"The Tan Sheet" is your go-to source for coverage and analysis of FDA's proposed "new paradigm" for approving nonprescription pharmaceuticals under conditions of safe use. See below for a sample of our extensive coverage of the agency's recent public hearing.
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New Paradigm Needs Clear Switch Criteria, Standard Dispensing Rules
by Elizabeth Crawford (email@example.com)
FDA should address concerns associated with consumers’ substantial role in self-care and the potential benefits of pharmacist oversight when developing the criteria to identify candidate drugs for nonprescription status under a potential new paradigm for drug approvals, health care experts say.
The agency intends to consider on a case-by-case basis what types of drugs can be made nonprescription if additional “conditions of safe use,” such as information technology or intervention by a pharmacist, are applied to help consumers appropriately self-select and use the products.
While each case will be unique, several health care leaders who presented at a public hearing March 22-23 in Silver Spring, Md., suggested FDA should standardize criteria for determining a drug’s switch potential under a new paradigm as well as processes for ordering and dispensing the drugs once they are switched.
The new criteria should expand on current OTC switch standards, but also take into account the added self-care burden placed on patients and the beneficial role of pharmacists, said Cynthia Reilly, director of the Practice Development Division of the American Society of Health-System Pharmacists.
Specifically, she suggests switch candidates under the new paradigm should:
- Have a well-established benefit-to-risk ratio
- Have a wide safety margin
- Not be systemic or an anti-infective agent about which emergency resistance is a concern
- Have a long marketing history as an Rx product in a large patient group to determine serious side effects
- Have evidence of efficacy and safety at the dose proposed for switch
- Be used for a condition that is readily detected by a patient or provider
- If necessary, require a level of lab work or monitoring by a pharmacis.
- Have reliable early warning signs that a pharmacist or patient can readily detect if toxicity can result in death or serious harm.
The products also should have uncomplicated instructions for use, said Marissa Schlaifer, the Academy of Managed Care Pharmacy’s director of pharmacy affairs.
She suggested FDA standardize dispensing and record-keeping requirements to include:
- Adding information about the products and the patient’s use of them to the patient’s medical record
- Standard clinical evaluation and interventions that pharmacists can follow prior to dispensing the drug
- Training on the selection of appropriate medicines and monitoring requirements
- How to protect patient health information
- When to refer patients to physicians or other health care professionals.
Other presenters at the meeting also noted a new paradigm for nonprescription approvals should require that pharmacists are reimbursed for their additional services, and that pharmacists likely would need additional liability coverage.