription "valid by facsimile (fax) only" or be verified verbally with the physicians office as in 1. (Indiana code 856 IAC 1-31-2) 3. Transferring prescription from another pharmacy – Prescription must include pharmacy name, phone number, address, Rx number and prescription information, original date, original date of fill, last refill, quantity remaining, pharmacist's name, DEA number, and date of transfer. (Indiana code 856 IAC 1-32) 4. Transferring prescription to another pharmacy – Must “void” the prescription in the computer (QS1) and on the original hard copy of the prescription and include

the pharmacy name, phone number, address, date of transfer, pharmacist name, DEA number. (Indiana code 856 IAC 1-32-2 through 4))

Valid medication orders are those orders received from staff physicians to treat patients in Triage or the inpatient unit. These orders may be written into the patient record, or may be communicated orally to a registered nurse who will immediately reduce the order to writing, identifying it as a verbal order. Medication orders do not constitute a prescription.

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