Drugs & Pharmacists - Fall 2024 - PHAR 672 - Texas A&M

Drugs & Pharmacists H Stephen Lee, PharmD Professor, College of Pharmacy PHAR 672 Fall 2024 1 Lecture Objectives At the conclusion of this presentation, the learners should be able to 1. Describe the general expectations of the profession of pharmacy; 2. List the...

Drugs & Pharmacists H Stephen Lee, PharmD Professor, College of Pharmacy PHAR 672 Fall 2024 1 Lecture Objectives At the conclusion of this presentation, the learners should be able to 1. Describe the general expectations of the profession of pharmacy; 2. List the qualifications/requirement and professional expectations of a pharmacist; 3. Define what a drug is, the regulatory bodies, and the approval process related to a drug; 4. Define what dietary supplements and herbal products are, and how they are regulated; and 5. Describe selected pharmacy law and their impacts on the practice of pharmacy. 2 Pharmacy and Pharmacists What is the profession of Pharmacy? The science and practice of (1) Preparing and dispensing of drugs, and reviewing of appropriate drug use, and (2) Providing additional clinical drug services, examples: (1) Drug therapy recommendation and consultation (e.g. medication therapy management, MTM) (2) Drug therapy monitoring [checking for effectiveness AND safety] (3) Health promotion, advising and advocacy (e.g. vaccination) (4) Drug prescribing in very specialized situations usually done by physicians [MD, DO], physician assistants [PA], dentists [DDS], advanced registered nurse practitioners [ARNP]/advanced practice registered nurse [APRN]) Occasionally done by pharmacist (by collaborative agreements, (3) Research 3 Pharmacy and Pharmacists What is a pharmacy? A location where the pharmacy service is conducted and provided Who are pharmacists? Pharmacists are healthcare professionals who specialize in ensuring the safe and effective use of medications 1. Medication expert (e.g. dose, frequency, dose changing) 2. Medication therapy expert (e.g. WHEN to use a drug, WHEN NOT to start a drug, WHEN to STOP a drug) Be licensed in the state Age over 21 Be of good moral character Graduated from an accredited School of Pharmacy Pass the NAPLEX (national competency exam) with a score of 75 POINTS Pass the MPJE of Texas (Texas law exam) with a score of 75 POINTS Completed 1500 hours of advanced practice experience 4  What is a Drug? According to the U.S. Food and Drug Administration (FDA), a drug is defined as: 1. Articles recognized in the official United States Pharmacopeia (USP), official Homeopathic Pharmacopeia of the United States, or official National Formulary (NF), or any supplement to any of them; and 2. Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; and 3. Articles (other than food) intended to affect the structure or any function of the body of humans or other animals; and 4. Articles intended for use as a component of any articles specified in clauses (A), (B), or (C); but does not include devices or their components, parts, or accessories. 5 Drugs Any substance that causes a change in Physiology or pathophysiology Can be a small chemical molecule Can be a protein (peptide) CANNOT be given by mouth 6 Drugs How do they work in the body? Drugs bind to a receptor on the surface or insides cells 7 Drugs How do they work in the body? Normal or Disease States With drugs Drugs 8 Drugs Names Chemical (IUPAC) name Generic name Brand (Proprietary) name Example 1 Names Example 2 Names Chemical (RS)-2-(4-(2-methylpropyl) Chemical (6-methoxy-2-[(4-methoxy-3,5-dimethyl-2- Name phenyl)propanoic acid Name pyridinyl)methylsulfinyl]-1H-benzimidazole Generic Generic Ibuprofen Omeprazole Name Name Brand Brand Motrin, Advil Prilosec Name Name 9  Drugs Other routes possible: Intraosseous (direct to the bone) Intrathecal (direct to the brain or spinal cord) Intraperitoneal (direct into the peritoneum) 10 https://www.osmosis.org/learn/Aspects_of_Safe_Medication_Administration Accessed 7/28/2024  Drugs Other routes possible: Intraosseous (direct to the bone) Intrathecal (direct to the brain or spinal cord) Intraperitoneal (direct into the peritoneum) 11 https://www.osmosis.org/learn/Aspects_of_Safe_Medication_Administration Accessed 7/28/2024  Drugs Other routes possible: Intraosseous (direct to the bone) Intrathecal (direct to the brain or spinal cord) Intraperitoneal (direct into the peritoneum) 12 https://www.osmosis.org/learn/Aspects_of_Safe_Medication_Administration Accessed 7/28/2024  Drugs Other routes possible: Intraosseous (direct to the bone) Intrathecal (direct to the brain or spinal cord) Intraperitoneal (direct into the peritoneum) 13 https://www.osmosis.org/learn/Aspects_of_Safe_Medication_Administration Accessed 7/28/2024  Drugs Other routes possible: Intraosseous (direct to the bone) Intrathecal (direct to the brain or spinal cord) Intraperitoneal (direct into the peritoneum) 14 https://www.osmosis.org/learn/Aspects_of_Safe_Medication_Administration Accessed 7/28/2024  Drugs Other routes possible: Intraosseous (direct to the bone) Intrathecal (direct to the brain or spinal cord) Intraperitoneal (direct into the peritoneum) 15 https://www.osmosis.org/learn/Aspects_of_Safe_Medication_Administration Accessed 7/28/2024  Drugs Other routes possible: Intraosseous (direct to the bone) Intrathecal (direct to the brain or spinal cord) Intraperitoneal (direct into the peritoneum) 16 https://www.osmosis.org/learn/Aspects_of_Safe_Medication_Administration Accessed 7/28/2024  Drugs By prescription only (requires a visit to a Controlled substance; 5 schedules prescriber) (Schedule I, II, III, IV, V) Lisinopril (Zesteril, Prinivil) Schedule I (C-I): HIGH abuse risk, NO safe, Apixaban (Eliqus) NO accepted medical use in the US Schedule II (C-II): HIGH abuse risk, but have Over-the-counter (nonprescription) safe and accepted medical use Available without a prescription; safe and Schedule III, IV and V: LESS abuse risk than effective when used as directed; for self- Schedule II, have safe and accepted medical treatment or relief of symptoms use Examples: https://www.pharmacy.texas.gov/consumer/broch2 Omeprazole (Prilosec), loratadine (Claritin).asp accessed 7/29/24 Acetaminophen (Tylenol), ibuprofen (Motrin, Advil) 17  Drugs By prescription only (requires a visit to a Controlled substance; 5 schedules prescriber) (Schedule I, II, III, IV, V) Lisinopril (Zesteril, Prinivil) Schedule I (C-I): HIGH abuse risk, NO safe, Apixaban (Eliqus) NO accepted medical use in the US Schedule II (C-II): HIGH abuse risk, but have Over-the-counter (nonprescription) safe and accepted medical use Available without a prescription; safe and Schedule III, IV and V: LESS abuse risk than effective when used as directed; for self- Schedule II, have safe and accepted medical treatment or relief of symptoms use Examples: https://www.pharmacy.texas.gov/consumer/broch2 Omeprazole (Prilosec), loratadine (Claritin).asp accessed 7/29/24 Acetaminophen (Tylenol), ibuprofen (Motrin, Advil) 18 Drugs – Examples Over-The-Counter Examples: Acetaminophen (Tylenol) Ranitidine (Zantac) Calcium carbonate (Tums) 19 Drugs – Examples Prescription Only Examples: Atorvastatin (Lipitor) Carvedilol (Coreg) Cephalexin (Keflex) Calcium acetate (PhosLo) 20 Drugs – Examples Prescription Only Over-The-Counter Examples: Examples: Examples: Atorvastatin (Lipitor) Ibuprofen Acetaminophen (Tylenol) Carvedilol (Coreg) Naproxen Ranitidine (Zantac) Cephalexin (Keflex) (Naproxen) Calcium carbonate (Tums) Calcium acetate (PhosLo) Omeprazole (Prilosec) 21 Drugs – Examples Examples: Controlled Substances Morphine (C-II) Examples: Oxycodone (C-II) Some (not all) Fentanyl (C-II) codeine or Zolpidem (Ambien, C-IV) dihydrocodeine products Alprazolam (Xanax, C-IV) 22 Drugs – Examples Prescription Only Examples: Controlled Substances Morphine (C-II) Oxycodone (C-II) Fentanyl (C-II) Zolpidem (Ambien, C-IV) Alprazolam (Xanax, C-IV) 23 Drugs – Examples Over-The-Counter Examples: Controlled Substances Morphine (C-II) Examples: Oxycodone (C-II) Some (not all) Fentanyl (C-II) codeine or Zolpidem (Ambien, C-IV) dihydrocodeine products Alprazolam (Xanax, C-IV) 24 Drugs – Examples Prescription Only Over-The-Counter Examples: Examples: Examples: Atorvastatin (Lipitor) Ibuprofen Acetaminophen (Tylenol) Carvedilol (Coreg) Naproxen Ranitidine (Zantac) Cephalexin (Keflex) (Naproxen) Calcium carbonate (Tums) Calcium acetate (PhosLo) Omeprazole (Prilosec) Examples: Controlled Substances Morphine (C-II) Examples: Oxycodone (C-II) Some (not all) Fentanyl (C-II) codeine or Zolpidem (Ambien, C-IV) dihydrocodeine products Alprazolam (Xanax, C-IV) 25 Drug Approval Process Responsible by the FDA NOT responsible by the FDA New human drugs Compounded drugs Biological products such as therapeutic Tabacco products proteins, vaccines, allergenic products, Cosmetics cellular and gene therapies, and products manufactured from blood plasma Medical foods Food additives intended for human Infant formula consumption Dietary supplements Risk-based, tiered approach for regulating Medical devices for people The food label, including the nutrition facts Human cells and tissues label Structure-function claims on dietary supplements and other foods The drugs MUST DEMONSTRATE 1. EFFICACY (effective against a Compounded drugs disease in clinical trials) 2. Adequate SAFETY 26  Approval for marketing Phase 4 1. Investigational New Drug (IND) Application 2. New Drug Application 3. Review Decision 4. Discussion from the Review 27 Modified from https://www.scilife.io/blog/how-to-get-fda-drug-approval Accessed 8/2/2024 Generic Drugs and Biosimilars: Cost-Effective Alternatives Generic Drugs Biosimilar Drugs Another a prescription drug that Another a prescription drug that has has the same active-ingredient a similar active-ingredient (biologic (small molecule) as a brand-name products, such as proteins) as a (original) drug brand-name (original) drug Use the FDA Orange Book to Use the FDA Purple Book to determine equivalency and determine equivalency and interchangeability interchangeability Usually cost less than brand-name drugs. The FDA determines these drugs to be as safe and effective as brand-name drugs if these drugs meet certain criteria 28 But, just because something comes in a pill form, it may not be a drug Dietary Supplements Drugs Herbal Medicine Herbal Extracts 29  “Things” that are commonly confused with drugs, but they are NOT considered as drugs Dietary Supplements Herbal and Herbal Supplement Examples: Common herbs used in traditional Vitamins, minerals medicine Omega 3 fatty acids, calcium Examples: Enzymes, probiotics Extracts (Ginkgo biloba, black cohosh, turmeric, echinacea) Regulated according to the DSHEA (Dietary Supplement Health and Education Act, 1994) Followed good manufacturing practices (GMPs) during manufacturing Manufacturer can make claims on effects on the structure or function of the body (e.g. support gut health, support prostate health) but cannot claim to treat/improve a disease The claims are approved by the FDA and contains the verbiage “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease“ on the bottle label. 30 Dietary Supplements and Herbals DO NOT require FDA approval BEFORE marketing The Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006) requires manufacturers to report serious adverse events (side effects) of their products to the FDA If any dietary supplement is found to be unsafe or violated the appropriate law, the FDA can take action to issue warning letters, product recalls, or seizures What about efficacy? Reduce the effectiveness of other drugs? Increase adverse drug reactions (“side effects”) of other drugs? The advertising is regulated by the Federal Trade Commission (FTC) 31 Pharmacy Law We always follow the stricter of the 2 sets of law GENERAL SCOPE FEDERAL LAW State Law Regulates the DRUGS Regulates the PHARMACY Availability in the US PRACTICE Prescription vs. Over-the-counter The people (pharmacists, Controlled substance, etc technicians, interns, etc) The locations (requirements of the facility) The practice (what people can do as pharmacy staff) 32 Some of the MAJOR FEDERAL LAW on DRUGS Year Federal Law Accomplishments Standards for drug purity and labeling 1906 Pure Food and Drug Act The original Food and Drug Administration (FDA) The requirement of Safety of drugs Food Drug and Cosmetics Pre-market approval for drugs 1938 Act (FDCA) Update on the FDA for the overseeing the act NO FALSE CLAIMS! Established accurate labeling Prescription only (RX) vs. over-the-counter drugs The Durham-Humphrey 1951 RX drugs can only be dispensed with a valid Amendment (to the FDCA) prescription Requirements of Efficacy (effectiveness) of drugs The Kefauver-Harris 1962 AND Safety of Drugs Amendment (to the FDCA) Good manufacturing practices (GMP) established 33 Some of the MAJOR FEDERAL LAW on DRUGS Year Federal Law Accomplishments Controlled substance and drug schedule (C I, C II, C III, C IV, Controlled Substance Act 1970 C V) based on the potentials for abuse and medical use (CSA) Requirements for record-keeping, security, reporting Poison Prevention Child-Resistant packaging for drugs and household 1970 Packaging Act (PPPA) substances Promotion the development of generic drugs The Abbreviated New Drug Application (ANDA) process to 1987 Hatch-Waxman Act speed up the drug-approval process Balance between generic drug market entry and patent protection Health Insurance Protection of patient health information 1996 Portability and Privacy and security regulations for healthcare providers, Accountability Act (HIPAA) including pharmacists and pharmacies 34 Some of the MAJOR FEDERAL LAW on DRUGS Year Federal Law Accomplishments Streamlined drug and device approval process Enhanced pediatric drug development Food and Drug Administration Updates on the approval for medical devices 1997 (FDA) Modernization Act Improved regulations of food and cosmetics (FDAMA) of 1997 Enhanced access to clinical trial database Guidelines for drug manufacturer to share off-label information Combat Methamphetamine Regulated the sales of pseudoephedrine and ephedrine- 2005 Epidemic Act (CMEA) containing products Food and Drug Administration Increased focus on drug safety and pharmacovigilance 2007 Amendments Act (FDAAA) Enhanced transparency through clinical trial databases Ryan Haight Online Pharmacy Regulation of online pharmacies to prevent illegal distribution 2008 Consumer Protection Act of controlled substances Biologics Price Competition and Regulatory framework for the approval of biosimilar and 2009 Innovation Act (BPCI Act) interchangeable biological products 35 Some of the MAJOR FEDERAL LAW on DRUGS Year Federal Law Accomplishments Expanded healthcare overage in many states Increased the way drugs are covered under some insurance 2010 Affordable Care Act (ACA) plans Established measures for preventive care Comprehensive Addiction and Expanded prevention, treatment, and recovery efforts from 2016 Recovery Act (CARA) the U.S. opioid crisis Increased access to opioid treatment SUPPORT for Patients and 2018 Increased ways to prevent drug diversion Communities Act Electronic prescribing of controlled substances Coronavirus Aid, Relief, and Changed some regulations of over-the-counter drugs 2020 Economic Security (CARES) Act Expanded the FDA authority to address drug shortages 36 The End 37