Pharm7e-Ch02-Presentation

[Audio] Welcome to the Pharmacy Labs for Technicians Fourth Edition watch and learn lessons..

[Audio] Chapter 2, Pharmaceutical Development.. 2.

[Audio] In the history of medicinal drugs section of this chapter, you will learn about the important contributors, events, and resources in pharmacology through the ages. In the drug regulation section, you will develop an awareness of federal laws that regulate drugs and the agencies that administer these laws. You will also learn about the procedure for getting a new drug to market..

[Audio] Chapter 2, Section 1, History of Medicinal Drugs.

[Audio] Early humans believed that good and evil spirits controlled the world. The sick were thought to be victims of evil forces or of a god's anger. As a result of these beliefs, medical treatment was controlled by religious leaders. At the same time, folk knowledge of the healing properties of natural substances started to become known..

[Audio] Hippocrates, Galen, and Dioscorides were instrumental in early remedies. Hippocrates, a Greek physician, was the first to propose that disease is caused by natural and not supernatural causes. He was also the first to dissect the body and study organ function. He is often called the "father of medicine". Galen, also a Greek physician, believed that disease was caused by an imbalance in the blood, phlegm, black bile, or yellow bile. These were known as the four humors. He believed in treating illness with herbal compounds to restore balance to the body. His writings about herbal compounds are known as galenicals. Dioscorides compiled the pharmaceutical text called De Materia Medica. In this text he described and classified compounds by substance instead of by the disease being treated..

[Audio] Li Shizhen and Sushruta provided important developments in medicine from China and India. Li Shizhen was a Chinese physician and the author of Bencao GangMu, a book that details plants, recipes, and causes of illnesses. Sushruta, a Hindu surgeon, wrote The Book of Life, a book that describes illnesses, medicinal plants, and preparations..

[Audio] In the Middle Ages, the Christian church became a dominant cultural force. Monasteries became treatment centers. Monks wrote and copied medical texts and grew medicinal plants. The practice of medicine and pharmacy passed again to religious leaders. Also during this time period, Paracelsus, a Swiss physician, challenged Galen's teachings by denouncing the philosophy of humors. He supported using individual drugs instead of mixtures. Paracelsus reasoned that treating diseases with individual drugs would make it easier to determine which agent helped, which made the patient worse, and how much of a drug was needed. These are principles still used in pharmacology today. Valerius Cordis was a German botanist and physician who published the Dispensatorium. This was the first official pharmacopoeia or listing of medicinal preparations..

[Audio] In the modern age, the French physiologist, Claude Bernard, demonstrated that certain drugs have specific sites of action within the body. He was one of the founders of experimental pharmacology, the science of drugs and their interactions with the systems of living animals..

[Audio] The colonies of early North America had few medical personnel available. Settlers depended on home remedies. Over time, colonies attracted immigrants including physicians and apothecaries. An apothecary was the forerunner of today's pharmacist and pharmacy. Colonial physicians commonly owned a dispensary or pharmacy. They prescribed, prepared, and dispensed drugs imported from Britain. The American Revolution forced Americans to make their own drugs..

[Audio] Note that the term apothecary can describe both the profession and a business..

[Audio] In 1820, the US Pharmacopeia or USP, was developed as the first official listing of drugs in the US. It was published by the Massachusetts Medical Society. The American Pharmacists Association was formed in 1852 to create a separation between pharmacy and medicine. Establishing this organization allowed pharmacists to increase in professional stature..

[Audio] By the second half of the 19th century, pharmacology had become a scientific discipline. A German professor named Oswald Schmiedeberg led European universities in creating pharmacology departments. During this time period, Ignaz Semmelweis recognized the role of hand washing in reducing infection, and Joseph Lister introduced antiseptics into surgery. These antiseptics were used to clean instruments and suture materials. Paul Ehrlich, a German bacteriologist, later introduced arsphenamine, the first drug to treat an infectious disease..

[Audio] Several other important discoveries were made in the 20th century. Two Canadian physiologists, Frederick Banting and Charles Best, extracted insulin from the pancreas to treat diabetes. Gerhardt Domagk, a German physician, introduced Prontosil, the first sulfa drug. Another antibiotic, penicillin, was discovered by Alexander Fleming, a British bacteriologist. Two scientists, Ernst Chain and Howard Florey, were instrumental in the mass production of penicillin during World War 2..

[Audio] Chapter 2, Section 2, Contemporary Pharmacy Practice.

[Audio] A pharmacist is licensed to prepare, sell, and dispense drugs and compounds through the filling of prescriptions. They also advise patients on the proper use of drugs. The pharmacist's primary role is to ensure that drugs are dispensed properly and used appropriately. This role is becoming increasingly focused on patient care and counseling. As a result, many dispensing responsibilities have shifted to the pharmacy technician..

[Audio] The pharmacy technician is an important member of the healthcare team who works under the supervision of a licensed pharmacist to assist with activities not requiring the professional judgment of a pharmacist. Technicians play a vital role in all aspects of drug distribution. Depending on state law, a pharmacy technician's responsibilities could include the following: Receiving prescriptions or refill requests Verifying information on prescription Counting, weighing, measuring, and mixing medication Preparing sterile intravenous (IV) and chemotherapy compounds Preparing prescription labels and selecting containers Establishing and maintaining patient profiles Ordering and stocking prescription and over-the-counter (OTC) medications Assisting with drug studies Transcribing prescriptions over the telephone.

[Audio] Potential responsibilities of a pharmacy technician continue as follows: Transferring prescriptions Tracking and reporting medication errors Checking another technician's work in the preparation of medicine carts Educating healthcare professionals about pharmacy-related issues Obtaining laboratory results for pharmacists Helping patients with OTC drugs Making sure patients are counseled by pharmacist Overseeing and maintaining automated dispensing systems Maintaining pharmacy records Cleaning the pharmacy.

[Audio] The Pharmacy Technician Certification Board or PTCB maintains a national certification program for pharmacy technicians. It develops standards and acts as the national credentialing agency. A pharmacy technician must pass a certification exam to become credentialed. This exam tests both knowledge and skills. PTCB certification is recognized by all states. Some states require pharmacy technicians to be registered with the state board. This provides a way for states to do a background check and track pharmacy personnel. Most states require pharmacy technicians to have a high school diploma or GED, be at least 18 years old, and have no history of felonies..

[Audio] Chapter 2, Section 3, Drug Regulation. 2.3 Drug Regulation.

[Audio] The Food and Drug Administration or FDA protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biologic products, and medical devices. It is responsible for ensuring that any drug or food product approved for marketing is safe when used as directed on the label. A New Drug Application is a vehicle through which a drug sponsor formally proposes that the FDA approve a new legacy drug for sale and marketing in the US. A drug sponsor is usually a pharmaceutical company..

[Audio] The Durham-Humphrey Amendment established two classes of drugs. A legend drug is sold only by prescription and labeled Rx only. An over-the-counter drug may be sold without a prescription..

[Audio] The drug approval process can be broken down into four phases. In the preclinical phase, the compound is developed and then tested on animals for toxicity. If major risks or early toxicity markers are not seen, the drug sponsor submits an investigational new drug application to the FDA. The second phase is the clinical phase. This is when clinical trials are conducted on human volunteers. The third phase is the New Drug Application review. This phase occurs once clinical trials are complete, and the sponsor files the NDA with the FDA. The NDA consists of all test results and proposed labeling..

[Audio] An investigational drug is a chemical or biological substance that the FDA has approved for human testing. This approval occurs after the FDA has approved the drug sponsor's investigational drug application. Human testing, referred to as a clinical trial, is used to determine whether new drugs or treatments are both safe and effective. A clinical trial protocol is developed by researchers and subject to approval by an FDA review board. Such a protocol includes a description of types of participants, a schedule of tests and procedures, the medications and dosage, and the length of the study. Participants are monitored throughout the study for safety and efficacy..

[Audio] During clinical trials, patients are typically separated into two groups. The experimental group receives the drug being tested, while the control group receives standard treatment or placebo. A placebo is an inactive substance that the patient believes is a medication but that has no pharmacologic effect. In general, neither trial participants nor the study investigators know whether a particular participant is in the experimental or the control group. This type of study is called a double-blind study. It is considered the gold standard of clinical trials..

[Audio] Clinical trials of new drugs proceed through four phases. In phase 1, the drug is tested on a small group of 20 to 100 healthy people. It evaluates safety, determines a safe dosage range, and identifies side effects. In phase 2, the drug is tested on patients who have the condition being treated. The goal in this phase is to determine whether the drug has a favorable effect. Phase 3 is when double-blind, placebo-to-drug or standard of care to drug comparisons occur. Dose escalations are used in this phase to determine efficacy. Phase 4 trials evaluate safety and how well the drug works in the real world. This last phase is also known as postmarketing surveillance..

[Audio] Figure 2.1 illustrates the drug review process from the preapplication steps to the FDA post approval phase. After the government approves a manufacturer's IND, a drug must pass through three phases of testing on human subjects before it is ready for final review by the FDA..

[Audio] Postmarketing surveillance or phase IV trials are important in identifying unexpected adverse effects once the drug is used on a larger number of people outside of clinical trials. If unexpected adverse effects are identified, appropriate action can be taken. These actions may include removing the drug from the market or changing its label. Professionals and consumers can report serious adverse reactions to MedWatch, the FDA's reporting program..

[Audio] Medication guides are paper handouts that contain specific risk information. They are dispensed to patients taking certain medications as part of the Risk Evaluation and Mitigation Strategy program. Medication guides include FDA-approved information to help patients avoid serious adverse events. They must be provided each time a medication is dispensed. Some medication guides are prepared for entire classes of drugs such as antidepressants and anti-inflammatories..

[Audio] FDA recalls may be issued when the FDA obtains information regarding safety concerns about a medication. They may occur through a company's own initiative or upon FDA request. The photo shows a bottle of Belviq, also known as lorcaserin. In February 2020, Belviq, a weight-loss drug, was voluntarily withdrawn from the market after a safety clinical trial showed an increased occurrence of cancer..

[Audio] Boxed or black box warnings alert prescribers about known problems with a drug. They are used for marketed drugs with known problems but deemed safe to continue using. A prescriber must weigh the advantage of using the drug with its risks..

[Audio] Boxed warnings are the sternest warnings put on drug labels. As you are learning pharmacology, you should make special note of these warnings..

[Audio] The FDA requires a specific format for a boxed warning: the text must be in boldfaced type and have bullets or subheads that highlight the serious adverse effects of the drug..

[Audio] A controlled substance is a drug listed on one of the Controlled Substances Act's schedules. The Drug Enforcement Administration is responsible for regulating the sale and use of specified drugs. DEA registration is required for all individuals and institutions that handle or prescribe controlled substances. A prescriber's DEA number must be associated with prescriptions for controlled substances..

[Audio] Controlled substances are divided into five categories or schedules. Product labels must indicate the schedule of the drug. Morphine sulfate, pictured in this label, is a Schedule 2 controlled substance. This schedule has the highest potential for abuse, drug tolerance, and psychological or physical dependence among drugs with accepted medical use. Note that the controlled drug schedule is printed in the area where the drug name is printed..

[Audio] Each category of controlled substances has its own set of restrictions for prescribing and refilling. Schedules 3 and 4 may be refilled five times, for a total of six fillings per prescription, within a six-month period. Schedule 5 may be available in certain states without a prescription. State regulations regarding refills vary. No refills are allowed on Schedule 2 products. A prescription for a Schedule 2 controlled substance is valid for variable lengths of time depending on state law. With the exception of e-prescriptions, the pharmacy must have on hand the original, signed prescription for Schedule 2 drugs..

[Audio] Inventory control is critical when dealing with Schedule 2 medications. The Controlled Substance Ordering System or CSOS is used for electronic ordering of Schedule 2 medications. DEA Form 222 is a triplicate form used for ordering Schedule 2 medications. The first and second copies go to the supplier while the third copy is stored in the pharmacy for 2 years. DEA Form 106 is used for documenting destruction of expired Schedule 2 medications. This form requires a witness to the destruction..

[Audio] This table summarizes the comparative abuse potential, dispensing instructions, and key examples of controlled substances. The abuse potential increases as the number denoting the controlled class gets smaller. For example, the abuse potential of Schedule 2 medications is much greater than that of Schedule 5 medications. Schedule 1 products are used for research only. The researcher must have a special license to obtain these products. Examples include heroin and marijuana. Schedules 2 through 4 all have accepted medical uses and have varying DEA dispensing instructions. No refills are permitted on prescriptions for Schedule 2 medications. Examples of drugs in this class are oxycodone and morphine. Schedule 3 medications can be refilled up to five times within six months. Codeine combination products and anabolic steroids fall into this class. Like Schedule 3, Schedule 4 controlled substances can be refilled up to five times within six months. Benzodiazepines, meprobamate, and phenobarbital are included in this class. Some drugs within Schedule 5 are sold without a prescription. Examples of products within this class are liquid codeine combination products..

[Audio] At some stage in the drug development process, a drug sponsor will apply for patent protection. A patent grants the drug sponsor the sole right to manufacture a drug. Under patent protection, both the generic and brand names of a drug belong to a drug sponsor. Once the patent expires, the manufacturer's proprietary right to the drug expires. At this point, other companies can produce the drug as a generic product or even under their own brand names. There is a substantial price difference between brand and generic products. Generic substitution is an important way of reducing healthcare costs..

[Audio] Oftentimes, it is easier to learn drugs using the generic names. For example, all the generic names of beta adrenergic blockers used for high blood pressure end in the suffix –olol. Examples of drugs in this class are metoprolol and propranolol. The brand names, however, vary and include Lopressor and Inderal..

[Audio] A drug company must submit an abbreviated new drug application to the FDA for approval of a generic product. It must demonstrate that the generic product is interchangeable with the original brand-name drug. A generic drug must meet following requirements compared to the original brand-name drug: Contain the same active ingredient Be identical in strength, dosage form, route of administration Have the same indications Meet the same batch requirements for identity, strength, purity, and quality Yield similar blood absorption and urinary excretion curves for the active ingredient.

[Audio] The FDA has devised an A/B rating system to establish the therapeutic equivalence of generic drugs. An A rating indicates that the drug is therapeutically equivalent to the reference drug product in terms of pharmaceutical equivalence, bioequivalence, labeling and Current Good Manufacturing Practices. A B rating indicates that the drug is not therapeutically equivalent to the reference drug product. This type of information is published in the FDA's Orange Book..

[Audio] Some medications are categorized as biologic drugs. These are defined as complex, large molecules made in the laboratory but derived from living organisms. They are difficult to replicate. A biosimilar drug is highly similar to the reference or originator drug. There can be no clinically meaningful differences between the biosimilar and reference product in terms of safety, purity, and potency. Biosimilar products cannot be automatically substituted for the reference product. Information on biological products is published in the FDA's Purple Book..

[Audio] Interchangeable products are biosimilar products that would be expected to produce the same clinical results as the reference drug. In addition, interchangeable products would be expected to produce no change in efficacy or safety if a patient were to switch back and forth between products. If two products were deemed to be interchangeable, they could be substituted without consultation from the prescriber. There are currently no interchangeable biosimilar products to date in the US..

[Audio] Over-the-counter drugs can be purchased without a prescription. Sometimes companies change the ingredients of their OTC products. They understand that consumers instantly recognize brand names and that this has marketing value. Companies are reluctant to change OTC brand names even when the ingredients change, so they continue to use the original brand name. There is potential for danger if a patient is unaware of the current ingredients. This is an area in which the pharmacy technician has tremendous responsibility and can play an important role. A pharmacy technician can inform patients about what conditions these products treat, help patients locate the OTC medication they need, and read ingredients to patients when helping select products..