Pharmacists' Roles in Pharmacy Practice PHA 035

Study Notes

Pharmacists play a vital role in drug discovery and development, involving various stages from research to post-marketing safety monitoring.
Their responsibilities include pharmaceutical compounding for customized patient care, ensuring tailored treatments based on individual needs.
Pharmacists are also involved in pharmaceutical marketing strategies, enhancing retail operations and customer engagement.
Compliance with pharmaceutical regulations is another key area where pharmacists navigate complexities to ensure adherence to laws and guidelines.
In public health, pharmacists advocate for policies and initiatives promoting community health and wellness.
Educational responsibilities encompass training future pharmacists and providing continuous education within the field.
In hospital settings, pharmacists manage medication therapies and collaborate with healthcare teams for patient safety.
Community pharmacists offer accessible healthcare services, including medication management, health screenings, and patient counseling.

A drug is defined as an agent used for diagnosing, treating, mitigating, curing, or preventing diseases in humans or animals.

Discovery and Development: Involves research for new drugs through isolation, synthesis, molecular modification, or discovering new uses for existing drugs.
Preclinical Research: Tests for drug toxicity using in vitro (outside the cell), in vivo (within the cell), and in silico (computer-aided) methodologies, along with preformulation and formulation studies.
Clinical Research: Requires submission of an IND (Investigational New Drug Application) containing prior studies and trial protocols before clinical trials can begin, usually reviewed within 30 days.

Phase 1: Involves 20-100 healthy volunteers to establish a safe dose and study general drug safety over several months.
Phase 2: Includes 100-1000 participants with the disease under examination, focusing on efficacy and side effects over several months to two years.
Phase 3: Engages over 1000 diverse volunteers to confirm efficacy and monitor adverse reactions for 1 to 4 years.

After clinical trials, an NDA (New Drug Application) is submitted, containing comprehensive data that the FDA reviews within 6-10 months.
Ongoing safety post-marketing involves filing a Supplemental NDA for any changes, an Abbreviated NDA for generics, and considering product line extensions based on market response.