pharm ch 1-2
Chapters 1 & 2
Learning Outcomes
• Identify the differences between the pharmacological and therapeutic methods of classifying drugs.
• Discuss the rationale behind using chemical, generic, trade and prototype identifiers.
• Identify the role of clinical judgment in medication administration.
• Outline the key U.S. drug regulations and identify how each have contributed to increased patient safety.
• Discuss of the process of FDA drug approval, and rationale for emergency authorization of new drugs.
• Classify medications based on risk for physical and psychological dependence.
History of Pharmacology – medication use goes back to 3000BC, it originated from the use of plants to treat symptoms, there are more than 20,000 medications approved by the FDA
Definitions RT Pharmacology:
• Pharmacology: The study of medicines – the how, when, where, why of use of drugs in the
body and the response they elicit when given.
• Pharmacotherapy (or Pharmacotherapeutics): Use of medications for prevention or specific
treatment of a disease process.
• Classification: Way in which medications are classified based on key similarities or chemical
make-up.
o Therapeutic – what is the reaction, what does the drug do to the patient
o Pharmacologic – every class has similarities to each other such as effects, outcomes, and needs to be watched almost the same way
What’s in a Name?
Chemical Name: N-(4-hydroxyphenyl)acetamide
Tells how the drug will be metabolized and excreted
Generic Name: Acetaminophen
Similarity in prefix and endings
Trade Name: Tylenol
Gets to be chosen by the company that made it
Prototype:
A drug chosen from a pharmalogical class and used as an example, helps to learn the effects of other drugs in the family
A Brief Mention of Biologics
• Biologics are medications made of living cells.
• FDA Approved.
• Up-and-coming meds used to treat inflammatory disease processes.
• Very expensive.
• Biosimilar drugs are medications that are similar to a designated biologic, but not an exact
duplicate copy. -the name of the drug will have the same name but end with 4 letters (ex: tylenol-urqt)
o Less expensive than biologics.
o For FDA approval, the biosimilar medication must have the same route of administration, dosage forms, and mechanism of action.
Question:
Why is it important for nurses to study medications? Nurses are the last defense for the patient so knowing the positive and negative effects a drug has will help deliver better care and quality safety.
Clinical Judgment & Pharmacology
• What is clinical judgment? The collection of the facts in a situation and creating an educated judgment
• According to NCSBN’s, CJ involves using nursing knowledge to:
Observe & assess presenting situations
Identify a prioritized client concern
Generate the best possible evidence-based solutions in order to deliver safe client care
Clinical Judgment is how nurses make decisions regarding medication administration – is it
appropriate, is it safe, was it effective? yes, it is appropriate. it is safe as long as the nurse has a good understanding of the drug. Yes, this is very effective as long as the nurse understands her patient and the drug
• New graduate nurses account for > 50% of medication errors that occur in clinical practice.
• Of those errors, >65% occurred due to a lapse in clinical judgment.
FDA: Drug Legislation & Approval Process
History of Drug Legislation
Until the early 1900’s, there were no laws or guidelines that governed the production and sale of
substances that claimed to “cure” a multitude of diseases.
“Snake Oil” salesman were free to make claims and distribute elixirs that were often a combination of harmless “filler” ingredients and addictive substances.
Key Legislation
• Drug Importation Act of 1848- was the first legalization to drugs from making its way into the US
• Biologics Control Act of 1902- went after snake oil sellers, made it to where dugs had to be inspected to make sure it was good
• Pure Food Drug Act of 1906- the father of the FDA, gave power to the government to regulate
• Sherley Amendment to the PFDA of 1912- prohibited the false use of medication/practice
• Food, Drug, & Cosmetic Act of 1938- newly developed drugs had to be tested for safety before people can use
• Kefauver-Harris Amendment of 1962- mandated that manufactures had to be inspected by the FDA to keep quality and safety
• Orphan Drug Act of 1983- gave company's bonuses for making medication for people with uncommon/rare diseases (usually less than 20,000)
Emergency Use Authorizations
• Allows for priority drugs to receive accelerated approval.
• Reserved for medications intended to treat life-threatening conditions, for which there are no
other effective treatments.
• FDA may grant approval prior to the completion of Phase III drug trials.
Prescription vs. Over-the-Counter (OTC)
Prescription Medications
• Must be prescribed by an authorizing agent (M.D., D.O., APRN, DPM, Dentist, etc.).
• Medications that either have a high risk for addiction or are used to treat complex medical
conditions.
• May require advanced administration technique (ex. Intravenous).
Over-the-Counter (OTC) Medications
• Do not require an order.
• Are often prescription medications being sold at a lower dosage level (ex. Cimetidine,
Famotidine for acid reflux).
• Are not considered to be addictive and can be used to treat mild or non-complex issues
(headache, fever, constipation).
• Herbal products and supplements are also considered to be OTC meds.
Controlled Substances
• Medications that have a high potential for addiction and misuse are regulated based on a
classification system.
• Close monitoring and restrictions are placed on these medications and may include limitations
in number of doses that can be dispensed at a time.
• Distribution falls under the authority of the Drug Enforcement Agency (DEA).
Advanced Practice RN’s
• The ability of an Advanced Practice RN to practice independently is based on individual state
licensure laws.
• Whether an APRN can prescribe medications independently can vary from state to state.
• May require co-signatures from physicians.