Pharmacy formulary system Policy is enumerating the aspects of how the hospital formulary is being managed through the the pharmacy department as well as unapproved indications for all formulary items and out of stock medication management.
As usual with most of the policies sample posted here, there is some default data that should be listed in the policy header and footer. Below are some of the info that you need to include in your pharmacy formulary system policy header:
- Hospital name, obviously.
- Pharmacy department operational policy and procedure, this header just to notify the reader that the following policy belongs to which department.
- Policy code or Number, for filing/indexing purposes.
- Edition Number, same purpose as above.
- Title of the policy, in our case; it would be pharmacy formulary system.
- Important dates [date reviewed, approved date, effective date and due for review date].
- Applies to [department] in this case it should be pharmacy department
- And last but not least, you’ll mention the nature of the policy, whether it’s going to be multidisciplinary or department specific. (Multidisciplinary policy)
Pharmacy Formulary System Policy
Definitions
- Formulary system: is a system describing the addition and deletion of drugs to/ from the approved medication list by pharmacy & 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 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.
Purpose
To set responsibility, authority, standards and other information relative to the procurement, preparation, distribution, restriction, approved indications and utilization of drugs at the hospital.
Policy
- The pharmacy department under the auspicious of the pharmacy and therapeutic P&T committee will operate a closed formulary, which is reviewed annually by the committee for any addition, deletion and drug restriction.
- Formulary shall be updated on an ongoing basis and published every three years.
- Formulary shall be available in pharmacy department and all patient care areas.
- All health care team will be informed of changes in writing on timely basis for any drug restrictions, formulary additions and deletions.
- 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 go thru non formulary drug process.
- 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.
- The use of unapproved indication or off labeled drug is full responsibility of the treating physician.
- The use of unapproved indication or off labeled drug needs prior approval from the head of the department before using in particular patient.
- Clear justification and references should be submitted along with request for single patient use formulary drug for an unapproved indication form.
- The pharmacist on duty is responsible to follow the procedure in case of out of stock medication depends an urgency patient situation.
Procedures and responsibilities
Formulary Designation
- Pharmacy and therapeutics committee will approve drugs only on the basis of safety, efficacy and cost effectiveness to be most advantageous in patient care shall be designated as formulary drugs. These drugs are listed in the formulary and routinely stocked by pharmacy department. Drugs are included in the formulary by their generic and brand names.
- Physicians shall prescribe drugs by their generic names.
- Pharmacy department will be responsible for procurement and stocking of most advantageous brands.
Formulary Addition
The requesting physician has to complete of the request form [request for addition of a new drug to the formulary) and get it approved by department head & medical director.
The form mentioned above must be sent to the P&T committee secretary.
The requesting physician shall consider the benefits of the requested drug in order to control the growth of the formulary, whenever possible.
After primary approval from the pharmacy department, the P&T committee secretary shall include the addition request in the agenda for the next meeting for the final decision.
If the P&T committee primarily approve the addition request a copy of the formulary update form will be sent to the concerned department and another copy will be sent to pharmacy purchasing office through P&T committee secretary in order to start the procurement process of the requested drug.
In case of disapproval of the request by the P&T committee, the secretary of P&T committee will notify the requestor by sending him a copy of the formulary update form (disapproved)
Note …. For each new drug addition, there should be a deletion of at least one drug from the formulary whenever possible.
The pharmacy purchasing officer will generate a computer stock code and a purchase order for the estimated quantity of the new drug as per approval of P&T committee.
Pharmacy supervisor will notify the physician upon receiving the drug by using (drug availability notification) form.
The pharmacy store supervisor will notify the medical and pharmacy staff for the availability of the approved new drug up on receiving, thru pharmacy director.
The primarily approved drug will be subjected to a further evaluation by both prescriber and pharmacy supervisor according to the approval criteria for a period of three months using the attached evaluation form.
The evaluation form of the primarily approved drug shall be submitted to P&T committee to for final decision.
Formulary Deletion
- A pharmacist or a physician can initiate deletion of a drug from the hospital formulary / pharmacy formulary by completing the formulary deletion request form.
- Deletion of a drug from formulary may be due to drug is no longer effective, not available the country, or another drug is considered to be more effective or same efficacy with less side effects.
- Submission of the completed form to P&T committee secretary for decision.
- A copy of the P&T committee formulary updates form (deletion) signed by and P&T committee chairperson will be submitted to pharmacy purchasing officer who will:
- Cancel all pending purchase order(s) and procurement of the deleted drug.
- Notify the pharmacy store supervisor to stop ordering of the deleted drug and to utilize any existing quantities.
- Notify all pharmacy supervisors of the deleted drugs.
- Deactivate the deleted drug in the computer master list.
- Delete the drug from the hospital formulary / pharmacy formulary.
Drug Restriction
Formulary drugs may be restricted in their use either by:
- Medical service, (e.g. Drug restricted to use by psychiatric specialist only).
- Prescribing criteria (e.g. A drug restricted to use by specific indication).
- Patient care area (e.g. A drug restricted to use only in ICU).
Using of Formulary Drugs for Unapproved Indication.
Management of Out of Stock Formulary Medications.
Attachments
- Attachment A: form for addition of new drug to the formulary.
- Attachment B: form for deletion of drug from formulary.
- Attachment C: monitoring of patient response to newly assed drug to the formulary.
- Attachment D: Form for P&T committee formulary updates.
- Attachment E: Request for Use of Formulary Drug for an Unapproved Indication form.
- Attachment F: Form for Drug availability notification.
- Attachment G: Pharmacy Borrowing Form.
You’re almost done and pharmacy formulary system policy is almost ready, what’s remaining is just few basic policy layout filling.
- References.
- Revisions: Revised as per timescale.
- Distribution: Here you should mentioned where this policy will be sent, and which departments will get a notification for it; for our current pharmacy formulary system policy we are going to sent it to:
- Chairperson of P&T committee.
- Pharmacy director.
- Pharmacy purchasing officer.
- Pharmacy store supervisor.
- Outpatient & inpatient pharmacy supervisors.
- Nursing director.
- Pharmacy department.
- Signed originals is maintained in manual 81 indexing office.
The policy is now finished, and it’s time to get proper signatures, whether your hospital is implementing an electronic signatures, or manual sign and stamp.
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