CHAPTER 2

During ___, The first hospital was established in?

1752

Pennsylvania Hospital (in Colonial America)

During ___, he was appointed as the apothecary in the first hospital built around this time

1752

Jonathan Roberts

At that time in ___, ___ were commonly practiced together in the community, with ___ often the responsibility of a ___

1752

medicine and pharmacy

drug preparation

medical apprentice

in ___, He proposed that the practices of medicine and pharmacy be separate

1752

John Morgan

During ___, drug therapy consisted of ___.

Early to Mid-1800s

strong cathartics, emetics, and diaphoretic

During ___, ___ rather than medicines were the treatments emphasized in hospitals

Early to Mid-1800s

clean air and good food

During ___, ___ was not seen as necessary in hospitals, except in the ___.

Early to Mid-1800s

Organized pharmacy service

largest facilities

By ___, with a population of ___, the US had only ___ with fewer than ___. This might have not been a bad thing, because hospitals were “___”

1873

43 million

178 hospitals

50,000 beds

places of dreaded impurity and exiled human wreckage

During ___, ___ played a small role in healthcare, physicians and pharmacists avoided them. This situation somewhat changed during the ___ when ___ sought out pharmacists for their experience in ___ and in ___

Early to Mid-1800s

Hospitals

Civil War

hospital directors

extemporaneous manufacturing

purchasing medical goods

In the ___ and ___, influx of immigrants in cities doubled. ___ were built and played a significant role in the progress of hospital pharmacy by ___

1870s

1880s

Catholic hospitals

charging small fees (allowing for service improvements) and training nuns in pharmacy

During ___, the ___ (now the ___) was formed, setting standards for pharmacy education

1900

American Conference of Pharmaceutical Faculties

American Association of Colleges of Pharmacy

During ___, A ___ became the minimum entry-level requirement for pharmacists

1907

2 year Ph.G. (graduate in pharmacy)

During ___, The ___ controversially described pharmacy as “nonprofessional” citing it as ___

1915

Flexner Report

unintellectual and profit-driven

During ___, ___ defined pharmacist clinical services as “anything done to expedite the recovery of the sick, whether at the bedside of the patient or the laboratory of the clinician”

1921

John C. Krantz Jr.

During ___, ___ developed, to the point of having more divisions of labor. More specialization in medical practice, a greater need for professional pharmaceutical services for handling complex therapies. Hospital pharmacists retained the traditional role of ___

Early 1900s

Hospitals

compounding

In ___, the concept of a “___” emerged, aiming to limit prescriptions to selected formulas

1932

Hospital Formulary

In ___, ___ and ___ first promulgated the concept of a ___ in US hospitals as a formal mechanism for pharmacy department and the medical staff to communicate on drug issues. Subsequently, the ___ jointly developed guidance on the P&T committee and on the operation of a ___

1936

Edward Spease

Robert Porter

pharmacy and therapeutics committee (P&T)

AHA (American Hospital Association) and ASHP (American Society of Health-System Pharmacists)

Hospital formulary system

In ___, the standard for pharmacy education increased to a ___

1954

5-year B.S degree

During ___, Drug products were distributed to ___ using ___. ___ of hospitals had an active ___ and a similar percentage of hospitals had a ___.

1957

hospital inpatients

floor stock or individual-patient prescription systems

58%

P&T committee

formulary or approved drug list

During ___, in ___, pharmacists became responsible for the ___ throughout the entire hospital, not just the pharmacy department

Mid-To Late 1900s

1958

safe and secure handling of medicines

During ___, in ___, the development of ___ services made a tremendous contribution to patient safety. Previously, ___ largely carried out this task in patient care areas

Mid-To Late 1900s

1960s

pharmacy-based intravenous (IV) admixture

nurses

In ___, the ___ began, shifting focus from drug product orientation to ___

1960s

clinical pharmacy movement

patient-centered care

In ___, first switches from prescription-only medicines to ___ (e.g. ___)

1983

P (pharmacy) medicines

ibuprofen and loperamide

In ___, the ___ was introduced

1986

hospital pharmacy on-call system

at ___, hospital pharmacists are essential for ___

present

medication management, patient safety, and clinical services

Philippines (associations)

• The Government Hospital Pharmacist Association - 1957

• Private Hospital Pharmacist Association - 1960

• Philippine Society of Hospital Pharmacist - 1962

Duties of Philippine Society of Hospital Pharmacist

• Spearheading the practice of hospital pharmacy in the Philippines

• Sponsor seminars (pharmacy health information, unit dose dispensing, clinical pharmacy)

• Hospital Pharmacy standards implemented through DOH

a department or service in a hospital which is under the direction of a professionally competent, legally qualified pharmacist

Hospital Pharmacy

Duties of a legally qualified pharmacist in a Hospital Pharmacy

• All medications are supplied for patients in the hospital, where

• Prescriptions are filled for ambulatory patients and/or outpatients, where

• Pharmaceuticals are manufactured in bulk, where

• Narcotic and other prescribed drugs are dispensed, where

• Injectable preparations should be prepared and sterilized and where

• Professional supplies are often stocked and dispensed

specialized practice of pharmacy within a hospital setting

Hospital Pharmacy

Hospital pharmacists work closely with other healthcare professionals, including ___ to ensure that patients receive ___

physicians, nurses, and other allied health professionals

safe and effective medication therapy

a specialized pharmacy department within a hospital or medical facility that is responsible for providing ___ to patients within the hospital’s care. It plays a crucial role in ensuring the ___ for both ___.

Hospital Pharmacy

pharmaceutical services

safe, effective and appropriate use of medications

inpatients and outpatients

Goals of a Hospital Pharmacy

• To provide the benefits of qualified pharmacists to patients and health care institutions, to the allied health professions, and to the profession of pharmacy

• To assist in providing an adequate supply of such qualified hospital pharmacists

• To assure a high quality of professional practice through the establishment and maintenance of standards of professional ethics, education, and attainments

• To promote research in hospital pharmacy practices and in the pharmaceutical sciences in general

• To disseminate pharmaceutical knowledge by providing for interchange of information among hospital pharmacists and with members of allied specialties and professions

Responsibilities of a Hospital Pharmacist

• Reviewing medication orders to ensure they are appropriate for the patient’s condition and medical history

• Monitoring medication therapy to ensure its safety and effectiveness

• Providing drug information and education to healthcare professionals and patients

• Compounding and dispensing medications

• Managing medication inventory and supply chain logistics

• Participating in medication safety initiatives and quality improvement programs

Minimum Standards for Pharmacies in Hospitals according to the ___, General Requirements:

Administrative Order #2014-0034, Regulations on the Licensing of Establishment

• Risk Management Plan

• Application (documents)

Requirements for Application (documents)

1. Standard petition form containing among others (name, age, citizenship and passport size picture, proposed drug establishment and place)

2. Proof of registration (DTI) - for single proprietorship

3. SEC (Securities and Exchange Commission) and articles of incorporation - for partnership/corporation

4. Valid certificate of registration of the establishment’s Filipino pharmacist by the PRC (Professional Regulation Commission)

5. Certificate of attendance to a FDA sponsored/Accredited Seminar on licensing

6. Affidavit of undertaking

Affidavit of undertaking providing that applicant shall:

• Change the establishment

• Display the duly approved LTO in a conspicuous place within establishment

• Notify the FDA in case of any change in name, location and pharmacist

• Tentative list of products intended to be sold using generic name with brand name

• Authenticated photocopy of contract of lease

• Evaluation

• Inspection (Pre-opening inspection & Post-licensing inspection)

• Decision on Application

• Validity (Initial - 2 years & Subsequent renewal - 3 years)

Minimum Standards for Pharmacies in Hospitals in terms of location premises

• Signboard

• Well-ventilated area not less than 15 square meters in floor area with concrete, tile or wooden flooring

• Compounding Rx and for washing and sterilizing (only for hospital pharmacy)

• Suitable and proper place for adequate storage of drugs and biological products

• Suitable cabinet for keeping poisons and/or DD’s

• Adequate water supply

Reference books and documents

• PNDF

• USP/NF (latest edition)

• R.A 3720 - Food, Drugs and Devices, and Cosmetics Act

• R.A 6675 - Generics Act of 1988

• R.A 5921 - Practice of Pharmacy and Setting Standards of Pharmaceutical Education

• R.A 10918 - Pharmacy Law

• R.A 8203 - Special Law on Counterfeit Drugs

• RPS (latest edition)

• Goodman and Gilman - Pharmacological Basis of Therapeutics (latest edition)

• Prescription Book

• DDB

• Exempt preparation book

• Poison book

• Record book for selected Non-rx drugs subject to abuse as determined by BFAD and/or DDB

Utensils, Apparatus and Other Equipment

• Biorefrigerator

• For hospital pharmacy only: (Rx balance, Glass volumetric measures, Mortar and pestle)

A staff as a minimum standard in hospital pharmacy entails?

Full-time valid registered pharmacist physically present while the drug store is open for business

Renewal of LTO

• Must have a history of satisfactory performance

• Consistent with BFAD (bureau of food and drugs) requirements without violations of existing laws and regulations

Administrative Sanctions

> Temporary closure:

• Absence of pharmacist (3x inspection)

> Suspension of LTO:

• Failure to produce invoices and receipts

• Failure to properly record and keep file of all Rx filled in the last 2 years

• Refusal to allow entry of FDA inspectors

> Revocation of LTO

• Sale or offer for sale of adulterated, misbranded, substandard, unregistered, expired and/or unsafe drug or drug products marked “not for sale”

• Failure to properly record DD as determined by the DDB

• Lack of pharmacist

• Failure to take necessary remedial or corrective measures within the prescribed period as directed by FDA