0% found this document useful (0 votes)
88 views

Document For Preparation For Psu Pre

Uploaded by

Criss Angel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
88 views

Document For Preparation For Psu Pre

Uploaded by

Criss Angel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 11

Preparation for PSU Pre-Registration Exams 1

DRAFT DOCUMENT FOR PREPARATION FOR PSU PRE-REGISTRATION EXAMS

Prepared by:
ANYASE RONALD AMAZA
Intern Pharmacist, Mbarara Regional Referral Hospital, 2017/2018

9th October, 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.

Page 1 of 11
Preparation for PSU Pre-Registration Exams 2

1. INDUSTRY PHARMACY PRACTICE


Industry covers a broad aspect of pharmacy practice including knowledge of pharmaceutical
manufacturing, pharmaceutical analysis, good manufacturing practices, pharmaceutics,
pharmaceutical regulation and many other aspects that may also be captured in the other practice
fields. Content to be covered is outlined below.

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

Page 2 of 11
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

Page 3 of 11
Preparation for PSU Pre-Registration Exams 4

ix. Analytical methods


x. Pharmaceutical calculations pertinent to manufacture and control of
pharmaceuticals
xi. Phenomenon of solution, pharmaceutical solvents, solubility
xii. Limit tests
xiii. Bioassays, biosimilar

2. COMMUNITY PHARMACY PRACTICE


Community pharmacy practice is one of the most employing fields for pharmacists in Uganda and
elsewhere. It requires a great appreciation of key concepts such as legal, regulatory, economic and
professional aspects; pharmacist-initiated therapy, drug management and therapeutics, among
others. Community pharmacy practice can broadly be categorized as: human and veterinary.

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

Page 4 of 11
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

3. HOSPITAL PHARMACY PRACTICE (CLINICAL


PHARMACY/PHARMACEUTICAL CARE)
Hospital pharmacy practice is arguably the most promising area of pharmacists’ areas of
competence. With the current paradigm shift from drug focus to patient focus, clinical pharmacy
practice through community pharmacy and hospital pharmacy services remains the principal focus
for pharmacists worldwide. This involves not only appreciation of areas such as drug management,
supply chain management, and legal considerations but also core contents as discussed below.
Management of different disorders herein categorized by body systems are pertinent to
understanding of clinical pharmacy problems. Appreciation of the pathophysiology, clinical
presentation, investigation, differential diagnoses, pharmacological and nonpharmacological
management is very pertinent.

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

Page 5 of 11
Preparation for PSU Pre-Registration Exams 6

vi. Understand the p-drug concept


vii. Communication and patient counselling skills for pharmacists
viii. Evidence based medicine
ix. Sources of clinical information
x. Interpretation of clinical laboratory data
xi. Concept of rational medicine use
xii. Elements of a good prescription
xiii. Pharmaceutical management cycle
xiv. Clinical pharmacokinetics
• Drug absorption
• Drug distribution, Distribution round the blood supply, Distribution to tissues,
Distribution to cells. Other distribution factors, Blood-brain barrier, Placental
barrier.
• Drug-drug interactions
• Drug metabolism
Phase I metabolism
− Phase I transformations catalysed by cytochrome P450 enzymes
− Phase I transformations catalysed by flavin-containing monooxygenases
− Phase I transformations catalysed by other enzymes

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

Page 6 of 11
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

Page 7 of 11
Preparation for PSU Pre-Registration Exams 8

F. Neurological System – Central Nervous System Pharmacy


i. Psychosis (Schizophrenia), Bipolar Affective Disorder (Mania), Major Depressive
Disorder (Depression), Substance Abuse (Alcohol), Anxiety Disorder, Epilepsy,
neurodegenerative disorders (Parkinson’s disease, Alzheimer’s, Huntington’s
disease), delirium, nodding disease, headache (migraines), dementia
ii. Clinical pharmacology of anxiolytics and hypnotics, antipsychotics,
antidepressants, anticonvulsants, analgesics, anaesthetics, CNS stimulants and
psychotomimetic, alcohol, and other pertinent drugs.
G. Endocrine System Pharmacy
i. Diabetes mellitus and its complications e.g. diabetic ketoacidosis (DKA),
hyperosmolar hyperglycaemic state (HHS), diabetic nephropathy, diabetic
neuropathy, diabetic foot, diabetic retinopathy, etc.
ii. Thyroid disorders, hyperthyroidism, goitre and hypothyroidism
iii. Parathyroid disorders
iv. Pituitary disorders
v. Addison’s disease
vi. Cushing’s disease
vii. Clinical Pharmacology of hormones; antithyroid drugs; oral hypoglycemic agents,
corticosteroids, insulin, etc.
H. Reproductive System Pharmacy
i. Erectile dysfunction and infertility, Hormonal contraception, Post-menopausal
hormonal therapy
ii. Sexual Transmitted Diseases e.g. syphilis, gonorrhea, genital warts, genital ulcer
disease, pelvic inflammatory disease, urethral discharge syndrome, abnormal
vaginal discharge syndrome, balanitis, congenital STI syndromes like neonatal
conjunctivitis, congenital syphilis
iii. Gynaecological conditions e.g. dysmenorrhea, menopause, abnormal uterine
bleeding
iv. Obstetric conditions e.g. conditions in pregnancy such as anaemia, HIV, malaria,
TB, diabetes, UTIs, hypertensive disorders like pre-eclampsia and eclampsia,
hyperemesis gravidarum, premature rupture of membranes, ectopic pregnancy,
chorioamnionitis, antepartum haemorrhage, abruptio placentae and placenta
praevia, postpartum haemorrhage, puerperal sepsis, postnatal depression, mastitis,
obstetric fistula
v. Clinical pharmacology and use of pertinent drugs used
I. Infections and infestations
i. Bacterial infections: Anthrax, Brucellosis, Diphtheria, leprosy, meningitis
(neonatal, and TB meningitis), Plague, Septicaemia, Tetanus, Typhoid and Typhus
fever, Tuberculosis
ii. Fungal infections: Dermatophytosis, Candidiasis
iii. Viral infections: avian influenza, chicken pox, measles, poliomyelitis, rabies,
haemorrhagic fevers (Ebola, Marbug, Yellow Fever, Rift Valley Fever, Craemian
Congo Haemorrhagic Fever), HIV/AIDS and its opportunistic infections
iv. Helminth parasitic infestation: intestinal worms (tape worms/taeniasis),
echinococcosis, dracunculiasis, onchocerciasis, schistosomiasis, lymphatic
filariasis, hook worm infestation, etc.

Page 8 of 11
Preparation for PSU Pre-Registration Exams 9

v. Protozoal parasitic infestations: malaria, leishmaniasis, human african


trypanosomiasis, etc.
vi. Clinical pharmacology of antimalarials, anticoagulants, thrombolytics,
antituberculous agents, antiretrovirals, colloids, crystalloids, and other pertinent
drugs.
J. Other conditions
i. Pain management: nociceptive pain, neuropathic pain, palliative care (hiccup,
anorexia, cachexia, pressure ulcers, etc.)
ii. Trauma: bites and stings (snakebites, insect bites and stings, animal and human
bites), fractures, burns, wounds, sexual assault/rape, head injuries
iii. Poisoning: general management of poisoning, organophosphate poisoning, paraffin
poisoning, alcohol (methanol and ethanol) poisoning, food poisoning, poisoning by
some drugs like warfarin, aspirin, paracetamol, barbiturates, opioids, NSAIDs,
metal poisoning (iron, mercury, lead, etc.), gas poisoning (carbonmonoxide), etc.
iv. Nutritional disorders: malnutrition, obesity, etc.
v. Eye conditions: conjunctivitis, stye, trachoma, keratitis, uveitis, orbital cellulitis,
postoperative endophthalmitis, xerophthalmia, cataract, glaucoma, refractive
errors, ocular tumours (retinoblastoma, squamous cell carcinoma of the
conjunctiva)
vi. Ear, Nose and Throat conditions: otitis externa, otitis media (suppurative, glue ear/
otitis media with effusion), mastoiditis, epistaxis, sinusitis, rhinitis, adenoid disease,
pharyngitis, tonsillitis, pharyngo-tonsillitis, peritonsillar abscess
vii. Skin conditions: bacterial infections (impetigo, boils-furuncle/carbuncle) viral
(herpes simplex, herpes zoster/shingles), fungal (tinea), parasitic (scabies,
pediculosis, tungiasis), inflammatory/allergic (acne, urticaria, eczema, psoriasis),
drug induced skin reactions (SJS, TEN, etc.)
viii. Oral dental conditions: halitosis, dentin hypersensitivity, malocclusion, fluorosis,
dental caries, pulpitis, dental abscess, gingivitis, periodontitis, stomatitis, aphthous
ulceration, periodontal abscess, oral candidiasis, herpes infections, hairy
leukoplakia, oral tumours (Burkitt’s lymphoma, Kaposi’s sarcoma)
ix. Musculoskeletal disorders: infections (pyogenic arthritis, osteomyelitis,
pyomyositis, TB of the spine/Pott’s disease), inflammatory/degenerative disorders
(rheumatoid arthritis, gout arthritis, osteoarthritis)
x. Surgical considerations: surgical antibiotic prophylaxis, anaethesia (general, local
and regional anaethesia), muscle relaxants

4. SUPPLY CHAIN PHARMACY PRACTICE


Supply chain practice is a lucrative field of the pharmacy profession which requires pharmacists
to possess knowledge and skills in management, business principles, economics, and various
aspects of the supply chain including procurement, warehousing practices, and regulatory aspects,
among many areas of focus. Notable employers in this practice include warehouses like National
Medical Store, Joint Medical Store, Distribution and Importation companies, hospitals, and other
pharmaceutical settings.

A. General Aspects
i. Definition of supply chain management
ii. Components of the supply management cycle

Page 9 of 11
Preparation for PSU Pre-Registration Exams 10

iii. Promotion of rational use of medicines e.g. NMS Act


iv. Regulatory provisions relating to supply chain management
v. Good distribution practices; principles and applications
vi. Concept of essential medicines, essential medicines and health supply list for
Uganda; barriers to access of essential medicines
vii. Medicine and Therapeutic Committee, roles and activities
viii. Pharmacovigilance
B. Supply chain management
i. Selection: selection criteria, development and application, managing tenders
ii. Procurement: procurement cycle, lead time, bidding, etc.
iii. Quantification: methods, advantages and disadvantages
iv. Ware housing: Good storage practices
v. Systems employed for pharmaceutical supply chain management
vi. Assessment of performance
C. Stock management
i. Definition of stock/inventory management
ii. Stock management systems: components, ordering, receiving and issuing,
dispensing, physical count, organising a store, etc.
iii. Documentation/ record keeping: Stock cards, stock books, etc.
iv. Consumption data: average monthly consumption, stock on hand, minimum stock
level, maximum stock level, quantity to order, etc.
v. Calculations involved in stock management
vi. Security concerns in management of pharmacy stores
vii. Management of expired and damaged commodities; how drugs expire, handling of
expired drugs, calculations involved

5. REGULATORY PHARMACY PRACTICE


Regulatory and legislative provisions influence the practice of all other fields of pharmacy and a
good understanding of the laws and regulations is indispensable for all pharmacists. National Drug
Authority is the main employer in this regard. However regulatory departments of pharmaceutical
companies such as manufacturers, distributors, and others require a pharmacist to understand both
national, local and international regulations on medicines and their uses.

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

Page 10 of 11
Preparation for PSU Pre-Registration Exams 11

ii. Pharmacy and Drugs Act


iii. Narcotic and Psychotropic Substance Control Act
iv. National Medical Stores Act

6. PROFESSIONAL PHARMACY PRACTICE


All pharmacists are expected to appreciate, apply and adhere to the professional, legal and ethical
issues related to practice of pharmacy in Uganda. This involves a clear understanding of the law
and code of ethics, especially as stipulated by the Pharmaceutical Society of Uganda.

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.

1. Council of the Pharmaceutical Society of Uganda, October 2017, Guide to Membership


Examination.
2. Makerere University College of Health Sciences, June 2011, Curriculum for the Bachelor
of Pharmacy Degree
3. Ministry of Health, 2016, Uganda Clinical Guidelines

Page 11 of 11

You might also like