2. Evidence-based medicine (EBM)
EBM is a philosophy of practice and an approach to decision-
making in the clinical care of patients.
The conscientious, explicit, and judicious use of current best
evidence in making decisions about the care of individual patients.
Evidence-based clinical practice requires integration of
Individual clinical expertise and patient preferences with,
The best available external clinical evidence from systematic
research and consideration of available resources.
EBM requires both clinical expertise and an intimate knowledge
of the individual patient’s situation, beliefs, priorities, and values to
be useful.
External evidence must be used to inform, but not replace,
individual clinical expertise.
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4. Steps of EBM
Step 1: Formulating a well-built question
Step 2: Identifying articles and other evidence- based resources that
answer the question
Step 3: Critically appraising the evidence to assess its validity
Step 4: Applying the evidence. Individualize, based clinical expertise
and patient concerns
Step 5: Re-evaluating the application of evidence and areas for
improvement .
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5. Evidence-based clinical practice guidelines
Are systematically developed statements to assist practitioner and
patient decisions about health care for specific circumstances.
Clinical practice guidelines are developed by a variety of groups
and organizations including
Federal and state government,
Professional societies and associations,
Managed care organizations,
Third-party payers,
Quality assurance organizations, and
Utilization review groups
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6. Evidence-based clinical practice guidelines…
Updated practice guidelines provide a concise summary of current
best evidence on,
what works and
what does not when considering specific health care interventions
Methods for development of valid practice guidelines emphasize
evidence-based approach,
formal quantitative techniques to calculate risks and benefits, and
incorporation of the patient's preference
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7. Evidence-based clinical practice guidelines…
Clinical Practice Guidelines vary in terms of :
The purpose of the guidelines
Development methods used
Format of the documents, and
Strategies for implementation
Influence thousands to millions of decisions on medical
interventions
The goals of development and implementation of evidence-based
clinical practice guidelines.
Is to help speed up the process of getting evidence into practice
To improve quality and efficiency of services
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8. Steps In Evidence-based CPG Development
Major steps common in the evidence-based guideline development
process includes the following steps:
1. Select an appropriate topic for creation of a guideline
2. Recruit appropriate multidisciplinary membership for a panel to be
involved in development of the guideline
3. Define the clinical questions to be addressed
4. Determine the criteria for evidence that will be considered
5. Conduct a systematic search for the qualifying evidence
6. Perform a systematic evaluation and grading of the evidence
7. Prepare a synthesis of the evidence.
8. Agree on procedures for a consensus process, or other procedures for
making recommendations, in the absence of higher levels of evidence for
decision-making
9. Formulate and grade recommendations based on the grade of evidence and
balance of benefits, harms, and costs of treatment options
10. Draft the guideline document
11. Conduct peer-review and pilot testing of the guideline
12. Revise the guideline as appropriate
13. Create tools for implementation of the guideline
14. Establish a plan for follow-up and periodic updating of the guideline
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9. Select A Topic For Guideline Development
High prevalence.
High frequency and/or severity of associated morbidity or mortality.
Availability of high-quality evidence for the efficacy of treatments
that reduce morbidity or mortality.
Feasibility of implementation of the treatment based on expertise
and other resources required.
Potential cost-effectiveness.
Evidence that current practice is not optimal.
Evidence of practice variation.
Availability of personnel, expertise, and resources to develop and
implement the practice guideline.
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10. Ethical and Legal issues in Drug Information
What is Ethics?
Ethics can be defined broadly as a set of moral principles or
values
Each of us has such a set of values
We may or may not have considered them explicitly
Veatch stated that “an ethical, or moral, issue involves judgments
between right and wrong human conduct or praiseworthy and
blameworthy human character”
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Ethical deliberation may be differentiated from other types of
decision-making by three characteristics:
1. It is ultimate or fundamental, there is no higher standard
against which to measure the rightness of the decision or
action
2. The issue is universal, the parties in disagreement do not
consider it simply a difference of opinion or taste- each party
believes there is a right or wrong answer- even if they’re not
sure what the answer is
3. The deliberation takes into account the welfare of all involved
or affected by the judgment at hand
12. Why People Act Unethically?
The person’s ethical standards are different from those of
society as a whole
The person chooses to act selfishly
In many instances, both reasons exist
Ethical Dilemmas in Pharmacy Practice
An ethical dilemma (situation with unsatisfactory choices)
is a situation a person faces in which a decision must be made about
appropriate behavior.
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13. Ethical Dilemmas in Pharmacy Practice….
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All pharmacists who provide DI must address the ethical
dilemmas that arise in the course of providing this service
Aspects of moral life that can prepare, guide and support
pharmacists faced with ethical during the course of providing
drug information:
Principles and rules
Moral emotions
Character and virtues, and
Rights
14. Resolving Ethical Dilemmas
1. Obtain the relevant facts
2. Identify the ethical issues from the facts
3. Determine who is affected
4. Identify the alternatives available to the person who must
resolve the dilemma
5. Identify the likely consequence of each alternative
6. Decide the appropriate action
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15. Ethics Analysis
Beauchamp and Childress defined ethics as “a generic term for
several ways of examining the moral life”
These authors described a process of deliberation and justification
that is necessary when confronting a moral dilemma
When we deliberate we are considering which judgment is
morally justified
They indicated that, “Particular judgments are justified by moral
rules, which in turn are justified by principles, which ultimately
are defended by an ethical theory”
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17. Contd…
These hierarchical levels of analysis (particularly rules and
principles) used as action-guides, which are utilized to justify a
particular judgment
Rule of ethics is specific to context and relatively restricted in scope;
for instance, the moral rule about confidentiality that specifically
addresses a patient’s right to consent prior to release of privileged
information
Principles are more broad and fundamental in scope; for example, the
principle of respect for autonomy, which is the patient’s right to decide
on personal issues
Ethical theories is integrated bodies of principles and rules that
may include mediating rules that govern cases of conflicts.
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18. Ethical theories
The prominent rules and principles guiding ethical decision-
making by health care professionals can generally be placed within
one of two broad ethical theories:
Consequentialist theory or
deontological (derived from the greek word deon, meaning
duty) theory
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19. Consequentialist theories
Describe actions or decisions as morally right or wrong based on
their consequences, rather than on any intrinsic features they may
have
Two cardinal principles
Beneficence (do that which at promotes a good outcome)
Nonmaleficence (do that which minimizes bad outcomes)
For example, an informed consent ethical rule can be of value
within consequentialist theory because consent generally results in
improved compliance and outcome good consequences
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20. Duty driven (deontological) theories
Look more to intrinsic qualities of an act or decision to assert its
moral rightness or wrongness
Consider other inherent features of an act, besides consequences, as
also relevant and often of greater importance
For example, in various forms of deontological theory, the act is
considered inherently wrong.
if it is dishonest or
breaks confidentiality, or
if it does not respect individual autonomy
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21. Analyzing Ethical Dilemmas
Veatch indicated that often we reach particular ethical decision
Without a great deal of conscious deliberation
Through our moral intuition, and
Without subsequent challenge from any external party
However, on occasion, when pondering consider carefully a certain
ethical judgment, we are called on (internally or externally) to
analyze and justify the basis for our conviction
when this occurs,
it is first important to understand the facts of the specific case
then described progression through three additional process stages of
reflection (on ethical rules, principles, and theories) by which we may
identify, analyze, and present reasons for our judgment
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22. Process of Ethical Analysis
I. Identification of relevant background information
A. Factual details of the issue at hand
B. Consideration of who is affected by the ethical issue
C. Learn and respectfully address the cultural perspectives
(including applicable legal requirements) for those affected by
the dilemma
II. Identification and justification of the relevant moral rules and
principles (action-guides) pertinent to the case
III. Deliberation, long careful consideration of something, through
the use of moral intuition and application of ethical theory, on
how to rank/balance the rules and principles pertinent to the case
in order to resolve the ethical dilemma
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23. Step I. Identification of Relevant Background Information
This first step deserves careful consideration and research
Once the facts of a case are known, the moral concerns
may be resolved.
This step has been divided into three parts:
Data gathering
Consideration of the welfare of all affected parties
Respect for the cultural perspectives of these parties
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24. Step II: Use of Rules and Principles (Action-Guides) to Assist in
Analysis of an Ethical Dilemma
This second process step of analysis will look at moral rules that
may apply to the specific case, as well as at more general pertinent
ethical principles
Defining the relevant action-guides as rules or principles help in
assessing which are more fundamental to the issue at hand
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25. Step III: Ethical Theory as a Means to Clarify or Resolve
Ethical Dilemmas
This third step of ethical analysis reveals how relevant moral rules
and principles interact within the preferred ethical theory to
address the given dilemma
When confronted with conflicting ethical rules or principles, the
pharmacist may resolve the dilemma through his or her moral
intuition of “the right thing to do”
this process step can lead to more rational and honest decision-
making or action-taking
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26. Ethical Rules and Principles (Action guides)
1. Nonmaleficence
A basic principle of consequentialist theory; encompasses the
duty to do no harm.
The obligation to avoid inflicting either physical or
psychological harm on others.
This tenet has a long history as part of the Hippocratic tradition,
where it has often been described in terms of the health care
provider’s duty to the individual patient.
The principle is also cited as justification for actions benefiting
all.
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27. 2. Beneficence
A basic principle of consequentialist theory that expresses the duty
to promote good.
Again, conflict can arise between what constitutes “good” for one
individual versus the larger societal group.
Good or bad consequences are also of importance within
deontological theories, but are evaluated along with other
principles that may be considered of equal or greater importance.
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28. 3. Respecting the patient-professional relationship
A moral rule, often referring to respect for the physicianpatient
relationship, but also applicable to other professional- patient
relationships, as well.
As expressed in Hippocratic traditions, this rule indicates that the
physician’s primary duty is to the patient and tends to give the
physician, rather than the patient, control in the relationship.
This rule is particularly noted in duty-driven (deontological)
ethical theories that consider the professional’s duty to the patient,
but also supports consequentialist theory to the extent that good
outcomes are enhanced.
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29. 4. Respect for autonomy
Principles described particularly within deontological theory.
This principle is founded on a belief in the right of the individual to
self-rule.
It speaks to the individual’s right to decide on issues that primarily
affect self.
5. Consent (give permission: agree)
A moral rule related to the principle of autonomy which states that
the client has a right to be informed and to freely choose a course
of action;
For example, informed consent to receive a therapy or procedure
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30. 6. Confidentiality
A moral rule, also related to the principle of autonomy, which
specifically addresses the individual client’s right to give or refuse
consent relative to release of privileged information
7. Privacy
Another rule within the principle of autonomy, more generally
relating to the right of the individual to control his or her own
affairs without interference from or knowledge of outside parties
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31. 8. Respect for persons
A principle expressing duty to the welfare of the individual,
particularly described within religionbased deontological theories.
This principle may also be expressed within dignity of life or
sanctity of human life principles.
It has common elements with the respect for autonomy principle,
but addresses more directly a belief in the inherent value of human
life, independent of characteristics or abilities of the specific
human being
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32. 9. Veracity
This term addresses the obligation to truth telling or honesty.
Veracity is considered an ethical principle within deontological
theory.
However, it is considered a useful rule within consequentialist
theory, to the extent that it promotes good
10. Fidelity
Another principle of moral duty in deontological theory that
addresses the responsibility to be trustworthy and keep promises
11. Justice
This concept has been presented within various principles that
relate to fairness and tendering what is due; providing that to which
the individual is entitled.
A number of justice theories have also been developed to connect
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33. Legal Responsibility for the Provision of Drug Information
Legal obligations of the DI specialist remain unclear
Professional standards of performance may be used by courts as an
objective measuring tool for the standard of care
Pharmacy profession is assuming an increased legal responsibility
to provide DI in the daily practice of pharmaceutical care
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34. Negligence
Currently, most litigation concerning pharmacists involves
negligence (Direct or proximate cause of personal injury or death).
Elements of negligence:
Duty breached
Damages
Direct causation
Defenses absent
When Evidence on:
Information provided was materially deficient
Deficient information was a proximate cause of injury suffered (or at
least a substantial contributing factor)
Recipient reasonably relied on the information provided
Information deficiency was due to failure to exercise reasonable care
Pharmacist knew or should have known that the safety or health of another
may have depended on the accuracy of the information provided
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35. Duty Breached
Duty must be a legal duty (not a moral or ethical duty)
Current law provides little guidance for disclosure of DI for
questionable purposes
Pharmacists must exercise independent professional judgment and
assume legal responsibility for that judgment, when exercised.
Reasonable care
That which would be considered acceptable and responsible
Recent cases against pharmacists have held that pharmacists who
gain information about the unique susceptibility of a patient are
liable for failure to warn of the risks
The court held the pharmacist liable for failing to warn a patient on
theophylline of the interaction with erythromycin that produced
seizures and consequent brain damage
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36. DI provision leading to Liability
Incomplete information
Inappropriate quality information
Outdated information
Inappropriate analysis
Dissemination of incorrect information
Inappropriate analysis
Published studies for DICs have reported that 41 to 83% of
requested information is patient - specific or judgmental in nature
In addition to liability for negligent information retrieval and
dissemination, the pharmacist's role involves information
interpretation, evaluation, and giving advice
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37. Defenses to Negligence and Malpractice
Legal defenses can avoid or reduce liability
Defenses include:
Statute of limitations
Comparative or contributory negligence
Informed consent
Governmental immunity, etc
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38. Some liabilities
Comparative negligence is the allocation of responsibility for
damages incurred between the plaintiff and defendant, based on the
relative negligence of the two
Concurrent negligence is the wrongful acts or omissions of two or
more persons acting independently, but causing the same injury
Vicarious liability is the imputation of liability on one person for
the actions of another
Respondeat superior refers to the proposition that the employer is
responsible for the negligent acts of its agents or employees
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39. Quality Assurance as a Liability Reducing Factor
Identify scope of activities and personnel requirements
Develop and follow policies and procedures or formal call triaging
protocols
Keep standard operating procedure manual available for
consultation.
Avoid violations of statutes and regulations
Do not recommend an unapproved use or dose; if a use differs
from the labeling, the requestor must be so notified
Do not recommend a use or dose of a drug based solely on foreign
literature or animal studies
Never extrapolate pediatric dosages from adult dosages
Maintain knowledge of the current literature, new drug
applications and supplemental approvals, labeling changes, and
new warnings
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40. Quality Assurance as a Liability Reducing Factor…
Do not present inadequate data or ignore contrary data
Avoid overly enthusiastic or exaggerated efficacy and safety claims; do
not attempt to diagnose or treat acute poisoning — direct such inquiries
to a poison control center or an emergency room.
Know the circumstances of the case and appropriate background
information (e.g., knowledge of causality criteria, laboratory findings,
concurrent drugs are necessary for adverse drug reaction inquiries;
special care is needed for drug identification questions, especially in
view of the surge of counterfeit drugs)
Responses of new employees, students, residents should be checked —
document, document, document
Maintain reasonable response time; if necessary prioritize requests
Obtain peer concurrence or outside professional consultation, if
necessary
Develop a QA mechanism to ensure that service is maintained at a high
level of quality (e.g., periodic audits or surveys)
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41. Labeling and Advertising
Labeling: Written or oral information used to supplement or
explain a product, regardless of whether the information
accompanies the product
Requires full disclosure
Advertisements
Require a fair balance, meaning there must be a discussion of both
benefits and risks, so as not to be misleading, and substantial evidence
from clinical trials must be included for comparative claims
Labeling and advertising liability
Doctrine of over promotion, under which adequate warning is
alleged to have been diluted by communications failing to
adequately convey the full impact of the warning
Promotion of off- label or non - FDA - approved indications
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42. Drug and Therapeutics Committee (DTC)
DTC is a committee designated to ensure the safe and effective use
of medicines
Role of the DTC
Evaluates the clinical use of drugs
Develops policies for managing drug use and administration
Manages the formulary system
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43. Functions of DTC
Promote better quality of care & Rational use of drugs through:
Advising medical, pharmacy & admin. Staff
Developing drug policies and procedures
Evaluation and selection of formulary drugs
Promoting interventions to improve drug use
Identifying and assessing drug use problems
Managing ADRs and medication error
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44. Advisory Functions of a DTC
Advise medical, administrative, and pharmacy departments
Advise and support other hospital organizations on drug related
issues
Participate in hospital committees and departments on all matters
concerning drugs
DTC has the most expertise to develop policies on:
New, non-formulary, restricted, investigational drugs
Generic substitution and therapeutic interchange
Standard treatment guidelines (and other interventions)
Interventions to promote more rational use of drugs
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45. Evaluation and Selection of Drugs for the formulary
Explicit evaluation criteria
efficacy, relative efficacy, effectiveness
safety, quality, cost
Consistent decision-making
evidence-based, local context, transparency
Use current literature
Primary literature (RCT)
Secondary (bulletins and reviews)
Reliable and current tertiary sources (textbooks)
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46. Identifying Drug Use Problems
Prescribing
Dispensing
Drug Administration e.g. unsafe injections
Adverse drug reactions
Medication error
Antimicrobial resistance surveillance
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47. Promoting Interventions to Improve Drug Use
Educational programs
Drug bulletins and newsletters
Managerial programs
Standard Treatment Guidelines
Drug utilisation evaluation or review (DUE / DUR)
Structured order forms, automatic stop orders
Regulatory programs
Drug registration
Professional licensing
Licensing of outlets
The DTC should: monitor, assess, report, correct the problem if
possible, prevent future problems of ADR and ME.
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50. Antimicrobial subcommittee
to promote better use of antimicrobials
Addresses issues relating to antimicrobial including prescribing
Develops policies concerning use of antimicrobials for approval
by the DTC and medical staff
should specifically include sections on methods to limit and
restrict use of antimicrobials
Assists in evaluating and selecting antimicrobials for the
formulary
Organizes educational programs for health care staff
Monitors antimicrobial resistance patterns
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51. DTCs: Guiding Principles
Transparent and unbiased decision-making
Explicit criteria and process
Documentation
Absence of conflict of interest
Objectivity
Evidence-based approach and levels of evidence
Consistency
Are the drugs in the formulary and STGs consistent?
Impact orientation
indicators of process, impact and outcome
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52. Factors critical to success
Factors critical to success include:
Clear goals and purpose
Wide representation - prescribers, nurses, pharmacists
no relation between DTC and manufacturers, suppliers
official status approved by the administration (local & MOH)
with strong management support
motivated, respected DTC members
respected and dynamic chairperson
Promotion & support by medical & pharmacy schools
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53. Impact and outcome indicators
Drug selection
no. drugs in the hospital formulary
% prescribed drugs belonging to the hospital formulary
Prescribing quality
% of patients treated in accordance with STGs
% of drug treatments meeting agreed criteria of DUE
Drug Safety
Mortality and morbidity rates per annum due to adverse
consequences of drug use (ADRs and medication errors)
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54. Professional writing
Writing is “to keep my job” or “to pass this course,”
Why you write?
to inform, instruct, persuade, or entertain
First three items are those usually considered in professional
writing.
Fourth, whenever possible, will help convince people to read what
has been written.
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55. Steps to write: Preparing to Write
Know the purpose
Expected endpoint
Author (participated either)
Writing or Revising the article
Conception and design of the study
Analysis and interpretation of the data
Final approval of the version that is published
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56. Steps to write: Preparing to Write
Not an author
Acquisition of funding
General supervision of the research group
If not authors, acknowledge them
Know the audience (Writing style)
Pure technical style: for professionals in the same field
Middle technical style: for everyone having some unifying
factor.
Popular technical style: for general public (common language)
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57. Steps to write: Preparing to Write
Know the requirements of the publisher
"Uniform Requirements for Manuscripts Submitted to
Biomedical Journals"
Scientific Style and Format.
The American Medical Association Manual of Style.
General Rules of Writing
Do sufficient research before getting started
Requires a lot of practice
Organize the information
Goal : Prepare a clear, concise, complete, and correct document
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58. Checklist in Preparation of Written Materials
Do research first
Make the document look "professional"
Use proper grammar and spelling
Keep things simple and direct.
Keep the document short
Use active sentences.
Cover things in whatever order is easiest
Get everything down on paper before revising
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59. Checklist in Preparation of Written Materials…
Avoid
Abbreviations and acronyms
The first person (e.g., I, we, and us).
Slash construction (e.g., he or she and him or her).
Contractions
Cite other references wherever appropriate (and get permission to
do so where appropriate)
Put yourself in the reader's position
Edit, Edit, Edit!
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60. Document Sections
Three main parts of a typical document
Introduction
Body
Conclusion
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61. Introduction
Start out strong
Inform the reader of what they can expect in the rest of the
document
Clear objective for the existence of the document
Background information (well referenced)
Hypothesis (if a research)
Not be a conclusion
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62. Body
All of the details
Concise (All necessary information)
Logical order
Keep an eye on the desired endpoint
Avoid materials that identify patient (if not get consent)
Put the information in your own words
Plagiarism: Copying of another's words or ideas without properly
giving credit
Copyright violations consist of copying another's work, even
with appropriate quotations and citation, without permission
Avoid extensive quotations
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63. Conclusion
Summarize it
Correspond to the objective
Follow the information presented in the body
Avoid extrapolating beyond the information available
Submission of the Document
Completed, proofread, and edited document is ready to be
submitted to
Journal (cover letter to introduce the document)
Transfer of copyright forms
Conflict of interest disclosures (including financial)
Other items that will be found in the directions for authors for
that journal
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64. Drug evaluation monograph
Drug formulary requires that drugs or drug classes be objectively
assessed based on scientific information.
e.g., efficacy, safety, uniqueness, cost, and other appropriate items.
The way to decide which drug is best for formulary addition is to
rationally evaluate all aspects of the drug in relation to similar
agents.
The issues that are evaluated include: dosage forms, packaging, requirements
of accrediting or quality assurance bodies, physician preferences, regulatory
issues, patient/nursing convenience, advertising, and consumer expectations.
Drug evaluation monograph provides a structured method to
review the major features of a drug product.
Once a monograph is prepared, it can easily be used as a
structured template or overview of a drug product.
Allows for easy comparison or contrast to other products that may be used
for the same indication or that are in the same product class.
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65. Contents of Monograph
Introduction
Institution name heading
Generic Name: Can include other common, nonofficial names,
e.g., TPA for alteplase.
Trade or Brand Name: If more than one, indicate company that
each is from.
Manufacturer (or source of supply): Include website address.
Therapeutic Category: For example, thrombolytic agent for
alteplase.
Classification: Antigulants
Status: Prescription, nonprescription, and/or controlled substance
schedule (if applicable).
Similar Agents: A list of common treatments used for the same
indication(s).
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66. Contents of Monograph…
Summary:
Includes a short summary of advantages and disadvantages of
the drug,
Particularly in relation to other drugs
Treatments used for each major indication, and
Any other significant information.
Recommendations:
Indicate whether or not the drug should be added to the Drug
Formulary of an institution
Assuming they would have patients that would be treated for
illnesses where this drug.
Also indicate specific formulary status for the drug (i.e.,
uncontrolled, monitored, restricted, and conditional)
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67. Contents of Monograph…
whether the drug will replace any other product that might
already be on the formulary.
In addition, present any information on how the drug is to be
placed in any clinical guidelines.
Body
Pharmacologic Data
Mechanism of action (usually brief)
Bacterial spectrum (if applicable)
Therapeutic Indications
FDA approved indications
clearly indicate they are not FDA approved.
How the drug, and similar drugs, fit into clinical guidelines.
Clinical comparison (abstract at least two studies
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68. Contents of Monograph…
Bioavailability/Pharmacokinetics:
A table summarizing the following, in comparison to the comparator
agent(s) can be very useful.
Absorption, Distribution, Metabolism and Excretion
Dosage Forms
Forms and strengths: Compare to other agents
Purity and composition information should be included for herbal and
alternative medications.
Explain any special information needed for preparation and storage, in
comparison to other products.
Dosage Range
Adults, Children, Elderly and Renal or hepatic failure
Special administration requirements
Restrictions in distribution (e.g., physician needs to be certified to prescribe)
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69. Contents of Monograph…
Known Adverse Effects/Toxicities
Frequency and type (a table comparing the drug to others can be
a clear and concise way of expressing this information)
Prevention of toxicity
Risk and benefit data
Special Precautions:
Usually includes pregnancy and lactation
Contraindications
Drug Interactions:
Drug-drug
Drug-food
Drug-laboratory
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70. Contents of Monograph…
Patient Safety Information
Includes medication error information
Patient Monitoring Guidelines
Includes effectiveness, adverse effects, compliance, and other
appropriate items.
Patient Information
Name and description of the medication
Dosage form
Route of administration
Duration of therapy
Special directions and precautions
Side effects
Techniques for self-monitoring
Proper storage
Refill information
What to do if a dose is missed
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71. Contents of Monograph…
Cost Comparison:
Use Average Wholesale Price (AWP) and institutional prices, and
make sure there is a comparison with any similar products at
equivalent doses
Date Presented to Pharmacy and Therapeutics Committee,
and Name and Title of the Person Preparing the Document
References
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