Unit 3
Unit 3
Unit 3
Department of Pharmacy
Topics:
1. PCNE Classification for Drug-Related Problems (DRPs) V9.00
• Problems
• Causes
• Planned Interventions
• Intervention Acceptance
• Status of the DRPs
2. Adverse Drug Reactions and its corresponding interventions
3. Side Effects and Toxicities of medication and its corresponding
interventions
4. Medication Adherence
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A Drug-Related Problem is an
event or circumstance involving
drug therapy that actually or
potentially interferes with
desired health outcomes.
Department of Pharmacy Structure of the PCNE Classification for
Drug Related Problems
Problems
Problems
3 primary domains, 7 subdomains
Causes
9 primary domains, (*43) 38 subdomains
Planned Interventions
5 primary domains, 17 subdomains
Intervention Acceptance
3 primary domains, 10 subdomains
Status of the DRP
4 primary domains, 7 subdomains
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Problem Domains in the PCNE Classification
The problem is defined as—
• the expected or unexpected event or circumstance that is, or
might be wrong, in therapy with drugs (the P-codes)
Code Primary Domain Description
P1 Treatment effectiveness The clinical effect of the drug treatment is not as
There is a (potential) problem with expected or there is no treatment
the (lack of) effect of
the pharmacotherapy
P2 Treatment safety The patient suffers from an ADR at normal dose or
Patient suffers, or could suffer, from from a toxic reaction
an adverse drug event
P3 Other Nothing seems wrong in the treatment, but there
is another problem related to the
medicines in use
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Problem Subdomains in the
PCNE Classification
Primary Domain CODE Problem
P1. Treatment effectiveness P1.1 No effect of drug treatment despite
There is a (potential) problem correct use
with the (lack of) effect of P1.2 Effect of drug treatment not optimal
the pharmacotherapy
P1.3 Untreated symptoms or indication
P2. Treatment safety P2.1 Adverse drug event (possibly) occurring
Patient suffers, or could suffer, from an
adverse drug event.
P3. Other P3.1 Problem with cost-effectiveness of the
treatment
P3.2 Unnecessary drug-treatment
P3.3 Unclear problem/complaint. Further
clarification necessary (please use as
escape only)
Causes Domains in the PCNE Classification
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Prescribing
selection
The cause of the DRP is related duration of the therapy
& drug
to the duration of treatment
C6 6. Drug use process The cause of the DRP is related to the way
The cause of the DRP is related the patient gets the drug administered by
to the way the patient gets the a health professional or carer, despite proper
Use
patient and his behaviour (intentional C7.5 Patient takes food that interacts
or non- intentional) C7.6 Patient stores drug inappropriately
C7.7 Inappropriate timing or dosing intervals
C7.8 Patient unintentionally administers/uses the drug in
a wrong way
C7.9 Patient physically unable to use drug/form as
directed
C7.10 Patient unable to understand instructions properly
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Causes Subdomains in the PCNE Classification
Primary Domain CODE Problem
The cause of the DRP can be related to Discharge/transfer information about medication
the transfer of patients between primary, *C8.3
incomplete or missing *
secondary and tertiary care, or transfer
within one care institution. Insufficient clinical information about the
*C8.4
patient.*
Patient has not received necessary medication at
*C8.5
discharge from hospital or clinic.*
C9.1 No or inappropriate outcome monitoring (incl.
Therapeutic Drug Monitoring)
9. Other
C9.2 Other cause; specify
C9.3 No obvious cause
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Planned interventions domains in the
PCNE Classification
• The problem will usually lead to one or more in interventions to correct the
cause of the problem. (The I-code)
• In this section you can indicate if the suggestion for the intervention to
patient or prescriber has been accepted. (A-Code)
DURATION OF THERAPY
• The greater the degree of drug exposure, the
greater the likelihood an ADR will occur.
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Risk Factors for ADRs
GENDER
• Females have a 1.5- to 1.7-fold greater risk of developing an
ADR compared to males: (Rationale: fat deposits)
• Overdosing
• gender-based differences in pharmacokinetics and
pharmacodynamics
• differences in immunological and hormonal makeup
• women are more likely to report adverse events than men
• women take more medications than men.
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Risk Factors for ADRs
COMORBID CONDITIONS
• Illnesses such as congestive heart failure, malnutrition,
obesity, hepatitis, cirrhosis, or diabetes can alter the
pharmacokinetics and pharmacodynamics of drugs,
leading to drug accumulation and toxicity.
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Risk Factors for ADRs
NARROW THERAPEUTIC INDEX DRUG
• majority of ADRs are dose-related, those drugs with
little separation between therapeutic and toxic
concentrations are highly associated with adverse
reactions
• Examples of Drugs with narrow TI
• aminoglycosides,
• anticonvulsants,
• digoxin,
• heparin,
• theophylline
• warfarin
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Risk Factors for ADRs
ETHNICITY AND GENETICS
Pharmacogenetics: the study of the differences in
genes encoding for drug-metabolizing enzymes, drug
transporters, or drug targets
Ex. . For example, 5–10% of the population carries two
decreased activity alleles for the drug-metabolizing
enzyme CYP2D6
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Risk Factors for ADRs
Pharmacogenetics can influence drug therapy in one of three
ways:
1. Genetic polymorphisms that are associated with altered
drug metabolism
ex. N-acetyltransferase polymorphism
• Fast acetylators: Asians, Eskimos
• Slow acetylators: Caucasians
• Drug-induced lupus: HIPSQ: hydralazine, isoniazid,
procainamide, sulfonamide, quinidine
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Risk Factors for ADRs
Pharmacogenetics can influence drug therapy in one of three
ways:
2. Genetic variations can produce unexpected or idiosyncratic
reactions
• hemolytic anemia in persons with a deficiency in glucose-6- phosphate
dehydrogenase (example)
✓ Treat symptomatically
• EXAMPLES:
• Chloramphenicol - Induce Aplastic Anemia
• G6PD + Antimalarials/ Sulfonamides - Hemolytic Anemia
• EXAMPLES:
Type C (Continuous)
• uncommon
• dose- related & time- related
• associated with the cumulative dose of the drug
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Subtype (Type C)
1. Drug Addiction- condition where a person takes a drug
compulsively, despite potential harm to themselves,
or their desire to stop.
• Example:
• Marijuana
• Opiates
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Subtype (Type C)
2. Drug Dependence-
• unwanted condition resulting to tolerance & physical
dependence;
• compulsion to take the drug repeatedly & experiences
unpleasant symptoms if discontinued
✓Corrective Measures:
✓Withdraw the medication under medical supervision
✓Psychotherapy
• EXAMPLE
Nicotine
Codeine
Caffeine
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Subtype (Type C)
• Physical Dependence: occurs when a drug has been used
habitually & the body has become accustomed to its effects.
The person must then continue to use the drug in order to feel
normal, or its absence will trigger the symptoms of withdrawal.
Type D (Delayed)
• Uncommon
• Usually dose related
• Occurs or becomes apparent sometime after use of
the drug
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Subtype (Type D)
1. Carcinogenicity: ability of any substance to cause or
induce cancer
✓Corrective Measures:
✓Monitor the patient
✓Inform the physician/ medical team
• EXAMPLES:
• Polycyclic/Aromatic Hydrocarbons
• Nitrosamines
• Azo dyes
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Subtype (Type D)
2. Teratogenicity: ability of any substance to cause
congenital malformations or birth defects
✓Corrective Measures:
✓ Avoid exposure during first trimester of pregnancy
• EXAMPLES:
• Aflatoxin
• Cyclamates
Department of Pharmacy Classification of ADRs
Type E (End-of-Use)
Uncommon;
generally occur shortly after stopping the drug
Withdrawal Symptoms:
• Anxiety
• Rhinorrhea
• Irritability
• Nausea & vomiting
• Insomnia
• GI cramping
• Chills
• Diarrhea
• Diaphoresis
• Piloerection
• Salivation
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Subtype (Type E)
• Withdrawal: noxious or unintended response occurring
when a drug is discontinued
• EXAMPLES:
• Opiate withdrawal
• Rebound insomnia & excitation (Benzodiazepine)
Department of Pharmacy Classification of ADRs
Type F (Failure of Therapy)
unexpected failure of efficacy
Common, dose-related
may result from:
a. Use of Counterfeit drugs
b. Use of substandard drugs
c. Use of placebo
d. Antimicrobial resistance (drug resistance): insensitivity of the
pathogen to an antimicrobial agent
Department of Pharmacy Classification of ADRs
Type F (Failure of Therapy)
✓ Corrective Measures: