1. Proc Proces essi sing ng of of Req Requi uire reme ment nts s for for Hospital Pharmacy Internship 2. Requ Requir irem emen ents ts fo forr Op Open enin ing ga Hospital Pharmacy 3. The The Hos ospi pita tall Pha Pharm rmac acy y Organization and It’ It’s s Personnel 4. The Hospital Pharmacy’s LayLayout and Its Location 5. Pha Pharm rmac acy y & Th Thera rape peut utiics Committee
PROCESSING OF REQUIREMENTS FOR HOSPIT HOSP ITAL AL PHARMACY PHARM ACY INTERNSHIP
PATRICIA ROSE ABALOS, ABALOS , RPh, MS M S Phar Pha r cand
Discussion Outline
Importance: Hospital Pharmacy Internship
Policies for Hospital Pharmacy Internship
Workflow Process
Procedures in Processing Requirements
Why we should take Hospital Pharmacy Internship program? Republic Act no. 5921 – 5921 – Pharmacy Law
Article III – Examination
Qualifications: a. Natu Natura ral-b l-bor orn n citiz citizen en of of the Phi Phili lipp ppin ines es b. Of good good mor oral al char charac acte ter r c. Shall Shall have have comp complet leted ed an Intern Internshi ship p Prog Program ram Prescription pharmacy Pharmaceutical Pharmaceutical manufacturing laboratory Hospital pharmacy d. BS Phar Pharma macy cy gr grad adua uate te •
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Section
18.
Candidate
for
Board
Policies for Hospital Pharmacy Internship
Who can undergo a Hospital Pharmacy Internship? o
Students enrolled in Internship 2
What are the prerequisites required prior to internship in hospital? o
Pharmaceutics 1
o
Internship 1
o
Pharmacy 5a (Hospital Pharmacy)
How many hours should be rendered for Hospital Pharmacy Internship? o
Total of 200 hours
Policies for Hospital Pharmacy Internship
What are the documents which shall be submitted to Internship coordinator 2 weeks after the internship? o
Original: Certificate of Internship (COI)
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Pharmacy Internship Daily Time Record (PIDTR)
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Duplicate: Certificate of Internship
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Performance Rating Report for Student Trainees (PRRST)
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Internship Activity Report (IAR)
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Checklist of Internship Activities
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Hospital Pharmacy Profile (HPP)
What are the further requirements for the completion of Hospital Pharmacy Internship? o
Internship examination to be given by coordinator
WORKFLOW
WHEN APPLYING
RIRL
Submission of Requirements
To Internship Coordinator 1. RIRL To the Hospital 1. Recommendation Letter 2. Other Requirements set by Hospital To Internship Coordinator 1. Acceptance Form
WHILE UNDERGOING
OJT
Document Processing
By Intern 1. PIDTR 2. HPP 3. Checklist of Internship Activities 4. IAR By Pharmacist 1. PRRST 2. IAR
Document Submission & Filing Kept by Student 1. Original COI 2. PIDTR Kept by Internship Coordinator 1. Duplicate COI 2. PRRST 3. IAR 4. HPP 5. Checklist of IAR
Request for Internship Recommendation Letter (RIRL)
Release of RIRL
Fill out RIRL
Intern Coor
Intern Coor review & signs RIRL College Sec Dean review & signs Recommendation Letter Release of Recommendation Letter and Internship Forms
Pharmacy Internship Daily Time Record (PIDTR) Student shall fill out PIDTR
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Pharmacist shall provide in the PIDTR
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Hospital Pharmacy shall issue
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Student shall submit to Internship Coordinator
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Internship Coordinator
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3 copies – Typewritten Min: 4hrs per day & Max: 8hrs per day Monday to Saturday Entry PRC license number & date issued Latest PTR number & date issued
Certificate of Internship with Hospital logo and letterhead
3 copies of PIDTR Original & Duplicate of COI Other Internship forms Countersign Forward to Dean for signature
Hospital Pharmacy Profile (HPP) & Checklist of Internship Activities
Student shall fill out & Submit to Internship Coordinator
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Internship Coordinator
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Hospital Pharmacy Profile Checklist of Internship Activities
Review the content Interview the student for verification
Internship Activity Report (IAR)
Student Fill out IAR Pharmacist Evaluate & Sign Student’s IAR Submit to Department Head Student Submit IAR to Internship Coordinator for review and filing
Performance Rating Report for Student Trainee (PRRST) Pharmacist Fill out PRRST
Pharmacist Evaluate & Sign Student’s PRRST Student Submit PRRST to Internship Coordinator for review and filing
Requirements for Opening a Hospital Pharmacy
PATRICIA ROSE ABALOS, RPh, MS Phar cand
Discussion Outline
Requirements for the Opening & Operations of Drugstores and Pharmacies
Definition: Different Types of Drug Outlets
General Requirements
Other Specific Requirements
Renewal of License to Operate
Requirements for the Opening & Operations of Drugstores and Pharmacies Section 39 of RA 5921 – Pharmacy Law (As amended by PD 1363 on May 2, 1978)
The minimum requirements necessary for the opening and operation of drugstores and pharmacies shall be in accordance with the rules and regulations to be prescribed by the Food and Drug Administration in accordance with the provisions of this Act. No application for the opening of a retail drugstore shall be approved unless it is signed by a Filipino registered pharmacist, either as owner or as supervising pharmacist pursuant to section 27 of this Act.
Display of Certificate Required Section 28 of RA 5921 – Pharmacy Law
It shall be the duty of every pharmacist engaged in the practice of pharmacy, either on his own account or under the employ of another, to display his certificate of registration in a prominent and conspicuous place in the pharmacy, drugstore, hospital pharmacy or drug establishment which he operates or in which he is employed. No pharmacist shall with his knowledge, allow his certificate of registration to be displayed in such establishments where he is not actually employed or operating therein in his professional capacity.
Definition: Different Types of Drug Outlets Chapter II of AO 56 s. 1989 (Revised Regulations for the Licensing of Drug Establishments & Outlets)
Drugstores Pharmacy or Botica Hospital Pharmacy or Dispensary
Retail Outlet for Nonprescription drugs N0n-traditional Outlet such as Supermarket and stores
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Drug outlet where registered drugs, chemical products, active principles, proprietary medicines or pharmaceutical specialties; and dental, medicinal, galenical or veterinary preparation are compounded and/ or dispensed
Drug outlet where registered non-prescription or OTC drugs are sold in the original packages, bottles or containers; or in smaller quantities not in their original containers
Definition: Dispensary AO 60 s. 1968
Dispensary includes
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Hospital Pharmacy or •
Clinic Dispensary
Where drugs, chemical-drug products, active principles, medicinal and galenical preparations, proprietary medicines and pharmaceutical specialties are sold and dispensed Located in the hospital or clinic dispensary
General Requirements: Applications Notarized Petition Form Proof of Registration as an Establishment • •
Single Proprietorship – Bureau of Trade Regulation and Consumer Protection Partnership or Corporation – SEC
Board Registration Certificate and PRC ID Certificate of Attendance to an FDA sponsored/ accredited Seminar on Licensing of Drug Outlets Notarized Joint Affidavit of Undertaking duly accomplished by Pharmacist and Owner Tentative list of products intended to be sold Authenticated copy of Contract Lease of the space to be occupied
Specific Requirements Reference Books & Documents
Premises • •
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Signboard Well-ventilated area nlt 15 sqm Place suitable for compounding prescription & washing and sterilizing bottles Adequate Storage of Drugs & Biological products Suitable cabinet for poisons & Dangerous Drugs
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PNDF RA 3720 RA 6675 RA 5921 RA 8203 RA 9994 RA 9711 RA 9502 USP – NF Remington: The Science and Practice of Pharmacy Goodman & Gilman Pharmacological Basis of Therapeutics
Record Books Duly Registered with FDA • •
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Prescription Book Dangerous Drug Book Exempt Preparation Book Poison Book Record Book for Selected Non-Rx Drugs subject to abuse as determined by FDA and/ or DDB
Specific Requirements
Utensils, Apparatus and Other Equipment •
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Refrigerator for Biologicals & Other Drug Products needing Refrigeration Prescription balance Glass volumetric Mortar and Pestle
A full time validly Registered Pharmacist •
Physically present while the drugstore is open to business
Other Additional Requirements •
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Invoices indicating the lot number or batch number of the Manufacturer’s stock pursuant to FDA Memorandum Circular No. 001 s. 1983 File of Prescription Dry seal or rubber stamp Red & White labels
Renewal of License to Operate
Validity
Schedule of Fees
Initial Period of Validity: 1 year
Initial: Php 50.00
Validity of Subsequent Renewal: 2years
Renewal: Php 1,000.00
The Hospital Pharmacy Organization and It’s Personnel
PATRICIA ROSE ABALOS, RPh, MS Phar cand
Discussion Outline
Purpose & Importance: Hospital Pharmacy Organization
Administrative Pharmacy
Sample Hospital Pharmacy Organzational Chart
Structure
of
Hospital
Purpose & Functions: Hospital Pharmacy Organization Must satisfy the needs of the Pharmacists Designed to meet specific requirements of the Pharmacy Service
Shows administrative authority flow essential in employee selection & categorization
Serves to establish the authority relationships between positions
Assign special task that achieve the pharmacy’s objectives
Accrediting & Regulating Agencies Department of Health Food and Drug Administration Licensure Act of the Bureau of Licensing and Regulations Hospital Operations and Management Services
Five Essentials of Good Management
PLANNING ORGANIZING DIRECTING COORDINATING CONTROLLING
Administrative Structure of Hospital Pharmacy DIRECTOR OF PHARMACY •
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Aka Chief Pharmacist or Pharmacy Manager Oversees both personnel and budgetary matters Secretary of Pharmacy & Therapeutics Committee As member of Hospital team – may be involved in community outreach programs Sets quality standards for the department, Evaluates policies and procedures and Implements changes & innovations Develops management strategies to assure Cost Effective pharmaceutical services and for Implementing Total Quality Management concepts Ensures Compliance with accrediting & regulating Agencies
Administrative Structure of Hospital Pharmacy ASSISTANT DIRECTOR OF PHARMACY •
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Aka Associate Director of Pharmacy or Assistant Chief Pharmacist Aids the Pharmacy Director in the operation of Pharmacy Supervises in daily Pharmacy Operations In the absence of Pharmacy Director – assumes the administrative responsibility
Administrative Structure of Hospital Pharmacy STAFF PHARMACISTS CLINICAL DUTIES
STAFF PHARMACISTS DISTRIBUTIVE DUTIES •
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Physician Order Review and Filling Unit-dose chart checking Extemporaneous compounding Purchasing, Inventory, Narcotic Drug Distribution and Control
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Therapeutic Assessment Advice Physicians, Participate in patient rounds Patient Discharge counseling and In Service education Monitoring and Evaluating drug therapy and Intervening when appropriate
PHARMACY TECHNICIANS & OTHER SUPPORT PERSONNEL •
Work under the direct supervision of a Pharmacist
The Hospital Pharmacy’s Lay-Out and It’s Location
PATRICIA ROSE ABALOS, RPh, MS Phar cand
Discussion Outline
Areas of Hospital Pharmacy
Value of Proper Store Design, Traffic Flow and Décor
Sample Hospital Pharmacy Lay-out
HOSPITAL
Serves as central point for the coordination and delivery of patient care to its community
Organized structure that assembles: 1. Health professional 2. Diagnostic and therapeutic facilities, equipment and supplies 3. Physical facilities into a coordinated system for delivering healthcare to the public
FUNCTIONS OF HOSPITAL PHARMACY
Department or division of the hospital wherein the following functions are performed by legally qualified, professionally competent pharmacists and their assistants: 1. Procurement 2. Storage 3. Compounding 4. Manufacturing 5. Packaging 6. Controlling 7. Dispensing 8. Distribution of medications
STRATEGIC PHARMACY DESIGN
Provides detailed recommendation for optimizing everything and everyone in pharmacy
Leads to improved and enhanced pharmacy efficiency
Better Management of staff, cost and safety
OVERALL PLANNING PROCESS
Master Program
Functional Program
Equipment Planning & Architectural Design
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Sets goals and objectives
Specifies the operational demands upon the facilities
Translates Master Program & Functional Program into physical space, equipment and furnishings
Physical Features of Hospital Pharmacy Location •
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Convenient for providing service to many departments and personnel All sections are not distant
Equipment •
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Extreme care in choosing items Must provide good service Has minimal maintenance Price within budget
AREAS OF PHARMACY
1. BULK STORES 2. OUTPATIENT PHARMACY 3. INPATIENT PHARMACY
AREAS OF PHARMACY: BULK STORES
Due to increasing volume & diversity prescriptions Implementation of JIT system
of
JIT (JUST-IN-TIME) system – supplies items as close to the time of use as possible in an effort to reduce large inventories, decrease space requirements, and lessen financial outlay
Growth and emphasis: less volume of individual items, but more deliveries more often
May reduce the amount of space required for bulk storage, but increase the amount of space needed for vendor bins, carts, pallets, and totes.
AREAS OF PHARMACY: BULK STORES 4 FUNCTIONS OF BULK STORES Ordering •
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Provides link to pharmaceutical vendors for JIT delivery and stock Has computers and printers that are linked to prime vendors and to other areas of the pharmacy for inventory control
Receiving •
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Aka Breakout area supplies are removed from their outer containers or vendor bins
Storing •
General Storage Pharmaceutical s must be separated and stored by category Controlled Substance storage Narcotics and other governmentcontrolled substances are stored in a vault or locked •
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Distribution •
Restocking both outpatient and inpatient pharmacies
AREAS OF PHARMACY: BULK STORES
AREAS OF PHARMACY: OUTPATIENT PHARMACY
Responsible for filling outpatient prescriptions and for providing pharmacy stock to clinics and off-site centers
Functions much like a retail pharmacy
It has completely different products and distribution systems than the Inpatient Pharmacy
Size is contingent on the number of outpatients served by the hospital
AREAS OF PHARMACY: OUTPATIENT PHARMACY 4 FUNCTIONS OF OUTPATIENT PHARMACY Ordering •
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Provides the link to Bulk Stores for delivery of stock Requires an administrative station with computers and printers
Receiving •
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Supplies from Bulk Stores are received here on a daily basis or several times a day Should be in close proximity to Bulk Stores
Storing •
Active Stores Where supplies received from Bulk Stores are stored Manufacturing compounding of special prescriptions that are not available commercially Prepackaging Medications are divided and packaged as needed in smaller containers for outpatient use
Distribution •
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Order Entry Prescriptions come into order entry as hard copies at the dispensing windows, electronically via computers, or by automated phone-in system Filling Workstations where pharmacists manually fill prescriptions Dispensing Dispensing windows are for outpatient prescription drop-off and pick-up
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AREAS OF PHARMACY: OUTPATIENT PHARMACY
AREAS OF PHARMACY: INPATIENT PHARMACY
responsible for filling orders for unit dose medications and intravenous (IV) medications for inpatients on patient units
Hospital-dispensed medications are packaged in single doses for accuracy and efficiency of dosage administration
Unit dose – single-dose packages
AREAS OF PHARMACY: INPATIENT PHARMACY 4 FUNCTIONS OF INPATIENT PHARMACY Ordering •
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Provides link to Bulk Stores for delivery and stock Patient Unit Support area may house the mainframe computer linked to automated dispensing machines for controlled substances located on the patient units •
Receiving •
Supplies from Bulk Stores are received here and taken either to unit dose picking or to IV/admixture storage
Storing •
Manufacturing compounding of special prescriptions that are not available commercially Prepackaging Medications are divided and packaged as unit dose for inpatient use
Distribution •
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Order Entry Communication hub Written medication orders are received and reviewed by the pharmacists Orders are compared with the patient’s medication history or profile Unit dose Picking workstation provides a space of limited dimensions containing a maximum quantity of drugs and allows the pharmacist or technician to “pick” the appropriate drugs IV Admixture •
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AREAS OF PHARMACY: INPATIENT PHARMACY
Pharmacy and Therapeutics Committee
PATRICIA ROSE ABALOS, RPh, MS Phar cand
Discussion Outline
What is Pharmacy Committee?
and
Therapeutics
Primary Purpose of Therapeutics Committee
Members of the Pharmacy and Therapeutics Committee
Issues discussed by Therapeutics Committee
Pharmacy
Pharmacy
and
and
What is a Pharmacy and Therapeutics Committee?
An advisory group of the medical staff which serves as the organizational line of communication between medical staff and pharmacy department
Policy recommending body to the medical staff and the administration of the hospital on matter related to drug use
Composed of Physicians, Pharmacists and other health professionals with the guidance of medical staff
Purpose of the Pharmacy and Therapeutics Committee 1. ADVISORY Recommends the adoption of, or assist in the formulation of, broad professional policies regarding evaluation, selection and therapeutic use of drugs in hospitals 2. EDUCATIONAL Recommends, or assists in the formulation of programs assigned to meet the needs of the professional staff for complete knowledge on matters related to drugs and drug use
ADMINISTRATIVE ORDER 51 s. 1988 Section 9 – Therapeutics Committee Subject: Implementing Guidelines for DOH Compliance with Republic Act 6675 (Generics Act of 1988)
9.1 REQUIREMENT
Therapeutic Committee shall be organized at the regional Health Offices, City Health Offices, special hospitals, national medical centers, regional hospitals and sanitaria
ADMINISTRATIVE ORDER 51 s. 1988 Section 9 – Therapeutics Committee 9.2 FUNCTIONS 1. Regularly maintain a list, specified in generic terminology, of the drugs that the agency will keep on stock, use, buy or prescribe Shall be limited in the DOH formulary Any new item outside the formulary should be recommended to the National Drug Committee for inclusion in the DOH formulary before the agency can include such item in its own list
ADMINISTRATIVE ORDER 51 s. 1988 Section 9 – Therapeutics Committee 9.2 FUNCTIONS 2. Recommend drug selection, procurement and stocking policies
utilization,
3. Evaluate and recommend appropriate action on: Requests for inclusion or exclusion of any drug product in the DOH formulary as well as in the agency drug list Reports ADRs and other incidents related to safety efficacy or quality of drugs Use of agency resources for drug products
ADMINISTRATIVE ORDER 51 s. 1988 Section 9 – Therapeutics Committee 9.2 FUNCTIONS 4. Identify and define – Information, education or training needs of the agency related to the implementation of RA 6675, the national drug policy, pharmacological science and rational drug use 5. Plan an orderly, systematic and thorough process of institutionalizing rational drug use that have immediate, medium and long term dimensions Plans should target 100% adoption of generic terminology in procurement, prescribing and dispensing
ADMINISTRATIVE ORDER 51 s. 1988 Section 9 – Therapeutics Committee 9.3 COMPOSITION 1.
1. Shall have at least 5 members except at District Hospitals which may have at least 3 members 2. Shall be designated by head of the agency and shall be a mix of the following professionals: Physician Pharmacist Nurse Dentist – non-voting member 3. Head of agency shall not be a member
