Innovations in Undergraduate

Pharmacology Teaching and Training

Michael VanceInnovation is the creation of the new or the

re-arranging of the old in a new way

A Wealth of OpportunitiesA Wealth of Opportunities

Community TeacherUseful Doctors

Academician

Administrator/Policy Maker

Pharmaceutical IndustryPublic Affairs

Researcher

Basic PractitionerConsultantSpecialist/

Super-specialist

Basic Competent/Confident Physician

Experimental

Teaching

Theoretical

Teaching

Medical Teaching

Medical education is Based on Medical education is Based on Lecture based LearningLecture based Learning

Classical Ways of Classical Ways of LearningLearning

Theory classTheory class Bed side ClinicsBed side Clinics SeminarSeminar TutorialsTutorials

Ethical issue/Patient Ethical issue/Patient

IrritantIrritant

Teacher has a leading position and student usually passively accepts the

information

Clinics – OvercrowdingClinics – Overcrowding

Teaching not up-to markTeaching not up-to mark

Integrated TeachingIntegrated Teaching

Problem basedProblem based

Patient specificPatient specific

Too Much Record KeepingToo Much Record Keeping

Classical Ways of Evaluation of Learning

Graduate Medical Graduate Medical Curriculum Curriculum

MCI-Basic RequirementMCI-Basic RequirementRecognition Recognition of common Diseases, of common Diseases, preventivpreventivee, , curative, Treatment executioncurative, Treatment execution & & rehabilitativerehabilitative aspect of medicineaspect of medicine

Exposure to field of practiceExposure to field of practice Skill development Skill development of Basic Techniques of Basic Techniques Self learning Self learning Inward/ OPD /Emergency LearningInward/ OPD /Emergency Learning Functioning Independently in rural and urbanFunctioning Independently in rural and urban Peer interactionPeer interaction Group Discussion and seminarsGroup Discussion and seminars Integrating Teaching and Problem Based TeachingIntegrating Teaching and Problem Based Teaching

Conventional-Theoretical, Clinical, and Experimental Teaching (with more focus on Clinical impartment of knowledge; with simulated software's for animal

experimentation or using A-Video Learning) blended with a system of teaching which is innovative

Waste of Waste of resourcesresources

, time, time

& Skills & Skills development development

of UGs & of UGs & PGsPGs

Extensive animal teaching without clinical usefulness in human /Clinical setting

“Humanized” Animals: Are they Effective?

Teaching thrust on Clinical Teaching thrust on Clinical TeachingTeaching

simulated software's

EXPERIMENTAL PHARMACOLOGY

VIDEOBASED 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

ExerciseThe 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.

EachGroup (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? Why3.What is the name of apparatus used to measure edema4.On what principal does it works5.Drugs screened by this method are use full for acute or Chronic inflammation6.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/PhenomenonWhy ACH not Used clinically

What type of Antagonism it utilizesDifference between Competitive and non competitive Blockers

What is the nicotinic response of ACHWhat 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 insight, Preventive insight, referral insights

Making them competent to provide Drug Information actively & passively

Update them with changing treatment guidelines

To train/develop basic skills of various procedures in clinical medicine, training them in dealing most common emergencies of causality /ICU/ CCU/ NICU/ Poisoning

Innovations

in

Teaching

To emphasize the “bridge” character

of pharmacologyTreatment Guidelines

To use multi-media computer-assisted Learning/AV

Discussionin Groups

Evidence based-Self Learning

Blending conventional teaching,training

InteractivePrescription competent/confident

Actual Problem Based/learning

Patients Specificlearning

Integrative Teaching

Integrative Teaching

Web LearningE learning

InterlinkingE-Library/

Objective structured practical examination (OSPE)

Equipping them with power of Literature

Equipping them with power of Literature

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?How to go?

•National libraries •Departm

ental libra

ries

Princip

al Offic

e PC•Head of Departments PC

E-libraries

Connecting/Interlinking E-Library

Mobile Alerts to Faculty , PGs, UGs (mobile database)Email Alerts to Faculty , PGs, UGs (email database)

E- Library Library Make Your students computer & Web FriendlyMake Your students computer & Web Friendly Make them learn how to search and retrieve Scientific Make them learn how to search and retrieve Scientific

InformationInformation How to Validate strength of evidence retrieved How to Validate strength of evidence retrieved Give them Power of LiteratureGive them Power of Literature E learning- team based E learning- team based Bed side learningBed side learning

The “Bridge” Character

Pharmacology

Obs & GyaneObs & Gyane

SurgerySurgery

EyeEye

Clinical MedicineClinical Medicine

MedicineMedicine

ENTENT

Pharmacology Pharmacology Backbone of TherapeuticsBackbone of Therapeutics

Patient Specific Problem Based

Learning

Problem-1Problem-1A 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-2Problem-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 conditionExplain 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 CampsTo develop Communication skill and Public Dealing- with humbleness

DRDRUG INFORMATIONOPD

DRUG AWARENESS FOR DOCTORS AND PARAMEDICAL STAFF

Innovative Primary Health Care Medical Education

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+ (HT+ DM+ Dyslipidemia + Obesity+

Insulin Resistance)Insulin Resistance)

Your P Drug For HT & Other Your P Drug For HT & Other Components-Pharmacological Components-Pharmacological

Explanation. What Information would Explanation. What Information would like to give to this patientlike 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 confirmedWhich among three available options in emergency drugs kit

would be best in such a situationAminophyllineTheophylline

Diuretics

GREETING FROM CITY OF TEMPELS JAMMU

Sudhaa Sharma Dalhousi 24/07/10

ADR of PhenytoinADR of Phenytoin

A patient with Four Cardinal SignsT remorR igidityA kinesian and bradykinesiaP ostural instability

Was started anti parkinsonism treatment which developed over a period of time Behavioral disturbances (hallucinations, paranoia, mania, insomnia, anxiety, nightmares)&Frank PsychosisHow will you manage the patient

A 62 year old female who is on inhalational A 62 year old female who is on inhalational steriods for Asthma presented with Low back steriods for Asthma presented with Low back pain. pain.

DEXA of same patient DEXA of same patient reveals Severe osteoporosis reveals Severe osteoporosis

in the lumbar vertebra.in the lumbar vertebra.

Case-4It 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 ADRWhat is the probable mechanism of this ADR

Naranjo ADR Naranjo ADR Probability Probability

ScaleScale

Naranjo CA. Clin Naranjo CA. Clin Pharmacol Ther Pharmacol Ther 1981;30:239-451981;30:239-45

To assess the adverse drug reaction, please answer the following questionnaire and give the pertinent score.

Yes No Do Not Know Score A1

. Are there previous conclusive reports on this reaction?

+1 0 0 ____

2. Did the adverse event appear after the suspected drug was administered?

+2 -1 0 ____

3. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered?

+1 0 0 ____

4. Did the adverse reactions appear when the drug was readministered?

+2 -1 0 ____

5. Are there alternative causes (other than the drug) that could on their own have caused the reaction?

-1 +2 0 ____

6. Did the reaction reappear when a placebo was given?

-1 +1 0 ____

7. Was the drug detected in the blood (or other fluids) in concentrations known to be toxic?

+1 0 0 ____

8. Was the reaction more severe when the dose was increased, or less severe when the dose was decreased?

+1 0 0 ____

9. Did the patient have a similar reaction to the same or similar drugs in any previous exposure?

+1 0 0 ____

10. Was the adverse event confirmed by any objective evidence?

+1 0 0 ____

Total Score ____

Total Score ADR Probability Classification 9 Highly Probable 5-8 Probable 1-4 Possible 0 Doubtful

Drug InteractionDrug Interaction

Proponalol + Nitrate

Which Condition may require this combination?

Drug Interaction Software and special situation Software

http://www.healthline.com/druginteractions?

Problem Based DI Problem Based DI LearningLearning

A 69-year-old man sees you in the A 69-year-old man sees you in the office for follow-up of his chronic office for follow-up of his chronic congestive heart failure. He also has congestive heart failure. He also has hypertension and type II diabetes hypertension and type II diabetes mellitus. He is on appropriate mellitus. He is on appropriate treatment of his diabetes, along with treatment of his diabetes, along with an ACE inhibitor and a loop diuretic. an ACE inhibitor and a loop diuretic. You decide to add digoxin to his You decide to add digoxin to his regimen.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+Nimsulide2.ATT3.OC PILL4.AMOXICILLINE +Cloxacine5.ACEI+ARBS6.Beta Blocker+ Nitrates7.ACEI+ Potassium Sparing diuretics8.Beat blocker+ CCB9.LEVODOPA +CARBIDOPA10.SULFONAMIDEz+ TRIMETHOPRIM11.Poly-pill

Debate For and Against

Corticosteroids friends or foeHRT

NSAIDsACEI +ARBs

Sensitize them with all basics of Clinical

research, clinical practices, most commonly used

Statistical methods & Scientific writings

BioethicsBioethics Principles of Principles of essentialityessentiality Research is necessary for the advancement of Research is necessary for the advancement of

knowledge-Should knowledge-Should add new Informationadd new Information Rationale Rationale Justification of Research QuestionJustification of Research Question Principles of precaution and Principles of precaution and risk minimisationrisk minimisation Principles of the maximisation of Principles of the maximisation of the public the public

interest interest and of distributive justiceand of distributive justice Principles of Principles of non-exploitationnon-exploitation Principles of Principles of voluntarinessvoluntariness, , informed consent informed consent

and community agreementand community agreement Respect for personsRespect for persons: : dignity and rights of each dignity and rights of each

trial participanttrial participant Participants must be Participants must be free to withdraw free to withdraw at any time at any time ConfidentialityConfidentiality must be protected must be protected CompensationCompensation

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 designStudy design

Longitudinal TrialsLongitudinal Trials Concurrent parallel study designConcurrent parallel study design Parallel Design With Placebo InitiationParallel Design With Placebo Initiation Parallel Evaluation of a combination Parallel Evaluation of a combination

TreatmentTreatment Multiple dosages parallel trialMultiple dosages parallel trial Cross over type of study designCross over type of study design Sequential study designSequential study design

Various tests of Various tests of significancesignificance

For quantitative dataFor quantitative data Standard error of Standard error of

meanmean SE of difference SE of difference

between two meansbetween two means Z-test if sample largeZ-test if sample large T-test if sample smallT-test if sample small

Student T testStudent T test Paired/UnpairedPaired/UnpairedANOVA ANOVA ANOVA Followed by ANOVA Followed by

multiple comparisonsmultiple comparisons

For qualitative dataFor qualitative data Standard Error of Standard Error of

proportionproportion SE of difference SE of difference

between two between two proportionsproportions Z-test if sample largeZ-test if sample large Chi-square if sample Chi-square if sample

smallsmall

Writing the reportWriting the report Title and investigatorsTitle and investigators SummarySummary IntroductionIntroduction ObjectivesObjectives Materials and methodsMaterials and methods Results and discussionResults and discussion Conclusion and recommendations Conclusion and recommendations LimitationsLimitations ReferencesReferences AppendicesAppendices

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.

Problem-1

120 PATIENTS

RANDOMISATION

GROUP I n=60Diacerine 50 mg daily+Inhaled Salbutamol+Exercise+ Local 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

PATIENTS OF COPD WITH OA

STATISTICAL ANALYSIS

INCLUSION CRITERIAPatients above 55 yearsBoth sexesPatients giving consentCOPD with OAStable COPDFEV1 <60%FEV1/FVC Ratio <70%One Knee Joint Involved with moderate to severe OAEXCLUSION CRITERIAChronic respiratory disease other than COPD Asthma Unstable respiratory statusRecent viral bacterialPulmonary infectionContinuous daily oxygen requirement Congestive cardiac failureInability to discontinue COPD medication UncooperativeH/O sensitivity to any of the drugsPatients not giving consentPatients taking drugs likely to interact with the drugs under studyNSAID, Corticosteroids, Glucosamine or DA requirement must

GROUP II n=60Placebo+

Inhaled Salbutamol+Exercise +Local Joint T/t

Inhaled Salbutamol X 2WK+ Exercise +Local treatment of Joint 2 WK

PresentPresentoror

PublishPublishFirst ? 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 study- Presentation 8minutes1.Rationale Justification of carrying the study2.Ethical issues3.Consort statement4.Inclusion /Exclusion of the study5.Study Design6.Randomization7.Blinding of the study8.Statistical test used9.Methodology10.Result analysis11.Discussion Made12.Conclusions made13.Highlight limitations of the study14.Future directions study lay15.Overall scientific content

Basic Record KeepingBasic Record Keeping Medico legal- aspects Medico legal- aspects Administrative Skills-Competent in Administrative Skills-Competent in

Dealing problems of HospitalDealing problems of Hospital Handling of Funds –How to seek Handling of Funds –How to seek

Funds Funds Media & VVIP HandlingMedia & VVIP HandlingDetermination

DedicationDisciplinedFocusedEarning / living with dignity Honored to be part of this professionTime 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