Practical 1: DOSAGE FORMS

COMPETENCY NO: PH 2.1: DEMONSTRATE UNDERSTANDING OF USE OF VARIOUS DOSAGE FORMS

(ORAL/LOCAL/PARENTERAL/ SOLID/ LIQUID)
PH 2.1.1: Identify various dosage forms- solid, liquid, topical dosage forms.
PH 2.1.2: Describe the various types of solid dosage forms in the given samples with merits and demerits of each.
PH2.1.3: Describe the various types of liquid dosage forms in the given samples with merits and demerits of each.
PH 2.1.4: Describe the various types of topical dosage forms in the given samples with merits and demerits of each.
PH 2.1.5: Describe all the components of commercial label of the given dosage form and its importance.
DOSAGE FORMS: solid, semisolid, liquid, newer dosage forms.

Dosage forms
Solid dosage forms Liquid dosage forms Pressurized New drug delivery systems
preparations
Solid dosage forms Semisolid Injections eg single or Aerosols Transdermal patches
dosage forms multidose vial
Tablets Creams Paints eg gum paints Inhalants Ocuserts
Capsules Ointments Gargles inhalations Progestasert
Plasters Suppositories Drops Liposomes, stealth liposomes
Spansules applications Lotion Insulin pumps( CSII), pen
Pessaries Liniment Medicated chewing gums
Bougies Syrups Osmotic pump
Granules spirit Targeted drug delivery system eg gold
nanoparticles
Pills Tincture Iontophoresis; phonophoresis
Powders emulsions Biotechnology product: rDNA technology
Troche/lozenges Gel eg: aluminium Spacer, nebulizer.
hydroxide gel Radiopharmaceuticals: I 131, Technetium 99.
Mouthwash eg Listerine Coated implantable devices eg sirolimus stent
Irrigating solution; Polymer drug conjugates eg PEG-IFNα.
sprays
1) Solid dosage forms: explain the advantages and disadvantages.
a)Tablet: describe the advantages and disadvantages.
Types: uncoated tablets, chewable tablets, effervescent tablets, scored tablet, sugar coated tablets, gelatin film
coated tablets, enteric coated tablets, dispersible /effervescent tablets, lozenges, immediate release tablets,
sustained release/ controlled release tablets, rapidly dissolving tablets (RDT).
b)Capsule: advantages and disadvantages. Hard & soft, modified release capsule ( Spansules)
c)Powders: simple powder, compound powder, effervescent powder, hygroscopic powder, dry powder inhalers.
d)Plasters: non-medicated & medicated plasters.
e) granules: eg: zinc granules, Calcitriol.
f) solid topical dosage forms: dusting powder; plasters, pellets.
g) other solid dosage forms: suppositories, Pessaries, urethral suppositories( Bougies).

2)Liquid dosage forms: syrup, elixir, suspension, emulsion (oil in water & water in oil), injections, paint, gargles,
drops, lotion, liniment, syrup, spirits etc.

3) local dosage forms: drops: eye drops; ear drops; nasal drops; nasal sprays; ointments, paste; gels & lotions;
jellies; powder; lotions; liniments; ointment; cream, ointment; paint; sprays; inhalation ( MDI-procedure for using
MDI, advantages & disadvantages, precautions for use of MDI); rotahaler ( procedure for use, medications given,
care of rotahaler); gargle & mouthwashes- medications given, advantages.
COMMERCIAL LABEL: Label that is applied over the dispensed medication. It consists of two parts:
a) primary label: containing information about the ingredients of dispensed medication.
b) secondary label: containing information about special precaution, it is pasted above the primary label with small gap in
between eg shake well before use.
Q1): Explain MDI; list parts of MDI; list steps of using MDI;
Q2): write difference between vial & ampoule.
Q3): what is a draught? What is excipient? What position is used in nasal spray & nasal drops installation?
 PRACTICAL 3: Preparation and administration of IV infusion
Competency PH 2.3: demonstrate the appropriate setting up of an intravenous drip in a stimulated environment (demonstrate,
observe, assist, and perform)
Materials needed: iv medications, IV fluids, syringe, spirit, swab, IV cannula, fixing tape, IV set, IV injection arm (mannequin), IV
stand, gloves.
Parts of IV set: spike (plunger), drip chamber (Murphy’s chamber), plastic tubing, control clamp (roller & regulator), latex tube,
needle adapter and needle with cover.
Procedure 1: preparation of IV drip set:
1. Observe aseptic precaution
2. Remove iv infusion bottle form plastic bag, remove nipple cap from bottle in case of plastic bottle.
3. Takeout IV set from plastic bag.
4. Attach needle to adapter of IV set.
5. Close the roller clamp( regulator) by bringing wheel at bottom of roller clamp
6. Insert spike ( plunger) of set into bottle by pushing in 2-3 clockwise jerks/pushes.
7. Turn the bottle upside down & hang it at suitable length. Insert air vent if needed
8. Squeeze & release drip chamber until it is half filled.
9. Open roller clamp & allow solution to run a little to remove air form IV set, now close roller clamp.
10. Apply the sprit swab over exposed skin, perform Venepuncture using sterile IV cannula & fix it using fixing tape
( separate competency in routed of drug administration)
11. Open roller clamp & adjust flow rates
12. Communicate to pt about completion of procedure.
13. Remove gloves, perform hand hygiene.
Drop/ Drip factor: number of drops (guttate = gtt) in one ml of fluid. Macro drip: in adult; 15-20 drops /ml or 100ml/hr.
Micro set: 60 drops/min.
Venepuncture: site preparation: perform hand hygiene and wear gloves; Uncover arm completely; ask patient to relax &
support her arm below vein to be used; wait for vein to swell; clean the site using alcohol swab in firm circular motion; allow
site to dry.
Procedure 2: procedure for IV cannulation.
1. Pull off cap from needle. Keep the cap aside, don’t throw it away.
2. Stabilize vein by pulling skin taut in longitudinal direction of vein using non dominant hand.
3. Insert needle with cannula at an angle of around 35 degrees.
4. Puncture skin & move needle slightly into vein (3-5mm).
5. Hold the cannulae, when blood appears in cannula lower angle of needle so that it becomes parallel to skin surface.
6. If no blood appears try again till blood appears.
7. Push cannula 2mm further into vein.
8. Remove needle while pressing at site of insertion to prevent bleeding.
9. Carefully place the cap back on needle.
10. Discard syringe in dustbin for sharp waste.
11. Remove tourniquet.
12. Clean & connect the cannula end to IV tubing.
13. Secure cannula to skin surface with adhesive tape.
14. Start the appropriate IV fluid.
15. Check for pain, swelling in area surrounding cannula.
16. If swelling present, stop fluid, remove cannula, & start afresh.
17. Otherwise set the drop rate of medication using roller clamp of drip chamber.
18. Communicate to patient about completion of procedure
19. Remove gloves & perform hand hygiene.
20. Monitor pts BP HR, RR & temperature & observe for side effects.
Q1) what are the indications for IV infusion.
Q2) what are the advantages and disadvantages of IV infusions.
Q3) Describe the different types of IV fluids.
Q4) write the difference between IV infusion and IV bolus.
Q5) draw a neat labeled diagram of IV drip set and label the parts correctly.
 PRACTICAL 4: CALCULATION OF DRUG DOSAGE
Competency PH 1.2 & 2.4:
a) Calculate the dosage of drugs using appropriate formula for an individual patient including
children, elderly & patient with renal dysfunction.
b) Demonstrate the correct methods of calculation of drug dosage in patients including those
used in special situations.

OBJECTIVES: At the end of this practical class, student should be able to:
A. Calculate the dose for adults as well as for pediatric patients.
B. Calculate the dose in case of renal disease.
C. Calculate the loading and maintenance dose
D. Calculate and understand drug dilutions & strength.

FORMULAS FOR DRUG DOSE CALCULATION:

1) Young’s rule ( in children less than 12 yrs)= (child dose= age x adult dose) / (age +12).
2) Fried’s rule: child dose= (age in months x adult dose)/ 150.
3) Clarks rule: child dose= ( weight in pound(lb) x adult dose) /150
4) Dilling s formula: child dose= ( adult dose x age ( yrs) / 20
5) Adult dose based on body weight: calculated dose: (adult dose x weight (kg)) /70
6) Adult dose based on BSA: calculated dose=( adult dose x BSA ( m2) / 1.73.
Where BSA (m2) = height (cm)0.725 x body weight( kg)0.425 x 0.007184 (Dubois formula).
7) for elderly there are no fixed formulas for calculating drug dose; dose is calculated
approximately based on creatinine clearance as follows: calculated dose= ( adult dose x
creatinine clearance in renal insufficiency)/ creatinine clearance in normal individual.
Creatinine clearance in healthy individual of 70 kg weight (1.73 sq.mt BSA) =100-120 ml/min.
8) Cockcroft Gault formula (drug dose in renal disease)=
 MALE= (140-age) x weight (kg)/ CLcr x 72.
 FEMALE= (140-age) x weight (kg) x 0.85/ (CLcr x 72).
Renal impairment is usually divided into three grades:
 Mild- GFR: 20-50ml/min
 Moderate- GFR: 10-20ml/min
 Severe: GFR: < 10ml/min.
9) LOADING DOSE= therapeutic plasma concentration X Vd (L) or LD= (Vd x Cp) / F.
10) MAINTENANCE DOSE= therapeutic plasma concentration X Clearance (CL) or
MD= (CL X Cp)/ F.
11) DRUG DILUTIONS & DRUG STRENGTHS:
SL NO ratio Percentage (%) concentration
1 1:100 1% 10mg/ml
2 1:1000 0.1% 1mg/ml (1000mcg/ml)
3 1:10,000 0.01% 0.1mg/ml ( 100mcg/ml)
4 1:1,00,000 0.001% 10mcg/ml.
 PRACTICALS 5: PRESCRIPTION WRITING EXERCISES
PH 1.10: Describe parts of a correct, complete and legible prescription. Identify errors in
prescription and correct appropriately.
PH 3.1: write a rational, correct and legible generic prescription for a given condition &
communicate the same to the patient.
OBJECTIVES: At the end of this practical class student should be able to:
 Define the term prescription
 Explain the meaning of rational prescription
 List all parts of prescription
 Explain importance of all parts of prescription
 List precautions while writing prescription
 Write a rational prescription for a given condition
 Appreciate the communication of prescription to the patient.
Definition: prescription is a written order of a physician to a pharmacist to dispense
medications to the patient. Prescription ( pre-before, script-to write) means “ to write before” a
drug can be prepared.
Parts of prescription:

1. Doctor details
2. Patient details
3. Superscription
4. Inscription
5. Subscription
6. Transcription
7. Signature & Date.
PRESCRIPTION FORMAT
DOCTOR’S NAME:------------------------------
QUALIFICATION: MBBS, MD.
REG No: ------------- -------------( ALLOPATHY)
FULL ADDRESS-------------------------------------
CONTACT No: telephone:------------------------ mobile:----------------------------email:------------------
Date:
Patient name:-----------------------
Address*:----------------------------
Age:---------------gender:------------------------ weight**:-------------
DIAGNOSIS:

1)Name of medicine***( generic):

Strength, Dosage, Instructions, Duration, total quantity
2) ---do-----
3)—do----
4)----do----

DOCTORS SIGNATUE & DATE WITH STAMP.

DISPENSED
Date:--------------- Pharmacist:-------------
Name of pharmacy:--------------------------
City:----------------------------------------------
 *: Postal address/ email/mobile.
 **: for pediatric patients
 *** in capital letters only.
 Minimum size of prescription blank should be 14X21cm( A5 size) or X1xX1cm size.
SAMPLE PRESCRIPTION: WRITE A RATIONAL, CORRECT & LEGIBLE GENERIC PRESCRIPTION
FOR A 46 YR OLD MALE PATIENT SUFFERING FROM STAGE 1 HYPERTENSION.
DR.GENERIC RATIONAL
REG No: KARNATAKA MEDCIAL COUNCIL: 234567.
90, AMBEDKAR ROAD, BENGALURU.
PHONE: 0832-234567, MOBILE: 9876543210
EMAIL: GENERIC.RATIONAL@GMAIL.COM
NAME OF PATIENT: Mr. Compliant.
Address:707, Batavia chambers, bengaluru, Karnataka
Phone: 2345678910, email: compliant@gmail.com
Age: 45 yrs, male, weight: 70 kg.
DIAGNOSIS: STAGE 1 HYPERTENSION

Inscription: tablet AMLODEPINE 5mg

Subscription: send 7 such tablets
Transcription: one tablet once a day, follow up after 7 days

Doctors signature, Date and stamp.

DISPENSED:
Date: 23/October 2022; Pharmacist: Best Pharm.
Name of pharmacy: standard medical store, city : bengaluru.

1. Describe a rational prescription

2. Steps for writing a rational prescription
3. Describe the types of prescription
4. Describe in details the various parts of prescription & explain the parts in detail
5. Describe the common errors in writing a prescription.
6. Explain E-prescribing.

1. Write a rational, correct & legible generic prescription for a 44yr old male
patient with acute attack of asthma & communicate the same to the patient.
2. Prescribe for type 2 diabetes mellitus patient aged 46yrs.
3. Adult patient suffering from generalized tonic clonic seizures.
4. Adult patient suffering form upper respiratory tract infection
5. Adult patient suffering from plasmodium vivax malaria
6. Iron deficiency anemia in pregnant female
7. Angina pectoris in 46 yr old male patient
8. Patient with acute severe asthma
9. Chronic bronchial asthma
10. Patient with status epilepticus
11. Patient with peptic ulcer
12. Patient with duodenal ulcer
13. Patient with acute abdomen
14. Patient suffering from dysmenorrhoea
15. Patient suffering from acute attack of migraine
16. Patient suffering from allergic conjunctivitis
17. Patient suffering from herpes zoster
18. Patient suffering with oral candidiasis
19. Patient suffering from vaginal candidiasis
20. Patient suffering from amoebic hepatic abscess
21. Patient suffering from intestinal amoebiasis
22. Patient suffering from primary syphilis
23. Patient suffering from typhoid in an area with Chloroquine resistance
24. Patient suffering from hyperthyroidism
25. Patient suffering from acute gouty arthritis
26. Patient suffering form multibacillary leprosy
27. Patient suffering from pulmonary tuberculosis
28. Patient suffering from urinary tract infection
29. Patient suffering from Falciparum malaria
30. Patient suffering from Cerebral malaria
31. Patient suffering from Dengue fever
32. Patient suffering from Congestive cardiac failure
33. Patient suffering from Partial seizures
34. Patient suffering from Depression
35. Patient suffering from Bipolar disorder
36. Patient suffering from Parkinsonism ( idiopathic)
37. Patient suffering from Myasthenia gravis
38. Patient suffering from Acute insomnia
39. Patient suffering from Apthous stomatitis
40. Patient suffering from Chronic simple glaucoma
41. Patient suffering from Myocardial infarction
42. Patient suffering from Acute attack of angina pectoris
43. Patient suffering from Swine flu fever
44. Patient suffering from Diabetic ketoacidosis
45. Patient suffering from Rheumatoid arthritis
46. Patient suffering from Alcohol dependence
47. Patient suffering from Acute angle glaucoma
48. Patient suffering from Osteoporosis/ osteomalacia
49. Patient suffering from Organo-compound poisoning
50. Patient suffering from Anaphylactic shock
 PRACTICAL 6: PRESCRIPTION AUDIT
COMPETENCY No: PH:3.2: PERFORM AND INTERPRET CRITICAL APPRAISAL(AUDIT) OF A GIVEN PRESCRIPTION.
OBJECTIVES: At the end of this practical class, student should be able to:
Understand the steps of critical appraisal (audit) of prescription
Evaluate the given prescription and rewrite the correct prescription.
INTRODUCTION: Word AUDIT means official examination and verification of accounts or dealing s as per dictionary meaning
but in medical parlance the word audit is used to focus on “evaluation of healthcare”. During drug prescribing irrational
prescriptions are common, more than 50% of medications are prescribed, dispensed or sold inappropriately. 50% patients
fails to take medications correctly (WHO) due to inappropriate prescribing. Many of these error can be minimized by
prescription audit and to provide feedback to doctors prescribing these medications about the dangers of inappropriate
prescribing.
Points to remember while doing a prescription audit (critical appraisal)
1. Check format of prescription
2. Check the parts of prescription-are all parts clearly mentioned and written
3. Is the diagnosis and treatment given correct
4. Drug prescribed correct and appropriate to diagnosis.
5. Check for polypharmacy (over prescribing) or under prescribing
6. Check whether drugs are prescribed by generic name or brand name
7. Check for drug-drug interactions
8. Check for unnecessary/ hazardous drugs
9. Check whether it is rational or irrational prescription
10. Check for correct dosage, route, time, frequency is mentioned correctly
11. Are instruction to pharmacist and patient correct
12. Check for refilling instructions wherever required.
Example: Criticize (audit) and rewrite the corrected prescription for an adult patient suffering from acute attack of gout.
Tab Allopurinol 50mg 1 tds
Tab APC 500mg 1 tds.
Patient is advised to take 1 glass of tomato juice along with drugs.
CRITICISM:
1. Form of prescription is not correct.
2. Superscription, subscription, inscription and signature is missing
3. Abbreviation should not be used in prescription
4. Drug allopurinol is incorrect as it is used in acute gout and is not effective in controlling pain, it is more suitable for
chronic gout.
5. Duration of treatment is not indicated
6. Tomato juice is avoided as it contains high uric acid concentration.
CORRECTED PRESCRIPTION:
DR. ABC,MBBS,
KMC reg no: 2345
#8, savarkar road, bengaluru, mobile 6789012345
Date: 04/04/2023.
For Mr. XYZ
Age: 44 yrs, gender: Male
Address: #6, Gandhi road, bengaluru
Mobile : 3456789021, email: xyzgandhi@outlook.co.in
Diagnosis: acute gout

Capsule indomethacin 25mg

Send 80 such tablets
Two tablets to be taken two times a day after meals for one week followed by one tablet to be taken two times a day for four weeks.
Capsule Omeprazole 20mg once daily on empty stomach early in morning
Send 28 such tablets.
Dr. ABC
Reg No: 2345
DISPENSED:
Date: 03/04/2023 PHARMACIST: SD
Name of pharmacy: XYZ pharmacy
City: bengaluru.
1) Criticize, prescribe and rewrite the following prescription in a female patient suffering form urinary
tract infection due to E.Coli.

Tab cotrimoxazole 1 tab 2 times/day X 7 days

Tab Norfloxacin 400mg 1 tab 2 times/day X 7 days
Cap Ampicillin 250m 1 tab 4 times/day X 7 days
Tab vitamin C 500mg 1 tab daily X 7 days
Signature
Registration number.

2) Criticize, prescribe and rewrite the following prescription in a male patient aged 30 years, weighing
45kg suffering from pulmonary tuberculosis.

Cap isonicotinic hydrazide 1 tab 4 times/day X 1(100mg) month

Cap Rifampicin (450mg) 1 tab 2 times/day X 1 month
Tab pyrazinamide (1.5gm) 1 tab/day X 1 month
Syrup codeine phosphate 1 teaspoon 3 times/day X 7 days
Signature
Registration number.

3) Criticize, prescribe and rewrite the following prescription in a female patient aged 20 yrs suffering
form gastric ulcer with severe epigastric pain.

Tab Omeprazole 20mg 1 tab 2 times/day X 2 weeks

Tab ranitidine 150mg 1 tab/day X 2 weeks
Tab ibuprofen 200mg 1 tab 2 times /day X 3 days
Tab Paracetomol 500mg 1 tab 2 times /day X 3 days
Tab Dicyclomine hydrochloride 10mg 1 tab 2 times /day X 3 days.

4) Criticize, prescribe and rewrite the following prescription in a female patient aged 15yrs suffering
from intestinal amoebiasis with vomiting.

Tab mebendazole 400mg 1 tab 3 times /day X 7 days

Tab Domperidone 10mg 1 tab 2 times /day X 7 days
Tab Diloxanide furoate 500mg 1 tab/day X 7 days.

5) Criticize, prescribe and rewrite the following prescription in a male patient aged 55yrs suffering
from dyspnoea, edema feet and productive cough in acute congestive cardiac failure.

Tab Captopril 25 mg 1 tab 3 times/Day X 1 month

Tab Digoxin 0.25mg 1 tab 2 times/day X 1 month
Syrup KCL 1 teaspoon 3 times/day X 1 month
Tab Furosemide 40mg 1 tab 2 times/day X 7 days
Tab hydrochlorothiazide 50mg 1 tab daily X 7 days.
 PRACTICAL 7: EVALUATION OF DRUG PROMOTIONAL LITERATURE
Competency number: PH 3.3: To perform a critical evaluation of drug promotional literature(DPL).
At the end of this practical session student should be able to:
 Define drug promotion.
 Describe different methods of drug promotion
 Enlist essential contents of drug promotion
 Critically evaluate a given drug advertisement.
World Health Organization (WHO) defines “ drug promotional activities” as “ all informational & persuasive activities by manufacturers and
distributors the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs”.
Promotional activities of drugs by pharmaceutical companies are governed by Organization of Pharmaceutical Producers of India (OPPI).
OPPI is a self regulatory code of pharmaceutical marketing practices .In practice doctors are expected to know about new developments in
drug therapy. Sources of information about drugs include:
 Written for: journals, reference books, drug bulletins, books etc.
 Verbally: through discussions in CMEs, meetings, journal clubs.
 Tapes/ video/ online educational materials:- journals, CDs.
 Drug information centers (DICs)
 Pharmaceutical industry
 Internet.
In the current scenario it is better to consider drug advertisement as a “necessary evil”. A doctors attitude towards a new drug should be “
you should not be the first person to use a new drug and at the same time you should not be the last person to discard an old drug”.
Methods of drug promotion by pharmaceutical industries:
 Through drug advertisements in professional journals, in non professional magazines or newspapers (for non prescription drugs
only), in drug information sheet to clinician.
 Free drug samples to clinicians
 Promotion in scientific and educational activieities like seminars, conferences etc
 Frequent visit by medical representatives to physicians.
 Drug advertisement s are of two types: for a new drug and for old drugs( after 4yr of introduction into market).
Sample checklist for critically appraising DPL:
1. International non proprietary name (INN) of each active ingredient
2. Pharmacological data: brief description of pharmacological effects & MOA
3. Clinical information:
 Indications
 Dosage regimen & relevant P/K information: average dose & dosing interval, average duration of treatment , use in special
situations eg renal, hepatic, cardiac or nutritional insufficiencies that require increased or decreased dosage
 Contraindications
 Precautions & warnings ( eg use in pregnancy, lactation , pediatric or geriatric population)
 Side effects, Adverse effects & adverse drug reactions.
 Drug interactions: clinically relevant.
 Over dose: brief clinical description of symptoms, non drug therapy and supportive treatment, specific antidotes.
4) Pharmaceutical information’s:
 Dosage form, strength of dosage form, excipients, storage conditions and shelf life (expiry date), pack size, description of product
and package, legal category (schedule drugs-eg narcotics and other controlled drug, prescription and non-prescription drugs)
Name and address of manufacturer and importer(s).
5)References in support of claim with date of publication
6)Promotional matter: figures, graph, pictures, tables etc to show superiority of product.
7)Pharmaceutical package insert as per regulatory authority norms
8)Price is usually not mentioned but price of medication should be asked and check within the price is justifies for that medication.
Critically evaluate a drug promotional literature on the basis of WHO criteria:
1. Type of promotional literature ( NEW/ REMINDER).
2. INN of drug (yes/no)
3. Brand name
4. Manufacturers address
5. Mechanism of action of drug
6. Amount of active ingredient as per dosage form or regimes
7. Name of other ingredients/ excipients
8. Approved therapeutic uses
9. Dosage form or regimen
10. Side effects
11. Precautions, contraindications and warnings
12. Major drug interactions
13. Promotional claims
14. References are from standard medical journals
15. Visuals, graphs and illustrations used appropriately
16. Any other comments/observations: eg use of catchy words
17. Conclusion
 PRACTICAL 8: ADVERSE DRUG REACTION REPORTING
COMPETENCY PH 1.6: DESCRIE PRINCIPLES OF PHARMACOVIGILANCE AND ADR REPORTINGSYSTEMS
PH 1.7: DEFINE, IDENTIFY AND DESCRIBE THE MANAGEMENT OF ADVEE DRUG REACTIONS.
PH 3.4: TO RECOGNISE AND REPORT AN ADVERSE DRUG REACTION.
OBJECTIVES: AT THE END OF THE PRACTICAL CLASS, STUDENT SHOULD BE ABLE TO:
1. Define ADR and other related terms and management of ADR.
2. Understands importance of ADR monitoring, describe principles of pharmacovigilance
3. Explain importance of pharmacovigilance programme of India
4. To identify/recognize an ADR and report the same using appropriate ADR.
Defn: as per WHO Defn (2002) pharmacovigilance is the science and activities relating to detection, assessment, understanding
and prevention of adverse effects or any other drug related problem.
Other Defn related to pharmacovigilance: s/e, ADR, ADR and medical error.
Types of ADRs:
1. A: augmented type of ADR eg Hypokalemia
2. B: bizarre type of ADR( idiosyncratic or genetically determined): Acute intermittent porphyria due to G6PD deficiency.
3. C: Chronic type: eg tardive dyskinesia with neuroleptics
4. D: delayed type: eg: teratogenicity or carcinogenicity
5. E: end of use type eg abrupt stoppage of steroids, Clonidine beta blockers
6. F: failure of therapy type eg failure of OC pills.
7. Others: iatrogenic diseases, drug induced disease- eg prolonged use, acute reactions or cumulative toxicity,
Photosensitive reactions: phototoxicity (sunburn) or photoallergy (cell mediated immunological response), Masking of
disease: eg use of streptomycin for minor infection may mask tuberculosis, Exacerbation of disease: Propranolol may
exacerbate bronchial asthma.
 Pharmacovigilance programme of India (PVPI): CDSCO, DGHS under aegis of MOHFW, Govt of India in collaboration
with IPC, Ghaziabad has started a nation wide programme called pharmacovigilance programme of India in 2004 for
protecting health of patients. This programme is coordinated by Indian pharmacopoeia commission (IPC) Ghaziabad.
The PVPI collaborates with Uppsala Monitoring Centre (UMC) Sweden which coordinates the international
pharmacovigilance activities across all countries.

 Methods in pharmacovigilance: individual case safety report, clinical review of case reports, cohort event monitoring,
longitudinal electronic patient records, spontaneous reporting, periodic safety update reports (PSUR), expedited
report, record linkage.
 Serious adverse event: that which results in death, life threatening, requires inpatient hospitalization or prolongation
of hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/ birth defect.
1. Who should report ADRs?
2. What to report?
3. Whom to report?
4. How to report?
 ADR reporting form: examples: white form issued by CDSCO, medwatch (US FDA), Yellow form ( UK), Blue form
( Australia).
 A case report of a suspected ADR should contain the following information:
1. Pts age, gender and brief medical history (when relevant)
2. Description of adverse reaction which includes: description (nature, localization, severity, characteristics); results of
investigations and test done if any; start date, course and outcome of event.
3. Suspected drugs: name ( brand or generic name; manufacturer details), dose, route, start/stop date, indications for use
4. Details of all other drug used (including self-medication)
5. Risk factors eg impaired renal function, previous exposure to suspected drug, previous allergies, social drug use.name
and address of reporter.
Causality scales: WHO causality scale: definite/certain; probable/likely; possible; unlikely; conditional/unclassified;
unassessable/unclassifiable.
 Steps of ADR monitoring: identify ADR; assess causality; documentation of ADR; reporting of ADRs to PV centers/ ADR
regulatory authorities.
 Documentation of ADR: an identifiable patient, and identifiable reporter; a suspect drug; a suspect adverse event.
 What happens after ADR is reported: specific warnings about product information; changing legal status about
medicine; rational use of medicines; in rare cases, removal of medicine from market, if risks outweigh their benefits.
 Prevention of ADRs: by following steps of rational drug therapy; ruling out history of previous drug reactions, allergic
disease and possibility of drug interactions; correct drug administration techniques ( eg Vancomycin given slow IV),
proper laboratory monitoring ( P.T in case of Warfarin); follow pharmacovigilance guidelines.
1. Describe the objectives of PvPI ?
2. Describe the drawbacks of spontaneous reporting?.
 PRACTICAL 9: TO PREPARE A LIST OF P DRUGS
COMPTENCY PH 3.5: TO PREPARE AND EXPLAIN A LIST OF P DRUGS FOR A GIVEN CASE/CONDITION.
AT THE END OF SESSION, A PHASE II STUDENT MUST BE ABLE TO:
1. DESCRIBE CONCEPT FO P DRUG ACCURATELY
2. EXPALIN DIFFERENCE BETWEEN ESSENTIAL DRUG CONCEPT AND P DRUG CONCEPT ACCURATELY
3. DESCRIBE THE PROCESS OF PREPARING LIST OF P DRUGS CORRECTLY, ACCURATELY.
INTRODUCTION: The term P in P drug may mean Personal, Preferred and particular. P drugs helps a prescriber to choose the
most appropriate drug from a wide range of drugs available in market. P drugs are selected for a given patient with a certain
clinical condition and may not be always be suitable for all the patients with same condition. It si important to remember that
the selected P drug is the P drug for that condition and not for the taient.
P drugs versus essential drugs: P drugs are the personal essential drugs. Thus P drugs should ideally be a small list selected from
NLEM. And they should be selected in a rational manner.
Steps for selecting a P drug:
1) Define the diagnostics: diagnosis of a disease from its signs and symptoms is necessary to select P drugs
2) Specify the therapeutic objectives: therapeutic objectives should be clearly defined eg to decrease blood glucose , to reduce BP
etc.
3) Make a list of effective groups of drugs: two ro more than two effective group of drugs for that diagnosis can be selected with
help of pharmacology textbook, reference books or hospital formulary.
4) Close an effective forum according to criteria: on the basis of efficacy, safety, suitability and cost of treatment.
 Efficacy: depends on both pharmacokinetic and pharmacodynamic property of drugs.
 Safety: side effects of different group of drugs are compared and a drug with fewer side effects is preferred.
 Suitability: certain groups of patients like the elderly, children, pregnant women, those with kidney and liver diseases
are high risk groups and should always be considered carefully while selecting P drug. It should be in the best
convenient dosage form as per diagnosis and dosage schedules for that particular disease.
 Cost of treatment: most effective drug should be chosen. The total cost of treatment is considered rather than cost per
unit.
Drug group efficacy safety Suitability cost
Group 1
Group 2
Group 3
Group 4
The se criteria can be graded as -/+-/ ++/ +++ for efficacy, safety and suitability for all groups by referring to textbooks and cost
can be checked from IDR /CIMS/ MIMS etc.
5) choose the P drug form among the effective group: considering the dosage form, dose schedule and duration of treatment: the
decision is based on personal experience of the physician with the drug for a particular diagnosis and not based on medical
literature or guidelines only. Medical literature helps only in deciding groups of drugs in beginning, later the experience of
physician with the drugs decided the choosing of P drug.
6) follow up of treatment: monitor the treatment through follow up is required to continue the same treatment or decide if
treatment requires changes.

Questions:
1. A 45 yr old male patient complains of occipital headache, heaviness and giddiness for 15 days. On repeated
examination BP was 150/96mm Hg patient was diagnosed as having mild hypertension. Select the appropriate P drug
and write the prescription of the patient.
2. A 60 yr old male patient complains of loss of peripheral pain. After ophthalmic examination patient was diagnosed to
have chronic open angle glaucoma. Select an appropriate P drug and write the correct prescription of the patient.
3. Miss sariak a 25 yr old male patient is 5 months pregnant. she comes to your clinic with large abscess in her right
forearm You conclude that she needs surgery and to relieve pain during surgery she needs pain medication. If you are
given option of aspirin and paraetamol, choose the P drug for this patient.
EXERCISE: select a Pd rug for a 60 year old male whose getting repeated attacks of constricting, chest pain starting with exercise
and relieving with rest since one month.
Step 1: define the diagnosis: stable angina pectoris, caused by partial occlusion of coronary artery.
Step 2: specify the therapeutic objective; to reduce myocardial oxygen demand by decreasing preload, contractility, heart rate or
afterload.
Step 3: make a list of effective groups: these include: nitrates, beta-blockers, calcium channel blockers.
Step 4: choose a group according to criteria:
Drug group efficacy safety Suitability cost
Nitrates ++ + +++ cheap
Beta blockers ++ + + Reasonable
Calcium channel ++ + + Reasonable
blockers
Nitrates are group of first choice having acceptable efficacy and equal safety, they offer advantages of an immediate effect by oral
route and easy handling by the patient at no extra cost. Injectable form of beta blockers and calcium channel blockers are
required to produce immediate effect.

efficacy safety suitability cost

Glyceryl trinitrate ++ + + Rs 4/tab
Sublingual tab 0.5mg Rs 8/ tab
Oral tablet 2.6mg
Isosorbide dinitrate ++ + + Rs 20 /100 tab
Sublingual tab 5mg Rs 50/50 tab
Oral tab 5mg
Pentaerythritol ++ + + Rs 7/10 tab
tetranitrate oral tab
10mg
Isosorbide mononitrate ++ + + Rs 26/100 tab.
oral tab 10mg
Step 6: choose the P drug, dosage form, dose schedule and duration o treatment:
Choose P drug and its dosage form: in this case the choice of P drug for acute attack of angina pectoris would be sublingual
tablets of Glyceryl trinitrate 0.5mg
Choose a standard dosage schedule: as it is taken during acute attack there is no strict dosage schedule ask the patient to spit out
he drugs as soon as pain is subsided if pain persists a second tablet should be taken after 5-10 minute if pain still persists ask the
patient to visit the doctor immediately.
Choose a standard duration of treatment theirs is no standard way ot predict how long the patient will suffer from attacks, so
duration treatment is determined by the need for follow up.
7) Follow Up: to monitor treatment whether to continue the same treatment or changes in treatment are required.

PRESCRIPTION
Dr. ABC KMC reg NO : 1234
Address: kailash apartments, savarkar road, bengaluru.
Date 30/ 03/ 2023.
Mr. xyz age: 58 yrs, fender: male, Batavia chambers, bengaluru.

Tablet GLYC ERYL TRINITRATE 0.5mg , send 3 such tablets.

One tablet to be placed under the tongue the tablet should be spitted off as soon as the pain subsides. If pain does not subside ti
should de retaken after 5 minute upto a maximum of 3 tablets.
Dr. ABC
Kmc reg No: 1234.
Name of pharmacy: sushruta medicals
Sushruta medical store, bengaluru.
 PRACTICAL 10: INTERACTION WITH PHARMACEUTICAL REPRESENTATIVE
Competency No PH 3.6: demonstrate how to optimize interaction with pharmaceutical representative to get authentic information on drugs.
Objective:
1) at the end of this session, a phase II student must be able to justify the importance of correct communication with a pharmaceutical
representative correctly.
2) at the end of this session, a phase II student must be able to explain the basic principles of communication with a pharmaceutical
representative correctly.
3) at the end of this session a phase II student should be able to enumerate different sources of drug information
4) at the end of this session, a phase II student should be able to authenticate information of drugs form pharmaceutical representative.

World Health Organization (WHO): describes pharmaceutical promotion as “ all information and persuasive activities by manufacturers and
distributors the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs.
Following is the checklist to optimize interaction with pharmaceutical representative to get authentic information on drugs:
1. How is it better than existing drugs: with regard to efficacy, dosage form, duration of action, adverse effect profile and drug
interactions, convenience of administration, suitability for a particular drug group eg pediatric, geriatric age group and special
situations such as pregnancy, lactation, hepatic or renal disease.
2. Price/cost: especially for “ me too drugs”.
3. The exact role or place of medication in therapeutics in current scenario.
4. Ask information medication that you want to enquire.
5. Take control of discussion as many times they keep on telling in extempore manner.
6. Ask for references mainly on efficacy and safety
7. To assess clinical efficacy do not use free samples but use actual drug available in medical stores and see results of those drugs.
 Also all points mentioned in DPL also apply while interacting with pharmaceutical representative.
 Also while communicating with drug representative the prescriber should first decide:
Place of communication, time allotted for communication, attitude of prescriber should be consultative in nature and prescriber should be in
learning mode, never be greedy about money.
Alternative communication channels in pharmaceutical industry:
 Internet based communication channels
 Academic journals as communication channels
 Scientific conferences as communication channels.

 The Medical representative (MR) may influence doctors behavior which can lead to irrational prescriptions. To avoid this doctor
should not:
 Accept direct gifts of equipment, indirect gifts through travel or accommodation,
 Accept samples of drugs for use by himself/ his family members/relatives/ friends. If she accepts them, they will be used only for
needy patients.
 Attend company sponsored courtesy snacks/ lunches. Dinners and social or recreational events, CMEs, workshops etc.

Exercise 1: comments on this scenario of doctor interaction with MR:

A medical representative came to visit for promotion of their pharmaceutical drug to Dr. WHO form ABC pharmaceutical company, with 50
sachets of their newly developed multivitamin Y as free samples and claimed that this multivitamin will give good results in their patients.
Company’s representative also informed Dr WHO that if their medical store near his clinic received minimum 1000 prescriptions of this
multivitamin every month, he would be given a free tour with his family anywhere in India. All the expenses would be borne by pharmaceutical
company. Dr WHO gave his patient’s this multivitamin only at Rs 50/- per sachet which was otherwise available in market at a cost of Rs 100/-.

Exercise 2: perform a role play in a stimulated environment with MR and give comments/ suggestions to improve upon.
 PRACTICAL 11: PREPERATION OF ESSENTIAL MEDICINES LIST
COMPETENCY NO PH 3.7: Prepare a list of essential medicines for a health care facility.
OBJECTIVES: at the end of the practical class the student should be able to:
1. Define the essential medicines and appreciate their importance in health care system
2. Describe the process of selecting essential medicines
3. Prepare a list of essential medicines for the healthcare centre.
Materials needed: national list of essential medicines
World health Organization (WHO) has defined essential Medicines (drugs) as “ those that satisfy the priority healthcare needs of the
population”/. Thus they should be available at all times, in adequate amounts and in appropriate dosage form. Essential drugs are thus an
important component in promoting rational use of medicines. The first model list of Essential medicines was issued by WHO in 1977 and
periodically revised once in every two years the current version is the 22 nd version published in 2021 containing 479 medicines from various
categories in 66 pages. The first Children’s essential medicines list was published in 2007 and the current version is the 8 th list. India also has
its own National List of Essential Medicines published from time to time, the latest version contains 384 drugs across 27 categories published
in year 2022 by Ministry of Health and Family Welfare. The selection of drug is based on level of healthcare centre I.e. primary, secondary or
tertiary health care level.
WHO selection criteria for essential medicine list:
1. The selection of drugs should be based on experience rather than being opinion based.
2. Medicines with long history of safety and efficacy in treating diseases should be included
3. Inclusion of newer drugs should be made only when they offer significant advantage over existing ones.
4. Quality, bioavailability and stability of drugs should meet the set standards of health care.
5. Medications with convenient dosage form and favorable pharmacokinetics that would ensure acceptability and
compliance should be selected.
6. In cases where two drugs bear close resemblance with respect to efficacy, stability, bioavailability etc then:
7. Drugs which were thoroughly investigated should be selected.
8. Drugs with favorable pharmacokinetic parameter should be selected.
9. Drugs with cost affordability should be selected I,e drugs with favorable cost benefit ratio should be selected.
10. WHO maintains that single drug or an active ingredient should find mention in EML. The fixed combination drugs
should be mentioned only when they offer relatively better therapeutic efficacy, safety, patient compliance .
11. Periodic review of EML every 2 yrs helps to incorporate significant new therapeutic advance and information if they
offer distinct advantage over previously selected drugs. Drugs no longer found to be safe and effective can be replaced.
Advantages of EML: promotes rational use of medicines.
Medicines will be easily accessible. Is serves as a guide for procurement and supply of medicines in public health sector.
Safe and effective medicines of good quality will be available.
Ensure appropriate treatment will be available to the patients.
EXERCISE: prepare a list of essential drug list for an emergency care unit.
Step 1: first visit an emergency care unit. Look carefully what all medications are present in emergency tray. The following
categories of drugs may be found: Analgesics, anti-emetics, antacids,antiallergics,steroids, bronchodilators, sedatives,
antiepileptics, local anesthetics, anticholinergics, antinarcotics, diuretics, cardiac drugs & ionotropes, drugs for hypoglycemia and
hyperglycemia, anticoagulants, thrombolytic, haemostatic’s, antibiotics, drugs acting on GIT, respiratory system, IV fluids etc.
Step 2: Now refer to the National List of Essential Medicines (NLEM) India. Make a list of essential medicines from NLEM.
1) Analgesics: inj diclofenac sodium, inj Paracetomol, inj Hyoscine.
2) Antiemetic: inj Metoclopramide, inj Ondansetron.
3) Antacids: H2 receptor blockers,( ranitidine); PPIs: Omeprazole
4) Antialllergics: H1 receptor antagonists: inj Chlorpheniramine maleate.
5) Steroids: inj hydrocortisone, inj Dexamethosone, inj methylprednisolone.
6) Bronchodilators: inj Salbutamol.
7) Sedatives: inj midazolam.
8) Antiepileptics: inj Phenytoin sodium, inj phenobarbitone.
9) Diuretics: inj Furosemide, inj Mannitol.
10) Local anesthetics: inj Lignocaine (plain & with adrenaline)
11) Cardiac drugs & ionotropes: inj dopamine, inj Dobutamine, inj Digoxin, inj Isosorbide dinitrate, inj lidocaine, inj adrenaline.
12) Anticholinergics: inj neostigmine, inj atropine.
13) Antinarcotics: inj naloxone.
14) for hyperglycemia: inj plain insulin; For hypoglycemia: inj 25% dextrose
15) Anticoagulant: inj heparin sodium ; Thrombolytic drugs: inj streptokinase.
17) Haemostatic drugs: inj Vit K1 (phytonadione); inj tranexamic acid.
18) Antibiotics: amoxicillin plus clavulanic acid for inj, inj ceftriaxone, inj cefixime, erythromycin tablets, Metronidazole tablets.
19) Antiseptics: hydrogen peroxide solution, povidone ointment.
20) Drugs specific for GIT: Loperamide capsules , ORS powder.
21) Drugs specific for Obstetrics: Oxytocin inj
22) Ophthalmology: Pilocarpine drops, Timolol, eye drops.
24) Respiratory system: Salbutamol inhaler & nebulizer.
25) IV fluids: normal saline, 5% dextrose, DNS etc ; 26) Miscellaneous: inj pralidoxime, inj tetanus toxoids.
Q) What are orphan drugs give examples.
Exercise: Prepare a list of antihypertensive medication for a health care facility. Prepare a list of Antianginal medication for a
health care facility; prepare a list of essential drugs for anesthesia department, ENT dept, Surgery dept, medicine dept etc.
 PRACTICAL 12: COMMUNICATION WITH PATIENT ON ALL ASPECTS OF DRUG USE
Competency PH 3.8: communicate effectively with a patient on proper use of prescribed medication.
OBJECTIVES: at the end of practical class, the student should be able to:
1. State the components of effective communication.
2. Realize and understand the importance of effective communication with the patient
3. Communicate effectively regarding the proper use of a drug to improve patient compliance in a stimulated patient.
COMMUNICATION is the process of effective sharing information or messages which ultimately leads to common understanding. It is
derived from Latin word (communis” meaning common. However communication is not simple or straightforward and is hardly ever 100%
successful. An effective communicator anticipates and plans for complete sharing of ideas. The 7C’s of effective communication are
Complete, Clear, Courtesy, Consideration, Concise, Concrete and Correct.
Types of communication:
 VERBAL : may be oral or written, includes information like diagnosis, prognosis and treatment, cost etc. constitutes only 7% of
communication.
 PARA VERBAL: includes tone, pitch, pacing, volume, and accent of voice contributes to 38% of communication.
 NON-VERBAL: forms 55% of communication, includes expression in forms of body language and other gestures like posture,
appearance, facial expression, eye contact, body positioning and spatial distance which affect patients contentment and
therapeutic results.
THREE TECHNIQUES (conversational skills, listening skills, technical skills) are must to make communication effective. Doctor patient
communication occurs during history taking, taking informed consent, breaking news (good/bad) and during taking care of patient. Core
communication skills required during doctor patient communication are:
1) Doctor-patient interpersonal skills:
 Appropriate physical environment
 Greeting patients
 Active listening and maintaining eye contact ( during patients complaints)
 Empathy, aspect, interest, warmth and support.
 Language
 Nonverbal verbal communication: poor eye contact, unwelcome facial expression.
 Collaborative relationship
 Closing the interview.
2) Information gathering skills:
 Showing warmth in questioning style
 Showing appropriate balance of open to closed question.
 Discuss personal and psychosocial issues of relevance.
 Silence, interruption and facilitation when needed
 Clarify information given to patient
 Sequencing of events
 Directing the flow of information
 Summarizing.
3) Information giving skills and patient education:
 Provide clear and simple information (diagnosis, explanation about diagnosis/disease)
 Put important thing first
 Using repetition
 Categorizing information to reduce complexity
 Using tools for effective education of patient,
 Motivating patient adherence to treatment plans (providing explanation about treatment, particularly medication information)
 Finally summarizing.
According to meeting of division of mental health WHO held in Geneva1993- effective doctor patient communication:
1. Is an integral part of diagnosis.
2. Enhance patient compliance to treatment plans.
3. Contributes to doctor satisfaction
4. May contribute to cost and resource effectiveness
Good communication about prescription to patients can avoid irrationality to some extent. Irrationality can also be due to patient’s part
because of following reason:
1. Patients asking for quick cure (asking injection in place of oral medication)
2. Poor health education and wrong beliefs (taking too much dose for quick relief)
3. Self medication of other drugs without prescription
4. Misinterpretation of information given on prescription
5. Non-compliance ( not taking complete course of therapy)
COMMUNICATION WITH SPECIAL PATIENTS:
THE ELDERLY: older adults learn at slower rate than younger persons.; They might also have problems such as poor vision, speech or hearing
Encourage feedback as to whether they understand the intended message.
TERMINALLY ILL PATIENTS: before interacting , be aware of your own feelings about death and about interacting with terminally ill patients.
CHILDREN: attempt to communicate in accordance to Childs developmental level; Ask open ended question rather than questions requiring
only a yes or no response; Nonverbal communication is very important with children therefore be aware of your facial expressions, tone of
voice, gestures etc.
  BARRIERS TO EFFECTIVE COMMUNICATION: environment as a barrier; the patient (client) as a barrier; doctor as a barrier; time as
a barrier; hospital support staff as a barrier; distancing tactics as a barrier.
1. Environment as a barrier: lack of privacy; physical barrier( arrangement of furniture); noise distraction (phone ringing).
2. Client as a barrier: timid nature; doctor must be busy ; diseases affecting communication( vocalization/ gesturing)
3. Doctor as a barrier: lack of awareness about communication skills; altitudinal problems; I don’t need to learn communication;
don’t have time for communication; doesn’t give importance to communication; lack of training in communication skills
4. Time as a barrier: lack of time management skills makes doctor incompetent
5. Hospital support staff as a barrier: poor communication skills; poor team work;
6. Distancing tactics as a barrier e.g. looking at watch, rudely asking the patient to hurry up etc.
COMMUNICATE EFFECTIVELY WITH A PATIENT ON PROPER USE OF PRESCRIBED MEDICATION: insulin, proton pump inhibitors, statins,
ferrous sulphate tablets, co-amoxiclav or cotrimoxazole.
3.8.1: communicate about the effects of prescribed drug with regards to the following:
1. Why the drug is needed
2. Which symptoms will disappear and which will not
3. When the effect is expected to start
3.8.2: communicate about the adverse effects of prescribed drug with regards to the following:
1. Which said effects may occur
2. How to recognize them
3. How long they will continue
4. How serious they are
5. What action to take
3.8.3 : communicate about the instruction of drug use as following:
1. How the drug should be taken
2. When it should be taken
3. How long treatment should continue
4. How the drug should be stored
5. What to do with left over drugs
3.8.4: communicate about warning of prescribed drug with regards to following:
1. When the drug should not betaken,
2. What is the maximum dose
3. Why the full treatment course should be taken
3.8.5: communicate about the future consultations with regards to the following:
1. When to come back ( or not to come back)
2. In what circumstances to come earlier
3. What information the doctor will need at the next appointment
3.8.6: conclude the consultation by asking the following question:
1. Ask the patient whether everything is understood
2. Ask the patient to repeat the most important information
3. As whether the patient has any more questions.
ADAPTED KALAMAZOO SCALE FOR ASSESSING COMMUNICATION:
ITEM TO BE OBSERVED RATING ( MARKED BY OBSERVER, CAN BE THE TEACHER HERE)
Builds relationship
Opens discussion
Gathers information
Understand subject perspectives
Shares information
Reaches consensus
Closure
Total score
EXERCISE: Perform role play in a simulated environment regarding the proper use of medication ( e.g. OC pills) to improve patient
compliance in a simulated patient. Few students will observe and comment on activity done. At the end the teacher will give his/her
suggestion/ comments to improve the communication to patient.
CHECKLIST:
 Explains that she will be on a contraceptive.
 To star on 5th day of menstrual cycle
 To start a new packet of OC pills at the end of menstrual cycle.
 If one pill is missed take one tablet immediately then continue taking the next tablet according to cycle
 If more than two pills are missed additional contraceptive methods to be chosen for the rest of menstrual cycle
 Explains what is withdrawal bleeding
 Explains breakthrough bleeding
 Explains adverse events and effects to OC pills usage.
 Explains when to revisit- time.
PRACTICAL 13: ADMINISTRATION OF DRUGS THROUGH VARIOUS ROUTES IN A STIMULATED ENVIRONMENT USING MANNEQUINS.
COMPETENCY NO PH 4.1: administer drugs through various routes in a stimulated environment using mannequins.
EXERCISE: HOW TO INJECT BY INTRAVENOUS ROUTE.
REQUIREMENTS: syringe, drug needle 20 G, liquid disinfectant, cotton wool, adhesive tape, tourniquet.
PROCEDURE:
Wash your hands properly with soap and water.
Reassure the patient and explain the procedure
Asks patient about any allergies or reactions to specific agents or medications in past.
Uncover the arm completely.
Have the patient relax and support the arm below the vein to be used.
Apply tourniquet, ask the patient to clench his fist and look for suitable vein.
Wait for vein to swell, disinfect skin
Stabilize vein by pulling the skin taut in longitudinal direction of vein. Do this with the hand you use for inserting the needle.
Insert the needle at an angle of around 35’.
Puncture the skin and move the needle slightly into vein (3-5mm).
Hold the syringe and needle steady.
If blood appears, hold the syringe steady your needle is in vein.
If blood does not come try again.
Loosen tourniquet, withdraw needle swiftly, check for pain, hematoma.
Press sterile cotton wool onto the opening. Secure with adhesive tape.
Check the patient for any reactions and give additional reassurance if necessary.
Clean up, dispose of biomedical waste safely and wash your hands.
EXERCISE: HOW TO INJECT DRUGS BY INTRAMUSCULAR ROUTE.
REQUIREMENTS: syringe filled with drug to be administered, needle 22G, liquid disinfectant, cotton wool, adhesive tape.
PROCEDURE:
Follow the common steps at first, then:
Insert the needle swiftly at angle of 90’
Aspirate briefly, if blood appears withdraw needle, replace it.
Inject slowly , withdraw needle swiftly.
Press sterile cotton wool onto the site, fix adhesive tape over area.
Check patient reaction and give additional reassurance, if necessary.
Clean up dispose of waste safely and wash your hands.
EXERCISE: HOW TO INJECT DRUGS SUBCUTANEOUSLY.
REQUIREMENTS: syringe with drug to be administered (without air), needle 25G, liquid disinfectant, cotton wool, adhesive tape.
PROCEDURE:
Follow the common steps at first, then:
Insert needle in base of skin fold at an angle of 20-30”
Release skin.
Aspirate briefly, if blood appears withdraw needle, replace it with a new one, if possible and start again from point 4.
Inject slowly (0.5-2minutes).
Withdraw needle quickly.
Press sterile cotton wool onto the opening. Fix with adhesive tape.
Check patient’s reaction and give additional reassurance if necessary.
Clean the area, dispose of biomedical waste safely and wash hands.

QUESTIONS:
Describe the procedure to administer drugs through the following routes:
1. Sublingual route.
2. Ear route.
3. Nasal route.
4. Eye route.
5. Rectal route.
6. Vaginal route.
7. Inhalational route.
 PRACTICAL 14: EFFECTS OF DRUGS ON BLOOD PRESSURE (VASOPRESSOR AND VASODEPRESSORS WITH APPROPRIATE BLOCKERS).
COMPETENCY NO: PH 4.2: DEMONSTRATE THE EFFECTS OF DRUGS ON BLOOD PRESSURE (VASOPRESSORS AND VASODEPRESSORS WITH
APPROPRIATE BLOCKERS) USING COMPUTER AIDED LEARNING.
OBJECTIVES: AT THE END OF THIS PRACTICAL SESSION PHASE II STUDENT SHOULD BE ABLE TO:
1. ENLIST VARIOUS VASOPRESSOR, VASODEPRESSORS AND THEIR BLOCKERS WITH THEIR MECHANISM OF ACTION ON BP.
2. DEMONSTRATE THE EFFECT OF VARIOUS DRUGS ON BLOOD PRESSURE (BP) IN A STIMULATED ENVIRONMENT.
DRUGS REQUIRED:
SL NO DRUGS DOSE (µG/KG) DRUGS DOSE (µG/KG)
1 Adrenaline 2-5 Propranolol 1mg
2 Noradrenaline 2-5 Acetylcholine 1-5
3 Isoprenaline 2-5 Atropine 0.5mg
4 ephedrine 1mg histamine 0.2-5
EFFECT OF VARIOUS DRUGS ON BP:
1. ADRENALINE: on sudden rapid IV injection, it produces biphasic response. There is marked increase in systolic and diastolic BP. It
returns to normal and a secondary fall in mean BP follows. (Lower concentrations are not able to act on α receptors but continue
to act on β receptors) . Effect on respiration is variable initially with an increased respiratory rate followed by transient apnea.
2. DALES VASOMOTOR REVERSAL: after administration of alpha blocker adrenaline will act only on beta 2 receptors to cause fall in
BP and increase in heart rate through reflex action (no biphasic response).
3. DALES VASOMOTOR RE-REVERSAL: after administration of Propranolol ( beta blocker) adrenaline will act only on beta-1 receptors
to cause a sharp rise in BP and increase inn heart rate through reflex action( no biphasic response).
4. NORADRENALINE: causes rise in systolic, diastolic and mean BP. However there is no Vasodilation. Peripheral resistance increases
due to alpha action. Its effects on respiration are insignificant.
5. ISOPRENALINE: it decreases the BP due to predominant α2 action. Effect on respiration is similar to adrenaline.
6. EPHEDRINE: has direct as well as indirect actions on α and β receptors. Repeated administration of ephedrine produces gradual
and sustained decrease in BP, however the response is not sustained and gradually decreases, this phenomenon is known as
tachyphylaxis or acute tolerance. It directly stimulates the respiratory centre.
7. TACHYPHYLAXIS: repeated administration of ephedrine produces gradual fall in BP. It causes NA release from sympathetic nerve
terminals and thus rise in BP. Frequent administration of ephedrine at short intervals leads to progressive depletion of NA stores
in nerve terminals causing a progressive decrease in response to ephedrine.
8. ACETYLCHOLINE: stimulates M3 receptors on endothelium. Its stimulation causes quick vasodilatation by NO and the net effect is
vasodilatation resulting in decreased BP. Acetylcholine is an agonist whereas atropine is and antagonist to muscarinic receptors.
9. NICOTINIC ACTION OF ACETYLCHOLINE: high dose of Ach given after atropine causes tachycardia and rise in BP due to stimulation
of nicotinic receptors in sympathetic ganglia and release of catecholamine’s. Because blood vessels do not possess
parasympathetic supply, the effect of sympathetic stimulation will only be seen I.e. rise in BP and heart rate.
10. HISTAMINE: function and effects of H1 receptor stimulation is similar to M3 receptors. They are present on vascular smooth
muscles and cause slow vasodilatation on stimulation leading to fall in BP. Histamine being a non selective agonist mepyramine is
H1 antagonist and cimetidine is H2 antagonist.
11. PRAZOSIN: is an alpha blocker , blocks the effects of rise in BP.
12. PROPRANOLOL: is a beta blocker, blocks the effects of fall in BP.
Adr NA Iso
HR + - ++
Mean BP + ++ -
+: increase; -: decrease; 0: no change; Adr; NA and Iso can be differentiated by measuring HR and mean BP.

Exercises:
1. Demonstrate the Biphasic response of adrenaline.
2. Demonstrate the Dale’s vasomotor reversal
3. Demonstrate the Dale’s vasomotor re-reversal
4. Demonstrate the Phenomenon of tachyphylaxis & effect of Tyramine on BP
5. Demonstrate the Nicotinic action of acetylcholine
6. Demonstrate the Effect of histamine and acetylcholine
7. Effect of antihistaminic and atropine in presence of histamine and acetylcholine.
8. Demonstrate the Effect of Propranolol on effect of IV administration of Adr, NA and Iso on dog BP.
9. Effect of Prazosin and Propranolol on effect of IV administration of Adr, NA and Iso on BP in dog
10. Demonstrate the effect of physostigmine on vasodepressor effect of cholinergic drugs
11. Name two agents that block both α and β receptors.
 PRACTICAL 15: COMMUNICATION WITH EMPATHY AND ETHICS ON ASPECTS OF DRUG USE
COMPETENCY NO 5.1: COMMUNICATE WITH THE PATIENT WITH EMPATHY AND ETHICS ON ALL ASPECTS OF DRUG USE.
OBJECTIVE: AT THE END OF SESSION THE PHASE II STUDENT MUST BE ABLE TO :
 COMMUNICATE WITH EMPATHY WITH THE PATIENT.
 COMMUNICATE WITH ETHICS WITH THE PATIENT.
 COMMUNICATE WITH THE PATIENT ON ALL ASPECTS OF DRUG USE.
Communication is a specialized thing and there should be separate training for making communication on various occasions. For
the doctor the following types of communication may be important in clinical practice:
1. Diagnostic communication: to get good history of illness; to find “ clients” concerns; as an aid to diagnosis and
management;
2. Interventional communication: communicating bad news, managing collusion; handling angry situation etc;
interventional procedures followed; procedure outcome measures identified;
3. Therapeutic communication: is made in several parts: as main therapy; as adjuvant therapy; to improve “ the Clients”
compliance to treatment; to improve relationship between the medical professionals and “ the Client”.
In all these types of communication the main requirement is “ ACTIVE LISTENING”.
Though sympathy and empathy sound the same there is an important difference between them: sympathy is a statement of
emotional concern while empathy reflects emotional understanding. Empathy is an experiential way of grasping another’s
emotional states. Empathy is an emotional experience between and observer and a subject in which the observation isbased on
visual and auditory cues, identifies and transiently experiences the subjects emotional state. Various methods to develop
empathy include lessons in cultural awareness, ethics discussions and role play in which the students take turns to play the role of
physicians, patient and other members of health care team. Methods to express empathy and compassion include the use of
nonverbal cues and positive gestures such as open body language, listening, making eye contact, taking notes, or repeating what
a patient says to confirm understanding.
There are three stages of empathy:
 Cognitive empathy is being aware of emotional state of another person.
 Emotional empathy is engaging with and sharing those emotions.
 Compassionate empathy involves taking action to support other people.
The golden rule in empathy is “treat others as you would like to be treated yourself”.
There are several barriers to empathy:
1. First anxiety interferes with empathy, time pressure is invoked as a concrete barrier to listening to patients, but
probably functions more as a psychological barrier.
2. A second barrier to empathy is many physicians still do not see patient’s emotional needs as a core aspect of illness
and care. Perceiving psychosocial needs of patient is also important.
3. Third barrier to empathy comes from negative emotions that arise when there are tensions between patients and
physicians. Physicians should be made aware of these emotions.
ETHICS: : medical ethics is concerned with obligations of doctors and the hospital to the patient along with other health
professionals and society. It deals with the distinction between what is considered right or wrong at a given time in a given
culture. The four principles of Beauchamp and Childress are autonomy, non-maleficience, beneficence and justice.
 Communication on various aspects of drug use: the following precautions observed by patient while taking medicines:
1. If you feel worse about taking medicines tell doctor immediately.
2. Double check you have the right medicine
3. Read the label correctly and follow directions
4. Take medicines exactly as prescribed
5. Ask if the medicine is likely to affect everyday tasks such as driving or concentrating in school.
6. Do not take medicine more than the recommended doses.
7. Always follow the doctors or pharmacists instructions.
8. Never share prescription medicine with anyone else, even if they have the same problem as you do.
9. If on medication and take over the counter medication ask the pharmacist first, there could be drug -drug interaction.
10. tell your doctor and pharmacist about taking any medicines or herbal supplements to avoid any drug interactions
11. Be sure to tell your doctor if you are pregnant or breastfeeding, as some medicines can be harmful to your baby.
12. Remember that drinking alcohol can dramatically worsen side effects of some medications
13. Do not decide on your own to take medicine prescribed earlier for the same symptoms, first consult the doctor.
14. Take antibiotics for the full length of time prescribed do not cut short if symptoms’ disappear.
15. Keep medicines in original labeled containers.
16. Medicines should not be stored in bathroom or kitchen as the high humidity or heat can affect the potency of drug.
17. Some medicines must be refrigerated, check with your pharmacist or doctor regarding the storage instructions
18. Make sure all medicines are stored safely and out of reach of children and pets.
19. If you suffer from some allergies tell the doctor or pharmacist before you start a new medicine.
20. If you experience some rash, itching, vomiting or difficulty in breathing tell your doctor immediately.

1. QUESTIONS: communicate with empathy and ethics about objectives of a prescription made for a diabetes patient.
2. Communicate with empathy and ethics about more adverse effects of anticancer drugs than ordinarily used medicines.
3. Communicate the treatment plan and instructions to patient at a suitable level of information.
 PRACTICAL 16: COMMUNICATION REGARDING OPTIMAL USE OF DRUG THERAPY, DEVICES AND STORAGE OF MEDICINES.
COMPETENCY PH 5.2: COMMUNICATE WITH THE PATIENT REGARDING OPTIMAL USE OF A) DRUG THERAPY B) DEVICES &
C) STORAGE OF MEDICINES.
OBJECTIVES: at end of practical session, phase II student should be able to describe:
 Optimal use of drug therapy correctly
 Medical device correctly
 Counsel a volunteer about optimal use of prescribed medicines correctly.
Most medical practitioners should be aware of patient’s rights I.e. right drug at right time through right route for right disease for
right person using right technique. Optimal medication therapy is based on a process that results in safe, effective, efficient,
culturally sensitive medication, drug administration and monitoring which achieves desired clinical outcomes for a specific
patient.
VARIOUS ASPECTS OF NON-OPTIMAL USE OF DRUGS INCLUDE:
1. DIAGNOSIS: inadequate examination of patient; incomplete communication between patient and doctor, lack of
documented medical history; inadequate laboratory resources.
2. PRESCRIBING: over-prescribing; under prescribing; incorrect prescribing; multiple prescriptions.
3. DISPENSING: incorrect interpretation of prescription, retrieval of wrong ingredients, inadequate labeling, inaccurate
counting, compounding or pouring, unhygienic practices, poor quality packaging materials.
PATIENT ADHERENCE: poor labeling, inadequate verbal instructions, inadequate counseling to encourage adherence, inadequate
follow-up/support of patients, treatment or instruction that do not consider patient beliefs, environment or culture.
MEDICAL DEVICES: FDA defines medical device as “ any instrument, machine, contrivance, implant, in vitro reagent
that's intended to treat, cure, prevent, mitigate, diagnose disease in man”.
There are three classes of medical devices:
1. Class 1 device: low risk devices e.g.: bandages, handheld surgical instrument, nonelectric wheelchairs.
2. Class II devices: intermediate risk devices: e.g.: CT scanners or infusion pumps for IV medications.
3. Class III devices: high risk devices e.g. pacemakers and deep brain stimulators.
Medical device standards are regulated in India by a law called the Drugs and Cosmetics Act, 1940 (DCA). The medical device
rules have been framed under DCA. Further in 2020 new rules classify medical devices into four classes:
Class A ( low risk): cotton wool, surgical dressing, alcohol swab etc.
Class B ( low moderate risk): thermometer, BP measuring device, disinfectants.
Class C ( moderate high risk): implants, hemodialysis catheter etc
Class D (high risk): angiographic guide wire, heart valves.
 Storage of medicines: points to remember are:
1. Heat, light and moisture may damage medicines.
2. Store medicines in a cool dry place.
3. Do not store medicines in bathroom cabinet as heat or moisture from shower bath or sink may damage medicines
4. Pills or capsules may get damaged by heat or moisture , keep in a dry place
5. Store medicines out of reach and sight of children.
6. Store medicines in a child latch or lock.
7. Medicine that has changed colour , texture or smell, even if it not expired should not be taken
8. Check the expiration date of medicine
9. Medicines should not be flushed down the toilet this is bad for water supply.
10. Unused medicines may be returned to pharmacist.
11. Medicines should not be kept in glove compartment of car, medicine can get too hot, cold or wet there.
The following points are to be considered regarding communication about drug therapy, devices and storage of medicines
1. Communication: Communicate about the adverse effects of prescribed drug with regards to: why the drug is needed; which
symptoms will disappear and which will not; when the effect is expected to start; what will happen if the drug is taken incorrectly
or not at all.; Communicate about adverse effect of prescribed drug with regards to: which side effects may occur; how to
recognize them; how long they will continue; how serious are they ; what action to take; communicate about instructions of drug
use on following: how the drug should be taken; when it should be taken; how long the treatment should continue; how the drug
should be stored; what to do with left over drugs; Communicate about the warnings of prescribed drug with regards to following:
when the drug should not be taken; what is the maximum dose; why the full treatment course should be taken.; Communicate
about future consultations with regards to the following: when to come back; in what circumstances to come earlier; what
information the doctor will need at the next appointment.; Conclude the consultation by asking the following questions: ask the
patient whether everything is understood; ask the patient to repeat the most important information.
2. Devices: the student should be able to communicate to patients on: step wise points or instructions on use of device;
communicate list of do’s and don’ts on the device; demonstrate proper use of device and ask the patient to show the same;
methods on handling , cleaning and storage of device; dangers of use of device on other persons, without prescription of doctor;
importance of keeping the device away form reach of children; contact number of manufacturer to be communicated on trouble
shooting.
3. Storage of medicines: the student should be able to communicate to patients on: ideal storage condition of pharmaceutical
product as per product label; effect of storage condition ; on potency and efficacy of drug; ill effects of improper storage condition
on human consumption; factors to be taken into consideration for drug storage like sanitation, temperature ,light , moisture,
ventilation and segregation; importance of storage of medicines away from reach of children, disposal of expired drugs.
QUESTIONS:
1. Communicate with a volunteer regarding optimal use of nebulizer prescribed for asthma.
2. Communicate with a volunteer regarding how to store medicines & regarding optimal use of prescribed drug therapy.
 PRACTICAL 17: MOTIVATION OF PATIENTS WITH CHRONIC DISEASES TO ADHERE TO TREATMENT
COMPETENCY NO PH 5.3: Motivate patients with chronic diseases to adhere to prescribed management by the health care
provider.
OBJECTIVES: At the end of phase II , student should be able to : define compliance, define adherence, explain types of non-
adherence, explain important parts of communicating with patient with chronic diseases to adhere to prescribed management,
explain disadvantages of non-adherence, must be able to motivate patient with chronic disease to adhere to prescribed
management correctly.
Medication adherence is defined by WHO as “the degree to which the patient’s behavior corresponds with the agreed
recommendations from a health care provider”.
There is fine difference between compliance and adherence: adherence is a more positive proactive behavior , which results in
lifestyle changes by the patient, who must follow a daily regimen, in contrast compliance is a passive behavior exhibited by a
patient who is simply “ doing as told” or following a list of instructions given by the treating doctor. Also overall adherence
includes adherence to advices on other aspects like change in lifestyle and food habits along with adherence to prescribed
medication. Adherence rates are higher in acute conditions than in chronic diseases.
Main causes of medication nonadherence include: forgetfulness, fear and worry, misunderstanding, adverse effects, complex
medication schedules, lack of symptoms and preventive medication, mental health problems.
There are several types of non-adherence:
 Primary non-adherence ( non-fulfillment adherence): here the medication is never initiated.
 Non-persistence: here patients decide to stop taking a medication after starting it, without being advised by physician.
It can be intentional ( because of beliefs , attitudes and expectations than influence patients motivation to begin and
persist with treatment regimen) or it could be unintentional non adherence as may happen in case of increased costs,
problems in accessing prescribers, difficult in following instructions like with inhaler therapy, problems with
remembering doses etc)
 Non-conforming: it can range from stopping doses, taking medications at incorrect times or in incorrect doses, to even
taking more than prescribed.
Consequences of non-adherence: waste of medication, disease progression, reduced functional abilities, lower quality of life,
increased use of medical resources like hospital visits and hospital admissions.
Methods to measure medication non-adherence:
 Direct methods: directly observed therapy, therapeutic drug monitoring,
 Indirect methods: patient questionnaires, patient self reports rates of prescription refills, assessment of patients
clinical response, electronic medication monitors. Biomarkers .
Strategies to improve medication adherence include setting up reminders, managing adverse effects effectively, decreasing cost
of medication requirements, understanding beliefs of patients , regimen simplification, ongoing communication etc.
For these strategies to become successful effective communication is required.
Communication methods to improve medication adherence:
1. Communication regarding pathophysiology of disease.
2. Communication regarding mechanism of action of medicines prescribed and their correlation with pathophysiology of
disease.
3. Communication regarding adverse effects of medicines prescribed
4. Communication regarding benefits of regular use of medicines
5. Communication regarding harmful effects of non-adherence to medicines
6. Understanding beliefs of patient regarding disease and treatment.
7. Communication regarding cost factor of treatment.

Questions:
1. Explain medication adherence.
2. Explain consequences of nonadherence in chronic diseases.
3. Explain methods to measure medication adherence
4. Elicit barriers affecting medication adherence
5. Explain measures to be taken to motivate patient to adhere to medications in chronic diseases.

Exercises:
1. Motivate a patient suffering from moderate hypertension to adhere to prescribed management.
2. Motivate a patient with COPD to adhere to prescribed management.
3. Motivate a patient with CCF to adhere to prescribed management.
4. Motivate a patient with classical angina to adhere to prescribed management.
5. Motivate a patient with depression to adhere to prescribed management.
 PRACTICAL 18: RELATIONSHIP BETWEEN COST OF TREATMENT AND PATIENT COMPLIANCE.
COMPETENCY NO: 5.4: EXPLAIN TO THE PATIENT THE RELATIONSHIP BETWEEN COST OF TREATMENT AND PATIENT COMPLIANCE.
OBJECTIVES: At the end of phase II , the student should be able to:
1. Assess the cost of treatment
2. Enumerate the various factors influencing patient compliance
3. Explain consequences of medication non-compliance in terms of cost to the patient
4. Communicate clearly to patient about relationship between cost of treatment and compliance.
A patient is considered adherent when he/she takes prescribed medications in the doses, frequency and duration as prescribed.
In USA 3% to 10% of total health care costs has been attributed ot medication nonadherence. Various factors have been found to affect
patient adherence to medications: these include:
1) Patient centered factors:
 Demographic factors: age, ethnicity, gender, educational status, marital status.
 Psychosocial factors: beliefs, motivation, attitude, patient prescriber relationship, health literacy, patient knowledge, physical
difficulties, tobacco smoking, alcohol intake history of good compliance.
 Therapy related factors: route of administration, treatment complexity, duration of treatment period, medication side effects,
degree of behavioral change required, taste of medication, requirements of drug storage.
2) Health system factors: lack of accessibility, long waiting time, difficulty in getting prescriptions filled, unhappy clinic visits.
3) Social and economic factors: inability o find time from work, cost and income, social support.
4) Disease factors: disease symptom, severity of disease.
 Methods of measuring medication adherence include:
1. INDIRECT METHODS like medication possession ratio (MPR) and proportion of days covered (PDC) . An MPR of 80% is often used
as cutoff between adherence and nonadherence based on its ability to predict hospitalizations across selected high prevalence
chronic diseases. These protocols are important in condition like COPD and asthma where the way the patients uses inhaled
therapy can also affect outcomes significantly. These methods include pill count and reviewing pill bottles against medication
lists.
2. DIRECT METHODS include observed therapy and blood or urine drug and metabolite concentrations are most commonly used in
research.
COST OF TREATMENT AND ADHERENCE: most of the costs attributed to medication nonadherence result from avoidable hospitalization.
Additional direct costs because of non-adherence are incurred by progression of controllable disease with:
1. Increased service utilization at physician offices, emergency rooms, nursing homes, and hospice or dialysis centers.
2. Avoidable medicine costs related to therapy addition as comordid conditions develop
3. Diagnostic testing that could be avoided by controlling primary illness.
First step in cost analysis is identification of various costs: like direct, indirect medical or non medical cost and intangible costs
1. Direct costs include medical or non medical
2. Indirect costs include those experienced by patients family or society as loss of earnings or productivity resulting from patient’s
illness
3. Intangible costs are attributed to amount of suffering that occurs due to illness or healthcare intervention, are usually difficult to
ascertain and quantify in monetary terms.
Examples of costs for economic evaluations:
Cost/unit; cost/treatment; cost/person; cost/person/year; cost/case prevented; cost/ life saved; cost/ DALY (disability adjusted life year);
cost/QALY ( quality adjusted life year); cost/ LYG ( life years gained).
The COMMONLY USED PHARMACOECONOMIC ANALYSIS METHODS include cost minimization analysis (CMA); cost effectiveness analysis
(CEA); cost utility analysis (CUA); cost benefit analysis (CBA).

EXERCISE: communicate to a volunteer the cost of therapy and adherence to medication in his own language.
 PRACTICAL 19: PRECAUTION IN USE OF DRUGS LIKELY TO CAUSE DEPENDENCE
COMPETENCY NO PH 5.5: DEMONSTRATE AN UNDERSTANDING OF THE CAUTION IN PRESCRIBING DRUGS LIKELY TO PRODUCE DEPENDENCE
AND RECOMMEND THE LINE OF MANAGEMENT.
OBECTIVES: At the end of phase II, the student must be able to:
1. Describe drugs likely to produce dependence correctly,
2. Describe the legality involved in prescribing drugs likely to produce dependence
3. Describe the basic treatment regimens for various addictions and withdrawal states along with psycho-social rehabilitation.
 Repeated administration of drugs may cause ABUSE AND DEPENDENCE.
 Sudden stoppage of drug precipitates withdrawal symptoms-termed as “DEPENDENCE”.
 In dependence there is a series of adaptive changes in CNS due to neuroadaptation.
 Drugs include benzodiazepines, morphine, alcohol, barbiturates etc.
 ADDICTION: in addiction, person feels emotional disturbances if drug is not administered.
 To produce pleasurable sensations/favorable effects, drug is taken repeatedly, gradually there is compulsion of drug called as
drug addiction, previously known as psychological dependence, eg cocaine and amphetamine cause addiction but do not cause
dependence, however tobacco contains nicotine can cause physical and mental dependence
 Reinforcement : drug itself produces effects, pleasurable sensations, and subject enjoys when drug is administered. He/she wishes
to take drug again I.e. drug seeking behavior.
Opioid, alcohol, barbiturates, benzodiazepines and cocaine produce sense of well being-termed as euphoria but causes high degree of
dependence (psychic+physical).
Continuous use of these drugs is associated with feeling of “kick” or flash” e.g. heroin.
Usually CNS stimulants such as cocaine, amphetamine, nicotine and caffeine produce psychological dependence while CNS depressant such
as barbiturates, opioids and benzodiazepines produce physical dependence of varying degree. Alcohol produces both kinds of dependence.
Initially there is psychological dependence but on heavy and prolonged use alcohol causes physical dependence.
Mechanism of dependence: these drugs modify dopaminergic and glutaminergic transmission in the CNS.
Withdrawal symptoms: vary from mild to severe.
When CNS depressant drugs are stopped suddenly, it causes excitation, when CNS excitant drugs are stopped suddenly it causes weakness
and excitation.
Drug habituation: is less severe desire for drug intake; tea, coffee and tobacco cause habituation rather than addiction / abuse, have less
severe withdrawal reactions.
Drug abuse: use of various illicit drugs called as drug abuse. These drugs are highly addictive and illegal substances like heroin, marijuana
etc. many drugs are used clinically but if they are misused—social disapproval of the manner and purpose of drug usage termed as drug
abuse.
Continuous usage: substance is taken at regular basis. Always tries to remain under the effects of drug eg: opioid, benzodiazepines and
alcohol.
Occasional usage: subject likes pleasurable effects of drug e.g. alcohol, cocaine, amphetamine in rave parties, cannabis etc.
Treatment: general treatment includes gradual withdrawal of drug; substitution therapy; psychotherapy; occupational therapy, psychosocial
interventions, substitution of less addicting drugs, withdrawal of substituted drug by gradual tapering of dose, aversion therapy (if
applicable); prevention of further dependence and education of patient and public.
Specific treatment:
1. Opiates dependence: methadone, buprenorphine, naltrexone etc.
2. Stimulants( such as cocaine or amphetamine ) benzodiazepines such as diazepam are use to help patient calm down,
antidepressants like fluoxetine and lofepramine may be used for underlying depression; dexamphetamine may be used for
amphetamine dependent patients.
3. Alcohol: chlordiazepoxide in first used in acute withdrawal symptoms. Naltrexone and disulfiram are used long term to help
prevent drinking alcohol again. Haloperidol or olanzepine may be prescribed for hallucinations during acute withdrawal;
ACAMPROSATE may be used in hospitals
4. Benzodiazepines: longer acting benzodiazepine is normally prescribed to people who are dependent on short acting
benzodiazepines
5. Nicotine: nicotine replacement therapy (NRT) such as patches, gums and sprays may be used as substitute therapy. Bupropion,
varenicline may be used to treat nicotine dependency. NRT is used as part of smoking cessation programme.

Exercise 1: Describe the phenomenon of dependence to drugs.

Exercise 2: Describe the use of medicines in management of drug dependence.
Exercise 3: describe the legality involved in prescribing drugs likely ot produce dependence ( drugs and cosmetics act 1940, pharmacy act 1949,
narcotic drugs and psychotropic substances act 1985).
 PRACTICAL 20: EDUCATION OF PUBLIC ABOUT ASPECTS OF DRUG USE INCLUDING DRUG DEPENDENCE AND OVER THE COUNTER (OTC)
DRUGS.
COMPETNECY NO PH 5.6: DEMONSTRATE ABILITY TO EDUCATE PUBLIC AND PATEINTS ABOUT VARIOUS ASPECTS OF DRUG USE INCLUDING
DRUG DEPENDENCE AND OTC DRUGS
OBJECTIVES: AT THE END OF PHASE II, THE MBBS STUDENT SHOULD BE ABLE TO:
1. DESCRIBE THE USES OF DRUGS,
2. EDUCATE PUBLIC AND PATIENTS REGARDIGN USES OF DRUGS
3. EDUCATE PUBLIC AND PATIENTS ABOUT DRUG DEPENDENCE
4. EDUCATE PUBLIC AND PATIENTS ABOUT OTC DRUGS.
DRUGS are used for various purposes:
1. Prevention of diseases: e.g. as prophylaxis
2. Treatment of disease: to cure a clinical condition; to provide symptomatic relief; to provide palliative treatment
3. Diagnostic purpose: e.g. phentolamine in pheochromocytoma, radio contrast media etc.
4. Miscellaneous: to alter the physiological state e.g. unconsciousness etc ; to facilitate surgery e.g. general anesthetics etc
Over the counter drugs (OTC) drugs: drugs usually available as prescription drugs and non-prescription drugs (OTC) drugs.
ADVANTAGES: used as self medication.
DISADVANTAGES: may cause adverse effects such as: use of aspirin may cause bleeding from GIT ; aspirin in children may cause reys
syndrome; overdose of Paracetomol may cause toxicity in children.
SELF MEDICATION: when medication is consumed without clinician’s prescription it is called self medication. WHO defines self medication as
selection and use of medicines by individuals to treat self recognized illnesses. Self medication is considered rational and justified if only OTC
drugs are used which is a part of self medication.
ADVANTAGES: OTC medications provide prevention and treatment for a vide range of conditions including but not limited to headaches,
common cold, musculoskeletal pain, allergies, anxiety, depression and heartburn. Commonly used drugs for these conditions include
antihistamines, opioid slide codeine, analgesics, hypnotics and laxatives.
Satisfaction to consumer, reduced burden on doctors/hospitals.
DISADVANTAGES: include toxicity due to overdose of OTC drugs.
EXAMPLES OF OTC DRUGS INCLUDE: chlorhexidine mouthwash, povidone ointment, clotrimazole ointment/cream/dusting powder,
dextromethrophan hydrobromide lozenge; diphenhydramine tablets; diclofenac ointment/ cream/gel; Paracetomol tablets; sodium chloride
nasal spray; oxymetazoline nasal solution 0.05%;xylometazoline spray; ketaconazole shampoo; Lactulose solution 10mg; benzoyl peroxide;
calamine lotion; Bisacodyl tablets 5mg.
Drug dependence has been covered in previous practical’s.

QUESTIONS:
1. Describe the importance of complying with the doctor’s prescription.
2. Describe the demerits of self-prescription
3. Describe the importance of identifying and reporting ADRs to concerned authorities with drug dependence
4. Describe the caution to be taken while using drugs causing dependence
5. Describe what safe use of OTC.
 PRACTICAL 21: LEGAL AND ETHICAL ASPECTS OF PRESCRIBING DRUGS.
COMPETENCY NO PH 5.7: DEMONSTRATE AN UNDERSTANDING OF LEGAL AND ETHICAL ASPECTS OF PRESCRIBING DRUGS.
OBJECTIVES: AT THE END OF THE SESSION THE PHASE II STUDENT SHOULD BE ABLE TO:
1. DESCRIBE THE RIGHT OF PATIENTS.
2. MENTION THE LEGAL REGULATIONS GOVERNING DRUG USE
3. DESCRIBE THE VARIOUS DRUG SCHEDULES.
RIGHTS OF PATIENTS: include right to :
1. Be adequately informed about illness and best possible treatment.
2. Be informed about the approximate expenses to be incurred.
3. Approximate hospital charges in language the patient and relative can understand.
4. Be informed about effective and safe medication.
5. Be informed about the details of health care professionals directly involved in health care of patients that include doctor, nurses
and other staff.
6. To maintain confidentiality of medical record related with patients illness and treatment.
7. Be involved in decision making with health care professional about the treatment given to him.

REGULATION GOVERNING MEDICATION USE: Drugs and cosmetics act 1940 and the Drugs and Cosmetics rules 1945. The Ministry of health
and family welfare (MOH & FWO enforce these legislations through the various Food and Drug Administration offices in every state.
MEDICINE LABEL: governed by following D & C rules 1945):
Rule 96( manner of labeling): drug label should have minimum information about: generic name and brand name; net contents and content
of active ingredient; name and address of manufacturer/pharmaceutical with manufacturing license number; specify batch number, date of
manufacture and date of expiry; maximum retail price to be displayed
Rule 97(labeling of medicine): medicine for internal use should have label Caution/ warning” statements for all prescription drugs under
schedules G, H and X . Medicines meant of r External Use should have label of “ FOR EXTERNAL USE ONLY”.
Rule 161: related to labeling, packing and limits of alcohol in ayurvedic, siddha or unani drugs.
DRUG SCHEDULES: SOME IMPORTANT DRUG SCHEDULES ARE:
1) a) SCHEDULE H(PRESCRIPTION DRUGS) AND SCHEDULE H1 drugs ( these drugs require records to be maintained for three years and shall
be open/available for inspections as and when required regarding their prescription to patients). The drug formulation should be labeled
with symbol Rx which shall be in red colour.
2) Schedule X: drugs having addiction or dependence liability e.g. sedative hypnotics. These drugs must be kept under lock and key in safe so
that only the responsible person can have access i.e. under the safe custody of a responsible person.. These drugs are available under
prescription form a registered medical practitioner and the prescription should be in duplicate and one copy should be preserved for about
two years by the retailer/supplier ad they should maintain a record for supply of these drugs in a special register for this purpose. Symbol
used for narcotic drugs is nrx in red colour and for other drugs included in schedule X is Xrx in red colour.
3) Schedule Y: it is related with requirement and guidelines on cinical trials and for import and manufacture of new drug; however as New
Drugs and Clinical trial rules 2019, comes in force (march 2019) the schedule Y shall not be applicable in respect of new drugs and
investigational new drugs for human use.
Other important drug schedules: are Schedule C, F, G,J, K P & W.

 ETHICAL ASPECTS OF DRUG USE: THE FOLLOWING ETHICAL PRINCIPLES SHOULD BE FOLLOWED WHILE PRESCRIBING
MEDICATIONS:
1. AUTONOMY
2. BENEFICIENCE,
3. JUSTICE AND
4. NON-MALEFICIENCE.

QUESTIONS: list the important drug schedules.

 STUDENT PARTICULARS

NAME:

AGE:

GENDER:

ADDRESS1:

ADDRESS 2:

MOBILE NUMBER:
LANDLINE NUMBER:
EMAIL ID:
BLOOD GROUP:
FATHERS NAME:
MOTHERS NAME:

SL IST INTERNAL ASSESSEMENT IIND INTERNAL ASSESSMENT IIIRD INTERNAL ASSESSMENT TOTAL MARKS (AVERAGE)
NO
THEORY PRACTICALS THEORY PRACTICALS THEORY PRACTICALS THEORY PRACTICALS

4
 INSTRUCTIONS TO THE CANDIDATE
ALL STUDENTS ARE HEREBY INSTRUCTED TO ATTEND ALL PRACTICAL CLASSES REGULARLY. ATTENDENCE IN ALL
PRACTICAL CLASSES IS COMPULSORY. ALL STUDENTS ARE INSTRUCTED TO WEAR APRON TO ALL PRACTICAL
CLASSES COMPULSORILY. ALL STUDENTS ARE INSTRUCTED TO COMPLETE THE GIVEN ASSISGNMENTS WITHIN THE
TIME PERIOD AND SUBMIT THE RECORDS WITHIN THE STIPULATED TIME PERIOD.

THE CBME PRACTICAL CLASSES ARE DIVIDED INTO FOUR SKILLS TOPICS WITH COMPETENCIES AS FOLLOWS:
 CLINICAL PHARMACY: COMPETENCY PH 2.1 TO 2.4.
 CLINICAL PHARMACOLOGY: COMPETENCY PH 3.1 TO 3.8.
 EXPERIMENTAL PHARMACOLOGY: COMPETENCY PH 4.1 TO 4.2
 COMMUNICATION TOPICS: COMPETENCY PH 5.1 TO 5.7.

THE UNDER GRADUATE MEDICAL EDUCATION PROGRAMME IS DESIGNED WITH GOAL TO CREATE AN INDIAN
MEDICAL GRADUATE (IMG) POSSESSING REQUISITE KNOWLEDGE, SKILLS ATTITUDES, VALUES AND
RESPONSIVENESS SO THAT HE OR SHE MAY FUNCTION APPROPRIATELY AND EFFECTIVELY AS A PHYSICAIN OF
FIRST CONTACT OF THE COMMUNITY WHILE BEING GOLBALLY RELEVANT.
TO FULFILL THIS GOAL HE/SHE MUST BE TRAINED TO PERFORM FIVE ROLES.
1. CLINICIAN
2. LEADER AND MEMBER OF HEALTH CARE TEAM
3. COMMUNICATOR
4. LIFELONG LEARNER
5. PROFESSIONAL.

 TO PERFORM THESE ROLES, EACH ROLE IS FURTHER DIVIDED INTO COMPETENCIES.

 A COMPETENCY IS AN OBSERVABLE ACTIVITY OF A HEALTH PROFESSIONAL INTEGRATING MULTIPLE
COMPETENCIES LIKE KNOWLEDGE, SKILLS, ATTITUDES AND VALUES APPROPRIATELY AND JUDICIOUSLY.

 GLOBAL COMPETENCIES ARE FURTHER DIVIDED INTO SUBJECT COMPETENCIES.

 PHARMACOLOGY HAS FIVE TOPICS WITH A TOTAL OF 85 COMPETENCIES:
1. KNOWLEDGE TOPIC: HAS 64 COMPETENCIES
2. SKILLS TOPIC : CLINICAL PHARMACY HAS FOUR COMPETENCIES 2.1 TO 2.4.
3. SKILLS TOPIC: CLINCIAL PHARAMCOLOGY HAS EIGHT COMPETENCIES: 3.1 TO 3.8.
4. SKILLS TOPIC: EXPERIMENTAL PHARAMCOLOGY HAS TWO COMPETENCIES: 4.1 TO 4.2
5. COMMUNICATION TOPIC: HAS SEVEN COMPETENCIES: 51 TO 5.7.
OF THESE ONLY FOUR COMPETENCIES 3.1 , 3.2, 3.3 AND 3.5 NEED CERTIFICATION.
 CONTENTS/ INDEX
Sl NO COMPETENCY COMPETENCY PAGE STAFF
NUMBER NUMBER SIGNATURE
SKILLS TOPIC: CLINICAL PHARAMCY
1 PH 2.1 DEMONSTRATE UNDERSTANDING OF VARIOUS DOSAGE FORMS
(ORAL/LOCAL/PARENTERAL; SOLID/LIQUID)
2 PH 2.2 PREPARE ORAL REHYDRATION SOLUTION FROM ORS PACKET AND EXPLAIN ITS
USE.
3 PH 2.3 DEMONSTRATE THE APPROPRIATE SETTING UP OF AN INTRAVENOUS DRIP IN
A SIMULATED ENVIRONMENT
4 PH 2.4 DEMONSTRATE THE CORRECT METHOD OF CALCULATION OF DRUG DOSAGE
IN PATIENTS INCLUDING THOSE USED IN SPECIAL SITUATIONS
SKILLS TOPIC: CLINICAL PHARAMCOLOGY
1 PH 3.1 WRITE A RATIONAL, CORRECT AND LEGIBLE GENERIC PRESCRIPTION FOR A
GIVEN CONDTION AND COMMUNICATE THE SAME TO THE PATIENT
2 PH 3.2 PERFORM AND INTERPRET A CRITICAL APPRAISAL ( AUDIT) OF A GIVEN
PRESCRIPTION
3 PH 3.3 PERFORM A CRITICAL EVALUATION OF DRUG PROMOTIONAL LITERATURE

4 PH 3.4 TO RECOGNISE AND REPORT AN ADVERSE DRUG REACTION

5 PH 3.5 TO PREPARE AND EXPLAIN A LIST OF P-DRUGS FOR A GIVEN CASE/CONDITION

6 PH 3.6 DEMONSTRATE HOW TO OPTIMISE INTERACTION WITH PHARMACEUTICAL

REPRESENTATIVE TO GET AUTHENTIC INFORMATION ON DRUGS
7 PH 3.7 PREPARE A LIST OF ESSENTIAL MEDICINES FOR A HEALTHCARE FACILITY

8 PH 3.8 COMMUNICATE EFFECTIVELY WITH A PATIENT ON PROPER USE OF

PRESCRIBED MEDICATION
SKILL TOPIC: EXPERIMENTAL PHARMACOLOGY
1 PH 4.1 ADMINISTER DRGUS THROUGH VARIOUS ROUTES IN A SIMULATED
ENVIRONMENT USING MANNEQUINS
2 PH 4.2 DEMONSTRATE THE EFFECTS OF DRUGS ON BLOOD PRESSURE
(VASOPRESSOR AND VASODEPRESSORS WITH APPROPRIATE BLOCKERS) USING
COMUPTER AIDED LEARNING (CAL).
COMMUNICATION TOPIC: PHARMACOLOOGY
1 PH 5.1 COMMUNICATE WITH THE PATIENT WITH EMPATHY AND ETHICS ON ALL
ASPECTS OF DRUG USE
2 PH 5.2 COMMUNICATE WITH THE PATIENT REGARDING OPTIMAL USE OF
A) DRUG THERAPY B) DEVICES AND C) STORAGE OF MEDICINES
3 PH 5.3 MOTIVATE PATIENTS WITH CHRONIC DISEASES TO ADHERE TO PRESCRIBED
MANAGEMENT BY HEALTH CARE PROVIDER
4 PH 5.4 EXPLAIN TO THE PATIENT THE RELATIONSHIP BETWEEN COST OF TREATMENT
AND PATIENT COMPLAINCE
5 PH 5.5 DEMONSTRATE AN UNDERSTANDING OF CAUTION IN PRESCRIBING DRUG
LIKELY TO PRODUCE DEPENDENCE AND RECOMMEND THE LINE OF
MANAGEMENT
6 PH 5.6 DEMONSTRATE ABILITY TO EDUCATE PUBLIC AND PATIENTS ABOUT VARIOUS
ASPECTS OF DRUG USE INCLUDING DRUG DEPENDENCE AND OTC DRUGS
7 PH 5.7 DEMONSTRATE AN UNDERSTANDING OF LEGAL AND ETHICAL ASPECTS OF
PRESCRIBING DRUGS.