formulary-system-unapproved-indication-and-out-of-stock-medication

Hello, Hope you're having a good day.

This page is a free sample showing what a hospital policy should look like. It can work at your place, you might need to modify it a little. The hospital here is HOSPITAL X. You might need to change that to your own institution name.

HOSPITAL X

PHARMACY DEPARTMENT POLICY AND PROCEDURES

Code / Policy No:

OPP/-

Edition No:

3

Title: 

FORMULARY SYSTEM, UNAPPROVED INDICATION AND OUT OF STOCK MEDICATION

Replaces:

OPP-PHARM-00

Date reviewed:

Oct 2020

Approved date:

Oct 2020

Effective date:

Oct 2020

Due for review:

Oct 2022

Applies to:

PHARMACY DEPARTMENT

Nature:

MULTIDISCIPLINARY

FORMULARY SYSTEM, UNAPPROVED INDICATION AND OUT OF STOCK MEDICATION

definitions

Formulary System: is a system describing the addition and deletion of drugs to/ from the approved medication list by Pharmacy and Therapeutic (P & T) Committee on the basis of safety, efficacy and cost effectiveness to be most advantageous in patient care.

Unapproved Indication: indication for which the drug is not licensed in FDA and still documented in respected reference as unapproved/ unlabeled or off labeled indication.

Out Of Stock Medication: is HOSPITAL X Formulary Drug that is currently not available in pharmacy and is needed within 24 working hours for life saving drugs and 48 working hours in case of non life saving drugs.

Life saving situation: is a condition where it is necessary to administer a particular life saving drug within 24 working hours in order to prevent what might result in a serious adverse patient event.

Policy purpose

To set responsibility, authority, standards and other information relative to the procurement, preparation, distribution, restriction, approved indications and utilization of drugs at HOSPITAL X

Policy

  1. The pharmacy department under the auspicious of the Pharmacy & Therapeutic (P & T) Committee will operate a closed formulary, which is reviewed annually by Pharmacy & Therapeutic (P & T) Committee for any addition, deletion and drug restriction.
  2. Formulary shall be updated on an ongoing basis and published every three years.
  3. Formulary shall be available in pharmacy department and all patient care areas.
  4. All health care team will be informed of changes in writing on timely basis for any drug restrictions formulary additions and deletions.
  5. Physicians shall not prescribe any medicine which is not included in the formulary (Non formulary drugs) and they shall consult and coordinate with pharmacy department before going thru non formulary drug process.
  6. The formulary drugs should be prescribed/ordered only for their approved indications. If the physician prescribed/ordered a formulary drug for unapproved indication, he/she should submit to the pharmacy with the medication evidence based documentation through a Request for Use of
    Formulary Drug for an Unapproved Indication.
  7. The use of unapproved indication or off labeled drug is full responsibility of the treating physician.
  8. The use of unapproved indication or off labeled drug needs prior approval from the head of the department before using in particular patient.
  9. Clear justification and reference/s should be submitted along with request for single patient use of formulary drug for an unapproved indication form.
  10. The pharmacist on duty is responsible to follow the procedure in case of out of stock medication depends an urgency patient situation.

**start herePROCEDURE & RESPONSIBILITIES

Procedure

Responsible Person/s

  • Not more than two (2) keys shall be available in outpatient pharmacy.
  • The outpatient pharmacy supervisor and the senior pharmacy clerk are the only pharmacy staff shall have the key.
  • The outpatient pharmacy shall be opened by the pharmacist supervisor or his/her designee.
  • The outpatient pharmacy shall be closed by the pharmacy senior clerk or his/her designee.
  • In case of emergency may happened in outpatient pharmacy out of duty hours, a copy of outpatient pharmacy keys will be available in inpatient pharmacy, safety staff, security man and pharmacist on duty (if possible) will be able to take the key and open the pharmacy to do the necessary action and they should return back the keys directly after solving the problem.
  • A form of (receiving the keys during emergency) will be filled by concern people.Inpatient pharmacies are opened 24 hours and the access shall be limited only to authorized personnel.
  • All medications that transferred from pharmacy to (unit/ward) or vice versa, should be only through locked medication trolleys or/and closed medication boxes.
  • For narcotics and controlled room one key is available with the narcotic & controlled in-charge and another backup kept with pharmacy supervisor.
  • Narcotics & controlled medications are stored in secured steel lockers inside a room with double door as per legal regulations.
  • All wards/units that have medications floor stock should be kept in locked cabinet inside secured medication room, narcotic and controlled medications should kept in a duple door cabinet, crash cart must kept locked.
  • Inventory for HOSPITAL X pharmacies for their stocks (medicines, paramedical items, cosmetics) is done annually and whenever it is necessary.

Outpatient pharmacy supervisor and senior pharmacy clerk

policy DISTRIBUTION:

CEO & Medical Director
Pharmacy Board
Quality Management Department
Signed original is maintained in Manual & Indexing Office

Recommended

inpatient Pharmacy Supervisor

outpatient Pharmacy Supervisor
HOSPITAL X

Approved

Chief Executive Officer (CEO)
HOSPITAL X


>