SASA Practice guideline 2022 ; ANAESTHESIA EQUIPMENT AND ANAESTHETISING FACILITIES Flashcards

Question

Ancillary equipment per theatre

Answer 1

Laryngoscopes (preferably with fibre-optic light carrier and light-emitting diode light source) Two functional handles with • Full range of adult blade sizes, preferably Macintosh pattern. • Appropriate range of paediatric laryngoscope blades when providing paediatric anaesthesia. Video-assisted laryngoscope (considered essential in all large level 1, level 2 and level 3 hospitals and high turnover obstetric units).

Answer 2

Laryngoscopes (preferably with fibre-optic light carrier and light-emitting diode light source) Two functional handles with • Full range of adult blade sizes, preferably Macintosh pattern. • Appropriate range of paediatric laryngoscope blades when providing paediatric anaesthesia. Magill adult and paediatric endotracheal tube-introducing forceps. Nonmetallic or plastic-coated, malleable endotracheal tube- introducing stylettes. Inflating device (syringe and a cuff pressure manometer) for endotracheal tube cuffs. Two kidney dishes as receivers for clean and dirty oral and endotracheal instruments. Designated difficult airway management trolleys with appro- priate equipment should be in every theatre complex. Anaesthesiologist’s chair on wheels with backrest. A wall clock with a sweep second hand or digital equivalent should be present in each theatre. Suction unit for exclusive use by the anaesthesiologist, generat- ing a minimum negative pressure of 50 kPa at a minimum airflow of 25 l/minute into a reservoir bottle of at least one-litre capacity. Adequate length of suction tubing and an appropriate range of cannulas/catheters for oral and endotracheal suction. Anaesthesia and surgical suction bottles should be graduated for volume.

Answer 3

Suction unit for exclusive use by the anaesthesiologist, generat- ing a minimum negative pressure of 50 kPa at a minimum airflow of 25 l/minute into a reservoir bottle of at least one-litre capacity. Adequate length of suction tubing and an appropriate range of cannulas/catheters for oral and endotracheal suction.

Answer 4

A wall clock with a sweep second hand or digital equivalent should be present in each theatre.

Answer 5

A monitor-defibrillator with adult and infant electrodes per theatre suite must be available. The ability to provide external cardiac pacing is desirable in all age groups, including neonates and paediatric patient

Answer 6

Operating table with Trendelenburg-position controls at the head of the table. • Two lateral padded straight arm supports. • Appropriate padding and equipment for the positioning of patients to prevent injury.

Answer 7

Drug trolley for exclusive use by the anaesthesiologist.

Answer 8

Topical anaesthesia spray.

Answer 9

Two intravenous (IV) infusion poles. An appropriate selection of IV fluids and IV cannulas must be available. In-line warmer for blood and IV fluids. Pressure infuser for both 500 ml (blood) and 1 000 ml IV bags. Infusion devices: volumetric pumps and/or syringe drivers.

Answer 10

A pair of strong scissors. A method of securing the anaesthesia breathing system to the operating table.

Answer 11

Warming blankets/convection warmers for use in the theatre. Availability of warming blankets/convection warmers is an absolute requirement for neonates and infants. Where infants and small children are to be anaesthetised, a full range of the necessary paediatric equipment (as outlined above) must be available.

Answer 12

Electrical generator backup for hospital and/or theatre complex. Uninterruptible power supply (UPS) or battery backup for life- support equipment.

Answer 13

In the event of a power outage (failure of main Eskom power supply), the following guidelines should be followed: 1. If the theatre complex only has one electrical backup system (generator/UPS), current elective cases should be completed as soon as possible, and all other cases postponed until the main power is restored. Urgent emergency cases may continue (See Appendix F[iii]). 2. If a theatre complex has a second backup power supply, e.g., a second generator or UPS unit, elective cases can continue if it is verified that the second backup supply has adequate capability for the duration of the power outage. 3. Equipment battery backup is not deemed to be a second backup power supply as the duration of the battery supply is not dependable enough to continue with an elective list.

Answer 14

A telephone in each theatre for communication. Individual illumination of the anaesthesiologist’s area, including an emergency backup, battery-powered illumination source. Blood salvage system. High-flow blood/fluid warmer. Syringe drivers programmed to administer target-controlled IV anaesthesia. Intermittent pneumatic calf compressors and related consum- ables. Low amperage peripheral nerve stimulator to assist with region- al anaesthesia techniques per theatre suite. Equipment for patient-controlled analgesia (PCA). Transportable ventilator and monitor. Video-assisted or normal light source fibre-optic bronchoscope. A rigid bronchoscope (this need not be for exclusive use by the anaesthesiologist) with attachments for ventilating apnoeic patients (available in the theatre suite). All electrical equipment should be able to operate from batteries, particularly when a reliable emergency electrical supply is not available.

Answer 15

Essential items A stethoscope. A multi-parameter vital signs monitor, incorporating and displaying: • An electrocardiogram (ECG) channel with 3- and/or 5-lead ECG monitoring. The unit must incorporate a diathermy filter. • Heart rate: Derived from ECG, pulse oximetry or non-invasive blood pressure (NIBP) readings. • An automated electronic NIBP module displaying systolic, mean, and diastolic blood pressure (BP), with an appropriate range of cuffs. • Pulse oximetry, displaying oxygen saturation and a plethys- mograph. • Anaesthetic agent analyser and capnography, displaying end- tidal anaesthetic agent concentrations and CO2 in mmHg, kPa or a percentage, and a capnograph. • Patient temperature for oropharyngeal, oesophageal, rectal, bladder or tympanic use, reading 22–42 °C minimum range. • Alarms: adjustable alarm limits for all parameters. Oxygen monitor (inspired and expired), with a low-limit alarm (may be incorporated in the multi-parameter vital signs monitor or the anaesthesia machine). Whenever an automatic ventilator is used, a breathing circuit pressure monitor with high- and low-limit alarms must be incorporated. A peripheral nerve stimulator to monitor neuromuscular function when muscle relaxants are used, with double burst stimulation, train-of-four and post-tetanic count facilities. A point-of-care (POC) device to estimate blood glucose. A POC device to measure haemoglobin and/or haematocrit. A thermometer that permanently displays the operating theatre temperature.

Answer 16

Invasive pressure module for intra-arterial/IV pressure monitor- ing incorporated in the multi-parameter vital signs monitor or anaesthesia machine. Portable ultrasound device for guided nerve blocks and vascular access. Blood gas analyser. Transportable vital signs monitor. Scale for weighing swabs. Processed electroencephalogram (EEG) depth of anaesthesia monitor. Non-invasive cardiac output monitor. Coagulation monitoring device. (Essential in a theatre where heparin is used, e.g., cardiac surgery, vascular surgery). Transoesophageal echocardiography equipment. Near-infrared spectroscopy (NIRS) cerebral oximetry monitor. See Table I for essential equipment list (anaesthesia)

Answer 17

Each bed space should be provided with: 1. An oxygen flow meter with attachment for oxygen tubing for mask or nasal prongs. 2. A hook, or pole, for suspension of IV fluids 3. Suction equipment, including a receiver, tubing, a rigid handpiece and a range of suction catheters, including Yankauer. 4. An automated NIBP monitor with appropriately sized cuffs. 5. A stethoscope. 6. A pulse oximeter. 7. Means of measuring body temperature. Within the RR, there must be: 1. A range of devices for the administration of oxygen to spontaneously breathing patients. 2. A self-inflating manual resuscitator, e.g., Ambu® bag or similar, able to deliver 100% oxygen and allow manual ventilation. A minimum of two per recovery room complex is required. 3. Equipment and drugs for airway management and endo- tracheal intubation. 4. Emergency drugs. 5. A range of IV equipment and fluids. 6. Drugs and equipment for acute pain management. 7. A range of syringes and needles. 8. An ECG monitor. 9. Patient-warming devices. There should be immediate access to: 1. A monitoring defibrillator, preferably with pacing capability. 2. A blood warmer. 3. A thermostatically controlled warming cupboard for IV solutions. 4. A refrigerator for drugs and blood. 5. A procedure light. 6. A range of appropriate anaesthesia and emergency drugs. 7. A surgical tray for procedures, including tracheostomy and chest drains. 8. POC access to diagnostic services, e.g., blood glucose, blood gases and radiology. 9. A peripheral nerve stimulator. 10. Other equipment as appropriate to the patient’s condition, e.g., wire cutters. 11. A ventilator.

Answer 18

The recovery trolley or bed must:• Have a firm base and mattress. • Tilt from either end, both head up and head down, to at least 15 degrees. • Be easy to manoeuvre. • Have functional and accessible brakes. • Have provision for the patient to be able to sit up. • Have straps or side rails capable of being dropped below the base or easily removed. • Include provision for a pole from which IV solutions may be suspended. • Include provision for monitoring, mounting portable oxygen cylinders, underwater seal drains and suction apparatus for use during transport

Answer 19

To promote maximum safety in relation to service procedures, the following points are important prerequisites: • Individual anaesthetic machines should be clearly identified, either by the maker’s serial number, or preferably by a hospital marking. This identification must extend to all the readily removable components, such as canisters and vaporisers, so that the performance and checking of these can be followed without confusion. • A record of service procedures performed on each machine, signed by the person responsible for the service, must be provided to the appropriate hospital personnel, e.g., department of anaesthesia, anaesthetic technical staff or theatre nursing staff, depending on local circumstances. • In newly built operating theatres, where operating suites have undergone major structural alterations, before the com- missioning of the area, all new and existing gas lines are pressure-tested, followed by gas flow and purity testing. This must be carried out by a third party licensed to install, and test medical gas lines. • When any medical gas installation is tested, the persons that should be present are the mechanical engineer from public works/hospital group, the mechanical engineer from health infrastructure, the hospital/facility engineer; the medical en- gineer; the medical gas engineer and the third party doing the testing. • The installation of new or altered gases requires certification once the installation is completed and deemed operational. • Adequate time must be available for service personnel to perform regular and emergency servicing without compro- mising safety. • Storage facilities should be available for nitrous oxide and oxygen within the operating theatre suite. This storage area should fulfil the criteria described in the appropriate South African Bureau of Standards (SABS) Code of Practice.

Answer 20

• Essential items are equivalent to a mandatory standard of care. • Recommended/desirable items should be available where resources allow and if appropriate for the surgical/ anaesthesia services delivered. • Regional (Level 2) hospital requirements will include most of the recommended equipment. • Tertiary (Level 3) and central/specialised hospital require- ments must include all items listed as “Recommended”. • SASA recommends that all new facilities be provided with piped medical air and oxygen and nitrous oxide. • SASA recommends a medical air supply for all new operating theatres, including theatres for minor proce- dures/occasional use. • SASA recommends AA at all sites. • Video-assisted laryngoscope is considered essential in all large level 1, level 2 and level 3 hospitals and high turnover obstetric units. • The ability to provide external cardiac pacing is desirable in all age groups, including neonates and paediatric patients. • Warming blankets/convection warmers are an absolute requirement for neonates and infants.

Answer 21

Low flow anaesthesia is anaesthetic gas delivery using a fresh gas flow less than the patient’s minute volume.

Answer 22

High-flow: greater than 4 litres per minute Moderate flow: 2–4 litres per minute Low-flow: less than 2 litres per minute Basal flow: 250–500 ml per minute 250 ml/min is the minimal basal oxygen requirement for metabolic processes at rest in a normothermic patient and must therefore be administered as 100% O2

Answer 23

• Anaesthesia machine capable of delivering accurate, fresh gas flow of less than 1 L per minute • Flow meters capable of increments of less than 100 ml • Leak of fewer than 100 ml on machine and circuit check done immediately before the case • Carbon dioxide absorber • Circle system with unidirectional flow valves

Answer 24

• Standard routine monitors as required for any anaesthetic (ECG, pulse oximeter, BP and other monitoring according to the case) • Inspired oxygen monitor • Capnography • Agent analyser • Ventilatory pressure and tidal volume

Answer 25

• Canister containing between 450 ml and 3 L of carbon dioxide absorbent that undergoes a colour change when exhausted (Soda lime or Baralyme undergo a colour change when exhausted). • When the absorber is exhausted, a rise in the inspired CO2 (FiCO2) is seen on the capnograph. • Absorber must be changed once FiCO2 is greater than 4 mmHg (0.5 kPa)

Answer 26

• Vaporiser out of circuit • Desflurane, isoflurane and sevoflurane are the agents of choice • Older, soluble, highly metabolised agents like halothane and enflurane cannot be delivered at high enough concentrations to be easily delivered with flows less than 1 L • Poorly metabolised gases like desflurane may accumulate during lengthy procedures at very low flows • The use of nitrous oxide is not recommended when using low flows as it increases the risk of hypoxia

Answer 27

• Gas delivery using a standard anaesthetic machine • Flow meters must be able to deliver flows from 250 ml to 10 L per minute • Flow meters must be graduated to measure accurately at flows less than 1 L, preferably in 50 ml to 100 ml increments

Answer 28

• Often called a circle system as gas flow is in a single direction from machine to patient and back from patient to machine • Circuit to be able to deliver constant gas flow at low resistance with minimal leak • Circuit to be checked before use for leaks during spontaneous and assisted ventilation • Do not proceed if leak is greater than 100 ml/min at 30 cmH2O

Answer 29

• Circuit requires two unidirectional valves that move freely with low resistance to flows down to less than 250 ml • Valves must delineate the circuit’s inspiratory and expiratory limb, allowing flow to occur through the circuit in one direc- tion only without mixing inspiratory and expiratory gases

Answer 30

• Inspiratory and expiratory oxygen concentration needs to be monitored constantly • Hypoxia can occur due to inadequate fresh gas flow, delivery of a low FiO2, changes in patients’ metabolic rate, and dilution by accumulating gases such as N2O, CO2, CO, and methane

Answer 31

• Fresh gas must be delivered into the reservoir bag or ventilator bellows and not directly into the circuit • Gas is delivered to the patient and returned via the CO2 absorber in a circular pattern using a “closed system”. The same gas is continuously recycled with small amounts released from the ventilator or breathing valve to allow for additional fresh gas to be introduced, with one-way valves producing unidirectional flow around the circuit.

Answer 32

What to give 1. Oxygen: A minimum of 250 ml of oxygen is needed to meet the basic metabolic requirements of a normothermic, awake patient at rest. The delivery of at least this amount of oxygen per minute is required in an anaesthetised patient. This replacement will be constant, provided the metabolic rate remains constant. At flows of less than 1 L per minute, a FiO2 of at least 50% is recommended. If the monitored FiO2 decreases, the minimum amount of oxygen delivered will need to be increased. 2. All circuits have a small leak that will usually be detected by the preoperative machine check (most machines will allow a leak of fewer than 40 ml per minute to pass this test). In addition to the gas loss from sampling lines and uncuffed tubes, this leak needs to be added to the minimal amount of gas delivered. Most people are comfortable with a minimum of 300–500 ml per minute fresh gas flow. 3. Volatiles are delivered from a vaporiser out of circuit. This gas replaces metabolised and absorbed volatile agent and gas vented to the atmosphere. A variable replacement is needed as it depends on the solubility and amount of agent metabolised 4. N2O, when used as an adjuvant anaesthetic agent, must always be added to at least 250 ml of oxygen. Saturation occurs quickly, and metabolism is minimal, so N2O will start to accumulate over time. It is not recommended to use nitrous oxide with low flow. 5. Air is often added to flows above 250 ml of oxygen to avoid complications from using 100% oxygen, provided the FiO2 is maintained

Answer 33

1. The entire circuit comprises about 6 L—the tubing makes up about 1.5 L, the ventilator or rebreathing bag about 2 L, the carbon dioxide absorber 2 L, and the patient’s tidal volume 0.5 L. 2. The aim is to obtain a constant concentration of volatile agent throughout this 6 L at the MAC value we require. 3. This 6 L needs to be changed five times to reach a steady gas state, so a total of 30 L of circuit gas needs to be changed. 4. If we introduce the volatile agent at 1 L per minute, it will take 6 minutes to change all the gas in the circuit once, and 6 x 5 = 30 minutes to reach steady state. At 250 ml, it takes 120 minutes to reach steady state. 5. One can also speed this up by setting a greater volatile concentration than is desired until the agent is at the required concentration on the agent analyser.

Answer 34

Use the above principles at the beginning of a case. The circuit contains no volatile agent. The aim is to saturate it with a certain MAC of volatile agent in a patient who will awaken quickly from the initial dose of the induction agent. • Following an initial IV and opiate induction. • Fresh gas flow of 2 L/minute and desflurane at 12% or sevoflurane at 4% until the end-tidal agent concentration reaches the desired concentration (6% desflurane or 2% sevoflurane). • Lower fresh gas flow to 250–500 ml and monitor oxygen and volatile concentration. Adjusting the vaporiser as needed.

Answer 35

• Using the above principles shows that changing the con- centration of volatile to a higher or lower MAC while at low flow can take quite a long time. • Rapid changes in concentration can be achieved by increasing the fresh gas flow to 2 litres.

Answer 36

• Due to the metabolism and absorption of volatile agents, the concentration of volatile agent in the entire system will slowly decrease over time. While the circuit receives low fresh gas flow, the absorbed and metabolised agent is not completely replaced; the result is a further decrease in alveolar volatile concentration. This may result in the patient becoming aware. • Therefore, a higher vaporiser setting than the desired end- tidal agent concentration is needed. • Minimally metabolised agents like desflurane, isoflurane and sevoflurane require a vaporiser setting of 10–20% higher than required to accommodate for this but may also start to accumulate over time. • An agent analyser eliminates this guesswork. • Nitrous oxide in a closed circuit will start to accumulate over time as it is minimally metabolised, resulting in hypoxia.

Answer 37

1. The same principles apply to wakening the patient at the end of the procedure. If the volatile agent is switched off and low fresh gas flow maintained, the patient can take between 10 and 20 minutes to wake up while the volatile concentration slowly decreases. 2. A fresh gas flow of 6 L will rapidly flush the circuit of residual volatile agent.

Answer 38

In paediatric anaesthesia, the same principles apply but use smaller bore tubing, size-appropriate filters and cuffed tubes.

Answer 39

1. Hypoxia – due to low delivered FiO2, dilution from other gases, increased metabolic rate. 2. Tachycardia – due to rapid changes in gas concentration with desflurane (the rule is fresh gas flow x volatile concentration should be less than 24, i.e., 2 L x 12% = 24). 3. Overdose – due to prolonged high fresh gas flow and high vaporiser setting. 4. Awareness – due to circuit leak or low vaporiser setting. 5. Hypercapnoea – carbon dioxide absorber exhaustion. 6. Prolonged awakening – fresh gas flow still low during emergence. 7. Low circuit volume – due to leaks in the circuit and can lead to inadequate ventilation as bellows and reservoir bag are not refilled, hypoxia and awareness.

Answer 40

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.

Answer 41

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.

Answer 42

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

Answer 43

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 rec- ommends 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.

Answer 44

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.

Answer 45

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

Answer 46

Pharmacovigilance is defined as the science and activities con- cerned 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.

Answer 47

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.

Answer 48

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.

Answer 49

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.

Answer 50

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.

Answer 51

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.)

Answer 52

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

Answer 53

The following product quality problems should be reported: • suspected contamination, • questionable stability, • defective components, • poor packaging or labelling, and/or • therapeutic failures

Answer 54

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

Answer 55

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

Answer 56

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.

Answer 57

• SASA deems the standard SANS 44/2014: Labelling of small-volume (50 ml 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, contrain- dications 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.