Dr. Tahereh Safarnavadeh Clinical Pharmacist The Formulary Process In the Name of GOD.
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Dr. Tahereh Safarnavadeh Clinical Pharmacist The Formulary Process the Name of G
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Transcript of Dr. Tahereh Safarnavadeh Clinical Pharmacist The Formulary Process In the Name of GOD.
Dr. Tahereh Safarnavadeh
Clinical Pharmacist
The Formulary Process
In the Name of GOD
What We are Speaking about
The Formulary Process
The Formulary List (Essential Medicines List,“EML”)
o Criteria in medicine selection
o Developing and implementing a formulary list
o Managing a formulary list: adding and deleting drugs
o Maintaining a formulary
o Improving adherence to a formulary
Hospital formulary
What is Formulary Process The cornerstone of rational drug use
Consists of preparing, using and updating
Standard treatment guidelines (STGs)
a Formulary list (essential medicines list, EML)
a Formulary manual
STGs and EMLs Lead to Better Prevention and Care
Hospital formulary
Criteria in Medicine Selection according to WHO (1999)
Sound and adequate data on efficacy and safety in a variety of medical settings
Adequate quality, including bioavailability and stability under the conditions
Efficacy, safety, quality, price and availability are used for similar medicines
The cost of the total treatment must be considered
Some casese may be influenced by PK properties, or local considerations
Most essential medicines should be formulated as single compounds
Drugs are specified by generic name
Hospital formulary
The Results of Appropriate Selection of Drugs
Cost containment and enhanced equity in access to essential medicines
Improved quality of care
Hospital formulary
The Steps in Developing and Implementing a Formulary List
Step 1Prioritize a list of common diseases and problems by
o Consulting all medical departments
o Reviewing the previous hospital mortality and morbidity records
Determine the choice treatment using STGs endorsed by
o The health ministry
o WHO
o Unbiased professional organizations and academia
o Expert committee
Hospital formulary
The Steps in Developing and Implementing a Formulary List
Step 1 continued
The alternative methods but not recommended:
o Reviewing the existing formulary list of the hospital concerned
o or any other hospitals in the country.
o The WHO model list of essential medicines (WHO 2002a)
The staff should not be forgotten
Hospital formulary
The Steps in Developing and Implementing a Formulary List
Hospital formulary
The Steps in Developing and Implementing a Formulary List
Step 2 continued
Each department, must be given the chance to comment on the list
The DTC must deliberate on their comments and provide feedback
All information to be discussed and deliberated upon , must be available such as:
o Disease profile
o STGs
o Evidence-based reviews where possible
Finally, the DTC must agree and disseminate the formulary list and the reasons
for its choices.
Hospital formulary
The Steps in Developing and Implementing a Formulary List
Hospital formulary
The Steps in Developing and Implementing a Formulary List
Step 4
Hospital formulary
Educate staff about the formulary list and monitor implementation
Managing a formulary list (EML): adding and deleting drugs
Hospital formulary
Managing a Formulary List (EML): Adding and Deleting drugs
Evidence from the literature to support the inclusion \
Declaration of interest
The request should be sent to the DTC secretary
The request is evaluated by the responsible person
Hospital formulary
Evaluations of Applications to Add new Medicines to the List
The efficacy, effectiveness and safety of the medicine as assessed by literature
Whether the hospital has the necessary clinical expertise and laboratory services
An estimation of the cost
Availability of the drug on the market
Managing a formulary list (EML): adding and deleting drugs
Criteria for consideration ofo New treatments for conditions not amenable to existing drug therapy
o Or treatments representing major improvements in survival and quality of life
Evaluations of applications to add new medicines to the list
Managing a formulary list (EML): adding and deleting drugs
Criteria for treatments representing minor improvements in therapy compared to existing listed medicines
Evaluations of Applications to Add new Medicines to the List
The committee should consider all of the above and in addition: Whether the new drug is really therapeutically equivalent, and not inferior in terms of
o Efficacy
o Safety
o Convenience of dosing/administration
Whether the total cost for a course of treatment with new drug is less
Managing a formulary list (EML): adding and deleting drugs
Criteria for treatments that are therapeutically equivalent to existing listed medicines
Evaluations of Applications to Add New Medicines to the List
Non-response or contraindications to available medicines
Stabilization on a non listed medicine before admission to hospital
Changing to another drug is detrimental
Managing a formulary list (EML): adding and deleting drugs
Criteria for use of non-formulary medicines
Evaluations of Applications to Add new Medicines to the List
Danger of increasing antimicrobial resistance with inappropriate drug use
The danger of serious side effects that could occur with inappropriate drug use
Managing a formulary list (EML): adding and deleting drugs
Criteria for restricting the use of certain drugs to specified specialist prescribers only
Written Report of the Drug Evaluation
Is compiled by the person who conducted the evaluation
Is discussed at a scheduled DTC meeting.
Managing a formulary list (EML): adding and deleting drugs
Written Report of the Drug Evaluation
Should contain the following information:
The drug monograph, Including Pharmacology
Pharmacokinetics
Efficacy as compared to placebo and other medicines
Clinical trial analysis (from the literature)
Adverse drug reactions
Drug interactions,
Cost comparison
Managing a formulary list (EML): adding and deleting drugs
Written Report of the Drug Evaluation
Should contain the following information: (continued)
Recommendations based on the evidence-based information
Expert recommendations
How much the new medicine would cost the hospital
Whether the new drug
o Belongs to the national EML
o Whether it is reimbursable by health insurance schemes
Managing a formulary list (EML): adding and deleting drugs
Discussion and voting procedures
The final decision should then be disseminated to all health-care staff in the form of
Minutes
Newsletters
And at departmental meetings.
Managing a formulary list (EML): adding and deleting drugs
Non-Listed Requests
A register of all non-listed medicine requests should be kept by the pharmacy
o The name of the requesting doctor
o The name and quantity of the medicine
o The indication for which the medicine was requested
At the end of the year, this information can tell the DTC about
o Prescriber adherence to the formulary list
o Can also help in deciding whether or not to add drugs onto the list
Managing a formulary list (EML): adding and deleting drugs
Pruning The List
If a new medicine is added, delete the previous medicine for two reasons:
o If the ‘new’ medicine is better, why continue to have a less good ‘old’ medicine?
o If no effort is made to consider deleting medicines, the list will grow in size
Managing a formulary list (EML): adding and deleting drugs
Maintaining a Formulary
Routine review of therapeutic categories is an important part of formulary management
An efficient formulary management process will not passively wait for applications
New drugs and treatments are emerging all the time
Without evaluation, the formulary may become a collection of older, less effective drugs.
Managing a formulary list (EML): adding and deleting drugs
Maintaining a Formulary
Managing a formulary list (EML): adding and deleting drugs
Maintaining a Formulary
• DTC should meet regularly to discuss and decide upon:
o Requests for the addition of new medicines and deletion of old medicines
o Systematic review of a therapeutic class of medicines
o Review of programes to identify and resolve medicine use problems.
• All decisions of the DTC should be documented (minuted)
Managing a formulary list (EML): adding and deleting drugs
Principles of Formulary List Management Select drugs
according to the needs of patients choice for the conditions identified
Avoid duplications, both therapeutic and pharmaceutical (dosage forms)
Use explicit selection criteria, based on proven efficacy, safety, quality and cost
Use evidence-based information whenever possible Be consistent with national EMLs and STGs
Managing a formulary list (EML): adding and deleting drugs
Principles of formulary list management
Consider requests only when made by health-care staff
Requests are justified using documented evidence on
Efficacy
Relative efficacy
Safety
Comparative cost-effectiveness
The person requesting any new drug declare any conflict of interest
Carry out annual systematic reviews of all therapeutic classes to avoid duplication
Managing a formulary list (EML): adding and deleting drugs
Improving Adherence to a Formulary
Reviewing and taking action on all non-formulary medicine use:
o Adding the medicine to the formulary
o Educating the prescriber about the non-formulary status of the medicines or banning use of It
Hospital formulary
Improving Adherence to a Formulary
Prohibiting the use of non-formulary drug samples in the hospital
Establishing procedures and approved drug list for therapeutic interchange
or substitution
Hospital formulary
Improving Adherence to a Formulary
Providing easy access to the formulary list
o With copies at each drug ordering location
o And in pocket manuals for staff
Involving medical staff in all formulary decisions
Advertising and promoting all formulary changes
Establishing agreed procedures for clinical trials with non-formulary
medicines
Hospital formulary
Summary
Is critical to good health care and consists of developing and implementing:
Formulary list (essential medicines list) consisting of
o The most cost-effective, safe
o Locally available drugs of assured quality
o That will satisfy the health care needs of the majority of the patients
Formulary manual containing summary information on medicines
Standard treatment guidelines
Hospital formulary
Summary
Critical to future use by health workers is their involvement in
o The development and updating process
o The quality of the content
o User-friendly format
o Adequate distribution and follow-up supervision
Hospital formulary
