Course Outline:
- Definition, Mission and Functions
- Organization and Staff
- Dispensing and Quotation
- Manufacturing
- IV Additives
- Radiopharmacy
- Consulting
- Training
- Warehouse Management
- Surgical Materials and Medicinal Supplies
- Pharmacovigilance
- International Rules of WHO
Post-Graduation Business Areas
Pharmacy Settings
- Pharmacy (Pharmacist or Co-Pharmacist)
- Hospital Pharmacist
- Oncology Pharmacist
- Clinical Pharmacist
Government & Regulatory
- Government
- Ministry of Health
- Official Association (FDA, EMEA, TiTCK)
- Social Security Service (Office Work)
Oncology Pharmacy Specialist
A licensed pharmacist with special training in how to design, give, monitor, and change chemotherapy for cancer patients. Also called BCOP (Board Certified Oncology Pharmacy Specialist). Oncology pharmacists play an important role in the delivery of care for individuals living with cancer.
Clinical Pharmacists
Clinical pharmacists work directly with physicians, other health professionals, and patients to ensure that the medications prescribed for patients contribute to the best possible health outcomes. They practice in healthcare settings with frequent interactions with physicians and other health professionals.
Industry Opportunities
- R&D (Research & Development)
- QQ (Quality Quantification)
- QA (Quality Assurance)
- Production
- Regulatory Affairs
- Sales & Marketing
- Product Manager
- Training
- Salesman
- Production Planning
- Pharmacovigilance
Key Definitions
Hospital
An institution for the care, cure and treatment of the sick and wounded, for the study of diseases, and for the training of doctors and nurses.
WHO Definition: The hospital is a complex organization utilizing a combination of intricate, specialized scientific equipment, and functioning through a corps of trained people educated to the problem of modern medical science.
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 nursing units and other services
- Special prescriptions are filled for inpatients
- Prescriptions are filled for ambulatory patients and outpatients
- Pharmaceuticals are manufactured in bulk
- Narcotic and other prescribed drugs are dispensed
- Injectable preparations are prepared and sterilized
- Professional supplies are often stocked and dispensed
Government/Public Hospitals
Run by Central or State Governments. Funded by the government. Can be general or specialized hospitals.
Non-Government Hospitals (Private)
Supported by client's fees, donations, or endowments. Further classified as either proprietary or non-profit organizations (social aid: Red Cross, Red Crescent, etc.).
Missions of the Hospital Pharmacist
Mission 1
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.
Mission 2
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
- Right Information
- Right Documentation
Objectives of Hospital Pharmacy
- 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 patients.
- To act as a data bank on drug utilization.
- To participate in research projects.
- 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.
Functions of Hospital Pharmacy
Primary Functions
- Provide specifications for the purchase of drugs, chemicals, biologicals, 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.
Additional Functions
- 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 with worn and missing labels.
Organization of Hospital Pharmacy
- Assay & Quality Control Division
- Drug Information Services
- Central Supply Division
- In-Patient Services Division
- Out-Patient Services Division
- Intravenous Admixture Division
- Purchase and Inventory Control
- Manufacturing and Packaging
- Research Pharmacist: Dealing with Pharmaceutical Research Divisions
- Pharmacist Specialist: Dealing with Radiopharmaceutical Divisions
- Administrative Services Division
- Unit Dose Dispensing and Administration
- Education & Training Division
Department/Division Wise Duties of Hospital Pharmacist
Administrative Services Division
- Plan and coordinate departmental activities.
- Develop policies regarding health professionals.
- Schedule personnel and provide supervision.
- Coordinate administrative needs of the Pharmacy and Therapeutics Committee.
- Supervise departmental office staff.
Education and Training Division
- Coordinate programs of undergraduate and graduate pharmacy students.
- Participate in hospital-wide educational programs involving nurses, doctors etc.
- Train newly employed pharmacy department personnel.
In-Patient Services Division
- Provide medications for all in-patients of the hospital on a 24-hour per day basis.
- Inspection and control of drugs on all treatment areas.
- Cooperate with medical drug research.
- Maintain prescription records.
Out-Patient Services Division
- Compound and dispense out-patient prescriptions.
- Inspect and control all clinical and emergency services.
- Maintain prescription records.
- Provide drug consultation services to staff and medical students.
Physical Layout Requirements for Hospital Pharmacy
Floor
- Should be smooth, tough and resistant to acid, base.
- A heavy linoleum flooring is preferred.
Walls
- Walls to be smooth without crevices, washable, light color.
- Drug cabinet light coloured wood or steel.
- Sterile solution room: waterproof, smooth, non-skid surface with drainage system.
Light
- Plenty of windows for day light.
- To make dust free Venetian window blinds to be used.
- Fluorescent light on prescription and distribution area.
- Adequate electric sockets and exhaust for gases.
Storage Requirements and Special Handling
General Drugs Storage
- Drugs to be arranged alphabetically in cabinet or as per use (antibiotics, anti-hypertensive, etc.)
- Bin card showing stock position.
- Short expiry to be placed in front and long expiry at the back.
- FIFO (first in first out) method to be followed.
- Drugs to be used before date of expiry or transferred to other hospitals.
- Expiry drugs to be disposed as per rule.
Cold Storage
- Drugs such as antibiotics, vitamins, liver extracts should be stored in Cold Room between 15 to 20°C.
- The room to be air conditioned with temperature control facility.
- Drugs like vaccines, sera, hormones etc to be stored at 2° to 8°C in deep freezers or walk-in cooler.
- Temperature monitoring through dial thermometer and temperature charting.
Narcotic Drugs
There should be separate, special arrangement for narcotic drugs like morphine, pethidine, barbiturates. Proper recording to be maintained. Always to be kept under lock and key.
Inflammable Items
Separate enclosure to be made for inflammables like spirit, gases & chemicals. Adequate ventilation and fire fighting arrangements. Exhaust fans & sky scrapers for air to pass through.
High-Risk Medications
They must be protected in special locker. They always to be kept under lock (as narcotic drugs).
- Propofol Inj
- Succinyl Inj
- Neostigmin Inj
- Atropin Inj
- Tracrium Inj
- Sosegon Inj
- Syntocinon Inj
- Bupicain Inj
- Calcium Gluconate Inj
- 25% Dextrose Water Inj
- Lignocaine Inj
- Ephedrine Inj
- Kinz Inj
- Intatan Inj
- Tramadol Inj
Personnel Requirements in Hospital Pharmacy
There are no standard rules regarding the requirement of personnel for inpatient pharmacy. The number of pharmacists required for a hospital are calculated on the basis of workload, and the number of beds available.
For a small hospital minimum 3 pharmacists are required. As the number of beds increases, the number of pharmacists also increases. Pharmacists should possess adequate pharmacy qualification and experience.
If manufacturing drugs is involved in pharmacy, adequate number of technicians, assistants, peons etc. are required.
| Bed Strength | Number of Pharmacists Required |
|---|---|
| Up to 50 beds | 3 |
| Up to 100 beds | 5 |
| Up to 200 beds | 8 |
| Up to 300 beds | 10 |
| Up to 500 beds | 15 |
Drug Distribution Systems
Definition
Supply of drugs in the hospitals and other clinics for the treatment of indoor and outdoor patients by indent system.
Types of Drug Distribution Systems
1. Individual Prescription Order System
Used by small and private hospitals because of reduced manpower requirements. Physician writes the prescription for individual patient who obtains the drugs prescribed by paying own charges.
Advantages: Medication orders are directly reviewed by the pharmacist. Provides interaction with pharmacist and other medical staff and patients. Provides clear control of inventory.
2. Complete Floor Stock System
Often used in 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:
- Charge floor stock drugs
- Non-charge floor stock drugs
Charge Floor Stock Drugs
Medicines (stocked in nursing stations) are charged to the patient's account after they have been administered.
Selection: Decision as to which drug shall be placed should rest with the PTC (Pharmacy and Therapeutic Committee). The list of drugs may vary from hospital to hospital and may change from time to time (e.g., mannitol injections, dextrose 50%, 25%).
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: Consideration is given to the cost of preparation, the quantity used, and the effect on hospital budget and reimbursement from third party payers (e.g., ampoules: digoxin, adrenaline; tablets: aspirin, paracetamol).
Pharmacy and Therapeutics Committee (PTC)
An advisory group of the medical staff and serves as the organizational line of communication between the medical staff and the pharmacy department. The committee assists in the formulation of broad professional policies regarding the evaluation, selection, procurement, distribution, use, safety procedures and other matters relating to drug use in the hospital.
Manufacturing in Hospital Pharmacy
Compounded Dosage Forms
- Oral Solids (Capsules, Tablets)
- Oral Liquids (Solutions, Suspensions, Emulsions)
- Topicals (Creams, Ointments, Gels)
- Suppositories, Inserts, Injectables
Sources of Compounded Formulas
- Pharmacopeia: e.g., USP Chapter 1161 - Pharmacy Compounding Practices; Pharmacy Compounding; Sterile Preparations-Pharmacy Practices
- Semi-official Pharmacist Society: e.g., Pharmacist chamber, Doctor's chamber
- Prescribed Formulas
- PTC Committee Recipes
Important Manufacturing Areas
General Manufacturing
- Liquid Formulations
- Eye Drops
- Creams
- Ointments
- Capsules
Solutions for Different Routes
- 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
IV Additives and Therapy
Aseptic Manufacturing in Hospital Pharmacy
The majority of aseptically prepared items are IV Additives, total parenteral nutrition and oncologic IV drugs (rarely ophthalmic drops). 40% of hospital inpatients receive IV preparations (and it is continuing to rise!).
Reasons for IV Therapy
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.
2. Routine Maintenance
IV fluids are sometimes needed for patients who 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.
3. Replacement
IV fluids to treat losses from intravascular and/or other fluid compartments, to correct existing water and/or electrolyte deficits or ongoing external losses (usually from GI or urinary tract).
4. Redistribution
Some hospital patients have marked internal fluid distribution changes or abnormal fluid handling (septic, critically ill, post-major surgery, or those with major cardiac, liver or renal co-morbidity).
Key Points for IV Additives
- Intravenous drug administration if not done properly can cause infection.
- Hand hygiene, aseptic technique, correct preparation and administration of IV drugs/solutions and line changes will minimize the risk of infection.
- Patients should be closely monitored for signs of infection.
- Good documentation is essential.
- Must be aware of both stability and compatibility of drugs administered by the IV route.
IV Preparation 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"
Radiopharmaceuticals
Radiopharmaceutical: A radioactive compound used for the diagnosis and therapeutic treatment of human diseases.
- In nuclear medicine, nearly 95% of 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.
Components of Radiopharmaceuticals
A radiopharmaceutical has two components: a radionuclide and a pharmaceutical. The usefulness of a radiopharmaceutical is dictated by the characteristics of these two components.
Design Considerations
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.
Dosage Calculation for Cytostatic Drugs
All cytostatic drug doses have to be calculated according to patient's surface area.
\[BSA \left( \text{Body Surface Area} = m^2 \right) = \sqrt{\frac{h(cm) \times W(kg)}{3600}}\]
Quality Control in Hospital Pharmacy Manufacturing
Definition
Quality Control is the part of GMP concerned with sampling, specifications, testing, with the organization, documentation and release procedures which ensure that the necessary and relevant tests 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 a QC Operation
- Choosing the control subject
- Choosing a unit of measure
- Setting a standard value
- Providing device
- Conducting actual management
- Interpreting the mean between the actual and standard
- Taking decision and acting on difference
Warehouse and Purchasing
Objectives
- 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.
General Operational Policies
- HPS (Hospital Pharmacy Store) is the main store for pharmaceutical, medical and surgical supply.
- The HPS shall be headed by a Senior Pharmacist who also supervises other pharmacists in the HPS.
- The Senior Pharmacist shall ensure the security of the HPS.
- The Senior Pharmacist shall be supported by administrative staff and general workers.
- The number of supporting staff shall be proportionate to the workload and budget.
- The HPS shall manage the procurement, storage and supply of all items according to TPS and GSP.
- The HPS shall keep Psychotropic Substances/Dangerous Drug under lock and key and controlled in accordance with relevant acts.
- Adequate space shall be made available so that First-in-First-Out (FIFO) can be implemented efficiently.
- Mechanical handling equipment and system shall be made available.
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.
Essential Medical Supplies Found in a Hospital Pharmacy
- Surgical Gloves
- Examination Gloves
- Glove Powder
- Syringes & Hypodermic Needles
- Cotton Wool
- Gauze Bandage
- Elastic Bandage
- Gypsum Bandage
- Plasters
- Applicator Sticks
- Bedpan
- Gloves Diaper for adult and baby
- Disinfectants
- Clinical Thermometer
- Cannula (Branule)
- Scalp Vein Set
- Gauze Infusion Set
- Sutures
- Sterile Gas Compressor
- Catheters (For both women and men)
Training and Consulting
Consulting about Medicines
Hospital pharmacists provide essential consultation services regarding medications to healthcare staff and patients.
Training Programs
To Nurses
Training on proper medication administration, storage, and handling procedures.
To Healthcare Staff
Education on drug interactions, side effects, and proper documentation procedures.
To Patients
Patient education on medication usage, potential side effects, and adherence to treatment plans.
Pharmacovigilance
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 Pharmacovigilance Programme
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
- To support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines
References
- Remington: The Science and Practice of Pharmacy, 21st Ed. David B. Troy (Ed.) Lippincott Williams & Wilkins USA ISBN 0-7817-4673-6
- Hospital Pharmacy, Wasfi Abbas (Ed) Department Pharmacy-Riyadh-KSA
- California Correctional Health Care Services Chapter 20 Vol 9 Pharmacy Service
- Hospital Pharmacy Procurement and Supply, Special Booklet
- Hospital Pharmacy 2nd Ed. Martin Stephens (Ed.) Pharmaceutical Press, 2011 GB ISBN 978-0-85369-900-2
