Transcript The Role of Hospital Pharmacists

Research & Pharmacy Profession
PHCL 311
Hadeel Al-Kofide M.Sc
Why do we need research?
•
Promotion
•
Better services to patients
•
Better for our career
•
Investigate problem
•
Gain knowledge
•
Prosper for the country/humanities…
Research & Pharmacy Practice
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Pharmacist is involved in the characterization, optimization &
selection of new drug candidates
•
Pharmacists develops & tests new formulations & drug
delivery systems
•
Pharmacists develops analytical methods for new active
principles & pharmaceutical forms
Different Research Fields in Pharmacy
Profession
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Universities
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Research institutes
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Industrial (drug companies)
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Hospitals
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Others
Qualifications Needed to Work in
Research Area
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The normal path to a career in research is to gain high
academic achievement in the BPharm programme to earn
direct entry to PhD studies
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PhD studies can be undertaken entirely within a university or
jointly with industry or a research institute
Types of Studies Used in Hospital Pharmacy
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Survey
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Clinical trials
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Questionnaires
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Case control
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Cross-sectional & follow-up approach
Important Elements of a Research Paper
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Abstract
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Introduction
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Methodology
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Results
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Discussion
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Conclusion
Important Elements of a Research Paper
Abstract
•
An abstract is a brief summary of a research article, thesis,
review, conference proceeding or any in-depth analysis of a
particular subject or discipline
•
It is often used to help the reader quickly ascertain the paper's
purpose
•
When used, an abstract always appears at the beginning of a
manuscript, acting as the point-of-entry
Important Elements of a Research Paper
Introduction
• Usually contains background information for the study:
 Current treatment paradigms for the disease
 Reasons why treatment under investigation may offer
benefit
• Contains study objectives
Important Elements of a Research Paper
Methodology
• Usually contains:
 Study design: Randomization, blinding & controls
 Study population (Inclusion & exclusion criteria)
 Sample size
 Data collection
 Statistical analysis
Important Elements of a Research Paper
Results
• Contains results (data) of the study
• Could be in written or table format
• No interpretation of data
Important Elements of a Research Paper
Discussion
• Interpretation of data (explains why you are getting these
results) & how it relates to clinical practice
• Relates to previous studies in the same field
• Recommendation for future research
• Limitations?
Important Elements of a Research Paper
Conclusion
• Summary of the results, usually 1 – 2 statements
• May be mentioned in the end of discussion section
Challenges That Face Research in Saudi
Arabia
• Group Discussion
Investigational Drugs & The
Role of Pharmacists
PHCL 311
Hadeel Al-Kofide MSc
Topics to be covered today
• Definitions
• FDA regulations in regards to drug approval
• The clinical investigations
• Investigational review board
• The role of hospital pharmacists
• Single & double blinded studies
• Formulation & Development of A Dosage Form
• In summary
• Drug withdrawal
What is Investigational New Drug?
• Investigational New Drug (IND) program is the means by
which a pharmaceutical company obtains permission to ship
use an investigational drug before a marketing application for
the drug has been approved. The FDA reviews the IND
application for safety to assure that research subjects will not
be subjected to unreasonable risk. If the application is
approved, the candidate drug usually enters a Phase 1 clinical
trial
Definitions
Clinical Trial or Study
• Any investigation in human subjects that is intended to
discover or verify the clinical, pharmacological or other
pharmacodynamic effects of an investigational product, to
identify any adverse reactions or to study absorption,
distribution, metabolism & excretion of an investigational
product with an object of ascertaining its safety, efficacy or
both
FDA Regulations
• Before an investigational drug be can be used in clinical
settings the sponsor must submit a Notice of Claimed
Investigational Exemption for a New Drug (FDA form 1571)
• It contains 15 points
FDA Regulations
1. Complete composition of the drug, its source &
manufacturing data
2. Results of all preclinical investigations
3. Background information of each clinical investigators
(training, experience & facilities)
4. An outline or protocol of the phases for clinical investigation
•
Also other requirements (total of 15)
Drug Development
1. Preclinical development
Extensive research that is done on
2. The clinical Investigation
compounds before therapeutic
indication found
Millions of compounds are tested
in an attempt to find one that may
have a pharmaceutical or medicinal
use
The Clinical Investigation
• Phase 1
• Phase 2
• Phase 3
The Clinical Investigation
Phase 1
• They are designed to determine a safe dose for phase 2 trials
• The purpose of these studies include: the determination of
human toxicity, absorption, metabolism, elimination,
pharmacodynamic, preferred route of administration & safe
dosage range
• It involves a small number of persons (20-80)
The Clinical Investigation
Phase 2
• Limited number of patients (100-200)
• Designed to investigate drug efficacy & relative safety
• Want to determine if the new drug has activity against a
particular disease
The Clinical Investigation
Phase 3
• These trials will be initiated if the information obtained from
the first two phases demonstrate reasonable assurance of safety
& effectiveness or suggests that the drug may have a potential
value outweighing possible hazards
• Done to determine a new drug’s safety, effectiveness & most
desirable dosage in treating a specific disease in a large group
of subjects
• Phase 3 trials are mostly conducted as a multi-centered trials
Institutional Review Board (IRB)
• IRB is an administrative body established to protect the rights
& welfare of human subjects (including patients) recruited to
participate in research activity
• The IRB has the authority to approve, require modification (in
order to approve), or disapprove all research activities
involving humans that fall under 1 or more justification criteria
Institutional Review Board (IRB)
• Justification criteria for IRB:
1. The research is sponsored by the organization
2. The research is conducted by or under the direction of any
employee or agent of the organization in connection with
institutional responsibility
3. The research interventions or interactions are performed at an
organization property &/or this research involves the use of
this institution's nonpublic information
Institutional Review Board (IRB)
• Information related to the study proposal is submitted to the
IRB investigators
• For submission usually use an IRB cover sheet
• Also must report any problems like serious adverse effects,
changes in the protocol that may affect the status of the
investigation & the willingness of patients to participate in it
The Role of Hospital Pharmacists
• The extent of the role of hospital pharmacists in investigational
drugs depend upon:
 Type of hospital
 Hospital facilities
 Equipments
 Specialized services
 Expertise of the pharmacy department
The Role of Hospital Pharmacists
• The basic roles of hospital pharmacists in investigational
drugs:
 Registration
 Control
In order to carry on these basic
roles it is imperative that the
hospital adopt certain policies for
the use of investigational drugs
 Storage
 Dispensing
 Maintenance of disposition records
 Drug information for every investigational drugs
The Role of Hospital Pharmacists
• Although the FDA does not require that investigational drugs
be stored & dispensed through a hospital pharmacy, many
hospitals require that all clinical investigational drugs to be
stored & dispensed by the hospital pharmacy
• Some hospitals have established a policy that no
investigational drug be administered to a patient unless it bears
a pharmacy department control or registration number
The Role of Hospital Pharmacists
• Some advantages of having a role for hospital pharmacies in
investigational drugs include:
 Drugs
can be stored, drug
dispensed
& accounted
Investigational
pharmacists
arefornow
being an essential part of the use of new
 They can beagents
observed
for shelf-life
& stability and then if
in different
hospitals
needed it could be sent back to the manufacturer
The Role of Hospital Pharmacists
• When the clinical investigator has written a clinical research
protocol they meet with the pharmacy to discuss the handling
& dispensing of the drug
• Certain points should be obtained at this stage
The Role of Hospital Pharmacists
• Information obtained at first encounter with the investigator:
1. Name of the drug
2. Dosage form & strength
3. Pharmacology
4. Purpose of the investigation (including copy of the proposal
which was already approved by the FDA & other required
committees)
The Role of Hospital Pharmacists
• Information obtained at first encounter with the investigator:
5. Route of administration
6. Dosage
7. Side effects, toxicity & any known antidote
8. Storage conditions
9. Stability of product
The Role of Hospital Pharmacists
• Information obtained at first encounter with the investigator:
10. Manufacturer
11. Name of the principal investigators & co-investigators
authorized to prescribe
12. Nursing unit
13. Sponsor
14. How the drug will be written or called
The Role of Hospital Pharmacists
• Information obtained at first encounter with the investigator:
15. Re-label or special label (with a caution saying: New Drug:
limited by Federal Law to Investigational Use)
16. Arrangement for obtaining additional drug along with
tentative utilization rate
The Role of Hospital Pharmacists
• These initial information should be recorded on a special form
called Investigational Drug Service Request Form: IRB cover
sheet
• After the pharmacist meet with the physician the product is
labeled with a control number, a disposition record is prepared
& the drug is stored
The Role of Hospital Pharmacists
• Then the clinician can prescribe the new drugs for
participating patients
• Before dispensing the medication pharmacy must check the
disposition record to see if the physician writing the order is an
authorized investigator
Single & Double Blinded Studies
• Pharmacists can be very helpful in establishing a single or
double blinded studies
• Single blinding
• Double blinding
Single & Double Blinded Studies
• The role of pharmacist in single blinded studies:
 Develop a simple system for coding drugs
 Assigning a series of numbers or letters with the drug &
placebo
 Example: compound name 429 assign series A, C & T for
the drug, & B, E & Y for placebo, how?
Single & Double Blinded Studies
• The role of pharmacist in single blinded studies:
 Sometimes it is requested to break the blinding for medical
emergencies, so if pharmacist was asked to break the
blinding he must determine the reason
Single & Double Blinded Studies
• The role of pharmacist in double-blinded studies:
 Use random generating tables, how?
 Sometimes manufacturer does all the blinding & sends the
drug & placebo to be directly given to the patient
Formulation & Development of A
Dosage Form
• If an investigator which to carry on a study but no
manufacturer is interested in sponsoring
• Pharmacists can formulate the new dosage form for this drug
• Must initially conduct studies to insure the identity, strength,
quality & purity of the compound
Formulation & Development of A
Dosage Form
• If an investigator which to carry on a study but no
manufacturer is interested in sponsoring
• Pharmacists can formulate the new dosage form for this drug
• Must initially conduct studies to insure the identity, strength,
quality & purity of the compound
Expanded Role for Hospital Pharmacists
• Other than the basic role they play in investigational drug
within a hospital they have additional value in:
 Study blinding
 Formulating a new dosage form
In Summary
• Pharmacists play a role in investigational drug development
• With their expertise they participate in labeling, storage &
dispensing of all drugs in the hospital
• Pharmacy is the logical place for the central repository for all
investigational drug information including the investigational
new drug number
WAIT….
We want to talk a little about the drug
withdrawal
FDA & Drug Approval
• During the 1980s & early 1990s, the FDA was criticized for
taking too long to review & approve drugs
• Then Congress, the FDA, & the pharmaceutical industry
negotiated the Prescription Drug User Fee Act (PDUFA) of
1992
• Under PDUFA, drug companies pay fees that allow the FDA
to add more resources & speed up drug review time
Myths About Drug Withdrawals & User Fees
The reality is that it's a rare occasion when a drug is taken off the market.
• Myth rate
#1: has
Drug
withdrawals
become
The drug withdrawal
been
constant overhave
the last
two decades, when
comparing the time before user fees & after, there has been no change in the
increasingly
common
because
since
user
rate of drug
withdrawals (2.7%
before
user feesever
& 2.8%
after
userfees,
fees)
the FDA has sped up drug approvals so much that
Faster reviews to get valuable & life-saving drugs on the market does not
translate into safety shortcuts
mistakes are slipping through
It isn't that the same number of FDA reviewers are working faster
It also isn't the case that shorter FDA review times mean abbreviated clinical
drug trials
Myths About Drug Withdrawals & User Fees
• Myth #2: User fees make it difficult for the FDA to
stay neutral
But Still FDA is Facing Serious Problems for
Fast Drug Approving
Example of Significant Drug Withdrawals
Drug name
Thalidomide
Fen-phen
(popular
combination of
fenfluramine &
phentermine)
Withdrawn
Remarks
1950s–1960s
Withdrawn because of risk of
teratogenicity; returned to market for
use in leprosy & multiple myeloma
under FDA orphan drug rules
1997
Phentermine remains on the market,
dexfenfluramine & fenfluramine – later
withdrawn as caused heart valve
disorder
Cerivastatin
2001
(Baycol, Lipobay)
Withdrawn because of risk of
rhabdomyolysis
Rofecoxib (Vioxx) 2004
Withdrawn because of risk of
myocardial infarction
Thank you