1. a)Major purpose/outcome of the doctor of pharmacy curriculum: -Prepare for a patient, pharmaceutical care, focused, centered pharmacist. Capable of acquiring licensure as a pharmacist. - Member of the healthcare delivery team. - Practitioner works in a patient care setting. b) Minor outcomes of the Pharm.D. program: - Abilities as a non-practitioner Rx that works indirectly with patients (Industrial, government) c) Nature of the Pharm.D. Degree: - Professional doctoral degree: Pharm. D., M.D., D.M.D., Ed. D., J.D., different from Ph.D. because its not specific to a specific field. Can get Ph.D. in any field to train to do research. 2. a)Pre-professional - Year 1 and 2 - Basic science - Calc/statistics - General electives in humanities and social sciences. -Professional - Years 3,4,5,6 P1,P2,P3,P4 - Pharm.D. Program b) General electives/professional electives - Professional electives are related to the field of pharmacy. c) Pharmaceutical (basic) science courses/pharmacy practice courses. - Pharmaceutics, medicinal chemistry, pharmacology, biotechnology. - Pharmacy practice ~ pharmaceutical care, Rx Tx (Pharmacotherapy), pharmacy economics, pharmacy management, pharmacy law, pharmacy ethics. d) IPE courses/APE courses IPE - Intro Practice Experience courses APE- Advanced Practice Expereince courses. P1, P2 - Summers have IPE P3, P4 - Summers have APE and P4 is all APE. (Rotations of give weeks each with 40 hours/week. 3) In order to progress into the professional part of the program: - Complete first 2 year curriculum - Minimum GPA of 2.8, slightly less than a B. - Must complete an interview , w/ Faculty member and student from upper class. - Looking for three things in the interview ~ understanding of what pharmacy is about. ~ Communication skills ~ Determine your ethical attitudes. In order to complete the professional part of the program: - GPA 2.5 - Maintain ethical standards. 4. Nature of the US healthcare system and the specific role the modern pharmacist plays as a part of that system, which, stated very succinctly, is: Patient centered pharmaceutical care - To be the expert on all aspects on the use of drugs in humans. 5. Professional academic program may differ fro other academic majors: - In Courses 6. The major career pathways available to pharmacy graduates divide between 2 broad categories: - Practitioner: Hospital, community, specialist. - Non-practitioner: Government, research. 7. Past experience indicates that the vast majority of students who complete this course will decide that: - Pharmacy is the path for them. However a few students will decide as a result fo this course that they will not continue in the Pharm.D. curriculum. Some reasons are: This might be beneficial for the student because?: -If students feel this is not the kind of work for them then they drop out, unsuccessful academically, unethical. 8. For students who decide that the Pharm.D. degree is the correct degree for them, what are some clues you can glean from this course as to how you can maximize your chances for success in school and inn a career after you graduate? - Get pharmacy training. - Maintain GPA - Don’t get Ds. - Adequate communication skills: Verbal, written, body language, listening. In summary: The fundamental elements of success in a pharmacy major; Academic, Ethical, having a realistic understanding. Students who are preparing to enter a career in the health professions, even during their pre-professional years, will benefit from developing a professional C.V. Due to : - Job interview - Any/teacher recommendation What is meant by the statement that a C.V. is "a work in progress?" - C.V. is continuously becoming an updated resume. Why do we suggest a standard format for the CVs that our pharmacy students prepare? - Helps guide us to the norm. Is it ok to deviate from the standard format? - Yes, it is our choice but still needs to resemble the norm. What are some items that are currently not considered appropriate for inclusion in a C.V.? -References, ethnicity, DOB, SSN, religion, martial status, or sexual orientation. Lecture 2 "What is Pharmacy?" "Pharmacy" as a "place" or a "site" Definitions- Pharmacy - Physical location where drugs are stored. Drugs may be compounded, dispensed sold. -Licensed pharmacist practice their profession. These pharmacists evaluate prescriptions and medication order. - Patients in hospital get medication orders. - Evaluate for interactions, Tx (Therapeutic treatment) appropriate, legitimacy, consulting patients of appropriate use, educate other healthcare professionals. - Rx issued by an authorized prescriber. What is a prescription? An order for a medication for a specific patient. -Forms of prescriptions Rx: Paper Telephone Fax E-mail, helps reduce medication errors due to handwriting. From an authorized prescriber, specifies: Name of patient. Name of prescriber. How to contact prescriber. DOI, Date of Issue. Quantity Drug Regimen What is a Drug Regimen? Name of Drug Brand Name Generic Name Chemical Name Dosage Form Strength, potency Route of administration, sometimes tells dosage form. Dose: Amt., frequency and duration. Ex. 500 mg. 8hr. 14 days. Special instructions on how to take medication. Authorized prescribers and prescriptive authority Determined by the State Full prescriptive authority, physicians. Initiative vs. alter. Ex. Physician prescribes (initiative) Limitation collaborative practice in disposed, pharmacist alters, pharmacist sees the patient often for ability to alter the drug. Pharmacist can give medication to tide over a patient. What is "limited prescriptive authority?" What kinds of drugs can be prescribed. Ex. Dentist prescribing heart medicine? To whom can you prescribe. Ex. Vet for human medicine. Independent vs. collaborative prescribing authority. Prearranged protocol APN(nurse practitioners) PA physician's assistant Pharmacist = MTM = medication therapy management. Related Terminology Drugstore vs. pharmacy - Drugstore- retail pharmacy. Is not applied to institution or clinical setting. Pharmacy - community setting. Druggist vs. Pharmacist Druggist is the older and improper form. R.Ph vs Pharmacist R.Ph, - not a degree, indication of licensure. Community Pharmacy vs. Retail Pharmacy Retail pharmacy is a better term. Medication; Drug; Medicine; Pharmaceuticals; Biologicals Medication - chemical in a finished dosage form intended to have bio pharmacological activity. Chemical- activity and Excipients - non-pharmacological activities. Rx - prevents, cures, dosage form, treats disease. Drug - negative connotation Medicine - Not as specific as medication. Pharmaceuticals - More than medication Biologicals - A pharmaceutical not derived synthetically or a plant Ex. Vaccines, bio tech drugs, protein-derived from modern molecular bio. "Pharmacy" as a "profession" Current implication - To optimize the outcome of pharmacotherapy in individual patients ( QOC - Quality of Life. List 8 characteristics of a "profession" Involve specific skills, knowledge, confidence. Involve a degree from a university Life long learning Service orientation (altruism) Patient centered Good oral character Licensure Membership and professional association In what way can "health professions" be considered to be "business" as well as "professions?" Healthcare is high-tech, costly Personnel intensive, with high training. Management, marketing, economics. Accounting, budgeting, and management of people. "Pharmacy" as a "business" Advertising, HR management (human resources). Core functions of pharmacists Overall function Patient-care, Rx care Collaborative chronic MTxM Drug distribution-dispensing function -Involves the efficient and safe system of product acquisition and provision for the patient. Right drug for the patient at the right time. Reimbursement - complex because of managed care. Compounding. Cognitive functions- functions Functions of knowledge, pharmacist only Ex. Counseling Collaborative chronic, MTxM ex. Hypertension, hyperlipidemia (cholesterol), Diabetes, asthma, aids, emphysema. Terminology - What is their significance of each team to pharmacy? Residencies and Fellowships Residencies structured experience, occur after graduation and licensure, last for at least a year, lower pay. Usually in hospital, industry, clinics, even community pharmacy. Do not lead to a degree but a certificate or credential. Residencies beyond a year are considered a fellowship - more specialized, fellowship imposes a heavier research emphasis. Formulation/Production/Compounding How you design a dosage form. Routes of Administration 1.GI route 2.Injection (parenteral) Sterile solutions Infusions 3. Topical Dermal, Mucosal, inhalations, patches, ointments, crèmes. Dosage Forms Pharmacists and patients with chronic diseases MTM Infusions Large Volume Parenterals (injections) Intravenous (intravascular), cancer chemotherapy drugs are given. TPN- Total parenteral nutrition Aseptic - non-infectious, without micro bacteria. Pharmacy Technicians Assistants to pharmacists to do non cognitive functions Experience, course in community college, certification test. Supervision of pharmacist, technicians mistake causes pharmacist liability Technicians work on non-cognitive functions. Drug dispensing. Give examples of "non traditional" roles for pharmacists. Explain what is meant by this. Career taksts that a more limited number of pharmacists pursue Pharmaceutical industry Drug discovery research Drug development and clinical investigation. Drug formulation and quality control. Q.C. Design dosage forms for new drugs. Drug information, drug safety, drug marketing and drug sales. Managed care Government agencies (military, FDA, pharmacy faculty member). Lecture 3 The U.S. Healthcare System and the Role of Pharmacists in the Healthcare System Diseases impacting the US Healthcare System: As indicated by the major causes of mortality Heart Disease Cancer Stroke Respiratory Diabetes, metabolic, cardiovascular (1 and 3) Accidents and Trauma Infectious diseases due to resistant organisms. Specific diseases with an increasing impact on the healthcare system Depression, obesity, Alzheimer's, and Parkinson's disease. Medication related morbidity - loss that occurs from illness - characteristics of modern pharmacotherapy - targeted to specific diseases, effective and potent, medications are harmful if not used correctly. ADR- adverse drug reaction. - problems leading to morbidity that is linked to pharmacotherapy - 1/2- 1 million Americans are sent to ER because of ADR. ODS - overdoses DDI - Drug drug interactions. - the pharmacist's potential to minimize drug-related morbidity - Expertise - access, accessible. - the 2 general types of drug errors or pharmacotherapy problems - Dispensing errors, realization that the Rx is bad. The major challenge in modern healthcare: Factors (General) driving healthcare costs Advances in biomedical science and technology Increase life expectancy Most people today get their healthcare paid for through insurance programs, desensitizing people from the true costs of healthcare. Costs of hospitals, physician services, pharmaceuticals. What is the GDP and how is it related to concerns about the overall costs of healthcare in the USA? GDP - Gross Domestic Product - total value of all goods and services. Produced in a certain country. How does the USA compare with other developed nations in terms of healthcare expenditures as a % of the GDP? US - 16%, healthcare costs are paid for by the company the person works for. Canada, UK, Spain, Switzerland, Germany. GDP % 8-12 % because others have universal healthcare. What is "Managed care," how is it related to the ever-increasing costs of healthcare, and why is it such a pervasive influence in health care today? Explain managed care using examples of it. Control and manage costs, utilization, quality and outcomes. HMO- Health maintenance organization, more restrictive. PPO - Preferred provider organization, less restrictive. PBM - Pharmacy benefit managers- medco, expresscripts, CVS/Caremark. What factors led to the rise of managed care its pervasive influence? Third part plants. Ex. Horizon BC/BS of NJ. (originally surgery cost) Ex. Aetna. Keeping costs down, Introduction in mid-1960s of Medicare and Medicaid. Medicare - elderly or disabled. Medicaid - Poor What is the perception of managed care? Providers - pharmacists, physicians, nurses, dentists - criticize that reimbursements are inadequate, complex programs. Patients/consumers - object to fact that managed care limits their access. Regulators/Legislators- its necessary means of containing costs. Pharmaceutical industry- fight managed care, fight Restrictive Formularies - will only allow to prescribe certain drugs, came out of Hospitals on restrictive formularies. Managed care and the future - will stay Summarize the influence and status of pharmaceuticals as a factor in the increasing costs of health care: Advancing technology, biotech drugs. Increase utilization of generics, costs down. Medicare Part B, increase costs. Pharmaceuticals are 15-20 % of healthcare monetary pie (healthcare dollar). What are some effects that the high cost of pharmaceuticals has on: The pharmaceutical industry- prestige goes down Pharmacy practitioners pushed pharmacists between PBM (Pharmacy Benefit Manager) and provider. Growth of mail order. Patients Forced many patients to consider less expensive ways of getting drugs. Lecture 4 Legal and Regulatory Realities Influencing Pharmacy Distinguishing between Laws and Regulations: Laws empower regulations, regulations stem from laws. How pervasive(to become spread throughout all parts of) is the influence of laws and regulations in healthcare? Very pervasive, heavily impacted by laws and regulations. Reasons why the profession of pharmacy and the pharmaceutical industry are particularly highly regulated: To protect the public health. Ensure drugs are safe and effective. To limit and control drug abuse and criminal use of drugs. To protect the public from being cheated from dishonest practitioners. Distinguish between Federal legislation/regulation and State legislation/regulation: Federal - laws passed by US congress (legislation) FDA- implement enforce laws (regulatory agency) DEA- Drug Enforcement Agency - involved in drugs of abuse (controlled substances) State- Trenton- senate and assembly. Pass laws, regulatory agencies. N.J. State board of medical examiners. (practitioners). Pharmacy ex. NJ state board of pharmacy State laws cant contradict federal laws. Federal- affect industry and practitioners. Classifying different general categories of laws: ~Criminal Law- pusher, illegal actions. ~Civil Law- ADR (adverse drug reaction) sued for damages ~Administrative law - Pharmacy regulations, ex. Outdated drugs, expired license. The Food and Drug Administration (The FDA, "The Agency"): ~ The FD&C Act- Food, Drug, and Cosmetic Act. Fundamental basis for FDA's authority, controls drug development process in pharmaceutical industry, as well as drug manufacturing in the industry. Controls over dispensing of drugs. ~ Adulteration and Misbranding of Drugs Substitution of inferior ingredients: Impure, subpotent, toxic, ineffective. ~Drug Safety- 1939 FDA made requirement that Drugs have to be proven safe when used as directed. This process of proving safety is done through clinical trials. ~ Drug Classes- 1951 - Regulations to establish classes of drugs - Rx only drugs, OTC drugs (non Rx). ~ Drug efficacy - 1962 - effective or efficacy (effectiveness) for approved indications.