Pharmacist Roles in Drug Development PDF

ROLES OF PHARMACISTS IN DIFFERENT AREAS OF PRACTICE PHA 035: PERSPECTIVES IN PHARMACY PERIODICAL 2 WEEK 1 LEARNING OUTCOMES 1. Describe the role of pharmacists in the drug discovery and development process. 2. Demonstrate the pharmacist's role in pharmaceutical compounding, ensuring customized p...

ROLES OF PHARMACISTS IN DIFFERENT AREAS OF PRACTICE PHA 035: PERSPECTIVES IN PHARMACY PERIODICAL 2 WEEK 1 LEARNING OUTCOMES 1. Describe the role of pharmacists in the drug discovery and development process. 2. Demonstrate the pharmacist's role in pharmaceutical compounding, ensuring customized patient care. 3. Understand the pharmacist's involvement in pharmaceutical marketing strategies and retail operations. 4. Describe the role of pharmacists in navigating and ensuring compliance with pharmaceutical regulations. 5. Evaluate the role of pharmacists in public health initiatives and policy advocacy. 6. Describe the role of pharmacists in Pharmacy education 7. Describe the roles and responsibilities of pharmacists in hospital and institutional settings. 8. Describe the roles and responsibilities of pharmacists in the community setting. WHAT IS A DRUG? An agent intended for use in the Diagnosis Mitigation Treatment Cure Prevention of diseases in humans or in animals STAGES OF THE DRUG DEVELOPMENT PROCESS 1: Discovery and Development – research for a new drug 2: Preclinical Research – drugs undergo laboratory and animal testing 3: Clinical Research – drugs are tested on people 4: FDA Review – thorough examination of submitted data related to the drug and make a decision to approve or not to approve it 5: Post-marketing Safety Monitoring – monitoring of drug safety once the product is available for use by the public STEP 1: DISCOVERY AND DEVELOPMENT I. Discovering a new chemical entity:  Isolation from natural sources  Organic synthesis  Molecular modification  Existing drugs with new discovered use II. Conducting experiments to learn about:  The drug’s PHARMACOKINETICS (ADME)  Mechanisms of action  Safe dose and route of administration  Drug interactions STEP 2: PRECLINICAL RESEARCH Finding out whether it has the potential to cause serious harm (toxicity) In vitro – outside the cell In vivo – within the cell In silico - computer-aided 1. Preformulation studies – initiated to define the physical and chemical properties of the drug 2. Formulation studies – develop the initial features of the proposed pharmaceutical product or dosage form STEP 3: CLINICAL RESEARCH Researches will file INDA (Investigational New Drug Application) which consists of the data gathered from animal studies, toxicity studies, manufacturing information, clinical protocol, and information about the investigator. This should be submitted BEFORE starting clinical trials. The review usually takes 30 days and can either result in approval or clinical hold due to either of the following reasons: Participants are exposed to unreasonable or significant risk. Investigators are not qualified. Materials for the volunteer participants are misleading. The IND application does not include enough information about the trial’s risks. PHASES OF CLINICAL TRIALS PHASE 1 PHASE 2 PHASE 3 PARTICIPANTS 20-100 HEALTHY 100-1000 people with the More than 1000 VOLUNTEERS disease/condition volunteers with the disease or condition (diverse) LENGTH OF STUDY Several months Several months to 2 years 1 to 4 years PURPOSE Establish safe dose Efficacy and side effects in a Efficacy, monitoring of small population adverse reactions Study the general safety of the drug Dose response, dose ranging and dose determination STEP 4: FDA REVIEW The researcher/developer will file an NDA (New Drug Application). This includes reports on all studies, data, and analyses. The review team has 6-10 months to decide. Along with clinical results, developers must include: Proposed labeling Safety updates Drug abuse information Patent information Any data from studies that may have been conducted outside the country Institutional Review Board compliance information Directions for use STEP 5: FDA POST-MARKET SAFETY MONITORING Supplemental Application (SNDA) – filed if there are any changes to be made from the original NDA Abbreviated New Drug Application – to be filed by generic manufacturers after the patent protection of the innovator drug expires Product Line Extension (depending on the market response) ROLES OF PHARMACISTS DRUG RESEARCH Provide management of investigational products Participate in trial feasibility Research Pharmacists can assist in: Pre-study services - assist in medication research, including literature searches on any pertinent background information regarding the study drug. Study services include compounding, study drug packaging, storage/inventory control, dispensing, delivery, patient counselling, adverse-reaction monitoring, and record-keeping. Post-study services include destroying unused drug supply, analyzing study data, and providing for transition-of-care services. TRANSITION-OF-CARE involves assisting patients moving from study treatment to post-study therapy. It is important that participants be counselled on health management after they discontinue study medications. COMPOUNDING, MANUFACTURE, QUALITY ASSURANCE The production pharmacist is responsible for: Initial drug design formulation Public launch and sales Risk management Infection control programs Ensure implementation of CGMP (Current Good Manufacturing Practices) Regulatory compliance MARKETING AND RETAIL Product and service development Market research Communication projects Sales programs Customer relations Managing of marketing programs Development of business strategies Pharmacists working as marketing professionals must be willing to constantly educate yourself so you’ll remain up to date and informed on industry trends and products. PRODUCT REGULATION Regulatory pharmacists can work both in the private and public sectors. They are responsible for: ○ Obtaining authorization of medicines for use in clinical trials, registration and marketing ○ Act as the link between the company and the local regulatory authorities on matters relating to the quality, safety, and efficacy issues of drugs OTHER RESPONSIBILITIES ✔ Ensure approval of registration applications of all medicines in applicable countries. ✔ Ensure the maintenance/ update of registrations in accordance with the relevant legislation, regulations and guidelines ✔ Compilation of registration dossiers for submissions ✔ Perform QA on all artwork and approve all printed packaging material ✔ Ensure compliance with quality requirements on release of medicine for sale in line with GMP and Bayer policies and procedures. ✔ Prepare and update data for MDR, MIMS or any other external product database for all marketed products in liaison with the Regulatory Affairs Head. ✔ Establish and maintain effective relationships with all stakeholders PUBLIC HEALTH AND PHARMACEUTICAL POLICY The public health role of the pharmacist is yet to be clearly defined, broadly recognized, and sufficiently promoted by public health agencies, pharmacy educators or other HCPs. Pharmacists also have a role in developing “population-specific, evidence- based disease management programs and protocols based upon analysis of epidemiologic and pharmacoeconomic data, medication use criteria, medication use review and risk reduction strategies.” Pharmacists should also be trained to contribute to a variety of public health services and functions, particularly those involving abusive substances and medicines. PHARMACY EDUCATION Involved in teaching and training of the future generations of pharmacists as lecturers and professors, or pursue senior management positions within the university and become department heads and deans. Pharmacists in the academe also engage in research and consultancy work. Duties of an academic pharmacist include: ○ Administrative activities ○ Scientific research ○ Teaching professional student pharmacists ○ Supervising research and teaching graduate students ○ Student advising ○ Supervising interns in experiential practice HOSPITAL AND INSTITUTIONAL PHARMACY Institutional pharmacies refer to pharmacies of institutions, organizations, and/or corporations that provide a range of pharmaceutical services, given exclusively to the employees and/or their qualified dependents. Tasks include: ○ Dispense medications ○ Counsel patients ○ Compounding of medications ○ Assist in the procurement of drug supply  COMMUNITY PHARMACY Community pharmacists are the health professionals that are most accessible to the public. The roles and responsibilities of community pharmacists are as follows: Promotes rational drug use to patients and clients. Dispense nonprescription and prescription drugs Make and supervise the filling and refilling of prescriptions. Checking of the labels of all dispensed drugs. Checking validity of prescriptions Monitors quality of stocks and their inventory. Responds to laws and policies implemented by DOH-FDA. Shall be pharmacovigilant to drugs' auxiliary effects and adverse effects while they are in the market. End of Week 1