Chapter 1 Introduction to Pharmacology PDF

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Chapter 1: Introduction to Pharmacology & its Legal and Ethical Aspects

Pharmacology and Health Sciences 

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Pharmacology o Study of drugs, their uses, and their interaction with living systems o Draws information from many scientific disciplines Why study pharmacology? o With increased use of OTC drugs, the need for information concerning interactions in prescription drugs is growing o Assist in preventing legal and ethical problems for the physician Role of professionals in medication administration o Physician prescribes a drug o Pharmacist dispenses the drug o To administer a drug means to give the medication by the route prescribed  Done by patient or by health care professional in a medical facility o 60% of visits to a physician result in a prescription Patient is the most important figure in the drug administration triangle. Role of professionals in medication administration o A complete medication profile, including prescription and OTC drugs, must be documented for all patients o Need to remain current on new medications and new uses for older drugs o Should have a working knowledge of all medications used at their site of employment

History of Pharmacology      

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In early civilizations, plant sources were commonly used to treat diseases The Chinese created the first pharmacopeia in the sixteenth century At the end of the nineteenth and beginning of the twentieth century, many laws were enacted to protect the public In the first half the twentieth century, medications were introduced for previously fatal chronic illnesses See Box 1-1 for a timeline of medications throughout the centuries. Rapid development in the last half of the twentieth century o Oral contraceptives o Medications for hypertension o Insulin DNA technology o Drugs to treat ED o Chemotherapy Twenty-first century o Medication delivery systems that result in prolonged effect Society and the need for drug regulation

Drug’s strength  The concentration of the active ingredient  Varies with the conditions under which the drug was prepared  Legend drugs must have consistent manufacture of the medication o Legislation is enacted at federal, state, and local levels. o Medical assistants must have working knowledge of regulations at all levels. Legislation requires that pharmaceutical companies provide sufficient information about side effects and drug interactions. Pharmaceutical companies cannot make false claims in their advertising. How can patients critically evaluate medication information online? o

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Drug Standards and Patient Safety        

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Ensures consumer is receiving safe, quality drugs with expected therapeutic properties Ensures that drug’s active ingredients have exact concentration or strength with each dosage Testing drugs for purity, safety, and efficacy has only been done in this century. What made testing of drugs possible? Drug standards—rules and regulations that are established for consumer safety; they ensure that all drugs are of uniform strength, quality, and purity Drug purity—specifies type and concentration of a substance that is allowed to be present in a drug Drug quality—ensures drugs meet standards published in National Formulary Why is it necessary to guarantee the uniform strength, quality, and purity of drugs? (so each prescription filled for a given medication is the same at all pharmacies) Drug efficacy—drug’s ability to produce the desired chemical change in the body o established by conducting clinical trials with placebos (drugs with no therapeutic effect) o OTC medications must meet same standards as legend drugs o vitamins and herbal supplements are not controlled by FDA From a safety perspective, what distinguishes the legal pharmaceutical market from the illicit drug market? (In the illicit drug market, the consumer does not enjoy the protection of drug laws that are present in the pharmaceutical market.) Dietary supplements were subject to the same regulations as foods according to the restrictions of the Department of Agriculture.

International, Federal, & State Statutes for the Regulation of Medications

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Drug control varies from country to country. Drug possession penalties vary from lenient punishments to harsh prison sentences or death. There are strict U.S. regulations for getting new drugs to market. Drugs are often available in other countries before being available in the United States. Some countries, such as Spain or the Netherlands, essentially legalized noncommercial consumption of drugs like marijuana. In other countries drug trafficking can be a criminal offense. Different cultures treat drug abuse differently. What entity exercises international controls over medications and promotes research on drug abuse? (The World Health Organization of the United Nations) How are international drug laws enforced? (No world judicial groups enforce laws concerning drugs; drug control varies from country to country.) Pre-twentieth Century Consumers unaware of a drug’s ingredients, strength, consistency o Dr. Smith’s Miraculous Cough Syrup o New Age Miracle Soothing Syrup Prescription was not required for medications o Some contained dangerous, detrimental drugs like morphine, opium Before 1906, who could legally make and sell medications in the United States? (Medicine men, mail order, in stores, by trained physicians, or “doctors”) Labeling of the medication with its concentration or potency was not required.

Federal Legislation Related to Drugs   

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Pure Food and Drug Act of 1906 First federal attempt to protect consumers by requiring standards of strength, purity, and quality “Dangerous” drugs labeled on container o Dangerous drugs include those that cause injury or death, addiction, or inconsistency of the medication U.S. Pharmacopoeia (USP) and National Formulary (NF) established to list officially approved drugs and formulas Medication strength: the amount of active ingredient in the medication Drug purity: quality or state of having the type and concentration of substances set forth by FDA standards for production of a drug Shirley Amendment of 1912 Prevented fraudulent claims by drug manufacturers Harrison Narcotic Act or Federal Narcotic Drug Act of 1914 Established the word narcotic and required the use of narcotic stamp on these medications Regulated the importation, manufacture, sales, and use of opium, codeine and the related medications

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1912: Shirley Law to prevent false claims by pharmaceutical companies The law had a loophole: Although the pharmaceutical companies could not make false claims about medications on the containers they were in, they still could make false claims in newspaper ads, catalogs, etc. Why was it important for the Shirley Act to be enacted? (Drug companies made claims about the uses of medications that were inaccurate and dangerous.) Food, Drug, and Cosmetic Act of 1938 established FDA to supervise and regulate drug safety all new drugs tested for toxicity all pharmaceutical firms are required to report adverse effects at regular intervals unsafe drugs removed from market FDA agents were authorized to seize improperly manufactured or packaged goods and to undertake criminal prosecution of responsible parties. What are some drugs recently taken off the market due to safety concerns? Durham-Humphrey Amendment (1951) specified how prescription drugs could be ordered and dispensed specified that all legend drugs be labeled “Caution: Federal law prohibits dispensing without a prescription” required warning labels for drowsiness, nervousness, habit-forming potential recognized OTC drugs not requiring a prescription 1962: Kefauver-Harris Amendment requires proof of both safety and efficacy. Comprehensive Drug Abuse and Control Act of 1970 Repealed 50 laws passed between 1914 and 1970 concerning drug control Drugs with abuse potential identified as controlled substances Controlled substances placed into Schedules I through V All prescribers, dispensers, drug manufacturers must have DEA number Also called the Controlled Substances Act of 1970 The Act was introduced after a series of confusing amendments to the Harrison Narcotic Act of 1914 to: o regulate manufacturing, distribution, and dispensing of drugs with abuse potential o prevent indiscriminate use of controlled drugs o identify legitimate handlers of those drugs o increase research and prevention of abuse and dependence o make provisions for treatment and rehabilitation of people who were drug-dependent Comprehensive Drug Abuse and Control Act of 1970 - Results Creation of BNDD and DEA o Bureau of Narcotics and Dangerous Drugs (BNDD) o Drug Enforcement Administration (DEA) Provided for prevention of drug abuse and drug dependence Required security of controlled substances Required the proven effectiveness of drugs before marketing

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What was the purpose of BNDD? (To register all persons who manufacture, dispense, prescribe, or administer any controlled substances.) What is the purpose of the DEA? (To continue regulation and enforcement of manufacturing and dispensing of dangerous and potentially abused drugs.) When was the DEA formed? (1973) Poisoning Prevention Packaging Act of 1970 o Child-resistant packaging Drug Listing Act of 1972 o Required the use of the National Drug Code on packaging Drug Regulation and Reform Act – 1978 o Briefer investigation of new drugs to allow faster access Orphan Drug Act of 1983 o Law was enacted to fund research of drugs for rare conditions. o Historically, this research has not been profitable for pharmaceutical companies. o Helps find new applications for old drugs as well as discovering new drugs. More than 200 drugs and biological products were brought to market after 1983 amendment. In comparison, in the decade before 1983, less than 10 orphan drugs were made. What are some examples of recent orphan drugs put out in the market? Drug Price Competition and Patent Term Restoration Act (1984) o Eased requirements for marketing generic drugs o Extended length of time of patents Omnibus Budget Reconciliation Act of 1990 (OBRA 1990) o OTC drugs are important to medical record Anabolic Steroids Control Act of 1990 o Now under umbrella of Controlled Substances Act of 1970 Drug Price Competition and Patent Term Restoration Act (1984) o Generic drug companies could prove bioequivalence without having to duplicate trials Prescription Drug Amendments of 1992 Food and Drug Administration Modernization Act (1997) o Both allowed rapid approval of meds by the FDA for life-threatening diseases and debilitating conditions Generic medication formulations sold under non-trademarked name: o Tylenol (brand name) o acetaminophen (generic name) Generic medication or formulation is cheaper. Pharmacists may substitute generic or bioequivalent drugs if brand name not specified. Physicians have the right to require brand-name drugs. States and insurance companies can have mandatory substitutions of brand names by generic medications.

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What types of testing must generic medications go through? (All inert ingredients provide bioequivalence and the active ingredients have not changed from those in the trademarked drug.)

The Food and Drug Administration and the Introduction of New Drugs      

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The approval process can be lengthy—up to 12 years. Only one drug in 5000 to 10,000 makes it to market. Millions of dollars are spent in research and development. Manufacturers are given 20-year patent; the earnings from their exclusive sales cover much of the cost of research. Why are new drugs so expensive? (The drug manufacturers try to recover as much of the money spent on research as possible.) What happens when a drug’s patent runs out? (Another company may manufacture the drug under another brand name or use the generic name that has been assigned by the USP.) Preclinical and clinical testing are required to ensure safety. Adverse reactions must be reported using FDA Form 3500. FDA must review application—takes 2 months to 7 years (24 months average). Post marketing surveillance continues after drug is released. See Box 1-2 for the steps in the development of new drugs. What is a clinical trial? What are its phases? (See Box 1-2 for answers.) What happens to drugs that are found unsafe? (If prior to approval, the drug is returned to the manufacturer for further initial testing or research; the FDA or manufacturer has the right to remove the drug from the market even after approval has been granted.) Drugs are placed into one of five schedules, based on the drug’s potential for abuse. Each schedule has its own prescription and dispensing restrictions. Each prescription must have a DEA number. Medications with highest abuse potential placed in Schedule I. What are the criteria for placement on the schedule list? o Evidence that the substance is being used in sufficient amounts to pose a medical threat to individuals or a hazard to the community o Significant diversion of the substance from legitimate use to illegal drug trafficking o Tendency of consumers to take the substance on their own initiative rather than on medical advice o A new drug with an action related to the action of a drug already on the controlled substances list, until a decision is made concerning its abuse potential Why are drugs moved from one schedule to another? (A drug may be moved from one schedule to another or may be removed from the list on reevaluation of abuse potential by the DEA.) Schedule I

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high potential for abuse severe physical or psychological dependence no accepted medical use in United States for research use only What are some examples of Schedule I drugs? (See Table 1-2.) Schedule II high potential for abuse severe physical or psychological dependence accepted medicinal use with specific restrictions What are some examples of Schedule II drugs? (See Table 1-2.) What prescription regulations are associated with Schedule II drugs? (See Table 1-2.) Schedule III moderate potential for abuse high psychological dependence low physical dependence accepted medicinal uses What are some examples of Schedule III drugs? (See Table 1-2.) What are the prescription regulations for Schedule III drugs? (See Table 1-2.) Schedule IV lower potential for abuse than Schedule III drugs limited psychological and physical dependence accepted medicinal uses same prescription regulations as Schedule III What are some examples of Schedule IV drugs? (See Table 1-2.) What are the prescription regulations for Schedule IV drugs? (See Table 1-2.) Schedule V low potential for abuse abuse may lead to limited physical or psychological dependence accepted medicinal uses small narcotic amounts present What are some examples of Schedule V drugs? (See Table 1-2.) Are there any dangers related to taking Schedule V drugs? (See Table 1-2.) What are the prescription regulations for Schedule V drugs? (See Table 1-2.)

The Drug Enforcement Administration and Controlled Substances in the Medical Office     

Large “C” shows the drug is a controlled substance. Roman numeral of the class appears within the C. See Figure 1-5 Controlled substances are labeled for easy identification. Who must register with the DEA? o all licensed health professionals who prescribe controlled substances o all establishments that dispense controlled substances

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Some states require state controlled-substance license. How often must DEA registration be renewed? (Every three years)

Ordering and Securing Controlled Substances  

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Prescription form may not be used Drugs are ordered using Federal Triplicate Order (DEA Form 222) o first copy to DEA o second copy to supplier o third copy retained by physician Upon receipt of medications, attach documentation to the third copy Keep separate from other drugs. Place in securely locked area. Some states require double-locking of opioid drugs. Why should stocks of controlled substances be kept to a minimum? (To reduce chance of loss or theft) What steps should be taken if a theft or loss of inventory occurs? What is required by law? (The local DEA office must be notified; if theft has occurred, it is required that the local police department be notified first, as well as the state bureau of narcotic enforcement.) What steps should be taken if contamination or damage to controlled substances occurs? (The local DEA office should be contacted for appropriate disposal instructions.)

Record Keeping and Inventory Control       

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Two employees sign receipt when new controlled medication is received. Inventory required every 2 years. Compare medication on hand to amount ordered and dispensed to patients. Two persons take inventory. Keep records for 2 years. Why is it important to count Schedule II substances with a partner? (To make sure there aren’t any errors; this also helps prevent fraud.) What information is included in an inventory? o Name and quantity of each controlled substance o Name, address, and DEA registration number of the physician o Date and time of the inventory process o Signature of the person(s) taking the inventory Schedule II records keep separate from other drug records must be readily available for inspection

Disposing of Scheduled and Nonscheduled Drugs  

Contact DEA for special form to dispose of expired controlled drugs. DEA issues instructions for disposal.

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Noncontrolled drugs may be flushed down the toilet, washed down the sink, or placed in the trash (special security required). If mailing a drug, registered mail should be used. Why? (To ensure safe shipment) Once the drug is destroyed, FDA issues a receipt that should be put in the controlled substances record.

Preventing Drug Dependence and Drug Abuse   

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Psychological drug dependence—strong desire for a drug Physical dependence—craving for a drug; affects body function Drug dependence occurs with prolonged drug use o Usually involves painkillers or drugs used to control emotional problems Medicating terminally ill patients for pain is a controversial issue. Chronic pain remains under-treated. Educate patients about potential for drug dependence. Using a drug in a way inconsistent with medical or social reasoning. Pharmacists often warn medical offices of patients using different doctors to obtain the same drug (“doctor-hopping”). Drug abusers may claim they have lost their prescriptions or medications. Document all prescription requests. Safeguard the prescription pad. The notion of drug abuse is culture-specific. Discuss the system of checks and balances in health care to prevent drug abuse. o Educate office workers about signs of drug abuse. o Observe for signs of drug abuse: “doctor-hopping,” demand for a specific drug, pinpoint pupils, lethargy, elation, unusual or violent behavior, disorientation. o Educate office staff about resources to identify and help an impaired health care professional. Never use prescription pads as note pads or for orders other than prescriptions.

Role of Allied Health Professionals in Medication Administration      

You must understand state laws where you are employed. You must have a working knowledge of all medications used in your office. Establish working relationships with your local retail pharmacists. Federal and state laws concerning medications and prescriptions must be followed Be aw...