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Questions and Answers
What is the maximum number of Diclofenac tablets that can be dispensed by a pharmacist without a prescription?
What is the maximum number of Diclofenac tablets that can be dispensed by a pharmacist without a prescription?
Which drug requires a prescription when used for more than 3 days?
Which drug requires a prescription when used for more than 3 days?
Under which schedule are antipsychotic medications categorized?
Under which schedule are antipsychotic medications categorized?
What is the dispensing limitation for omeprazole when sold over the counter?
What is the dispensing limitation for omeprazole when sold over the counter?
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Acyclovir can be classified into different schedules based on its form. What is the schedule for acyclovir cream?
Acyclovir can be classified into different schedules based on its form. What is the schedule for acyclovir cream?
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What factors influence the schedule classification of a medication?
What factors influence the schedule classification of a medication?
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In which schedule would Acyclovir be classified when used as a tablet for systemic treatment?
In which schedule would Acyclovir be classified when used as a tablet for systemic treatment?
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Which of the following medications is classified as Schedule 0?
Which of the following medications is classified as Schedule 0?
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What schedule classification requires medications to be sold behind the counter by registered pharmacy personnel?
What schedule classification requires medications to be sold behind the counter by registered pharmacy personnel?
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What is a possible reason for a medication's classification to be higher in risk?
What is a possible reason for a medication's classification to be higher in risk?
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Which schedule allows for cold and flu preparations to be available over the counter without a prescription?
Which schedule allows for cold and flu preparations to be available over the counter without a prescription?
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Which of the following statements is true regarding the scheduling of medicines?
Which of the following statements is true regarding the scheduling of medicines?
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What is a characteristic feature of Schedule 1 medications?
What is a characteristic feature of Schedule 1 medications?
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What is the primary role of the South African Health Products Regulatory Authority (SAHPRA)?
What is the primary role of the South African Health Products Regulatory Authority (SAHPRA)?
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What must be true for a medicine to be sold in South Africa?
What must be true for a medicine to be sold in South Africa?
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What does the scheduling of medicines primarily indicate?
What does the scheduling of medicines primarily indicate?
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Which act outlines SAHPRA's mandate?
Which act outlines SAHPRA's mandate?
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What is a characteristic of prescription drugs?
What is a characteristic of prescription drugs?
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What was the former name of SAHPRA before it was changed in 2017?
What was the former name of SAHPRA before it was changed in 2017?
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Which of the following schedules is NOT part of the classification system for medicines?
Which of the following schedules is NOT part of the classification system for medicines?
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What is a key requirement to issue a prescription in South Africa?
What is a key requirement to issue a prescription in South Africa?
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What information is required regarding the prescriber on a prescription?
What information is required regarding the prescriber on a prescription?
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Which detail is NOT typically required for patient information on a prescription?
Which detail is NOT typically required for patient information on a prescription?
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What is the best practice regarding the name of the medication on a prescription?
What is the best practice regarding the name of the medication on a prescription?
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What additional information must be provided in a Schedule 6 prescription compared to a regular prescription?
What additional information must be provided in a Schedule 6 prescription compared to a regular prescription?
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Which of the following details about medication dosage is required on a prescription?
Which of the following details about medication dosage is required on a prescription?
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When prescribing medication for children, which additional detail is recommended but not legally required?
When prescribing medication for children, which additional detail is recommended but not legally required?
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What specific format must the dosing frequency for Schedule 6 medication clearly state?
What specific format must the dosing frequency for Schedule 6 medication clearly state?
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Which of the following is a component of the medication details on a prescription?
Which of the following is a component of the medication details on a prescription?
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How many total prescriptions can a patient receive from an original prescription under Schedule 0-5?
How many total prescriptions can a patient receive from an original prescription under Schedule 0-5?
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What does 'Stat dose' signify on a prescription?
What does 'Stat dose' signify on a prescription?
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What must a patient do to continue receiving medication under Schedule 6?
What must a patient do to continue receiving medication under Schedule 6?
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Which abbreviation means 'as required' on a prescription?
Which abbreviation means 'as required' on a prescription?
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Which of the following timing abbreviations indicates medication should be taken every eight hours?
Which of the following timing abbreviations indicates medication should be taken every eight hours?
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What does 'Nocte' mean in prescription terminology?
What does 'Nocte' mean in prescription terminology?
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Which of the following is NOT a current abbreviation used for oral medication delivery?
Which of the following is NOT a current abbreviation used for oral medication delivery?
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If a patient collected their medication under a 6-month repeat prescription only twice, what happens after the 6 months?
If a patient collected their medication under a 6-month repeat prescription only twice, what happens after the 6 months?
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What is the maximum duration for which NSAIDs can be sold over the counter as Schedule 2 medications?
What is the maximum duration for which NSAIDs can be sold over the counter as Schedule 2 medications?
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Which medication listed requires a prescription for prolonged use beyond the specified maximum?
Which medication listed requires a prescription for prolonged use beyond the specified maximum?
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What schedule classification applies to medications prescribed for chronic conditions?
What schedule classification applies to medications prescribed for chronic conditions?
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Under which conditions should PPIs like omeprazole be dispensed over the counter?
Under which conditions should PPIs like omeprazole be dispensed over the counter?
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What is the schedule classification for antimicrobial medications such as antibacterials?
What is the schedule classification for antimicrobial medications such as antibacterials?
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What is a factor that affects the scheduling of a medicine?
What is a factor that affects the scheduling of a medicine?
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Which schedule classification allows certain antibacterial creams to be purchased without a prescription?
Which schedule classification allows certain antibacterial creams to be purchased without a prescription?
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Acyclovir is classified differently depending on its formulation. In what form is Acyclovir classified as Schedule 4?
Acyclovir is classified differently depending on its formulation. In what form is Acyclovir classified as Schedule 4?
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Which statement is true regarding the sale of medications classified under Schedule 1?
Which statement is true regarding the sale of medications classified under Schedule 1?
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What could potentially increase a medicine's schedule classification?
What could potentially increase a medicine's schedule classification?
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Which medication is classified as Schedule 2 when sold in specific formulations?
Which medication is classified as Schedule 2 when sold in specific formulations?
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What may influence the classification between Schedule 2 and Schedule 3 for certain drugs?
What may influence the classification between Schedule 2 and Schedule 3 for certain drugs?
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Which of the following medications could be categorized as Schedule 0?
Which of the following medications could be categorized as Schedule 0?
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What is the total duration a prescription can be repeated under Schedule 0-5?
What is the total duration a prescription can be repeated under Schedule 0-5?
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What is required for a prescription under Schedule 6 after the initial supply?
What is required for a prescription under Schedule 6 after the initial supply?
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Which of the following correctly interprets the abbreviation 'prn' on a prescription?
Which of the following correctly interprets the abbreviation 'prn' on a prescription?
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What does the abbreviation 'Mane' indicate regarding medication timing?
What does the abbreviation 'Mane' indicate regarding medication timing?
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If a patient collects only two prescriptions from a series of six months under Schedule 0-5, what happens after the six months?
If a patient collects only two prescriptions from a series of six months under Schedule 0-5, what happens after the six months?
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Which abbreviation indicates medication should be taken every eight hours?
Which abbreviation indicates medication should be taken every eight hours?
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What does 'q.i.d.' signify in terms of medication frequency?
What does 'q.i.d.' signify in terms of medication frequency?
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Which term indicates the method of medication delivery 'via the rectum'?
Which term indicates the method of medication delivery 'via the rectum'?
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What is the primary purpose of scheduling medicines in South Africa?
What is the primary purpose of scheduling medicines in South Africa?
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Which act governs the registration of medicines in South Africa?
Which act governs the registration of medicines in South Africa?
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What is a characteristic of prescription drugs?
What is a characteristic of prescription drugs?
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Which requirement must be met to issue a prescription in South Africa?
Which requirement must be met to issue a prescription in South Africa?
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How does SAHPRA ensure the safety of drugs sold in South Africa?
How does SAHPRA ensure the safety of drugs sold in South Africa?
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What is the significance of a medicine's schedule classification?
What is the significance of a medicine's schedule classification?
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What was the former name of the South African Health Products Regulatory Authority (SAHPRA)?
What was the former name of the South African Health Products Regulatory Authority (SAHPRA)?
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What is one of the roles of SAHPRA in relation to clinical trials?
What is one of the roles of SAHPRA in relation to clinical trials?
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What characterizes a Schedule 6 prescription?
What characterizes a Schedule 6 prescription?
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Which statement about electronic prescriptions is true?
Which statement about electronic prescriptions is true?
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What must be included on a prescription according to Regulation 33?
What must be included on a prescription according to Regulation 33?
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What is the primary role of an authorized prescriber?
What is the primary role of an authorized prescriber?
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Under what conditions can Schedule 7 items be obtained?
Under what conditions can Schedule 7 items be obtained?
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What is a requirement for the format of dosing frequency in a Schedule 6 prescription?
What is a requirement for the format of dosing frequency in a Schedule 6 prescription?
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Why is an advanced electronic signature required for electronic prescriptions?
Why is an advanced electronic signature required for electronic prescriptions?
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Which detail is NOT essential for the prescription to be valid?
Which detail is NOT essential for the prescription to be valid?
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What neurotransmitter is released by adrenergic neurons?
What neurotransmitter is released by adrenergic neurons?
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Which type of receptor responds to the binding of acetylcholine?
Which type of receptor responds to the binding of acetylcholine?
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What is the primary classification of neurons that release acetylcholine?
What is the primary classification of neurons that release acetylcholine?
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What are the two main types of receptors for acetylcholine?
What are the two main types of receptors for acetylcholine?
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Which receptor type is activated by noradrenaline?
Which receptor type is activated by noradrenaline?
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What is the primary function of the sympathetic nervous system during a threat?
What is the primary function of the sympathetic nervous system during a threat?
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Which of the following describes the primary role of the parasympathetic nervous system?
Which of the following describes the primary role of the parasympathetic nervous system?
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How do sympathetic neurons affect parasympathetic neurons?
How do sympathetic neurons affect parasympathetic neurons?
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Which of the following is NOT a characteristic of the sympathetic nervous system?
Which of the following is NOT a characteristic of the sympathetic nervous system?
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What physiological effect is primarily caused by the activation of the parasympathetic nervous system?
What physiological effect is primarily caused by the activation of the parasympathetic nervous system?
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Which neurotransmitter is primarily associated with the sympathetic nervous system?
Which neurotransmitter is primarily associated with the sympathetic nervous system?
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In which situation would the parasympathetic nervous system be most active?
In which situation would the parasympathetic nervous system be most active?
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What type of muscle contraction is primarily stimulated by parasympathetic activity?
What type of muscle contraction is primarily stimulated by parasympathetic activity?
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What type of receptors are nicotinic receptors?
What type of receptors are nicotinic receptors?
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Which G-protein is associated with M2 and M4 muscarinic receptors?
Which G-protein is associated with M2 and M4 muscarinic receptors?
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What is the primary function of M1, M3, and M5 muscarinic receptors?
What is the primary function of M1, M3, and M5 muscarinic receptors?
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Which signaling pathway does activation of M1 receptors primarily involve?
Which signaling pathway does activation of M1 receptors primarily involve?
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Where are nicotinic receptors that are responsible for muscle action found?
Where are nicotinic receptors that are responsible for muscle action found?
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What is the primary role of the sympathetic division within the autonomic nervous system?
What is the primary role of the sympathetic division within the autonomic nervous system?
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What happens to vascular endothelial cells when muscarinic receptors are stimulated?
What happens to vascular endothelial cells when muscarinic receptors are stimulated?
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Which neurotransmitter is primarily released by parasympathetic postganglionic neurons?
Which neurotransmitter is primarily released by parasympathetic postganglionic neurons?
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What type of ion channels are opened as a result of M2 receptor activation?
What type of ion channels are opened as a result of M2 receptor activation?
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Which second messenger is associated with the activation of phospholipase C by M1 receptors?
Which second messenger is associated with the activation of phospholipase C by M1 receptors?
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How do the sympathetic and parasympathetic systems function in relation to each other?
How do the sympathetic and parasympathetic systems function in relation to each other?
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Which type of receptors does acetylcholine bind to in the effector organs supplied by the parasympathetic division?
Which type of receptors does acetylcholine bind to in the effector organs supplied by the parasympathetic division?
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What effect does the sympathetic nervous system typically have on heart rate?
What effect does the sympathetic nervous system typically have on heart rate?
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In what manner can the activities of the autonomic nervous system divisions impact organ function?
In what manner can the activities of the autonomic nervous system divisions impact organ function?
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What is released by sympathetic postganglionic neurons and what is its primary action?
What is released by sympathetic postganglionic neurons and what is its primary action?
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What is the effect of parasympathetic stimulation on digestive organs?
What is the effect of parasympathetic stimulation on digestive organs?
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What type of receptors are activated by ACh in somatic nerves at the motor end plate?
What type of receptors are activated by ACh in somatic nerves at the motor end plate?
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Which neurotransmitter is primarily released by postganglionic sympathetic nerves?
Which neurotransmitter is primarily released by postganglionic sympathetic nerves?
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In which system does ACh act as a dominant neurotransmitter released by postganglionic nerves?
In which system does ACh act as a dominant neurotransmitter released by postganglionic nerves?
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Where are the ganglia in the parasympathetic system typically located?
Where are the ganglia in the parasympathetic system typically located?
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How do sympathetic and parasympathetic systems impact the enteric nervous system (ENS)?
How do sympathetic and parasympathetic systems impact the enteric nervous system (ENS)?
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What type of receptor does ACh act on in adrenal medulla cells?
What type of receptor does ACh act on in adrenal medulla cells?
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Which component is NOT part of the enteric nervous system (ENS)?
Which component is NOT part of the enteric nervous system (ENS)?
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What characterizes the synaptic organization of autonomic nerves compared to somatic nerves?
What characterizes the synaptic organization of autonomic nerves compared to somatic nerves?
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Study Notes
South African Health Products Regulatory Authority (SAHPRA)
- SAHPRA previously known as Medicines Control Council (MCC)
- Regulates all health products including clinical trials, complementary medicines, medical devices and in vitro diagnostics
- Mandated by Medicines and Related Substances Act (Act No 101 of 1965 as amended) and Hazardous Substances Act (Act No 15 of 1973)
- All medicine sold in South Africa must be registered with SAHPRA
Scheduling of Medicines
- Classified into schedules 0, 1, 2, 3, 4, 5, 6 based on risk and benefit of drug use.
- Higher schedule number indicates higher risk
- Schedule based on safety, toxicity, need for professional diagnosis and management, potential for dependency or abuse
- Some drugs can fall into multiple schedules depending on the dosage form and quantity e.g. Acyclovir
- Schedule 0 medications can be purchased in general stores or pharmacies without prescription e.g., aspirin, paracetamol
- Schedule 1 medications can be purchased over the counter at a pharmacy without a prescription. It must be kept behind the counter and sold by registered pharmacy personnel e.g. various cold and flu preparations and NSAIDs
- Schedule 2 medications can be purchased over the counter at a pharmacy without a prescription. Usually limited to a 3-day course e.g. various cold and flu preparations and NSAIDs, PPIs (max 14 days)
- Schedule 3 medications require a prescription and can be collected from a pharmacy dispensary e.g. medication for chronic conditions, longer term use of NSAIDs, PPIs
- Schedule 4 medications require a prescription and can be collected from a pharmacy dispensary e.g. antimicrobials such as antibacterials and antifungals
- Schedule 5 medications require a prescription and can be collected from a pharmacy dispensary e.g. psycho-active drugs such as antidepressants, sedatives, antipsychotics
- Schedule 6 medications require a prescription and can be collected from a pharmacy dispensary e.g. narcotic analgesics
Prescription Requirements
- Prescriber details include name, qualification, registration number with relevant statutory health council, and physical address
- Patient details include name, ID number, age, gender, address, and body mass (for children)
- Medication details include generic name or trade name, dosage form, strength, quantity to be supplied, and administration/frequency instructions
- Schedule 6 prescriptions require quantity to be written out in figures and words (e.g., thirty tablets (30))
- Schedule 6 prescription maximum supply duration is 30 days
Prescription Repeat
- Schedule 0-5: May be repeated up to 6 months (original prescription + 5 repeats), prescription expires after 6 months regardless of how many times it has been collected
- Schedule 6: No repeat prescriptions allowed, patient must obtain a new prescription every month
Abbreviations
- Stat dose: single dose to be given immediately e.g. 10mg Adrenaline IV stat
- Mane: in the morning, Nocte: in the evening - now specify time exactly
- Daily: daily or e.g. 8 am, noon, 6 pm, midnight
- Twice daily: 12 hourly or 12 hrly
- Three times a day: 8 hourly or 8 hrly
- Four times a day: 6 hourly
- As required: as required for....(pain/ nausea) etc.
- Oral: per os or p.o.
- Intramuscular: IM or IMI
- Intravenous: IV or IVI
- Subcutaneous: Subcut or S.C.
- Rectal: per rectum or P.R.
- Vaginal: per vagina or P.V.
- Via nasogastric tube: Vis N.G.T.
South African Health Products Regulatory Authority (SAHPRA)
- SAHPRA regulates all South African health products including clinical trials, complementary medicines, medical devices and in vitro diagnostics
- Previously known as the Medicines Control Council (MCC)
- Mandate outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) and the Hazardous Substances Act (Act No 15 of 1973)
- No medicine can be sold in South Africa without SAHPRA registration
Scheduling of Medicines
- Medicine scheduling classifies medication based on risk
- Schedule classification considers:
- Medicine's safety and toxicity
- Indication for use
- Need for professional diagnosis and management
- Potential for dependency or abuse
- Certain medications can be classified in more than one schedule depending on formulation and use.
Medicine Schedules -
- Schedule 0 - Simple analgesics (e.g., Aspirin, Paracetamol) - Available in general stores or pharmacies without a prescription
- Schedule 1 - Certain antibacterial and antifungal skin creams - Available over the counter at a pharmacy without a prescription
- Schedule 2 - Various cold and flu preparations - Available over the counter at a pharmacy without a prescription
- Schedule 3 - Medication for chronic conditions (e.g., blood pressure, diabetes); longer term use of NSAIDs and PPIs - Available in a pharmacy dispensary on prescription only
- Schedule 4 - Antimicrobials such as antibacterials and antifungals - Available in a pharmacy dispensary on prescription only
- Schedule 5 - Psycho-active drugs (e.g. antidepressants, sedatives, antipsychotics) - Available in a pharmacy dispensary on prescription only
- Schedule 6 - Narcotic analgesics (e.g. morphine), stimulants such as methylphenidate (Ritalin®) - Available in a pharmacy dispensary on prescription only for a maximum of 30-day supply
- Schedule 7 - Prohibited items used in scientific studies (e.g., Heroin) due to high abuse potential - Available with a permit from the Director-General only
- Schedule 8 - Amphetamine, dexamphetamine and nabilone - Available with a permit from the Director-General only
Prescription Writing
- A prescription is an order from an authorised prescriber for a drug to be dispensed to a patient
- Prescription can only be prepared by an authorised prescriber (e.g. medical practitioner)
- Must be written legibly in print, handwritten, or typed, or prepared electronically
- Must be signed in person or with an advanced electronic signature
- Must include the date of issue
- Electronic prescriptions are permissible provided that they have an advanced electronic signature
Prescription Content
- The quantity of medication prescribed should not exceed a 30-day supply.
Repeat Prescriptions
-
Schedules 0-5: Prescriptions may be repeated up to a maximum of 6 months
- I.e. The original prescription + 5 repeats
- Prescription expires after 6 months regardless of how many times it was filled
-
Schedule 6: Repeat prescriptions are not allowed
- Patient must obtain a new prescription every month
Abbreviations on Prescriptions
- Abbreviations originated from Latin terms used for dispensing
-
Terms used historically:
- Stat dose: Single dose to be given immediately (e.g., 10mg Adrenaline IV stat)
-
Mane: In the morning; Nocte: In the evening
- Now specify the time exactly
- Daily: abbreviated to dly, /day, d; now use the term daily and when e.g. 8 am, noon, 6 pm, midnight
- Twice daily: bd, bid; now use the term 12 hourly or 12 hrly
- Three times a day: tds, tid; now use the term 8 hourly or 8 hrly
- Four times a day: qid; now use the term 6 hourly
- As required: prn; now write "as required for…" (pain/nausea) etc.
Terms for delivery of medication:
- Oral – per os or p.o.
- Intramuscular – IM or IMI
- Intravenous – IV or IVI
- Subcutaneous – Subcut or S.C.
- Rectal – per rectum or P.R.
- Vaginal – per vagina or P.V.
- Via Nasogastric tube – Vis N.G.T.
Cholinergic Receptors
- There are two main types of cholinergic receptors: nicotinic and muscarinic
- Nicotinic receptors are ligand-gated ion channels
- Nicotinic receptors are found at the neuromuscular junction (Nm), and in nerve tissue (Nn)
- Muscarinic receptors are G-protein coupled receptors
- There are five subtypes of muscarinic receptors (M1-M5), each found in distinct locations
- M1, M3, and M5 receptors are coupled to Gαq proteins, which activate phospholipase C
- Activation of phospholipase C leads to the production of diacylglycerol (DAG) and inositol triphosphate (IP3)
- DAG activates protein kinase C, which can lead to smooth muscle contraction
- IP3 causes the release of calcium from intracellular stores, which can also lead to smooth muscle contraction
- IP3 can also stimulate the release of nitric oxide (NO) from vascular endothelial cells, which leads to vasodilation
- M2 and M4 receptors are coupled to Gαi proteins, which inhibit adenylyl cyclase
- Gαi proteins are guanine nucleotide-binding proteins
- Inhibition of adenylyl cyclase leads to a decrease in cyclic AMP (cAMP) levels
- This leads to the opening of potassium channels and the inhibition of sodium/potassium channels
Divisions of the Nervous System
- The nervous system can be divided into the central nervous system (CNS) and the peripheral nervous system (PNS)
- The CNS consists of the brain and spinal cord
- The PNS consists of all the nerves that connect the CNS to the rest of the body
- The PNS can be further divided into the somatic nervous system and the autonomic nervous system (ANS)
- The somatic nervous system controls voluntary movements
- The ANS controls involuntary functions
- The ANS can be further divided into the sympathetic nervous system and the parasympathetic nervous system
- The sympathetic nervous system is responsible for the "fight or flight" response
- The parasympathetic nervous system is responsible for the "rest and digest" response
- The sympathetic and parasympathetic nervous systems often have opposing effects on the same organ systems
- This is because the two systems are tonically active, meaning that they are always active to some degree
- As a result, antagonism of one system results in enhanced activity of the other
Organ System Effects of the ANS
-
The sympathetic nervous system has the following effects on organ systems
- Increases heart rate and contractility
- Dilates pupils
- Relaxes bronchioles
- Decreases gut motility and secretion
- Relaxes bladder
- Stimulates sweating
- Stimulates glycogenolysis and lipolysis
-
The parasympathetic nervous system has the following effects on organ systems
- Decreases heart rate and contractility
- Constricts pupils
- Constricts bronchioles
- Increases gut motility and secretion
- Contracts bladder
- Stimulates saliva production
### Structure of the Autonomic Efferent Pathway
- All preganglionic neurons leaving the CNS release acetylcholine (ACh), which binds to nicotinic (Nn) receptors on postganglionic neurons
- Parasympathetic postganglionic neurons release ACh, which binds to muscarinic (M) receptors on the effector organ
- Sympathetic postganglionic neurons release noradrenaline (NA), which binds to α or β receptors on the effector organ
Enteric Nervous System
- The enteric nervous system (ENS) is a network of nerves located in the gut wall that regulates digestion
- The ENS can function independently of the CNS
- The ENS is innervated by the sympathetic and parasympathetic nervous systems, which can influence its activity
- Parasympathetic stimulation typically activates the ENS
- Sympathetic stimulation typically inhibits the ENS
Neurotransmitters in the ANS
- The two main neurotransmitters of the ANS are acetylcholine (ACh) and noradrenaline (NA)
- ACh is released by preganglionic neurons of both the sympathetic and parasympathetic nervous systems
- ACh is also released by postganglionic neurons of the parasympathetic nervous system
- NA is released by postganglionic neurons of the sympathetic nervous system
Classification of Autonomic Receptors
- Autonomic receptors can be classified based on the neurotransmitter that they bind to
- Cholinergic receptors bind to ACh
- Adrenergic receptors bind to NA or adrenaline
- There are two main types of cholinergic receptors: nicotinic and muscarinic
- There are two main types of adrenergic receptors: α and β
- There are three subtypes of α receptors (α1, α2A, and α2B)
- There are three subtypes of β receptors (β1, β2, and β3)
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Description
This quiz covers the South African Health Products Regulatory Authority (SAHPRA), previously known as the Medicines Control Council (MCC). It includes regulations on clinical trials, drug scheduling, and safety classifications of medicines in South Africa. Test your knowledge on the laws and guidelines governing health products.