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Pharmacology
study of medicine:
1. How drugs are administered
2. Where drugs travel in the body
3. Responses that drugs produce
Medication characteristics
-therapeutic applications
-interactions
-adverse effects
-mechanism of action
- many drugs prescribed for >1 disease
-elicit different responses in the body depending on: age, gender, body mass, health status, genetics
Therapeutics
focuses on disease prevention as well as Tx and pain- pharmacotherapeutics application of drugs for treating disease and alleviating pain
Therapeutic classification of drugs
based on therapeutic usefulness in treating diseases or disorders (ex. antidepressants, antipsychotics, antineoplastics)
Pharmacologic classification of drugs
based on the way a drug works at the molecular, tissue or body system level
-addresses a drugs mechanism of action- how a drug produces its physiological effect on the body
(ex. calcium channel blockers, diuretics, adrenergic antagonists)
Prototype drugs
serves as a model for drug class:
-well understood
-Has known action and adverse effects
-used to compare other drugs in the same class
-May not be the most widely used drug in its class
-Disagreements may exist over which drug should be prototype drug
Newer drugs in the same class may replace the prototype drug b/c they:
-Are more effective
-Have a more favorable safety profile
-Have longer duration of action
Chemical drug name
-Describes physical and chemical properties of drug
-Often complicated, and difficult to remember or pronounce
Generic drug name
-Assigned by U.S. Adopted Name Council
-Lowercase
-Only one generic name
Trade drug name
Assigned by company marketing the drug
-Capitalized
-Also called proprietary, product, or brand name
-Drug developer has exclusive rights to name and market a new drug for 17 years in the United States
Trade name vs generic drugs
-difficult to tell difference in effect b/t 2 forms of drug, even if dosage is same
-Inert ingredients ("fillers") may cause problems
-Key comparison is bioavailability— physiologic ability of the drug to reach its target cells and produce its effect.
-Measuring how long drug takes to exert its effect gives crude measure of bioavailability.
Over the counter (OTC) drugs
-Do not require healthcare provider's order
-May have serious adverse effects if not used properly
-More easily obtained than prescription drugs
-Self-treatment is sometimes ineffectual
Black box warnings
One of the primary alerts for identifying extreme adverse drug reactions discovered during and after the review process
Scheduled drugs
-Drugs that have a significant potential for abuse, addiction or dependence are placed into five categories called schedules
-Schedule I drugs have the highest abuse potential, Schedule V the lowest
Schedule I drugs
Limited or no therapeutic uses
abuse potential: highest
potential for physical dependency: high
potential for psychological dependency: high
(Ex. heroin, LSD, marijuana, peyote, ecstasy)
Schedule II drugs
Abuse potential: high
Potential for physical dependency: high
Potential for psychological dependency: high
(ex. methadone, hydromorphone, oxycodone, fentanyl, methamphetamine, cocaine, phenobarbital)
Schedule III drugs
Used therapeutically with prescription
Abuse potential: moderate
Potential for physical dependency: moderate
Potential for psychological dependency: high
(ex. ketamine, <15 mg hydrocodone, <90 mg codeine, benzphetamine, anabolic steroids)
Schedule IV drugs
Abuse potential: lower
Potential for physical dependency: lower
Potential for psychological dependency: lower
(ex. alprazolam, clonazepam, diazepam, lorazepam)
Schedule V drugs
Therapeutic use w/o prescription
Abuse potential: lowest
Potential for physical dependency: lowest
Potential for psychological dependency: lowest
(ex. cough syrups)
Nurse responsibilities
- know what drug is ordered
-name of drug and classification
-intended purpose or use
-effects on body
-contraindication
-special considerations (age, other drugs, etc.)
-side effects
-why drug was prescribed
-how med is supplied by pharmacy
-how med is administered, including dosage ranges
Nursing before, during, after drug administration
Before: know all variables of condition- vitals, I&O, pain, adverse effects, purpose of med, dose, pt history
During: nurse must know how to give med and whether patient is able to take the medication as prescribed
After: be prepared to recognize and react to adverse effects
adverse drug event
adverse event r/t drug administration
side effect
non-therapeutic reaction to a drug- may be transient (short lived)
allergic/anaphylactic reactions
-Serious side effects
-Must be carefully monitored
-Nurse must document allergic reactions
Five rights of drug administration
Right patient
Right medication
Right dose
Right route of administration
Right time of delivery
Three checks of drug administration
1. Checking drug with MAR or medication information system when removing it from storage
2. Checking drug when preparing it, pouring it, taking it out of the unit-dose container, or connecting the IV tubing to bag
3. Checking drug before administering it to the patient
4 most common medication errors
1. Errors in patient assessment (e.g., inadequate medication history)
2. Errors in prescribing (e.g., wrong drug, incorrect dose)
3. Administration errors (e.g., route or time of administration)
4. Distracting environmental factors (e.g., interruptions during preparation)
Drug adherence
-taking a medication in the manner prescribed by the health care provider
-Patient has an active role in ensuring compliance Factors that can cause a patient to deviate from compliance:
• Cost of drug
• Forgetting doses
• Annoying side effects
• Self-adjustment of doses
• Fear of dependency
-Nurse must be vigilant in questioning patients about their medications
STAT
medication is to be given immediately, and only once
ASAP
drug should be available for administration within 30 minutes of the written order
PRN
drug is administered as required by the patient's condition
ac
before meals
ad lib
as desired/directed
pc
after meals
Rx
take
Never use abbreviations
q, qh, qd, qhs, qod, U, IU, trailing zero, no use of leading zero, MS
Single order
drug is to be given only once at a specific time
Routine order
Orders not written as STAT, ASAP, NOW, or PRN
Standing order
written in advance of a situation that is to be carried out under specific circumstances
Enteral
• Tablet, capsule or liquid
• NG- and G-tube
• Some tablets may be crushed or capsules opened
• Some variability in bioavailability may occur with enterally administered medications
Sublingual and Buccal
Tablet is NOT swallowed
• Sublingual: under the tongue
• Buccal: between the cheek and gums
• Rapid onset secondary to rich blood supply in this region
• Not suitable for extended release formulations of drugs
• No eating or drinking until the medication is dissolved
Topical
Applied to skin and mucous membranes
• Transdemal, opthalmic, otic, nasal, vaginal
• Produce a local effect
• Never placed on abraded or denuded skin (unless otherwise directed)
Parenteral
• Intradermal, subcutaneous, intramuscular, intravenous
• Use aseptic technique when preparing and administering parenteral medications
• Nurse must know correct anatomical locations
Inhalations
• Drugs applied to respiratory tract
• Inhalers, nebulizers
Protocols and Techniques for All Routes of Drug Administration
• Verify medication order, check allergy history
• Wash hands and apply gloves, if indicated
• Identify patient (two forms of ID)
• Ask patient about known allergies
• Inform patient about drug
• Position patient
• Remove prepackaged drug at bedside
• Unless instructed to do so by a licensed nurse, do not leave drugs at bedside
• Document administration and pertinent patient responses
Pharmacologist
a scientist who conducts research experiments and tests drugs to study their effects on animals and humans
Retail Pharmacist
The majority of pharmacists work in retail pharmacy. Retail pharmacists dispense and verify medications, counsel patients on medication use and general health topics, and recommend over-the-counter products. Additionally, depending on the pharmacy, retail pharmacists may vaccinate patients or offer medication therapy management to patients with chronic disorders or both. Retail pharmacists manage pharmacy technicians and may choose to pursue a management track.
independent pharmacist
In addition to the responsibilities described under retail pharmacy, pharmacists working at an independent pharmacy may compound medications and, depending on the size of the pharmacy they own, they may manage finances, order and take inventory of items sold at the pharmacy, manage personnel, make payroll, etc.
hospital pharmacist
Hospital pharmacists advise health care providers and patients on the safe and effective use of medications and are responsible for choosing, preparing, storing, compounding, and dispensing medications. Other responsibilities include monitoring medication use, implementing hospital regulations related to medication, and other administrative tasks. Individuals interested in hospital pharmacy typically complete a pharmacy residency program.
clinical pharmacy
Clinical pharmacists work with physicians and other health care professionals to ensure that medications contribute to optimal patient health outcomes. Responsibilities may include evaluating patient response to prescribed medications, attending patient rounds in hospital units and counseling patients. Clinical pharmacists work in hospitals, health clinics, nursing homes and insurance companies. Individuals interested in clinical pharmacy typically complete a pharmacy residency program.
managed care
Managed care pharmacists work directly with other health care professionals to provide medication therapy management, while considering the pharmacoeconomic impact on patients. They provide a broad range of clinical services including monitoring patient safety and outcomes, managing formularies, and patient education. Managed care pharmacists typically work for health plans and pharmacy benefit management companies..
Industry
There are a broad range of opportunities available to pharmacists in the pharmaceutical industry. They can participate in research and development, quality assurance, drug information, sales, marketing, regulatory affairs or clinical trials. Individuals interested in working in the pharmaceutical industry typically participate in postgraduate fellowship programs available at many pharmaceutical companies.
consultant pharmacy
Pharmacy consultants typically work with long-term care facilities and review drug regimens, offer pharmacokinetic dosing services, patient counseling and therapeutic drug monitoring. Long-term care facilitates include nursing homes, mental institutions, home health agencies, hospice care, correctional institutions, rehabilitation centers and adult day care centers.
academia
Pharmacists interested in training the next generation can pursue a career as faculty member at a college or school of pharmacy. Pharmacy faculty teach, conduct research, participate in public service, precept students and contribute to patient care. Individuals interested in a career in academia should consider residencies with significant teaching components.
nuclear pharmacy
Nuclear pharmacists compound and dispense radiopharmaceuticals for use in medical procedures. Individuals interested in nuclear pharmacy must complete a training program after earning a Doctor of Pharmacy degree and should consider residency programs that focus on nuclear pharmacy.
government agencies
The National Institutes of Health, FDA, US Centers for Disease Control and Prevention, United States Department of Homeland Security, Federal Bureau of Prisons, Veterans Administration, and Armed Forces all employ pharmacists. Pharmacists working with a governmental agency engage in a wide range of tasks, including patient care, biomedical and epidemiological research, reviewing new drug applications, and developing and administering health care policy.
FDA (Food and Drug Administration)
-approve new drugs to be sold in the US
-process New Drug Applications (NDA)
-regulate package inserts
-regulate drug advertising
-issue recalls
-federal agency
DEA (Drug Enforcement Agency)
-federal agency
-enforce the CSA ( controlled substances act)
-track controlled substances manufactured and sold
-investigates all violations involving controlled substances
-set the DEA Sch. Definitions
-issue DEA numbers
BOP (Board of Pharmacy)
-regulate licensing of pharmacists
-regulate licensing of pharmacy technicians
-set state laws/ requirements
-outline the operating guidelines in the pharmacy
-investigate violations of the operating guidelines
-determine state regulated controlled substances
-state agency
Joint Commission on Accreditation of Healthcare Organizations
-watches over healthcare organizations
-third party auditors/ regulators for insurance providers
DEA Schedule I
-no accepted medical use
-extremely high potential for abuse
-high potential for psychological and physical dependency
-ex. marijuana, heroin, mdma
DEA Schedule II
-does have medical use
-high potential for abuse
-relative potential for psychological and physical dependency
-ex. oxycodone, codeine, retalin
-no refillls allowed
-cannot be "called in" or transmitted electronically unless it is an absolute emergency
DEA Schedule III
-does have medical use
-moderate abuse potential exits
-ex. vicodin and tylenol w/ codeine
DEA Schedule IV
-abuse potential exists
-ex. ambien, darvocet, lorazepam
DEA Schedule V
-lowest abuse potential
-ex. cough medicine w/ codeine or anti-diarrheas
DEA Form 222
-add the 1st, 3rd, and 5th digits
-add the 2nd, 4th, and 6th digits. double it
-add the two totals together. the second digit is the check digit
-preceded by two letters: first letter represents the type of practice or institution the DEA number is issued to, the second letter represents the first letter of the practitioner's last name
sig
-tells pharm techs how to dispense it
-also printed on the prescription it is dispensed in but translated into regular words for the patient
Expiration dates: DEA Sch II
no expiration
Expiration dates: DEA Sch III thru V
six months
Expiration dates: Legend Drugs
twelve months
Refills: DEA Schedule II
no refills allowed
Refills: DEA Schedule III thru V
-up to 5, but only 5 times
-if a patient can only afford 50 at a time then they will only get 250 total
Refills: Legend Drugs
up to twelve months worth
DEA Controlled Drug Prescriptions must contain at least:
-date of prescription issue
-patient's name and address
-practitioner's name, address, and phone number
-drug name
-drug strength
-dosage form and instructions
-exact quantity prescribed
-complete directions for use
-number of refills authorized
-a valid DEA number
Schedule II drug prescription:
-must be manually signed by the practitioner. no exceptions
-may not be faxed or called in, except for a valid emergency
-may not have any refills
FDA Recall Class I
would be used in a case where there is a probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
FDA Recall Class II
would be used in a case where use of a violative product may cause temporary health problems and the probability of serious adverse health consequence is remote
FDA Recall Class III
may be used in a situation in which use of a violative product is not likely to cause adverse health consequence, but has violated some FDA regulation
FDA Market Withdrawal
appropriate when a product has a minor violation that would be not subject to FDA legal action. the manufacture must remove the product from distribution markets or correct the violation. "a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal"
FDA Medical Device Safety Alert
used only for medical apparatus equipment. this is when a medical device may present an unreasonable risk of substantial harm. in some cases, these situation also are considered recalls
NDA Process: Initial Development: Pre Clinical
pre-clinical (animal) testing
NDA Process: Initial Development: Investigational New Drug Review (IND)
-review of pre-clinical trial results
-determination of safety to use on humans
-authorization to ship across state lines
NDA Process: New Drug Clinical Trials: Phase I
-involves 25-100 volunteers
-safety tolerated dosage determined
-identification of major side effects
-emphasis on safety and maximum tolerated dosages
NDA Process: New Drug Clinical Trials: Phase II
-involves 100-300 volunteers
-emphasis on the drug effect against what it's designed to treat
-effets compared with similar patients receiving different treatments
NDA Process: New Drug Clinical Trials: Phase III
-involves 300-3000 volunteers
-emphasis on the drugs overall effect
-effects compared with patients taking placebos
-study of different population and different dosages
-testing the drug in combination with other drugs
-final phase before presenting to FDA for approval
NDA Process: New Drug Post Approval Trials: Phase IV
-ongoing/post approval trials
-health-care professionals to report any adverse findings
-lasts eternally, as long as the drug is on the market
NDA Process Time
-can usually take 12-15 years
-patent only last 20 years from the time the application for patent was filled
Federal Food and Drug Act of 1906
-known as the Pure Food and Drug Act
-provided authority for federal inspection of meat products and prohibited the sale of adulterated foods
-required that "secret elixirs" containing ingredients like: cocaine, heroin, morphine and alcohol which were available at most stores as miracle cure-alls be labeled with correct information about their ingredients as well as suggested dosages
-replaced by the Federal Food, Drug and Cosmetic Act of 1938
Narcotic Tax Act of 1914
-known as FDCA 1938
-replaced the Food and Drug act of 1906
-provided better clarification about misbranding definitions
-provided better clarification about adulteration definitions
-gave the FDA authority to require adequate testing of new drugs for safety
Federal Food, Drug and Cosmetic Act of 1938
-
created a distinction between "OTC" and "Legend Drugs"
-required legend drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription."
-emphasis on this act was to insure safety through qualified medical supervision
The Kefauver-Harris Amendment of 1962
-known as the "Drug Efficacy Amendment"
-required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval
-required drug advertising to be more closely regulated and disclose accurate information about side effects
The Bureau of Narcotics and Dangerous Drugs (BNDD)
-predecessor agency of the DEA
-BNDD merged into the DEA in 1973
Drug Abuse Prevention/ Control Act of 1970
-known as the CSA
-completely replaced the Harrison Act
-required the use of DEA numbers
-required comprehensive record keeping and transaction tracking
-enforced the DEA under the US Dept of Justice
Poison Prevention Packaging Act of 1970
-also known as the PPPA
-designed to reduce the risk of children ingesting dangerous substances
-required locking caps on most prescription
Combat Methamphetamine Epidemic Act (2005)
-enacted to regulate the OTC sales of pseudoephedrine
-identity and address of each purchaser to be kept for two years
-daily sales of regulated products not exceed 3.6 grams
-30 day purchase limit not to exceed 9 grams
-30 day purchase via mail order not to exceed 7.5 grams
Poison Prevention Packaging Act of 1970
-also known as the PPPA
-designed to reduce the risk of children ingesting dangerous substances
-required locking caps on most prescription
Combat Methamphetamine Epidemic Act (2005)
-enacted to regulate the OTC sales of pseudoephedrine
-identity and address of each purchaser to be kept for two years
-daily sales of regulated products not exceed 3.6 grams
-30 day purchase limit not to exceed 9 grams
-30 day purchase via mail order not to exceed 7.5 grams
National Drug Code (NDC)
-used to identify legend drugs
-part of the drug listing act of 1972
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