PHLE- Module-3 PDF

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MODULE 3 PRACTICE OF PHARMACY COMPOUNDING & DISPENSINGPHARMACY CLINICAL & HOSPITAL PHARMACY PHARMACEUTICAL CALCULATIONSPRACTICE OF PHARMACYI. Clinical Pharmacy ConceptsII. Clinical Pharmacy ServiceIII. Hospital PharmacyIV. BioethicsV. Clinical Laboratory TestVI. TherapeuticsVII. ...

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MODULE 3

 PRACTICE OF PHARMACY  COMPOUNDING & DISPENSING PHARMACY  CLINICAL & HOSPITAL PHARMACY  PHARMACEUTICAL CALCULATIONS

PRACTICE OF PHARMACY I. II. III. IV. V. VI.

Clinical Pharmacy Concepts Clinical Pharmacy Service Hospital Pharmacy Bioethics Clinical Laboratory Test Therapeutics VII. Complementary & Alternative Medicine

I. Clinical Pharmacy Concepts A. Introduction Clinical Pharmacy  branch of pharmacy where the pharmacist provides patients care that optimizes the use of medications & promotes health, wellness & disease prevention  a practice in which the pharmacy utilizes his professional judgment in the application of pharmaceutical sciences to foster the safe & appropriate use of drugs, in or by patients, while working w/ members of the health care team (Francke 1969)  health science specialty whose responsibility is to assure the safe & appropriate use of drugs in patients through the application of specialized knowledge & functions in patient care  patient-oriented Clinical Pharmacist: ☛ Interact with the health care team (MD, RN, RPh, PT, RT) ☛ Interview & assess the patient information: Dugs being taken, food & drug allergies ☛ Design & implement a therapeutic plan ☛ Make Therapeutic recommendation: Adverse Drug Reaction Drug Interaction ☛ Monitor Patient’s Response to therapy ☛ Provide drug information Pharmaceutical Care  is the responsible provision of drug therapy for the purpose of achieving definite outcomes that improves a patient’s QOL (quality of life)  a patient-centered practice in which the practitioner assumes responsibility for a patient’s drug-related needs & is held accountable for this commitment (Cipolle 1998) Major functions of Pharmaceutical Care:  Identifying potential & actual drug-related problems  Resolving actual drug-related problems  Preventing potential drug-related problems Expected Outcomes of Pharmaceutical Care:  Cure a disease  Elimination or reduction of patient’s symptoms  Arresting or slowing the disease process  Preventing disease & symptoms Knowledge & Skills Required in Clinical Pharmacy Knowledge  disease, drug therapy, non-drug therapy, laboratory, & diagnostic testing Skills  communication, patient monitoring, physical assessment, drug information provision, therapeutic planning

General Clinical Pharmacy Functions:  Providing drug information to physician & other health professionals  Medication history taking  Medication profile preparation  Drug therapy monitoring  Patient education & medication  Counseling  Disease screening, monitoring & maintenance care for patients with chronic diseases  Participation in the management of emergency medical care  Health information source for the public  Drug use review & patient care audits  In-service education for physicians, nurses & other health professionals  Specialized functions & services (ASHP 1983) B. Prescription  a written order for medication issued by a licensed physician, dentist, veterinarian, or only licensed medical practitioner. Parts of Prescription:

1. Name & Address of the Patient 2. Date when Prescription was written 3. Superscription  Rx sign; “RECIPE” meaning “take thou”  forms the beginning of a direct order from the prescriber to the compounder 4. Inscription  list of ingredients & their respective quantities 5. Subscription  direction to the pharmacist 6. Transcription  direction to the patient 7. Name, Address, PTR number of the prescriber Incorrect Prescription (DOH AO no. 62) Features: Erroneous -Fill BN preceded GN: (Lipitor®) Atorvastatin -Keep GN is parenthesis: (Atorvastatin) Lipitor® BN is not in parenthesis: Atorvastatin Lipitor® -Report to nearest DOH Violative -Fill GN is not written -Keep BN is written, GN is not written legibly -Report to nearest DOH terms that hinder Generic Dispensing -Ask the Px to return to prescriber to get the proper Rx Impossible -Fill Only GN is written (not legible) -Keep GN does not correspond to the BN -Report to nearest DOH Both GN & BN are written, but not legible -Ask the Px to return

C. Evidence-base Medicine (EBM) ”the conscientious, explicit & judicious use of current best evidence in making decisions about the care of the individual patient. It means integrating individual clinical expertise with the best available external clinical evidence from systematic research” EBM Integrated Components Clinical Expertise  Clinician’s Cumulated Experience Education & clinical Skills

Patient Values  Personal & Unique Concerns, Expectations, & Values

Best Evidence  Clinically Relevant Research with sound methodology (Sackett D, 2002)

Hierarchy of Evidence:  Systematic Reviews  Randomized Clinical Trials  Non-Randomized clinical Trials  Observational Studies  Expert Opinions Drug Information Sources: Provide the most Primary Source

current information

Secondary Source For quick &

Tertiary Sources

selective screening of the primary literature Provide easy & convenient access; information may be outdated

Journal articles (Journal of Pharmacy & Pharmacology, New England Journal of Medicine) Abstacting & indexing Services (Index Medicus, clinArt, DrugDex) Textbook’s (Harrison’s Principles of Internal Medicine, Applied therapeutics)

D. Drug Development Drug Discovery & Screening (~2 yrs) discovery of the lead compounds from biologic products screening for activity chemical design synthesis & characterization

Pre-clinical Studies tested on animals efficacy, safety, toxicity, mechanism (PK/ PD)

Investigational New Drug Clinical Trials( 4-5 years)  tested on humans Phase I: Screening for Safety initial assessment of safety, tolerance, PK & PD healthy human volunteers (20-100)  single side

Phase II: Establishing the Test Protocol initial assessment in the target population IIa  identification of doses IIb  assess & efficacy well-controlled narrowly-defined population (100-300) double-blinded randomized clinical trials

Phase III: Final Testing confirmation of doses expanded tolerability profile more varied population (100-3000) multicenter multisite double-blind RCT benefit-risk ration

New Drug Application Marketing Phase IV: Post Marketing wider population detect previously unknown AE & DI different formulation, dosage, duration of therapy

Patent-usually last for 20 years when Patent Expires  Generic Counterparts, become available

Phases of Product Development: Pre-clinical Stage Animal Studies Phase 1 Assess safety in healthy human volunteers Phase 2 Evaluate effectiveness of a drugs in patients with disease or condition Phase 3 Large-scale multicenter clinical studies (hundreds to thousands) Phase 4 Post-marketing studies

F. Pharmacoepidiomolgy Study Design Pharmacoepidiomology  study of use & effects of drugs in a large population 1. Case Report or Series about a single case or a series of related cases 2. Cross-sectional Study  Prevalence Studies observational prevalence study ⇉ prevalence of disease & risk factors survey the population at single point in time Example: Prevalence of colon cancer & high fat diet in a certain population more colon cancer & high fat diet in US vs less colon cancer & low fat in Japan 3. Case-control Study Retrospective Study observational study samples chosen base on presence (cases) or absence (controls) of disease information recollected about risk factors Example: People with lung cancer & people with lung cancer & see who smoke more Advantage: Inexpensive Disadvantage: Recall Bias 4. Cohort Study Prospective or retrospective follow-up Study observational Study samples chosen based on presence or absence of risk factors subjects followed over time for development of disease Example: Smoker & Nonsmokers then see who develops lung cancer Advantage: Less recall bias Disadvantages: Time-consuming, Expensive 5. Randomized Controlled Clinical Trial Gold Standard -assessing effects of drugs Experimental Study Design-intervention compares two or more treatments/ intervention to placebo Randomization =each subject has an equal & known probability of being assigned to a certain group =refers to the assignment of intervention in a study decreases/ reduces bias eliminates comfounding factors extraneous variables that may interfere w/ the result Random Sampling  is done so that a representative portion of the population can be taken Blinding:  Single patient does not know the group assignment  Double  patient & physician do not know  Triple  patient, physician, & pharmacist do not know Blinded Study  neither the study subject nor the study staff is aware Placebo controlled  “hidden blank” w/ inclusion & exclusion criteria Disadvantage: Expensive, time-consuming, Ethical Considerations (cannot compare new treatment to placebo if there is a standard of care) 6. Cross-over Study  comparing treatments in w/c participants are switched to the other

II. Clinical Pharmacy Services A. Patient Record/ Database 1. Medical History General Patient Information name, age, sex, residence, date, & time of admission Chief Complaint (CC)  reason for seeking medical care History of Present Illness (HPI)  narrative that describes the patients current medical problem Past Medical History (PMH)  brief description of current & previous medical condition that may or may not be related to the present illness Personal, Social History, Lifestyle diet use of Tobacco: Pack year= ppd x years  alcohol (drinking habits)  illicit drugs  marital status  sexual history Family Medical history (FMH)  medical history of the patient’s first degree relative Medication History current & past medication  OTC drug use  ADR  compliance Obstetrics & Gynecologic History Obstetrics score: GxPx (EPAL) G2P2 (2002)  details of past pregnancy present pregnancy menstrual history Immunization History vaccines received  data received Developmental History  developmental milestone Review of System (ROS) Patient’s complaints not included in the HPI 2. Physical Exam findings 3. Present Working Impression: Preliminary Diagnosis 4. Laboratory Summary Hema: CBC Coagulator: PT, aPIT ABG result Blood Chem: BUN, Crea, Na, K, Cl, Ca Urinalysis result Gramstain/ Culture sensitivity ECG result: *ECG  Gold standard for detecting heart conditions involving irregularities in electrical conduction & rhythm

Imaging: Xray, MRI, CT scan 5. Patient’s Problem List ☛Potential & Actual Problem ☛Intervention ☛Status 6. Drug Therapy Plan ☛Drug Prescribed ☛Indication ☛Compliance 7. Pharmacist’s Care Plan Health care need Pharmacotherapeutic Goal Recommendation, Intervention Monitoring Parameter desired endpoint  frequency of monitoring

B. Medication Order Review Medication Orders  prescription in the hospital or institutional setting Drug Related Problems: ☛ unnecessary drug therapy ☛ wrong drug ☛ wrong patient ☛ dose too high, too low ☛ ADR & DI ☛ need for additional drug therapy ☛ inappropriate compliance (patient, prescriber) C. Pharmacoeconomics Studies comparing value of drug or therapy w/ another 1. Cost of Illness (COI)  measure the costs attribute to a specific disease  Direct Medical Costs  related to the therapy (drug, insulin, syringe, glucostrips)  Indirect Medical Costs  not related to the therapy (fare, loss in productivity) Direct non-medical Costs  salary of the health care professional 2. Cost Benefit Analysis (CBA)  identify & measure all the costs in providing treatment & comparing w/ the benefits that result 𝐵𝑒𝑛𝑒𝑓𝑖𝑡  𝐵𝑒𝑛𝑒𝑓𝑖𝑡 − 𝑡𝑜 − 𝑐𝑜𝑠𝑡 = 𝐶𝑜𝑠𝑡𝑠

3. Cost Minimization Analysis (CMA)  compare two or more treatment w/ the same therapeutic outcome  look for the treatment w/ the lowest possible cost  Example: Branded & Generic Cost 4. Cost Utility Analysis (CUA)  assess the perceived, mental, physical,& general functioning of the patient  integrates patient preferences & health related QOF  measures the consequences in terms of the quality adjusted life year (QALY) gained QALY  physical, social & emotional aspect a patient’s well being  chronic disease  meaintenance  integrates patient preference in the health related DOL Ex: ACEi vs ARBs 5. Cost Effectiveness Analysis (CEA)  compare treatment alternatives w/ cost measured & treatment outcomes expressed in terms of therapeutic objectives  compares fro the intervention w/ the greatest therapeutic outcome summarizing the benefits & resources Example: Drug A Drug B 10 5 𝑚𝑚𝐻𝑔 < $10 $10  𝐶𝑜𝑠𝑡 − 𝑡𝑜 − 𝑒𝑓𝑓𝑒𝑐𝑡𝑖𝑣𝑒 𝑟𝑎𝑡𝑖𝑜𝑛 =

Example: Control of HTN Decrease BP Losartan BP 120/80 everyday

COI CBA CMA CUA CEA

𝑐𝑜𝑠𝑡 𝑡𝑕 𝑒𝑟𝑎𝑝𝑒𝑢𝑡𝑖𝑐 𝑒𝑓𝑓𝑒𝑐𝑡 (𝑖𝑛 𝑚𝑒𝑎𝑠𝑢𝑟𝑎𝑏𝑙𝑒 𝑢𝑛𝑖𝑡𝑠 )

ICER (Incremental Cost-Effectiveness Ratio) Cost Outcome  Currency ($) Currency ($) “ No comparison “ Utility (QC applied in unit) “ Therapeutic Objectives “

D. Adverse Drug Reaction E. Drug Incompatibilities F. Drug Utilization Review (DUR)  an authorized, structured & continuing program that reviews, analyzes & interpret patterns of drug usage in a given health care delivery system against pre-determined standards Prospective DUR (before dispensing)  used to review medication profiles to assess the appropriateness of prescription Retrospective DUR (after dispensing)  used to review, analyze, interpret, patterns of drug usage

G. Drug Information Sources 1. Primary  provides most current information  written by researcher  journal articles 2. Secondary  for quick & selective screening of primary literature  abstract indices 3. Tertiary  provide easy & convenient access  textbooks  may be out dated

H.Drug Monitoring 1. Therapeutic Drug Monitoring  encompasses the measurement of serum drug levels & the application of clinical pharmacokinetics to improve patient care.  determination of plasma concentration of drugs to adjust therapy  optimizes individual drug therapy  maintain the drug concentration in the blood Trough Level  lowest drug level in the body Peak Level  highest drug level timing of blood collection is crucial (just before the next dose  obtain trough levels) Uses: Direct relationship between drug concentration & therapeutic effect Drugs w/ established therapeutic range Drugs w/ no active metabolites or irreversible actions Effect cannot be assessed quantitatively by clinical assessment Inter-individual variability in plasma drug concentration 𝐓𝐃

low therapeutic index(5 mmol/L (required Folinic Acid) 5- 20 mg/L Lidocaine, Amiodarone, 1- 25 mg/L

Clinical Pharmacokinetics  study of the time course of the ADME of drugs & their corresponding pharmacological response Application: Time to maximal response Need for a loading dose Dosage alteration Choosing a formulation 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 & clinical effect is better than the relationship between drug dose & its effect Drug toxicity & disease presentation are difficult to distinguish from clinical assessment alone Therapeutic Range  the range of drug concentration within which the drug exhibits maximum efficacy & minimum toxicity in the majority of patients Commonly monitored Drugs: Aminoglycoside: Gentamicin Tobramycin Netilmicin Amiacin Vancomycin Cardioactie Agents: Digoxin Procainamide Lidocaine Disopyramide Flecainide

Therapeutic Guidelines provide clear & concise, independent & evidence-based recommendations about patient management that have been developed.  Objectives of TGS: To reduce chance of error by establishing standard protocol for how care is carried out

2. Criteria- monitored Antibiotics  optimizes antibiotic therapy  prevent drug resistance Meropenem, Doripenem, Fluconazole, Azithromycin, Pineracillin- Lazobactam, Cefepime (4g), Ceflobipirole (5g) Pharmacokinetic Studies  pre-clinical studies that determine the new drug’s absorptive, distributive, metabolic, & excretory pathways Pharmacologic Studies  pre-clinical studies that determine the action of new drug in animals to estimate the magnitude of its intended therapeutic effect Toxicologic Studies  pre-clinical studies in animals that determine the relative safety in humans & monitor parameters that will be used in clinical trials

I. Patient Medication Counseling According to ASHP: provision of oral & written information about drugs & other health-related information to a patient or his/her representatives during dispensing process or hospital stays Scope: Name of Medication (GN, BN, classification)  techniques of self-monitoring use, benefit actions onset of action  potential drug interaction route, dosage form & storage contraindication  direction for use  relationship w/ lab or x-ray procedure actions in case of missed dose refill process  disposal of drugs & devices Precaution Any other relevant health information unique to an individual patient Side & adverse effects Questions: Close  narrow  used when a direct answer is needed  answerable by “yes” or “no”  chronic use  choppy interview   quality & quantity of information   opportunity to develop rapport w/ the patient Open  wide-ranging  not directly answerable by “yes” or “no”  chronic use  lengthy interview   quality & quantity of information  can develop rapport, assess disposition of the patient Leading or Loaded  usually closed  contain their own answer  imply judgment on the patient  not fruitful  must be avoided Double or Multiple  presents the patient w/ two or more inquiries at the same time  traps the patient in a barriage of questions  patient gets confused, irritated Communication Skills: Attending & active listening skills Empathic Responding Skills Reflecting  concentrating on the Stop talking emotional meaning Get rid of distractions React to the ideas, Paraphrasing  conveying the (Not to the person) essence of what was said Read non-verbal messages  Listen to how something is said Focusing  getting back to the topic of conversation Provide feedback to clarify any message Interviewing Skills Influencing Skills Ask open questions Give relevant advice Ask closed questions Make good suggestions  Check if the patient has Share correct information understood or requires more Summarize main points of information information given Avoid suggesting during dataEmphasize key points with “This is important…” gathering phase Provide a balance of questions Supplement spoken word with written instruction Do not jump into conclusion  Keep goals of the conversation  Give reasons for key advice in mind Check for accuracy of patient’s Avoid shifting from one topic to understanding another until one is finished Give definite, concrete, explicit instruction  Maintain objectivity

Stages in Patient Counselling: I. Medication Information Transfer II. Medication Information Exchange III. Medication Education IV. Medication Counseling Various strategies & techniques are in place for use in counseling & educating patients. The effective domain of learning process involves the formation of attitudes such as: - Feelings - Beliefs - Perceptions - Emotions - Appreciations The Behavioral domain of learning process involves: - Actions - Decision making - Physical abilities Forms of Nonverbal Communications -speech related (e.g. timing & pauses) -non-verbal behavior (e.g. posture & position, eye contact, proximity to other person, etc) -use of body -aspects of personal appearance (e.g. clothing & hairstyle, smell, etc) -symbols -sign language -written word -use of media Elements of Communication Process: - FeedBack - Barriers - Sender

Proxemics  involves the structure & use of space important in patient counselling Kinesis  involves the manner of using the parts of the body during communication w/ the patient Counseling  define by Bri...