Syllabus for SAPC professional examinations

The professional practice of the pharmacist is focused on the medicines that he/she handles and the outcomes of treatment with such medicines. Pharmacists must thus have knowledge in the aspects of preventative and promotive health care, ill health prevention, emergency care and the general well-being of the community, the economic, legal and logistic aspects relating to the acquisition, storage and distribution of medicines and be able to advise the public in this regard.

ln order for the pharmacist to provide or advise on the choice, initiation, maintenance and termination of various drug therapies for more general illnesses, he/she must have a basic knowledge of pharmaceutics, pharmaceutical chemistry, pharmacology and toxicology. Knowledge of the aspects of professional pharmacy practice will ensure that the principles of pharmaceutical care are upheld by the pharmacist in practice, namely, the attitudes, behaviors, commitments, concerns, ethics, functions, responsibilities and skills of the pharmacist in the provision of medicine therapy with the goal of achieving definite therapeutic outcomes towards the patient’s health and quality of life.

The essential areas of pharmacy practice covered in this section of guidelines are

                                     1. APPLIED PHARMACEUTICS AND PHARMACEUTICAL CHEMISTRY

                                      2. APPLIED PHARMACOLOGY AND TOXICOLOGY

                                       3. LAWS PERTAINING TO PHARMACY PRACTICE

                       4. APPLIED PROFESSIONAL PHARMACY PRACTICE & PHARMACY ADMINISTRATION

1.  APPLIED PHARMACEUTICS AND PHARMACEUTICAL CHEMISTRY:

The examination in applied pharmaceutics and pharmaceutical chemistry consists of two parts i.e. section based on pharmaceutics and a section based on pharmaceutical chemistry. Candidates are allowed for three (3) hours to complete the examination. The examination is in an open book format and consists multiple choice questions, although long questions may also be included where appropriate. Copies of examination papers may be purchased from Council.

APPLIED PHARMACEUTICS:

Selected references:

Pharmaceutics: The science of dosage form design. Aulton, M.E.(ed)., churchill Livingstone, London, 1988 (ISBN 0-443_03643_8)

Pharmaceutical Practice: collett, D.M. and Aulton, M.E. (eds)., churchill Livingstone, London, 1990 (ISBN 0_443-03644_6)

AIMS OF THE PROFESSIONAL EXAMINATION IN APPLIED PHARMACEUTICS (SYLLABUS)

 1 .     Basic principles of compounding and dispensing

The candidate must be able to perform and have an understanding of the following components of compounding and dispensing:

  

1.1            Calculations

                           Pharmaceutical calculations dealing with concentration, dilutions & titurations                                                                                                                                                                                                                                                                                                                                                                                                   .

1.2            Storage and Stability

·         Chemical kinetics and the role of accelerated stability testing;

·         The role of temperature, hydrolysis, solvolysis, photolysis, trace metal catalysis and hygroscopicity in drug and dosage form stability.

1.3             Containers and closures

·         The ideal requirements of a container or package;

·         Materials used to manufacture containers and closures;

·         Child resistant containers;

·         Unit dose packaging.

          2.   Pharmaceutical preparations

          

            The candidate must have a knowledge and understanding of the following pharmaceutical dosage forms:

2.1            Solutions

·         The rationale behind using solutions as an oral dosage form;

·         Aqueous and non-aqueous solution formulations;

·         Formulation additives;

·         Types of preparations ( oral and non-oral);

·         Stability of solutions;

·         Compounding and manufacturing of solutions;

·         Antiseptic and disinfectant solutions.

2.2            Suspensions

·         The physical properties of a well formulated suspension;

·         Pharmaceutical applications;

·         Formulation;

·         Stability testing;

·         Compounding and manufacture;

·         Materials used in suspensions;

2.3            Emulsions and creams

·         Emulsion types;

·         Formulation of emulsions, including emulsifying agents and other additives;

·         Stability and stability testing;

·         Compounding and manufacture;

·         Drug release from emulsions.

2.4            Ointments, pastes and gels

·         Formulation of dermatological preparations;

·         Microbial contamination and preservation;

·         Physicochemical criteria for dermatological preparations.

2.5            Suppositories and pessaries

·         Absorption of drugs from the rectum;

·         Formulation and compounding of suppositories;

·         Drug release from suppositories and pessaries;

·         Rectal formulations other than suppositories.

2.6            Powders and granules

·         Advantages and disadvantages of powdered and granulated products;

·         Types of dispensed preparations;

·         Preparations requiring further manipulation at the time of dispensing;

·         Formulation and compounding of powders and granules.

2.7            Tablets and capsules

·         Advantages of tablets and capsules;

·         Types of tablets and capsules;

·         Essential properties of tablets;

·         Influence of tableting method on formulation;

·         Tablet excipients;

·         Dispensing of tablets;

·         Sustained release preparations;

·         Raw materials for gelatin capsules;

·         Hard and soft gelatin capsules;

·         specific formulation requirements of other compressed dosage forms;

·         Bioavailability aspects of tablets and capsules.

2.8            Therapeutic aerosols

·         Definitions and uses of therapeutic aerosols;

·         Important physicochemical properties;

·         Deposition of aerosols in the human respiratory tract;

·         Design, formulation and generation of aerosols;

·         Testing of aerosols;

·         Drug absorption and clearance from the respiratory tract.

2.9            Sterile pharmaceutical preparations

The compounding and dispensing of sterile pharmaceutical preparations includes microbiology and preservation, sterilization and aseptic technique, parenterals, opthalmics, cytotoxics and radiopharmaceuitcals. The candidate should thus have an understanding of:

·         Sources and incidence of contamination;

·         Growth and multiplication of microorganisms in pharmaceutical preparations;

·         Consequences of contamination;

·         Control of microbial contamination;

·         Preservation of pharmaceutical preparations;

·         Microbial standards for pharmaceutical preparations;

·         Significance of sterility and sterilization protocols;

·         Methods of sterilization and sterility testing;

·         Sterilisation controls and good aseptic technique;

·         Routes and methods of parenteral drug administration;

·         Bioavailability of drugs from injections;

·         Formulation, preparation and sterilization of injections;

·         Closures, packaging and quality assurance of injections;

·         Methods of administration of intravenous infusions;

·         Infusion additives;

·         Formulation and preparation of ophthalmic products;

·         Dispensing of cytotoxic agents;

·         Therapeutic radiopharmaceuticals;

·         Formulation and facilities required for the preparation of radiopharmaceuticals;

·         Uses of radio-pharmaceuticals for diagnostic and therapeutic purposes.

2.10        Modified release drug delivery systems

·         Drug release requirements;

·         Types of modified release drug delivery systems;

·         Formulation methods to achieve modified drug release;

·         Advantages of using modified release drug therapy;

·         Limitations of modified release delivery systems.

               3.  Bio-pharmaceutics and pharmacokinetics.

The candidate must have an understanding of the bio-pharmaceutics and pharmacokinetics:

3.1            Absorption

·         Mechanisms of drug transport across the gastrointestinal-blood barrier;

·         Physiological factors influencing drug absorption from the gastrointestinal tract (GlT);

·         Physicochemical factors influencing drug absorption from the GIT;

·         Dosage form factors influencing drug absorption from the GlT.

3.2            Bioavailability

·         The concept of bioavailability;

·         The concept of bio-pharmaceutics;

·         Assessment of bioavailability;

·         Representation of bioavailability data;

·         Absolute and relative bioavailability;

·         Criteria for valid in vivo bioavailability testing.

·          

3.3            Practical pharmacokinetics

·         Concepts in pharmacokinetics;

·         Drug distribution.

·         Compartmental models of drug distribution;

·         Drug elimination;

·         Dosage regimens;

·         Pharmacokinetic influences on dosage regimen designs;

·         Factors affecting steady state plasma concentrations of a drug.

3.4            Therapeutic drug monitoring

·         Guidelines for therapeutic drug monitoring;

·         Sample collection;

·         Pharmacokinetic drug profiles;

·         Population pharmacokinetics;

·         lnfluence of disease states on pharmacokinetics.

APPLIED PHARMACEUTICAL CHEMISTRY (SYLLABUS)

selected references:

Principles of Medicinal Chemistry. 4'h Edition. Foye, W.O, Lemke, T.L. & Willams, D.A. Willams & Wilken Publishers, 1995 (ISBN-0683-0332309)

Other texts of similar content that will provide excellent background reading for candidates include:

Textbook of Organic, Medicinal and Pharmaceutical Chemistry. Delgado, J.N & Remers,W.A. (Eds)

LippincotlRaven, 1998 (ISBN 397-51583-9)

AnalyticalChemistry: Principles and Techniques., Hargis, L.G. Prentice Hall, NJ. 1997 

 The Organic chemistry of drug design and drug action, RB Silverman, Academic Press, lnc London,

1992

Burgers medical and drug discovery, 5th Edition, Wolff ME ed (ISBN 0471575607)

Other suitable texts on instrumental analysis and drug identification should also be consulted.

1.     The basic principles of organic pharmaceutical chemistry and structure-activity relationships that influence drug actions.

Candidates should have an understanding of:

·         The principles of organic chemistry, the structures of organic compounds and the reactions of organic functional groups in the synthesis of organic compounds of pharmaceutical importance and structure determination of unknown compounds;

·         Principles of quantitative and qualitative chemical analysis of substances of pharmaceutical importance;

·         Organic medicinal and pharmaceutical compounds with special emphasis on the correlation of structural, physico-chemical and chemical properties with biological activity, drug sources, mechanisms of drug action, drug design and selectivity, drug incompatibility and drug interactions;

·         Drug structures and structure-activity relationships, mechanisms of action and other factors that influence drug action within specific drug classes.

2.     General principles in molecular mechanisms of drug action

Candidates should have an understanding of:

·         The general principles of drug action and the pharmacological activities of drugs with the major focus on the molecular mechanisms of drug action.

      3.      Analysis of substances of pharmaceutical importance

      Candidates should be able to describe the application of physical methods used in the identification, separation and structure determination of organic compounds, such as:

       

•  Weight analysis
•  Volumetric analysis including neutralization, precipitation analysis & complexometry.
•  Mass spectroscopy.
•  Thin-layer, column, and gas-liquid chromatography
•  Infrared, ultraviolet, nuclear-magnetic resonance spectroscopy.

        

4. The actions of drugs in biochemical terms

Candidates should have a thorough understanding of, and be able to interpret the actions of drugs, where relevant, in biochemical terms, including:

·         The structures, functions and transformations occurring within living cells in terms of established chemical principles;

·         The structures and functions of biopolymers, nucleic acids and proteins;

·         The metabolism and regulation of cellular processes.

APPLIED PHARMACOLOGY AND TOXICOLOGY:

Selected references:

Pharmacology.  4^th  Edition. Rang, H.P., Dale, M.M.  & Ritter, J.M., (2000). Churchill Livingstone, Edinburgh. ( ISBN 0443 059748 or 0443 059942)

Other texts of similar content that will provide useful background reading for candidates include:

A Textbook of Clinical Pharmacology, 5^th Edition. Ritter, J.M., Lewis, L.D. & Mant, T.G.K. (1999) Arnold, London. ( ISBN 0-340-705930)

Basic and clinical Pharmacology. 7th Edition. Katzung, B.G., Appelton & Lange, Norwalk, Connecticut, (lSB N 0-83S5-0538-4).

Pharmacology. 2nd Edition. Mycek, M.J., Harvey, R.A., & champe, p.c., (part of Lippincott's lllustrated Review series), Lippincott-Raven, phitadetphia. ( tsBN 0- 397-51567_79)

Pharmacotherapy: A Pathophysiologic Approach. 3'd Edition. Dipro, R.L., Talbert, p.E., yee, G.c., Matzke, G.R., Posey, L.M., Appelton & Lange, Norwatk, connecticut, (tsBN 0-8385_7926_0)

South African Medicines Formulary. sth Edition. Gibbon, C.J. (2000). Health & Medical publishing Group of the South African Medicat Association. (tsBN 0-g75098-31-3)

AIMS OF THE PROFESSIONAL EXAMINATION IN APPLIED PHARMACOLOGY AND TOXICOLOGY (SYLLABUS)

1.     Basic principles of pharmacology and toxicology

Candidates should have an understanding of:

·         The underlying principles of pharmacology and toxicology;

·         Pharmacodynamics;

·         Pharmacokinetics;

·         Drug metabolism;

·         Drug evaluation;

·         Drug interactions.

2.    Actions of drugs on various body systems

Candidates should have a thorough knowledge of the pharmacological classification of drugs and the actions of these drugs on body systems including:

·         Autonomic drugs;

·         Cardiovascular drugs;

·         Drugs with important actions on smooth muscle;

·         Drugs that act on the central nervous system;

·         Drugs with important actions on blood, inflammation and gout;

·         Endocrine drugs;

3.    Specialized drug actions including chemotherapeutic drugs

Candidates must have a sound knowledge and understanding of the effects of specialized drug actions including:

·         The principles of antimicrobial drug actions;

·         Antimicrobial therapy, modes of action and therapeutic indications;

·         Anti-fungal agents;

·         Antiviral chemotherapy and prophylaxis;

·         Drugs with limited indications;

·         Urinary antiseptics, disinfectants and other antiseptics;

·         Anti-parasitic, anti-protozoal and anti-helmintic drugs;

·         Cancer chemotherapy;

·         lmmuno-pharmacology.

4.    Vaccines and other biological products

Candidates should have an understanding of:

·         Vaccines and immune globulins;

·         Other complex biologic products.

5.    Toxic effects of drugs prescribed for use by the patient

Candidates must have a thorough knowledge of the toxicology of drug therapy to enable successful pharmacist intervention in appropriate situations in pharmacy practice:

·         Basic principles of toxicology;

·         Chelators and heavy metals;

·         Management of the poisoned patient.

LAWS PERTAINING TO PHARMACY PRACTICE

Selective references:

The pharmacist is required to be cognizant of all legislation relating to pharmacy practice including the Pharmacy Act, 1974 (Act 53 of 1974) as amended, the Medicines and Related Substances Control Act, 1965 (Act 101 of 1965) and other relevant acts. A compendium of laws has been prescribed as the principal reference for the Test in the laws pertaining to pharmacy practice:

PSSA Compendium of Laws and Regulations Relating to Pharmacy Volume 1,2A01 published by Butterworths. The compendium is available from Butterworths Publishers at Tel: 031 - 268 3007 (Customer Services) or Toll free number 0800 00 4493, Butterworths Publishers, P O Box 4, MAYVILLE, 4058, e-mail address: contact@butterworths.co.za,

Pharmacy Amendment Act, 1997 (Act 88 of 1997). Government Gazette No 18525, 12 December'1 997;

AIMS OF THE PROFESSIONAL EXAMINATION IN THE LAWS PERTAINING TO PHARMACY PRACTICE (SYLLABUS)

The candidate must have a thorough knowledge and understanding of the following enactments and regulations thereto:

                 .         Pharmacy Act, 1974 (Act 53 of 1974) as amended, including the "Ethical Rules";

          ·         Medicines and Related Substances control Act, 1965 (Act 101 of 1965);

          ·         Hazardous Substances Act, 1973 (Act 15 of 1973);

          ·         Relevant extracts of the Liquor Act, 'l 989 (Act 27 of 1989);

          ·         Relevant extracts of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972);

          ·         Relevant extracts of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock                         Remedies Act, 1947 (Act 36 of 1947);

         

          ·         Relevant extracts of the Health Professions Act, 1974 (Act 56 of 1974) as amended;

          ·         Relevant extracts of the Nursing Act, 1978 (Act 50 of 1978) as amended.

     

APPLIED PROFESSIONAL PHARMACY PRACTICE AND      PHARMACY ADMINISTRATION

Selected references:

lntroduction to Business Management, 5th Edition., Cronje, du Toit & Motlatla

Communication Skills in Pharmacy Practice, 3'o Edition., Tindall, W.N. , Beardsley, R.S & Kimberlain, C.L. Lea & Febiger, Philadelphia,1994

AIMS OF THE PROFESSIONAL EXAMINATION IN PHARMACY ADMINISTRATION (SYLLABUS)

        1.    General management principles

The candidate must have an understanding of the following components of basic management principles:

         

     ·         Basics of business management;

     ·         Planning, implementing and managing operational plans and projects;

     ·         leadership and teamwork in the management process;

     ·         Control and planning in the management process cycle;

     ·         Management principles involved in the procurement, storage and distribution of medicines

     ·         And other pharmaceutical products;

     ·         Basic principles in record keeping, statistical methodologies and research methods to ensure optimum medicine supplies to the patient and/or community.

  

       2.    The functional management of an organization.

The candidate must have an understanding of the following components of functional management principles:

 ·         Basics of marketing management including marketing concepts and objectives;

·         Managerial tasks in marketing management including planning, organizing, providing                                     leadership and controlling marketing efforts;

·         Marketing strategies including the environment, target markets, utilizing marketing information and marketing instruments in marketing strategies.

      3.    Financial management relating to pharmacy practice

The candidate must have an understanding of the following components of financial management principles:

·         Nature and meaning of financial management including environmental factors that influence financial management;

·         Basic concepts and techniques in financial management including financial analysis and ratios, planning and control;

·         Concepts of assets, liabilities, debtor control and stock control;

·         Short and long term financing of stock and other assets;

·         Management of assets and the principles and implementation of budgeting techniques;

·         Financial implications of procurement, storage and distribution of medicines.

     4.    Human resource management

Candidates are required to have a thorough knowledge and understanding of human resource management and human resource utilization:

·         Key concepts of human resource management function;

·         Human resource management functions within the pharmacy including human resource

·         Recruitment, maintenance, activities and utilization;

·         Basic principles in training and development of human resources;

  

·         Managing workplace performance of pharmacy personnel.

      5.    Communication

Candidates must have an understanding of:

·         Basic principles in communication and the provision of information;

·         Communication techniques, including the ability to apply technological advances in communication in the procurement and distribution of medicines;

  

·         Effective communication techniques between colleagues, other health care professionals and patients.

PROFESSIONAL PHARMACY PRACTICE

Selected references

.      South African Medicines Formulary. 4th Edition. Medical Association of South Africa in cooperation with the Pharmaceutical Society of South Africa;

.      MIMS  Medical Specialties. Recent Edition, MIMS publishers, Pretoria

.       MIMS Desk Reference (MDR). Recent Edition, MIMS publishers, pretoria.;

·  The Merck Manual of Diagnosis and rherapy. 16th Edition. Merck & co. lnc. Rathway.

·  MIMS  Self-medication Guide. Recent Edition, MIMS publishers, pretoria;

· Handbook  of Nonprescription Drugs. 1Oth Edition. American Pharmaceutical Association, Washington,D.C.;

· Martindale. The Extra Pharmacopoeia. 32nd Edition, The Pharmaceutical Press. London;

· Daily Drug Use. Talmud, J., 6th Edition. Tincture Press. Cape Town;

· Pharmacy Practice. Greeff, O.B.W., Pharmaceutical Society of South Africa, Braamfontein;

· Pharmacist lnitiated Therapy, 1993. Dekker, A., Dreyer,A., Smit, R. Juta publishers. Cape Town

· English/Afrikaans Dictionary.

· Other texts of similar content include Minor Illness or Major Disease C. Edwards and , C. Symptoms in Pharmacy, by A. Blenkinsop.

AIMS OF THE PROFESSIONAL EXAMINATION IN PROFESSTONAL PHARMACY PRACTICE (SYLLABUS)

1.    Dispense and ensure the optimal use of medicines prescribed to the patient

The candidate must have a thorough knowledge and understanding of the following aspects of dispensing and the provision of medicines to a patient or caregiver including, inter alia:

·         Prescription reading;

·         Pharmacist medication reviews and intervention;

·         Labeling and dispensing of medicines;

·         Calculation of doses for adults, children and infants;

·         . Providing emergency supplies of medicines;

2.    Safe, rational and appropriate use of medicines

The candidate must have a thorough knowledge of medicines and the effects of medicines to ensure the optimal use of medicines by the patient including, inter alia:

·         Drug interactions;

·         Side-effects of prescribed medicines;

·         Effects of polypharmacy in medicine therapy;

·         Correct use and storage of prescribed medicines;

·         Medicines used during pregnancy and breast-feeding;

·         Medicines used in young children and the elderly.

3.    Health care education and information

The candidate must have a thorough knowledge of the actions and effects of medicines in health care to provide information and ensure the optimal use of medicines by the patient including, inter alia:

·          lnformation on the correct storage and supply of drugs, medicines and chemicals;

·          Appropriate drug therapy for individual patients;

·          Correct use of prescribed and non-prescribed medicines;

·          Drug interactions and side-effects of drugs;

·          Use of medicines during pregnancy, breast-feeding and the aged;

·          Advice on the use of therapeutic goods and appliances;

·         Counselling and educating patients on the promotion of good health and reduction of incidence of illness;

·         Non-drug management, including no treatment and/or referral to other health care professionals;

·         Maintaining healthy lifestyles and disease prophylaxis.

4.    Essential clinical services including screening and referral services

The candidate must have a thorough knowledge and understanding of the aspects of treatment, referral, screening and education in primary health care and public health campaigns including, inter alia:

·         Blood pressure testing;

·         Cholesterol screening tests;

.         Diabetes and blood glucose screening tests;

·         Pregnancy testing;

.         Urine analysis, where appropriate;

·         First aid measures, where appropriate

5.    Principles of pharmaceutical care

       The candidate must have an understanding of the aspects of the outcomes of therapy and the design, implementation and monitoring of pharmaceutical plans including inter alia:

·         Promoting and contributing to rational drug use;

·         Designing, implementing and participating in pharmaceutical care plans in drug therapy

.         Selection and drug usage;

·         Monitoring and assessing the drug therapy of patients;

  

·         Evaluating drug usage and optimizing health outcomes;

·         Providing drug information to patients, caregivers and other health care professionals to ensure the optional use of medicines;

·         Participating in therapeutic and drug utilization review committees.