Aa New Applications of Hospital Pharmacy Ders

Prévia do material em texto

New Applications of 
Hospital Pharmacy 
Ass.Prof.Dr.H.Cem Özyurt 
Fall. 2018 EMU 
Phar 473 
Outline of Phar 473 : 
Defination 
Mission and functions 
Organization 
Staff 
Dispensing and quotation 
Manufacturing 
IV additives 
Radiopharmacy 
Consulting 
Training 
Warehouse management 
Surgical materials and medicinal supplies 
Pharmacoviligance 
International rules of WHO 
Post graduation bussines areas : 
-Pharmacy (pharmacist or co-pharmacist ) 
-Goverment 
 -Ministry of Health 
 -Official Association (FDA,EMEA,TİTCK) 
 -Social Security Service (Office work) 
- Hospital 
- - Hospital pharmacist 
- - Oncology Pharmacist 
- - Clinical Pharmacist 
 
 
Oncology pharmacy specialist –Oncology Pharmacist 
 
A licensed pharmacist with special training in how to design, give, monitor, and 
change chemotherapy for cancer patients. Also called BCOP and board certified 
oncology pharmacy specialist. 
 
Oncology pharmacists play an important role in the delivery of care for individuals 
living with cancer. As an integral part of the cancer care team, oncology pharmacists 
represent a broad range of expertise and levels of practice, skills, and responsibilities. 
 
Clinical pharmacists 
 
Clinical Pharmacist work directly with physicians, other health professionals, and 
patients to ensure that the medications prescribed for patients contribute to the best 
possible health outcomes. Clinical pharmacists practice in health care settings where 
they have frequent and regular interactions with physicians and other health 
professionals, contributing to better coordination of care. 
Industry 
 -R&D 
 -QQ 
 -QA 
 -Production 
 -Regulatory Affair 
 - Sales & Marketing 
 -Product Manager 
 -Training 
 -Salesman 
 -Production Planning 
 - Pharmacovilligance 
Hospital pharmacy and pharmacist video 
Definitions: 
HOSPITAL: 
Hospital is an institution for the care, cure and 
treatment of the sick and wounded, for the study of 
the diseases, and for the training of the doctors and 
nurses. 
 
Definition according to WHO: 
The hospital is a complex organization utilizing 
combination of intricate, specialized scientific 
equipment, and functioning through a corps of 
trained people educated to the problem of modern 
medical science. 
Hospital type: 
1. Government or Public Hospital: 
These are run by Central or State Governments. 
These are funded by the government. 
They can be general or specialized hospitals. 
 
2. Non–Government Hospitals (private): 
They are supported by client’s fees, donations, or endowments 
(relating to funds or property donated to institutions or 
individuals). 
 
Non-government hospitals are further classified as either 
proprietary or non–profit organization (social aid : red cross , 
Red Crescent ...etc ). 
Hospital pharmacy : 
The department or service in a hospital which is under 
the direction of a professionally competent, legally 
qualified pharmacist, and from which all medications are 
supplied to the nursing units and other services, where 
special prescriptions are filled for patients in the hospital, 
where prescriptions are filled for ambulatory patients 
and out-patients, 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. 
Definitions: 
The missions of the hospital pharmacist (1) 
It is the profession that strives to continuously 
maintain and improve the medication management 
and pharmaceutical care of patients to the highest 
standards in a hospital setting. 
 
To be part of the medication management in 
hospitals, which encompasses the entire way in 
which medicines are selected, procured, delivered, 
prescribed, administered and reviewed to optimize 
the contribution that medicines make to producing 
informed and desired outcomes 
 
To enhance the safety and quality of all 
medicine related processes affecting patients 
of the hospital 
To ensure the 7 “rights” are respected: right 
patient, right dose, right route, right time, 
right drug with the right information and 
documentation. 
The missions of the hospital pharmacist(2) 
• To ensure the availability of right 
medication, at right time, in the right 
dose at the minimum possible cost. 
• To professionalize the functioning of 
pharmaceutical services in a hospital. 
• To act as a counseling department for 
medical staff, nurses and for patient. 
• To act as a data bank on drug utilization. 
• To participate in research projects. 
 
Objectives of Hospital Pharmacy 
• To implement decisions of the pharmacy 
and therapeutics committee. 
• To co-ordinate and co-operate with other 
departments of a hospital. 
• To plan, organize and implement 
pharmacy policy procedures in keeping 
with established policies of the hospitals. 
Objectives of Hospital Pharmacy 
(Continue) 
• Provide specifications for the purchase of 
drugs, chemicals, biological etc. 
• Proper storing of drugs. 
• Manufacturing and distribution of 
medicaments such as transfusion fluids, 
parenteral products, tablets, capsules, 
ointments, and stock mixtures. 
• Dispensing and sterilizing parenteral 
preparations which are manufactured in 
hospital. 
• Dispensing of drugs as per the prescriptions of 
the medical staff of the hospital. 
Functions of Hospital Pharmacy 
• Filling and labelling of all drug containers from 
which medicines are to be administered. 
• Management of stores which includes purchase 
of drugs, proper storage conditions, and 
maintenance of records. 
• Establishment and maintenance of “Drug 
Information Centre”. 
• Providing co-operation in teaching and research 
programmes. 
• Discarding the expired drugs and containers 
worn and missing labels. 
Functions of Hospital Pharmacy 
(Continue) 
Organization of hospital pharmacy 
 Head of pharmacy services 
(M.Pharm) 
Dispensing 
 Dept 
(D.Pharm) 
Werehouse 
Pharmacist 
(B.Pharm) 
Quality 
Control 
Pharmacist 
(M.Pharm 
Medical Stores 
Pharmacist 
(B or D Pharm 
Manufacturing 
Dept. 
(M.Pharm) 
Manufacturing 
of steril fluids 
(B.Pharm/M.Pharm 
Other 
Manufacturing 
Services 
(B.Pharm) 
inpatient 
outpateint 
Ideally Organization of Hospital Pharmacy 
• DIRECTOR OF PHARMACY 
• ASSOCIATE DIRECTOR OF PHARMACY 
• ASSISTANT DIRECTOR OF PHARMACY: Dealing with 
1. ASSAY & QUALITY CONTROL DIVISION 
2. DRUG INFORMATION SERVICES 
3. CENTRAL SUPPLY DIVISION 
4. IN-PATIENT SERVICES DIVISION 
5. OUT-PATIENT SERVICES DIVISION 
6. INTRAVENOUS ADMIXTURE DIVISION 
7. PURCHASE AND INVENTORY CONTROL 
8. MANUFACTURING AND PACKAGING 
9. RESEARCH PHARMACIST: Dealing with PHARMMCEUTICAL RESEARCH 
DIVISIONS 
10. PHARMACIST SPECIALIST: Dealing with RADIOPHARMACEUTICAL 
DIVISIONS 
 Above all are commonly dealing with; 
ADMINISTRATIVE SERVICES DIVISION 
UNIT DOSE DISPENSING AND ADMINSTRATION 
EDUCATION & TRANING DIVISION 
Duties & Responsibilities of Hospital Pharmacy 
1.To provide the benefits of a qualified hospital 
pharmacist to patients and health care institutions, to 
the allied health professions (dental hygienists, 
diagnostic medical sonographers, dietitians, medical 
technologists, radiographers, respiratory therapists 
etc), and to the profession of pharmacy. 
 
2. To assist in providing an adequate supply of such 
qualified hospital pharmacists. 
3. To assure a high quality of professional practice 
through the establishment and maintenance of 
standards of professional ethics, education. 
 
4. To promote research in hospital pharmacy 
practices and in the pharmaceutical sciences in 
general. 
 
5. To disseminate (To spread) pharmaceutical 
knowledge by providing for interchange of 
information among hospital pharmacists and with 
members of allied specialties and professions. 
Duties & Responsibilities of HospitalPharmacy 
(Continue) 
DEPARTMENT/DIVISION WISE DUTIES OF HOSPITAL 
PHARMACIST 
Administrative Services Division 
1. Plan and coordinate departmental activities. 
2. Develop policies regarding health professionals. 
3. Schedule personnel and provide supervision. 
4. Coordinate administrative needs of the Pharmacy and 
Therapeutics Committee. 
5. Supervise departmental office staff. 
 
Education and Training Division 
1. Coordinate programs of undergraduate and graduate 
pharmacy students. 
2. Participate in hospital-wide educational programs 
involving nurses, doctors etc. 
3. Train newly employed pharmacy department 
personnel. 
Pharmaceutical Research Division 
1. Develop new formulations of drugs, especially dosage forms 
not commercially available, and of research drugs. 
2. Improve formulations of existing products. 
3. Cooperate with the medical research staff of projects 
involving drugs. 
 
In-Patient Services Division 
1. Provide medications for all in-patients of the hospital on a 24-
hour per day basis. 
2. Inspection and control of drugs on all treatment areas. 
3. Cooperate with medical drug research. 
4. Maintain prescription records. 
Out-Patient Services Division 
1. Compound and dispense out-patient prescriptions. 
2. Inspect and control all clinical and emergency services 
3. Maintain prescription records. 
4. Provide drug consultation services to staff and medical 
students. 
 
Drug Information Services Division 
1. Provide drug information on drugs and drug therapy to 
doctors, nurses, medical and nursing students. 
2. Maintain the drug information center. 
3. Maintain literature files. 
Departmental Services Division 
1. Control and dispense intravenous fluids. 
2. Control and dispense controlled substances. 
3. Coordinate and control all drug delivery and distribution 
systems. 
 
Purchasing and Inventory Control Division 
1. Maintain drug inventory control. 
2. Purchase all drugs. 
3. Receive, store and distribute drugs. 
4. Interview medical service representatives. 
Central Supply Services Division 
 Develop and coordinate distribution of medical supplies and 
irrigating fluids. 
 
Assay and Quality Control Division 
1. Perform analyses on products manufactured and purchased. 
2. Develop and revise assay procedures. 
3. Assist research division in special formulations. 
Manufacturing and Packaging Division 
1. Manufacture wide variety of items in common use at the 
hospital. 
2. Operate an overall drug packaging and prepackaging program. 
3. Undertake program in product development. 
4. Maintain a unit dose program. 
 
Sterile Products Division 
1. Produce small volume parenterals. 
2. Manufacture sterile ophthalmologic, irrigating solutions etc. 
3. Prepare aseptic dilution of lyophilize and other "unstable" 
sterile injections for administration to patients. 
Radiopharmaceutical Services division 
1. Centralize the procurement, storage and dispensing of 
radioisotopes used in clinical practice 
 
Intravenous Admixture Division 
1. Centralize the preparation of intravenous solution 
admixture. 
2. Review each I.V. admixture for physio-chemical and 
therapeutic incompatibilities. 
ASEPTIC AREA WAREHOUSE 
Typical layout of hospital pharmacy 
FACILITIES REQUIRED IN SMALL HOSPITAL 
In smaller hospitals, with one pharmacist only, one 
room is required for pharmacy, having a combination of 
dispensing, manufacturing, administrative and all other 
sections of complete pharmaceutical service. 
For sterile products there should be a separate room or 
area. 
 A separate area is required for :- 
 Inpatient services and unit dose dispensing 
Outpatient service 
An office for the chief pharmacist 
A compounding room 
Prepacking and labelling room 
A store room 
Sterile products room 
 A separate area for drug information services and 
space assigned on various nursing units for unit 
dose drug administration. 
In large hospitals, (with 200 or more beds) 
departmentalization of pharmacy activities is required. 
 
THE DRUGS THAT HAVE HIGH RISK 
 
• They must be protected in special locker 
• They always to be kept under lock (as narcotic drugs) 
LIST OF HIGH RISK MEDICATION 
Propofol Inj Kinz Inj Nalbin Inj 
Succinyl Inj Intatan Inj Bupiron Inj 
Neostigmin Inj Tramadol Inj Isoflourene Inj 
Atropin Inj Avil Inj Decadron Inj 
Tracium Inj Dobutamine Inj Dopamin Inj 
Sosegon Inj Heprin Inj Valium Inj 
Syntocinon Inj Norpin Inj Morphine Inj 
Bupicain Inj Dormicum Inj Serenace Inj 
Calcium Gluconate Inj KCL Inj Streptokinas Inj 
25% Dextrose Water Inj Ketamin Inj Digoxin Inj 
Lignocaine Inj Thiopental Inj Adrenaline Inj 
Ephedrine Inj 
Design parameters: 
FLOOR SPACE REQUIREMENTS 
25 sq. meter is the minimum required area for any sized hospital. 
1 sq. meter per bed in 100 beded hospital. (100 sq.M) 
0,65 sq. meter per bed in 200 beded hospital.(130 sq M) 
Floors of pharmacy should be smooth, easily washable and acid 
resistant. 
In manufacturing sections, drains should be provided, walls should 
be smooth, painted in light colour. 
Wooden cabinets are laminated. 
Fluorescent lamps are placed above priscription counter. 
For converting to square meter use 0,0929 
Personnel requirement in hospital 
pharmacy: 
 No standard rules regarding the requirement of personnel for 
inpatient pharmacy. 
 Number of pharmacists required for a hospital are calculated 
on the basis of workload, and the number of bed available. 
 For a small hospital minimum 3 pharmacist are required. As 
the number of bed increases, the number of pharmacist also 
increases. 
 Pharmacist should possess adequate pharmacy qualification 
and experience. 
 If manufacturing drugs is involved in pharmacy, adequate 
number of technicians, assistants, peons etc. required. 
Bed strength Number of pharmacist required 
Upto 50 beds 
Upto 100 beds 
Upto 200 beds 
Upto 300 beds 
Upto 500 beds 
3 
5 
8 
10 
15 
Pharmacist requirement according to bed strength 
DEFINITION 
 
 Supply of drugs in the hospitals and 
other clinics for the treatment of indoor 
and outdoor patients by indent system. 
Drug Distribution System 
The Flow of Order 
 
*Doctor visits patient;writes medication 
 order (or prescription) 
*Order written on doctor’s order sheet, 
 placed in patient’s record 
*Doctor,nurse or unit clerk input 
 admitting information in patient’s record 
*Many hospitals have gone to electronic 
 charts and ordering. 
Technology is used in the hospital pharmacy 
to increase accuracy and improve efficiency 
and quality of pharmacy services. Automated 
pharmacy services are replacing some of the 
routine, time-consuming filling procedures. 
For instance, large automated robots are now 
being used to perform some of the filling 
procedures with near 100% accuracy 
Automation in The Hospital Pharmacy 
Movie about automation 
or robotic system 
Indoor Patient Service 
Types 
 Individual prescription order system 
 Complete floor stock system – 
 charge floor system and 
 non charge floor stock system 
 Combination of individual drug order and 
floor stock system 
 Unit dose dispensing system 
 Charge non-floor stock system 
 1. INDIVIDUAL PRESCRIPTION ORDER 
SYSTEM 
 Used by small and private hospitals because 
of reduced man power requirements. 
 Physician writes the prescription for 
individual patient who obtains the drugs 
prescribed by paying own charges. 
Advantages: 
Medn. orders are directly reviewed by the 
pharmacist. 
 Provides interaction with pharmacist and 
other medical staff and patients. 
 Provides clear control of inventory. 
 Often used in the government hospitals 
 The drugs are given to the patients 
through nursing stations and the 
pharmacy supplies from the drug store of 
the hospitals. 
 Drugs on nursing station or ward may be 
divided into 
a) Charge floor stock drugs 
b) Non charge floor stock drugs2.THE COMPLETE FLOOR STOCK SYSTEM 
Charge floor stock drugs: 
Medicines (stocked in nursing stations) are charged to the 
patient’s account after they have been administered. 
Selection of “charge” stock drugs: Decision as to which 
drug shall be placed should rest with the PTC (Pharmacy 
and Therapeutic Comittee). The list of drugs may vary 
from hospital to hospital. 
 In the same hospital the list of drugs may change from 
time to time as per the recommendations of the PTC. 
 e.g. mannitol injections, dextrose 50%, 25% 
 
PTC –Pharmacy and Therapeutics Comittee : 
 
-is an advisory group of the medical staff and 
serves as the organizational line of 
communication between the medical staff 
and the pharmacy department. 
The comittee assists in the formulation of 
broadprofessional policies regarding the 
evalution, selection, procurement, 
distribution, use, safety procedures and other 
matters releating to drugs use in the hospital 
 
Non charge floor stock drugs: 
Used by patients in unit ward and for which there may be 
no direct charge to the patient’s account . 
Cost of this group of drugs, is calculated as, per day cost of 
room or ward . 
Selection of non charge stock drugs: Consideration is given 
to the cost of preparation, the quantity used, and the 
effect on hospital budget and reimbursement from third 
party payers (Employees’ state insurance scheme).It varies 
from hospital to hospital. 
Ampoules: digoxin, adrenaline 
Tablets: aspirin, paracetamol 
A typical medication order sheet, 
which includes the full name of 
the patient, the date and time the 
order was written, the name and 
dose of drug, the route of 
administration, and the time or 
frequency of dosing, is shown 
in below.Typically, these 
instructions are written by the 
physician in ink; however, these 
orders may be transmitted 
electronically, typed or written by 
the physician, or given orally to 
nursing or pharmacy. 
 An medication order sample : 
Maintaining drug treatment records 
Ordering and stocking medications and medical 
supplies 
Repackaging medications 
Dispensing medications 
Providing information about the proper use of 
medications 
Collecting and evaluating information about 
adverse drug reactions and interactions 
Preparing medications in various dose forms for 
dispensing 
Services DivisionPatient -Out.4 
• Dispense out-patient prescriptions 
• Maintain prescription records. 
• Provide drug consultation services to 
staff and medical students. 
A general account is opened for each patient who 
comes into the hospital ,during the registration. 
Medicine and medical material’s cost which used 
in the period of the treatment is collected when 
the patient is discharged from the hospital. 
This cost is paid either by the patient or by 
the social security institution. 
 
Billing : 
Off-office departments of 
 Hospital Pharmacy : 
Manufacturing-general 
 -IV additives 
 -Sterile products 
Radiopharmaceutical service 
Quality control Laboratory 
Warehouse management 
 -Medicines 
 -Chemicals 
 -Surgical and medicinal materials 
General 
Manufacturing 
COMPOUNDED 
DOSAGE FORMS: 
Oral Solids (Capsules, Tablets) 
Oral Liquids (Solutions, Susp, Emulsions) 
Topicals (Creams, Ointments, Gels) 
Suppositories, Inserts 
Injectables 
Origine of compounded formulas: 
 
* Pharmacopeia : e.g. USP Chapter 
1161>Pharmacy Compounding Practices 
 
<795 Pharmacy Compounding 
Monographs of accepted bulk drug substances 
are being developed 
<1206> Sterile Preparations-Pharmacy Practices 
has been recommended as guidelines for sterile 
preparations compounding. 
* Semi official Pharmacist society 
 e.g. Pharmacist chamber, Doctor’s chamber 
 
* Prescribed formulas 
 
 
* PTC Comitee Recipe’s 
 
 
 
Important headlines about manufacturing: 
 
• In general manufacturing in Hospital Pharmacy: 
 Liquid formulations 
 Eye Drops 
 Creams 
 Ointments 
 Capsules 
 
 
Solutions can be formulated for different 
routes of administration 
 
Orally: Syrups, drops 
 
In mouth and throat: Mouth washes, gargles, 
 throat sprays. 
 
In body cavities: Douches, enemas, ear drops, 
 nasal sprays. 
 
On body Surfaces: Collodions, lotions. 
• Aseptic manufacturing in Hospital Pharmacy 
 The majority of aseptically prepared items are 
 IV Additives,total parenteral nutrition and 
 oncologic IV drugs (Rarely ophtalmic drops). 
 
 40% of hospital inpatients receive IV 
 preparations 
 (and it is continue raising!) 
 
Hospitalised patients need intravenous (IV) fluid 
and electrolytes for one or more of the following reason: 
 
1-Fluid resuscitation 
IV fluids may need to be given urgently to restore 
circulation to vital organs following loss of intravascular 
volume due to bleeding, plasma loss, or excessive 
external fluid and electrolyte loss, usually from the 
gastrointestinal (GI) tract, or severe internal losses (e.g. 
from fluid redistribution in sepsis). 
 
 
IV Therapy 
2-Routine maintenance 
IV fluids are sometimes needed for patients who simply 
cannot meet their normal fluid or electrolyte needs by oral or 
enteral routes but who are otherwise well in terms of fluid 
and electrolyte balance and handling i.e. they are essentially 
euvolaemic (till reacing normal blood volume), with no 
significant deficits, ongoing abnormal losses or redistribution 
issues. However, even when prescribing IV fluids for more 
complex cases, there is still a need to meet the patient’s 
routine maintenance requirements, adjusting the 
maintenance prescription to account for the more complex 
fluid or electrolyte problems. Estimates of routine 
maintenance requirements are therefore essential for all 
patients on continuing IV fluid therapy. 
3-Replacement 
In some patients, IV fluids to treat losses from intravascular 
and or other fluid compartments, are not needed urgently 
for resuscitation, but are still required to correct existing 
water and/or electrolyte deficits or ongoing external losses. 
These losses are usually from the GI or urinary tract, although 
high insensible losses occur with fever and burns patients can 
lose high volumes of what is effectively plasma Sometimes, 
these deficits have developed slowly with associated 
compensatory adaptations of tissue electrolyte and fluid 
distribution that must be taken into account in subsequent 
replacement regimens (e.g. cautious, slow replacement to 
reduce risks of pontine demyelinosis). 
4-Redistribution 
In addition to external fluid and electrolyte losses, some hospital 
patients have marked internal fluid distribution changes or abnormal 
fluid handling. This type of problem is seen particularly in those who 
are septic, otherwise critically ill, post-major surgery or those with 
major cardiac , liver or renal co-morbidity. Many of these patients 
develop oedema from sodium and water excess and some sequester 
fluids in the GI trac or thoracic/peritoneal cavities. 
Deciding on the optimal amount, composition and rate of 
administration of IV fluids to address these often complex needs is 
inherently difficult yet assessment, prescribing and monitoring of IV 
fluids in general admission and ward areas of hospitals, is often left 
to junior doctors and hard-pressed nurses who may lack required 
training and competence. 
Evidence suggests that mismanagement of fluids is common, 
particularly in general ward areas with the potential for adverse 
outcomes including excess morbidity and mortality, prolonged 
hospital stays and increased costs. 
 
ISMP Safe Practice Guidelines for Adult IV 
Push Medications 
(Prepared by the Institute for Safe Medication 
Practices (ISMP)) 
IV Additives: 
Must beware of both stability and 
compatibility of drugs administer by the IV 
route 
IV addiction 
• Beginany IV preparation by washing 
 your hands thoroughly using 
 a germicidal agent such as chlorhexidine gluconate 
or 
 povidone-iodine 
• All jewelry should be removed from the hands and 
wrists before scrubbing and while making a sterile 
product 
• Wear gloves during procedures 
• Laminar airflow hoods are normally kept running 
• Eating, drinking, talking, or coughing is prohibited 
in the laminar airflow hood 
• Working in the laminar flow hood should be free 
from interruptions 
*Work in the center of the work 
 area within the laminar airflow 
hood at least six inches inside the 
edge of the hood 
*Make sure nothing obstructs the flow of air 
from the high-efficiency particulate air (HEPA) 
filter over the preparation area 
*Nothing should pass behind a sterile object 
and the HEPA filter in a horizontal airflow hood 
or above a sterile object in a vertical airflow 
hood 
Process 
• First pharmacist will determine iv dosage, 
diluents, volume of diluent, and rate of 
administration are correct 
• Next the label will be checked against the 
original order. 
• The final solution with additives will then 
be checked against the label to ensure that 
the proper dose has been prepared 
• “Read the label three times” 
Compatibility 
 
A pharmacist education should 
prepare him/her to deal with 
problems of physical, chemical, and 
therapeutic incompatibilities and to 
design suitable alternatives when 
these problem arise 
Incompatibility: 
Physical: visible change e.g. 
Precipitation,adsorbtion to packaging. 
Solubility changing,light decomposing 
Chemical: may or not visible change, 
deterioration or inactivation of an active 
ingredient 
Therapeutic: drug-drug or drug-disease 
interaction that lead to potentiating of drug 
effect, drug toxicity, deterioration 
Discussing of all incompatibility 
Contamination: 
 
Medication errors in intravenous 
drug preparation and administration 
 
 
 Discussing of possible reasons 
Discussing of total incompatibility 
Two weeks minimum 
Labels for IV admixtures should bear the following 
information: 
 patient’s name and identification number 
 room number 
 fluid and amount 
 drug name and strength (if appropriate) 
 infusion period 
 flow rate (e.g., 100 mL/hr or infuse over 30 min) 
 expiration date and time 
 additional information as required by the 
institution or by state or federal guidelines 
 In chemotherapy, generally cytotoxic drugs are 
used. 
 By working within controlled envoriment of 
 the aseptic suite. The pharmacy operators 
 are also protectted whilst preparing 
 medication. 
Oncologic preparation: 
• During the aseptic manufacturing filter 
sterilization 
 mostly uses under Laminar Air Flow Cabinet (LAF) 
 
• Cleaning and disinfection of all places and working 
area is necessary. 
 
• The manufacture of medicinals are a complex 
 operation and must conform to GMP 
 requirements of the releated country. 
• All manufacturing must controlled by the QQ 
 Department using compendial (Microbial and 
 chemical) testing. 
• API’s and Excipients, labels, packing components, 
 in-process samples and finished product are 
 tested according to GMP rules and compendial 
 expectations. 
Necessary Standard Operation Procedure (SOP) 
Which releated to testing and formulary and 
additionally envorimental monitoring, cleaning 
works should developped before. 
Radiopharmaceutical’s 
 A radiopharmaceutical is a radioactive compound used for 
the diagnosis and therapeutic treatment of human diseases. 
 
 In nuclear medicine nearly 95% of the radiopharmaceuticals 
are used for diagnostic purposes, while the rest are used for 
therapeutic treatment. 
 
 Radiopharmaceuticals usually have minimal pharmacologic 
effect, because in most cases they are used in tracer 
quantities. 
 
 Therapeutic radiopharmaceuticals can cause tissue damage 
by radiation. 
 Because they are administered to 
humans, they should be sterile and 
pyrogen free, and should undergo all 
quality control measures required of a 
conventional drug. 
 
 A radiopharmaceutical may be a 
radioactive element such as 133Xe, or a 
labeled compound such as 131I-iodinated 
proteins and 99mTc-labeled compounds. 
 A radiopharmaceutical has two components: 
 a radionuclide and a pharmaceutical. 
 
 The usefulness of a radiopharmaceutical is 
dictated by the characteristics of these two 
components. 
 
 In designing a radiopharmaceutical, a 
pharmaceutical is first chosen on the basis of its 
preferential localization in a given organ or its 
participation in the physiologic function of the 
organ. 
Dosis calculation : 
 
 
All cytostatic drug dose have to calculate according to 
patient’s surface area. 
 
The equation : 
BSA (Body Surface Area =m2) = 
ℎ 𝑐𝑚 𝑥 𝑊(𝑘𝑔)
3600
 
 
Quality Controls in Hospital 
 Pharmacy Manufacturing 
 Definition : 
 Q.C.is the part of GMP concerned with 
sampling, specifications, testing, with the 
organization, documentation and release 
procedures which ensure that the necessary 
and relevant test are actually carried out and 
that materials are neither released for use, nor 
products released for sale or supply, until 
their quality has been satisfactory. 
Steps of an QC operation : 
 
1) Choosing the control subject 
2) Choosing an unit of measure 
3) Setting a standard value 
4) Providing device 
5) Conducting actual management 
6) Interpreting the mean between the actual 
and standard 
7) Taking decision and acting on difference 
 
Establish, validate, and implement all the Q.C. procedure, 
maintain sufficient standards and reagents. 
Evaluate, maintain, and store reference and working 
standards for substances. 
Ensure the correct labeling of containers of materials and 
products. 
Ensure that the stability of API and product is monitored . 
Participate in the investigation of complaints related to 
quality of product. 
Participate in environmental monitoring. 
Role of Q.C. 
Warehouse and purchasing 
• To ensure an adequate storage space and 
continuous supply of pharmaceutical, medical 
and surgical inventories to improve customer 
service. 
• To ensure the facility design, construct and build 
comply with the requirements of TPS, GSP and 
other relevant guidelines from MOH and other 
authorities. 
• To obtain measurable financial performance and 
customer satisfaction on logistic, procurement 
and supply processes. 
OBJECTIVES : 
General Operational Policies 
a) HPS is the main store for pharmaceutical, medical 
and surgical supply. 
b) The HPS shall be headed by a Senior Pharmacist 
who also supervise other pharmacists in the HPS. 
c) The Senior Pharmacist shall ensure the security of 
the HPS. 
d) The Senior Pharmacist shall be supported by 
administrative staff and general workers. 
e) The number of supporting staff shall be 
proportionate to the workload and budget 
managed by the HPS. 
f ) The HPS shall manage the procurement, storage 
 and supply of all items according to TPS and GSP. 
g) The HPS shall keep Psychotropic Substances / 
 Dangerous Drug under lock and key and controlled 
 in accordance with the Dangerous Drug Act 1952 
 and Poison Act 1952. 
h) The HPS shall ensure the supply is able to meet the 
pharmacotherapy and medical needs of the 
patients. 
i) Adequate space shall be made available so that 
First-in-First-Out (FIFO) can be implemented 
efficiently. j) Mechanical handling equipment and 
system shall be made available. 
j) Mechanical handling equipment and system shall 
be made available. 
k) Computerised system for the management of HPS 
shall be made available for procurement, storage, 
supply and payment so as to meet the 
requirements of TPS.This is in addition to e-
Procurement, Integrated Hospital Inventory System 
(IHIS), Teleprimary Care (TPC) andother existing 
systems. 
l) Comprehensive records of all transactions shall be 
electronically documented, maintained and hard 
copies shall be generated at regular intervals. 
m) The HPS shall manage all the product recalls 
according to stated processes and procedures. 
n) All disposals of items and documents shall be 
carried out in accordance with standard 
procedures and regulations. 
o) The design of the building shall be rodent and 
vermin-proof. 
p) Good housekeeping such as cleaning, 
sanitation and inspection shall be carried out 
as scheduled. 
General Development & Maintenance Policies 
a) Location 
b) Security against theft 
c) Fire security 
d) Safety from weather hazard 
e) Storage Area 
 There shall be sufficient physically separated areas 
 with appropriate storage conditions for orderly 
 segregation of products namely biological, 
 refrigerated, inflammable and corrosive liquid and 
 solids, medical gases, cytotoxic drugs, Dangerous 
 Drugs and Psychotropic Substances. 
Controlled storage environment: 
 
Where controlled storage environment is 
required, it conditions shall be continuously 
monitored using appropriate equipment at 
predetermined intervals. Maximum and 
minimum temperature of the day shall be 
monitored and recorded. 
Medical supplies 
What are medical supplies? 
They are designed to aid in the diagnosis, monitoring or 
treatment of medical conditions. 
A hospital that keeps key pieces of medical equipment on-
hand at all times is a hospital that is ready for any case that 
might pass through their doors. The nature of medical 
treatment requires that in order to provide complete care, 
you must be in possession of complete equipment. 
Surgical Gloves 
Examination Gloves 
Glove Powder 
Syringes & Hypodermic Needles 
Cotton wool 
Gauze bandage 
Elastic Bandage 
Gypsium bandage 
Plasters 
Applicator sticks 
Bedpan Gloves 
Diaper for adult and baby 
Disinfectants 
Clinical Thermometer 
Cannula(Branule) 
Elastic Bandage 
Plaster 
Scalp Vein Set 
Gauze 
Infusion Set 
Sutures 
Sterile Gas Compressor 
Sterile Syringe 
Catheters ( For both women and men) 
Essential Medical Supplies Found In A Hospital Pharmacy 
 
Consulting about medicines 
Training : 
- To nurse 
- Health care Staff 
- Patient 
Pharmacovigilance (PV) is defined as the 
science and activities relating to the 
detection, assessment, understanding and 
prevention of adverse effects or any other 
drug-related problem. 
Pharmacovilligance 
WHO established its Programme for International 
Drug Monitoring in response to the thalidomide 
disaster detected in 1961. Together with the WHO 
Collaborating Centre for International Drug 
Monitoring, 
 The European Medicines Agency (EMA) 
coordinates the European Union 
(EU) pharmacovigilance system and 
operates services and processes to 
support pharmacovigilance in the EU. 
WHO promotes PV at the country level. At the 
end of 2010, 134 countries were part of the 
WHO PV Programme. The aims of PV are to 
enhance patient care and patient safety in 
relation to the use of medicines; and to support 
public health programmes by providing 
reliable, balanced information for the effective 
assessment of the risk-benefit profile of 
medicines. 
Official 
guidelines : 
References: 
1 Remington The Science and Practice of Pharmacy, 21.th Ed. 
 David Btroy(Ed.) Lippincott Williams & Wilkins USA 
 ISBN 0-7817-4673-6 
2 Hospital Pharmacy, Wasfi Abbas (Ed) Department Pharmacy- 
 Riyadh-KSA 
3 California Correctional Health Care Services Chapter 20 Vol 9 
 Pharmacy Service 
4 Hospital Pharmacy Procurement and Supply, Special Booklet 
5 Hospital Pharmacy 2.nd Ed. Martin Stephens (Ed.) 
 Pharmaceutical Press, 22011 GB ISBN 978 0 85369 900 2