Clinical Pharmacy - Pharm.D Final Year

1. Clinical Pharmacy II
Part 1: Rational Use of Drugs
Dr. Muhammad Saalim
YIPS – Clinical Pharmacy II 1

2. Contents
• Concept of rational use of drugs
• Rational Prescribing
• Rational Dispensing
• Problems of Irrational drug use
• Factors causing Irrational drug use
• Learning about Drug Use Problems

3. Waaaaait …

4. What did you do last year??

5. Subject: Pharmacy Practice -VI (Advanced Clinical Pharmacy-II) New Scheme
Paper: 2Marks 100
Topic
MCQs
Marks SEQs Marks
Total Marks
1. RATIONAL USE OF DRUGS: Rational Prescribing, Rational Dispensing, 1
5
1 6
5+3=8
Problems of Irrational Drug Use 1
Learning about drug use problem, 1
Sampling to study drug use 1
1 1+3=4
Indicators of drug use 1
INTRODUCTION TO ESSENTIAL DRUGS: Criteria for selection, Usage and Advantages. 1
2. DRUG UTILZATION EVALUATION & DRUG UTILIZATION REVIEW (DUE/DUR):
Development of protocol of use of few very low therapeutic index drug groups like
Steroids
2
4 1 6 4+6=10
Vancomycin 1
Cimetidine. 1
3. CLINICAL PHARMACOKINETICS: Therapeutic Drug Monitoring of Digoxin 1
5 1 6 5+6=11
Theophyline 1
Gentamycin 1
Lithium
1
Phenytoin
Cabamazepine
Phenobarbitone
Primidone
Valparoic Acid
1
Cyclosporins
Vancomycin
4. PHARMACEUTICAL CARE, ITS SCOPE, MANAGEMENT AND APPLICATION OF
CARE PLAN.
2 2
1 6
2+3=5
5. CLINICAL THERAPEUTICS:
General Strategy 1
4 4+3=7
Terminology of Disease. 1
Management and
Treatment
1
Drug Selection 1
ToS

6. ToS
7. CLINICAL TOXICOLOGY:
General information
1
4 2 12 4+12=16
Role of pharmacist in treatment of poisoning and general management of poisoning & over
dosage.
1
Role andStatus of Poison Control Centre 1
Antidotes and their mechanism of action 1
8. SAFE INTRAVENOUS THERAPY & HAZARDS OF INTRAVENOUS
THERAPY.
3 3 1 6 3+6=9
9. NON-COMPLIANCE:
Definition, introduction, importance and extent of non-compliance
Methods of assessment
Reasons for non-compliance
Strategies for improving compliance and Designing of compliance trials.
1
4 1 6 4+6=10
1
1
1
10. DISEASE MANAGEMENT:
Unit V: Central nervous system unit (Stroke, Epilepsy, Psychosis)
1
8 2 12 8+12=20
Unit VI: Infectious diseases (Meningitis, tuberculosis, dermatological infections, Rabies,
Urinary track infection, Malaria fever, Typhoid fever, Fungal infections of skin, AIDS, Dengue
fever, Common Cold, Pharyngitis & Tonsillitis, Conjunctivitis)
2
Unit VII: Endocrinology Unit (Diabetes Mellitus, Hyper/Hypo-thyroidism, pituitary gland
non-malignant disorders)
1
Unit IX: Nephrology Unit (Renal failure, nephrotic syndrome) 1
Unit X: Hematology Unit (Bleeding disorders/coagulopathies/clotting disorders e.g.
thrombocytopenia, hemophilia, Vit. K deficiency, Anemia).
2
Unit VIII: Oncology Unit (Types of tumors, Brief introduction to oncological diseases e.g.
prostate cancer, breast cancer, lungs cancer )
1
Total 40 40 10 60 100

7. UHS Final Exam 2021

8. What is Rational Use of Drugs?
• “The rational use of drugs requires that patientsreceive
medications appropriate to their clinical needs, in doses that
meet their own individual requirements for an adequate
period of time, and at the lowest cost to them and their
community”
(WHO conference of experts Nairobi 1985)

9. What does RUD mean?
• correct drug
• appropriate indication
• appropriate drug considering efficacy, safety, suitability for
the patient, and cost
• appropriate dosage, administration, duration
• no contraindications
• pharmacaoeconomics
• correct dispensing, including appropriate information for
patients
• patient adherence to treatment

10. Drug Use Process

11. Why RDU/RUM?
• Factors that have led sudden realization for rational
drug use are.
• Drug explosion
• Efforts to prevent the development of
resistance
• Growing awareness
• Increased cost of the treatment
• Consumer Protection Act (Is there one in Pakistan?).

12. Drug vs Medicine?

13. Keep In
Mind!
One Size
Does’nt
Fit All

14. Why is RUM Important?
• ADRs and ADEs (Difference??)
• Antimicrobial Resistance (AMR)
• Malaria
– choroquine resistance in 81/92 countries
• Tuberculosis
– 0-17 % primary multi-drug resistance
• HIV/AIDS
– 0-25 % primary resistance to at least one anti-retroviral
• Gonorrhoea
– 5-98 % penicillin resistance in N. gonorrhoeae
• Pneumonia and bacterial meningitis
– 0-70 % penicillin resistance in S. pneumoniae
• Diarrhoea: shigellosis
– 10-90% ampicillin resistance, 5-95% cotrimoxazole resistance
• Hospital infections
– 0-70% S. Aureus resistance to all penicillins & cephalosporins
WHO Country Data

15. Side Effects, ADRs and ADEs
• Side effect: Unwanted effect occurring at normal dose –
related to pharmacological properties.
• ADRs: Refers to unwanted, uncomfortable, or dangerous
(noxious) effects that a drug may have. May be dose
related, allergic or idiosyncratic.
• ADEs/Serious ADR: Any untoward medical occurrence
that at any dose results in death, life-threatening, requires
or prolongs hospitalization, or results in persistent
or significant disability or incapacity.
 Further reading: https://www.ema.europa.eu/en/documents/scientific-
guideline/international-conference-harmonisation-technical-requirements-registration-
pharmaceuticals-human-use_en-15.pdf

16. Factors Effecting Use of Medicine
Treatment
Choices
Prior
Knowledge
Habits
Scientific
Information
Relationships
With Peers
Influence
of Drug
Industry
Workload &
Staffing
Infra-
structure
Authority &
Supervision
Societal
Information
Intrinsic
Workplace
Workgroup
Social &
Cultural
Factors
Economic &
Legal Factors

17. Strategy to promote RUM
• STEP 1: IDENTIFY PATIENTS PROBLEM
- Focus on History
• STEP 2: DIAGNOSIS
- Based on history, physical chekup, current complaints
and lab findings
• STEP 3: THERAPEUTIC OBJECTIVES
- Symptomatic Relief or Treatment of Disease?
- Aggressive vs Passive Treatment
- QALY

18. • STEP 4: SELECT THE TREATMENT
- Lifestyle Changes, Medication (Prescribing the right
drug)
• STEP 5: START THE TREATMENT AND
COUNSEL
- Schedule, Side effects, Risks of ADR, Missing the
Dose, Stopping the Therapy etc.
• STEP 6: MONITOR (Passive and Active)
Strategy to promote RUM contd ..

19. Core Policies to Promote RUM
1. A mandated multi-disciplinary national body to coordinate
medicine use policies (FDA, DRAP)
2. Clinical guidelines (NIH, DRAP, do we need another body??)
3. Essential medicines list based on treatments of choice (WHO) –
Do we any such list in Pakistan??
4. Drugs and therapeutics committees in districts and hospitals
(THQ, DHQ) – Exist?
5. Problem-based pharmacotherapy training in undergraduate
curricula
(Basic Training and Course Design - PMC, PCP, HEC, Individual
Colleges)
6. Continuing in-service medical education as a licensure
requirement (PMC, PCP)

20. Core Policies contd ..
7. Supervision, audit and feedback (Pharmacists, P & T
Committee)
8. Independent information on medicines (From Where?)
9. Public education about medicines (Sponsored by??)
10.Avoidance of perverse financial incentives (Trips,
Conferences, Fridge, AC, TV etc)
11.Appropriate and enforced regulation (How?)
12.Sufficient government expenditure to ensure availability of
medicines and staff ???

21. Reality Check ..
• Global sales of medicines 2019-20 : US$ 1.25 trillion
• Drug promotion costs in USA 2004: US$ >50 billion
• Global WHO expenditure in 2020: US$ 5.84 billion
– Essential Medicines expenditure 2%
– Essential Medicines expenditure on
promoting rational use of medicines 10% (of 2%)
– WHO expenditure on promoting
rational use of medicines 0.2%

22. Rational Prescribing
YIPS – Clinical Pharmacy II

23. Rational Prescribing
• In light of WHO guidelines for rational use
of drugs
- A prescriber should have the following four
aims:
1)Maximize Effectiveness
2)Minimize Risks
3)Minimize Costs
4)Respect the Patient's Choices.

24. STEPS to Rational Prescribing
Another popular framework to support rational prescribing
decisions is known as STEPS (Preskorn, 1994). The STEPS
model includes five criteria to consider when deciding on the
choice of treatment:
• Safety
• Tolerability
• Effectiveness
• Price
• Simplicity

25. Why are we studying
Prescribing?
• Can Pharmacist Prescibe?
• If not …
• Can Pharmacist Help Prescribe?
• A Pharmacist can definitely Educate.

26. What's expected of us
Behavior Ethical Aspect
Do the very best you can for every patient Beneficence
In all cases, do no harm Non-maleficence
Tell the patient the truth Veracity
Be fair Justice
Be loyal Fidelity
Allow the patient to be the ultimate decision
maker
Autonomy
Always protect your patient's privacy Confidentiality

27. Rational
Prescribing
Summary

28. Irrational Prescribing
 Poor choice of a medicine
 Polypharmacy or co-prescribing of interacting
medicine
 Prescribing for a self-limiting condition
 Continuing to prescribe for a longer period than
necessary
 Prescribing too low a dose of a medicine
 Prescribing without taking account of the
patient'swishes.

29.  Inappropriate or irrational prescribing can result in serious
morbidity and mortality, particularly when childhood
infections or chronic diseases such as hypertension, diabetes,
epilepsy and mental disorders are being treated.
 Inappropriate prescribing also represents a waste of
resources and, as in the case of antimicrobials, may harm the
health of the public by contributing to increased antimicrobial
resistance.
 Over-willingness to prescribe stimulates inappropriate
patient demand and fails to help the patient understand when
they should seek out support from a health care professional.
Consequences of Irrational Prescribing

30. WHO Guide to Good Prescribing
• WHO has produced a Guide for Good Prescribing - a
problem-based method
• Developed by Groningen University
in collaboration with 15 WHO offices
and professionals from 30 countries
• Field tested in 7 sites
• Suitable for medical students,
post grads, and nurses
• Widely translated and available
on the WHO medicines website

31. Rational Dispensing
YIPS – Clinical Pharmacy II

32. Dispensing – Prerequisites
i. Stability of dispensed medicine and their ingredients
ii. Principles of compounding
iii. Dosage form and dosage schedule
iv. Physical, chemical and therapeutic incompatibilities
v. Packaging materials and methods
vi. Labeling procedures
vii. Legal requirements

33. Rational Dispensing – Basics
• The objective of rational dispensing shall be to ensure
that patients receive adequate information on the use
of dispensed drugs in order to derive the desired
benefits to them. In this regard the following shall be
put in place:
i. Dispensing shall only be carried out on duly licensed
premises;
Licencing Requirements
in Pakistan?

34. Rational Dispensing – Basics
ii. The minimum information requirement on the label of
a dispensed medicine shall be the following:
• Name of patient,
• Generic name of dispensed drug,
• Strength of the drug,
• Dosage instruction in symbols or words as may be
appropriate,
• Duration of treatment
• Date of dispensing, and
• The name of the institution where the drug was
dispensed

35. Rational Dispensing – Basics
iii.The patient shall be counselled on the use of dispensed
drugs, in a conducive environment suitable for effective
communication; and
iv.Dispensing shall be carried out in a suitable container that
will be childproof and ensure the stability of the drug
dispensed.

36. The Dispensing Cycle

37. Dispensing Process
1. Receiving of Prescription
2. Interpretation of prescription
3. Checking of Prescription
4. Filling of prescription
5. Labelling of Prescription
6. Handling of Prescription
7. Records

38. 1. Receiving of Prescription
- The dispenser receives the “correct” prescription from the
prescriber directly or through Patient. It can be through
Phone, oral/verbal and/or online computer system.
• Origin of the prescription
• Validity of the prescription
• Relevant instructions
• Information about patient
• Therapeutic appropriateness
• Economic considerations
• Communication with prescriber for unclear instructions
Rational Dispensing Process (GDP)

39. 2. Interpretation of prescription
• Name of the drugs
• Dosage, administration and duration
• Availability of drugs
• Retrieves drugs from storage area
3. Checking of the prescription
• Check the expiry date and storage condition of the
prescribed drug.
• Follow FIFO rule
• Checks and counter check (identify strength & dosage
form)
Rational Dispensing Process (GDP)

40. Rational Dispensing Process (GDP)
4. Filling of prescription
- The dispenser should have true knowledge of the medication and its
proper use and can:
• Precisely dispense products
• Re-check drugs and dosages
5. Labeling of prescription (identification of drugs and
instructions)
- The dispenser communicates in correct way to take the medication to
the patient through
• labels with patient’s name, drug name and directions for use, date of
dispensing, identity of dispenser
• Identity of prescriber
• symbolic instructions in case of illiterate patients
• Use of auxiliary labels
• Name and sign of dispenser

41. 6. Handling of Prescription
- Instruction to Patients:
• Repeat orally the labeled instructions
• Ask the patient to repeat the instruction
• Emphasizes the need for compliance
• Providing warnings and cautions
• Gives special attention to certain cases ( pregnant women,
those with visual/hearing problems, children and elderly
patients, those taking multiple medications
Rational Dispensing Process (GDP)

42. 7. Records
- Dispenser keeps accurate records of the following
operations
• Enters details of encounter on patient profile card
• Enters in prescription register
• Completes inventory records
- There are many potential areas in which the dispenser can
make mistakes. Dispensing requires trained, skilled,
responsible individual, proper policies and incentives must be
provided to attract such personnel and develop this
profession
Rational Dispensing Process (GDP)

43. Irrational Dispensing
• Incorrect interpretation of the prescription
• Retrieval of wrong ingredients
• Inaccurate counting, compounding, or pouring
• Inadequate labeling
• Unsanitary procedures
• Packaging:
• Poor-quality packaging materials
• Odd package size, which may require repackaging
• Unappealing package

44. Irrational Drug Use
&
Learning About Drug Use
Problem
NEXT CLASS
AND MORE ….