Chapter 2: Pharmaceuticals: Development, Safeguards, and Delivery

Sources of Drugs:
- Plants
o Red yeast rice: lowers cholesterol
Lovastatin uses same mechanism of action
o Estrogen replacement therapy for bone density increased risk for cancer
Natural product had the same risk
- Animals
- Synthetic chemicals
o Thyroid hormone less adverse effects
- Genetically engineered chemicals
Plants:
- Date to primitive times
- Classified according to their physical and chemical properties
o Alkaloids
o Glycosides
o Gums
o Oils
o Resins
Genetically engineered chemicals
- Genetically engineered drugs: developed using DNA technologies.
o Insulin made from recombinant DNA increased the purity
The more pure the drug the less adverse effects
- Genomics: the study and identification of genes and gene function.
o Researchers are now able to manipulate the chemical formulas of drugs to produce:
Specifically targeted drugs with fewer adverse effects.
- Proteomics: the study of protein structure and function.
o This technology is essential in biomarker discovery.
- Transcriptomics: the study of the transcriptome
o Aids in understanding the development and differentiation of a cell
- Metabonomics: the study of metabolic responses to drugs, environmental changes, and diseases.
o Can possibly predict an individual patients response to drug treatment.
Genetics for drug Metabolism:
-

Extensive: 2 lane highway enzymes use both

Intermediate: 1 lane closed backs it up drug accumulates in the body adverse effects are seen
sooner
Poor: Both lanes are closed no effect must choose another drug
Ultra-fast: 6 lane bypass moves through quickly no therapeutic response without a high dose

Drug Nomenclature
- Chemical name
o Precisely describes the drugs atomic and molecular structure
- Generic name
o Nonproprietary name; identifies the drugs active ingredient.
Example: Furosemide

Trade name
o Brand or proprietary name
Example: Lasix

Implications for Nursing:

- Order a drug by the generic name.
- Many trade names sound alike.
- The nurse should check the drug name at least three times.
- Pharmacy bar code system
Drug Classification
- Drugs that share similar characteristics are classified as a pharmacologic group or family
- Allows for increased understanding of medications
- Drugs that share similar characteristics can be classified by:
o Chemical classification
o Physiologic classification
o Therapeutic classification
Sources of Drug Information
- Where can nurses obtain reliable and up-to-date drug references?
o Drug publications
o Pharmacists
o Internet-based drug guide
*If you are unfamiliar with a medication look it up PRIOR to administering it
- Drugs.com for patient education?
Patient blogs are NOT credible

Standards for Drug Purity and Content:

- Pure Food and Drug Acts
o Protected people from misbranded or poisonous drugs, meds, liquors, and foods
- Federal Food, Drug, and Cosmetics Act of 1938
o Amendment to Pure Food and Drug Act
o Regulations for medical devices and cosmetic safety
o Prohibited use of cancer causing agents in food or drugs
- Kefauver-Harris Amendment
o Drug Efficacy Amendment
o Prove effectiveness and safety of a drug before approved

o No false advertising information must be proven accurate

o Generic names required to be less expensive not a new drug
Procedure for Drug Development and Approval
1. Discovery of a potential new drug molecule.
2. Preclinical trials: provide basic safety, bioavailability, pharmacokinetic, and initial efficacy data about
the drug.
3. Clinical trials: performed on humans in several phases.
*Only about 10% of new drugs that begin clinical trials are approved.

Phase 3: Where most risks of the drug therapy are identified

- Double blind study (1-3 thousand pts) monitored for safety and effectiveness of drug
Legislation to Promote Truth in Advertising
- Sherley Amendment (1912)
o Prohibited false statements about the identity of the drug
o Did not regulate the false curative/therapeutic statements
- The FFDCA of 1938 provided labeling requirements for the first time.
- Federal Trade Commission regulates the advertisement of medications aimed at the general public
(present day)
Legislation Regarding Controlled Substances
- Harrison Narcotic Law of 1914
o Provided regulation regarding the manufacture and distribution of certain drugs
- The 1970 Comprehensive Drug Abuse Prevention and Control Act
o Established the Drug Enforcement Agency (DEA)
o Five categories, known as schedules, were established

Classed by potential for abuse

o I: highest
o V: lowest
Hydrocodone: Schedule to CII not CIII now
o CII is the highest level of controlled drugs
Opioids: potential for abuse go to CNS
o BBB: highly lipophilic, small, unionized to get across biological membrane

Nursing Management of Controlled Substances:

- Prescribing, dispensing, and storing of controlled substances is subject to governmental control.
- Procedures are precisely defined by law for every step, from manufacture to administration to wasting or
discarding.
- Many hospitals use an automated system to electronically track the use of stock drugs.
**Know CII handling protocol for ANYWHERE you work**
Legislation Regarding Drug Distribution
- The Durham-Humphrey amendments (1952)
o Nonprescription drugs (over-the-counter drugs)
o Legend (prescription) drugs
Labeled properly
Procedures for the distribution of legend drugs
Online Pharmacies
- Increased usage
- Average saving of 24% to consumers
- Not all online pharmacies are regulated
- The Ryan Haight Internet Pharmacy Consumer Protection Act of 2005
o Regulates the ordering and dispensing for online pharmacies
Nongovernmental Intuitional Controls
- Additional regulations may be implemented by the institution
- Accrediting bodies play an additional role in institutional controls.

Safeguards in Drug Development, Manufacture, and Distribution in Canada

- Similar to those in the US
- Canadian Food and Drugs Act
- Canadian Narcotics Control Act
Effect of Legal and Institutional Controls on Nursing Management of Drug Therapy
- Drug laws and nurse practice acts vary from state to state.
- Nurses must be familiar with the current regulations in their states and in their practice settings.
- In professional practice, nurses must adhere to and obey established drug control laws and protocols.
- Nurses cannot provide drug therapy without proper authorization.
- Nurses are responsible for drug security and safe administration.
*Anyone who as access to make clinical judgment is responsible
*Know how to use the system to check the medication prior to administration
Patient Education as a Safeguard in Drug Therapy
- Teaching focus and content
- Evaluating and documenting educational outcomes
- Consumer drug information on the internet
Importance of Nursing Management of Drug Therapy
- Nurses are legally responsible for the drugs they administer.
- Safe drug administration: have a thorough understanding of therapeutic drug actions and adverse drug
reactions.
- Can modify drug regimens (in some clinical settings)
- Using the nursing process to the pharmacologic aspects of patient care is especially important because
long-term use of drug therapy is frequently necessary to control chronic disease processes.
- Nursing management of drug therapy may be considered an applied science.

Chapter 3: Drug Administration

Which route has the fastest absorption rate?
- Must know the target site
o Asthma: inhalation fastest get to the alveoli the fastest
*IV= fastest rate of absorption directly into the bloodstream
Also most dangerous (faster rate)
Drug Administration Routes: General Consideration
- Enteral route (most common)
o Gastrointestinal (GI) tract is used for the ingestion and absorption of drugs
- Parenteral route
o Avoids the GI tract
o Associated with all forms of injections:
intramuscular (IM) slow/immune system must have time to recognize the antigens to
build antibodies
subcutaneous (SC or SQ)
intravenous (IV)
- Topical route
o Applied to the skin or mucous membranes
o Lipophilic to get through the skin
Local and Systemic Effects
- Local effects: effect at the site of administration manage risk and adverse effects
- Systemic effects: distributed throughout the body systems
o Certain drugs given topically are absorbed by the skin
- Enteral Route: absorbed from the stomach and small intestine
o Go through 1st-pass metabolism lose some of drug
- Parenteral route and some topical drugs: transported directly into the blood
o Advantage of not having to go through the 1st pass effect
Enteral Route and Forms
- Uses GI tract for the administration and absorption of drugs
- Variety of forms
o Oral route: most common enteral route
o Some oral drugs are given for their local effect in the GI tract
o Most drugs are given to achieve a systemic effect.
ExceptionVancomyocin: treats Cdiff in intestinal tract localized in oral form
Enteral Dosage Forms
-

Tablets (active ingredient is mixed with lactose or sugar)

o solid dosage form
o Enteric coated tablet has a wax-like layer.
Allows the drug to dissolve in the intestines instead of the stomach
o Sustained-release tablets are formulated to release a drug slowly over an extended period
NEVER crush these will not be absorbed slowly in body
Intent is for it to work over a slow period of time needs a slow release could cause
OD
o Sublingual and buccal tablets

Designed to dissolve rapidly in the vascular mucous membranes of the mouth

Buccal tablets placed in cheek
Sublingual tablets under the tongue
Avoid the first-pass phenomenon no harsh/acidic stomach environment
o Troches
Used to achieve a local effect in the mouth or pharynx
Area treated above stomach dissolve in mouth to help effected area
Capsules
o Encased in solid dosage forms, paste, powders, and liquids in a shell of hard or soft gelatin
o Disadvantage: the dosage cannot be divided
Syrups
o A concentrated solution of sugar that contains the medication
Elixirs
o A clear hydroalcoholic mixture
o Cloudiness indicates contamination
Emulsions and suspensions
o Emulsion: two liquids that do not mix well are combined
Can crack (separate) no longer useful
o Suspension: is a drug preparation consisting of two agents
Nasogastric or gastrostomy (NG) tube forms
o Either liquid or crushed and in a liquid vehicle administered through a tube
o Liquid drug form is preferred causes less clotting of tubes than crushed and dissolved drugs.
o Enteric-coated or sustained-release preparations cannot be crushed.
Example: Drug that lower seizure threshold crushing tablet release more at once
induce seizure

Nursing Management in Enteral Drug Administration

- Core drug knowledge
o Gastric acids and enzymes destroy many drugs
o Food may interfere with the dissolution and absorption of certain drugs
- Assessment of relevant core patient variables
o Important aspect of drug administration
Core Patient Values:
- Health status
o A primary consideration for an oral drug is the patients condition.
o Assess for ability to tolerate the drug
- Life span and gender
o The high sugar content of syrups can mask unpleasant drug flavors
o Elixirs: not used in children or in adults who should avoid ethanol
- Environment
o Oral drug forms are easily self-administered
Maximizing Therapeutic Effect:
- Medications may be mixed with food or fluids.
- Shake liquid medication immediately before administration
- Drugs administered through an NG/G tubes are instilled slowly.
NG and G tubes need to be flushed after administration of medications. Adverse Effects:
Minimizing adverse effects

Enteric coated drugs and sustained-release form should never be chewed, crushed, or broken.
Sucrose-containing syrups may increase the risk of gingivitis or dental caries (over time)
Check for proper placement NG or G tube prior to administration
Follow the cardinal rules of drug administration.

Parenteral Route
- Intramuscular administration (Flu shot)
o Injecting drugs into certain muscles.
o Onset of action faster than with oral meds
o The most common sites for IM injection:
Ventrogluteal
Deltoid rectus femoris
Vastus lateralis muscles.
- Subcutaneous administration (Insulin or Heprin)
o Under the skin into fat and connective tissue.
o Must be highly soluble, low volume, and nonirritating
- Intravenous administration
o Directly into the bloodstream
o Ensures prompt, sometimes immediate, onset of action
o Eliminates the uncertainty associated with varied absorption rates from other routes.
o One of the most dangerous routes.

IM sites

Subq sites

Other Parenteral Delivery Routes

- Intradermal
o Injections are made into the dermis just below the epidermis.
o Primarily for local anesthesia and for sensitivity tests
Allergy and TB tests.
- Intra-articular
o Injecting a drug into a joint.
- Intra-arterial
o A catheter inserted into an artery leading directly to the targeted treatment area.
- Intrathecal
o A drug is delivered into the cerebrospinal fluid.
Nursing Management in Parenteral Drug Administration
- Drugs distributed directly to the vascular system.
- Avoids erratic absorption
- GI irritant nature of the drug use this route to avoid

Faster onset of action than those administered orally or topically.

Assessment of Relevant Core Patient Values

- Health status
o Chosen if patient cannot tolerate oral drugs.
- Life span and gender
o Infants have small muscle mass.
o Elderly people have decreased muscle mass overall and decreased tissue elasticity.
- Lifestyle, diet, and habits
o More expensive than oral forms.
- Environment
o Requires increased patient teaching.
Maximizing Therapeutic Effects
- Select the appropriate-sized syringe and needle is key to administering an IM or SC injection.
- A continuous IV drug infusion should be monitored
- After administration of an intermittent IV drug, the lock must be flushed to maintain patency.
Minimizing Adverse Effects
- Follow the six rights of drug administration
- Sterility of syringe
- Site selection incorrect placement of the needle may damage blood vessels or nerves.
- Z-track: for drugs that are irritating
- Continuous IV infusion must be closely monitored.
Topical Route:
- Apply the drug preparations to the skin or mucous membranes, including the eyes, ears, nose, rectum,
vagina, and lungs.
- Primary advantage: usually act locally.
- Disadvantage: most are intended for only one specific site.
- Many different drugs can be given topically.
Topical Drug Forms:
- The most common and widely used: lotions, creams, liquids, ointments, and emollients.
- Transcutaneous or transdermal drug delivery systems deliver a specific amount of a drug.
o Applied to skin
- Drops or ointment Eye
- Suppositories or ointments Rectum
- Suppositories, creams, foams, liquids, or tablets Vaginia
- Liquid sprays, drops, or aerosol preparations Nose
- Inhalers respiratory conditions.
Nursing Management in Topical Drug Administration
- Assessment of relevant core patient variables
o Inspecting the skin for integrity.
- Planning and intervention
o Maximize therapeutic effects and minimize adverse effects:
Wear gloves
Sterile technique is used when the skin is broken
Adverse effect remove the medication
Observe the six rights of drug administration

**Remember**
- Drugs that are highly lipophilic, small, and unionized get across biological membrane
o Opioids potential for abuse b/c go to CNS (cross BBB)
o Anti-diarrheal hydrophilic/ionized slows down receptors to small intestine
- Lack of therapeutic effect absorption was most likely the cause
- Early onset of a drug metabolism most likely the cause
- First Pass Effect: some of the drug is metabolized by the liver deactivates some of the medication
o How much drug you lose going through metabolism
o Lowers the amount of drug to the target area
o Oral meds
- Subq injections: contain a smaller volume
o Ex: insulin
o Rates are varied upon different locations
Stomach arm leg (fastest to slowest)