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APhA Policy Manual

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POST-MARKETING SURVEILLANCE

Browse policies organized by category. Select a category to view the related policy statements.

1 categories • 3 policies
Pharmacogenomics/Personalized Medicine
BIOTECHNOLOGY NEW DRUG APPLICATIONS AND INVESTIGATIONAL NEW DRUGS PHARMACEUTICAL CARE PHARMACY PRACTICE POST-MARKETING SURVEILLANCE

  1. APhA supports the inclusion of pharmacogenomic analysis in the drug development/approval and postmarketing surveillance processes.

2023
Pharmacist’s Role in Patient Safety
EDUCATION, CURRICULUM AND COMPETENCE FOR PHARMACY PHARMACY PRACTICE POST-MARKETING SURVEILLANCE PRESCRIPTIONS AND PRESCRIPTION ORDERS QUALITY ASSURANCE

  1. It is APhA’s position that patient safety initiatives must include pharmacists in leadership roles.
  2. APhA encourages dissemination of best practices derived from nationally aggregated reporting data systems to pharmacists for the purpose of improving the medication use process and making informed decisions that directly impact patient safety and quality.
  3. APhA encourages the profession of pharmacy to continually review and evaluate ways to enhance training, curricula, continuing education and accountability of pharmacists to improve patient safety.
  4. APhA encourages risk management and post-marketing surveillance programs to be standardized and include infrastructures and compensation necessary to allow pharmacists to support these patient safety programs.
  5. APhA supports the creation of voluntary, standardized and interoperable reporting systems for patient safety events to minimize barriers to pharmacist participation and to enable aggregation of data and improve quality of medication use systems. The system should be free, voluntary, non-punitive, easily accessible, and user friendly for all providers within the healthcare system.
  6. APhA supports the elimination of hand-written prescriptions or medication orders.

2021
Post-marketing Surveillance
POST-MARKETING SURVEILLANCE

  1. APhA supports and encourages the active participation of pharmacists in initiating, organizing, and maintaining post-marketing surveillance programs including, but not limited to, adverse drug reaction reporting and drug product problem reporting for drugs and other health care products.
  2. APhA recognizes post-marketing surveillance as a process that systematically and comprehensively monitors the patterns of use and the harmful or beneficial effects (whether expected or unexpected) of prescription and non-prescription drugs and other health care products as they are used in the general population. The ultimate purpose of post-marketing surveillance is to develop and systematically disseminate information that can be used to provide safe and cost-effective drug therapy.
  3. APhA supports the development of educational programs to foster the active involvement of pharmacy practitioners and students in post-marketing surveillance programs.
  4. APhA encourages public and private collaboration in the funding and development of post-marketing surveillance methodologies and programs.
  5. APhA encourages FDA and the pharmaceutical industry to actively involve pharmacists in spontaneous adverse reaction reporting systems and to provide appropriate and timely feedback on collected data.

2015
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