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EFFECTIVE DATE:     5/96                                                    REVIEW DATE: 12/04

 POLICY EDITION:        3                             REVISION DATE:      12/01

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      WISHARD MEMORIAL HOSPITAL POLICY

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DEPARTMENT:               Pharmacy Services            POLICY NO.:    731-515

TITLE: Compounding Pharmaceutical Products            SUBJECT:   Compounding

      PURPOSE

 To provide guidelines for the general compounding procedures for Wishard Health Services Department of pharmacy Services.  The process shall log all compounds such that products can be tracked in case of ingredient recall by manufacturer or FDA.

       POLICY

 The compounding of all medication products shall be performed in accordance to ASHP and USP guidelines and standards, thus insuring that an appropriate product is dispensed.

         SPECIAL INSTRUCTIONS

 I.          Non-Sterile Medications

A.  Non-sterile compound medications shall be compounded by approved pharmaceutical procedures utilizing approved equipment.  All preparation areas and equipment shall be cleaned prior to preparing a compounded medication.  Standard formulations shall be maintained in a Pharmacy Formulation Notebook.  Non-standard formulations shall be researched and documented to determine effectiveness, stability and compatibility before being prepared.  A log book will be maintained for all compounded medications.

1.    All compounded medications prepared by pharmacy technicians shall be verified by a pharmacist prior to mixing.  The pharmacist shall initial the log book.  The pharmacist=s initials verify the following:

a.      Correct medication and strength

b.      Correct volume and/or quantity of ingredients

c.      Correct calculations

d.      Correct balance adjustment (if balance used)

e.      Correct balance measurements (if balance used)

f.      Correct labeling

2.    A log book will be maintained for all compounded medications (Appendix).  The following information must be recorded.

a.      Date

b.      Ingredients

c.      Manufacturer

d.      Manufacturer lot number

e.      Manufacturer expiration date

f.      Quantity prepared

g.      Number of units prepared

h.      Comments

I.      Initials of individuals filling/checking

j.      Final disposition of compound (RX#, or inpatient area or clinic)

3.     Each unit of use container will be labeled with the name of the medication, strength, quantity and an appropriate expiration date assigned.

4.     The number of batches and specific numbers of unit-of-use items will be recorded for Monitrend Workload Monitoring.

5.    All areas and equipment shall be cleaned and returned to proper location(s) immediately after use by the responsible person who used the equipment.

II.   Sterile Medications

A.  Sterile compounded medications shall be compounded by approved pharmaceutical procedures, utilizing approved equipment.  Sterile Compounds shall be prepared in sterile environments, utilizing sterilized equipment.  Standard formulations shall be maintained in a Pharmacy Formulation Notebook.  Non-standard formulations shall be researched and documented to determine effectiveness, stability and compatibility before being prepared.  A sterile compound log book will be maintained for all sterile compounded medications.

1.    All compounded medications shall be verified by a pharmacist prior to mixing/admixing.  The pharmacist shall initial the log book.  The pharmacist=s initials verify the following:

a.      Correct medication and strength

b.      Correct volume and/or quantity of ingredients

c.      Correct calculations

d.      Correct balance adjustment (if balance used)

e.      Correct balance measurements (if balance used)

f.      Correct labeling

 

2.    A log book will be maintained for all compounded medications (appendix).  The following information must be recorded.

a.      Date

b.      Ingredients

c.      Manufacturer

d.      Manufacturer lot number

e.      Manufacturer expiration date

f.      Quantity prepared

g.      Number of units prepared

h.      Comments

I.      Initials of individuals filling/checking

3.     Each unit of use container will be labeled with the name of the medication, strength, quantity and the appropriate expiration date.

4.     The number of batches and specific numbers of unit-of-use items will be recorded for Monitrend Workload Monitoring.

5.    All areas and equipment shall be cleaned and returned to proper location(s) immediately after use by the responsible persons who used the equipment.  Equipment which needs to be resterilized shall be returned to CSR with proper identification for appropriate sterilization.

 

                                                                                                                                                    

      Director of Pharmacy                                                         Date

 

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