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PHAR5 MONTHLIES

CHAPTER 1

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Key Terms and Definitions:

Institutional Pharmacy Practice – provision of
distributional and clinical pharmacy services at broad
range of institutional settings
Integrated Health Systems – integrate all care under
umbrella of central organization (inpatient/acute care,
primary care/outpatient care, etc.)
Practice Guidelines – tools that describe processes
found by clinical trials or consensus opinion of experts
on most effective treatment (clinical practice guideline,
practice parameter, protocol, preferred practice
pattern, guideline)
Privileging – process by which oversight body of
health care organization; authorizes individual to
perform specific scope of patient care
Regulation – governmental order having the force of
law

Types of Hospitals:

General – provide patient services, diagnostic and
therapeutic for variety of medical conditions (PGH,
Chinese Gen. Hosp.)
Special – provide diagnostic and therapeutic services
for patient s who have specified medical condition,
both surgical and non-surgical (Lung Center of the
Phil., QI, National Children’s)
Rehabilitation and Chronic Disease – provide
diagnostic and therapeutic services to
handicapped/disabled individual requiring restorative
and adjustive services
Psychiatric – provide diagnostic and therapeutic
services for patients who have psychiatric related
illness (National Center for Mental Health)

Practice Model – operational structure defining how and
where pharmacist practice
 Drug Distribution-Centered Model - distribute drugs;
process new medication orders; reactive
 Clinical-Pharmacist-Centered Model - primary types
of pharmacist (clinical and distributive)
 Patient-Centered Integrated Model - clinical and
distributive functions; exhibit high degree of ownership
of and accountability for entire medication-use process
Key Features
 Practice is interdisciplinary and team-based
 Medication and preparation and distribution will be
more efficient with automation, centralization, and the
use of trained technicians
 Increasing contribution in direct patient care
 Influence medication-use process through health
information technology
 Pharmacists will need to justify their value for
allocation of health care resources
 Pharmacotherapy plan should be developed for every
patient
 Continuous training to practice pharmacy
 Collaborate better to community pharmacists
Key Individuals In Pharmacy Department

Classifications:


Type of Service – general, special, rehab, psych
Length of Stay
o Short (acute; <30 days)
o Long Term (chronic; >30 days)
Ownership
o Governmental – public (PGH, Lung Center of the
Phil.); federal = all states ; state = city – country
o Non-Governmental
 Non-Profit – (St. Luke’s)
 For Profit – individual, partnership,
corporation (USTH)
Bed Capacity
o Very Small = <100
o Small = 100-500

Medium = 500-1000 (USTH)
Large = >1000 (St. Luke’s)

Pharmacists
o Dispensing Pharmacist - preparation either
direct or supervision
o Clinical Pharmacist - interdisciplinary patientcare teams, and interact directly with patients;
clinical pharmacy training, pharmacy residency
 Generalist - provide clinical pharmacy
services to a wide range of patients
 Specialist - defined expertise in one or more
areas (critical care, oncology)
 Both roles
o Director/Supervisor - good knowledge of
regulations and laws; basic skills in HR
management, leadership, budget management;
ensuring quality of medication use
o Others - informatics, investigational drug services,
research, sterile compounding, and emergency
care
Pharmacy Technicians - purchasing, stocking,
preparation and compounding; under direct
supervision of pharmacist; maintenance of automated
dispensing technology and other information
technology systems; collection of laboratory values

removes contaminants efficiently  BCMA . constantly changing  Monitored closely  Drug therapy is often changed or adjusted  High incompatibilities. based on scientific evidence (Best Practices developed by American Society of Health-System Pharmacists) Importance of Pharmacy Leadership – Director of Pharmacy (Pharmacist in Charge) has ultimate responsibility and accountability for all aspects of the pharmacy service.manages the drop count in IV solutions. predefine minimum and maximum rates of administration Unique Aspects of Different Patient Care Areas  Inpatient Care o Critical Care Units  Patients are of higher acuity level.Bar Coded Medication Administration. tasked with imposing fines and taking other legal actions (FDA. save working time  Unit Based Cabinet .and other clinical data Importance of Automation and Technology – serve to increase efficiency and accuracy of dispensing.  Ambulatory care clinics  Home health care  Medication therapy is managed by therapist by one-on-one appointment Interdisciplinary Health Care Team: physicians. does not typically have force of law Full-Time Equivalent – method for standardizing number of full (40 hours/week FTE) and part-time (20 hours/week 0. hospital pharmacies should function as clinical departments with mission of fostering appropriate use of medicines Practice Standards – authoritative advisory document.discharge counceling  Outpatient Care  Similar to community pharmacy without general merchandise  Clinic patients. issued by expert body. electronic verification  Pharmacy Robot – contain hundreds of bar coded packages placed in designated spaces on long rods  Filling Syringes . DOH) Practice Standards – practice guidelines. patients being discharged from inpatient settings. redirect staff. lead 3 revisions of USP. interface or integration with pharmacy information systems  Smart Pumps . assuring drug packages have appropriate. practices that profession develops and imposes on itself. place medication closer to user. Bellevue Hospital. social workers) Accreditation and Standards of Practice Accreditation – determination by accrediting body that eligible healthcare organization complies with accrediting body’s applicable standards   Regulatory Bodies – law enforcement bodies whose purpose is public protection.5 FTE) employees History (I)    1752 o Jonathan Roberts – first American Hospital Pharmacist o Pennsylvania Hospital – first hospital in Colonial America 1841-1901 o Charles Rice – pioneering hospital pharmacy practices. and errors  General Care Units  Acuity of patients is less  Drug therapy is stable  Medication reconciliation  Appropriate discharge orders . pharmacists (+respiratory therapists. interactions.located in patient care area (nurses are the keeper) and contain compartments where individual medications are stored. patients with prescriptions written in emergency departments  Emergency department.Computerized Prescriber Order Entry.fills syringes  Automated IV Solution Preparation . Drug Enforcement Administration. offers advice on minimum requirements or optimal method for addressing important issue. Centers for Medicare & Medicaid Services. greater needs  Critically ill. etc. readable barcodes  CPOE . nurses. quality of service is affected by leadership skills CHAPTER 2 Key Terms and Definitions:     Mirror to Hospital Pharmacy – publication documenting state of pharmacy services in hospitals in late 1950s ASHP Hilton Head Conference – conference of hospital pharmacy leaders and pharmacy educators in 1985 in Hilton Head. NYC 1856-1916 o Martin Wilbert .

quinine o Civil War – extemporaneous manufacturing and in purchasing medical goods 1870s & 1880s o Catholic Hospitals – charged patients small fee. improve patient safety o Centralized . and using technology  Monitoring (Physician/Nurse/Pharmacist) . privileging  Transcribing (Nurse/Ward Clerk) . must understand potential breakdowns  Dispensing (Pharmacists) . and control Major elements of hospital pharmacists' professional identity Bulk compounding and sterile solution manufacturing unsuitability of many commercially available dosage forms for hospital use. 13 FTE pharmacist per 100 occupied beds History (II) A 50-Year Perspective In-charge of drug product acquisition. transcribed by nurse or ward  Unit Dose Drug Distribution System o receives original/direct copy o reviewing of medication order before first dose is dispensed o single unit packaging o ready to administer form as possible o not more than 24-hour supply of doses is delivered/available at patient care area o patient medication is concurrently maintained per patient Advantages: Greater nursing efficiency.       1800s o Few hospitals – “places of dreaded impurity and exiled human wreckage” o Played a small role in health care where pharmacists played small roles o Strong cathartics.influence prescribing of other health professionals. distribution. close relationship between physicians and pharmacist Major role in patient safety Getting involved in the medication-use process . and patients Major role in promoting rational drug therapy .clearly label medications.come in contact regularly with physicians.physically transferring drug product following review and approval of prescription to area responsible for administering medication to the patient  Administration (Nurse) . more efficient for preparation and distribution of medication o Decentralized . using barcoding systems. fast supply for emergencies  Patient Prescription Systems . improving prescribing and monitoring. diaphoretics o Clean air and good food o Newer alkaloidal drugs: morphine. improve drug product distribution Medication Use Process:  Prescribing (Physicians) . emetics. cost savings.one supplier.physician writes prescription for limited number of drugs.reviewing laboratory values that are correlated with the expected medication-therapy outcomes Drug Distribution Systems:  Floor Stock Systems . willing to train or obtain training for nuns in pharmacy 1890s o Hospital as center of medical care – advance in surgery o Growth of community hospitals. better use of pharmacists' talents. determinant of availability of pharmacists o 300 beds or more = employed full-time pharmacist o Today.prescriber's written order is copied and entered into pharmacy records.every floor = stock. strychnine. and unit dose packaging. nurses.greater accuracy in dispensing and administration. relied on community pharmacies to supply medicines Early 1900s o More specialization in medical practice o Greater need for professional pharmaceutical services for handling complex therapies o Compounding is retained o Improve product quality and standardization 1920s o Hiring of hospital pharmacists for prohibition *alcohol was commonly prescribed o Inventory control and manufacture of alcohol containing preparations 1930s o Pharmacy-related issues in hospitals o Creation of Committee of Pharmacy (by AHA) o Develop minimum standards for hospital pharmacy department o Prepare a manual of Pharmacy Operation o Any hospital larger than 100 had warrants to the employment of a registered pharmacist 60-70 Years Ago o Pharmacy as a complementary service department and not an essential service o Hospital size. reducing time and effort involved in accessing drugs.

and other parties interested in medication use process. medical staff. promulgated by Edward Spease and Robert Porter  AHA and ASHP . more consistent  In early days of clinical education.D) Postgraduate Residency Education and Training  Hospitals were expanding. framework on how medicationuse policies are established and implemented Formulary . right time  Achieving optimal outcomes from medication use  "The mission of pharmacists is to help people make the best use of medicines. nursing. creator of information resources (AHFS Drug Information.S in Pharmacy) 5 years (B.selection of drug products most useful in patient care.S or B. philhealth) o Expanded clinical research and drug product development o Greater complexity and cost of drug therapy with sophisticated pharmaceutical product marketing o Growing interest in improving the quality of health care services  Direct Factors (internal) o Visionary Leadership .authoritative advisory document.affects hospital pharmacy.approved drug list o Foster optimal patient outcomes from medication use  Right drug (whatever the physician ordered). surpass minimum requirements established by law or regulation. dosage forms. based on best scientific evidence. assesses medication use. makes recommendations on policies. sterile solutions. Pharmacy and Therapeutics (P&T) Committee medical staff of hospital/health system with oversight for medication management. faculty members from schools of pharmacy began establishing practice sites in hospitals.early hospital pharmacy leaders were trying to create a new model for pharmacy practice in hospitals and not as extensions o Professional Associations o  American Pharmaceutical Association (APhA) ."  Answer drug information questions related to dosage. pharmacist=secretary of committee. American Journal of Health System Pharmacy) Pharmacy Education  Hospital Pharmacy has benefited by gaining practitioners who are better educated and better prepared to meet the demands  Hospital Pharmacy leaders have put considerable pressure on pharmacy educators to upgrade pharmacy curriculum.S or B. and pharmacy department administration  Organized effort was needed to achieve improvements in hospital pharmacy internships or residencies Practice Standards . which often had a large impact on the nature of the hospital's pharmacy service  Evolution of Minimum Requirements for Pharmacist Education in the US Minimum Requirement (Length of Curriculum and Degree Awarded) 2 years (Graduate in Pharmacy) 3 years (Graduate in Pharmacy or Pharmaceutical Chemist) 4 years (B. formulary. creating a growing unmet need for pharmacists  Pharmaceutical education was out of touch with needs  Internship training required by state boards for licensure was not adequate preparation  Hospital pharmacist required specialized training in manufacturing. voluntary  Minimum Requirements for Pharmacies in Hospitals (ASHP) . pharmacy. practices that a profession develops and imposes on itself. issued by expert body.developed guidance on P&T committee and on the operation of a hospital formulary systems Formulary System . right patient. administration.directions for clinical practice in pharmacy: o Clinical pharmacy should not be thought of as something separate from pharmacy practice at a whole o Hospital pharmacies should function as clinical department Year 1907 1925 1932 1960 2004 o Transformation  Indirect Factors (external) o Shift of national resources into health care (medicare.S in Pharmacy) 6 years (Pharm. that offers advice on minimum requirements or optimal method for addressing problem.oldest national pharmacist  American Society of Health-System Pharmacist (AHSP) . and pharmacology  Asked for advice on ADR and clinical comparisons of products  Hilton Head Conference .

Survey: A key component in the accreditation process. American Osteopathic Association  principal accreditation agency for osteopathic medical colleges and health care facilities D. yet attainable as “best practices” in applicable settings. analysis. Medicaid) o Private (Kaiser) A.    Rule: An authoritative recommendation meant to guide behaviors associated with specific limited situations. to be progressive and challenging. law. legally qualified pharmacist  Pharmacist authority to develop administrative policies for the department  Development of professional policies for the department with the approval of the pharmacy and therapeutics committee  Ample number of qualified personnel  Adequate facilities  Expanded scope of Pharmacist’s responsibilities: Chapter 3 Key terms:              Accrediting body: An organization or entity that establishes standards for accreditation and pharmacy guidelines. governmental agencies. Organized pharmacy department under professionally. Regulation: Governmental order having the force of law. Quality improvement: A formal approach to the analysis of performance and the systematic approach to improve it. Guidelines are written to establish reasonable goals. Influence by External Bodies Health system pharmacy practice is highly regulated by accrediting bodies. Certification: Confirmation by an entity that an organization complies with the entity’s predetermined standards. The Joint Commission: The principal accrediting organization for the operation of hospitals and other health care organizations Law: A legally binding requirement imposed by a legislative body. Standard: A statement that defines the performance expectations. expert opinion. 1. CMS: Centers for Medicare Medicaid service A) Medicare – federal B) Medicaid – state  develops CoPs (Conditions of Participation) o CoP: one or more standards that define the requirements for compliance used to improve quality and protect the health and safety of beneficiaries  accreditation is for three years CERTIFY CMS ACCREDIT Joint Commission HFAP (Healthcare Accreditation Program) NIAHO (National Accreditation for Organizations) Facilities Integrated Healthcare B. and services. Guideline: Voluntary guidance and direction to practitioners and other audiences based on consensus of professional judgment. professional organizations. or regulation. National Integrated Accreditation for Healthcare Organizations  integrate requirements based on the CMS CoPs with ISO 9001 Standards o ISO 9001: global principles designed to provide assurance that quality is . Joint Commission  independent non-profit organization dedicated to improving the safety and quality of healthcare  principal accrediting body for the operation of hospitals and other healthcare organizations C. Certifying body: An organization or entity that establishes standards for certification and determines that a health care organization complies with the standards. Healthcare Facilities Accreditation Program (HFAP): The American Osteopathic Association’s (AOA) accrediting organization for the operation of hospitals. Compliance: Meeting or adhering to the requirements of a standard. treatment. and improvement of the performance systems and processes to achieve desired outcomes. structures. and documented evidence. other standard-setting entities They hold pharmacists accountable for maintaining minimum standards of practice. whereby a surveyor(s) conducts an on-site evaluation of an organizations’ compliance with standards. rule. National Integrated Accreditation for Healthcare Organizations (NIAHOSM): Det Norske Veritas’ (DNV) accrediting organization for the operation of hospitals Performance improvement: The continuous measurement. Health-system Certification and Accreditation programs  Reimbursement programs: o Governmental (Medicare. Deemed status: An accrediting organization approved by CMS that is in compliance with Medicare Conditions of Participation. or processes that must be in place for an organization to provide safe and high quality care.

Pharmacy Professional Organizations A.    imbedded in supplier-customer relationships  designed to facilitate the development and implementation  accreditation is for three years Federal and State Laws and Regulations laws – imposed by an authority regulations – governmental orders having the force of law rules – specific. Occupational Safety and Health Administration  sets and enforces safety standards for workers  deals with workplace accidents and exposure to hazardous materials D. Food and Drug Administration  protecting the public health by assuring the safety. and products that emit radiation B. compensation. medical devices. National Institute for Occupational Safety and Health  for the prevention of work-related injury and illness E. injury. American Pharmacists Association  national professional society of pharmacists C. National Fire Protection Association  aims to reduce the worldwide hazard of fire  large number of flammable materials in pharmacies 4. and healthcare products B. American Society of Health-system Pharmacists  accrediting body for practice sites that conduct pharmacy residency programs and technician training programs Influence by Internal Bodies 1.2. our nation’s food supplements. and disability F. and treatment of employee groups H. Office for Civil Rights  prohibiting discrimination in employment hiring. and security of human and veterinary drugs. food ingredients. United States Pharmacopeia  ensures quality of medicines. Environmental Protection Agency develops and enforces regulations pertaining to environmental laws and issues G. Drug Enforcement Administration  enforces the federal controlled substances laws and regulations C. dietary supplements. cosmetics. Centers for Disease Control and Prevention  protecting health and promoting quality of life through the prevention and control of disease. efficacy. American College of Clinical Pharmacy  for clinical pharmacists B. State Boards of Pharmacy  licensure requirements 3. Nongovernmental Standards-Setting Entities A. Pharmacy and Therapeutics Committee 2. promotion. limited situations A. biological products. Medical Executive committee  . and other health care products  promotes the safe and proper use of medications  verifies ingredients in dietary supplements  provides standards for drugs.