To characterize a good drug review for hospital formulary inclusion
Method
A systematic review was done in January 2017 on all new drugs reviewed in the past 10 years for inclusion into the formulary of a teaching hospital in Singapore. Evaluation reports of all new drug requests (excluding drug appeals) were retrieved and analyzed according to the nature of drugs.
Results
From 2007 to 2016, a total of 258 new drug requests were studied.
The most thorough examinations were done for new drug compounds. Appraisal criteria included perspectives from all healthcare professionals, as exemplified below:
1) Novelty: therapeutic class, mechanism of action, pharmacodynamics
2) Approval: both local and overseas authorities, indication, age limit
3) Dosage: ease of dosing and intake, adjustment in renal and hepatic impairments, drug-drug interaction [pharmacokinetics dependent]
4) Formulation: simplicity of administration / nursing, usual storage / handling, risk of selection error
5) Efficacy: place of therapy, level of evidence, comparative efficacy
6) Safety: warning or serious adverse drug reaction (ADR), common ADR, relative safety [implication on patient monitoring]
7) Cost: patient price, government subsidy
8) Usage: unmet need, predicted use
For line extension products (e.g. combination / modified-release tablets), the discussions were abbreviated, but included important criteria such as approval, dosage and administration.
Assessment of new biologic drugs were similarly if not more stringent than new chemical drugs, due to their high costs.
All write-ups were impartial and objective, without personal opinion of reviewer, so as not to influence the perceptions of voting members.
All data were presented clearly and straightforward, for the decision makers were all busy clinicians, with shortage of time to read unfocused lengthy reports.
Conclusion
New drug reviews should be comprehensive, for hospital formulary affects not only the physicians (common beliefs that the most cost-effective drugs have been selected for use in the entire hospital, hence indirectly / invisibly affecting prescribing patterns), but also the administrators (hospital budget required to stock these drugs). Reviewer should be clinically trained and be familiar with medical selection of drugs on the day-to-day ground, in order not to miss out any important considerations. Nevertheless, drug reviews could be abridged for line extension products, to shorten processing time and ease reviewer’s workload. The above criteria could be developed into a checklist to guide future decisions for hospital formulary inclusion, and cut-off points for approval be tailored to individual hospital’s comfort.
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