(Hospital Name) Pharmaceutical Services
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PHARMACEUTICAL SERVICES

A.     FORMULARY POLICIES & PROCEDURES

1.    DEFINITION & DESCRIPTION OF THE FORMULARY

The formulary is a continually revised compilation of pharmaceutical information (plus important ancillary information) that reflects the current clinical judgment of the medical staff. Only pharmaceuticals so selected by the medical staff, working through the Pharmacy & Therapeutics Committee, are routinely available from the Pharmacy.

2.    THE PHARMACY & THERAPEUTICS COMMITTEE

The Pharmacy & Therapeutics Committee is an advisory group of the medical staff and serves as the organizational line of communication between the medical staff and the pharmacy. This committee is composed of physicians, pharmacists, and other health professionals selected with the guidance of the medical staff. It is a policy recommending body to the medical staff and the administration of the hospital on matters related to the therapeutic use of drugs.

The primary purpose of the Pharmacy & Therapeutics Committee are (1) advisory and (2) educational. It recommends the adoption of, or assists in the formulation of, policies regarding evaluation, selection and therapeutic use of drugs.

The functions of the Committee are:

  • to serve in an advisory capacity to the medical staff and hospital administration in all matters pertaining to the use of drugs (including investigational drugs);

  • to develop a formulary of drugs accepted for use in the hospital and provide for its constant revision. The selection of items to be included in the formulary is based on objective evaluation of their relative therapeutic merits, safety, and cost. The Committee strives to minimize duplication of the same basic drug type, drug entity, or drug product;

  • to establish programs and procedures that help ensure cost-effective drug therapy;

  • the Committee specifies those drugs which are therapeutically equivalent with regard to strength, dosage form and frequency of use. Those drugs when prescribed may be exchanged by the pharmacist assigned to that patient.

  • to participate in quality-assurance activities related to the distribution, administration, and use of drugs;

  • to review adverse drug reactions occurring in the hospital;

  • to initiate or direct drug-use review programs and studies and review the results of such activities;

  • to advise the pharmacy on the implementation of effective drug distribution and control procedures;

  • to make recommendations concerning drugs to be stocked in hospital patient-care areas.

3.    REGULATIONS FOR PRESCRIBING AND DISPENSING MEDICATIONS

a.     Writing Medication Orders and Prescriptions

Medication orders for inpatients must be entered on the physicians order sheet. A complete order consists of the following:

  • the patients name;

  • the non-proprietary (generic) name of the drug ordered;

  • the dosage form;

  • the strength of the drug;

  • the directions for administration of the drug including route and frequency;

  • the signature of the physician writing the order; along with their identification number (must include at all times) and their pager number where they can be reached.

  • the date and time the order is written.

An order changing the dose or route of administration of a drug should be identified as a change. If the new order requires a change in the route of administration or in the size or type of dosage form, it should clearly specify this.

All drugs should be ordered or prescribed by non-proprietary (generic) names. All drugs will be dispensed by the non-proprietary name or approved therapeutic equivalent unless otherwise specified by the ordering physician. Medication orders and prescriptions must be written using the metric system and approved abbreviations.

Orders for medications not included in the Formulary must be accompanied by a “Formulary Drug Request Form” to be completed by the ordering physicians. The pharmacist may consult the attending staff physician prior to filling orders for such preparations. Such medications are not normally stocked by the pharmacy, necessitating a delay in filling the request (usually 4 to 24 hours). Nonformulary drugs either have not been considered by the P&T Committee, or have been judged to be inferior or only equivalent to other drugs already on the formulary. Non-formulary drugs can be brought into the hospital upon the approval of the chairman of the P & T Committee or their designee.

b.     Antibiotic Restriction Program

Prior approval by an ID Physician is needed before certain anti-infectives can be prescribed. The anti-infectives are:

  • Imipenem/Cil. (Primaxin);

  • Meropenem (Merrem) (Adults);

  • Aztreonam (Azactam)

  • Lipid Amphotericin-B Formulations (Abelcet or Ambisone)

  • Linezolid (Zyvox)

  • Quinupristin/dalfopristin (Synercid)

Prior to writing the order, the physician must page (Pager Number Here).

An ID physician who shall review the case will answer the page.

If approved, the order can be written.

The ID physician will call the Pharmacy for release of the medication.

Without prior approval, NO medication will be sent.

c.  Verbal/Telephone  Orders

1.    Physician's verbal and telephone orders can only be accepted and recorded by a Registered Nurse.

2.3.     To accept verbal/telephone orders the Registered Nurse will:

    3.1      Repeat the order to the physician

    3.2      Enter the date, time and order on the physician's order sheet legibly.

    3.3      If the order is for a medication, the order should include: name, strength, dose form and route of administration.

    3.4      Sign the order including:

  • indicate T.O. for telephone order

  • print the physician's full name and title

  • name, title, date and time

4. All telephone orders must be countersigned by the physician within twenty four (24) hours.

d.  Stat and Now Medication Orders

“Stat” orders for medications will be given immediately. The use of this term should be reserved for emergency situations and not be used to denote an initial dose.

"Now” orders for medications will be administered within 30 minutes. This term should not be used to denote an initial dose.

Initial doses of medications will be administered at the next regularly scheduled administration time unless otherwise requested. If a drug is ordered “Stat” or “Now”, and then is to be continued at regular intervals, the next dose will begin at the next regularly scheduled administration time.

e.     Controlled Substances

Use of narcotics, amphetamines, barbiturates, and other designated dangerous drugs are controlled in the United States by the Drug Enforcement Administration (DEA). Individuals prescribing and dispensing controlled drugs are required to registered with DEA. Physicians wishing to prescribe controlled drugs should register for Schedules II, III, IV, and V with DEA. Registration in Schedule I is needed only for those physicians who wish to conduct research using substances which presently have no accepted medical use, have an extremely high potential for abuse or possess hallucinatory proprieties. DEA assigns the physician a nine digit registration number.

A listing of controlled substances in the Formulary is presented in Part II, Table B.

f.     Generic Substitution

Pharmacy will fill medication orders and prescriptions with approved, stocked generically identified product regardless of the brand name for which the medication order or prescription is written.

Drugs are approved for generic substitution by the Pharmacy & Therapeutics Committee.

Two or more drugs products are considered to be generic equivalent if they contain the same active ingredients and are identical in dosage form, strength and route of administration. They may differ in other characteristics such as color, taste, shape, packaging, expiration time, and labeling.

The pharmacy strives to stock only one brand of a drug for which generic equivalents are available. Selection of which brand to stock is governed by procedures approved by the Pharmacy & Therapeutics Committee.

g.     Automatic Stop Order and Renewal Policy

Responsibility: The Director of the Pharmaceutical Care Division is to ensure compliance with this policy.

Purpose: To establish procedures to assure the proper management of medication and minimize risks to the patients while maximizing appropriate medication regimens. This will allow the medical practitioner to determine whether the drug administration is to be continued or altered.

Policy:    All re-written medication orders must be specific to the name of the drug, strength, route and frequency of administration. Unless a physician writes for a specific duration of drug therapy all drugs (see specific exemptions) will expire after 8 days. No “duration of hospital stay” orders can be written.

Exceptions:

1.   ALL Schedule II     48 hours (2 days) except Methadone P.O., Duragesic patch (8 days)

2.    Anticoagulants (inc. IV. heparin and warfarin) 48 hours

3.    *Antibiotics are good from time written for:

        a.  empiric therapy  72 hours (3 days)

        b.  prophylactic   1-3 doses over 24 hours - must be specified by physician.

        c.  therapeutic   120 hours (5 days)

All orders not specifying duration of therapy will be discontinued after 72 hours.

4.    Intravenous solutions with or without additives shall be valid for 48 hours from time written.

5. The Chief of any service may specify that certain drugs should require daily renewal, e.g. research medication, anti-neoplastics and any other toxic medication. the Pharmaceutical Care Division and Nursing shall be notified in writing of these changes.

6.    Methadone may be administered or dispensed in an oral form ONLY when used in a treatment program. Hospitalized patients under care for a medical or surgical condition or permitted to receive methadone in a perenteral form when the attending physician judges it advisable. (Federal Register Vol. 54 No 40 March 1989)

7. All existing medication orders shall be reviewed and re-written by the accepting physician when a patient is transferred to or from the operating room or another unit. Medication orders for patient transferred from one unit to another but within the same service need not be re-written.

8.    sodium polystyrene sulfonate (24 hours)

9.    Ketoralac injectable 120 hours    (5 days) NOT RENEWABLE.

*Physician notification tag will be placed on patient chart by nursing, If NOT renewed, medication will be automatically discontinued as per Stop Order Policy.

h.     Emergency Carts

Emergency carts are maintained on all  nursing units. Immediately following use, nursing personnel will contact central supply (ext. number here) and obtain a replacement container.

i.   Floor Stock Items

There is no floor stock at (Hospital Name). All items come directly from the pharmacy as needed for the patient.

j.     Reporting Adverse Drug Reactions and Medications Event

Any healthcare professional can report a medication event/adverse drug reaction. Upon discovery of an actual or potential medication event or adverse drug reaction, please notify the Pharmacy Department at (number or extension here).

An FDA-reportable adverse drug reaction is defined as:

  • All adverse reactions to newer prescription drugs (e.g., on the market less than five years);

  • All adverse reactions to older therapeutic and diagnostic agents when (1) the reaction is serious and not listed in the labeling and (2) the older drug has been used in conjunction with other drugs where the possibility of interaction exists;

  • Unusual increases in numbers or severity of reactions;

  • Incidences of therapeutic failure which suggest possible problems with drug bioavailablity;

  • Congenital anomalies;

  • Overdoses to newer therapeutic agents when the reaction is severe or not listed in the labeling.

  • All serious or unusual adverse reactions to nonlegend medications.

Physicians, pharmacists, and nurses are expected to report all suspected adverse drug reactions. When a suspected adverse drug reaction has been judged to meet the FDA guidelines, an FDA DRUG EXPERIENCE REPORT (form FD-1639) will be completed and forwarded to the Food and Drug Administration.

k.     Patients Use of Medications Brought From Home

Every effort will be made by Nursing to return all medication brought by the patient to a family member. When this is not possible, these medications will be inventoried, stored and returned at discharge along with any other patient valuables.

If a medication brought from home by the patient is to be administered in the hospital to the patient, a medication order must be written by the physician. The medication must be identified by the Pharmacy. Each dose will be dispensed by the Pharmacy and must be documented in the MAR.  Each dose taken by the patient must be documented in the MAR.

l.   Patients Self-Administration of Medications

1. Self-administration of medication by patients is not permitted except by special request of the physician and then is restricted to antacids and oral S.L. Nitroglycerine tablet as follows:

1.1 Patients shall not administer drugs to themselves unless, specific permission had been written on the Medication Order Sheet by the physician responsible for the care of the patient.

1.2 Patient must be instructed as to proper use in self-administrating of the drug.

The Director of Pharmacy is to ensure compliance with this policy.

m. Policy Regarding Drug Samples

Distribution of medication samples by pharmaceutical company representatives in the hospital is forbidden. Complimentary samples may be provided directly to physicians or other appropriate health care professionals only in response to specific request.

n.  Adding Drugs to the Formulary

Drugs are admitted to the formulary according to their non-proprietary (generic) names. No drug or preparation shall be admitted to the formulary unless its formula or composition is known and its therapeutic value has been established to the satisfaction of the Pharmacy and Therapeutics Committee.

Any member of the Medical Staff may request the addition of a drug to the formulary by submitting a request, along with supporting information, to the Pharmacy. Pharmacy will forward the request, along with supplemental information gathered by the Drug Information Service, to the Pharmacy and Therapeutics Committee. For each drug, specific consideration is given to:

  • pharmacologic classification

  • therapeutic indications

  • dosage forms available

  • bioavailability and pharmacokinetics

  • dosage range

  • known side effects and toxicities

  • special precautions required

  • advantages of the drug over similar agents

  • disadvantages of the drug compared to similar agents

  • therapeutic comparisons with other drugs or treatments

  • cost comparisons with other drugs or treatments.

o.  Removing Drugs from the Formulary

Request for deletion of a drug from the formulary shall be submitted in writing to the Director of Pharmacy who shall forward the request, along with supplemental information gathered by the Drug Information Service, to the Pharmacy and Therapeutics Committee for action. The Committee may invite the requesting party to attend this meeting and discuss the request.

The formulary is reviewed yearly in its entirety by the Pharmacy and Therapeutics Committee to assure that it contains only those drugs most useful for patient care. The Committee may elect to delete any non-emergency drug where usage velocity reflects a relative lack of use.

p.     Regularly Scheduled Doses

Unit-Dose Distribution System

Additional labels may have to be typed for large items which will not fit into the standard zip-lock bags or for items which should be individually labeled, e.g. antacids, ointments, nitroglycerin tablets.

Medical Abbreviations

Medication orders which contain abbreviations can only be dispensed if these abbreviations appear on a list specifically approved by the medical staff. Any other abbreviation must be clarified with the prescribing physician.

Regularly Scheduled Doses

The following times serve as guidelines for the scheduling of medication doses in the (Name here) Hospital. These times have been approved by the medical staff and are stated in the Department of Nursing policy and procedures.

Frequency          Administration Time                      Doses to be  
                                                                    Supplied by Pharmacy

h.s.                      10 PM                                              1

q.d.                      10 AM                                              1

bid                       10 AM - 6 PM                                    2

tid                        10 AM - 2 PM - 6 PM                         3

qid                       10 AM - 2 PM - 6 PM - 10 PM             4

ac                        1/2 hour before meals                         3

pc                        1/2 hour after meals                            3

q2h                      10-12-2-4-6-8-10-12-2-etc.                  12

q3h                      9-12-3-6-9-12-3-6                               8

q4h                      10-2-6-10-2-6                                     6

q6h                      12-6-12-6                                           4

q8h                      6 AM - 2 PM - 10 PM                          3

q12h                    10 AM - 10 PM etc.                             2

q.  TPN (Hyperalimentation Orders:)

A) All orders for Neo Natal TPN orders can be written for 7 days (Tuesday-Monday). All Adult TPN orders can be written for 3 days.

B) All new TPN orders as well as change orders for existing TPN solutions must be received in the Pharmacy (B-134) no later than 12 Noon daily.

r.     Chemotherapy Orders

All orders for Chemotherapy must be written and then reviewed in the Chemotherapy Pharmacy Laboratory Room (Number Here) no later than 12 Noon on the day therapy is to be administered. This service is provided Monday through Friday between the hours of 8 a.m. and 3 p.m. Telephone number for the Chemotherapy Laboratory is (Number Here).

   NOTE:  No Chemotherapy orders will be prepared by the pharmacy, evenings, nights or weekends.

s.     Controlled Substances

A resident, when eligible, must register individually but may meanwhile - use the Hospital registration number when prescribing controlled substances to hospital inpatients. The housestaff officer must also use the 4-digit code number assigned to them. Individual identification code numbers are available from Medical Records Department and are kept on file with the Office of Graduate Medical Education.

B. LOCATIONS AND HOURS OF OPERATION

Hours of Services

1. The Pharmacy Administration offices are located (location info here).

2. The Administrative Offices are open daily, Monday through Friday excluding holidays from 8:00 AM to 4:00 PM.

3. The Pharmacy Administrative Offices may be reached daily during the listed above on extensions (Numbers Here) and the Director at (Number Here).

4. The In-Patient Pharmaceutical Service Laboratory listed room (Number here) may be contacted by calling extensions (Number here).

5.    Hours of the Chemotherapy Pharmacy located in (Number Here) are Monday through Friday from 7:00 AM to 3:00 PM excluding holidays. Weekend coverage is provided on an on-call basis from the Central Pharmacy. All medication will be provided for weekend coverage.

6. The Central In-Patient Pharmaceutical Service Laboratory is open 24 hours/day, seven (7) days/week, 365 days/year.

1.  CLINICAL PHARMACY SERVICES

Clinical Pharmacy Services provide consultations and assistance in the following areas:

  • drug use evaluation (DUE)

  • adverse drug reaction (ADR) reporting

  • drug-related educational activities.

  • discharge counseling for selected medications

  • pharmacokinetics

C. REFERENCES FOR DETAILED DRUG INFORMATION

The following drug reference works are available in the (Location Here)

  • AHFS Drug Information        

  • Facts & Comparisons

  • Physicians Desk Reference

  • Trissels Handbook on Injectable Drugs

  • Harriett Lane Handbook

  • APHA Geriatric Dosage Handbook

  • APHA Pediatric Dosage Handbook

  • ASHP Medication Teaching Manual

  • other appropriate related texts and journals.

 

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