Respond to the questions below. Your response to each of the questions should be composed in complete sentences and paragraphs, be approximately 100–150 words in length, and follow APA format. For resources, start with the textbook. Explain what is meant by “drug standards”. Include the role of the FDA in drug standards.
seminar_option2_rubric.xlsx
woodrow_ppt_chapter_1_8e.pptx
woodrow_ppt_chapter_7_8e.pptx
Unformatted Attachment Preview
Students are expected to:
Submit an alternative assignment if unable to attend the live Seminar.
Submit alternative assignment by the unit deadline, EOD Tuesday.
Instructors – Enter the total available points for seminar in cell H2. Then, enter values between 0 – 4
Content Quality
Introductory
Emergent
0-1
2
Submission does not
relate to the topic.
Spelling/ Grammar/
Formatting/
Mechanics/APA* (APA
Significant errors in
spelling and/or
grammar. Major flaws in
only applies to alternative
writing mechanics and
assignments that explicitly
formatting.
indicate APA is required)
Length* (applies to
Submission does not
alternative assignments
meet length
with length
requirements.
requirements)
Feedback:
Includes all
question/topics with
most opinions and
ideas stated clearly.
Poor spelling and
grammar are apparent.
Does not use APA
style formatting when
needed.
Submission meets
length requirements
but uses excessive
quoting (>50%).
ve Seminar.
H2. Then, enter values between 0 – 4 in the yellow cells in the Score column.
Practiced
Proficient/Mastered
Score
3
4
0-4
Weight
Final Score
Answers all questions with
Answers all questions creative and clear
with opinions and ideas opinions/ideas using
stated clearly.
references when
appropriate.
50%
0.00
Uses Standard
American English with
rare errors and
misspellings. Minor
errors in APA style
formatting.
Consistently uses
Standard American
English with rare
misspellings. Appropriate
mechanics and APA style
formatting applied.
25%
0.00
Submission meets
length requirements
but uses excessive
quoting (>20%).
Submission meets the
length requirements.
25%
0.00
100%
0.00
Final Score
Percentage
0
#DIV/0!
Essentials of Pharmacology for
Health Professions
Eighth Edition
Chapter 1
Consumer Safety and Drug
Regulations
© 2019 Cengage. All rights reserved.
Orphan Drugs
•
Over the Counter Medication (OTC)
– Health care practitioners:
▪
▪
▪
▪
Inform patients with knowledgeable answers about
medications
Have a serious, responsible attitude about all aspects of
drug therapy
Be aware regarding the legalities of dispensing
medications
Consider misconceptions and facts
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Drug Laws (1 of 3)
•
1900s in the United States
– Laws were passed with regard to the dispensing of
drugs
•
Drug standards
– Set to assure consumers that they are getting what they
pay for
▪
All preparations with the same drug name must be of
uniform strength, quality, and purity
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Drug Laws (2 of 3)
•
Drug preparations
– Drug companies must not add other active ingredients or
varying amounts of chemicals
•
Illegal (illicit) drugs
– Lack of enforcement of drug standards poses consumer
danger
▪
No controls on quality can lead to deaths from overdose
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Drug Laws (3 of 3)
•
Three major acts
– 1906 Pure Food and Drug Act
– 1938 Federal Food, Drug, and Cosmetic Act and
Amendments Of 1951 and 1962
– 1970 Controlled Substances Act
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
1906 Pure Food and Drug Act
•
•
•
•
First attempt to establish consumer protection in drug
and food manufacture
Required drugs to meet minimal standards of strength,
purity, and quality
Demanded labeling for preparations containing
dangerous ingredients
Established United States Pharmacopeia (USP) and
National Formulary (NF)
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
1938 Federal Food, Drug, and Cosmetic Act and
Amendments of 1951, 1962 and 1972
•
•
FDA established under the Department of Health and
Human Services (DHHS)
Established more specific regulations for preventing
adulteration of (tampering with) drugs, foods, and
cosmetics
– Example: “Warning” labels must be present on certain
preparations
▪
“May cause drowsiness,” “may cause nervousness,” “may
be habit-forming,” etc.
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
1970 Controlled Substances Act
•
•
•
Established the Drug Enforcement Administration
(DEA)
Set tighter controls on a specific group of drug: those
being abused by society. These include depressants,
stimulants, psychedelics, narcotics, and anabolic
steroids
Provided guidelines for five schedules of controlled
(designated by a capital C) substances ( C I, II, III, IV,
and V)
– Refer to Table 1-1.
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Additional Drug Legislation
•
The 1983 Orphan Drug Act
– Gives financial incentives to develop medications for
diseases that affect a small number of people
•
Omnibus Budget Reconciliation Act (OBRA) of 1990
– Mandates:
▪
▪
OTC drugs be documented as part of a medical record
Pharmacists provide drug use review and patient
counseling
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
FDA
•
Food and Drug Administration (FDA)
– Oversees drug testing before release
– Inspects plants where foods, drugs, medical devices or
cosmetics are made
– Reviews new drug applications for food additives
– Investigates/removes unsafe drugs from the market
– Ensures labeling of foods, cosmetics, and drugs
– Concerned with general safety standards in the
production of drugs, foods, and cosmetics
– Responsible for the approval and removal of products on
the market
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
DEA
•
Drug Enforcement Administration (DEA)
– Concerned only with controlled substances
– Enforces laws against drug activities (illegal drug use,
dealing, and manufacturing)
– Monitors need for changing the schedules of abused
drugs
– Created as the need for better control of addictive drugs
became urgent
– Handles all the needs and safety controls for the more
dangerous drugs
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Health Care Professionals and the Law and
Ethics (1 of 2)
•
Guidelines for those who dispense medications
– Keep a current drug reference source available at all
times
– Keep controlled substances locked securely
▪
Locked safety box in a locked cupboard
– Conceal and secure prescription pads
– Properly destroy expired drugs and old records
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Health Care Professionals and the Law and
Ethics (2 of 2)
– Keep accurate records of each controlled substance
dispensed, received, or destroyed during past two years
– Keep up-to-date with current FDA news, DEA activities,
and registration renewals
– Establish a working rapport with a pharmacist
– If you work in an office, maintain a professional rapport
with pharmaceutical representatives
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Essentials of Pharmacology for
Health Professions
Eighth Edition
Chapter 7
Responsibilities and Principles of
Drug Administration
© 2019 Cengage. All rights reserved.
Responsible Drug Administration (1 of 5)
•
Responsibilities of the health care provider
– Adequate, up-to-date information about all medications
to be administered
– Wisdom and judgment to accurately assess the patient’s
needs for medications, to evaluate the response to
medications, and to plan appropriate interventions as
indicated
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Responsible Drug Administration (2 of 5)
– Skill in accurate delivery of the medication, in the best
interests of the patient, and with adequate
documentation
– Patient education to provide the necessary information
to the patient and family about why, how, and when
medications are to be administered and potential side
effects and precautions with administration by the
layperson
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Responsible Drug Administration (3 of 5)
•
Requirements
– Be familiar with medication before administration
▪
Typical and most frequently used drugs of the systems
– Thorough knowledge of the typical and most frequently
used drugs
– Plan thoroughly for patient care
▪
Prior assessment, interventions, and evaluations
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Responsible Drug Administration (4 of 5)
– Train to develop skills in delivery of medications
▪
Maximize the effectiveness of the drug with the least
discomfort to the patient
– Educate patients
▪
Emphasize the importance of taking medications in the
proper dosage, on time, and in the proper way
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Responsible Drug Administration (5 of 5)
– Take moral, ethical, and legal responsibilities into
account
▪
▪
Consult those in authority—supervisors or
administrators—and/or policy and procedure books
Documentation on the patient’s record is always required
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Medication Errors (1 of 4)
•
Occur in all health care settings
– More errors are reported from acute care settings, where
the risk is greatest
– Common situations in which errors occur
▪
▪
▪
▪
▪
▪
Administering a drug to the wrong patient
Administering the wrong drug
Administering a drug via the wrong route
Administering a drug at the wrong time
Administering the wrong dosage
Wrong documentation
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Medication Errors (2 of 4)
•
Meticulous care in preparation and administration
reduces chances of error
– However, if a mistake is made, report it immediately
– File an incident report
– Reporting medication errors:
▪
▪
Medication Errors Reporting (MER) program
Institute for Safe Medication Practices (ISMP) Patient
Safety Organization (PSO)
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Medication Errors (3 of 4)
•
Medication reconciliation
– Method used to compare what the patient is taking to
what the patient’s physician ordered
▪
▪
Performed every time there is a change in the patient’s
care
Aims to prevent medication errors caused by omissions,
duplications, errors in doses, or medication interactions
(The Joint Commission, October 2012)
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Medication Errors (4 of 4)
•
Steps in medication reconciliation
–
–
–
–
–
Develop a list of current medications
Develop a list of medications to be prescribed
Compare the medications on the two lists
Make clinical decisions based on the comparison
Communicate the new list to appropriate caregivers and
to the patient
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Principles of Administration (1 of 8)
•
Basic principles
– Cleanliness of self and area
– Organization of medications and supplies
– Preparation area location and lighting
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Principles of Administration (2 of 8)
•
Six Rights of Medication Administration
–
–
–
–
–
–
Right medication
Right amount
Right time
Right route
Right patient
Right documentation
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Principles of Administration (3 of 8)
•
Right medication:
– Compare the name of the drug prescribed with the label
on the package, bottle, or unit-dose packet
– Never give medication when the name of the medication
is obscured in any way
– Check the correct dosage form
– Never give medications that someone else has prepared
– Never leave medications at the bedside unless
specifically ordered by the doctor
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Principles of Administration (4 of 8)
•
Right amount:
– Extremely important
– Drug dosage ordered must be compared very carefully
with the dose listed on the label of the package, bottle,
or unit-dose packet
– Consult a table of equivalents if necessary, to convert
from one system to another
▪
Calculations must be checked by another trained health
care practitioner, pharmacist, or doctor to verify accuracy
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Principles of Administration (5 of 8)
•
Right time:
– For maximum effectiveness, drugs must be given on a
prescribed schedule
▪
Physician’s order specifies the number of times per day
that the medicine is to be administered
o
o
o
Intervals
Before or after meals
Hour of sleep
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Principles of Administration (6 of 8)
•
Right route:
– Route of administration effects vary
▪
▪
▪
Degree of absorption, speed of drug action, and side
effects
Physician’s order specifies the route of administration
Route may not be changed without the physician’s order
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Principles of Administration (7 of 8)
•
Right patient:
– Identify the patient by use of certain techniques to
reduce the chance of error
▪
▪
▪
Wrist identification band
Call or ask patient to state their name
Date of birth in ambulatory care setting
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
Principles of Administration (8 of 8)
•
Right documentation:
– Every medication given must be recorded on the
patient’s record
▪
▪
▪
▪
▪
Dose, time, route, and location of injections
Unusual or adverse patient reactions
PRN basis
Administrator signature
Narcotics administered
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
MedWatch
•
FDA form to assist health care professionals in
reporting serious, adverse events or product quality
problems
– Associated with medications, medical devices, or
nutritional products regulated by the FDA
▪
Goal is to help the FDA better monitor product safety and
take swift action to protect patients and healthcare
providers
© 2019to
Cengage.
All rights reserved.
Introduction
Cost management
…
Purchase answer to see full
attachment
