Created by Jennifer Majeske, Mineral Area College

Created by Jennifer Majeske, Mineral Area College
Chapter 3 Drug Development

Learning Objectives Define the term drug and distinguish between active and inert ingredients. Identify several scientific discoveries of medications that improved individuals’ quality of life and life span. Define the terms drug tolerance, psychological dependence, and physical dependence. Contrast the regulation and labeling requirements for over-the-counter drugs, homeopathic medications, and dietary supplements. Categorize drugs according to their various sources: natural, synthetic, synthesized, or semisynthetic.

Learning Objectives Define the term pharmacogenomics and its future impact on drug development and dosing. Understand the classifications that describe the various uses of drugs: therapeutic, pharmacodynamic, diagnostic, prophylactic, and destructive agents. Discuss the process and role of the Food and Drug Administration (FDA) and the United States Pharmacopeia in the marketing of new pharmaceutical products. Review statistics and costs of getting a new investigational drug to market.

Learning Objectives Understand the process for FDA approval for generic drugs, and define the terms bioequivalence and therapeutic equivalence. Explain the parts of a National Drug Code number and its use by the pharmacy technician. Identify the three classes of FDA drug recalls. Identify the major sources of consumer and professional drug information. Understand postmarketing surveillance reporting programs for medication and product safety. List four drugs that are subject to risk evaluation and mitigation strategies, for their safe use. Identify the function of various commonly used pharmaceutical reference texts.

Introduction Technological advances in pharmaceuticals have transformed people’s lives. The development of these drugs was built on a scientific framework provided by earlier major research discoveries. Pharmacology – the study of how drugs work inside the body. Improved regulations of drugs, lengthy drug trials testing the efficacy and safety of medications before they are marketed.

What Is a Drug? Drug: substance taken into or applied to the body for the purpose of altering the body’s biochemical functions and thus its physiological processes.

What Is a Drug? Early civilizations drugs were derived from plant sources and were compounded into powders, extracts, and tinctures. Herbal remedies continue to be used today. Scientific advancements in chemistry, anatomy and physiology, pathophysiology and genetics have led to the development of more potent and toxic medications. Today’s drugs include: Dietary supplements – vitamins, minerals, and herbs Homeopathic remedies Over-the-counter (OTC) Prescription Drugs are available as brand and/or generic and can be classified as controlled substances.

What Is A Drug? Drugs can contain one or more active ingredients that have specific therapeutic uses. Active ingredient – the biochemically active component of the drug that exerts the desired therapeutic effect – desired pharmacological action of a drug on the body. Drugs also contain one or more inactive or inert ingredients. Inert ingredient – has little or no physiological effect on the body. What are some examples of common inert ingredients? Inert ingredients stabilize the formulation; provide raw material; ensure sterility; mask unpleasant tastes.

Significant Drug Discoveries
Created by Jennifer Majeske, Mineral Area College Significant Drug Discoveries What would our lives be like without vaccines, insulin, penicillin, the birth control pill, or HIV medication?

Smallpox – The First Vaccination
Created by Jennifer Majeske, Mineral Area College Smallpox – The First Vaccination 1796 Dr. Edward Jenner performed the first experimental vaccination. Dairy workers who had been exposed to cowpox were immune to smallpox. Jenner realized cowpox exposure provided immunity to smallpox. Antibody – the part of the body’s immune system that neutralizes antigens or foreign substances. Jenner introduced bacteria from a cowpox lesion into a healthy individual and discovered that the healthy individual did not contract smallpox despite exposure.

Smallpox – The First Vaccination
Created by Jennifer Majeske, Mineral Area College Smallpox – The First Vaccination Jenner coined the term vaccination, a term that comes from the Latin word vacca – meaning cow. Vaccine – a substance introduced into the body to produce immunity to disease. Smallpox was the first disease in history to be eradicated. Early vaccinations had high complication rates due to problems with purity and mass production. Today, drug consistency is virtually guaranteed, and vaccines are quite safe. Pharmacists in many community pharmacies can now administer vaccines.

Insulin – A Lifesaver! Sir Frederick Banting and Charles Best – discovered insulin while experimenting with beagles. Previous research showed a link between the pancreas and diabetes – “the sugar disease.” Dogs with diabetes were kept alive with an extract from the pancreas, isletin. This extract was later isolated and purified and named insulin after the Latin word island. Hailed as one of the most significant advances to medicine at the time. Discovery of this drug extended the lives of millions of people; today more than 15 million diabetic patients live near-normal lives.

Penicillin – The First Antibiotic
Created by Jennifer Majeske, Mineral Area College Penicillin – The First Antibiotic Antibiotic: a chemical substance that kills or inhibits the growth of bacteria. 1928, Dr. Alexander Fleming, discovered penicillin by accident. Fleming isolated an extract from the bacteria-killing mold; identified it from the Penicillium genus; named the agent penicillin.

Penicillin – The First Antibiotic
Created by Jennifer Majeske, Mineral Area College Penicillin – The First Antibiotic Penicillin saved many soldiers’ lives during WWII. 1945, penicillin could be mass produced and brought to the market. Today, there are hundreds of synthetic antibiotics, but continual research is needed to overcome bacterial resistance. The stronger the dose of antibiotics, creates a higher risk of side effects. Due to drug resistance, the required dose to threat an ear infection, with amoxicillin, has doubled in the past 30 years.

The Scourge of Polio One of the most destructive diseases of the 20th century. Polio is characterized by muscle weakness and paralysis of lower extremities. Typically children were affected by polio; left with residual paralysis requiring braces and crutches for life. 1952 – 21,000 cases of the most serious form of polio – paralytic polio – were reported in the U.S. Iron lung – a noninvasive negative-pressure ventilator, was used to treat severe symptoms by artificially maintaining respiration during acute polio infection until the patient could breath independently.

The Scourge of Polio 1953, American physician Jonas Salk created an injectable vaccine from animal cultures that contained the killed viruses of three kinds of polio. Salk developed a process using formalin, a chemical that inactived or killed the whole virus. A “killed” vaccine does not transmit or contain a live virus. Mass immunization programs were initiated in 1955, that year there were 28,000 reported cases of polio. One year later, there were only 15 cases of polio. 1994, polio was declared eradicated in all of the Americas; world-wide cases have dropped from hundreds of thousands to just under a thousand today.

The Pill Few contraceptive methods existed before the pill. 1930’s research on reproductive biology identified the female sex hormones estrogen and progesterone and understanding of their functions. Research continued though funding was scarce, and the hormones were difficult and expensive to synthesize. Early approved birth control pills contained high doses of both estrogen and progesterone to ensure prevention of pregnancy. High doses contributed to high incidences of side effects including nausea, headache, and blood clots.

The Pill Over time and with additional research the dosages of sex hormones have been decreased, reducing the risk of adverse effects. Written patient information on the risk of the pill must be included with each dispensed birth control prescription. An estimated 100 million women worldwide today are on the pill. Many different combinations and names of brand and generic birth controls are on the market. When taken appropriately, the pill is 99%+ effective in preventing pregnancy.

HIV/AIDS 1980’s saw the emergence of a formidable virus – the human immunodeficiency virus (HIV) – when epidemiologists noted an outbreak of rare pneumonia and cancers in New York City. 1983, HIV is independently isolated and verified by the Pasteur Institute in France and the National Cancer Institute in the U.S. This virus progressively attacks the immune system causing the development of acquired immunodeficiency syndrome (AIDS). Transmitted through bodily fluids during sexual contact, intravenous drug use, or tainted blood transfusions.

HIV/AIDS Lifetime treatment of HIV is estimated at more than $400,000 per person. 1987, the first antiviral drug to treat HIV was approved by the FDA. Since 1987, many additional oral and injectable HIV drugs have been developed. Combination therapy of three to four drugs is currently the common prescribed treatment to control the virus. Vaccines have so far been infective; medications give to a pregnant HIV-infected patient have been shown to be effective in reducing transmission to a newborn at delivery.

HIV/AIDS HIV drugs have many adverse side effects, are expensive and can interact with many medications. Diagnosis of HIV or AIDS, in the early years of the disease, was considered a death sentence. Approximately 50,000 cases of HIV/AIDS are reported each year; more than 1.2 million people live with the disease in the U.S. alone. Regimented medication therapy allows many of those affected to live near-normal lives.

Sources of Drugs Drugs are derived from various sources and can be classified as: Natural Synthetic – created artificially Synthesized – created artificially but in imitation of naturally occurring substances Semisynthetic – containing both natural and synthetic components Biogenetically engineered drugs are a major source of new drug development in the 21st century.

Natural Sources of Drugs
Created by Jennifer Majeske, Mineral Area College Natural Sources of Drugs Some drugs are naturally occurring biological products made or taken from single-celled organisms, plants, animals, minerals, and humans. Laboratory Sources of Drugs Many naturally occurring substances have been combined with other ingredients to produce synthetic, synthesized, and semisynthetic drugs. Synthetic Drugs – a drug that has been created from a series of chemical reactions to produce a specific pharmacological effect; phenobarbital, sulfa antibiotic. Synthesized Drugs – a drug created artificially in the laboratory but in imitation of a naturally occurring drug; epinephrine hydrochloride (EpiPen); digoxin, aspirin and quinine; many antibiotics. What other synthesized drugs exist today?

Laboratory Sources of Drugs
Created by Jennifer Majeske, Mineral Area College Laboratory Sources of Drugs Semisynthetic Drugs – a natural drug that has been chemically modified in the laboratory to do one or more of the following actions: (1) improve the efficacy of the natural product (2) reduce its side effects (3) overcome developing bacterial resistance (4) broaden the spectrum of bacteria that can be treated Many antibiotics are modifications of existing natural drugs. These antibiotics are more effective against different strains of bacteria or bacteria that have developed resistance to the natural product.

Biogenetically Engineered Drugs
Created by Jennifer Majeske, Mineral Area College Biogenetically Engineered Drugs Biotechnology – combines the science of biology, chemistry, and immunology to produce synthetic, unique drugs with specific therapeutic effects. These drugs can be created by the means of recombinant DNA techniques. Deoxyribonucleic acid (DNA) – is the complex, helically shaped molecule that carries the genetic code. DNA is made up of four base pairs; A, T, C and G; repeated millions/billions of times throughout a genome. Genome – the entire DNA in an organism, including its genes. The DNA contains directions for creating messenger ribonucleic acid (RNA) – contains arranged sequences for making amino acids into proteins.

Created by Jennifer Majeske, Mineral Area College Biogenetically Engineered Drugs Proteins determine how an organism looks, how its body metabolizes drugs or fights infections, and how it might behave. A defect in DNA might increase the risk for developing certain diseases. Genetic engineering – the process of utilizing DNA biotechnology to create a wide variety of drugs. Biotechnology has led to a new field of study blending two areas of science: pharmacology and genomics. Pharmacogenomics – this field of study examines the relationship between an individual’s genes and his or her body’s response to drugs.

Created by Jennifer Majeske, Mineral Area College Biogenetically Engineered Drugs The vision of pharmacogenomics is to design and produce drugs that cater to an individual’s genetic makeup. Genetic engineering would specify drugs like blood thinners, that would produce the intended pharmacological effect without the additional risk of adverse reactions. More than 900 biogenetically engineered drugs are under development currently.

Drug Classifications Drugs are classified by the FDA as: Prescription Over-the-counter (OTC) Homeopathic Dietary supplements (not directly regulated by the FDA) Vitamins Minerals Herbs Pharmacy personnel must have a solid understanding of the different state and federal laws regarding the dispensing, marketing and sale of these drugs.

Prescription Drugs Prescription drug – formerly known as a legend drug, can only be dispensed upon receipt of a prescription from a licensed healthcare professional in a state. All prescription drugs are labeled “Rx only.” Prescription drugs are available as brand name or generic. Why is it important for you as a pharmacy technician to know brand and generic drug names?

Controlled Substances
Created by Jennifer Majeske, Mineral Area College Controlled Substances Some prescription drugs are classified as controlled substances by the Controlled Substances Act of 1970. Drugs are organized into five schedules or classes according to their potential for abuse and addiction. Which schedule has the highest potential for abuse? Drug tolerance – a condition in which the body adapts to a drug so that higher doses are needed to produce the same therapeutic effect achieved earlier with lower doses. Drug tolerance can lead to psychological, physical dependence, or drug addiction.

Controlled Substances
Created by Jennifer Majeske, Mineral Area College Controlled Substances Psychological dependence – a condition in which a patient takes a drug on a regular basis because it produces a sense of well-being. Patients can experience anxiety or withdrawal symptoms if they stop taking the drug. Physical dependence – taking a drug continuously so that when the medication is stopped, physical withdrawal symptoms occur. Addiction – compulsive and uncontrollable use of controlled substances. Addicted patients will do anything to support their drug habit. Technicians must review carefully prescriptions for controlled substances.

OTC Drugs Over-the-counter (OTC) drugs – a drug that can be purchased without a prescription. OTC drugs must be recognized as safe and effective by the FDA when labeled directions on the container are followed. Most OTC drugs are indicated for short-term therapy (7 days) and self-limited conditions. Some OTC drugs can be used long-term with physician approval. Many OTC drugs were once prescription drugs approved by the FDA after expiration of the manufacturer’s patent.

OTC Drugs What are some examples of OTC drugs that were once prescription drugs? OTC drugs must have adequate labeling, written in easily understood terms, to assist the customer in proper usage, assuming no contact with a pharmacist or typed directions from a physician. Labels must contain “Drug Facts” box listing active ingredients, purposes, use of the product, warnings and directions for age-appropriate dosing. Drug labels must also have an expiration date as well as list of inactive ingredients.

OTC Drugs Some OTC drugs and supplies are sold “behind the counter.” Pseudoephedrine Federal and state laws and regulations controlling the dispensing (pg. 13) Plan B (no longer restricted to “behind the counter) Age restrictions Insulin syringes Possible abuse/diversion Certain asthma medications Additional need for pharmacist counseling

Homeopathic Medications
Created by Jennifer Majeske, Mineral Area College Homeopathic Medications Homeopathic medications – use of subclinical doses of natural extracts or alcohol tinctures to stimulate the body’s own immune system to overcome the specifically targeted symptom. Homeopathy is derived from the Greek root words homos – “similar” and pathos – “suffering or disease.” Most homeopathic medications are OTC, some however are considered prescription only. Homeopathic medications use was popular in the early 19th century and remains popular in parts of Europe. “Natural treatments” is another designation of homeopathic medications; minimal risk of side effects.

Dietary Supplements Dietary supplements: vitamins, minerals, herbs. Dietary supplement – exerts weak pharmacological effects on the body similar to drugs. Dietary supplements can cause side effects, adverse reactions, and drug interactions. Dietary supplements are considered “food supplements” that maintain health. Consumers should not exceed the recommended daily dose or “serving size.” The FDA can only regulate dietary supplements when patient safety concerns exist. Technicians need to gather information from patients about their use of herbs or other dietary supplements.

USP and Dietary Supplements
Created by Jennifer Majeske, Mineral Area College USP and Dietary Supplements The USP Verified Mark is placed on dietary supplements when the quality of the product has been verified under the USP’s dietary supplement verification program. The dietary supplement: Contains ingredients listed on its labels, in the declared potency and amounts; does not contain harmful levels of specified contaminants; has been made according to FDA good manufacturing practices (GMPs) Process of USP Verification: is a voluntary comprehensive testing and evaluation process done by participating manufacturer’s. What sorts of things are USP’s staff scientists looking at when verifying a dietary supplement? USP’s standard are FDA-enforceable per the Federal Food, Drug, and Cosmetic Act.

Use of Drugs Medications not only treat and cure illnesses but aid in their diagnosis and prevent onset. Pharmacy technicians must be familiar with the therapeutic uses of commonly prescribed drugs. Several classifications for uses of drugs exist, most of these categories are not mutually exclusive. Classifications include: Therapeutic agents Pharmacodynamic agents Diagnostic agents Prophylactic agents Destructive agents

Therapeutic Agents Therapeutic agent – a drug that targets a specific need in the body. Maintaining health Regulate metabolism; contribute to the maintenance of normal growth and function Relieving symptoms Anti-inflammatory drugs; narcotics; diuretic (water pills) Combating illness Antibiotics; antiviral medications; drugs for Alzheimer’s disease Reversing disease processes Medications that control depression, blood pressure and cholesterol

Pharmacodynamic Agents
Created by Jennifer Majeske, Mineral Area College Pharmacodynamic Agents Pharmacodynamic agent – a medication that alters body functioning in a desired way. Pharmacodynamic agents can be used to relax muscles, dilate pupils, or change blood glucose levels. Caffeine is considered a pharmacodynamic agent. Why? What other examples are there of pharmacodynamic agents?

Diagnostic Agents Diagnostic agent – a chemical containing radioactive isotopes that is used to diagnose or treat disease. Isotopes are forms of an element that contain the same number of protons but different number of neutrons. Unstable radioactive isotopes give off energy in the form of radiation. Isotopes can be used as tracers, helping pinpoint, diagnose and treat certain disorders. Radiopharmaceuticals – is working with radioactive isotopes, and is a specialized area of pharmacy practice; nuclear pharmacy. Specialized training and certification is required to work with these agents.

Prophylactic Agents Prophylactic agent – prevents illness or disease from occurring. Prophylactic agents include: Antiseptic and germicidal liquid chemicals for pre-operative hand washing procedures Vaccines Influenza; mumps; hepatitis Pneumonia; rubella Shingles; chicken pox Tetanus; smallpox Measles; poliomyelitis Antibiotics

Destructive Agents Destructive agent – has a – cidal action; it kills bacteria, fungi, viruses – normal and abnormal cancer cells. Radioactive iodine Many antibiotics, given in high doses and/or IV infusions are bactericidal – these agents kill rather than inhibit bacteria that are sensitive to these drugs. Penicillin Antineoplastic drug – a drug used in cancer chemotherapy to destroy malignant tumor. Different antineoplastic drugs used in combination to slow the growth of cancer cells, at different phases.

Destructive Agents Most of these drugs cannot distinguish, effectively, between cancer and normal cells. Side effects like hair loss, immunosuppression, and ulcerations of the mouth or GI tract commonly occur. Agents used in cancer chemotherapy are considered hazardous drugs. These drugs require special storage, preparation, and monitoring. Additional and specialized training is required to work with these destructive agents.

United States Pharmacopeia
Created by Jennifer Majeske, Mineral Area College United States Pharmacopeia The United State Pharmacopeia (USP) was charged in 1938 by Congress to develop official compendia and public standards for all prescription and OTC drugs marketed in the U.S. Today, they continue to develop authoritative, unbiased information on drug quality and disseminates this information to help healthcare professionals. United States Pharmacopeia – National Formulary (USP – NF) contains standards for medicines, dosage forms, drugs substances, etc. A manufactured drug product must conform to these standards to avoid possible charges of adulteration, misbranding and to be considered for approval by the FDA.

Food and Drug Administration
Created by Jennifer Majeske, Mineral Area College Food and Drug Administration The FDA assurers the American public that drugs that are approved are both safe and effective. New drugs must meet strict standards and undergo a fairly lengthy and expensive research process before coming to market. Stringent regulations were developed in response to medication tragedies involving the drug thalidomide. Technicians need to be aware of the FDA approval process which includes: Development of brand name drugs Bioequivalent generics Packaging and labeling Continuing oversight by the FDA

Drug Approval Process Regulations for manufacturers while researching new chemical entities and developing those chemicals into brand or trade name drugs. Before an investigational new drug application (INDA) is reviewed by the FDA or clinical trials are initiated; extensive preclinical animal lab research must be done; once an investigational new drug (IND) is approved by the FDA and the study is approved by the institutional review board (IRB), human trials may begin. Human Use Committee reviews, approves and monitors all medical research involving humans. Informed consent – a document that must be signed by each research subject, that states, in easily understandable terms, the purpose and risk of the research.

Clinical Studies Three phases of clinical studies: Phase 1 – initial study or trial of new drugs in humans Small number of healthy volunteers Gather sufficient data concerning the drug’s actions and potential side effects Phase 2 – evaluate the effectiveness and safety of a drug for a given indication or disease state Small number of patients Well controlled and closely monitored by FDA Phase 3 – larger clinical trials Better assess the benefits and risks of the investigational drug on patients

New Drug Application for Brand Name Drugs
Created by Jennifer Majeske, Mineral Area College New Drug Application for Brand Name Drugs After a promising Phase 3 studies, the pharmaceutical manufacturer can apply for a new drug application (NDA). The NDA must prove the case for both the safety and effectiveness of the drug. Scientific studies are evaluated and recommendations are forwarded to the FDA. If the benefit of the drug outweighs the risks, generally the drug is approved; the approval process may take a year or longer. FDA can opt to fast-track a drug if it shows to be very promising early on in testing.

New Drug Application for Brand Name Drugs
Created by Jennifer Majeske, Mineral Area College New Drug Application for Brand Name Drugs Drug development is risky as well as costly. 5,000 to 10,000 screened compounds; 250 of which enter preclinical research testing; 5 enter human trials; 1 new compound is approved. Cost of development: more than 1 billion dollars. Taking an average of 15 years of research and development. Patent protection on new drugs provides financial incentive for manufacturers.

Abbreviated New Drug Application for Generic Drugs
Created by Jennifer Majeske, Mineral Area College Abbreviated New Drug Application for Generic Drugs Generic drug – contains the same active ingredient as the brand name product and delivers the same amount of medication to the body in the same way and in the same amount of time. More than 1 billion generic drugs are dispensed every year; approximately 80% of all prescription drugs. This number is expected to rise to 85% by 2016 as more brand name drugs go “off patent.” (See table 3.1) Once a patent is due to expire, a generic pharmaceutical company can submit an abbreviated new drug application (aNDA).

Abbreviated New Drug Application for Generic Drugs
Created by Jennifer Majeske, Mineral Area College Abbreviated New Drug Application for Generic Drugs These drug applications are termed “abbreviated” because they generally are not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Generic applicants must prove scientifically that their product is bioequivalent – or performs in the same manner as an already approved brand name drug. Bioavailability - the time it takes the generic drug to reach the bloodstream and exert a pharmacological effect on healthy volunteers, is one way that scientists demonstrate bioequivalence. Bioavailability includes how a drug is absorbed, metabolized, distributed or eliminated from the body.

Cost Savings of Generic Drugs
Created by Jennifer Majeske, Mineral Area College Cost Savings of Generic Drugs Most insurance plans encourage cost saving measures, this includes the use of generic drugs unless a physician states “brand name drug necessary.” Generics offer cost savings of 30% to 80% over their brand name counterparts. 2010, the average co-pay for generics was just over six dollars; preferred and nonpreferred brand name drugs were four to five times higher. Generic manufacturers are granted a 180-day exclusivity period by the FDA for one or more manufacturers of aNDAs after the expiration of a patent.

National Drug Code Number
Created by Jennifer Majeske, Mineral Area College National Drug Code Number Once a brand name receives FDA approval it is assigned a unique National Drug Code (NDC) number, that appears on all drug stock labels and copies of duplicate prescription labels. The 10- to 11-character NDC number is made up of the following: A four- or five-digit labeler code, identifying the manufacturer A three- or four-digit product code, identifying the drug A one- or two-digit package code, identifying package size and type The NDC number plays a vital role for pharmacy technicians in preventing avoidable medication errors.

Drug Information for Health Professionals
Created by Jennifer Majeske, Mineral Area College Drug Information for Health Professionals Manufacturers must provide scientific information to the pharmacist with all prescription drug products. Product package insert (PPI) – is sent to the pharmacy from the wholesaler, contained in the stock medication. Table 3.2 outlines the specific order of the information on the PPI. The PPI is for the pharmacist and technician, not the patient. What is included in the PPI? Black box warning is a warning statement on the PPI indicating the possibility of serious or even life-threatening adverse reaction.

Drug Information for Health Professionals
Created by Jennifer Majeske, Mineral Area College Drug Information for Health Professionals The black box warning is indicated by a thick black border, surrounding the statement. This box is required by the FDA and is based on post surveillance studies. Data is collected via voluntarily submitting reports from pharmacists and physicians. Manufacturers must submit all reports to the FDA for further review and investigation. Why would the FDA issue a black box warning for a drug? What are some examples of drugs that have black box warnings?

Drug Information for Consumers
Created by Jennifer Majeske, Mineral Area College Drug Information for Consumers Consumers are informed about side effects, adverse reactions, and black box warnings through a patient package insert, or a supplemental printed medication guide called a MedGuide. The list of drugs requiring these information sheets and approval for the information on these sheets is developed by the FDA. Manufactures must provide patients with an easily understood format. The MedGuide is designed to do what? Consumers should be encouraged to read all information provided on drugs, and call or ask the pharmacist with any questions or concerns.

Postmarketing Surveillance
Created by Jennifer Majeske, Mineral Area College Postmarketing Surveillance Drugs have a risk of toxicity, and because of this the FDA works to continually gather information about approved medications, particularly any serious adverse reactions, not identified from research studies. An adverse drug reaction (ADR) – a negative consequence to a patient from taking a particular drug. The FDA established two nationwide postmarketing surveillance systems to allow for the reporting of adverse effects of certain medications. This adverse event reporting system (AERS) consists of the following: MedWatch VAERS Quarterly newsletter:

MedWatch Is a voluntary program that allows any healthcare professional or consumer to report a serious adverse event associated with the use of any drug, biological device, or dietary supplement. Once reported information is gathered and assessed the FDA can respond in one of two ways: 1) issuing safety alerts for drugs, biologics, dietary supplements, and counterfeit drugs 2) request medication-labeling changes to the PPI

Vaccine Adverse Event Reporting System (VAERS)
Created by Jennifer Majeske, Mineral Area College Vaccine Adverse Event Reporting System (VAERS) Vaccine Adverse Event Reporting System (VAERS) is operated by the FDA and Centers for Disease Control and Prevention (CDC), to collect and analyze information on adverse events that occur after an immunization. This information is used to provide safest strategies of vaccine use and further reduce the rare risks associated with vaccines. VAERS reports can be made online Via phone Or by mail of fax on a downloaded form

Risk Evaluation and Mitigation Strategies
Created by Jennifer Majeske, Mineral Area College Risk Evaluation and Mitigation Strategies The FDA Amendments Act of 2007 gave the FDA the authority to require that a risk evaluation and mitigation strategy (REMS) be developed by drug manufacturers to ensure that the benefits outweighed the risks of their drugs. The development of MedGuides, for consumer education on high-risk drugs, was a strategy authorized by this amendment. Some drugs require more focused strategies. What examples are provided in your book? A centralized database in maintained by drug manufacturers to closely monitor patients on these high-risk drugs and periodic assessment reports are made to the FDA on the status of the REMS for each drug.

iPLEDGE Program This program was designed for two reasons: 1) to prevent fetal exposure to the drug isotrentinoin 2) to inform and educate all healthcare providers and patients on drug risks and how to use this medication safely Pharmacies must be enrolled and certified to participate in this program; patients must also register and agree to meet conditions required during treatment. Contraceptive counseling is required to patients prior and during treatment with this drug. What sort of conditions must be met by the pharmacy and the patient in connection with this drug?

Transmucosal Immediate-Release Fentanyl (TIRF)
Created by Jennifer Majeske, Mineral Area College Transmucosal Immediate-Release Fentanyl (TIRF) This program is designed to mitigate the risk of misuse, abuse, addiction, overdose or severe complications due to various medication errors involving fentanyl. Prescribers, pharmacies and wholesalers must complete and education program, enrolling them and certifying them to participate in this program. Patients must sign an agreement with the prescriber; do not transfer the medication to others; if opioid therapy is discontinued the TIRF therapy must also be discontinued. Medication must be stored and discarded to prevent harm to children and pets.

Subutex and Suboxone These medications are prescribed to treat opioid dependence. Certified physicians DEA number starts with an “x.” The goals of this program are to mitigate the risks of accidental overdose, misuse, and abuse and to inform patients of serious risks. Pharmacies that dispense these drugs must provide a MedGuide on each prescription and counsel on the safe use of the medication, including potential interactions. Patients should be counseled on proper storage of the medications to deter from theft or access by children.

Tikosyn This antiarrhythmic drug can cause serious and sometimes fatal arrhythmias. The REMS program was developed to establish dispensing and administering protocols. Only physicians and pharmacies that have been enrolled, educated and certified in the program can prescribe and dispense. Physicians must follow FDA-approved and manufacturer guidelines when providing this medication. A special stamp, provided by the manufacturer, must be placed on each prescription dispensed.

Drug Recall Process After approval the FDA continues to monitor drugs on the market, sometimes forcing the manufacturer to recall the product if it is contaminated, of poor quality or if it causes serious adverse reactions. When the risk is greater than the perceived benefit, the FDA may issue a drug recall and withdraw the drug from the market; other cases the manufacturer may be allowed to voluntarily withdraw the medication from the market. There are three classes of recalls. Class I is the most serious of recalls and requires immediate attention.

Pharmaceutical Equivalence and Pharmaceutical Alternatives
Created by Jennifer Majeske, Mineral Area College Pharmaceutical Equivalence and Pharmaceutical Alternatives In all states, technicians are allowed to substitute a generic drug for a brand name drug as long as the generic drug is considered “equivalent.” The FDA Online Orange Book provides information on generic substitution. Pharmaceutically equivalent drug products are formulated to contain the same amount of active ingredient in the same dosage form in order to meet the same standards. Characteristics like shape, scoring configuration, release mechanisms, packaging, etc. can be different

Created by Jennifer Majeske, Mineral Area College Pharmaceutical Equivalence and Pharmaceutical Alternatives Pharmaceutical alternative drug products contain the same active therapeutic ingredient but contain different salts or are available in different dosage forms Approval must be obtained before a substitution occurs when involving different salts and dosage forms. Drugs are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile. If the generic product is listed as an “A” category the drug is considered therapeutically equivalent and can be safely substituted; a “B” category has some discrepancy in its therapeutic effect and the product cannot be substituted.

Created by Jennifer Majeske, Mineral Area College Pharmaceutical Equivalence and Pharmaceutical Alternatives Some physicians and patients do not like to substitute brand name medications for generics. The physician is then permitted to write “brand medically necessary” on the prescription to see that the brand name medication is dispensed. Patients can request the brand name of a medication even if the physician didn’t indicate that it was necessary, this often results in a higher co-pay. Patients may also request a generic when the physician has noted “brand medically necessary”, though the physicians office should be contacted to approve the generic over the brand

Other Pharmacy Drug References
Created by Jennifer Majeske, Mineral Area College Other Pharmacy Drug References Physician’s Desk Reference Drug Facts and Comparisons American Drug Index Micromedex Handbook of Nonprescription Drugs Remington: The Science and Practice of Pharmacy Homeopathic: Pharmacopeia of the United States (HPUS) Homeopathic Pharmacopeia of the United States Revision Service (HPRS) American Hospital Formulary Service Stability of Compounded Formulations The Lawrence Review of Natural Products

This workforce solution was funded by a grant awarded by the U.S. Department of Labor’s Employment and Training Administration. The solution was created by the grantee and does not necessarily reflect the official position of the U.S. Department of Labor. The Department of Labor makes not guarantees, warranties, or assurances of any kind, express or implied, with respect to such information, including any information on linked sites and including, but not limited to, accuracy of the information or tis completeness, timeliness, usefulness, adequacy, continued availability, or ownership. This work by Mineral Area College is licensed under the Creative Commons Attribution 4.0 International License.

Resources Picture on slide 6 Four colors of pills by Sage Ross is licensed under CC BY Picture on slide 9 Question marks by clipartcottage is licensed under CC BY Picture on slide 10 Syringe by Wikimedia Commons is licensed under CC BY YouTube on slide 13 Alexander Fleming, the inventor of Penicillin by Dan Izzo

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