Historical and Legal Perspectives
Pre-Christian
Evil spirits which need t be driven from the body
Egyptians- used laxatives and opium
Ancients Greeks- Hippocrates said that disease was from natural or scientific causes- physician
was to assist in recuperation
400 drugs cited- encouraged rest, proper diet, fresh air, massage, and hydrotherapy
Dioscorides included 700 drugs in a formulary
Middle Ages
After the fall of Rome, Europe was in the dark ages- no gains in medicine
Most knowledge held by the Church
Cholchicine was used for gout and iron for anemia
Arabs more advanced and separated pharmacy and medicine
Arabs had formulary and first set of standards- Crusades sparked Renaissance
Renaissance
15th century- medical schools established in Europe
16th Century- Cordus wrote the first printed pharmacopeia for community use *****
17th Century- ipecac, coca, and benzoin
Eighteenth and Nineteenth Century
1700- nurses in hospital had no training
1785- William Withering introduced Digitalis for heart disease******slows heart rate and
strengthen contractions----PR below 60 do not give*********OD Bradycardia, light looks yellow
not clear to patient, NV
1796- Edward Jenner gave the first public inoculation for smallpox---model for all vaccines***
1815- Morphine discovered which led to discovery of codeine also Quinine(antimalaria and leg
cramps) and atropine (anticholenerginic and speeds heart rate) *****
1820- US Pharmacopeia developed: national pharmacopeia to maintain standards of drug
preparation. ****
1846- Ether used as an anesthetic: chloroform also used in childbirth. OK’d by Queen Victoria
1860- Nightingale established school of nursing and expected nurses to be responsible for drug
administration
1888- NF established to supplement the USP- (NF included mixtures and formulas)*****
Twentieth Century
1922- Doctors Banting and Best discovered insulin for clients with diabetes. Took the pancreas
of hogs and cows and ground them up and used that as insulin.
1929- Alexander Fleming- penicillin- actual use was in 1941-1942- WWII
WWII also prompted discovery of antimalarials and the other antibiotics
1940’s- antihistamines and steroids
1955- Polio vaccine by Jonas Salk- injection
1960’s- Sabin-TOPV-sugar cubes- put vaccine on sugar cubes instead of using injection for polio
Late 1950’s- oral contraceptives- changed the outlook of drugs for diseases only
Historical perspective of Nursing and Drug Administration
1919 NLN recommended 2 courses on med administration
1940’s: nurses did not give IM’s
1950’s to present:
Increased technology- responsible for PCA’s, IV’s, etc.
1952: Client teaching-Dr. Mildred Montag*******
Chained to med cart: know actions; how to calculate; side effects; how to administer
meds
Drug Legislations
1906- Pure Food and Drug Act
Made the USP-NF official
To protect the public from harmful substances
Labeled meds containing narcotics
1912- Sherley Amendment
Prohibited fraudulent claims
1914- Harrison Narcotic Act- 1st law aimed at preventing addiction *******
A United States federal law that regulated and taxed the production, importation and
distribution of opiates. The act was proposed by Representative Francis Burton Harris of
New York and was approved on December 17, 1914
Federal Food, Drug and Cosmetic Act***
1938- Federal Food, Drug and Cosmetic Act- established FDA****
Required drug testing to prevent death/harm labeling information:- 100 deaths from sulfa
Dose and Frequency
No false statements
Name and address of the manufacturer
“Warning: May be Habit Forming”******
Harmful to pregnant women, children, people with certain diseases
Durham-Humphrey Amendment******
1951-1952
“legend” drugs could be dispensed by prescription only- first legislation to distinguish between
prescription and over the counter meds
No refilling of drugs without the doctors OK and subject to limits
“Caution: Federal Law Prohibits Dispensing without a Prescription” label *****
Kefauver-Harris Amendment****
1962-1965: gained momentum due to thalidomide babies- given in England for morning sickness
and caused severe birth defect
Tightened controls on drug safety, contraindications, and adverse reactions
Required all marketed drugs to be effective***
Required testing of all drugs marked between 1938-1968 for effectiveness****
Controlled Substances Act of 1970***
Strengthened Harrison Narcotic Act of 1914
DEA (Drug Enforcement Administration) formed which is responsible for drug law enforcement
Created scheduled drugs
Scheduled Drugs***memorize***
Schedule I- available only for research (FDA approved research)- includes heroin, marijuana, LSD
(highly addictive drugs)
Schedule II- accepted therapeutic use but high abuse potential- prescriptions may not be
refilled- morphine, Demerol, Dilaudid aka hydromorphone, Seconal, Ritalin, Oxycodone aka
Oxycontin-SR aka Percocet- semi synthetic morphine, Codeine
Schedule III
Lower abuse potential than Schedule II
Tylenol #3, Paregoric, Vicodin aka Lorcet aka Hydrocodone
Morphine derivative similar to codeine but more addicting
Greater antitussive effect
Tussionex- hydrocodone with chlorpheniramine
Marinol- synthetic marijuana- controls vomiting
Schedule IV- similar to III
Penalties for illegal possession different in certain states
Darvon- aka propoxyphene
Valium- diazepam
Librium aka Chlordiazepoxide
Dalmane aka flurazepam
Xanax- alprazolam- do not confuse with Lorazepam which is Ativan also a IV
Ambien---aka Zolpidem
Phenobarbital
Darvocet- propoxyphene with acetaminophen
Schedule V- low abuse potential
May be sold OTC in some states while others require prescription- If OTC, some
restrictions apply like signature in ledger
Lomotil, Robitussin with Codeine, Donnagel PG- with Paragoric
Cough Suppressants with codeine or diarrhea meds with tincture of opium
Nurse and Controlled Substance
PRN order rewritten every 72 hours
No phone orders for Schedule II****except in emergency****
Telephone orders must be countersigned within 24-48 hours for the hospital and 72 hours for
the pharmacy
Schedule III or IV must be rewritten every 6 months or after 5 refills
Kept in med cart under double lock (careful with keys and pin numbers)
Check orders carefully
Sign out for any med coming out of the narcotic sheet. Sign and count as you go.
Nurse responsible for counting and signing out stock narcotics
Count at the end of shift with oncoming nurse and document and sign the narcotic sheet
Follow protocol for contaminated or wasted narcotics
Nurse abusing/diverting controlled substance may lose nursing license for awhile and then will
have to earn the right to have a probationary license.
New Drugs and Testing
Is regulated by the FDA- Federal Drug Administration which is concerned with general safety,
standards in production of drugs, food and cosmetics. They are responsible for adding or
removing drugs from the market
1978 Drug Regulation and Reform Act decreased time periods for drug testing (must have
informed consent)
1. Animal testing
Can only assess toxic and therapeutic levels. Study absorption and metabolism and
kidney excretion with these studies. Adverse reactions.
2. Human testing
Okayed only after the animal studies. Must have voluntary informed consent. The
Nuremburg code is ethical codes enacted due to the human study by Nazi Germany
during the Holocaust. The benefit/risk ratio is considered and if at any time they feel it
is too risky they will pull the study. They must use both healthy and ill patients and
must use drug for some and placebo for others. Double blind testing.
Generic Drugs
Pharmaceutical companies that develop a drug give it a trade name. (Valium, Demerol)
The drug also has a generic official name (diazepam, meperidine)
Drug also a chemical name
To recoup the money for drug development, only the developing pharmaceutical company can
market the drug for a specified number of years under the trade name for 17-20 years
1984- Drug Price Competition and Paten Term Restoration Act: said that when the patent of a
trade period is over, generic drug companies can market the drug by showing bioequivalence
(absorbs and acts the same as the original drug)
Can’t be called by the trade name if produced by another company. Can’t have its characteristic
appearance and shape so generics look different—confusing the customer
Generic and trade have the same chemical compound but inactive ingredients may be different
(binders, fillers, dyes, preservatives)
Pro’s- lower cost, more reimbursement, lower co-pay
Con’s- Clients don’t recognize appearance- get anxious. May have a reaction to inactive
ingredient
Nurses must teach and dispel myths
Drug Oriented Society
“all you have to do is take a pill”
Not as receptive to alternate therapy such as diet and lifestyle changes
Strong media influence- headache, hemorrhoids-heartburn-Viagra
Nurse must have broad knowledge of drugs, actions, side effects, food interactions, etc.
Take on empty stomach or with food.
Drug Interactions
ETOH interactions- increases CNS depressant and interacts with Flagyl
Diet restrictions with MAO inhibitors, L-dopa to reduce protein
Caffeine/tobacco influences
Bronchodilators and smoking- need increased dose-quit smoking you can decrease the dose
Caffeine and CV drugs- caffeine raises blood pressure and will negate the hypertension
medication.
MAOI’s
Discovered with INH-isoniazid (tuberculosis drug)
Increases serotonin and dopamine by inhibiting the MAO enzyme
Nardil-phenelzine (generic name)
Contraindications: Pts. With cardiovascular disease, under 16 years, pregnancy and lactation,
should not abruptly discontinue drug.
MAOI’s- Contraindicated Drugs and Food
Drugs
Levodopa
Insulin
Any antidepressant
Benadryl
Diuretics
Adrenergic drugs
Foods:
No tryamine tryptophan
Nothing fermented or aged (beer, wine, cheese, sour cream, yogurt)
No liver, figs, raisins, bananas, pineapple
No processed food (corned beef, salami, pepperoni, hot dogs)
MAOI Interactions
Hypertensive crisis- severe headache- palpitation, sweating, chest pain, possible intracranial
hemorrhage, and even death
Assessment
Allergies: cross-allergies are common
Iodine based dyes/solutions and seafood
Eggs and flu/measles vaccine
Rash, itching, hives, laryngeal edema, CV collapse-shock
Side effects: N&V, diarrhea, drowsiness
Toxic effects: anemia, leukopenia, nephrotoxic
Idiosyncratic reaction: unexpected abnormal reaction as dimetapp and hyper child and
barbiturate and hyped elderly person
Avoid leading questions and questions that put the client on the defensive
Open-ended questions best-----only close ended in emergency
Other meds taking OTC’s like ASA and Hep
Using one or two drug stores increases interactions
Liver or kidney disorders
Decreased vision
Knowledge deficit
Is the med effective- verifying with BP’s, temps, etc.
How does client cope with adverse reactions and interactions
Over the Counter Medicines
AKA non-prescription and/or non legend drugs
Became legal classification with 1951 Durham-Humphrey amendment
All OTC’s required review by FDA in 1972 to ensure effectiveness as well as safety: looks at
advertising and labeling of the OTC’s. Some formally legend drugs are deemed safe for self
medication and changed to OTC- ibuprofen
OTC- categories
Analgesics
Cold, Cough, and Allergy meds
Antacids
Laxatives
GI Preps
Sleeping aids
Vitamins
OTC
Read the label
Compare cost
Consult pharmacist- buy prescriptions and non-prescriptions at the same drug store
Limited effectiveness
Problem will resolve itself with non-pharmacological measures
Cold Medicine
Histamines released from the mast cells are responsible for signs of cold (mast cells are in the
nose)
Last 7-10 days
Antihistamines decrease histamine activity by blocking the receptor sites for histamine
activation
Dry secretions
Eliminated slowly from the body- half life of 30-36 hours
Time release sound good but amounts released at any one time may be too little to be effective
Common side effect: drowsiness- give at HS
Avoid use with ETOH or CNS suppressants
Hyperactivity seen sometimes with children
Dizziness, hypotension, sedation, and confusion in the elderly may lead to falls
Urinary retention!!! Pseudophed (remember state boards)
Physician consultation is required if client has a history of hypertension, CV disease,
hyperthyroidism, asthma, narrow-angle glaucoma, or BPH
Decongestants
Congestion caused by dilated blood vessels and fluid collection in the nasal mucosa
Decongestants act through vasoconstriction on the nasal blood vessels
May be oral or topical spray
Rebound reaction with vasodilation stuffiness
Limit to 3 days use
Oral meds cause: jitteriness, increased BP, hyperglycemia, cardiac irregularities- Dr Consult as
with Cold medicines
Cough Preparations
Cough is due to postnasal drainage into the respiratory tract- cough is dry and nonproductive
Causes lack of rest
Use increased humidity and fluids work as well
Cough suppressant work by inhibiting the cough reflex in the medulla
Avoid as much as possible with a productive cough since secretion needs t be coughed up and
out
Limit use to 7 days and then see doctor
Some have codeine
Dextromethorphan is a narcotic derivative without addictive potential and is found in Robitussin
and Benylin
Expectorants
Supposed to loosen, liquefy secretions and facilitate their removal from the lower respiratory
tract
Humidity and fluids can do the same things
May cause GI upset and N/V
Terpin hydrate elixir has high alcohol content and may be abused.
Guaifenesin-Mucinex-Antituss-Robitussin
Sore Throat
Must distinguish strep from viral first
Salt-water gargles, non-medicine hard candy, humidity, and fluids will be more effective
Tylenol or ASA for pain
Multisystem Cold Preps
Read the label carefully for ingredients and don’t overdose- watch acetaminophen
Analgesics and Antipyretics
ASA and acetaminophen are the most common analgesics for mild to moderate pain
Both have antipyretic properties also.
ASA is also an anti-inflammatory agent unlike acetaminophen
Acetaminophen is preferred for children sin ASA use with viral infections in children is linked to
Reye’s syndrome and Tylenol comes in liquid form
ASA
GI upset
Use enteric coated ASA- Ascriptin or Ecotrin
Enteric coated bypasses the stomach and dissolves in the alkaline environment of the small
intestines (causes delayed absorption)
Enteric coated should not be taken with antacid since the antacid will cause it to break down in
the stomach
Buffered ASA-Bufferin
Take with a full glass f water or food to minimize irritation
Gastric ulcers- bleeding in stool- anemia
Hazard with children
Signs of overdose:
1st symptoms is increased respirations- Tachypnea
Ringing in the ears (tinnitus)
Dizziness
Confusion
Headache
Flushing
Convulsions
Hallucinations
Don’t give with Heparin, Lovenox, or Warfarin. It has anti-platlet activity- take with chest pain
Acetaminophen-Tylenol-Tempra
High doses cause liver damage
Watch infant, children dosages and don’t mix
Watch combination drugs- read labels
Ibuprofen
Non-steroidal anti-inflammatory analgesic
200 mg every 4-6 hours
Prescription strength is 300-800 mg 3-4 times a day
If use with ASA it reduces anti-inflammatory response and causes GI irritation
Inhibits prostaglandin production which causes dysmenorrhea.
Dr. consult if have chronic disease like diabetes, ulcers, or are on anticoagulants
More expensive than aspirin
Laxatives
Most misused and abused of all the OTC medicines
Try non-pharmacological measures first
Bulk forming- Metamucil
Saline laxatives- MOM and Epsom salts
Stimulant laxatives- Dulcolax, Ex-lax, Senokot
Lubricants
Mineral Oil- decrease in fat-soluble vitamins
Stool Softeners-Colace-Surfak
Antacids
Don’t self-medicate if acute gastric or chest pain- SOB- sweating
Hematemesis- vomiting blood, don’t use antacid
Distress lasting longer than 2 weeks- don’t use
Occult bleeding- do not use
Liquid more effective and less costly in liquid form***
Sodium Bicarbonate- baking soda- large doses may result in alkalosis- high in sodium- not for
regular use
Calcium carbonate- neutralizes stomach acids but causes rebound (Tums)
Magnesium- diarrhea
Aluminum- constipation
Riopan and Aludrox are low sodium antacids
Nurse’s Role in OTC’s
Assessment
Teaching before moment of discharge
Explanation of how they affect legend drugs
Side effects/Toxic effects
Evaluate compliance
Definitions
Pharmacology- the study of all aspects of drugs and their effects on living systems
Pharmacodynamics- studies the biochemical and physiologic action/effect of a drug (drug
action, adverse effects and allergy)
Allergic reactions: rash, itching, hives, laryngeal edema, anaphylactic shock
Side effects/Adverse effects: N/V/D, drowsiness, fatigue, dizziness
Toxic effects: leukopenia, Anemia, Nephrotoxic- dose will be decreased or discontinued
Idiosyncratic Reactions- unexpected abnormal reaction