Clinical/Hospital Pharmacy

Margarita M. Gutierrez, RPh, MHPEd (OnGoing) University of the Philippines Manila

HOSPITAL PHARMACY
It may be defined as the practice of pharmacy in a hospital setting including its organizationally related facilities or services.

HOSPITAL PHARMACY
It is the department or division of the hospital wherein the procurement, storage, compounding, manufacturing, packaging, controlling, assaying, dispensing, distribution and monitoring of medications through drug- therapy management for hospitalized and ambulatory patients are performed by legally qualified, professionally competent pharmacists.

Clinical Pharmacy
A practice in which the pharmacist utilizes his professional judgment in the application of pharmaceutical sciences to foster the safe and appropriate use of drugs, in or by patients, while working with members of the health care team (Francke 1969)

Clinical Pharmacy
Health science specialty whose responsibility is to assure the safe and appropriate use of drugs in patients through the application of specialized knowledge and functions in patient care

Clinical pharmacist
Interact with the health care team Interview and assess patients Make therapeutic recommendations Monitor patient response to drug therapy Provide drug information

 Pharmaceutical Care Is the responsible provision of drug therapy for the purpose of achieving definite outcomes that improves a patients quality of life (Hepler and Strand 1990)

 Pharmaceutical Care A patient-centered practice in which the practitioner assumes responsibility for a patients drug-related needs and is held accountable for this commitment (Cipolle 1998)

Major Functions of Pharmaceutical Care

- Identifying potential and actual drugrelated problems - Resolving actual drug-related problems - Preventing potential drug-related problems

Expected Outcomes of Pharmaceutical Care

Cure of disease Elimination or reduction of symptoms Arrest or slowing down of a disease process Prevention of disease or symptoms

Knowledge and Skills Required in Clinical Pharmacy

Knowledge
Diseases Drug therapy Non-drug therapy Laboratory and diagnostic testing

Skills
Communication Patient monitoring Physical assessment Drug information provision Therapeutic planning

General Clinical Pharmacy Functions

Providing drug information to physicians and other health professionals Medication history taking Medication profile preparation Drug therapy monitoring Patient education and medication counseling Disease screening, monitoring and maintenance care for patients with chronic diseases

General Clinical Pharmacy Functions

Participation in the management of emergency medical care Health information source for the public Drug use review and patient care audits In-service education for physicians, nurses and other health professionals Specialized functions and services (ASHP 1983)

DRUG INFORMATION SOURCES

A. TERTIARY RESOURCES

>> textbooks, compendia, review articles in journals, full text computer databases and other general information such as those that maybe found in the Internet

 easy to use familiar to most practitioners concise overview of info on a specific topic convenient fairly complete info

Less current info due to lagtime Information may not be complete Transcription errors/incorrect info interpretation Human bias Lack of expertise by authors

B. Secondary Resources
INDEXING consists of providing bibliographic citation information (e.g., title, author, & citation of the article) ABSTRACTING includes a brief description (or abstract) of the info provided by the article or resource cited

C. PRIMARY LITERATURE = consists of published and unpublished clinical research studies and reports

NOT A PRIMARY LITERATURE: review

articles or editorials found in journals
REVIEW ARTICLES: general overviews and meta-analyses

PRIMARY LIT: controlled trials, cohort

studies, case series & case reports

access to more detailed information personally assess the utility & validity of results more recent

may provide misleading conclusions based on only 1 trial need to have good skills in evaluation time needed to evaluate the large volume of literature

STUDY DESIGNS

Descriptive versus analytic studies

Descriptive studies report frequency of conditions and characteristics of study population Analytic studies

examine relation between variable to detect risk factors and make inferences

Observational versus experimental studies

Observational studies
the exposure to a factor is observed and not manipulated EXPOSURE versus OUTCOME

Experimental studies
Manipulation of study factor or exposure; randomization of subjects

Analytic studies/Observational studies

COHORT

Analytic studies/Observational studies

Cases of endometrial cancer Use Estrogens Post Menopausal women free of Endometrial Cancer Dont use estrogens Non-cases Cases of endometrial cancer Non-cases

Example: Cohort study of the risk of estrogens for endometrial cancer

With outcome

Subjects selected for the study

w/o outcome

No direction of inquiry Onset of study-time CROSS-SECTIONAL STUDY DESIGN Question: What is happening?

Case-Control Study
Example: Case Control Study of the risk of estrogens for Endometrial Cancer
Use Estrogens Dont use estrogens CASES OF ENDOMETRIAL CANCER

Use Estrogens Dont use estrogens CONTROLS

RANDOMIZED CLINICAL TRIAL DESIGN

EXPERIMENTAL CROSSOVER DESIGN

TYPES OF BLINDING TO ASSIGN TREATMENT IN CLINICAL TRIALS

Knowledge of Tx

Knowledge of Tx

BLINDING None Single Double

PATIENT Yes No NO

INVESTIGATOR Yes Yes No

Other epidemiologic study designs

Case Reports: reports of events observed in single patients Case Series: collections of patients, all of whom have single exposure, whose clinical outcomes are the evaluated and described

REVIEW!!!
A. Classified by how subjects are recruited into the study Case-Control studies Cohort studies o Experimental studies B. Classified by how data are collected for the study Retrospective studies Prospective studies Cross-sectional studies

IDENTIFY THE STUDY DESIGN

To test the pharmacy-based disease management program for a group of hypertensive patients and to assess its impact on patients selected outcome measures, selected pharmacies were randomized to either an intervention or control group; intervention pharmacists received specific training to follow patients over 8 weeks while control pharmacists continued to provide standard care.

IDENTIFY THE STUDY DESIGN

Children with diarrhea who sought admission to San Lazaro Hospital were chosen as cases in the study. Controls were neighbors of the cases who were of the same age. Mothers of both groups of children were interviewed on sanitation practices related to child feeding.

IDENTIFY THE STUDY DESIGN Study was set-up to identify characteristics that are associated with the development of ADEs in hospitalized patients through ADE reports generated and pharmacists interviews of patients

PHASES OF PRODUCT DEVELOPMENT

New Chemical Entity

Preclinical Studies

Investigational New Drug Application

Clinical Trials

Preclinical Studies

New Drug Application

Postmarketing

STEPS IN DRUG DEVELOPMENT

New Chemical Entity Organic synthesis Molecular modification Isolation from plants

STEPS IN DRUG DEVELOPMENT

1. PRE-CLINICAL RESEARCH
Chemistry Physical Properties Biologic Characterization Pharmacology Drug Metabolism Toxicology Preformulation Studies

2. Synthesis & Purification 3. Animal Testing

STEPS IN DRUG DEVELOPMENT

4. Investigational New Drug Application
to protect the rights and safety of the subjects to ensure that the investigational plan is sound designed to achieve the stated objectives

clinical hold Investigational Review Board 5. CLINICAL STUDIES

CLINICAL STUDIES
Phase I
o for assessing safety o 20-100 Human subjects: healthy volunteers (patients in some protocols) o designed to determine: human pharmacology of the drug, SAR, side effects (dose-dependent)

CLINICAL STUDIES
Phase II
o evaluates the effectiveness for individual patients with the disease/condition o short-term side effects and risks

CLINICAL STUDIES
Phase III
o expanded patient base o additional data on effectiveness & safety to evaluate overall benefit-risk relationship

CLINICAL STUDIES
Phase IV
o continued clinical investigations and postmarketing surveillance o manufacturing scale up o drug formulation may be modified slightly

o Phase V
o product development may continue o additional clinical studies on special populations; for new indication

OTHER APPLICATIONS

Supplemental New Drug Application Abbreviated New Drug Application

THERAPEUTIC GUIDELINES

provide clear and concise, independent and evidencebased recommendations about patient management that have been developed by experts

Objectives of TGS
To improve quality and consistency of medical care
To reduce chance of error by establishing standard protocol for how care is carried out

THERAPEUTIC DRUG MONITORING

Therapeutic Drug Monitoring

Encompasses the measurement of serum drug levels and the application of clinical pharmacokinetics to improve patient care

Clinical Pharmacokinetics
Study of the time course of the ADME of drugs and their corresponding pharmacological response Applications:
Time to maximal response Need for a loading dose Dosage alterations Choosing a formulation

Therapeutic Drug Monitoring

to ensure appropriate, safe, efficacious, and economical drug therapy to the patient Economical, Clinical and Humanistic Outcomes of drug therapy for a specific patient

Drugs requiring TDM

Intensity of pharmacologic effect is proportional to the drug concentration at the site of action Drugs have an established therapeutic plasma range Relationship between plasma drug concentration and clinical effect is better than the relationship between drug dose and its effect Drug toxicity and disease presentation are difficult to distinguish from clinical assessment alone

Commonly monitored drugs

Aminoglycosides: gentamicin, tobramycin, netilmicin, amikacin, vancomycin Anticonvulsants: phenytoin, carbamazepine and occasionally phenobarbital

Commonly monitored drugs

Cardioactive agents: digoxin, procainamide, lidocaine, disopyramide, flecainide Others: theophylline, lithium, methotrexate and ciclosporin

Therapeutic Drug Monitoring Monographs

Digoxin Therapeutic Range: 1-2 ng/mL Signs of toxicity:
Diarrhea, vomiting, abdominal pain, visual disturbances, drowsiness, confusion, arrhythmias

Therapeutic Drug Monitoring Monographs

Lithium prophylaxis Therapeutic range:
Acute mania (0.6-1.0 mmol/L)

Therapeutic Drug Monitoring Monographs

Lithium prophylaxis Signs of toxicity
Blurred vision, polyuria, polydipsia, anorexia, nausea, vomiting, diarrhea, abdominal pain, muscle weakness, lethargy, drowsiness, tremor, confusion, ataxia, renal impairment Serious toxicity: disorientation, convulsions, coma and possibly death

Therapeutic Drug Monitoring Monographs

Phenytoin Therapeutic range: 5-20 ug/mL Signs of toxicity
Nystagmus, blurred vision, ataxia, drowsiness (> 30 mg/L): dysarthria, lethargy, coma

Therapeutic Drug Monitoring Monographs

Carbamazepine Therapeutic range: 4-12 ug/mL Signs of toxicity
Nystagmus, diplopia, drowsiness, ataxia

Therapeutic Drug Monitoring Monographs

Theophylline Therapeutic range:
Asthma (10-20 ug/mL) Neonatal apnea (5-15 ug/mL)

Signs of toxicity
Nausea, vomiting, cardiac arrhythmias, seizures

DRUG-RELATED PROBLEMS

Categories of Drug-related problems

1. Medication Errors any preventable event that may lead to inappropriate medication use or cause harm to the patient while the medication is in the control of a health care professional, patient or consumer.
- National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)

NO ERROR
1.1

TAXONOMY OF MEDICATION ERRORS

Category A

Circumstances or events that have the capacity to cause error

ERROR, NO HARM
Note: Harm is defined as death, or temporary or permanent impairment of body function/structure requiring intervention. Intervention may include monitoring the patients condition, change in therapy, or active medical or surgical treatment.

1.2

Category B

An error occurred but the medication did not reach the patient
1.3

Category C

An error occurred that reaches the patient, but did not cause harm.
1.3.1 Medication reaches the patient and is administered 1.3.2 Medication reaches the patient but not administered
1.4

Category D

An error occurred that resulted in the need for increased patient monitoring, but no patient harm.

CLASSIFICATION OF MEDICATION ERRORS

Category E An error occurred that resulted in need for treatment or intervention and caused temporary patient harm
1.5 1.6

Category F

An error occurred that resulted in initial or prolonged hospitalization and caused temporary patient harm

CLASSIFICATION OF MEDICATION ERRORS

1.7

Category G

An error occurred that resulted in permanent patient harm 1.8 Category H An error occurred that resulted in a near-death event (e.g., Anaphylaxis, cardiac arrest)
1.9

Category I An error occurred that resulted in patient death

Categories of Drug-related problems

2. Adverse Drug Events 2.1 Patient Factors Adverse drug reactions Patients reactions to the drug

2.2 Drug Factors Drug-Drug interactions Drug-Food Interactions Drug-Disease Interactions Other incompatibilities

SPECIAL POPULATIONS

The Neonates

Human Pregnancy
Normal length of human pregnancy (TERM): 37-42 completed weeks of gestation Preterm: <37 weeks of gestation at birth Post-term: > 42 weeks onwards
**Earliest in pregnancy at which newborn babies can sometimes survive is 23-24 weeks gestation.

Neonates and Birth Weights

Neonatal Period: first 28 postnatal days Low Birth Weight (LBW): < 2500 g Very low birth weight (VLBW): < 1500 g Extremely low birth weight (ELBW): <1000 g

* Gestation at birth (more than birthweight) prognostic value

Drug Disposition in Neonates

Placenta

Cross-section through a third-trimester placenta with baby. The placenta (blue) consists of about 20 tree-like structures called cotyledons (see circular magnified area). The babys blood vessels, arriving by way of the umbilical cord, spread out within the placenta, sending a large branch into each cotyledon. Mothers blood (darker red) intimately surrounds the cotyledons.

Available Routes
Enteral erratic in newborns IV ensures maximum bioavailability Rectal e.g. paraldehyde and diazepam (seizures), paracetamol (analgesia) Buccal e.g. glucose gel (hypoglycemia)

Available Routes
(Preterm Babys) Skin extremely thin and poor barrier to water loss; permeable to substances
E.g. alcohol (chlorhexidine in 70% methylated spirit) chemical burn and systemic methyl alcohol poisoning

IM avoided (except for Vitamin K) due to small muscle bulk

Pediatrics

International Committee on Harmonization (2000)

Preterm newborn infant Term newborn infant (0-7 days) Infants and toddlers (28 days to 23 months) Children (2-11 years) Adolescents (12 to 16-18 years)
** reflect biological changes

Adverse Drug Reactions

Typically occur at lower doses than in adults, and are usually atypical
Enamel hypoplasia and permanent discoloration of teeth: tetracyclines Growth suppression: corticosteroids Paradoxical hyperreactivity: phenobarbital

Adverse Drug Reactions

Hepatotxicity: valproate Reyes syndrome: salicylates (drowsiness, coma, hypoglycemia, seizures and liver failure)

The Elderly

Age Related Changes in Pharmacokinetic Processes

Drug Absorption
Drug Distribution Drug Metabolism Drug Excretion
iintestinal blood flow, surface area, & motility delay drug absorption; slow onset of drug action ibody water, lean body mass & plasma proteins; hfat content; hplasma drug concentrations & pharmacologic effects iliver blood flow, liver organ size & enzyme concentration; i the rate of drug metabolism & hduration & intensity of drug action irenal function & blood flow slow the rate of drug excretion, & hduration & intensity of drug action

Pharmacodynamics
UCSF Division of Geriatric Primary Health Care Lecture May 2001

Some effects are increased

Alcohol, fentanyl, diazepam, morphine, theophylline

Some effects are decreased

isoproterenol and beta -blockers

High Risk Situations

UCSF Division of Geriatric Primary Health Care Lecture May 2001

Patient seeing multiple providers Patient on multiple drugs Patient lives alone and/or has cognitive impairment Discharge from hospital or any change in venue

The Pregnant and Lactating

Problem Drugs in Pregnancy

Alcohol fetal alcohol syndrome
small skull (microcephaly) abnormal facial features heart defects impeded growth and mental retardation

Problem Drugs in Pregnancy

Tobacco miscarriage or premature labor Nicotine depresses the appetite Reduced ability of the lungs to absorb oxygen

Problem Drugs in Pregnancy

Cocaine and Methamphetamine Miscarriage premature labor abruptio placentae Withdrawal symptoms for babies

Problem Drugs in Pregnancy

Heroin and Other Narcotics premature birth low birthweight breathing difficulties Hypoglycemia intracranial hemorrhage

Problem Drugs in Pregnancy

PCP (phencyclidine, or angel dust) withdrawal symptoms (lethargy with tremors)

Problem Drugs in Pregnancy

Marijuana premature birth Low birthweight

Problem Drugs in Pregnancy

Other Medications Isotretinoin chronic malformations Phenytoin and carbamezapine heart and face defects mental retardation

Problem Drugs in Pregnancy

Other Medications Ergotamine and methylsergide premature labor

Problem Drugs in Pregnancy

Other Medications Aspirin, ibuprofen, and other NSAIDs increased risk of uncontrolled bleeding delayed or extended labor

Pregnancy Category
an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy does not include any risks conferred by pharmaceutical agents or their metabolites that are present in breast milk

Category

Interpretation
Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities to the fetus in any trimester of pregnancy.
Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and wellcontrolled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. Eg. Amoxicillin, paracetamol

Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women. Eg. Rifampicin, theophylline

Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a lifethreatening situation or serious disease for which safer drugs cannot be used or are ineffective. Eg. phenytoin, tetracycline

Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant. Eg. isotretinoin, thalidomide

Drug Safety in Lactation

Nearly all drugs transfer into breast milk to some extent milk (7.2) is slightly more acidic than plasma (7.4) weakly basic drugs transfer more readily into breast milk

PATIENT CASE

 General patient information Chief complaint

Date and time of admission, patients name, age, race, gender Reason or reasons the patient is seeking medical care

 History of Narrative that describes the current medical problem present illness Past Brief description of current and medical previous patient problems history unrelated to the present illness

 Social Contains information about the history patients use of tobacco, alcohol, and illicit drugs; patients occupation, marital status, sexual history, & living conditions Family Brief summary of the medical history histories of the patients first degree relatives

 Include demographic information, dietary information, social habits, current & past prescription & non-prescription medications, allergies, ADRs & compliance Review of Summarizes all patient systems complaints not included in the HPI Physical Short description, vital signs, examination systemic examination (skin, HEENT, hear, chest, abdomen, genitalia, neurologic)
Medication history

Laboratory & diagnostic test results

Patient problem list and plans

COUNSELING AND COMMUNICATION

Non-compliance
Non-compliance or non-adherence, is a patients failure to follow a drug regimen as instructed
inadequate/excessive intake incorrect frequency discontinuation intake of medication other than prescribed

Verbal Communication Skills

Includes the ability to listen, understand and respond to other peoples statements and the ability to interpret the nonverbal ways of other people.

Active listening makes people feel that

they have the full attention of the health professional

Active Listening
LISTENING FILTERS
Organizational Role
Attitudes

Previous experiences

Values

Bias, etc.

RESPONDING

REMEMBERING

UNDERSTANDING

INTERPRETING

HEARI NG

EVALUATING

Body Language
Raising the hand Shifting body positions Crossed arms Leaning toward the speaker

Desire to speak or interrupt Desire to interrupt Shutting out the other person Receptiveness Hopelessness Disagreement

Raising the hands and then letting them fall limply

Frequent throat clearing

Barriers to Verbal Communication Physical barriers Lack of privacy

Hindering Behaviors
technical language and medical jargon frequent interruption expressing bias closed posture/ threatening posture reading notes during interview Avoiding eye contact Asking multiple questions at once Engaging in sarcasm Ignoring emotion of patient mumbling

PHARMACEUTICAL CARE PLAN

Pharmaceutical Care Plan

Assessment Plan Monitoring

DRUG UTILIZATION REVIEW

Drug Utilization Review

Review of medication profiles to ensure the appropriateness of prescriptions or medication orders Prospective DUR (before dispensing) or Retrospective DUR (after dispensing)

PHARMACOECONOMIC METHODOLOGIES

Cost of Illness (CI)

evaluates the direct and indirect costs of a particular disease non comparative serve as a baseline information

Measures of Cost
Direct: paid directly by the health service
medical non-medical

Measures of Cost
Indirect: costs experienced by the patient or society
e.g. loss of earnings; loss of productivity

Intangible: impossible to measure in monetary terms

e.g. pain, worry, distress of patient/family

Cost-Minimization Analysis (CMA)

identify the alternative with the lowest cost among various interventions with equivalent outcomes or consequences e.g. comparing generic drugs with their branded counterparts

Example: CMA
Cost of Therapies DRUG A DRUG B Costs Acquisition cost Administration Monitoring Adverse Effects Subtotal Outcomes Antibiotic Effectiveness 250 75 75 100 500 90% 350 0 25 25 400 90%

Note: both interventions are considered equally effective

Result = Cost of Drug A > Cost of Drug B

Cost-Effectiveness Analysis (CEA)

compares treatment or other forms of health intervention that yield different levels of health benefits Benefits can be defined and measured in the same natural units

Example: CEA
Cost of Therapies DRUG A DRUG B Costs Acquisition cost Administration Monitoring Adverse Effects Subtotal Outputs Extra years of life 300 50 50 100 500 1.5 400 0 0 0 400 1.6 400/1.6

Cost-effectiveness ratio 500/1.5

=$333 =$250 per extra year of life

Cost-Benefit Analysis (CBA)

comparing the resources consumed (costs) and the output (benefit) expressed in monetary terms

CBA: Example
Cost of Therapies DRUG A DRUG B Costs Acquisition cost 300 400 Administration 50 0 Monitoring 50 0 Adverse Effects 100 0 Subtotal 500 400 Benefits Days at work ($) 1,000 1,000 Extra months of Life ($) 2,000 3,000 Subtotal ($) 3,000 4,000 Benefit to Cost ratio 3000/500 = 6:1 4000/400 = 10:1 Net Benefit 2500 3600

Cost-Utility Analysis (CUA)

assess perceived mental, physical and general functioning over time of the management of chronic diseases

outcome is a unit of utility

CUA: Example
Cost of Therapies DRUG A DRUG B Costs Acquisition cost Administration Monitoring Adverse Effects Subtotal Utilities Extra years of Life Quality of life index QALYs Cost-to-utility ratio 300 50 50 100 500 1.5 0.33 0.5 400 0 0 0 400 1.6 0.25 0.4

500/0.5 400/0.4 = $1000 =$1000 per extra quality of life year

PHARMACY ETHICS

 Nonmaleficence:

To do no harm

Beneficence: Duty to promote good Respecting the patient-professional relationship Respect for autonomy: Respect for the individuals right to decide on issues that affect self Consent: right to be informed and to choose a course of action

 Confidentiality:

right to give or refuse consent relative to release of privileged information Respect for persons Veracity: obligation to tell the truth, or honesty

CLINICAL LABORATORY TESTS

GENERAL PRINCIPLES
Sources of Laboratory Error
- spoiled / incomplete specimen - Improper timing of obtaining the specimen - Faulty reagents, technical errors, wrong procedures - Failure to take diet and medication into account

GENERAL PRINCIPLES
Clinical Performance
Sensitivity small changes or deviations from normal can be detected Specificity false (+) results are minimal

Laboratory Results
Quantitative ranges (e.g. 1.2 3 mEq/L) Qualitative (+) or (-) outcomes Semi-quantitative varying degrees of (+) , e.g. 1+, 2+, 3+ for glucose in urine

GENERAL PRINCIPLES
Accuracy versus Precision
Accuracy extent to which mean measurement is close to the true value Precision reproducibility of the assay

HEMATOLOGICAL TESTS
3 Types of Formed Elements
Red Blood Cells (RBC) White Blood Cells (WBC) Platelets

Complete Blood Count (CBC) Hemoglobin (Hb), hematocrit (Hct), total WBC, total RBC, mean cell volume (MCV), and platelet count

HEMATOLOGICAL TESTS
A. Red Blood Cells (erythrocytes)
1. RBC Count indirect estimate of the bloods Hb

content

HEMATOLOGICAL TESTS
2. Hct (Packed Cell Volume, PCV)
Low Hct: Anemia, over hydration, or blood High Hct: polycythemia vera or dehydration

HEMATOLOGICAL TESTS
3. Hemoglobin
estimates the oxygen carrying capacity of the RBC
Low Hb: anemia

HEMATOLOGICAL TESTS
4. RBC Indeces (Wintrobe indices)

Mean Cell Volume (MCV) ratio of Hct to RBC count

Low MCV: microcytic RBCs High MCV: macrocytic RBCs

HEMATOLOGICAL TESTS
Mean Cell Hemoglobin (MCH)
amount of Hb in an average RBC

Mean Cell Hemoglobin Concentration (MCHC) average concentration of Hb in

an average RBC
Low MCHC : hypochromia

HEMATOLOGICAL TESTS
5. Reticulocyte Count

measure of immature RBCs with remnants of nuclear material

Inc: hemolytic anemia, acute blood loss, response to treatment of a factor deficiency Dec:drug-induced aplastic anemia

HEMATOLOGICAL TESTS
6. Erythrocyte Sedimentation rate Inc: used to differentiate conditions with similar symptomatology (angina pectoris vs. myocardial infarction)

HEMATOLOGICAL TESTS
B. White Blood Cells 5 Major Types: Granulocytes (a) Neutrophils (b) Basophils (c) Eosinophils Nongranulocytes (d) Lymphocytes (e) Monocytes

HEMATOLOGICAL TESTS B. White Blood Cells

Inc. WBC count (Leukocytosis): infection (esp.bacterial), leukemia, or tissue necrosis Dec. WBC count (Leukopenia): bone marrow depression w/c may result from metastatic carcinoma, lymphoma, or toxic reactions to substances such as antineoplastic agents.

HEMATOLOGICAL TESTS
NEUTROPHILS mature: Polymorphonuclear
leukocytes (PMNs), polys, segmented neutrophils, or segs - immature: bands or stabs
- NEUTROPHILIC LEUKOCYTOSIS: e.g.pneumonia

HEMATOLOGICAL TESTS
OTHER CAUSES OF NEUTROPHILE COUNT INC

Certain viruses (herpes zoster, chicken pox) Rickettsial disease (Rocky Mountain spotted fever) Fungi and stress (physical exercise, acute hemorrhage or hemolysis, acute emotional stress) Inflammatory diseases (acute rheumatic fever, RA, acute gout)

HEMATOLOGICAL TESTS
OTHER CAUSES OF NEUTROPHILE COUNT INC Hypersensitivity reactions to drugs Tissue necrosis (MI, burns, certain CA) uremia, diabetic ketoacidosis Myelogenous Leukemia Epinephrine and Lithium

HEMATOLOGICAL TESTS
NEUTROPENIA
decreased number of neutrophils
overwhelming infection of any type Viral infections (mumps, measles) Idiosyncratic drug reactions Chemotherapy

HEMATOLOGICAL TESTS
BASOPHILS referred as MAST CELLS
BASOPHILIA CML (Chronic
Myelogenous Leukemia)

A decrease in number is not apparent.

HEMATOLOGICAL TESTS
EOSINOPHILS EOSINOPHILIA acute allergic reactions and parasitic infestations

HEMATOLOGICAL TESTS
LYMPHOCYTES
produce antibody B lymphocytes (antibody mediated) T lymphocytes (cell mediated) LYMPHOCYTOSIS viral infection LYMPHOPENIA immunodeficiency, AIDS

HEMATOLOGICAL TESTS
MONOCYTES phagocytic cells MONOCYTOSIS TB, subacute bacterial endocarditis

HEMATOLOGICAL TESTS
C. Platelets (thrombocytes)
smallest formed elements in the blood

Thrombocytopenia: idiopathic thrombocytopenic

purpura, or from drugs as quinidine and sulfonamides

COMMON SERUM ENZYME TESTS

A. Creatinine Kinase (CK)
Formerly known as Creatine Phosphokinase myocardium, skeletal muscles and brain tissue aids in the diagnosis of acute myocardial or skeletal muscle damage () vigorous exercise, a fall, deep IM injection

COMMON SERUM ENZYME TESTS

B. Lactate Dehydrogenase (LDH)
LDH1, LDH2 heart LDH3 lungs LDH4 and LDH5- liver and skeletal muscle

COMMON SERUM ENZYME TESTS

C. Alkaline Phosphatase (ALP)

Inc.: partial or mild biliary obstruction, increase osteoblastic activity (Pagets disease, hyperparathyroidism, or osteomalacia)

COMMON SERUM ENZYME TESTS

D.Aspartate Aminotransferase (AST)
SGOT (Serum Glutamic Oxaloacetic Transaminase) Major (heart, liver tissues); minor (skeletal muscle, kidney tissue, pancreatic tissue)

COMMON SERUM ENZYME TESTS

E. Alanine Aminotransferase (ALT)
SGPT (Serum Glutamic Pyruvic Transaminase) Found in the liver (major), heart, skeletal muscles, and kidney

COMMON SERUM ENZYME TESTS

F. Cardiac Troponins (I, T, and C) I (cardiac muscles) C (skeletal and cardiac muscles) T (cardiac and skeletal muscles)

LIVER FUNCTION TESTS

A. Liver enzymes (LDH, ALP, AST, ALT) - only indicate liver damage NOT livers ability to function B. Serum Bilirubin BILIRUBIN breakdown product of Hb; predominant pigment of the bile
3 major causes of increase (jaundice) Hemolysis Biliary obstruction Liver Necrosis

URINALYSIS
1. APPEARANCE normal: clear, pale yellow to
deep gold Red color presence of blood or phenolphthalein Brownish yellow color presence of direct bilirubin Red, orange, yellow, brown drugs (rifampicin)

URINALYSIS
2. pH normal: 4.5 9

3. SPECIFIC GRAVITY normal: 1.003 1.035

() DM, Nephrosis; () Diabetes insipidus 4. PROTEIN abnormal glomerular permeability - PROTEINURIA - ALBUMINURIA

URINALYSIS
5. GLUCOSE GLYCOSURIA (+) DM 6. KETONES
KETONURIA uncontrolled DM, starvation, or low CHO diets

URINALYSIS
MICROSCOPIC EVALUATION - Normal: 0 1 RBC, 0 4 WBC, occasional casts
HEMATURIA trauma, tumor, systemic bleeding disorder (+) squamous cell vaginal contamination (menstruation) CASTS (+) renal disease CRYSTALS BACTERIA UTI

RENAL FUNCTION TESTS

A. BUN (BLOOD UREA NITROGEN) UREA end product of purine metabolism, produced by liver, excreted by kidneys

Inc.: renal disease Dec.: significant liver disease

B. SERUM CREATININE CREATININE metabolic breakdown product of muscle creatinine phosphate C. CREATININE CLEARANCE

Cockroft and gault

CLcr (male) mL/min = [(140 -age in yr) (BW kg)] [72 x Pcr in mg/dL]

CLcr (female) = CLcr male x 0.85

ELECTROLYTES
Sodium (Na+) major extracellular fluid cation Hyponatremia Total body depletion of Na mineralocorticoid deficiency Overhydration CHF Cirrhosis renal failure

ELECTROLYTES
Hypernatremia Loss of free water DI Excessive Na intake Impaired Na excretion

ELECTROLYTES
B. Potassium (K+) most abundant intracellular cation
Hypokalemia
Excessive mineralocorticoid activity Vomiting, diarrhea, laxative abuse Diuretic use (mannitol, loop, thiazides) Glucosuria

ELECTROLYTES
Hyperkalemia
Renal insufficciency, excessive intake, drugs During vigorous exercise Cellular breakdown Metabolic acidosis

ELECTROLYTES
C. Chloride (Cl-) major extracellular anion; maintains acid base balance

Hypochloremia
Excessive loss of GI fluids, CRF Diuretic therapy, Fasting, Adrenal Insufficiency

Hyperchloremia
ARF, Dehydration, excessive salt/ Cl intake

MINERALS
C. Magnesium 2nd most abundant intra and extracellular cation nerve conduction muscular contractility membrane transport and integrity

MINERALS
Hypomagnesemia - poor intestinal absorption - excessive GI loss Hypermagnesemia - increased intake w/ RF - Hepatitis - Addisons disease

MINERALS
Calcium (Ca2+) bone and tooth structural integrity nerve impulse transmission muscle contraction pancreatic insulin release H+ release from stomach cofactor for some enzyme reactions blood coagulation

MINERALS
Hypocalcemia - deficiency in production or response to parathyroid hormone
- Hypoparathyroidism - Pseudohypoparathyroidism - Hypomagnesemia

- Low intake of vit D - Loop diuretics Hypercalcemia - Hyperparathyroidism - Pagets disease - high intake of Ca or vit D - Thiazide therapy

B. Phosphate (PO4) major intracellular anion, phosphate source for ATP synthesis - influenced by Ca (inversely proportional) Hyperphosphatemia
- low Vit D intake - Hypoparathyroidism - hyperthyroidism

MINERALS

Hypophosphatemia
Al containing or Ca acetate containing antacids chronic alcoholics Hyperparathyroidism High vit D

OTHER LABORATORY TESTS

A. Prothrombin Time (PT)
Warfarin monitoring Extrinsic Pathway: Factors II, VII, IX, X (1972) N: 10-12 sec Inc PT Inadequate Vit K in the diet Drugs (coumarins)

OTHER LABORATORY TESTS

B. Activated Partial Thromboplastin Time (aPTT)
Intrinsic Pathway : Factors VIII, IX, XI, XII Common Pathway: Factors II, V, X MONITORS Heparin Therapy N: 21- 45 sec Inc aPPT Severe liver dysfunction Inadequate vit K Poor or inadequate nutrition

Clinical Pharmacy for Common Diseases

1. Hypertension
1. Primary/ essential 2. Secondary/ underlying disease

Stages of hypertension
normal Prehypertension

Systolic (+19) Diastolic (+9) <120 <80 120-139 80-89

Remedy
Lifestyle modificat ion DOC: thiazide diuretics (hydrochlo rothiazide)

Stage I -forever na may HPN

140-159

90-99

Stage II

>160

>100

Other types
Emergency HPN (BP 180/120) with target organ damage Gestational HPN (BP 140/90) Pregnancy induced -no underlying Dx DOC: Methyldopa

Non pharmaceutical treatment in HPN

1.stop smoking 2. limit sodium intake 3. limit alcohol intake 4. exercise 5. healthy diet 6. loose weight -every 10kg lost in weight BP drops

CHOICE OF ANT HYPERTENSIVE DRUGS BASED ON PATIENT CHARACTERISTIC

1. DM + kidney disease
Ace inh and aRBS C/I: thiazide diretics S/E: hyperuricimia (incuric acid and TGA) Hypertriglyceremia Hyperglycemia

2. CHF ( congestive heart failure)

-signs and symptoms edema bipedal edema - ace inh + diuretics CCBs only severe oxidation Effects: vasodilaton

3.) Miocardial infarction Ace Inh + b-blockers

4.) asthama or with pulmonary disease Asthma- not for b-blockers Selective BEAMS dec sensitivity to high dose- bronchoconstriction

DIABETES MELLITUS
Risk factor: obese BMI: kg/m2

Based on BMI
<18 Underweight

18-23
23-25 25-30

Normal
Overweight Obese I

>30

Obese II

Complication
a. macrovascular (CAD, MI) b. microvascular 1. retinopathy 2. neuropathy 3. nephropathy

 Post prandial Insulin will be released -to utilize glucose ( glycogen storage) Obese: always eat -receptors become insensitive to insulin -glucose accumulate

Diagnosis
1. Fasting blood sugar 6-8 hrs fasting -screening of fat 2. RBS-(randomized blood sugar)

N (mg/dL) impaired DM FBS <110 111-125

141-199

>126
>200

RBS <140

Causes

Type I Insulin dependent autoimmune

Antibodie are againsta beta cell

Type II Non insulin dependent Increase glucose uptake Insulin resistance Impaired insulin secretion

T I vs
age FMH body sy symptoms early thin PolyphagiaPolydipsia Polyuria

T II
Delayed + obese + Asymptomatic

Ketone bodies

(+)

(-)

Gestational diabetes
When pregnant insuin resistant DM screening 50g glucose challenge(interferes with release of insulin) Confirmatory test- 100glucose/ tolerance Test (3 hrs ,140 RO) DOC: insulin sq lipid

Inhibitors of insulin
a. glucosan b. epinephrine c. NE d.cortisol e. growth hormone

TX for DM type II
Step 1 SI: lifestyle modification, diet, exercise,

Step II: OHA

a.) sulfonyl urea( glipizide, glibenclamide) Adv: most fast blood glucose reduction AE: weight gain, hypoglycaemia b.) biguanide (metformin) -obes patient - adv: good lipid profile AE: metabolic acidosis

c. Alpha-glucosidae inhibitor (acarbose) Ae: gi flatulence

d. insulin sensitizer ( thiazolidine) resiglitazone

step III
insulin a.) rapid acting (insulin aspo, aspu, gluco) b. slow acting (reg insulin, pregnant IV) c. intermediate (NPH) neutral protein of hagedorn d.) long acting- glargne (lantus)

BRONCHIAL ASTHMA
SEVERITY Daytime sy Night drugs MILD <1 week <monthly B2 agonist (salbutamo l (ventoln) MID/MODERATE SEVERE Persistent weekly daily Mos-weeks Long acting b2 agonist -inhaled glucocorticoids -bedomethasone Nightly Long acting b2 agonist Inhaled corticosteroid -prednisone ( oral glucocorticoid)

CONGESTIVE HEART FAILURE

Sx/Sy: dyspnea ( diff in beam) Orthopenea ( diff in breathing in supine) Paroxysmal nocturnal dyspnea (sudden and nightly)

New York heart association

CI CII Within the limit of normal Ordinary extraction (dyspnea)

CIII CIV DOC

Less than ordinary exertion At rest ACE inh delivered first line

HOSPITAL PHARMACY

THE HOSPITAL
A hospital has been defined in terms of its form, that is, its physical make up and the quantitative nature of its services.

Clinic
a facility or area where ambulatory patients are seen for special study and treatment by a group of physicians practicing together, and where the patient is not confined in a hospital.

Classification of hospital
Type of service General - patient w/ any type of illness Special - ex: cancer, psychiatric, pediatric

Classification of hospital
Length of stay Short-term - < 30 days Long-term - 30 days

Classification of hospital
Ownership Governmental

- federal & state hospitals (county & city hospitals)

Non-governmental - non-profit oriented: church operated - profit oriented: individual, partnership & corporation

Classification of hospital
Bed capacity Under 50 beds 50-99 beds 100-199 beds 200-299 beds 300-399 beds 400-499 beds 500 beds & over

Supporting Services
1. Nursing service - nursing care 2. Dietary service - procurement, planning & preparation of food for the patient & hospital staff - supplies sterile linen, OR packs & other medical surgical supplies

3. Central supply service

Supporting Services
4. Medical record - serve as basis for planning service & continuity of patient care - provide data for use in research education - serve as basis for review & evaluation of the care rendered to the patient

Supporting Services
5. Blood bank - generally under the supervision of a licensed physician who has a basic interest in hematology - cytological & gross anatomical analysis - clinical laboratories

6. Pathology

Supporting Services
7. Radiology - diagnostic & therapeutic application of radiant energy - anesthesia care - very important liaison between the hospital & the patient & his community

8. Anesthesia 9. Medical social service

Main type of Medical Staff

OPEN STAFF - one in which certain physicians, other than those on the attending or active medical staff, are allowed to use the private room facilities These physicians are termed members of the courtesy medical staff. CLOSE STAFF - one in which all professional services, private & charity are provided and controlled by the attending or active medical staff

Specific Types of Medical Staff

1. Honorary staff - consists of former staff members, retired or emeritus, & of other practitioners whom the medical staff chooses to honor

Specific Types of Medical Staff

2. Active staff - responsible for the delivery of the pre-ponderance of medical service within the hospital - most involved in the organizational & administrative duties pertaining to the medical staff

Specific Types of Medical Staff

3. Associate staff - consists of individuals who are being considered for advancement to the active medical staff - appointed & assigned to the various services in the same manner as are members of the active medical staff

Specific Types of Medical Staff

4. Courtesy staff - consists of practitioners who are eligible for staff membership, who are given privileges to admit an occasional patient to the hospital - may neither vote nor hold office in the medical staff organization

Specific Types of Medical Staff

5. Consulting staff - consists of medical practitioners of recognized professional ability who are not members of the preceding categories of staff membership

Specific Types of Medical Staff

6. Resident staff - receiving specialized clinical training in a hospital, usually after completing an internship

Hospital Pharmacists Responsibilities

I. Central pharmacists responsibilities A. Dispensing Area 1. Ensures that established policies and procedures are followed 2. Checks for accuracy of dose prepared: a) IV admixture b) unit dose

Hospital Pharmacists Responsibilities

3. Provides for proper drug control: a) Ensures that drugs are stored and dispensed properly and b) ensures that all drug laws are followed 4. Ensures that good techniques are used in compounding IV admixtures and extemporaneous preparations

Hospital Pharmacists Responsibilities

5. Provides for proper record keeping and billing: a) patient- medication records, b) extemporaneous compounding records, c) IV admixture records and billing d) investigation- drug records e) reports

Hospital Pharmacists Responsibilities

6. Maintains professional competence, particularly in knowledge of drug stability and incompatibilities 7. Ensures that new personnel are trained properly in the policies and procedures of the dispensing area 8. Coordinates the activities of the area with the available staff to make the best possible use of personnel and resources

Hospital Pharmacists Responsibilities

9. Keeps the dispensing area neat and orderly 10. Communicates with all pharmacy staff regarding new developments in the area and assists in employee evaluations

Hospital Pharmacists Responsibilities

11. Provides drug information as necessary to the pharmacy, medical, and nursing staffs 12. Coordinates the over- all pharmaceutical needs of the patient- care areas with the dispensing area

Hospital Pharmacists Responsibilities

B. Patient- Care Area 1. Supervision of drug administration: A. reviews and interprets each unit dose and IV admixture medication order to ensure that it is entered accurately into the unit dose or IV admixture system

Hospital Pharmacists Responsibilities

B. confirms periodically that administered doses are noted correctly on the patients chart C. ensures that records from administered narcotics are kept correctly and that the physician is informed of all automatic stop orders D. ensures that proper drug administration, techniques are used

Hospital Pharmacists Responsibilities

E. acts as liaison between the pharmacist and the nursing and medical staffs F. communicates with nurses and physicians concerning medicationadministration problems G. periodically inspects the medication areas on the nursing units to ensure that adequate levels of floor stock drugs and supplies are maintained

Hospital Pharmacists Responsibilities

H. ensures that drugs and supplies are procured from the dispensing area as required I. ensures that the other supportive services performed by the department of pharmacy are carried out correctly J. coordinates all pharmacy services on the nursing- unit level

Hospital Pharmacists Responsibilities

K. ensures that the medication area is neat and orderly L. ensures that proper security is maintained in the medication area to prevent pilferage

Hospital Pharmacists Responsibilities

2. Direct patient care A. identifies drugs brought into the hospital by patients B. obtains patient medication histories and communicates all pertinent information to the physician C. assists in drug- product and entity selection

Hospital Pharmacists Responsibilities

D. assists in drug- product and entity selection E. assists the physician in selecting dosage regimens and schedules, then assigns drug- administration times for these schedules

Hospital Pharmacists Responsibilities

F. monitors patients total drug therapy for effectiveness/ uneffectiveness, side effects, toxicities, allergic drug reactions, drug interactions, and appropriate therapeutic outcomes G. counsels patients on: a) medications to be self- administered in the hospital b) discharge medications

Hospital Pharmacists Responsibilities

H. participates in cardiopulmonary emergencies by: a) procuring and preparing needed drugs, b) charting all medications given c) performing cardiopulmonary resuscitation, if necessary

Hospital Pharmacists Responsibilities

II. Ambulatory pharmacists responsibilities A. Dispensing Area 1. Ensures that established policies and procedures are follow

2. Checks for accuracy in the work of supportive personnel

Hospital Pharmacists Responsibilities

3. Ensures that proper techniques are used in extemporaneous compounding 4. Provides for adequate record keeping and billing: patient medication records, investigational drug records, outpatient billing, reports, and prescription files

Hospital Pharmacists Responsibilities

5. Maintains professional competence 6. Ensures that new personnel are trained properly in the policies and procedures of the ambulatory pharmacy

Hospital Pharmacists Responsibilities

7. Coordinates the activities of the area with the available staff to make the best use of personnel and resources 8. Keeps the ambulatory pharmacy area neat and orderly at all times

Hospital Pharmacists Responsibilities

B. Patient Care Area 1. Inspects the medication areas on the nursing unit periodically to ensure an adequate supply of stock drugs and their proper storage

2. Identifies drugs brought into the clinic by patients

Hospital Pharmacists Responsibilities

3. Obtains patient-medication histories and communicates pertinent information to the physician 4. Assists in drug product and entity selection 5. Assists the physician in selecting dosage regimens and schedules

Hospital Pharmacists Responsibilities

6. Monitors the patients total drug therapy for effectiveness, side effects, toxicities, allergic drug reactions, drug interactions, and appropriate patient outcomes 7. Counsels patients on the proper use of their medication

Hospital Pharmacists Responsibilities

8. Prepares medications for IV administration 9. Provides medications and/ or supplies for patient home care

Divisions Administrative Services

1. Plan & coordinate departmental activities. 2. Develop policies. 3. Schedule personnel & provide supervision. 4. Coordinate administrative needs of the Pharmacy & Therapeutics Committee. 5. Supervise departmental office staff.

Education & Training

1. Coordinate programs of undergraduate & graduate pharmacy students. 2. Participate in hospital wide educational programs involving nurses, doctors, etc.

3. Train newly employed pharmacy department personnel.

Pharmaceutical Research
1. Develop new formulations of drugs especially dosage forms not commercially available & of research drugs. 2. Improve formulations of existing products.

3. Cooperate w/ the medical research staff on projects involving drugs

In-patient Services
1. Provide medications for all in-patients of the hospital on a 24-hour per day basis. 2. Inspection & control of drugs on all treatment areas.

3. Cooperate w/ medical drug research.

Out-patient Services
1. Compound & dispense out-patient prescriptions. 2. Inspect & control all clinic & emergency service medication stations. 3. Maintain prescription records. 4. Provide drug consultation services to staff & medical students.

Drug Information Services

1. Provide drug information on drugs & drug therapy to doctors, nurses, medical & nursing students & the house staff. 2. Maintain the drug information center. 3. Prepare the hospitals pharmacy newsletter. 4. Maintain literature files

Departmental Services
1. Control & dispense IV fluids. 2. Control & dispense controlled substances. 3. Coordinate & control all drug delivery & distribution systems.

Purchasing & Inventory Control

1. Maintain drug inventory control. 2. Purchase all drugs. 3. Receive, store & distribute drugs. 4. Interview medical service representatives

Central Supply Services

1. Develop & coordinate distribution of medical supplies & irrigating fluids.

Assay & Quality Control

1. Perform analyses on products manufactured & purchased. 2. Develop & revise assay procedures. 3. Assist research division in special formulations

Manufacturing & Packaging

1. Manufacture wide variety of items in common use at the hospital. 2. Operate an overall drug packaging & prepackaging program. 3. Undertake program in product development. 4. Maintain a unit dose program

Sterile Products
1. Produce small volume parenterals. 2. Manufacture sterile ophthalmologics, irrigating solutions, etc. 3. Prepare aseptic dilution of lyophylizal & other unstable sterile injections for administration to patients.

Radiopharmaceutical Services
1. Centralize the procurement, storage & dispensing of radioisotopes used in clinical practice

IV Admixture
1. Centralize the preparation of IV solution admixture. 2. Review each IV admixture for physicochemical incompatibilities.

PHARMACY AND THERAPEUTICS COMMITTEE

Objective
To achieve optimal patient care and safety through rational drug therapy

Primary Purposes
Policy development - formulates policies regarding evaluation, selection, and therapeutic use of drugs and related devices

Primary Purposes
Education - recommends or assists in the formulation of programs designed to meet the needs of the professional staff for complete current knowledge on matters related to drugs and drug use

Organization
The PTC should be composed of at least the ff. voting members: physicians, pharmacists, nurses, administrators, quality assurance coordinators, and others as appropriate.

Organization
A chairperson from among the physician representatives should be appointed. A pharmacist should be designated as secretary

Functions and Scope

To serve in an evaluative, educational, and advisory capacity to the medical staff and organizational administration in all matters pertaining to the use of drugs To develop a formulary of drugs accepted for use in the organization and provide for its constant revision

Functions and Scope

To establish programs and procedures that help ensure safe and effective drug therapy To establish programs and procedures that help ensure cost- effective drug therapy

Functions and Scope

To establish or plan suitable educational programs for the organizations professional staff on matters related to drug use To participate in quality assurance activities related to distribution, administration, and use of medications

Functions and Scope

To monitor and evaluate ADRs in the health- care setting and to make appropriate recommendations to prevent their occurrence To initiate or direct (or both) drug use evaluation program and studies, review the results of such activities, and make appropriate recommendations to optimize drug use

Functions and Scope

To advise the pharmacy department in the implementation of effective drug distribution and control procedures To disseminate information on its actions and approved recommendations to all organizational healthcare staff

Formulary System
Definition: A method whereby the medical staff of an institution, working through the PTC, evaluates, appraises, and selects from among the numerous available drug entities and drug products those that are considered useful in patient care

Formulary
Definition: A continually revised compilation of pharmaceuticals that reflects the current clinical judgement of the medical staff

Main Parts of a Formulary

Part I. Information on hospital policies and procedures concerning drugs. This includes:
1. categories of drugs 2. brief description of the PTC 3. hospital regulations regarding prescribing, dispensing, and administration of drugs 4. pharmacy operating procedures 5. information on using the formulary

Part II. Drug Product Listing

This is the heart of the formulary and consists of descriptive entries for each formulary item plus one or more indices to facilitate use of formulary. The entries may be arranged in any of the ff. ways: alphabetically by generic name alphabetically within therapeutic class combination of the two systems

Those entries must contain the ff. minimum information:

generic name of the basic drug entity common synonyms and brand names dosage form/s, strength/s, packaging/s and size/s stocked by the formulary formulation (active ingredients) of a combination of product additional information such as: unusual pediatric and adult dose, special cautions and notes, controlled substances symbol

Part III. Special Information

This varies from hospital to hospital and may include: list of hospital- approved abbreviations rules of calculating pediatric dosages dosing guides for patients with renal impairment lists of dialyzable poisons, etc.

Purchasing & Inventory Control

Turnover rate: cost of good sold -------------------------------------------------------average of beginning & ending inventory

Purchasing & Inventory Control

Low turnover causes: duplication of stocks large purchases of slow moving items dead inventory High turnover causes: small volume purchasing Satisfactory turnover rate: 4 times a year

Dispensing
In-patient Dispensing 1. Use of charge plate - use of a plastic or metal card prepared on patients admission 2. Envelope system - used to dispense drugs to the nursing station & at the same time is also used as a charge ticket

Dispensing
3. Drug basket method - used by hospitals for stocking non-charge floor stock drugs & related products on the nursing station

4. Mobile dispensing unit - utilizes a specially constructed stainless steel truck

5. Mechanical dispensing - Ex. Brewer system

I. Erroneous Prescription
The brand name precedes the generic name. The generic name is the one in parenthesis. The brand name is not in parenthesis.

Prescription 1

Erroneous prescription

II. Violative Prescription

The generic name is not written. The generic name is not legible and a brand name that is legible is written. The brand name is indicated and instructions added (such as the phrase No substitution) that tend to obstruct, hinder, or prevent generic dispensing.

Prescription 3

Violative prescription

III. Impossible Prescription

Only the generic name is written but is not legible. The generic name does not correspond to the brand name. Both the generic name and the brand name are not legible.

Prescription 5

Impossible prescription

Procedures to be followed for each incorrect prescription:

Erroneous prescriptions shall be filled. Such prescription shall be kept and reported by the pharmacist to the nearest DOH office for proper action. Violative or impossible prescriptions shall not be filled. They shall be kept and reported to the nearest DOH office for appropriate.

Drug Distribution Systems

The pharmacy department makes drugs available at the nursing unit for patient use usually in one of four ways:
1. a complete floor- stock system 2. individual prescription medication for each patient 3. a combination of 1 & 2 4. unit dose dispensing, either centralized in the pharmacy or decentralized at the nursing unit level

. Floor-stock System
used in small hospitals where pharmacists are not available to dispense individual doses for patients.

2 classes
Free floor stock- consists of a predetermined list of medications that are available on every nursing unit of the hospital for use at no specific charge to the patient. Charge floor stock- is medication available at each nursing unit of the hospital and for which a charge is made to the patient

Advantages:
ready availability of the required drugs elimination of drug returns reduction in number of drug order transcriptions for the pharmacy reduction in the number of pharmacy personnel needed

Disadvantages
possible increase in medication errors due to elimination order review increased drug inventory on the pavilion greater opportunity for pilferage increased hazards associated with drug deterioration possible lack of proper storage facilities on the ward greater in roads are made upon the nurses time

II. Individual Prescription Order System used predominantly in small hospitals where a pharmacist is not on the premises all the time.

Advantages:
reduced manpower requirements individualized service all medications directly reviewed by the pharmacist provides interaction of pharmacist, doctor, nurse, and patient provides closer control of inventory

Disadvantages:
possible delay in obtaining required medication increase in cost to the patient

III. Combination of I & II use the individual drug order system as the primary means of dispensing but also utilize a limited floor stock; most commonly used, incorporates unit-dose dispensing as well.

IV. Unit Dose Dispensing the pharmacist prepares every dose of medication ready for administration

Advantages:
improved pharmaceutical service 24 hours a day and patients are charged only those doses which are administered to them all doses are prepared in the pharmacy giving nurses more time for direct patient care allows checking or interpreting of the doctors original order thus reducing medication error

Advantages
eliminates excessive duplication of orders and paper works at the nursing station and pharmacy eliminates credit IV preparation and reconstitution done at the pharmacy more efficient utilization of professional and non- professional personnel

Advantages
reduced revenue loss conserves space in nursing units by eliminating bulky floor stocks eliminates pilferage and drug waste extend pharmacy control and coverage throughout the hospital

Advantages
improved communication of medication orders and delivery systems ward work as drug consultants and help provide the team effort needed for better patient care

Major Forms of Unit Dose System:

Centralized - the most common and probably the most cost- efficient - orders are interpreted and almost all drug doses are picked and placed in the patient drawers of the medication carts in a central pharmacy

Major Forms of Unit Dose System:

Centralized - the most common and probably the most cost- efficient - orders are interpreted and almost all drug doses are picked and placed in the patient drawers of the medication carts in a central pharmacy

Major Forms of Unit Dose System:

Decentralized - have one or more satellite pharmacies scattered throughout the hospital from which most of the single unit doses are distributed - routine packaging of medication is usually carried out

Major Forms of Unit Dose System:

Systems Combining 1 & 2 - some distribution activities are performed in the patient- care areas while the rest are performed centrally

Major Forms of Unit Dose System:

Partial - some unit dose systems are only partially complete due to special circumstances of certain hospitals

Drugs for the Emergency Box

Aminophylline Amphetamine Amyl nitrite inhalation Atropine sulfate Caffeine sodium benzoate Calcium gluconate Chloroprophenpyrimadine maleate Digoxin Diphenylhydantoin sodium Epinephrine HCl Heparin Hydrocortisone Isoproterenol Magnesium sulfate injection Metaraminol bitartrate Mannitol injection Nalorphine HCl Neostigmine methylsulfate Norepinephrine injection Pentobarbital Pentylenetetrazol injection Phenobarbital Phenylephrine Phytonadione injection Picrotoxin injection Procaine amide Protamine sulfate Saline for injection Sodium molar lactate solution Water for injection

Compounding
IV Fluids- functions as a means for fluid replacement, electrolyte balance restoration and supplementary nutrition, and as vehicles for administration of other drug substances and in TPN Large volume parenterals- 100-1000mL Small volume parenterals- 25-50mL

Compounding
IV Admixture - when one or more sterile products are added to an IV fluid for administration - it is prepared with aseptic technique or environment provided by laminar flowhood, in which the air is filtered through HEPA (high efficiency particulate air) filter

Compounding
- HEPA filters remove 99.97% of all particles larger than 0.3 um - the flow of air may be in either a horizontal or vertical pattern - the best way to determine the proper functioning of a HEPA filter is to use the dioctylphthalate (DOP) test using the vapor at room temperature

Compounding
Total Parenteral Nutrition - IV administration of calories, nitrogen, and other nutrients in sufficient quantities to achieve tissue synthesis and anabolism - originally, the term hyperalimentation was used to describe the procedure

Nutritional Assessment
a decision was made to initiate specialized nutrition support functional GI tract? YES Enteral Nutrition
nasogastric nasoduodenal

NO Parenteral Nutrition
PPN TPN

nasojejunal
gastrostomy jejunostomy

TPN
- Dudrick developed the technique for administering fluids for PN by way of the subclavian vein into the superior vena cava where the solution is diluted rapidly by the large volume of blood available, thus minimizing the hypertonicity of the solution

TPN
PN is indicated for patients who are unable to ingest food due to carcinoma or extensive burns and patients who refuse to eat, as in the case of depressed geriatrics or young patients suffering from anorexia nervosa and surgical patients who should not be fed orally Normal Caloric Requirement: 2500 cal/ day for adults

Formulation of TPN:
Protein- source of amino acid Carbohydrates- provide energy Lipid- source of essential fatty acids Electrolytes- for proper enzymatic and energy conserving or expending reactions within the body (e.g. sodium, potassium, magnesium, calcium, chloride, phosphate)

Formulation of TPN:
Trace elements e.g. zinc, copper, selenium, chromium, iron, manganese, cobalt, molybdenum Vitamins- for long- term therapy Fluids Container: silicone based bags, superseded by PVC and ethylvinyl acetate

Physical Considerations

Preparation Room

Anteroom

Clean Room
specially constructed room in which the air supply, air distribution, room pressure, temperature and humidity are controlled to meet appropriate cleanliness level

Major Sources of Contamination

Natural Air Personnel Equipment Materials

Laminar Air Flow Hood (LAFH)

an equipment that makes use of a High Efficiency Particulate Air (HEPA) filtration

may be in a horizontal, vertical or convergent flow type

Proper Use of LAFH

Proper Use
operational efficiency of the LAFH should be inspected and certified regularly sanitize the walls and workbench with 70% alcohol and sterile non-linting wipes

observe proper arrangement of items inside the hood

Proper Use
do not overload the hood avoid unnecessary motion inside the hood work at least 6 inches in the hood to avoid turbulence

Proper Use
avoid spraying liquids and throwing sharp objects into the HEPA filter clean the hood after use

TPN Materials

TPN Materials
needle syringe micropore filter infusion set TPN bag TPN bottle vials ampules

Needle
Gauge 19 viscous liquids Gauge 21 mobile liquids Gauge 23 vent needle

Needle

Syringe

Syringe

Micropore Filter
Minisart pore size: 0.3 microns

Infusion Set

TPN Bag
made of EVA (Ethylene Vinyl Acetate) Nutrimix

TPN Bottle
usually D5W bottle (PGH)

Vials

Ampules

Aseptic Technique

Aseptic Techinque
refers to the ability of personnel to handle sterile components in a clean environment and without introducing microorganism into the product

TPN Compounding

THANK YOU!
margarita02gutierrez@yahoo.com