Clincial Pharmacy Final Proff, Doctor of Pharmacy PharmD.

1. Final
Professional
Ghulam Murtaza Hamad
Punjab University College of Pharmacy, Lahore, Pakistan
Session 2016-21
2021

2. GM Hamad
Table of Contents
01 Rational Use of Drugs 01
02 Introduction to Essential Drugs 39
03 Drug Utilization Evaluation / Drug Utilization Review 53
04 Clinical Pharmacokinetics 68
05 Pharmaceutical Care, its Scope, Management of Care Plan 113
06 Clinical Therapeutics 138
07 Clinical Toxicology 151
08 Safe Intravenous Therapy & Hazards of IV Therapy 159
09 Non-Compliance 168
10
Disease Management
5) Central Nervous System Unit
6) Infectious Diseases
7) Endocrinology Unit
8) Oncology Unit
9) Nephrology Unit
10) Hematology Unit
173
182
243
295
326
334
11 Past Papers 347
12 References 353

3. Chapter 1 – Rational Use of Drugs
GM Hamad
RATIONAL USE OF DRUGS
Rational means Logical, Sensible, Reasoned or Perceptive
DRUG USAGE
 Drugs have been used in diverse societies and cultures. Drugs have been
used for medical, recreational and social purposes. Pharmacists are well
educated regarding conventional drug usage, Meaning by drug
interactions, ADRs, ADEs. A few pharmacist know about herbal and
homeopathic medications. Similarly, most of the life-threatening events,
such as poison control are dealt in poison control centers or hospitals.
 Nevertheless, pharmacist is the custodian of the drugs and know almost
all aspects of the drugs. Unfortunately, pharmacist – most important
professional regarding drug information, is not taking a leading role or is
not being given.
 But what about the perception of people regarding the drug name. How
they classify it. What in their perception is considered a drug.
 Patients receive 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, 1985).
RATIONAL PRESCRIBING AND PRESCRIPTION WRITING
 Once a patient with a clinical problem has been evaluated and a
diagnosis has been reached, the practitioner can often select from a
variety of therapeutic approaches.
 Medication, surgery, psychiatric treatment, radiation, physical therapy,
health education, counseling, further consultation and no therapy are
some of the options available, of these options, drug therapy is by far
the most frequently chosen. In most cases this requires the writing of a
prescription.
 Most important aspect in rational drug usage is;
PATIENT EDUCATION
 Patient education is based on learning and learning involves three
processes:
1. Knowledge – acquire, understand, reinforce.
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4. Chapter 1 – Rational Use of Drugs
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2. Attitude (affective) – based on ones’s feelings, perceptions,
beliefs, emotions.
3. Behavior – knows, feels and act– in association with social and
environmental factors.
DEMANDS OF RATIONAL PRESCRIBING
 Rational prescribing demands that patient receives;
­ Drugs appropriate to their needs
­ Doses that meet their individual requirements
­ For an adequate period of time
­ At the lowest cost to them and to the community.
 Appropriate indication – appropriate drug
 Appropriated route of administration, dosage and duration –
appropriate patient
 Appropriate patient information – appropriate evaluation.
RATIONAL PRESCRIBING CRITERIA
 Like any other process in healthcare, writing a prescription should be
based on a series of rational steps:
1. Make a specific diagnosis
2. Consider the pathophysiologic implication of diagnosis
3. Select a specific therapeutic object
4. Select a drug of choice
5. Determine the appropriate dosing regimen
6. Devise a plan for monitoring the drug’s action and determine an end
point for therapy, Correct dispensing – appropriate packaging and
dispensing
7. Plan a program of patient education – to ensure patient compliance.
Five `RIGHTS' OF MEDICATION
 Do the right things right
1. Right patient
2. Right drug
3. Right dose
4. Right route
5. Right frequency
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5. Chapter 1 – Rational Use of Drugs
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FACTORS THAT CONTRIBUTE TO IRRATIONAL USE OF DRUGS
IMPACT OF INAPPROPRIATE USE OF DRUGS
 It can be seen in many ways:
1. Reduction in the quality of drug therapy leading to increased
morbidity and mortality.
2. Waste of resources leading to reduced availability of other vital
drugs and increased costs.
3. Increased risk of unwanted affects such as adverse drug reactions
and the emergence of drug resistance, e.g., malaria or multiple
drug resistant tuberculosis.
4. Psychosocial impacts, such as when patients come to believe that
there is "a pill for every ill". This may cause an apparent increased
demand for drugs.
PROBLEMS WITH RATIONAL USE OF DRUG
IRRATIONAL DRUG USE – PRESCRIBING AND DIAGNOSIS
1. Complex disease or health problem
­ Patients has many symptoms but is embarrassed to talk about the
main one, so the situation does not get addressed.
2. Lack of basic diagnostic Modalities or tests
­ Prescriber does not do a physical exam and prescribe drugs based on
(objective findings) verbal information.
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6. Chapter 1 – Rational Use of Drugs
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3. Overworked Prescribers
­ In a health facility, only one prescriber and 300 patients visit per day
for consultation.
4. Lack of basic diagnostic equipment
­ No microscope to examine urine or blood samples.
­ No X-ray machine or MRI machine to test for tuberculosis, tumor
location and size.
5. Prescribing un-necessary medical therapy
­ Prescribing drug for no medical indication
­ Drug duplication (aspirin + clopidogrel) for prophylaxis
­ Treating avoidable ADRs.
6. Not prescribing drug for any ailment or ignoring few ailments for which
drug can be prescribed
­ Un-treated condition of the patient, bothering the patients, not
giving prophylactic therapy.
7. Prescribing old drug by habit, less efficacious than newer efficacious
drugs
­ E.g., prescribing digoxin, when more efficacious drugs exist.
8. Prescribing old drug by habit, less safe than newer drugs
­ Prescribing diamicron, while more advance formulation exist,
diamicron MR more safe.
9. Not identifying patient condition, which is refractory to drug, not
switching to a better drug
­ E.g., Erythromycin which still interacts with statins, so patient does
not get the effects due to concomitant administration of a drug,
while azithromycin do not.
10.Prescribing inappropriate dose, dosage, frequency and duration of
therapy
­ Antibiotic is prescribed as injectable for 2 days.
11.Prescribing drug with considering drug-drug interaction, drug –food
interaction, contraindications
­ Digoxin with verapamil
­ Fexofenadine with orange juice
­ Milk with ciprofloxacin
­ Beta-blocker in asthma and bradycardia.
12.Prescribing drug without giving necessary instructions to the patients
­ Avoid Ciprofloxacin and tetracycline with milk and antacids.
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7. Chapter 1 – Rational Use of Drugs
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­ Insulin prescribed without proper instructions.
IRRATIONAL DRUG USE – PRESCRIBING ISSUES
1. Prescribing expensive drugs when low-cost equivalents are available
­ Ampicillin injection is given when patient can be cured using tablets
only.
2. Selecting wrong drug for patient’s illness
­ Anti-diarrheal drug is prescribed when patient is dehydrated and only
require re-hydrating solution (ORS).
3. Prescribing several drugs when few drugs can provide the same effect
­ Sulfadoxine/pyrimethamine and paracetamol is prescribed when
patient has only fever not malaria.
4. Prescribing drugs when disease is self-limiting and patient would be
fine without taking any drug
­ Ampicillin or antibiotic is prescribed when patient has simple cold
without fever and sore throat.
5. Prescribing drugs without dose adjustments in elderly and infants or
any other specific condition
­ Not adjusting dose of theophylline in infants.
6. Prescribing drugs without adjusting dose in disease conditions
­ No adjustment of drugs in renal disease and liver disease.
­ Reduce dose of beta-blocker to 50% if GFR 10 – 50 mL/min.
­ Reduce dose of verapamil and erythromycin in Liver impairment.
7. Prescribing old drugs without updating drug information from
authentic and un-biased source
­ Diamicron is being given to patients when more advance Diamicron
MR is available with improved efficacy and safety profile.
8. Dose tapering for the drugs which require dose tapering
­ Benzodiazepines, corticosteroids and opioids.
9. Prescribing without taking into account the risk vs benefit ratio of the
drugs being prescribed
­ For example, in general population – lactating women, pregnancy,
pediatrics and geriatrics.
IRRATIONAL DRUG USE – DISPENSING
1. Wrong interpretation of prescription
­ Ampicillin prescribed but amoxicillin is dispensed.
2. Wrong quantity dispensed
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8. Chapter 1 – Rational Use of Drugs
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­ Artemether/lumefantrine (Coartem) is prescribed – 4 tablets 2 times
daily – a total of 24, but only 16 tablets were dispensed without
telling the patient, which only lasts for 2 days.
3. Incorrect or inadequate labelling
­ Sulfadoxine/pyrimethamine is dispensed (white tablets) with no
proper labelling on the container – which means patient fails to
remember or will be confused if taking more than 2 drugs with same
kind of color and shape.
4. Incorrect or insufficient dispensing information
­ Patient (child) is prescribed paracetamol 500 mg, but is provided 250
mg tablets with telling the parents to give two tablets.
5. Un-sanitary/unhygienic practices
­ Tablets were retrieved for counting to give 20 tablets – a few tablets
fell on the floor and were picked up and dispensed to the patients.
6. Dispensing near expiry medicine
­ Medicines that will be expired in 2 days and were given for 7 days
treatment.
7. Dispensing in similar kind of container with almost similar labelling
pattern
­ Avoid using same containers for similar shape and color tablets or
capsules to avoid confusion on patient’s part.
COMMON ERRORS
1. Prescribing exceedingly high dose
2. Prescribing more toxic drugs than necessary
3. Prescribing an unnecessary drug
4. Prescribing a drug that will lead to drug-drug interaction
5. Prescribing drugs with no proven benefits
6. Prescribing expensive medicines even when cheaper and equipotent are
available
7. Prescribing parenteral dosage form when oral formulation is proved to
be more beneficial
8. Poor prescription writing
9. Usage of certain drugs by the patients for minor ailments without
consulting the physician
10.Usage of potent drugs in high doses to obtain quick relief for the
sufferings
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9. Chapter 1 – Rational Use of Drugs
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11.The patients do not complete the prescribed regimen and cease the
administration halfway through the course when the symptoms begin to
subside
12.Omission of needed information – DDIs, Antacids and Iron with
tetracycline/cipro absorption
13.Inappropriate drug prescription - prescribing anti-psychotic drug for drug
induced Parkinson symptoms, metoclopramide
14.Prescribing laxatives for reduced bowel activity – associated with anti-
histamines (diphenhydramine), anti-depressants (amitriptyline), anti-
psychotic drug (thioridazine)
15.Prescribing anti-hypertensive associated with the use of NSAIDs.
NON-COMPLIANCE AND IRRATIONAL USE
 Four types of non-compliance leading to medication error:
1. The patient fails to obtain medication
2. The patient fails to take medication
3. The patient prematurely discontinues medication
4. The patient (or another person) takes medication inappropriately.
For example, the patient share a medication with others for any of
several reasons.
REASONS OF IRRATIONAL DRUG USAGE
1. Lack of sources to provide un-biased information regarding currently
used medicines – practitioners rely on medical representatives for the
information
2. Lack of proper training for the medical students and physicians in writing
proper prescriptions
3. Lack of diagnostic facilities in a hospital – difficulties for a prescriber to
reach a conclusion
4. Patients want quick relief from the ailments – pressure on prescriber to
prescribe a drug for a self-limiting symptoms
5. Due to ineffective control of drug regulatory authorities – availability
and dispensing of prescription drugs as over the counter drugs
6. Prescribers are influenced by manufacturers – incentives for prescribing
their drugs
7. Patients have more liberty to decide whether to purchase all the drugs
or only a few of them.
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10. Chapter 1 – Rational Use of Drugs
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DRUG USE IN DEVELOPING COUNTRIES
Outcomes
Examples of
IDU
Causes of IDU
Strategies for
Improvement
Challenges
International
Level
Lack of Access
Substandard
drugs,
unreliable
Med-info.
High prices
Drug marketing
& profiteering,
Patents and
Trade
agreements
Provide Tec-
Assis. &
funding
Finances,
Priorities
National
Level
Poor health indices
Substandard
drugs
Budgetary
constraints,
weak laws &
regulations,
poor
infrastructure
NDP & A
Budgetary
constraints,
poor
infrastructure
Health
System Level
Loss of confidence &
wastage of resources
Drug
shortages,
expired
drugs
Lack of MIS
Unreliable
supplies, bad
procurement
practices, poor
infrastructure
Drug
Committees
Essential
Drugs list
Lack of trained
manpower,
Budgetary
constraints
Prescriber
Level
Drug wastage, drug
resistance
Poly
pharmacy,
wrong drugs,
over
prescribing
Lack of
knowledge,
patient
overload
Training,
S.T.G
Lack of
training
Dispenser
Level
Drug wastage, drug
resistance
Inadequate
patient
counseling
Lack of
Knowledge,
Patient
overload
Training
Lack of
training
Patient &
Community
Level
Drug resistance, drug
dependence Increased
costs of treatment,
Death
High cost of
drugs,
sharing of
drugs, self
medication,
Poverty,
illiteracy,
culture, self
medication
Community
outreach,
Advertising,
posters,
Leaflets
Illiteracy,
traditional
medicines,
Poverty
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11. Chapter 1 – Rational Use of Drugs
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CONSEQUENCES OF IRRATIONAL DRUG USE
1. Irrational use of novel antibiotics can lead to the development of
resistance.
2. Irrational drug use does not produce desired therapeutic outcome –
additional pain and discomfort to the patient.
3. Patient and the government has to bear the increased cost of treatment.
AVOIDABLE MISTAKES
1. Prescribing multiple drugs
2. Prescribing to keep up with the latest fad
3. Prescribing an older drug out of habit
4. Prescribing to satisfy the expectations of the patients
5. Prescribing out of pressure from pharmaceutical companies
6. Prescribing without making proper diagnosis
7. Prescribing without proper instructions – dose, dosage form, frequency
and duration.
PROBLEMS WITH IRRATIONAL USE OF INJECTIONS
 Un-necessary use of Injections are associated with:
­ Higher costs
­ Increased need of trained staff
­ Increased time to administer the drug
­ Possible transmission of serious pathogens
­ Increased risk of adverse drug reactions – abscess formation
­ Patient’s discomfort.
 General use of injections should be restricted to followings:
­ Oral administration is not tolerable and is not possible.
­ If there is a clear absorption problem; vomiting and severe diarrhea.
­ Drug of choice is only available in parenteral dosage form, e.g.,
insulin and gentamicin.
­ High concentrations are needed and is not achievable via oral route,
e.g., meningitis.
­ Urgent treatment is required due to severe and rapidly progressing
illness, e.g., septicemia.
­ Patient is unlikely to comply with oral therapy.
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12. Chapter 1 – Rational Use of Drugs
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EDUCATIONAL, MANAGERIAL AND REGULATORY STRATEGIES FOR
INTERVENTION IN RATIONAL DRUG USE
Strategies Interventions Targeted category of persons
International
-Technical assistance
-Drug Donations
-Funding
W.H.O, World Bank and Various
international organizations
Regulatory
-Drug registration
-Essential drug list
-Laws and regulations restricting
dispensing, prescribing & the entire
pharmaceutical industry
-Ministry of Health
-Ministry of Health
-Ministry of Health and other
relevant ministries and agencies
Managerial
-Establishing a priority list for drug
procurement
-Establishing Drug Committees
-Establishing price indicators
-Standard operating procedures for
dispensing and drug storage
-Standard diagnostic and treatment
guidelines
-Storekeepers, Administrators,
purchasers and Health workers
-All health Units
-Accounts and Purchasers
-Drug Use supervisors
-Administrators, purchaser and
unit Heads
-Store keepers and Dispensers
-Prescribers
Educational
-Formal training (curriculum review)
-Continued Medical Education
-Increased supervision and support
-Medical and in-service training
for all Health workers
-All Health workers
-Patients and community
Guidelines Prescribing as per guidelines Doctors, Pharmacists, Nurses
Essential
Medicine List
-Available medicine as per the
guidelines for majority of
population
Hospitals, Doctors, Pharmacists,
Nurses
Drug and
Therapeutic
Committee
-Establishing a priority list for drug
procurement
-Establishing Drug Committees
-Establishing a drug utilization
information system for monitoring
and evaluation
-Establishing procedures for
selection, procurement and
distribution
-Storekeepers, Administrators,
purchasers and Health workers
-All health units
-Accounts and Purchasers
-Drug Use supervisors
-Administrators, purchaser and
unit Heads
-Store keepers and Dispensers
-Prescribers
Un-biased
Drug
Information
-Drug Information Centers
-Continued Medical Education
-Increased supervision and support
-Medical Journals, Newsletter,
Treatment Guidelines
-Medical and in service training for
all Health workers
-Patients and community
-Administrators, Units Heads and
Purchasers
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CHALLENGES TO RATIONAL DRUG USE
1. WIDESPREAD IRRATIONAL PRESCRIBING
 Despite the growing body of knowledge on rational use interventions,
numerous studies have documented the continuing widespread
irrational prescribing of drugs.
2. INJECTION THERAPY
 can also be an example of irrational drug use.
3. LIMITED KNOWLEDGE
 Knowledge alone is not enough to change behavior, and that complex
and multifaceted solutions are needed.
4. EXPENSIVE NEW DRUGS
 Many new drugs and second-line drugs are very expensive and
accordingly unaffordable for many governments and consumers.
5. EDUCATION AND TRAINING
 Drugs and therapeutics committees may have difficulty to run in
situations where medical and pharmacy training is still very
traditional; with much emphasis on drug knowledge and very little on
public health, prescribing skills, drug management and patient care.
6. INFLUENCE OF PHARMACEUTICAL REPRESENTATIVES
 Doctors often gets visits from these representatives introducing new
drugs or reminding doctors of their products.
 Doctors should stick to the principles of rational prescribing.
7. CONSUMER DECISION
 The consumer takes the final decision about whether and where to
seek health care, what medicine is actually taken, how much and
when, and from what source.
 These decisions are influenced by knowledge, culture, drug
promotion and personal finances.
8. INDEPENDENT DRUG INFORMATION
 Independent drug information and public education about drug use
are complicated and costly and have always been underserved and
underfunded.
 They also tend to be organized by NGOs thus with informal networks
and objective evaluation of interventions and publication of the
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14. Chapter 1 – Rational Use of Drugs
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results are not easily arranged.
9. LACK OF INDEPENDENT DRUG INFORMATION AND ADVICE
 Worldwide, some 50% of people fail to take their medicines correctly.
Part of the problem is that self-medication is widespread.
10.PROFIT MOTIVES AND PRESSURE TO PLEASE PATIENTS
 Purchases of drugs in certain localities take place in the private
sector, where prescribing and selling functions are often combined.
 Profit motives and pressure to please the patient can lead to over-
treatment of mild illnesses, overuse of injections and misuse of anti-
infective drugs.
RATIONAL DRUG USE BY CONSUMERS
 Establishing effective drug information systems to provide independent
and unbiased drug information, including on traditional medicine to the
general public and to improve drug use by consumers.
PROGRESS
 An extensive review by WHO of public education on drugs provided
valuable insight into strategies used, and their strengths and weaknesses
(Public Education in Rational Drug Use: A Global Survey).
 WHO guide to investigating drug use in the community has contributed
to a growing body of knowledge on consumer understanding, attitudes
and practices regarding drug use. (How to Investigate Drug Use in
Communities).
 Experiences with independent drug bulletins are being shared with
developing countries through networks such as the International Society
of Drug Bulletins.
 Development of drug information centers. These are important source
of independent drug information. Linking these centers electronically
contributes to sharing of information and experience.
WHO GUIDE TO GOOD PRESCRIBING
1. Make diagnosis
2. Set therapeutic goal for the individual patient
3. Decide on the therapeutic approach
4. Choose a drug class
5. Choose a generic drug within a class
6. Individualize dose, formulation, frequency, and duration
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7. Verify suitability of chosen drug
8. Write prescription
9. Inform patient
10.Monitor for effects and adverse effects
11.Alter prescription, if necessary.
CHARACTERISTICS OF GOOD AND BAD PRESCRIBING
GOOD PRESCRIBING BAD PRESCRIBING
Effective Ineffective
Safe Unsafe
Patient centered and individualized Not patient centered
Acceptable to patient Not suitable for patient
Appropriate (not too little or too much) Inappropriate
Addresses expectations of patient Causes patient distress and harm
Judicious use of resources Higher cost
Well informed (evidence based) Poorly informed
Based on unbiased information Based on biased information
Low vulnerability to outside influences Vulnerable to outside influence
RATIONAL DISPENSING
THE ROLE OF DISPENSERS IN PROMOTING RATIONAL DRUG USE
 Identify who can be a dispenser
 Identify factors that influence dispensing
 Describe methods to enhance dispenser-patient communications
 Identify ways to influence a dispenser's behavior.
PRESCRIBER AND DISPENSER
 In the real world of drug use (rational and irrational)
PRESCRIBER
 A Prescriber is anyone with a recommendation for treatment.
DISPENSER
 A Dispenser is anyone who gives out a treatment.
DISPENSERS
 Pharmacists, pharmacy technicians
 Pharmacy assistants
 Nurses, nurse aids
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 Doctors
 Drug sellers
 Shopkeepers
 Family members.
DISPENSER REQUIREMENT
KNOWLEDGE / SOURCE OF INFORMATION
 Drug information
 Product information
 Consultation
SKILLS
 Communication skill
 Promotional/marketing techniques
OTHERS
 Supply
 Dispensing equipment
 Dispenser-prescriber relationship
 Status/role in the health care system
DISPENSING PROCESS
 Receive prescription
 Interpret prescription
 Retrieve medication/ingredients
 Prepare and process
 Communicate with patient
 Ensure patient's understanding
 Monitor compliance by patient
 Keep records.
POTENTIAL ERRORS AND PROBLEMS
 Wrong interpretation of prescription (or diagnosis)
 Retrieval of the wrong drug from stock
 Wrong dosages
 Inadequate packaging/labeling
 Inaccurate counting, compounding
 Inadequate or nonexistent labeling
 No knowledge of proper drug compliance
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 Insufficient knowledge of the disease process
 Insufficient time to talk with patients about their drugs
 Inability to communicate to patients about therapy
ASSESSING DISPENSING CONDITIONS
 Dispensing point conditions
 Dispensing time? Communication time?
 How often do errors occur?
 Who is responsible for dispensing?
 Dispensing training in country?
 Salaries and wages for dispensers?
 Dispensing packaging?
ROLES OF PHARMACIST IN ENSURING RATIONAL DRUG DISPENSING
 Procurement
 Distribution
 Prescribing
 Information
 Additional roles:
­ Communication with physician
­ Treatment guidelines
­ Research on prescribing and utilization
­ Consumer education
PHARMACIST ROLE IN APPROPRIATE DISPENSING
FRAUDULENT PRESCRIPTIONS
 Legitimate prescription with alterations made by patient
 Stolen prescription pads of a legitimate prescriber but with contact
changes
 Drug seekers who phone for their own prescriptions and use their own
phones for verification
 Drug abusers who use stolen pad to write prescriptions
 Individuals present themselves at emergency to obtain controlled
substance prescription to modify it later or copy for re-use
STEPS THE PHARMACIST MUST TAKE TO ENSURE THE VALIDITY OF
PRESCRIPTIONS
I. ENSURE THAT ONLY STATE-AUTHORIZED PRESCRIBERS WRITE/ORDER
PRESCRIPTIONS
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 The DEA defines a practitioner as a physician, dentist, podiatrist,
veterinarian, state-registered practitioner.
 The pharmacist must know the laws in each state/province, if presented
with a prescription from that state.
 If the pharmacist is presented with a questionable prescription, he or
she may want to use the contact information on the prescription.
 States have the authority to determine the scope of treatment by
prescribers.
 States may restrict the ability of certain practitioners to write
prescriptions only for certain indications or specific conditions — for
example, dentists being restricted to treatments related to oral health.
 If the pharmacist has questions regarding whether a valid prescriber-
patient relationship exists, he or she may contact the prescriber or ask
the patient when they last saw the prescriber, or ask other general
questions related to the interaction with the prescriber.
 Verify prescriber registration #.
II. PRESCRIPTION MONITORING PROGRAM (PMP)
 In US, every state has PMP - generally track every controlled substance
dispensed in the state and include patient name, controlled substance
name and quantity, date dispensed, prescriber and pharmacy identity.
 The pharmacist must be judicious in accessing information in the PMP.
The pharmacist must never abuse the privilege of reviewing the
information in the database.
 The pharmacist should access information only when a prescription is
presented.
 The pharmacist must always adhere to federal and state privacy and
security laws, and act in a professional, ethical manner.
III. REVIEW OF PRESCRIPTION
 The pharmacist must take the time to comprehensively review the
prescription order the patient presents. The pharmacist may conduct the
following review steps in any order:
­ Review the prescription order for any changes or alterations.
­ Both handwritten and computer-generated prescriptions are
subject to alteration.
­ Check if the prescription appears to be a photocopy that might
indicate duplication of the original order by the patient.
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­ The pharmacist should specifically examine the date of the order,
the quantity and strength; and signature on the prescription
order to ensure that the prescriber’s handwritten signature is
included on the prescription as required by the DEA.
­ Any alterations must be brought to the attention of the
prescriber,
­ In the case of Schedule III-V medications, a pharmacist may
contact the prescriber to authorize a verbal telephone order for
prescriptions.
­ The pharmacist may not receive oral authorization for a Schedule
II controlled substance prescription.
­ Obtain treatment plan. If customers are submitting prescriptions
for large quantities of drugs.
­ Review the date issued, Review the medication, strength, dosage
form and quantity.
­ Document, document, document! The pharmacist regularly hears
this mantra for many actions taken in the pharmacy, but
documentation is even more important when verifying a
controlled substance prescription. The pharmacist must document
the steps they have taken to verify the prescription, including any
calls to the prescriber(s), conversations with the patient,
medication history review, and PMP access and review on the
prescription itself or in the pharmacy management system.
PHARMACY CONTROLS TO ENSURE APPROPRIATE DISPENSING
1. The pharmacist should take necessary actions to prevent widespread
prescription drug abuse and ensure appropriate dispensing in the
pharmacy.
2. Receive and validate prescription (print, DEA#, Date, Doctor name,
License # etc.)
3. Understand and interpret prescription (patient, medicine, dose)
4. Identify area prescribers who most often prescribe narcotic or dubious
prescriptions and review these prescriptions carefully
5. Communication by the pharmacist to both the prescriber and patient is
necessary because it may uncover rational reasons for prescribing .
6. Once the pharmacist identifies the prescribers and patients who should
be flagged, the pharmacist and pharmacy staff must ensure that all
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federal and provincial laws and regulations, and other protections, are
maintained when doing so
7. The pharmacist should implement a substance order management and
inventory system to closely monitor receipt and dispensing of drugs.
8. Prepare and label items for issue (self-checking, double checking,
counter checking, FEFO not FIFO, read the label twice), do not select
medicine based on color or place of the container, do not open many
containers at the same time.
9. Measure the tablets or capsules without touching them, use spatula,
clean white paper or lid of the container
10.Label should be kept upward while pouring medicine from container
11.Make final check and record actions taken
12.The pharmacist should review logbooks, perpetual inventory, invoices,
receipts and other pharmacy distribution records to flag excessive
ordering or dispensing by certain pharmacists or on certain shifts.
IMPROVING PATIENT COMPLIANCE WITH THERAPY
 Dispenser-patient communication
 Packaging for patient use
 Labeling
 Written information
DISPENSER-PATIENT COMMUNICATION
 Dispensers communicate with patients how to take drugs
 Ensuring their understanding is very important.
CONCLUSION
 Dispensing is a critical part of drug use
 Dispensing is often neglected in training and EDP programs
 Interventions exist to improve dispensing
 Patients benefit from better dispensing.
DRUG USE PROBLEM
 Drug misuse means using drugs in a way that harms you or causes you to
harm others. You can misuse illegal drugs, prescription drugs, or over-
the-counter drugs.
 Most of the time, a drug problem starts with casual use. You may not
think there will be a problem if you use a drug once or twice.
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 But drug use can become a drug problem and drug dependency, and it
sometimes happens quickly.
 The use of medications in both developed and developing countries
often shows a striking discrepancy with principles of clinically acceptable
practice.
 In most developing countries the sources of misuse range from travelling
drug peddlers and small grocery shops to prescribers in teaching
hospitals.
STEPS TO LEARN ABOUT THE DRUG USE PROBLEMS
1. EXAMINE
 Identify a priority drug use issue (e.g., poly-pharmacy, un-necessary
medication)
­ Which potential problems carry the highest clinical risk (DDIs)
­ Which involve expensive or widely used drugs (steroid use by GPs)
­ Which are potentially the easiest to correct (treatment guidelines
and EDL to avoid un-necessary medication)
 Collect data to measure current practices (how and what options are
available to collect data)
­ Which source of data will give you the best information (hospital
staff, patient, GPs)?
­ How large a sample is necessary to get reliable information?
­ What are the groups of interest e.g., doctors and nurses or public
sector and mission facilities?
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2. DIAGNOSE
 Identify specific problems and causes and describe in detail apparent
problems in drug use.
­ What specific practices are the problems (poor storage, lack of
knowledge, drug administration, adverse event)
­ What is an ideal practice (gold standard)?
­ Who are the most important providers, e.g., the influence
leaders in the community, or those with the best or worst
practices?
­ Are there high-risk patients, e.g., pregnant mothers or young
children?
 Identify the apparent causes of the problem.
­ What social and cultural factors influence practices?
­ Providers knowledge and belief
 Cultural forces and peer practices
 Patient demand and practices
­ How do economic constraints influence providers and patients?
 Identify constraints to change
­ Economic factors prevent change
­ Drug supply factors will hinder change
­ Work environment
3. TREAT
DESIGN AND IMPLEMENT INTERVENTIONS
 Select target behaviors to change and design an intervention program.
­ Which behaviors can be changed most cost effectively?
­ What are the possible economic consequences?
­ What are the most appropriate interventions, given their different
costs, complexities, and chances of success?
­ What personnel is required, and what training will they need?
 Acceptability and Effectiveness
­ Conduct pilot tests to determine the acceptability and
effectiveness of an intervention.
 Implement in stages
­ Implement the intervention and collect data to measure changes.
­ Is the intervention implemented as expected?
­ How can program impacts be measured?
­ Are the data reliable?
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4. FOLLOW UP
 Measure Changes in outcomes and evaluate the intervention's success.
­ Was the intervention implemented as planned, e.g., the number
of educational sessions or supervisory visits?
­ What are the measurable changes, e.g., in knowledge, beliefs,
patient satisfaction, clinical results, expenditures, etc.?
­ How cost effective is the intervention compared to other
strategies?
­ How generalizable are the results to other settings?
 Feedback results.
­ To program personnel, to providers, and to consumers, to
encourage them to maintain and increase positive changes.
­ Use results to improve the impact of the program or to guide
decisions about other problems to investigate.
COLLECTION OF DATA TO LEARN ABOUT DRUG USE
 Collect data to learn about the exact nature of the problem, and to find
out some of its underlying causes.
 Drug use encounter, a term which we use to describe the period of
interaction between a health provider who is offering care (including
pharmaceuticals) and a patient who is seeking care.
 Drug use encounters can occur in many places including:
­ Hospital inpatient units
­ Hospital outpatient
clinics
­ Health centers
­ Private physicians
­ Traditional healers'
practices
­ Licensed pharmacies
­ Drug retail shops
­ Marketplace stalls
 Drug use encounters may involve many different individuals in
recommending and selecting therapies, including:
­ Physician
­ Nurse
­ Clinical officer
­ Traditional healer
­ Injectionist
­ Dresser /Attendant
­ Pharmacist
­ Pharmacy clerk
­ Shopkeeper
­ Trader
­ Patient
­ Relative or friend
METHODS OF COLLECTING DATA
 Selection of method to be used depends on:
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­ The nature of the problem
 How complex is the behavior involved?
 How much is known about the problem already?
­ The objectives of collecting data
 Is the objective describing a problem, measuring change, or
monitoring performance?
 How much information is needed to choose among possible
interventions?
­ The availability of resources
 Are technical experts available to assist in processing and
analyzing data?
 Is there an existing source of data?
­ The time available
 How much time can be spent in gathering data?
 Is there a need to demonstrate short-term change?
 The data can be of two types;
I. Qualitative data
II. Quantitative data
QUANTITATIVE DATA
 Quantitative data, are numeric data collected in the form of counts,
rates, or classifications. Quantitative data are very useful for finding
out what practices are happening in a given situation, and how
often they are happening. These data can therefore be used to identify
specific problems or to measure the success of interventions to change
these problems.
 Opportunities for collecting quantitative data include:
­ Routinely reported data: The least costly alternative if data are
already available, reliable, and suitable to describe the problem
being studied.
­ Data gathered from record systems: Large samples of data can
often be collected retrospectively from medical or pharmacy
record systems at relatively low cost - the quality of the data may
be low since the data were often collected for other purposes.
­ Sample surveys: The most widely used method for collecting
health data, surveys gather information, once or at multiple points
in time, about a sample of people, health facilities, or events (e.g.,
prescribing encounters)
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 Quantitative methods describe drug use patterns, or pinpoint specific
problems that need attention.
 However, quantitative methods are usually not good for
understanding why these patterns or problems exist.
 Qualitative techniques are better suited to examine underlying feelings,
beliefs, attitudes, and motivations.
SOURCES OF QUANTITATIVE DATA ON DRUG USE
LOCATION OF DATA DATA SOURCES USEFUL FOR STUDYING
Public Sector
Administrative
Offices, Medical
Stores
RETROSPECTIVE: Drug supply
orders
- Stock cards
- Shipping and
delivery receipts
-Aggregate patterns of drug
use and expenditures
-Comparative use of
drugs within therapeutic classes
Health Facility,
Clinical Treatment
Areas and Medical
Record Departments
RETROSPECTIVE: Patient
registers
- Health worker logs
- Pharmacy receipts
- Medical records
PROSPECTIVE:
- Patient observations
- Patient exit surveys
- Inpatient surveys
-Aggregate patterns of drug use
and expenditures
- Drug use per case, overall
and by group (age, sex, health
problem, etc.)
- Provider-specific prescribing
patterns
- Features of patient prescriber
interaction
Health Facility
Pharmacies
RETROSPECTIVE: Pharmacy logs
- Prescriptions retained in
pharmacies
PROSPECTIVE:
- Patient exit surveys
- Patient observations
- Aggregate patterns of drug
use and expenditures
- Dispensing practices
- Features of patient-dispenser
interaction
Pharmacies and
Retail Drug Outlets
RETROSPECTIVE: Prescriptions
retained in pharmacies
PROSPECTIVE:
- Customer exit surveys
- Customer observations
- "Simulated visits"
- Private sector prescribing
practices drug sales without
prescription
- Self-medication practices
- features of customer sales
attendant interaction
Households
RETROSPECTIVE: Family
medical records
- Household surveys
PROSPECTIVE:
- Household drug audits
- Family medical records
- Total community drug use-
care-seeking behavior
- Self-medication practices
- Family drug use
- Patient compliance
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QUALITATIVE DATA
 Qualitative methods are based on talking to people or observing their
behavior. Qualitative methods often involve trained interviewers or
observers. However, managers and policy makers can use qualitative
methods to assess the factors that underlie a problem so that they can
decide how to solve it. Managers themselves do not need to know how
to carry out qualitative techniques, but only what these techniques are
and how they may be useful.
I. INTERVIEWS
OVERVIEW
 An extended discussion between a respondent and an interviewer based
on a brief interview guide that might cover between 10-30 topics.
 Guided by a list of open-ended topics rather than a set of fixed
questions, and the respondent is continually probed to provide more
depth and detail on these topics.
 Issues of interest to the respondent are allowed to emerge - often
completed with key informants, who may be opinion leaders or other
people in a special personal or professional position who are expected to
provide insights into the perspective of a group.
SCOPE
 A few (5-10) in-depth interviews with people who reflect the feelings of
a particular group will often be enough to get a feel for the important
issues.
 If the target population is diverse, generally 5-10 interviews would be
held with members of each important subgroup.
STRENGTHS
 Helps in establishing trust between the interviewer and respondent.
 Particularly useful with less educated or illiterate respondents, and in
cultural groups where abrupt, direct questioning is considered
inappropriate.
 Can generate unexpected insights or new ideas and information,
because the topics covered depend on the opinions and feelings of the
respondent.
WEAKNESSES
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 Time-consuming compared to more structured questionnaires.
 Analysis of large amounts of open-ended data can be difficult.
 Key informants may say what is socially acceptable or what they believe
the interviewer wants to hear.
 Interviewers must be well-trained to avoid bias and well-informed about
the material discussed.
II. DISCUSSIONS
OVERVIEW
 Moderated discussion about a defined set of topics among a small
number of participants (usually 6-10), who share key characteristics like
age, gender, or job.
 Focus groups typically last for 1-2 hours, and the conversation is usually
recorded so that details can be reviewed later.
 Participants talk under the guidance of a moderator who keeps the
discussion focused, ensures that everyone participates, and tries to
encourage the participants to discuss topics in-depth.
 An assistant, who does not take part in the discussion, takes notes about
the topics discussed, points of agreement and disagreement, and the
non-verbal interactions of the participants.
 An informal location (e.g., restaurant) and a relaxed atmosphere
encourages open, free-flowing conversation.
SCOPE
 The number of FGDs conducted depends on the target population; if the
target population is homogeneous, fewer groups are needed, but if the
population is diverse, generally 2-4 groups would be held for each
important subgroup.
 Subgroups are usually defined on the basis of factors like urban-rural
location; level of prescriber training; type and size of health facility; or
even quality of previous practices (e.g., health workers who follow
standard treatment norms vs. those who do not).
STRENGTH
 Useful in finding out how people behave and why they behave
differently.
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 Inexpensive to conduct and quick to organize; often the entire process
of planning, recruiting participants, holding discussions, and analyzing
data can take place in as little as 2-3 weeks.
 The exchange of ideas and the support of other participants encourage
participants to express feelings and beliefs.
 Can be very useful in anticipating responses or misunderstanding about
educational materials prepared for an intervention.
WEAKNESSES
 Because participants are not chosen randomly and because only a few
groups are held, opinions and attitudes may not represent the larger
population.
 The success of focus groups depends on the skill of the moderator in
encouraging meaningful discussion among participants.
 The analysis of focus group data can be very subjective and highly
influenced by the biases of the analyst.
 FGDs are good at finding out the direction of behavior, but they only
indicate frequency of behavior in very general terms.
 Some discussions may distort or exaggerate feelings of certain
participants, or they may be dominated by a few strong-willed
individuals.
III. OBSERVATIONS
OVERVIEW
 Systematic observations by trained observers of a series of encounters
between health providers and patients.
 Data can be recorded as a list of observed behaviors and impressions, or
by scoring each interaction on a predetermined set of indicators and
scales.
 In a typical study, a trained observer would first get to know the health
providers to be observed and would introduce a non-threatening reason
for the observations, in order to make their behavior as natural as
possible.
 Observers sometimes keep a diary to record their feelings about the
setting being observed and features of patients or providers that seem
related to observed practices.
SCOPE
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 Observation studies vary greatly in scope. If we want to quantify the
frequency of certain behaviors, the number of encounters observed
needs to be rather large, at least 30 or more in each category of interest
 If we want to understand the typical features of clinical episodes, a few
days' observation in five or six carefully selected settings might be
enough.
STRENGTHS
 Observations are the only feasible way to learn systematically about
what happens during the complex interactions between persons seeking
care and medical providers.
 They are the best method to study issues like patient demand, the
influence of sales attendants on customers' selection of products, or the
quality of communication between prescribers and patients.
 Because health providers are seen in their working environment,
observers can gain insights about behavior that are impossible for an
outsider to obtain.
WEAKNESSES
 Presence of observers may cause shifts towards socially appropriate
behavior; however, in many settings observers "blend in" over time.
 Observation studies require skilled observers, who can make people feel
at ease, and also be careful and unbiased in reporting their observations.
 Observation is less useful when the behaviors of interest occur
infrequently or for only a subgroup of encounters (e.g., for specific age
groups or diagnoses)
IV. QUESTIONNAIRES
OVERVIEW
 Questionnaires contain a fixed set of items that are asked to a large
sample of respondents selected according to strict rules to represent a
larger population.
 Questionnaires are usually administered by interviewers trained to
collect this kind of information in a standardized way.
 Can focus on material that is factual, such as what respondents know, or
on factors that are harder to quantify like attitudes, opinions, or beliefs.
 In contrast to an in-depth interview, all questions are identified in
advance, and each respondent is asked precisely the same questions.
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 Answers are often limited to a fixed set of response categories; if
questions are open-ended, they are coded later according to fixed
criteria.
SCOPE
 Questionnaire surveys usually include at least 50-75 respondents from
the target population.
 If the target population has several subgroups with potentially different
levels of knowledge, attitudes, or opinions, then the sample would
usually include at least 50-75 randomly selected persons from each
subgroup.
 The required sample size depends on the nature of the target
population, how the sample is drawn, the desired degree of accuracy,
and available resources.
STRENGTHS
 Questionnaires are familiar and understandable to most people,
including health managers and respondents.
 Skills required to develop survey forms, design samples, collect and
process data, and analyze results are often locally available.
 Questionnaire surveys are the best method to find out:
1. The frequency of specific behaviors
2. The relative strength of different attitudes and opinions
3. Characteristics of the target population.
WEAKNESSES
 Attitudes and opinions are often difficult to quantify.
 People will sometimes give an answer when asked a direct question,
even if the question is irrelevant or if none of the responses apply.
 Many respondents tend to answer what they feel interviewers expect to
hear.
 Results are sensitive to which questions are asked, and how they are
worded.
 For populations that are not homogeneous, the samples needed are
large, requiring many interviewers or a long period of time to collect the
data.
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SAMPLING TO STUDY DRUG USE
OBJECTIVES
 Describe the principles on which sampling is based
 Identify and describe different sampling methods
 Select a sample of health facilities from a list using at least two different
methods
 Compare the results of the methods
 Instruct others how to sample for drug use studies.
SAMPLING
 Sampling is a process by which we study a small part of a population to
make judgments about the entire population.
 Sampling involves selecting a number of units from a defined
population.
SAMPLING DEFINITIONS
SAMPLING UNIT
 The thing that is sampled: for example, a person, clinical episode, or
health facility.
STUDY POPULATION
 All the sampling units that could possibly be included in the sample.
SAMPLING FRAME
 A list of all the available sampling units in the study population.
REPRESENTATIVE SAMPLE
 A representative sample has all the important characteristics of the
study population from which it is drawn.
SAMPLING METHODS
 Two categories of sampling methods
­ Non-probability sampling
­ Probability sampling
1. NON-PROBABILITY SAMPLING
 Non-probability sampling does not involve random selection. Does that
mean that non-probability samples are not representative of the
population? Not necessarily. But it does mean that non-probability
samples cannot depend upon the rationale of probability theory.
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 With non-probability samples, we may or may not represent the
population well, and it will often be hard for us to know how well we
have done so.
I. CONVENIENCE SAMPLING
 Study units available at the time of data collection are selected for the
sample.
 Example: I would include in this category the traditional "man on the
street" (of course, now it is probably the "person on the street"),
interviews conducted frequently by television news programs to get a
quick (although nonrepresentative) reading of public opinion. I would
also argue that the typical use of college students in much psychological
research is primarily a matter of convenience.
II. QUOTA SAMPLING
 Different categories of sample units are included until a certain number
has been reached in each category. In quota sampling, you select people
non-randomly according to some fixed quota. There are two types of
quota sampling: proportional and non-proportional:
 Proportional Quota Sampling
­ For instance, if you know that population has 40% women and
60% men, and you want a total sample size of 100, you will
continue sampling until you get those percentages.
­ So, if you have already got the 40 women for your sample, but not
the sixty men, you will continue to sample men but even if
legitimate women respondents come along, you will not sample
them because you have already "met your quota.
 Non-Proportional Quota Sampling
­ In this method, you specify the minimum number of sampled units
you want in each category. here, you are not concerned with
having numbers that match the proportions in the population.
­ Instead, you simply want to have enough to assure that you will
be able to talk about even small groups in the population
2. PROBABILITY SAMPLING
 A probability sampling method is any method of sampling that utilizes
some form of random selection.
 In order to have a random selection method, you must set up some
process or procedure that assures that the different units in your
population have equal probabilities of being chosen.
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 Humans have long practiced various forms of random selection, such as
picking a name out of a hat.
I. SIMPLE RANDOM SAMPLING
 Used in situations where the number of sampling units is relatively
small.
 Process of Simple Random Sampling:
­ Identify all possible units available for sampling
­ Decide on the size of the sample
­ Choose units by a lottery method or use computers to generate
random numbers.
II. SYSTEMATIC SAMPLING
 Systematic sampling with equal probability:
­ Numbered list of all possible units
­ # units  desired sample size = sampling interval
­ Random # x sampling interval = random start
­ Round number up to choose sample unit
­ Add sampling interval to random start for subsequent units.
 Systematic sampling with probability proportional to size:
­ Units are sorted in decreasing order by some measure of size (like
population or number of visits)
­ Calculate the cumulative total
­ Cumulative total  sample size = sampling interval
­ Random # x sampling interval = random start
­ Add sampling interval to previous total for subsequent units.
III. STRATIFIED SAMPLING
 Used when the sampling frame contains clearly different categories
(strata), For example,
­ Urban and rural facilities
­ Facilities with and without doctors
­ Government and mission facilities.
 Process of Stratified Sampling:
­ Organize the list of sampling units by stratum
­ Select units within each stratum using a random method (simple
random sampling or systematic sampling).
 It ensures that you will be able to represent not only the overall
population but also the sub-groups.
IV. CLUSTER SAMPLING
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 Used when, for logistic reasons, it is easier to select sample units in
groups.
 Process of Cluster Sampling:
­ Select a cluster of sample units – area or geographical. Example:
health center with multiple prescribers or Islamabad, Rawalpindi.
­ Include the entire cluster or select a subsample or Select a
random sample unit to start each cluster (a house, a patient, etc.)
­ Include neighboring sample units until a certain cluster size is
reached.
V. MULTISTAGE SAMPLING
 Combine the simple methods described earlier in a variety of useful
ways that help us address our sampling needs in the most efficient and
effective manner. When we combine sampling methods, we call this
multi-stage sampling.
 Randomly select primary sampling units at the first stage:
­ Specific communities
­ Specific health facilities
 Within the primary sampling units, randomly select the final sampling
units at the second stage:
­ Drug use encounters
­ Patients
­ Prescribers
 Sometimes in complex samples, additional stages are needed. For
example, consider the idea of sampling Punjab Province residents for
face-to-face interviews. We might sample various districts throughout
the province – cluster sampling but still difficult So, we might set up a
stratified sampling process within the clusters.
 In this case, we would have a two-stage sampling process with stratified
samples within cluster samples cities and then districts.
DRUG USE INDICATORS
 Appropriate use of drugs is one essential element in achieving quality of
health and medical care for patients and the community as a whole.
 To improve drug use practices:
­ An essential tool for such work is an objective method to measure
drug use in health facilities that will describe drug use patterns
and prescribing behavior.
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­ The drug use indicators are intended to measure specific aspects
of the behavior of health providers in health facilities in a
reproducible manner, irrespective of who measures them
or when the measures are taken.
WHO/INRUD (WORLD HEALTH ORGANIZATION/INTERNATIONAL NETWORK OF
RATIONAL USE OF DRUGS)
 Developed drug use indicators to be used as measures of performance in
three general areas related to the rational use of drugs in primary care.
They are called core drug use indicators.
TYPES OF INDICATORS
 Prescribing indicators
 Patient care indicators
 Health facility indicators
1. PRESCRIBING INDICATORS
 The indicators of prescribing practices:
­ Measure the performance of health care providers.
­ Measure several key dimensions for appropriate use of drugs.
 Include practices observed in a sample of clinical encounters taking place
at outpatient health facilities for the treatment of acute or chronic
illness.
 These encounters can be observed
­ Retrospectively
­ Prospectively
AVERAGE NUMBER OF DRUGS PER ENCOUNTER
 Purpose - To measure the degree of polypharmacy.
 Prerequisites - Combination drugs are counted as one.
 Calculation - Average, calculated by dividing the total number of
different drug products prescribed, by the number of encounters
surveyed. It is not relevant whether the patient actually received the
drugs.
 Example - In health centers in Indonesia patients are prescribed an
average of 3.3 drugs per consultation.
PERCENTAGE OF DRUGS PRESCRIBED BY GENERIC NAME
 Purpose - To measure the tendency to prescribe by generic name.
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 Prerequisites - Investigators must be aware of actual names used in the
prescription rather than only having access to the names of the products
dispensed.
 Calculation - Percentage
 Example - In health units in Nepal an average of 44% of drugs are
prescribed by generic name.
PERCENTAGE OF ENCOUNTERS WITH AN ANTIBIOTIC/INJECTION PRESCRIBED
 Purpose - To measure the overall level of use of two important, but
commonly overused and costly forms of drug therapy.
 Prerequisites - A list must be available of all the drug products which are
to be counted as antibiotics; investigators must be instructed about
which immunizations are not to be counted as injections.
 Calculation - Percentages
 Example - In dispensaries in Nigeria 48% of all outpatient encounters
were prescribed one or more antibiotics, while an injection was
prescribed during 37% of all consultations.
PERCENTAGE OF DRUGS PRESCRIBED FROM ESSENTIAL DRUGS LIST OR
FORMULARY
 Purpose - To measure the degree to which practices conform to a
national drug policy.
 Prerequisites - Copies of a published national essential drugs list or local
institutional formulary to which data on prescribed drugs can be
compared.
 Calculation - Percentage
 Example - In dispensaries in Tanzania on average 88% of drugs
prescribed appeared on the national essential drugs list.
2. PATIENT CARE INDICATORS
 To understand way drugs are used it is important to consider what takes
place at health facilities from both the provider's and the patient's
perspectives. Patients - with a set of symptoms and complaints, and with
expectations about the care they will receive - leave with a package of
drugs or with a prescription to obtain them in the private market.
 The patient care indicators - what patients experience at health facilities,
and how well they have been prepared to deal with the pharmaceuticals
that have been prescribed and dispensed.
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AVERAGE CONSULTATION TIME
 Purpose - To measure the time that medical personnel spend with
patients.
 Prerequisites - accurate recording - the time between entering and
leaving the consultation room. Waiting time is not included.
 Calculation - Average, calculated by dividing the total time for a series of
consultations, by the number of consultations.
 Example - In Malawi patients spend an average of 2.3 minutes with
health workers in the consultation room.
AVERAGE DISPENSING TIME
 Purpose - To measure the average time that personnel dispensing drugs
spend with patients.
 Prerequisites - accurately recording the average time patients spent with
pharmacists, - the time between arriving at the dispensary counter and
leaving. Waiting time is not included.
 Calculation - Average, calculated by dividing the total time for dispensing
drugs to a series of patients, by the number of encounters.
 Example - In health centers in Tanzania patients spend an average of 78
seconds receiving their drugs.
PERCENTAGE OF DRUGS ACTUALLY DISPENSED
 Purpose - degree to which health facilities are able to provide the drugs
which were prescribed.
 Prerequisites - Information on which drugs were prescribed, and
whether these drugs were actually dispensed at the health facility.
 Calculation - Percentage,
 Example - In health facilities in Nepal, 73% of prescribed drugs were
actually dispensed at the health facility.
PERCENTAGE OF DRUGS ADEQUATELY LABELLED
 Purpose - degree to which dispensers record essential information on
the drug packages they dispense.
 Prerequisites - Investigators must be able to examine the drug packages
as they are actually dispensed at the health facility.
 Calculation - Percentage,
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 Example - In Region A only 10.2% of drugs dispensed were adequately
labelled.
PATIENTS' KNOWLEDGE OF CORRECT DOSAGE
 Purpose - effectiveness of the information given to patients on the
dosage schedule of the drugs they receive.
 Prerequisites - Access to a written prescription or to a patient card
against which patients' knowledge on the dosage schedule can be
checked
 Calculation - Percentage,
 Example - In 23 health facilities in Bangladesh 63% of patients were able
to repeat the correct dosage schedule of the drugs they had received.
3. HEALTH FACILITY INDICATORS
 The ability to prescribe drugs rationally is influenced by many features of
the working environment.
 Two particularly important components
­ An adequate supply of essential drugs
­ Access to unbiased information about these drugs.
AVAILABILITY OF COPY OF ESSENTIAL DRUGS LIST OR FORMULARY
 Purpose - extent to which copies of the national essential drugs list or
local formulary are available at health facilities.
 Prerequisites - A national essential drugs list or a local formulary must
exist for that level of care.
 Calculation - Yes or no, per facility.
 Example - In Country A only 28% of health facilities had a copy of the
national list of essential drugs.
AVAILABILITY OF KEY DRUGS
 Purpose - availability at health facilities of key drugs - common health
problems.
 Prerequisites - A short list of 10-15 essential drugs must be compiled
that should always be available.
 Calculation - Percentage, available/stock * 100
 Example - In health centers in Nigeria, on average 62% of 14 key
essential drugs were actually in stock.
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STUDY DESIGN OF DRUG USE INDICATOR
 Three main objectives
­ To describe current treatment practices
­ To compare performances of individual facilities and prescribers
­ Monitor drug use behaviors
SELECTION OF FACILITY
 The first activity is to select the type of health facilities to be studied,
drawing randomly from a larger group of facilities. Prescribing indicators
measure aspects of outpatient treatment. They are designed for use in
health centers, dispensaries or hospital outpatient departments, both
public and private.
 In general, a single drug use study would focus on one type of facility, so
that the results make sense. The prescribing indicators are less useful in
inpatient settings, or in specialty outpatient clinics in referral hospitals
where the drug use patterns are more complex.
TYPE OF PRESCRIBING ENCOUNTER TO BE INCLUDED
 In addition to general medical visits for acute or chronic illness, there
can be separate clinics for well-child visits, pre-natal and post-natal
visits, dental visits, specialist consultations, and so forth. Adult,
paedreatics, new patients or re-attendants. Treatment practices for
these different types of encounters can be quite different.
 A study which mixes different types of encounters in an unsystematic
way will produce results that are difficult to interpret. Indicators studies
should be restricted to a sample of general illness encounters,
representing a mix of health problems and ages.
CHOOSE – RETROSPECTIVE OR PROSPECTIVE DATA
RETROSPECTIVE
 Drawing random encounters from historical medical records
 If adequate resources of retrospective data exist
 Include – clinical registers, treatment records and copies of prescriptions
 Method of selecting random sample of patient encounter
 Specific names and routes of drug administrations
 Major weakness – incomplete.
PROSPECTIVE
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 Data from the patients as they present for the treatment in patient care
and facility indicators always require the collection of prospective data.
 Prospective data is often complete and generally collected over a short
period of time.
 Major weakness:
­ May exist biases
­ Seasonality, peculiarities in staffing
­ Providers know they are being observed
­ Results in socially desirable directions
SAMPLE SIZE OF DRUG USE INDICATORS
 Studies of drug use practices sometimes use an incorrect unit of analysis.
 Prescribing practices in a group of health facilities can be thought of in a
variety of different ways which include:
­ Areas or locations - a sample may include different regions or
districts; or within a single region, it might include urban, peri-
urban and rural areas.
­ Health facilities - a sample may be drawn from a number of health
facilities of the same type, or from different types of facilities such
as hospital outpatient departments, polyclinics and health
centers.
­ Health providers - sometimes it will be possible to know the
identity and background of the individual providers (doctors,
nurses, paramedical workers, pharmacists) who treated patients
in the sample, and to examine provider-specific differences in
treatment patterns;
­ Prescribing encounters - encounters are collected from several
health facilities in the sample and studied as a whole.
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INTRODUCTION TO ESSENTIAL DRUGS
DEFINITION
Essential medicines, as defined by the World Health Organization, are the
“medicines that satisfy the priority health care needs of the population"
THE CONCEPT OF ESSENTIAL MEDICINES
 A limited range of carefully selected essential medicines leads to better
health care, better drug management, and lower costs. These are the
medications to which people should have access at all times in sufficient
amounts. The prices should be at generally affordable levels.
 These essential medicines should be:
­ Available at all times
­ In adequate quantities
­ In appropriate dosage forms
­ At affordable prices.
EDL BACKGROUND
 Twenty-eighth World Health Assembly in 1975, EDL idea was
materialized. The Director General pointed out that the selection of
essential drugs would depend on the health needs and on the structure
and development of the health services of each country. Lists of
essential drugs should be drawn up locally, and periodically updated,
with the advice of experts in public health, medicine, pharmacology,
pharmacy and drug management. By resolution WHA 28.66 the
Assembly requested the Director-General to advise Member States on
the selection and procurement, at reasonable costs, of essential drugs
corresponding to their national health needs.
 Following wide consultation, an initial Model List of Essential Drugs was
included in the first report of the Expert Committee on the Selection of
Essential Drugs in 1977. The concept of essential drugs was quickly taken
up by Member States: by the end of 1998 about 140 countries had
developed their own national lists of essential drugs, often in
combination with standard treatment guide-lines and stratified
according to the level of care. Many countries have also successfully
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applied the concept to teaching hospitals and facilities providing
specialized care. Health insurance schemes increasingly use national lists
of essential drugs as a reference.
HISTORY
 The first WHO EDL was published in 1975 – including 220 medicine and
vaccines. List is revised every two years by WHO expert committee. In
2002, revised procedure approved by WHO. Revisions were made
essential to provide up to date information due to constant change in
medical needs of population and due to availability of newer medicines.
 The term essential drug list (EDL) was replaced by essential medicine list
(EML), due to wrong notion of general pubic as specific drugs as
potential of abuse. Requirement of EML may vary from country to
country and even with in a state – essential drugs one country may not
be essential to another due to disease prevalence and economic
conditions. Keeping this in view, WHO made a list of EML which serve as
a guide for other countries to develop their own. WHO gave freedom to
the countries to add or delete drugs as per their requirements.
RATIONALE BEHIND THE ESTABLISHMENT OF EDL
 Advancement of science and technology gave birth to numerous brands
of drugs – indiscriminately marketed sans taking into account health
care needs of local population. Another important and major concern is
that population belonging to the rural areas could not access the
essential drugs.
 The reality that for millions of people – particularly poor and
disadvantaged – the medicine are unavailable, unaffordable, unsafe and
improperly used.
 More than 156 countries have a national list of essential drugs, out of
which 81% have been updated in the last 5 years and one third in two
years. In 2007, 30 years after the introduction of essential medicine
concept, a model EML for children was also introduced. But it does not
mean that drugs mentioned are limited, thus it should not be viewed
that those drugs that do not find a mention in EML are not useful.
EDL IN PRACTICE
 Model lists have proved to be valuable in improving the quality of health
care and reducing costs. Better quality of care is achieved when the list
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43. Chapter 2 – Introduction to Essential Drugs
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of essential drugs is linked to evidence-based treatment guidelines,
especially when the supply system guarantees the availability of the
selected drugs. Treatment guidelines can also focus training and serve as
a standard for supervision and medical audit; prescribers become more
familiar with the drugs and can better recognize adverse drug reactions.
Lower costs are achieved through selecting cost-effective treatment.
 A limited range of drugs in the supply system may lead to economies of
scale and competition between manufacturers, further reducing the
costs. Market approval of a pharmaceutical product is usually granted on
the basis of efficacy, safety and quality and rarely on the basis of a
comparison with other products already on the market, or cost.
However, in some developing and most developed countries the
majority of drug costs are covered by public funds or through health
insurance schemes. Most public drug procurement and insurance
schemes have mechanisms to limit procurement or reimbursement of
drug costs.
 An evaluation process is therefore necessary, based on a comparison
between various drug products and on cost/benefit considerations. The
advantage of a new treatment over the existing one is then compared to
its extra cost. Such information has proved very helpful in taking
informed decisions about the selection of essential drugs. The model list
is intended to help with this evaluation.
EDL CONCEPT AND RATIONALIZATION OF DRUG USE IN HEALTH CARE
 Greater international coordination – whether drug donations are
needed. Shorter lists are valuable in emergency situations. Model lists
are informational and educational tools for health professionals and
consumers. Addresses issued related to drug use. Helpful in developing
strategies of drug procurement, supply, donations, financing, research
priorities for drug use in specific diseases.
RECENT TREND
 The first lists - a means to guide the procurement of drugs. In recent
years, more emphasis has been placed on the development of treatment
guidelines as the basis for drug selection and supply, and on the
evidence underlying the development of those treatment guidelines.
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EDL AND DEGREE OF EXPERTISE
 Now many medications which require a high degree of expertise to
ensure safe and effective use. Adequate specialist skills and
complementary resources are needed before the introduction of some
classes of drugs.
 Examples of situations where specialist control of drug use is necessary
are:
­ The use of reserve antimicrobials for multidrug-resistant bacteria.
­ Establishing adequate regimens for treatment of tuberculosis and
leprosy.
­ The use of antineoplastic and immunosuppressive drugs. The use
of antiretroviral drugs.
­ The use of antimicrobial, antifungal and antiviral agents for the
treatment of opportunistic infections in immunocompromised
patients.
PRINCIPLES UNDERLYING THE CONCEPT OF EDL
 Medicine list only comprises a selected number of medicines that could
be used effectively in treating numerous conditions in majority of
population. These limited drugs can be procured, distributed and utilized
in a more rational, economic and efficient manner.
 Since the drugs in the list have proven benefits, efficacy and safety, the
prescribers should be trained and educated in the use of drugs. The
personnel involved in the health care system should educate patients
regarding their drug therapy which becomes easy with limited number
of drugs.
EDL – A COMMON CORE
 A tentative identification of a “common core” of basic drugs which have
universal relevance and applicability with the full understanding that
exclusion does not imply rejection.
 This does not imply that no other drugs are useful, but simply that these
basic drugs, when used in accordance with appropriate therapeutic
guidelines, are the most cost-effective for meeting the health care needs
of majority of the population.
 In certain situations, there is a need to make available additional drugs
essential for rare diseases. (orphan drugs)
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MODEL LIST OF ESSENTIAL MEDICINE
 The classification of drugs has been done based on the therapeutic
indication. The model list comprises of 27 classes in alphabetic order.
Each class of therapeutic agent have been further subdivided
­ E.g. anti-infective drugs are subdivided into anthelmintics, anti-
fungal and anti-bacterial.
 The drugs that are mentioned in the list are those that are commonly
used and easily available dosage forms.
ESSENTIAL MEDICINES WHO MODEL LIST
1. Anesthetics
1.1 General anesthetics and oxygen
1.1.1 Inhalation medicines
Halothane Inhalation
Isoflurane Inhalation
Nitrous oxide Inhalation
Oxygen Inhalation (medicinal gas).
1.1.2 Injectable medicines
Ketamine Injection: 50 Mg (as hydrochloride)/ml in 10-ml
vial.
Propofol Injection: 10 mg/ml: 20 mg/ml.
1.2 Local anesthetics
□ Bupivacaine Injection: 0.25%; 0.5% (hydrochloride) in vial.
Injection for spinal anesthesia: 0.5%
(hydrochloride) in 4-ml ampoule to be mixed
with 7.5% glucose solution.
□ Lidocaine Injection: 1%; 2% (hydrochloride) in vial.
Injection for spinal anesthesia: 5%
(hydrochloride) in 2-ml ampoule to be mixed
with 7.5% glucose solution.
Topical forms: 2% to 4% (hydrochloride).
Lidocaine + Epinephrine (Adrenaline) Dental cartridge: 2% (hydrochloride) +
epinephrine 1:80 000.
Injection: 1%; 2% (hydrochloride or sulfate) +
epinephrine 1:200 000 in vial.
Complementary List
Ephedrine Injection: 30 mg (hydrochloride)/ml in 1-ml
ampoule.
(For use in spinal anesthesia during delivery, to
prevent hypotension).
1.3 Preoperative medication and sedation for short-term procedures
Atropine Injection: 1 mg (sulfate) in 1-ml ampoule.
□ Midazolam Injection: 1 mg/ml.
Oral liquid: 2 mg/ml [c].
Tablet: 7.5 mg; 15 mg.
Morphine Injection: 10 mg (sulfate or hydrochloride) in 1-ml
ampoule.
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 The square box symbol (□) is primarily intended to indicate similar clinical performance
within a pharmacological class.
 Where the [c], symbol is placed next to the complementary list it signifies that the
medicine(s) require(s) specialist diagnostic or monitoring facilities, and/or specialist medical
care, and/or specialist training for their use in children.
 The generic names of drugs have been used which is accompanied by their respective doses
and available dosage forms.
Clinical guidelines and a list of essential medicines lead to better prevention and care
CRITERIA FOR SELECTING EDL
 The selection of drugs should be based on the experience rather than on
opinion. These medicines with long history of safety and efficacy
determined by clinical studies should be included. Inclusion of fewer
drugs should be made only when these drugs offer any significant
advantage over the existing ones. The quality, bioavailability and
stability should be the set standards.
 The choice of essential medicines depends on several factors, including
the disease burden and sound & adequate data on the efficacy, safety
and comparative cost- effectiveness of available treatments.
 Stability in various conditions, the need for special diagnostic or
treatment facilities and pharmacokinetic properties are also considered
if appropriate. Most essential medicines should be formulated as single
compounds. Fixed-ratio combination products are selected only when
the combination has a proven advantage in therapeutic effect, safety or
compliance over single compounds administered separately.
- Examples of combination medicines that have met these criteria
include new formulations for tuberculosis and malaria.
 In cost comparisons between medicines, the cost of the total treatment,
and not only the unit cost of the medicine, is considered. Cost and cost-
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effectiveness comparisons may be made among alternative treatments
within the same therapeutic group but will generally not be made across
therapeutic categories (for example, between treatment of tuberculosis
and treatment of malaria). The absolute cost of the treatment will not
constitute a reason to exclude a medicine from the Model List that
otherwise meets the stated selected criteria.
- The patent status of a medicine is not considered in selecting
medicines for the Model List. In cases where two drugs bear close
resemblance with respect to efficacy, stability, bioavailability etc.
then the drug with thorough investigation should be selected:
- Which has more appealing PK parameters.
- Which can be prepared in appreciable quantity and quality at an
affordable cost.
 The cost to benefit ratio is an important criteria, in simple terms rather
than unit cost – total cost of the treatment should be taken into account.
 WHO maintains that a single drug or an active ingredient should find a
mention in EML. The fixed combination drugs should be mentioned only
when they offer relatively better therapeutic efficacy, safety patient
compliance etc.
 If pharmaceutical dosage form is the criteria for selecting drugs, then the
following guidelines should be considered:
- The dosage form which has appreciable utility and widely
available should be selected.
- PK profile and extent of bioavailability.
- Stability of the dosage form under the storage conditions
prevalent in the area.
- Dosage forms for special groups like pediatrics, geriatrics and
pregnancy.
- The controlled and sustained release forms of short acting drugs
should find a mention only accompanied with justifiable
documentation.
FACTORS AFFECTING EDL CRITERIA
1. Pattern of prevalent diseases
2. The treatment facilities
3. The training and experience of the available personnel
4. The financial resources
5. Genetic, demographic and environmental factors.
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6. Some drugs are considered essential only if a therapeutic program is
planned to address the diseases for which these drugs are used.
- For example, the cytotoxic drugs are essential only if a
comprehensive cancer treatment program is planned. Such a
program requires adequate hospital, diagnostic and clinical
laboratory facilities for its implementation.
7. In contrast, the drugs used in palliative care are always essential, even
when a comprehensive cancer treatment program does not exist.
CONSIDERATION OF PHARMACEUTICAL DOSAGE FORM
 As a general rule, pharmaceutical forms are selected on the basis of their
general utility and wide availability internationally. In many instances, a
choice of preparations is provided, particularly in relation to solid dosage
forms. Tablets are usually less expensive than capsules, but, while cost
should be taken into account, the selection should also be based on a
consideration of pharmacokinetics, bioavailability, stability under
ambient climatic conditions, availability of excipients, and established
local preference.
 In a few instances where there is no uniformity of tablet strength (for
example acetylsalicylic acid and paracetamol), a dosage range is
provided from within which suitable tablet strengths should be selected
on the basis of local availability and need. Specific pediatric dosages and
formulations are included in the list only when indicated by special
circumstances. In many instances, dosage is specified in terms of a
selected salt or ester, but in others (for example chloroquine) it is
calculated, in accordance with common practice, in terms of the active
moiety.
 For certain drugs with short half-lives that are rapidly metabolized, such
as carbamazepine, calcium-channel blockers and theophylline,
conventional-release dosage forms must often be taken three or four
times a day to maintain drug levels in the required narrow range.
Sustained release dosage forms can reduce the frequency of drug
administration, thereby improving compliance and, often, the
therapeutic effectiveness of the drug by maintaining a more constant
drug level than can be obtained using traditional dosage forms. Because
the preparation of sustained-release products is difficult and requires
special expertise, a proposal to include such a product in a national list
of essential drugs should be justified by adequate documentation.
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STEPS IN THE DEVELOPMENT OF EDL
1. Prioritize a list of common problems/diseases being treated in the
hospital and determine the first choice of treatment for each problem.
2. Draft, circulate for comment, and finalize the formulary list.
3. Develop policies and guidelines for implementation.
4. Educate staff about the formulary list and monitor implementation.
5. Managing a formulary list (EML): adding and deleting drugs.
PRINCIPLES OF EML MANAGEMENT
1. Select drugs according to the needs of patients.
2. Select drugs of choice for the conditions identified.
3. Avoid duplications, both therapeutic and pharmaceutical (dosage
forms).
4. Use explicit selection criteria, based on proven efficacy, safety, quality
and cost.
5. Use evidence-based information whenever possible.
6. Be consistent with national EMLs and STGs.
7. Consider requests for the addition of new drugs only when made by
health-care staff, not by the pharmaceutical industry.
8. Require that requests for the addition of new drugs are justified using
documented evidence on efficacy, relative efficacy, safety and
comparative cost-effectiveness and that the person requesting any new
drug declare any conflict of interest.
9. Carry out annual systematic reviews of all therapeutic classes to avoid
duplication.
QUALITY ASSURANCE OF EDL
 Priority should be given to ensuring that the available drugs have been
made according to good manufacturing practices and are of generally
recognized quality. This requires knowledge of and confidence in the
origin of the product. The risks of procuring drugs from anonymous
sources cannot be over stressed.
 It is recommended that drugs should be purchased directly from known
manufacturers, their duly accredited agents or recognized international
agencies known to apply high standards in selecting their suppliers.
 Quality assurance of drugs, as embodied in product development, good
manufacturing practice and subsequent monitoring of quality
throughout the distribution chain to utilization, is a crucial element in
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any essential drug program. The importance of the bioavailability of
drugs in the assessment of their quality.
PHARMACO-VIGILANCE AND EDL
 Little is known about the clinical consequences of different prescribing
patterns between countries or between regions within a country.
Systematic and comprehensive data are available on the use of drugs
after they have been marketed, However, data are often not used to
their full potential or in accordance with generally accepted criteria.
 Moreover, data on the effects of overdose and uncommon or long-term
adverse effects are usually not available at the time of registration. To
optimize the usefulness and/or benefits of drugs in actual use,
continuing pharmaco-vigilance is needed.
BENEFITS OF EDL
1. The concept helps to focus the national revenue to the essential
medicines, required by majority of the drugs thereby decreasing the
foreign exchange.
2. This concept is basically concerned with increasing the availability of
essential drugs to the hardest populations residing in the rural areas.
3. The essential drugs list proves to be beneficial which eases the problems
encountered drug prescription. Moreover, limited no. of drugs in the list
ease the process of dispensing and enhance the patient compliance.
4. Due to limited no. of essential drugs mentioned in the list, their
procurement, supply and storage can be made in systemic manner. This
ultimately assures continuous supply, effective management of stock
and reduction in waste.
5. The essential drug concept though indirectly may prove to be beneficial
in reducing the poverty, the easy availability of the health care and
improves the standard of living.
ADVANTAGES
 Better procurement policies
 Better transport and management
 Recusing the cost of procurement
 Effective monitoring and evaluation of pharmaceutical use
 Effective control of pharmaceuticals in public circulation
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 Enforcing rational prescribing by focusing on limited list of
pharmaceuticals.
COMPULSORY TO ONLY PRESCRIBE DRUGS UNDER THE MODEL
 It allows the countries, states or even hospital to compile an EML of their
own according to their needs (WHO model list serve as a guide)
 The list being flexible can be regularly updated to keep up with the rapid
advancements made in the field of pharmacy.
A CONTINUAL PROCESS
 The selection of essential drugs is a continuous process, which should
take into account changing public health priorities and epidemiological
conditions, as well as progress in pharmacological and pharmaceutical
knowledge.
 It should be accompanied by a concomitant effort to supply information
and provide education and training to health personnel in the proper
use of the drugs.
STEPS IN REVIEW OF APPLICATIONS TO THE MODEL LIST
1 Summary of application posted on WHO Medicines website.
2 Specialist assessment of comparative efficacy, safety and cost-
effectiveness.
3 Review of assessments by Expert Committee member (“presenter”);
formulation of draft recommendation.
4 Review of draft recommendation by relevant Expert Advisory Panel
members; and posted on WHO Medicines website.
5 Review by presenter, prepares final draft recommendation.
6 Discussion of draft recommendation and proposed text for WHO Model
Formulary by the Expert Committee.
PAKISTAN DRUG POLICY
1 The specific objective of the National Drug Policy are as under:
a. To develop and promote the concept of essential drugs ensure
regular, uninterrupted and adequate availability of such drugs of
acceptable quality and at reasonable prices.
b. To inculcate (educate/teach) in all related sectors and personnel
the concept of rational use of drugs with a view to safeguarding
public health from over-use, mis-use or inappropriate use of
drugs.
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c. To encourage the availability and accessibility of drugs in all parts
of the country with emphasis on those which are included in the
National Essential Drugs List.
d. To attain self-sufficiency in formulation of finished drugs and to
encourage production of pharmaceutical raw materials by way of
basic manufacture of active ingredients.
e. To protect the public from hazards of substandard, counterfeit
and unsafe drugs.
f. To develop adequately trained manpower in all fields related to
drugs management.
g. To develop a research base particularly for operational and
applied research with a view to achieving the above-mentioned
objectives.
h. To develop the pharmaceutical industry in Pakistan with a view to
meeting the requirement of drugs within the country and with a
view to promoting their exports to other
2 In order to ensure availability of safe, effective and quality products at
reasonable prices.
3 Pakistan has a fairly modern legislation namely the Drugs Act, 1976.
4 Under this law comprehensive rule have also been framed on various
aspects of drug control.
5 The law provides a system of licensing of each manufacturing house and
registration of all finished drugs with a view to ensuring efficacy, safety
and quality of the drugs sold in the market.
6 For licensing and registration Central Licensing and Registration Board
comprising of experts from the field of medicines and pharmacy are
established.
7 Quality Control is ensured through inspection and laboratory services.
8 The law also provides for compliance of Good Manufacturing Practice by
the manufacturers, for fixing drug prices and for regulation of imports,
export, and sale of drugs.
9 Under this Act, the manufacturing, registering and import/export are
regulated by the Federal Government whereas the sale is regulated by
the Provincial Governments.
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NATIONAL ESSENTIAL DRUGS LIST (NEDL)
PREPARATION OF NEDL
 The Federal Government and each provincial government until 1993 had
their own lists of drugs for purchases for the government institutions.
 There was urgent need to prepare a National list of Essential Drugs of
Pakistan with graded lists for various levels to be implemented uniformly
both at the Federal and Provincial levels.
 A National Essential Drugs List of Pakistan was thus prepared in 1994 in
view of the health needs of the country with the help of specialists
organizations in the field of medicines and pharmacy from all over the
country.
BULK PURCHASES FOR HEALTH INSTITUTIONS
 Bulk purchases of drugs for all government and semi-government health
institutions shall be made in accordance with this list.
 Effective and well-organized operating systems shall be developed for
procurement and distribution of such drugs for the population. This shall
envisage quantification of the actual needs for drugs and effective
logistics for supply.
PROMOTION OF ESSENTIAL DRUGS CONCEPT
 The Essential Drug Concept and the National Essential Drug List will be
promoted in the public and private sector. Policy will be geared to
increase share of essential drugs in local production and to make such
drugs available at affordable prices where-ever needed. Efforts will also
be made to promote rationality in essential drug prescribing and use. To
encourage this, Drug Information Sheets in line with those of WHO
model providing concise, accurate and comprehensive information shall
be prepared and widely circulated.
 A comprehensive public information shall be launched to enhance
understanding and acceptance of the Essential Drugs Concept by the
patient and the health care personnel. The doctors in the public sector
shall be persuaded to prescribe rationally cost-effective drugs from the
Essential Drugs List.
 Unbiased information about drugs shall be published and widely
circulated to the Federal and Provincial Health Institutions. A system of
audit and accountability shall also be introduced.
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REVIEW OF NEDL
 Periodically reviewed and revised every year and made more pragmatic
by a committee that includes competent specialists in clinical medicine,
pharmacology and pharmacy and from other related fields and
published.
CRITERIA FOR SELECTION OF EDS
 For the selection of essential drugs and for establishing a national
program for the use of essential drugs, the guidelines and criteria
recommended by the WHO shall be followed.
AVAILABILITY OF EDS
 Essential drugs which could be in short supply - establishment of hospital
pharmacy for manufacture of such drugs and also by providing
incentives to the local industry
CONSTITUTION OF HOSPITAL PHARMACY AND THERAPEUTIC COMMITTEE
 All teaching divisional and district hospitals shall constitute “Pharmacy
and Therapeutic Committees” to monitor and promote rational use of
drugs in the hospitals.
GENERIC NAMES FOR EDS
 Only generic names will be used for drugs in the NEDL all public sector
drug lists, inventory sheets and tender documents.
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DRUG UTILIZATION EVALUATION (DUE) /
DRUG UTILIZATION REVIEW (DUR)
Acronyms associated with the evaluation of medications use;
DRUG USE REVIEW (DUR): 1969, prescription drugs. Retrospective evaluation
to monitor medication use patterns (trends) and it was quantitative.
ANTIBIOTIC USE REVIEW (AUR): 1978, Retrospective evaluation of antibiotic
use and it was also quantitative. It was limited to identifying pattern of use.
DRUG USE EVALUATION (DUE): 1986, Multidisciplinary involvement.
Expansion of AUR to all drugs. It was limited to the evaluation of prescribing
and outcome only.
MEDICATION USE EVALUATION (MUE): 1992, Expansion of DUE to include all
medications. Evaluation expanded to include all aspects of medication use:
Prescribing, dispensing, administration, monitoring etc.
DEFINITION
“MUE is a performance improvement method that focuses on evaluating and
improving medication – use processes with the goal of optimal patient
outcomes.”
 MUE may be applied to a medication or therapeutic class, disease state
or condition, a medication-use process (prescribing, preparing and
dispensing, administering, and monitoring), or specific outcomes. It is a
potential tool in the evaluation of health care system, with main
objective to ascertain drug use in society.
 Casual observation, as well as more systematic study of prescribing
practices, frequently reveals a pattern of diversity among prescribers in
the treatment of even the most common conditions.
SPECIFIC POPULATION
 Elderly – incorrect use of medication and poly-pharmacy
 Children – poor development of functions and most of the drugs are
intended for adults.
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IMPROVED OUTCOMES
 Decrease in Potential hazards
 Decrease in Un-necessary finances
 Thus, it is necessary to have a periodic review of the pattern of drug
utilization to ensure safe and effective treatment.
PURPOSE
 The purpose of DUR is to ensure drugs are used appropriately, safely and
effectively to improve patient health status.
RISING IMPORTANCE OF DUE
 All these factors contribute to the increasing importance of DUE.
­ The boost in the marketing of new drugs
­ Wide variations in the pattern of drug prescribing and
consumption
­ Growing concern about the delayed adverse effects,
­ Increasing concerns regarding the cost of drugs and
­ Volume of prescription.
CRITERIA
 Predetermined criteria for appropriate drug therapy are compared
against a patient’s or a population’s records. Non-adherence to criteria
results in drug therapy changes.
 In addition, continual improvement in the appropriate, safe and
effective use of drugs has the potential to lower the overall cost of care.
 DUR allows the pharmacist to document and evaluate the benefit of
pharmacy intervention in improving therapeutic and economic
outcomes while demonstrating the overall value of the pharmacist.
 Prospective DUR often relies on computerized algorithms to perform key
checks including drug interactions, duplications or contraindications with
the patient’s disease state or condition.
ISSUES REQUIRING DUE
 Poly-pharmacy is one problem; providers may use three, four, five, and
sometimes more medicines to treat the most trivial conditions for the
sake of satisfying a patient’s need to receive medicines (or the
pharmaceutical seller’s need for profit). Other reasons for poly-
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pharmacy include lack of diagnostic competence or confidence and an
inadequate knowledge of treatment regimens.
 Other common medicine use problems are choosing incorrect
medicines, prescribing the incorrect dose, prescribing medicines that
cause adverse drug reactions (ADRs) or medicine interactions, and using
more expensive medicines when less expensive medicines would be
equally or more effective.
GENERAL AIM
 A system of improving the quality of medicine use in hospitals and
clinics, is an ongoing, systematic, criteria-based program of medicine
evaluations that will help ensure the appropriate use of medicine.
 A DUE can be structured so that it will assess the actual process of
administering or dispensing a medicine (i.e., appropriate indications,
dose, medicine interactions) or assess the outcomes (i.e., cured
infections, decreased lipid levels.)
OBJECTIVES
1. Promoting optimal medication therapy
2. Preventing medication-related problems
3. Evaluating the effectiveness of medication therapy
4. Improving patient safety
5. Establishing interdisciplinary consensus on medication-use processes
6. Stimulate improvements in medication-use processes
7. Ensure standardization in medication-use processes
8. Enhancing opportunities, through standardization, to assess the value of
innovative medication-use practices from both patient-outcome and
resource-utilization perspectives
9. Minimizing procedural variations that contribute to suboptimal
outcomes of medication use
10.Identifying areas in which further information and education for health
care professionals may be needed
11.Minimizing costs of medication therapy. These costs may be only partly
related to the direct cost of medications themselves
12.When medications are selected and managed optimally from the outset,
the costs of complications and wasted resources are minimized, and
overall costs are decreased
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