chapter 1 notes
definitions
biotechnology: process that may involve manipulating DNA and RNA and recombining genes into hybrid molecules that can be inserted into living organisms (usually E. coli) and reproduced
brand (trade) name: manufacturer’s chosen name for a drug, which is protected by a patent
controlled substance: drugs, substances, and certain chemicals used to make drugs that are categorized by federal law according to therapeutic usefulness and potential for abuse, also known as scheduled drugs
drug classifications: groups of medications that are classified according to their effects on the particular body systems, therapeutic uses, and chemical characteristics
generic name: chemical or official name of the drug that is independent of the manufacturer and often indicates the drug group
over the counter (OTC) drugs: medications available for purchase without a prescription
pharmacoeconomics: costs of drug therapy, including costs of purchasing, dispensing, storage, administration, and laboratory and other tests used to monitor patient responses, also considers losses due to expiration
pharmacogenomics: aka pharmacogenetics; study of how a person’s genome leads to different responses to drugs
generally refers to the genetic polymorphisms that occur in a patient population like an ethnic group rather than an individual person
pharmacotherapy: use of drugs to prevent, diagnose, or treat signs, symptoms, and disease processes
drug therapy
when prevention or cure is not reasonable, relief of symptoms can greatly improve a patient’s quality of life
placebo: inert substances containing no medication and given to reinforce a person’s expectation to improve
prescription drugs: medications that are ordered in writing by a licensed healthcare provider
prototype: often the first drug of a particular drug class to be developed, usually the standard against which newer, similar drugs are compared
medications: drugs given for therapeutic purposes for their local or systemic effects
drugs with local effects act at the site of application
systemic effects > circulates the bloodstream and acts on the various body tissues
drug sources
historically drugs came from plants, animals, and minerals
now, most drugs are synthetic compounds created in labs
synthetic drugs are more standardized in their chemical characteristics and are more consistent in their effects + less likely to produce allergic reactions
semisynthetic drugs (many antibiotics) are naturally occurring substances that have been modidied
biotechnology
important source of drugs
involve manipulation of DNA and RNA and recombining genes into hybrid molecules that can be inserted into living organisms (usually E coli) and can be reproduced into clones
cloning makes it possible to identify the DNA sequence in a gene and to produce a protein product, such as how insulin is made
drug classifications and prototypes
drugs are classified according to their effects on a particular body system, their therapeutic uses, and their chemical characteristics
ex. morphine > CNS depressant and a narcotic or opioid analgesics
therapeutic classifications usually reflect the conditions the drugs are used for
antidepressants, antihypertensives
chemical classifications group drugs based of their chemical composition
many drugs are named for their chemical characteristics rather than their therapeutic uses (e.g. benzos)
prototype: an individual drug that represents a group of drugs
often the first drug of a drug class to be developed
the standard of comparison
ex. morphine for opioid analgesics
penicillin for beta-lactam antibiotics
drug names
the two most used names are the generic (official) name and the brand (trade) name
generic name (e.g. amoxicillin) is related to the chemical or official name and is independnet of the manufactuer
end of the name often indicates the drug group (-cillins are penicillins)
the United States Adopted Names Council
brand name is designated and patented by the manufactuer
amoxicillin is manufactured by several manufacturers and some will assign a specific trade name (Amoxil, Larotid) and some who use the generic name
in drug literature…
brand/trade names are capitalized
generic names are lowercase unless in a list or in the beginning of a sentence
drugs may be prescribed by either the generic or trade name
generic equivalents are available for most drugs and can be substituted for trade name medication unless there is a comment for “do not substitute”
generic drugs are required to be therapeutically equivalent and less expensive than trade named drugs
drug marketing
patents protects new drugs for years during a time only the pharmaceutical manufacturer that developed it can market it
return on its investment during development and as an incentive to develop other drugs
cannot be manufactured or marketed until the drug patent expires
pharmacoeconomics
involves the costs of drug therapy (purchasing, dispensing… including the salaries of pharmacists and pharm techs), storage, administration (the salaries of nurses, costs of supplies), and lab/other tests used to monitor pt responses
goal: ID drug therapy regimens that provide the desired benefits at the lowest cost
pharmacogenomics
the study of how one’s genome affects the body’s response to drugs
information about a patient’s pharmacogenomics helps providers choose the best drugs and the drug doses that are likely to work best
the use of this information enhances the likelihood of best practices in drug therapy
access to drugs
prescription and non-prescription drug
American consumers have two ways to access therapeutic drugs
prescription drugs: which requires a written order
a licensede healthcare provider such as a physician, dentist, or nurse practitioner writes the prescription
over the counter (OTC) drugs: medications that do not require a prescription
acquiring or using prescription drugs for nontherapeutic purposes by people who are not authorized to have the drugs or for whome they are not prescribed is illegal
american drug laws and standards
main goal: protect the public by ensuring the drugs are safe and effective
The Food, Drug, and Cosmetic Act of 1938 regulate the manufacture, distribution, advertising, and labeling of drugs
requires that official drugs must meet standards of purity and strength as determined by chemical analysis or animal response to specifed doses
Durham Humphrey Amendment designates drugs that must be prescribed by a licensed physician or nurse practitioner and must be dispensed by a pharmacist
US Food and Drug Administration is charged with enforcing the law
Public Health Service regulates vaccines and other biologic products
Federal Trade Comission can suppress misleading advertisements of non-prescription drugs
Drug Laws and Amendments
Pure Food and Drug Act
1906, established official standards and requirements for accurate labeling of drug products
established forerunner of FDA
Shirley Amendment
prohibited fraudulent claims of drug effectiveness
Harrison Narcotic Act
restricted manufacture, sale, etc of opium, cocaine, marijuana, and other drugs
Food, Drug, and Cosmetic Act
revised and broadened FDA powers
gave FDA control over drug safety
required proof of safety from the manufacturer before a new drug could be marketed
authorized factory inspections
established penalties for fraudulent claims and misleading labels
Amendment
required governmental certification of biologic products > insulin and antibiotics
Durham Humphrey Amendment
designated drugs that must be prescribed by a physician or NP and dispensed by a pharmacist
Kefauver Harris Amendment
required a manufacturer to provide evidence (research studies) that a drug was effective for its claims and conditions
gave the government authority to standardize drug names
Comprehensive Drug Abuse Prevention and Control Act: Controlled Substance Act
regulated distribution of abused drugs
categorized drugs according to therapeutic usefulness and potential to abuse
replaced all previous laws regarding narcotics
Drug Regulation Reform Act
established guidelines for research studies and data to be submitted to the FDA by manufacturers
shortnened the time required to develop and market new drugs
Orphan Drug Act
decreased taxes and competition for manufacturers who would produce drugs to treat selected serious rare diseases
Blank
1987, stablished new regulations designed to speed up the approval process for high priority medications
Prescription Drug User Fee Act
allowed the FDA to collect user fees from pharmaceutical companies to shorten review time
specified a review time of 12 mo for standard drugs and 6 mos for priority drugs
NIH Revitalization Act
requires inclusion of women and minorities in NIH funded research studies
FDA Modernization Act
updated regulation of biologic products
increased patient access to experimental access to experimental drugs and medical devices
accelerated review of important new drugs
allowed drug companies to disseminate information about off label uses and costs of drugs
Best Pharmaceuticals for Children Act
encouraged pharmaceutical companies to conduct studies and label drugs for use in children
provided funds for 5 y for pediatric drug studies
Medicare Prescription Drug Improvement and Modernization Act
afforded the largest overhual of Medicare
provided entitlement benefit for prescription drugs and other benefits for seniors and those with medical disabilities
Combat Methamphetamine Epidemic Act
established federal law that regulated retail OTC sales of ephedrine, pseudoephedine, and phenylpropanolamine products due to their use in the manufacturing of illegal drugs
these drugs are:
kept behind the counter/in a locked case
limited in purchase to no more than 3.6 g a day and 9 g a month
dispensed after purchasrs produce ID and sign a sales lig
handled by trained employees
to prevent illegal production of meth
Ryan Haight Online Pharmacy Consumer Protection Act
applies to all controlled substances in all schedules
established federal law that it is illegal to distribute a controlled substance via the internet unless the online pharmacy holds a DEA registration that authorizes it to operate as one
Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act
dedicates more federal resources to combat the opioid crisis through alternate strategies for pain management including increased focus on nonopioid pain relief, expanded treatment options for people with susbtance use disorders
greater access to APRN delivered care and telehealth services
amends the Controlled Substances Act and permanently authorize NPs and provide a 5 year authorization for clinical nurse specialists, and certified nurse midwives to prescribe medication assisted treatments (MAT) for opioid use disorders
TITLE II (Controlled Substances Act)
regulates the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, and anabolic steroids
requires the pharmaceutical industry maintain physical security and strict record keeping for drugs and substances
drugs, susbtances, and certain chemicals used to make drugs are categorized into five distinct categories according to potential for abuse and therapeutic usefulness > controlled substances
the Drug Enforcement Administration enforces the Controlled Substances Act
must be registered with the DEA to handle controlled substances
prescribers have a number assigned to them by the DEA that is included on written prescriptions
prescriptions for schedule II drugs cannot be refilled, new prescription required
Nurses
store drugs in locked cotainer
administer only to patient
record dose on narcotic sheets and patient’s medication administration record
maintain accurate inventory
report discrepancies
categories of controlled substances
schedule I
drugs that have no accepted medical use, lack of accepted safety, high abuse potential
heroin
LSD, (lysergic acid dithylamide)
MDMA or ecstasy
mescaline
peyote
schedule II
drugs that are used medicallu with high abuse potentials
opioid analgesics (codeine, hydromorphone, methadone, meperidine, morphine, oxycodone)
CNS stimulants > cocaine, meth
barbiturate sedative hypnotics (pentobarbital)
schedule III
drugs with less potential for abuse than previous schedules, but abuse can lead to psychological or physical dependence… have an accepted medical use in the US
androgens and anabolic steroids
CNS depressants
CNS stimulants
mixtures containing small amounts of controlled substances
schedule IV
drugs with accepted medical use in the US but with some potential for abuse
benzodiazepiines
sedative hypnotics
prescription appetite suppressants
schedule V
products containing moderate amounts of controlled substances
may be dispensed by a pharmacist without a physician’s prescription but with some restrictions regarding amount, record keeping, and other safeguards
cough suppressants with small amounts of codeine
antidiarrheal drugs
medical assited treatment
used in the management of substance abuse disorders
medication in combination with counseling or behavioral therapy
SUPPORT for Patients and Communities Act assists states in implementing updates to their plans of safe care and improving data sharing between states
**** it is critical that patients voluntarily constent to participation while in the criminal justice system in order to protect their individual decision making rights and autonomy when facing legal sanctions
drug approval processes: FDA
the FDA is responsible for ensuring drugs are safe and effective before approving them to be marketed
review of research studies about proposed new drugs… the organization themselves do not test the drug
testing procedure
1962 Kefauver-Harris Amendment > newly developed drugs undergo estensive testing before being marketed for general use
FDA’s center for drug evaluation and research reviews results
Clinical trial of 5 phases
Phase O
drug testing in animals and small groups of humans
Phase 1: a few doeses are given to a certain number of healthy volunteers to determine safe dosages, routes of administration, absroption, metabolism, excretion, toxicity
Phase 2: subjects with disease or symptom being treated and compared to healthy volunteers
Phase 3: drug is given to different populations with different dosages. half test, half placebo (double blind)
help determine whethere potential benefits of a drug outweight the risks
Phase 4: FDA allows drug to be marketed and postmarketing monitoring continues
NIH Revitalization Act: policy of the NIH that women, racial and ethnic minorities be included in clinical drug trials
newly developed drugs must include sex-related effectiveness and safety information
BOXED WARNING
about drugs that can cause serious adverse effects
approval of prescription and nonprescription drugs
FDA’s CDER approves prescription drugs and approves drugs for OTC availability
OTC > consumer makes decision
CDER handles the transfer of drugs from prescription to OTC
In understanding the use of controlled substances for patients, it is important that the nurse knows that controlled drugs are
a. categorized according to prescription or nonprescription status
b. regulated by state and local laws more than federal laws
c. those that must demonstrate high standards of safety
d. scheduled according to medical use and potential for abuse
A patient is asking what the difference is between a prescription for 800 mg of a medication that can be purchased on an OTC basis as a 200-mg tablet. To address this issue, it is important that the nurse knows that OTC drugs
a. are considered safe for any consumer to use
b. are not available for treatment of most commonly occurring symptoms
c. often differ in indications for use and recommended dosages from their prescription versions
d. are paid for by most insurance policies
safety in drug administration
rights of medication administration
patients must adhere to the rights of medication administration
right drug
right dose
right patient
right evaluation
right assessment
right right
right time
right reason
right documentation
right patient goals
right to refuse medication
error reduction strategies during medication administration
quiet zone to prepare meds
placing quiet zones at entrance to medication room
following protocol and checklists
wearing a sah or vest to avoid interruption to the nurse
educating staff on reducing interruptions
having a drug guide available
verifying two patient identifiers to prevent misidentificationb
quality and safety education for nurses initiative (QSEN)
just like a thing to make sure nurses are well educated on basic competencies
curriculum development
QSEN DOMAINS: patient-centered care, teamwork and collaboration, safety, evidence-based practice, quality improvement, and informatics
national patient safety goals
joint commission concerned with strategies to enhance safety goals related to medication safety
DO NOT USE LIST OF UNNACCEPTABLE ABBREVIATIONS
TARGETED HIGH RISK ACTIVITIES
a healthcare facility must demonstrate safe medication management using risk reduction activities with medication labeling and use of anticoagulant medications
perioperative area, all medications must be labeled in syringes and basins if transferred from og packaging
high alert medications
ISMP identifies drugs that when used in error have a heightened risk of causing significant patient harm
Classes/Categories of Medications
Adrenergic agonists, IV (e.g., epinephrine, phenylephrine, norepinephrine)
Adrenergic antagonists, IV (e.g., propranolol, metoprolol, labetalol)
Anesthetic agents, general, inhaled, and IV (e.g., propofol, ketamine)
Antidysrhythmics, IV (e.g., lidocaine, amiodarone)
Antithrombotic agents (anticoagulants), including warfarin, low molecular weight heparin, IV unfractionated heparin, direct oral anticoagulants and factor Xa inhibitors (dabigatran rivaroxaban, apixaban, edoxaban, betrixaban, fondaparinux), direct thrombin inhibitors (e.g., argatroban, bivalirudin, dabigatran), thrombolytics (e.g., alteplase, reteplase, tenecteplase), and glycoprotein IIb/IIIa inhibitors (e.g., eptifibatide) cardioplegic solutions
Chemotherapeutic agents, parenteral and oral
Dextrose, hypertonic, 20% or greater
Dialysis solutions, peritoneal and hemodialysis
Epidural or intrathecal medications
Hypoglycemics, oral
Inotropic medications, IV (e.g., digoxin, milrinone)
Insulin, subcutaneous and IV
Liposomal forms of drugs (e.g., liposomal amphotericin B) and conventional counterparts (e.g., amphotericin B deoxycholate)
Moderate sedation agents, IV (e.g., dexmedetomidine, midazolam, lorazepam)
Moderate and minimal sedation agents, oral, for children (e.g., chloral hydrate, midazolam, ketamine [using the parenteral form])
Opiates, IV, transdermal, and oral (including liquid concentrates, immediate- and sustained-release formulations)
Neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium)
Parenteral nutrition preparations
Sodium chloride for injection, hypertonic (greater than 0.9% concentration)
Sterile water for injection, inhalation, and irrigation (excluding pour bottles) in containers of 100 mL or more
Sulfonylurea hypoglycemics, oral (e.g., chloropropamide, glimepiride, glyburide, glipizide, tolbutamide)
Specific Medications
Epoprostenol (Flolan), IV
Insulin U-500 (special emphasis*)
Magnesium sulfate injection
Methotrexate, oral, nononcologic use
Opium tincture
Oxytocin, IV
Nitroprusside sodium for injection
Potassium chloride for injection concentrate
Potassium phosphate injection
Promethazine injection
Vasopressin, IV or intraosseouspregnancy categories for safety
Beers criteria for potentially inappropriate medications used in older adults
list of meds that are best avoided in older adults due to adverse effects that have been linked to poor health outcomes
sources of drug information
pharmacology and other textbooks
drug reference books
journal articles
point of care references
internet websites