Transcript Document

Innovations in Undergraduate
Pharmacology Teaching and
Training
Michael Vance
Innovation is the creation of the new or the
re-arranging of the old in a new way
A Wealth of Opportunities
Academician
Basic Practitioner
Administrator/
Policy Maker
Basic Competent/
Confident
Physician
Consultant
Specialist/
Super-specialist
Public Affairs
Researcher
Community Teacher
Useful Doctors
Pharmaceutical
Industry
Medical education is Based on
Lecture based Learning
Medical
Teaching
Theoretical
Experimental
Teaching
Teaching
Classical Ways of Learning
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Theory class
Bed side Clinics
Seminar
Tutorials
Ethical issue/Patient
Irritant
Teacher has a leading position and student usually
passively accepts the information
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Clinics – Overcrowding
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Teaching not up-to mark
Integrated Teaching
Problem based
Patient specific
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Too Much Record Keeping
Classical Ways of
Evaluation of Learning
Graduate Medical Curriculum
MCI-Basic Requirement
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Recognition of common Diseases, preventive,
curative, Treatment execution & rehabilitative
aspect of medicine
Exposure to field of practice
Skill development of Basic Techniques
Self learning
Inward/ OPD /Emergency Learning
Functioning Independently in rural and urban
Peer interaction
Group Discussion and seminars
Integrating Teaching and Problem Based Teaching
Conventional Teaching Methods
Vs
Modern Methods of Teaching
Debatable and Subjective
Conventional-Theoretical,
Experimental Teaching (with
Clinical,
and
more focus on Clinical
impartment of knowledge; with simulated software's for animal
blended with a
system of teaching which is innovative
experimentation or using A-Video Learning)
Extensive animal teaching
without clinical usefulness in human
/Clinical setting
Waste of
resources
, time
& Skills
development
of UGs &
PGs
“Humanized” Animals: Are they Effective?
Teaching thrust on Clinical Teaching
simulated software's
EXPERIMENTAL PHARMACOLOGY
VIDEO
BASED LEARNING
AND EXAMINATION OF PGs and UGs
Identify the video and interact
•Oral Feeding
•Intra-cardiac blood drawing
•Intra-peritoneal injection
•Blood drawing from orbit plexuses
•Writhing response
•Tail flick reflex
•Rota rod
•Skinner behavior
•MES induced convulsions
•Leptozole induced convulsion
•Catalepsy
•Staub tail phenomenon
•Taming behavior
•Stereotype behavior
•Stunning behavior
•Sexual behavior
•Loss of writing reflex by ether anesthesia
•Writing reflex in rabbit
Exercise
The effects of two drugs A, B are given below on 1% carrageenin induced rat hind
paw edema method. Observe the readings and answer question that follows.
Each
Group
(n=10)
Drug
Dose
(mg,
ml·/kg
P.O)
HIND PAW VOLUME (MEAN ± S.E.M) (C.C)
B.D.A
A.D.A
½ hr.
1 hr.
3 hr.
5 hr.
6 hr.
I
D.W
10.
2.26
±
0.06
3.88
±
0.12
4.18
±
0.14
5.00
± 0.18
3.95
± 0.11
3.38
±
0.10
II
A
100
2.23
±
0.06
3.63
±
0.07
3.76
±
0.07
4.35
±
0.20
3.50
±
0.31
3.00
±
0.34
III
B
100
2.25 ±
0.10
2.80
±
0.09
2.81
±
0.07
2.61
±
0.06
2.61
±
0.06
2.51
±
0.06
1.Read this table carefully and comment
2.Based on the above results, which compound will you select to develop as anti-inflammatory Agent? Why
3.What is the name of apparatus used to measure edema
4.On what principal does it works
5.Drugs screened by this method are use full for acute or Chronic inflammation
6.Is this method helps researcher to comment on mechanism of action of the anti-inflammatory drugs.
7.What are the advantages and disadvantages of this method in drug screening
Explain the Mechanism of action/Phenomenon
Why ACH not Used clinically
What type of Antagonism it utilizes
Difference between Competitive and non competitive Blockers
What is the nicotinic response of ACH
What is the mechanism
What is the other response we can note on dog other than changes in BP and HR
Need of Hour is to
develop one
system of
Innovation in
Teaching and
Training of UGs &
PGs which
is
Innovative
Evidence Based, interactive, Integrative,
based on self learning, self assessing,
patient specific, problem based learning,
Bridging knowledge of Pharmacology and
Clinical Medicine, making UGs and PGs as
Prescription Competent and confident.
Developing their
investigation
Preventive insight, referral insights
insight,
Making them competent to provide Drug
Information actively & passively
Update them
guidelines
with
changing
treatment
To train/develop basic skills of various
procedures in clinical medicine, training them
in dealing most common emergencies of
causality /ICU/ CCU/ NICU/ Poisoning
Prescription competent/
confident
To emphasize the
“bridge” character
of pharmacology
Treatment Guidelines
Equipping them
with power of
Actual Problem Based/
Literature
learning
Interactive
Innovations
in
Teaching
To use multi-media
computer-assisted
Learning/AV
Patients Specific
learning
Discussion
in Groups
Interlinking
E-Library/
Web Learning
E learning
Blending
conventional
teaching,
training
Evidence
based-Self
Learning
Integrative
Teaching
Objective structured
practical examination
(OSPE)
Million Dollar question
Can there be one comprehensive ,innovative
way to have blend of all above innovations to be
started in for UGs and PGs ?
How to go?
Connecting/Interlinking E-Library
E-libraries
Mobile Alerts to Faculty , PGs, UGs
Email Alerts to Faculty , PGs, UGs
(mobile database)
(email database)
Library
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E- Library
Make Your students computer & Web Friendly
Make them learn how to search and retrieve Scientific
Information
How to Validate strength of evidence retrieved
Give them Power of Literature
E learning- team based
Bed side learning
Pharmacology
Backbone of Therapeutics
The “Bridge” Character
Obs & Gyane
Surgery
Eye
Clinical Medicine
Pharmacology
Medicine
ENT
Patient Specific
Problem Based Learning
Problem-1
A female patient of 42 years age presented in Medical OPD with
Morning stiffness >30 minutes of MTPs/MCPs/PIPs Joints and
swelling of the these joints. The nature of Joints involved was
Bilateral Symmetrical, Inflammatory Polyarthritis. The other
complaints were Fatigue, weakness, decreased appetite, Weight
loss, on and off fever. The disease was more than 2 years.
Sacroiliac joint was not involved. Rest in all most all other larger joints
like knee/Ankle/Wrist, Shoulder, the process of Pain and
inflammation had started. The patient had severe anemia .The
patient had a long history of Pain Killer use and similar use of many
alternative and unknown drugs from unknown quacks also. The other
complaints present were of APD/GERD and Psychosomatic
symptoms. The Investigation profile of patients from the available
records was as follows RF (Latex agglutination Method) - Normal.
The same was done three times over a period of time from start of
treatment and was persistently coming normal. S uric acid -5.3mg/dl;
Hb was 7 gm% and LFT was well within normal range. Patient was
only treated on the line of non specific athralgia
Problem-2
A male patient 35 years old with history of chronic
smoking, alcohol, mild hypertensive was on long
term diuretic (thiazide therapy). Presented with
acute pain and swelling/inflammation with First
metatarsophalangeal joint involvement. The attacks
began abruptly and reached maximum intensity in
8- 12 hours. The joint was red, hot, and exquisitely
tender. It was an Unilateral attack involving tarsal
joint. The serum uric acid was 5.9mg/dl at the time
patient presented with pain. But his BP was 158/98
mm of Hg and presented with Dyslipediemia. How
to proceed with such patient ?
Identify Clinical Condition
Patient presented with intense pain and burning sensation locally
How will you treat the above condition
Explain the mechanism and guidelines for the use of two most common group
of drugs used for such pain
Innovation in teaching should also aim to develop UGs
& PGs as Community –teacher in basic language
Free Prescription Evaluation Camps
To develop Communication skill and Public Dealing- with humbleness
DRUG AWARENESS FOR DOCTORS AND
PARAMEDICAL STAFF
Innovative Primary Health Care Medical Education
DRDRUG INFORMATION
OPD
A Yong Female patient on being diagnosed as
Subclinical – Hypothyroidism with anemia and Ca &
Vit D deficiency asked few questions to treating
doctor about her treatment and drug-In DIC
T3,T4 Normal; TSH-9 mIU/L
•Should Treatment b started or not for Hypothyroidism
•How long will Duration of treatment continue.
•What to do if I forgets to take the prescribed tablet
•When will Clinical & Biochemical response be seen
•Why thyroxine need to be taken early morning empty stomach
•Which Investigation I should get done and how frequently
•What is target serum TSH level for adequate treatment
•What shall decide the change in dose as per response
•What are the Side effects and Contraindications for treatment
•What about other Co morbid Conditions
•What about potential Drug Interactions
•What Dietary Advises
HT with Metabolic Syndrome
(HT+ DM+ Dyslipidemia + Obesity+ Insulin
Resistance)
Your P Drug For HT & Other ComponentsPharmacological
Explanation. What Information would like to give to
this patient
Patients was brought in the emergency in rural health center With c/o
Breathlessness, dysneoa, cyanosis. But because of resource limited setting
inexperience of treating doctor to deal and non availability of diagnostic facilities
to establish diagnosis of Acute attack of asthma and Acute LVF Could not be
confirmed
Which among three available options in emergency drugs kit would be best in such
a situation
Aminophylline
Theophylline
Diuretics
GREETING FROM CITY OF TEMPELS
JAMMU
Sudhaa Sharma
Dalhousi
24/07/10
ADR of Phenytoin
A patient with Four Cardinal Signs
T remor
R igidity
A kinesian and bradykinesia
P ostural instability
Was started anti parkinsonism treatment which developed over a period of time
Behavioral disturbances (hallucinations, paranoia, mania, insomnia, anxiety,
nightmares)&
Frank Psychosis
How will you manage the patient
DEXA of same patient reveals Severe
osteoporosis in the lumbar vertebra.
A 62 year old female who is on inhalational steriods
for Asthma presented with Low back pain.
Case-4
It is a well-known fact that angiotensin converting enzyme inhibitors (ACEI) alone can control blood pressure in
approximately fifty per cent of the patients with mild to moderate hypertension and many consider them 'first line' drugs
for blood pressure. Ninety per cent of patients with mild to moderate hypertension can be controlled by a combination of an
ACEI with a Ca+ channel blocker, ß-adrenergic receptor blocker or a diuretic. But in five to twenty per cent of patients, ACEI
can induce bothersome dry cough which usually develops between the 1st week and 6 months after initiation of therapy.
Cessation of therapy is needed sometimes to control the dry cough. This adverse effect may be mediated by the
accumulation of bradykinin, substance-P, and/or prostaglandins in the lungs. Once ACEI is stopped, the cough usually
disappears within 4 days. Therefore, in spite of current recommendations for ACEIs to be used as first line
antihypertensives, physicians are using angiotensin II receptor antagonists very commonly because of the fact that they have
a comparable efficacy as antihypertensives but without cough. The latter act at the AT1 receptor level and have nothing to
do with angiotensin converting enzyme, whose inhibition actually is responsible for the production of cough. Few studies have
reported losartan to produce cough. Since dry cough due to losartan is rare we feel this case is worth reporting.
A 49-year-old obese woman recently diagnosed as a case of primary moderate hypertension was advised to start losartan of a
reputed manufacturer at a dose of 50 mg, o.d. with salt restriction and exercise. The patient had no history of smoking,
alcohol consumption, any other associated pathology or concurrent drug intake. She started to have severe dry, irritating
cough during the 8th week after the initiation of the drug therapy. There was no history of such an episode in the recent
past. There was no history of any allergy either.
Clinical examination revealed a clear chest and there was no sign of any infection, bronchitis, pulmonary tuberculosis, asthma
or sinusitis. There were no symptoms and signs of gastroesophagal reflex disease. Investigations revealed normal X-ray chest
and sinuses. All basic investigations like eosinophilic count, Hb, TLC, DLC, ESR, platelet count, sputum for AFB, routine urine
and stool examination, blood sugar, blood urea, creatinine, LFT, RFT and ECG were found to be normal, except the lipid profile
which showed an increased tryglyceride level (190 mg/dl).
The patient was advised to stop the drug, when the cause of the cough could not be ascertained thinking on the line that this
adverse effect might be due to losartan itself and therefore no treatment was prescribed for the treatment of the cough.
The patient was changed over to amlodipine (5 mg, o.d.) for the time being and it was found that the cough disappeared on
the 8th day after stopping losartan in the patient. Further rechallenge was not done in the interest of the patient fearing
reappearance of adverse drug reaction (ADR) and ethical constraints. Thus, the appearance of dry irritating cough in a
patient taking losartan could not be explained by a concurrent disease, drug or chemicals and a dechallenge improved the
condition.
Naranjao's adverse drug reactions (ADR) probability scale evaluation was done to assess the likelihood of ADR . It was
further confirmed by WHO-UMC causality assessment criteria. Since this ADR was not dose dependent and unpredictable.
What is the Naranjo’s Score?
What is Causality assessment by WHO- UMC causality assessment criteria?
Is it Type-I or Type II ADR
What is the probable mechanism of this ADR
To assess the adverse drug reaction, please answer the following questionnaire and give the pertinent score.
Naranjo ADR
Probability Scale
Naranjo CA. Clin Pharmacol
Ther 1981;30:239-45
A1 Are there previous conclusive reports on
. this reaction?
2. Did the adverse event appear after the
suspected drug was administered?
3. Did the adverse reaction improve when the
drug was discontinued or a specific
antagonist was administered?
4. Did the adverse reactions appear when the
drug was readministered?
5. Are there alternative causes (other than the
drug) that could on their own have caused
the reaction?
6. Did the reaction reappear when a placebo
was given?
7. Was the drug detected in the blood (or
other fluids) in concentrations known to be
toxic?
8. Was the reaction more severe when the
dose was increased, or less severe when the
dose was decreased?
9. Did the patient have a similar reaction to
the same or similar drugs in any previous
exposure?
10. Was the adverse event confirmed by any
objective evidence?
Yes
+1
No
0
Do Not Know
0
Score
____
+2
-1
0
____
+1
0
0
____
+2
-1
0
____
-1
+2
0
____
-1
+1
0
____
+1
0
0
____
+1
0
0
____
+1
0
0
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+1
0
0
____
Total Score
____
Total Score
ADR Probability Classification
9
5-8
1-4
0
Highly Probable
Probable
Possible
Doubtful
Drug Interaction
Proponalol + Nitrate
Which Condition may require this
combination?
Drug Interaction Software and special situation Software
http://www.healthline.com/druginteractions?
Problem Based DI Learning
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A 69-year-old man sees you in the office for
follow-up of his chronic congestive heart failure.
He also has hypertension and type II diabetes
mellitus. He is on appropriate treatment of his
diabetes, along with an ACE inhibitor and a
loop diuretic. You decide to add digoxin to his
regimen.
Sensitizing them with
Drug Advertisement in medical journals
Pharmaco- economics
Impart them Knowledge of using Software of
DI/Food/Alcohol/Smoking interactions, make them
competent in dealing with Drugs in Special situation like
Pregnancy, Lactation / Hepatic dysfunction/Renal
compromised patients/Cardiac compromised patients-by
using softwares.
Comment & Interact for rationality
1.PCM+Nimsulide
2.ATT
3.OC PILL
4.AMOXICILLINE +Cloxacine
5.ACEI+ARBS
6.Beta Blocker+ Nitrates
7.ACEI+ Potassium Sparing diuretics
8.Beat blocker+ CCB
9.LEVODOPA +CARBIDOPA
10.SULFONAMIDEz+ TRIMETHOPRIM
11.Poly-pill
Debate
For and Against
Corticosteroids friends or foe
HRT
NSAIDs
ACEI +ARBs
Sensitize them with all
basics of Clinical research,
clinical practices, most
commonly used Statistical
methods & Scientific
writings
Bioethics
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Principles of essentiality
Research is necessary for the advancement of
knowledge-Should add new Information
Rationale Justification of Research Question
Principles of precaution and risk minimisation
Principles of the maximisation of the public interest
and of distributive justice
Principles of non-exploitation
Principles of voluntariness, informed consent and
community agreement
Respect for persons: dignity and rights of each trial
participant
Participants must be free to withdraw at any time
Confidentiality must be protected
Compensation
Post Graduate Guide-Service Jointly by
Pharmacology and PSM Departments
• Choosing Research Question
•Advise on Ethical issues- both preclinical and
Clinical studies
•Designing Research Protocol for descriptive/
interventional preclinical or clinical studies
(Phase 1-4) for your research and thesis of PGs
•Scientific editing
•Medical writing
•Statistical Advise Before, During and After
submitting research protocol
Study design
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Longitudinal Trials
Concurrent parallel study design
Parallel Design With Placebo Initiation
Parallel Evaluation of a combination
Treatment
Multiple dosages parallel trial
Cross over type of study design
Sequential study design
Various tests of significance
For quantitative data
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Standard error of mean
SE of difference
between two means
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Z-test if sample large
T-test if sample small
Student T test
Paired/Unpaired
ANOVA
ANOVA Followed by
multiple comparisons
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For qualitative data
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Standard Error of
proportion
SE of difference between
two proportions
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Z-test if sample large
Chi-square if sample small
Writing the report
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Title and investigators
Summary
Introduction
Objectives
Materials and methods
Results and discussion
Conclusion and recommendations
Limitations
References
Appendices
Problem-1
IL-1ra is significantly effective in regulating both STAT6 mRNA and
NF-kappaB mRNA expression simultaneously and there by
playing important role in pathogenesis of Asthma and COPD.
Diacerine (50mg od) is an interlukin 1 antagonist widely used in
the treatment of OA because of its pain relieving and disease
modifying effect. However, it has never been tried in for patients of
Asthma or COPD, nor any preclinical study could be cited in
review of literature.
Draw Protocol for phase 2 randomized placebo control
comparative clinical trial to analyze the efficacy and safety of
Diacerine (IL-1 antagonist) in patients of stable COPD and make
the CONSORT for same to be submitted for approval from IEC
and ICMR for funding and then to conduct research as thesis.
Parallel study design With Placebo
PATIENTS OF COPD WITH OA
120
PATIENTS
Inhaled Salbutamol X 2WK+ Exercise +Local
treatment of Joint 2 WK
RANDOMISATION
GROUP I n=60
Diacerine 50 mg daily+
Inhaled Salbutamol+
Exercise+ Local T/t
GROUP II n=60
Placebo+
Inhaled Salbutamol+
Exercise +Local Joint T/t
Post Drug Objective Parameters like lung functions (FEV1
and FVC, FEV, FEF25-75) And Subjective Parameters like
improvement in respiratory symptoms, QOL & safety (BP,
HR, ADR) were assessed and Compared
STATISTICAL
ANALYSIS
INCLUSION
CRITERIA
Patients above 55 years
Both sexes
Patients giving consent
COPD with OA
Stable COPD
FEV1 <60%
FEV1/FVC Ratio <70%
One Knee Joint Involved
with moderate to severe
OA
EXCLUSION
CRITERIA
Chronic respiratory disease
other than COPD Asthma
Unstable respiratory status
Recent viral bacterial
Pulmonary infection
Continuous daily oxygen
requirement
Congestive cardiac failure
Inability to discontinue
COPD medication
Uncooperative
H/O sensitivity to any of
the drugs
Patients not giving consent
Patients taking drugs likely
to interact with the drugs
under study
NSAID, Corticosteroids,
Glucosamine or DA
requirement must
Present
or
Publish
First ?
Unethical Publication practices
Gift Authorship
Pressured Authorship
Ghost Authorship
Duplicate Submission
Salami Publication
Plagiarism
Publications adding no new information
Scientific Fraud
Fabrication (altering truthful information)
Falsification (Inventing information where none previously existed)
Critically analyze the given clinical research paper for the
following parameters and Draw the CONSORT of the studyPresentation 8minutes
1.Rationale Justification of carrying the study
2.Ethical issues
3.Consort statement
4.Inclusion /Exclusion of the study
5.Study Design
6.Randomization
7.Blinding of the study
8.Statistical test used
9.Methodology
10.Result analysis
11.Discussion Made
12.Conclusions made
13.Highlight limitations of the study
14.Future directions study lay
15.Overall scientific content
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Basic Record Keeping
Medico legal- aspects
Administrative Skills-Competent in Dealing
problems of Hospital
Handling of Funds –How to seek Funds
Media & VVIP Handling
Determination
Dedication
Disciplined
Focused
Earning / living with dignity
Honored to be part of this profession
Time management
Leadership and Team quality
Theodore Levitt
Just as energy is the basis of life itself, and
ideas the source of innovation, so is innovation
the vital spark of all human change,
improvement and progress