Anaesthesia Equipment and Anaesthetising Facilities: Medication

Essential Drugs Programme

Off-label drug use

Ampoule labelling standard

Substitution of medicines and devices

National Pharmacovigilance Programme

Ampoule sharing

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Essential Drugs Programme

To provide equal access to medicines for all South Africans, whilst improving the supply of listed items at a lower cost, the Essential Drugs Programme (EDP) of South Africa was established in terms of the National Drug Policy (NDP) in 1996.

The World Health Organization (WHO) defines essential medicines as those that satisfy the priority healthcare needs of the population. Essential medicines must always be available within health systems in adequate quantities, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford.

In the health objectives of the NDP, the government of South Africa clearly outlines its commitment to ensuring the availability and accessibility of medicines for all people.

The criteria for selecting essential medicines in South Africa were based on the WHO guidelines for drawing up a national EML. Essential medicines are selected with due regard to disease prevalence, evidence of efficacy and safety, and comparative cost.

The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations. It happens by means of the ministerial appointment of a National Essential Medicines List Committee (NEMLC), which draws up and revises the national list of essential medicines for three levels of care: primary health care, secondary and tertiary hospital level.

The tables below summarise current recommendations of essential drugs for anaesthesiology. The list indicates agents that should be available to provide safe anaesthesia at regional hospital level.

Premedication
Benzodiazepines	Lorazepam
	Midazolam
Induction agents	Propofol
	Etomidate
	Ketamine
	Thiopental

 

Volatiles
Induction	Halothane
	Sevoflurane
Maintenance	Isoflurane

 

Muscle relaxants
Depolarisers	Suxamethonium
Non-depolariser	Cisatracurium
	Vecuronium
Rapid sequence intubation	Suxamethonium
	Rocuronium
Reversal agents	Neostigmine with either atropine or glycopyrrolate

 

Analgesics
Oral	Paracetamol
	NSAIDs, e.g. ibuprofen
IV	Fentanyl
	Morphine
	Ketamine
Postoperative	Morphine
	Tramadol
	Diclofenac IM
Fluids	Ringer’s lactate
	0.9% NaCl

 

Treating anaesthesia complications
Malignant hyperthermia	Dantrolene
	CVS support – adrenaline (epinephrine)
LA toxicity	Lipid emulsion (20%)
Acute hypotension	Ephedrine IV, 3–5 mg
	Phenylephrine IV, 50–100 mcg
Acute hypertension	Alfentanil (obtund the hypertensive response)
	Magnesium sulfate
	Labetalol

 

PONV
Prophylaxis	Dexamethasone
	Ondansetron
	Promethazine
Treatment	Metoclopramide
	Promethazine, deep IM, 25–50 mg

 

Regional neuraxial
Spinal	Bupivacaine 0.5% (spinal use) plain or hyperbaric (+glucose)
Epidural	Bupivacaine 0.5%
	Lidocaine 2% (preservative-free)
Regional blocks	Lidocaine 1% or 2%
	Bupivacaine 0.5%
Topical anaesthesia	Lidocaine jelly
	Lidocaine topical spray
	Lidocaine/prilocaine, topical cream, 2.5/2.5%
Chronic neuropathic pain	Amitriptyline
	Carbamazepine
Emergency medication	In addition to drugs used to provide anaesthesia, the following need to be available
Cardiac arrest	Adrenaline
Antidysrhythmics	Amiodarone
	Dopamine
	Dobutamine
	Lignocaine
	Verapamil
	Adenosine
Bronchodilators	Salbutamol
	Aminophylline
Corticosteroids	Hydrocortisone
	Dexamethasone
	Methylprednisolone
Vasopressor	Phenylephrine and ephedrine/etilephrine
	Labetalol
Vasodilators	TNT
Antibiotics for prophylaxis	As per current recommendations
	Cefazolin
	Metronidazole
	Gentamicin
	Clindamycin
Others	Sodium bicarbonate
	Calcium chloride/gluconate
	Beta blocker (propranolol, atenolol)
	Digoxin
	Furosemide
	Mannitol
	Dextrose
	50% Oxytocin
Reversal agents	Naloxone
	Flumazenil

NSAIDs – nonsteroidal anti-inflammatory drugs, IV – intravenous, IM – intramuscular, CVS – cardiovascular system, LA – local anaesthetic, PONV – postoperative nausea and vomiting, TNT – trinitroglycerin

The drugs listed are the minimum requirement for safe anaesthesia that should be available in all facilities. In addition, see table below for a list of highly desirable drugs in regional, tertiary and central hospitals.

Drugs which are highly desirable in regional, tertiary and central hospitals
Inhalants	Sevoflurane
	Desflurane
Analgesics	Alfentanil
	Sufentanil
	Remifentanil
Relaxants	Rocuronium
	Atracurium
Other	Dexmedetomidine
	Esmolol
	Noradrenaline
	Ketorolac
	Paracetamol IV
	Sugammadex
Chronic neuropathic pain	Gabapentin
	Duloxetine
	Pregabalin

Off-label drug use

Off-label prescription and/or use refers to the prescription or use of a medicine or medical device outside of its approved label, i.e., outside of the indication for which the manufacturer has submitted studies to the satisfaction of regulators and which has therefore not been proven at all or to the level at which it would satisfy regulators to register the product for that particular indication or use.

Medicines are not always tested or registered for certain patient groups or diseases. Medicines are sometimes used in contexts or for conditions other than for which they have been registered. Medicines registration processes in South Africa are sometimes slower than those in other markets, and sometimes, there are no alternatives available to patients.

Medicines (and medical devices) are registered based on their safety profile being acceptable, and on their proven efficacy (or performance).

Off-label use of medicines may be indicated if sufficient evidence (defined as peer-reviewed acceptance of indication) exists for such use. Medicines are often used in such a manner in the paediatric population.

Under South African law, informed consent should be provided for the specific healthcare intervention. The World Medical Association (WMA) requires that, in the case of off-label prescriptions, the patient must be informed about the character of the prescription.

The Consumer Protection Act (CPA) requires patients to be informed of the nature of the specific goods or services they are to receive, and the conditions under which they are to be provided. Furthermore, this information is to be provided in plain language, which means that the patient should understand what an off-label prescription and use means.

The National Health Act (NHA) requires the patient to be informed about the benefits, risks and consequences of, in this case, off-label use. The CPA has more stringent tests in relation to warnings about risks and requires that the patient’s attention be drawn to the specific risks conspicuously, and where there is a risk that is ‘serious’ or ‘unusual’, that the consent be provided in writing.

Where there are no alternatives available to patients, or where off-label use is, in the opinion of the profession, the best for certain patients, this fact should be explained to the patient as well.

It must be borne in mind that, under consumer legislation, the practitioner shares the legal liability for any possible harm that results from the use (or off-label use) of a product with all others in the supply chain. This harm may be because the product is unsafe, due to product failure or due to inadequate instructions or warnings being issued.

The CPA states that goods must be “reasonably suitable” for the purpose for which they were intended. Products registered for specific indications in other jurisdictions may be easier to justify as “reasonably suitable” than those not registered anywhere for the particular indication and/or with limited data on their safety and efficacy.

Due to pharmacovigilance (post marketing surveillance) requirements on pharmaceutical companies (similar provisions exist for medical device companies), practitioners are advised to contact the medical departments of such companies to enquire as to the recorded safety profile of the product when used off-label, as well as whether there is information available on whether the product is, or could be, reasonably suitable for the off-label purpose.

Ampoule labelling standard

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SASA deems the standard SANS 44/2014: Labelling of small volume (50 ml or less) parenteral drug containers, as essential and to be adopted.

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The key feature of this standard is that labels will be much more legible in the clinical arena. The standard focuses on font size, text legibility and orientation, text contrasts, ordering of label content, and language. It mandates the use of the drug’s generic name on the label and states that, if used, the trade name may not exceed the size of the generic name. To create space for clearer labelling on small ampoules, English is now the only mandatory language. The standard also recommends that, where applicable, manufacturers should on part of the label utilise the colours specified for identifying specific drug classes on syringe labels, as per the SABS SANS 26825.

Substitution of medicines and devices

The substitution of health goods occurs in resource-constrained settings because of healthcare priorities in formularies and treatment guidelines. Legislation relating to substitution in health care (and in general consumer goods) impacts this practice.

The WMA has serious concerns about the practice of substitution.

There is a difference between generic and therapeutic substitution, with generic substitution generally permitted by South African law, but therapeutic substitution is not. The WMA recommends that national medical associations lobby for therapeutic substitution to be declared illegal, where the practitioner does not issue a new and valid prescription.

Drug therapy should be individualised based on a complete clinical patient history, current physical findings, all relevant laboratory data, and psychosocial factors.

Where generic products are on the market, the WMA recommends that practitioners ensure that there are quality assurance procedures in place to ensure their lot-to-lot bioequivalence and their chemical and therapeutic equivalence.

The Medicines and Related Substances Act only permits generic substitution within the criteria set by the section 22F:

1. Pharmacists must inform patients with a prescription for dispensing of the benefits of the substitution.
2. When substitution has taken place, the pharmacist must take reasonable steps to inform the prescriber of such substitution.
3. Pharmacists may dispense the generic instead of the prescribed medicine, unless expressly forbidden by the patient.
4. The prescriber has written in their own hand on the prescription the words “no substitution” next to the item prescribed.
5. The retail price of the generic is higher than that of the prescribed medicine.
6. The product has been declared not substitutable by the South African Health Products Regulatory Authority (SAHPRA).
7. Although there was, in the past, a list of non-substitutable products issued by SAHPRA, the current list only contains rules relating to biologics. SASA, however, strongly recommends that practitioners who deem that the generally accepted circumstances under which substitution should not take place, are present in a particular case, should ensure that a non-substitutable order is issued to clearly indicate the opinion of the practitioner.

The CPA also prohibits the substitution of any goods without the consent of the consumer (patient).

Therefore, the WMA, the Medicines Act, and the CPA, read with the NHA, make it clear that:

1. Information must be provided on drug choices and the patient’s condition to enable the practitioner to select medicines carefully.
2. Once the patient consents to the medicine selected, that medicine should not and cannot be changed without the patient’s consent.
3. In the case of therapeutic substitution, practitioners should re-evaluate the patient and the options and issue a new prescription.

The WMA and South African postmarketing surveillance of medicines require that all adverse drug reactions (ADRs) or therapeutic failures be reported. This is and should also be the case in instances of generic substitution.

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The WMA recommends that practitioners document ADRs and report it to appropriate drug regulatory authorities.

The WMA recommends that medical practitioners and pharmacists cooperate within the definitions set by their respective roles, making it clear that the practitioners assess and prescribe based on an assessment of the patient’s pharmacological needs. It furthermore states that pharmacists have the role of “reviewing prescription orders to identify interactions, allergic reactions, contraindications and therapeutic duplications.” They should, however, discuss “concerns with the prescribing physician, but the pharmacist should not change the prescription without consulting the prescriber”.

SASA recommends that, in the practical theatre setting, the practitioner be able to issue an advanced instruction to the hospital pharmacist that generic substitution would not be indicated for a particular patient or patient group, and that a specific medicine should therefore be available in theatre.

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SASA does not support the practice where third parties, even if they are pharmacists, contact patients to recommend therapeutic or generic substitution.

National Pharmacovigilance Programme

SAHPRA is responsible for ensuring the safety, efficacy and quality of all medicines used by the South African public. The National Pharmacovigilance Programme is coordinated by SAHPRA and has a dedicated unit, The National Adverse Drug Event Monitoring Centre (NADEMC), in Cape Town, which monitors the safety of all registered medicines in South Africa.

What is pharmacovigilance?

Pharmacovigilance is defined as the science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines (i.e., ADRs). This activity aims to improve the safe and rational use of medicines, thereby improving patient care and public health.

What is an adverse drug reaction?

SAHPRA defines an ADR as a response to a medicine that is noxious and unintended, including lack of efficacy, and which occurs at any dosage and can also result from overdose, misuse, or abuse of medicine.

Who should report adverse drug reactions?

All healthcare workers, including doctors, dentists, pharmacists, nurses, and other health professionals, are encouraged to report all suspected adverse reactions to medicines (including vaccines, X-ray contrast media, traditional and herbal remedies), especially when the reaction is not in the package insert, potentially serious or clinically significant.

What happens to a report?

All ADR reports are entered into a national ADR database. Each report is evaluated to assess the causal relationship between the event and the medicine.

A well-completed ADR/product quality form submitted could result in any of the following:

• additional investigations into the use of the medicine in South Africa;
• educational initiatives to improve the safe use of the medicine;
• appropriate package insert changes to include the potential for the reaction, and
• changes in the scheduling or manufacture of the medicine to make it safer.

ADR reporting aims to reduce the risks associated with using medicines and ultimately improve patient care.

Will reporting have any negative consequences on the health worker or the patient?

An ADR report does not constitute an admission of liability or that the health professional contributed to the event in any way. The outcome of a report, together with any important or relevant information relating to the reaction, will be sent back to the reporter as appropriate. The details of a report are stored in a confidential database. The names of the reporter or any other health professionals named on a report and that of the patient will be removed before any details about a specific ADR are used or communicated to others. The information is only meant to improve the understanding of the medicines used in the country.

Is the event possibly an adverse drug reaction?

The following factors should be considered when an ADR is suspected:

• What exactly is the nature of the reaction? (Describe the reaction as clearly as possible and, where possible, provide an accurate diagnosis.)
• Did the reaction occur within a reasonable time relationship to starting treatment with the suspected medicine? (Some reactions occur immediately after administration of a medicine while others take time to develop.)
• Is the reaction known to occur with the medicine as stated in the package insert or other reference? (If the reaction is not documented in the package insert, it does not mean the reaction cannot occur with that medicine.)
• Did the patient recover when the suspected medicine was stopped? (Some reactions can cause permanent damage, but most reactions are reversible if the medication is stopped.)
• Did the patient take the medicine again after the reaction abated (i.e., rechallenge)?
• If so, did the same reaction occur again? (In most situations, it is not possible or ethical to rechallenge the patient with the same medicine. If such information is available or if such a rechallenge is necessary, recurrence of the event is a strong indicator that the medicine may be responsible.)
• Can this reaction be explained by other causes, e.g., underlying disease/s; other medicine/s; toxins or foods? (It is essential that the patient is thoroughly investigated to decide the actual cause of any new medical problem. A medicine-related cause should be considered when other causes do not explain the patient’s condition.)

What types of reactions should be reported?

The following ADRs should be reported:

• all ADRs to newly marketed drugs or new drugs added to the EML,
• all serious reactions and interactions,
• ADRs that are not clearly stated in the package insert, and/or
• all adverse reactions or poisonings to traditional or herbal remedies.

Report even if you are not certain that the medicine caused the event.

What product quality problems should be reported?

The following product quality problems should be reported:

• suspected contamination,
• questionable stability,
• defective components,
• poor packaging or labelling, and/or
• therapeutic failures.

How can adverse drug reactions be prevented from occurring?

Some ADRs are unavoidable and cannot be prevented. However, most ADRs can be prevented by following the basic principles of rational use of medicines.

How are adverse drug reactions reported?

1. Reporting of suspected ADRs can be done via the eReporting link on the SAHPRA website (https://www.sahpra.org.za). Alternatively, an ADR/product quality report form should be completed and emailed to adr@sahpra.org.za. The form can be obtained from the SAHPRA website. Report forms may also be accessed via the following website: http://www. mccza.com.
2. The National Adverse Drug Event Monitoring Centre C/o Division of Pharmacology, University of Cape Town, Observatory, 7925 (021) 447 1618; Fax: (021) 448 6181

Ampoule sharing

Ampoule sharing (Appendix F [ii]) is prevalent in public and private sector anaesthesia practice and refers to withdrawing multiple doses of drug from a single-use ampoule. This practice mostly relates to “expensive drugs” and paediatric anaesthesia – an attempt at cost saving in the first instance, and time-saving or convenience in paediatric cases. From the clinical governance point of view, there is little doubt that ampoule sharing is certainly not in our patients’ best interests. The inability to maintain sterility once an ampoule is opened, the risk for cross infection with subsequent sepsis, the possibility of mistakes in labelling or administration, and the risk of theft from an open ampoule negate the small cost benefit of sharing a single large ampoule between patients.

- SASA deems the standard SANS 44/2014: Labelling of small-volume (50ml or less) parenteral drug containers, as essential and to be adopted. - The WMA recommends that practitioners document ADRs and report it to appropriate drug regulatory authorities. - The WMA recommends that medical practitioners and pharmacists cooperate within the definitions set by their respective roles, making it clear that the practitioners assess and prescribe based on an assessment of the patient’s pharmacological needs. It furthermore states that pharmacists have the role of “reviewing prescription orders to identify interactions, allergic reactions, contraindications and therapeutic duplications.” They should, however, discuss “concerns with the prescribing physician, but the pharmacist should not change the prescription without consulting the prescriber”. - SASA recommends that, in the practical theatre setting, the practitioner be able to issue an advanced instruction to the hospital pharmacist that generic substitution would not be indicated for a particular patient or patient group, and that a specific medicine should therefore be available in theatre.

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South African Society of Anaesthesiologists (SASA) Practice Guidelines_2022_To be Reviewed in 2026