UNIT 1: THE PRACTICE OF CLINICAL PHARMACY - Pioneered by: David Burkholder, Paul Parker, and

CLINICAL PHARMACY Charles Walton at the University of Kentucky in the

- A health science disciple in which pharmacists
provide patient care that optimizes medication therapy
and promotes health, wellness, and disease
prevention.
- It includes broad responsibility for safe and
appropriate use of drugs in patients which include
rational selection, monitoring, dosing and control of
the patients overall drug therapy program.
*OTC – self-limiting illnesses or for minor symptoms
- not maintenance drug
Ex: Paracetamol – NSAID – prn
- NSAID – NMT 3 days for fever, NMT 5 days for
inflammation and pain
*Acetaminophen overdose – hepatic necrosis
*Drug Selection
EBM (Evidence-based medicine) – use of best
evidence in making decision about the care of individual
patient.
*JNC 8: Standard Guideline for the treatment of HTN
BP Goal Initial tx
Age ≥ 60 <150/90 Black – initiate thiazide or
Age < 60 <140/90 CCCB’s alone or in combi
HTN + <140/90 Non-black – initiate thiazide
HTN + CKD <140/90 CCB/ACE inhibitors/ARBs
Alone in combi except ACE
inhibitors + ARBs
For HTN + CKD – initiates ACE
inhibitors or ARBs
PHARMACY VS CLINICAL PHARMACY
Pharmacy in general
- Knowledge on synthesis, chemistry and preparation
of drugs
- Product-oriented
Clinical Pharmacy
- More oriented to the analysis of population needs with
regards to medicines, ways of administration, patterns
of use, drugs effects on the patients
- Patient-oriented practice
later part of the 1960s
Clinical Pharmacology – is a professional disciple that
combines basic pharmacology and clinical use. Its
development began in the early 1950s, primarily as a result of
the efforts of Harry Gold
1960 – start of the emergence of clinical pharmacy due to poor
medicine control system
USA – approach is unit dose dispensing and decentralization
of pharmacy services
*UDDS – medication in a single unit packaging
- Ready to administer form
- Within 24 hours
*Decentralization – ward pharmacist
- Both clinical and drug distribution duties
U.K – unifies prescription and administration records in the
ward – “ward pharmacy”
1970 – signalled the transition to clinical pharmacy
1980 – growth of clinical pharmacy practice because of the
ability to promote cost effective medicines
1988 – U.K endorsed clinical pharmacy services to secure
value for money
1997 – pharmacists grade and time spent on wards were
increased
Application of different scientific principles:
A. Pharmacology
B. Toxicology
C. Therapeutics
D. Clinical pharmacokinetics
E. Pharmacoeconomics – cost vs outcomes
F. Pharmacogenomics is the study of how genes affect a
person’s response to drugs.

Clinical Pharmacy – arouse out of dissatisfaction with old Clinical Pharmacy Settings
practice norms and the pressing need for a health professional - Hospitals
with a comprehensive knowledge of the therapeutic use of - Community pharmacists
drugs - Nursing homes
- The clinical pharmacy movement began at the - Home-based care services
University of Michigan in the early 1960s - Clinics
 - Any other setting where medicines are prescribed and Ex: Diabetes Mellitus – chronic hyperglycemia (high glucose sa
used blood)
- Caused by absolute lack of insulin (Type I – common
Goals of Clinical Pharmacy in children) or relative lack of insulin (Type II DM)
To promote the correct and appropriate use of - Death due to complication
medicinal products and devices. These activities aim at: 1. Assessment
- Minimizing the risk of treatment-induced adverse - Complications is due to blood sugar is poorly
events continued:
*Ex. Steroids o Macrovascular – CAD – risk factor;
- Cushing’s syndrome – buffalo hump Atheroma(plaque) deposit to form
- Continuous use – type C ADR Atherosclerosis, stroke
- Occurs due to long period of administration o Microvascular – Diabetic retinopathy –
- Reversible damage is irreversible
- Addison’s Disease (Adrenal insufficiency)  Diabetic nephropathy – in DM –
- No productivity of steroids in the body concentrated blood can lower down
- Due to abrupt withdrawal after 10-14 days of renal blood supply that triggers
administration renin release that activates RAAS
- Fatal then the Aldosterone is used for
- Solution: taper the dose slowly sodium and water retention and it
*Ex. NSAIDS – COX1 – produce prostaglandin as can lead to increase of blood
gastroprotectant volume and blood pressure
- GI irritation  KIDNEYS REQUIRE ADEQUATE
o Soln: take it with meals – after 30 mins BLOOD SUPPLY TO FUNCTION
o Add proton pump inhibitor NORMALLY
o Shift to Selective COX2 inhibitors o Diabetic Neuropathy
 Increase the risk of thromboembolic 2. Plan
effects - Type I DM – insulin
 It is okay to use this as long as - Type II DM – Oral anti-diabetic drugs
there is no history of *Recommend lifestyle modification
thromboembolic effects 3. Monitoring
- Maximizing the clinical effects of medicines - FBS: <126 mg/dL
- Minimizing the expenditures for pharmacological - Pre-prandial RBS: 80-110 mg/dL
treatments - Post-prandial RBS: <140 mg/dL
*Ex. Antiphychotics - HBA1C - <6.5%
- Typical – EPS + cholinergic agents - BP goal: JNC 8 <140/90
- Atypical – less EPS - LDL goal: <100mg/dL
- Eye examination
Three basic components of the clinical role in the practice of 4. Provide drug information/Counselling
pharmacy - Insulin – Arms, thigh
- Communication o Subcutaneous
- Counselling o Rotate the injection site (to prevent
- Consulting lipodystrophy)
o Proper timing of administration
Primary jobs of Clinical Pharmacist  Ultrarapid/Insulin LAG – 5
- To interact with the health care team mins before meal or after a
- To interview and assess patient meal
- To make specific therapeutic recommendation  Long acting – once a day
- To monitor patient response to drug therapy
- To provide drug information
  Intermediate/Protamine –  A – No error capacity to
BID – prebreakfast (2/3), cause harm – SALAD
predinner (1/3)  B – Error occur, but did not
 Regular insulin – 30 min reach the patient
before meals  C – Error reached patient,
but no harm
*ADR: hypoglycaemia – prevent by proper timing  D – Error occurred that
- Mgt: give glucose supplements resulted in… increase
- Awake: glucose tabs patient monitoring, no
- Unconscious: IV infusion of D50 water patient harm
- First manifestation is tachycardia  E – … need for treatment
- Fatal or intervention, temporary
patient harm
Activities of Clinical Pharmacists  F – … initial or prolonged
1. Therapeutic Drug Monitoring hospitalization, temporary
- Assuring steady state concentration in patient harm
therapeutic range by blood concentration  G – … permanent patient
measurement of drugs with narrow harm
therapeutic indices  H – … near death event
*Goal: Ensure that the drug in the body is within
 I – … Death
the therapeutic range
- Ex. Allergic Reaction
*Narrow therapeutic indices drugs:
 PREVENTION – right drug, dose,
o Digoxin
route, frequency, duration
o Warfarin
 Promote rational drug
o Theophylline
therapy
o Phenobarbital
 DETECTION – investigating
o Quinidine
unusual circumstances, Rxs
o Phenytoin
 MITIGATION – providing ready
o Heparin
access to antidotes
o Amiodarone
 Make the condition less
o Aminoglycosides
severe
*Therapeutic Index = Toxic Dose 50/Effective
 Ex. Anaphylactic shock –
Dose 50
Epinephrine or IV
*High TI = safer drugs
diphenydramine
2. Drug information
5. Resuscitation or Code Blue
- Information about medications to physicians,
- Prepare medications that may be needed
nurses, other health care practitioners
during a code
3. Patient Care Rounds
- Assist with dose calculation to ensure
- Pharmacists are an integral part of the
therapeutic dose
rounding ream and evaluate drug therapy
 First drug given: Epinephrine 1mg ever 3-5 mins
and dosing during rounds
until stable
4. Adverse Drug Events – any adverse events
o Normalize circulation of patient
associated with the use of drugs in human
o Worsen Myocardial Infarction, contract
- Prevention, detection, mitigation of adverse
heart muscle, increase heart rate –
drug events
increase demand of the drug
- Ex. Adverse Drug Reaction – noxious ,
 Ventricular tachycardia – do the defribrillation
unintended reaction reaction to a drug
 3 times after every defrib. No response – give
- Ex. Medication Error - preventable
Amiodarone or Lidocaine or other arrhythmic
 Category in Medication Error
agents
6. Medication Dosing *BSA = √ht (in)x wt(lb) = PI
Dosing adjustment: 3131
- Organ dysfunction – elimination organ
*BSA = √ht (cm)x wt(kg) = KC
kidney for metabolism, liver for elimination
3600
- Age or weight – based on BSA
*Dose = BSA x Adult dose
- Switching between different routed of
1.73 m 2
administration
o A 52-year old patient is weighing 132 lbs
 Creatinine is a chemical waste product in the
with a height 5’2’’. The physcian
blood that passes through the kidneys to be
prescribed a medication digoxin with a
filtered and eliminated in urine
dose of 0.25mg. Compute for the dose
 CrCl helps to estimate the glomerular filtration
of the patient based on BSA. – 0.23 mg
rate (Gfr): the rate of blood flow through the
7. Formulary – list of drugs available in the specific
kidney
institution
*Creatinine – important biomarker that assess by
8. Anticoagulation – heparin, warfarin
the kidney
- There should be protocols and processes for
- Produce as a product of metabolism of
handling high risk drugs
muscle
- Daily monitoring of laboratory values and
- Normally creatinine is renally excreted
dose adjustment as appropriate
- Increased creatinine = problem in the
*Have narrow therapeutic index
kidney
*Warfarin
*If drug is excreted via kidney, but have kidney
- PT-INR (2 – 3)
disease, the dose should be LOW
- With Prosthetic heart valve (2.5 – 3.5)
*CrCl – close approximate on how your kidneys
- PT-INR > goal with no bleeding
work.
o < 5 temporary stop the dose or
*Cockcroft-Gault formula
reduce the dose
o CrCl = (140-age) x kg x 0.85
o 5 -9 temporary stop the dose
72 x SCr
o > 9 minor bleeding, stop the dose
- 0.85 for female only.
and give Vitamin K
o CrCl = UV
 Vit K – antidote for
P
warfarin
 U – creatinine in urine
o Moderate to severe bleeding – stop
 V – volume of urine for 24 hrs
the dose, give Vit K and give FFP
 P – creatinine in plasma
(Fresh Frozen Plasma)
o The serum creatinine of a 72 years-old
*Increase Anticoagulant – Increase bleeding
female weighing 65kg was found to be
9. Nutrition
5mg/dL. What is the CrCl of the patient?
- Sterile preparation of TPN
– 10.44 mL/min
- Resolving incompatibilities and adjusting the
o The plasma creatinine of a patient was
nutritional formula as appropriate
found to be 0.9 mg/dL. Over 24 hour
10. Anti-Infective Stewardship
period, 1250 mL of urine was collected
- Review antibiotic, antiviral, antifungal
and the concentration of creatinine in
medication use by comparing to patient’s
urine was found to be 185mg/dL. What
condition, site of infection, culture and
is the CrCl of the patient? – 178.43
sensitivity results
mL/min
11. Outcomes Management
*Serum Creatinine – amount of serum found
- Participating in compliance with care
in the blood
measures by assuring core therapies are
*High CrCl – Low SCr
received by eligible patients
*Low CrCl and High SCr – have kidney
12. Managing Transition of Care
disfunction
- Medication reconciliation
13. Narcotic Stewardship
- Pain management using opioid analgesics
*Ex. Mefanamic acid – NMT 7 days due to GI
Irritation and Cardio Problems
*Ketorolac – NMT 5 days due to GI irritation and
Cardio problems
*Tramadol – 5 days habit forming
14. Pharmacogenomics
- Relationship between genomes and the
efficacy elimination, and toxicities of
medications
- Evaluate genetic code of patients in order to
better predict a drug response
15. Medication Therapy Management Services
- Services that optimize therapeutic outcomes
for individual patients
- A systematic process of collecting patient-
specific information, assessing medication
therapies to identify medication-related
problems, developing a list of medication-
related problems, and creating plan to
resolve them
16. Documentation
- Means by which healthcare professionals
communication with one another
- Physician consultations of the pharmacist
- Drug information question results
- Relevant drug serum concentrations and
their interpretation
- Patient education
SOAP Notes
Subjective
- Information that explains the reason for the encounter
- Information that the patient reports concerning
symptoms, previous treatments, medication used, and
adverse effects encountered
- These are considered nonreproducible date because
the information is based on the patient’s interpretation
and recall of past events
- Identification and Chief complaint
- Medical history
- Review of Systems(ROS)/ Physical Examination
- Social History
Objective
- Information from physical examination laboratory
results, diagnostic tests, and present medications
- Objective data are measurable and reproducible
Assessment
- A brief but complete description of the problem,
including a conclusion or diagnosis that is supported
logically by the subjective and objective data
- The assessment should not include a
problem/diagnosis that is not defined above.
Plan
- Specific solution for each problem outlined in the
assessment
- Numbered list to match the Assessment
- Recommendations for drug dose, frequency, duration
- Monitoring
- Follow-up

Clinical Pharmacy Practice Areas

- Ambulatory care
- Critical care
- Drug information
- Geriatrics and long-term care
- Internal medicine and subspecialities
- Cardiology
- Endocrinology
- Gastroenterology
- Infectious disease
- Neurology
- Nephrology
- Obstetrics and gynecology
- Pulmonary disease
- Psychiatry
- Rheumatology
- Nuclear pharmacy
- Nutrition
 - Pediatrics Problems resulting from unmet drug-related needs
- Pharmacokinetics Drug-Related Needs
- Surgery - Appropriate Indication
- Oncology - Effectiveness
- Safety
Pharmaceutical Care - Compliance
- “Responsible provision of drug therapy for the - Untreated indication
purpose of achieving definite outcomes that improve a Drug therapy Problems
patient’s quality of life” – Hepler and Strand, 1990 - Unnecessary drug therapy
- Outcomes: - Nonmedical medication
- Cure of disease - Addiction/recreational drug abuse
- Elimination or reduction of symptoms - Nondrug therapy more appropriate
- Arrest or slowing of a disease process - Duplicate therapy
- Prevention of disease or symptoms - Treating avoidable adverse reaction
- Patient-focused pharmacy requires the integration of - Wrong drug
knowledge and skills to provide better patient care - Dosage form inappropriate
- Contraindication present
Major functions of pharmaceutical care - Condition refractory to drug
1. Identifying potential and actual drug-related problems - Drug not indicated for condition
2. Resolving actual drug-related problems - More effective drug available
3. Preventing potential drug-related problems - Dosage too low
- Wrong dosage
Five steps in the pharmaceutical care process - Frequency inappropriate
1. A professional relationship with the patent must be - Duration inappropriate
established. - Incorrect storage
2. Patient-specific medical information must be - Incorrect administration
collected, organized, recorded and maintained. - Drug interaction
3. Patient-specific medical information must be - Adverse drug reaction
evaluated and a drug therapy plan developed - Unsafe drug for patient
mutually with the patient. - Allergic reaction
4. The pharmacist must ensure that the patient has all - Incorrect administration
supplies, information and knowledge necessary to - Drug interaction
carry out the drug therapy plan. - Dosage increase or decrease too quickly
5. The pharmacist must review, monitor, and modify the - Undesirable effect
therapeutic plan as necessary and appropriate, in - Dosage too high
concern with the patient and health care team. - Wrong dose
- Frequency inappropriate
Five key drug-related needs of patient - Duration inappropriate
1. Patients have an appropriate indication for every drug - Drug interaction
they are taking. - Inappropriate compliance
2. Patients’ drug therapy is effective. - Drug product not available
3. Patients’ drug therapy is safe. - Cannot afford drug product
4. Patients can comply with drug therapy and other - Cannot swallow or otherwise administer drug
aspects of their care plans. - Does not understand instructions
5. Patients have all drug therapies necessary to resolve - Patient prefers not to take drug
any untreated indication. - Needs additional drug therapy
- Untreated condition
- Synergistic therapy
- Prophylactic therapy