Understanding Rems for Drug Approval
The main factor that determines drug approval is whether the related benefits outweigh risks. FDA REMS goes beyond the labeling of the product for risk management. Main considerations in this regard are the following:
- seriousness of condition or disease
- expected treatment duration
- patient population size
- drug expected benefits
- seriousness of potential/known adverse events
Such evaluations are not only necessary for the approval process but also continue through the drug life cycle. This way it is possible to assess the efficacy and safety of the existing drugs continuously based upon event reports and clinical post marketing studies. For every drug the FDA approves, associated usability risks are communicated via inserts and product package. Going beyond this for risk management involves REMS.
FDA may call for REMS at any product life-cycle stage. Manufacturers get 120 days for submission for marketed drugs. In case of new drugs, manufacturer needs to include proposed REMS as per NDA submissions. After approval, it will create enforceable manufacturer and FDA obligations. Specific element outline is available for the pharmaceutical companies to follow. They should include these within specified documents.
It should be both specific and concise including explicit components and goals at different points, right from launch. Any failure with compliance regarding this and medical device usability testing will lead to misbranding along with substantial penalties. Proposed REMS contains various elements such as:
- Medication guide: patient documents highlighting drug safety information that pharmacists need to distribute to patients when they receive these drugs.
- EASU: elements for assuring safe use involve controlled strict systems in place for enforcing drug’s appropriate use. This includes certification requirements of the physician for drug prescription, patient's central registry enrolment, and drug distribution restricted to specialty pharmacies.
- Communication plan: this involves health care professional education regarding appropriate, safe drug use. It contains materials and tools disseminated to appropriate stakeholders.
- Implementation plan: this refers to description of EASU implementation.
- Assessment submission timetable: it is assessment frequency of REMS performance in perspective of associated objectives and goals. According to FDA, one should undertake this first after 18 months, and three years and then seven years after the launch of the drug. Send the evaluation reports to FDA for determination of additional modifications and actions to REMS program.
There are separate instructions for the physicians regarding eligibility for the prescriptions, requirements for first prescription, and things to follow. For prescribing, they need to review the prescribing information of the drug, pharmacy and prescriber training program. They need to complete the assessment form. Submit this to application holder, and enroll REMS after completion and submission of enrolment prescriber form.
Before prescribing, they need to counsel patients regarding associated risks and complete agreement form between patient and provider. Patients also need to undergo counseling regarding the drug they are going to use and sign the agreements. Everyone has some kind of responsibility including the wholesalers, inpatient and outpatient pharmacies.
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ABOUT THE AUTHOR
James Williams is an expert when it comes to Risk Evaluation and Mitigation Strategies aka REMs in relation to the medical industry. He recommends BioTrak.com as the name you should be trusting for any information related to medical device usability testing, FDA standards and more.
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