Document For Preparation For Psu Pre
Document For Preparation For Psu Pre
Prepared by:
ANYASE RONALD AMAZA
Intern Pharmacist, Mbarara Regional Referral Hospital, 2017/2018
PREAMBLE
Prior to registration of a pharmacist in Uganda, one is required to have undergone, among many
requirements, 3 major criteria of evidenced assessment. Firstly, one must have successfully
finished a degree of Bachelor of Pharmacy (BPharm) from an accredited university. This is
followed by successful passing of the pre-internship/eligibility exam. Secondly, one must undergo
a one-year supervised internship program as prescribed by the Council of the Pharmaceutical
Society of Uganda (PSU). And lastly, one must successfully pass the pre-registration/membership
exam set by the PSU.
In preparation for the final step to registration as a member of PSU and consequently, with the
Pharmacy Board, Ministry of Health, one must adequately prepare for the pre-registration
examination during the entire internship period. This document provides an insight on the various
areas that could be examinable and are priority fields of competence for a registering pharmacist.
It could also act as a discussion and revision guide for intern pharmacists.
The areas of preparation are arranged according to the fields of pharmacy practice currently
recognised as of priority relevance in regards to pharmacist competences and job availability. They
may exclude other pertinent areas of emerging or already existent pharmacy practice fields. This
major fields of concern include:
1. Industrial pharmacy practice (pharmaceutical manufacturing)
2. Community pharmacy practice (human and veterinary pharmacy)
3. Hospital pharmacy practice (clinical pharmacy/pharmaceutical care)
4. Supply chain pharmacy practice (supply chain management)
5. Regulatory pharmacy practice (pharmaceutical regulation)
6. Professional pharmacy practice (professionalism, management, law and ethics)
It is expected of every intern pharmacist to have undergone practical training in all the above fields
of pharmacy practice. The contents of this document require one to understand the subject matter
and apply reasoning and criticism in answering potential questions in the pre-registration
examination.
Disclaimer
This document is in no way a panacea to passing the pre-registration examination. No liability
shall be held by the author in any form for the use of this document. Any suggestions to make the
document more beneficial to members are welcome, after consultation of and through the author.
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Preparation for PSU Pre-Registration Exams 2
A. General aspects
i. General principles of current good manufacturing practices (cGMP) and current
good laboratory practices (cGLP)
ii. Terminology in industrial pharmacy practice and cGMP
iii. Location, design and layout of a pharmaceutical factory
iv. Documents involved in various pharmaceutical procedures and processes
v. Different departments and their roles
vi. Personnel involved in various pharmaceutical processes
vii. Equipment used in any pharmaceutical process
B. Stores – Procurement, Receipt, Storage and Issuing of Raw Materials
i. Procurement of raw materials – requisite documentation and personnel
ii. Receipt of raw materials – procedure, equipment and documentation
iii. Sampling of raw materials – procedure, equipment and documentation
iv. Storage of raw materials in the raw material store – different aspects involved (good
storage practices)
v. Issuing raw materials for production – procedure and documentation
C. Production – Pharmaceutical Unit Processes
i. Pharmaceutical unit processes for various dosage form production especially
parenterals and tablets, also capsules, syrups, etc. e.g. mixing, filling, sterilisation
sifting, granulation, drying, milling, blending, compression, coating, distillation,
evaporation, separation, etc. – definition, description, significance, application, in-
process checks, equipment used and their principle of operation
ii. Dispensing of raw materials – procedures, documents, equipment and personnel
involved.
iii. Line clearance – significance, procedure, and documentation
iv. Cleaning of equipment used
v. Packing of finished products – types of packaging materials, processes, equipment,
documents e.g. labelling, capping, wrapping, weighing, strapping, etc.
D. Quality Control – In-Process Checks and Quality Control Tests
i. Equipment employed in the quality control of drugs – principle of operation, usage,
and calibration
ii. Sampling – procedure, equipment, documentation
iii. Chemical and microbiological quality control tests – description and specifications
for raw materials, bulk products and finished products
iv. Stability studies – tests done and documents involved, shelf life determination
v. In-process checks done during the production of drugs i.e. during the various unit
processes including packaging
E. Quality Assurance (QA)
i. General functions of QA – responsibilities, activities, roles, QMS
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Preparation for PSU Pre-Registration Exams 3
ii. Validation and qualification – process validation (e.g. of aseptic filling, cleaning,
mixing, etc.), Method of Analysis validation, Steriliser validation, water system
validation, vendor qualification, HVAC qualification, personnel qualification, etc.
iii. Complaint handling, deviation handling, product recall, risk management, change
control, rejection handling
iv. Product/batch release process
v. Product development
vi. Inspection and quality audits, annual product quality review,
vii. Document control – SOPs, BMR, Site master file, Master formulae, Log books, etc.
viii. Corrective action preventive action (CAPA) – description, significance, procedures
and personnel involved
ix. Reprocessing and reworking
F. Regulatory Affairs
i. Functions of regulatory affairs department
ii. Activities e.g. licensing i.e. GMP, ISO, manufacturing, suitability of premises,
import and export; product registration, retention and registration renewal;
marketing authorization, dossier preparation, compilation and submission.
iii. Documents – GMP certificates, ISO certificates, export license, import license,
certificate of suitability of premises, manufacturing license, dossiers (CTD), etc.
G. Warehousing
i. Transfer of finished products from production area to warehouse – procedure,
documents, personnel
ii. Good storage practices in the warehouse
iii. Dispatch of released finished products – process, personnel, documents
H. Maintenance and Utilities in pharmaceutical industry
i. Different types of utilities for pharmaceutical manufacture – water, air, humidity,
steam, compressed air, vacuum, cooling water – uses, production, control,
equipment.
ii. Pharmaceutical waters – types, preparation, limits, and documents used
iii. Water treatment/purification – process, equipment, controls, WFI production,
documents, chemicals used and water system validation
iv. HVAC system – relevance, components and their functions
v. Clean rooms – relevance, description, classification, application and environmental
monitoring
vi. Waste management – effluent treatment, solid waste disposal process
I. Miscellaneous aspects
i. Drug research and development – processes, phases
ii. Dosage forms – types, uses, examples of ingredients
iii. Biopharmaceutics – concept, bioequivalence and bioequivalent studies,
bioavailability and factors
iv. Bio-indicators and antibioindicators (sterilisation processes)
v. Bio-waivers
vi. Drug design
vii. Formulation and pre-formulation – rheology, polymorphism, powder flow, drug
stability
viii. Drug delivery systems
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Preparation for PSU Pre-Registration Exams 4
A. General aspects
i. General principles of current good pharmacy practices (cGPP)
ii. Roles of a pharmacist in a community pharmacy, reasons for increasing role of
pharmacists in community pharmacies, activities of community pharmacists
including: prescription handling, dispensing, extemporaneous
preparations/compounding, etc.
iii. Location, design and layout of a community pharmacy i.e. start-up and set-up
iv. Documentation used in a community pharmacy
v. Different departments/personnel employed in a community pharmacy (human and
veterinary) and their roles
vi. Management of a community pharmacy
vii. Patient counselling and patient education
viii. Communication skills required in community pharmacy practice
ix. Self-care and self-medication
x. Problems related to drug use in communities and their solutions
xi. Family planning, use contraceptives and other methods
xii. Public health and promotion
B. Pharmacist initiated therapies i.e. minor illnesses
i. Dermatological conditions: Acne, Bacterial infections, Decubitus ulcers (bedsores),
Nappy rash, Burn wounds, Dermatitis (eczema), Calluses and corns, Whitlows
(Paronychium), Hair loss (Alopecia), Insect bites & stings, Parasitic infections-
scabies, Psoriasis, Stretch marks, Dandruff, Fungal infections, Viral infections,
Urticaria
ii. Genito-urinary: Cystitis, Dysmenorrhea, Premenstrual tension
iii. Musculoskeletal and connective tissue: Osteoarthritis, Gout, Backache, Muscular
pain, Trauma, Inflammatory connective tissue conditions
iv. GIT conditions: Diarrhea, Constipation, Nausea & vomiting, Dyspepsia, Peptic
ulceration & gastritis, Heart burn, Spastic colon syndrome, Flatulence
v. Neurological disorders: Headache, Facial pain (neuralgia), Listlessness/fatigue,
Sleep disturbance, Stress conditions
vi. Nutritional disorders: Regulation of lactation, Weight control, Vitamin & mineral
deficiencies
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Preparation for PSU Pre-Registration Exams 5
vii. Ophthalmological conditions: Dry eyes, Stye & chalazion, Conjunctivitis, Arc eyes,
Blepharitis/lid oedema, Subconjunctival bleeding, Foreign objects in the eye,
Watery eyes
viii. Parasitic diseases: Malaria, Worm infestation
ix. Respiratory ailments: Allergic rhinitis, Asthma, Halitosis, Hoarseness, Cough, Sore
throat, Ear ache, Wax in the ears, Sinusitis, Cold & influenza symptoms
x. Dental and oral: Apthous ulcers, Cold sores, Thrush (oral candidiasis), Teething,
Tooth ache
xi. Vascular conditions: Varicose veins, chilblains
C. Veterinary pharmacy practice
i. Terms and nomenclature
ii. Classification of veterinary animals
iii. Assessment of systems’ functions
iv. Comparative anatomy, physiology and pathology: Digestive system, Respiratory
system, Reproductive system, Cardiovascular system, Urinary tract disorders,
Abdominal problems.
v. Introduction to veterinary practice
vi. Description and Patho-physiology of common diseases and conditions
vii. General principles of management of veterinary diseases and conditions: Common
signs and symptoms, Examination procedures
viii. Classes of drugs: Parasiticides, Antimicrobials, Vaccines, Dewormers, Antiseptics
and disinfectants, Vitamins and minerals, Hormones, Anesthetics, Drug
administration
ix. Common veterinary diseases: Neurological diseases, Metabolic diseases,
Respiratory diseases, Reproductive disorders, Urinary tract disorders, Abdominal
problems, Worm infestation
x. Nutrition
xi. Operations aspects of veterinary pharmacies: Regulations and policy, Staffing
A. General Aspects
i. Concept of pharmaceutical care
ii. Roles of a pharmacist in a hospital
iii. Pharmaceutical care process
iv. Adverse drug reactions, medication errors and drug interactions
v. Pharmacokinetic parameters and related equations
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Preparation for PSU Pre-Registration Exams 6
Phase II transformations
− Metabolic stability
− The first pass effect
• Drug excretion
• Drug administration
− Oral administration
− Absorption through mucous membranes
− Rectal administration
− Topical administration
− Inhalation
− Injection
− Implants
• Drug dosing
− Drug half-life
− Steady-state concentration
− Drug tolerance
− Bioavailability
− Formulation
− Drug delivery
B. Urinary System Pharmacy
i. Urinary tract infections; Vaginal infections; Urethritis, Cystitis, Prostatitis, Acute
pyelonephritis, Hospital acquired UTI, UTI in pregnancy, recurrent UTI
ii. Benign Prostatic Hypertrophy, Urinary incontinence
iii. Acute and chronic renal failure, pharmacokinetic and pharmacodynamic changes in
renal failure, hemodialysis and peritoneal dialysis, nephritic and nephrotic
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Preparation for PSU Pre-Registration Exams 7
syndrome, drugs that induce renal failure, complications of acute and chronic renal
failure, dose adjustment in renal failure
iv. Clinical Pharmacology of pertinent drugs used.
C. Cardiovascular System Pharmacy
i. Essential Hypertension, Coronary artery disease/ischaemic heart disease/angina,
Myocardial infarction, Arrythmias, Rheumatic heart disease, Congestive heart
failure, dyslipidaemia
ii. Deep vein thrombosis, pulmonary embolism, infective endocarditis, atrial
fibrillation, pericarditis, rheumatic heart disease and rheumatic fever, stroke
iii. Anaemia, sickle cell disease, bleeding disorders, shock, fluid and electrolyte
imbalance (intravenous fluid therapy), dehydration, hypoglycaemia,
iv. Congenital infections, trauma, aneurysms, atherosclerosis, thromboembolic
phenomenon, cardiomyopathies
v. Role of hereditary lifestyle in cardio-vascular disorders, Role of pollutants in
respiratory and cardiovascular disorders
vi. Clinical Pharmacology of Glycosides, anti-arrythmias, antihypertensives such as
vasodilators and ß-blockers, calcium channel blockers, Anti-angina drugs,
expectorants, antitussives, NSAIDS, cholesterol lowering medicines such as statins,
fibrates
D. Respiratory System Pharmacy
i. Asthma i.e. acute and chronic asthma
ii. Chronic Obstructive Pulmonary Disease (COPD)
iii. Acute and Chronic Rhinitis, Coryza, Influenza
iv. Drug-induced Pulmonary Disorders
v. Pertussis, Laryngitis, Bronchitis
vi. Pneumonia
vii. Tuberculosis
viii. Other restrictive/obstructive and allergic disorders of the respiratory system,
pulmonary edema, respiratory failure
ix. Clinical pharmacology of respiratory drugs
E. Gastrointestinal System Pharmacy
i. Gastrointestinal infections; Cholera, Amoebiasis, giardiasis, typhoid, dysentery,
peritonitis, pancreatitis, peptic and gastric ulcer disease, peritonitis, irritable bowel
syndrome and inflammatory bowel syndrome, gastro-esophageal reflux disease,
diarrheal diseases, constipations, haemorrhoids, intestinal worms, nutritional
disorders, kwashiorkor, marasmus, vitamin and mineral deficiencies, liver diseases,
hepatitis, liver cirrhosis, drug-induced liver failure, pancreatitis, jaundice,
cholecystitis, gallstones.
ii. Clinical Pharmacology of anti-ulcer, laxatives/purgatives, anti-diarrhea agents,
motility enhancing agents, medicines used in Crohn’s disease and ulcerative colitis,
etc.
iii. Tube feeding and administration of medicines through tube feeds
iv. Pharmacokinetic alterations in liver disease
v. Investigative procedures; stool, urine and blood examination, Radiology Biopsies
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Preparation for PSU Pre-Registration Exams 9
A. General Aspects
i. Definition of supply chain management
ii. Components of the supply management cycle
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Preparation for PSU Pre-Registration Exams 10
A. General aspects
i. Laws, regulations and guidelines affecting pharmacy practice: definitions,
examples, and elements of national pharmaceutical regulation
ii. Need for regulation of pharmaceutical products
iii. Medicinal products vs medical devices: definitions and classification, product
liability
iv. National Drug Authority: mandate, roles, functions and activities e.g. Licensing,
Drug Registration/ Marketing Authorization, Pharmacovigilance/Post-marketing
surveillance, Recalls, Good Manufacturing Practices compliance, Drug
Import/Export/Disposal, Quality control of medicines including Labelling,
Enforcement, Clinical trials, Drug Promotion, Advertisement, etc.
B. Laws and regulations
i. National Drug Policy and Authority Act; Regulations/statutory instruments under
National Drug Policy and Authority Act
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Preparation for PSU Pre-Registration Exams 11
A. General aspects
i. Definitions: ethics, morality, law, professionalism,
ii. Ethics: theories, basic principles, applications
iii. Profession: values, elements, governance, etc.
iv. Code of conduct; guiding principles and obligations
v. Difference between law and ethics
vi. Professional standards of pharmacists in different practice fields e.g. retail
pharmacy, industrial manufacturing, etc.
vii. Practical applications
REFERENCES
The following were the pertinent sources of information in coming up with this incredible guide
that will surely make preparation for the exam much easier.
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