An aseptic dispensing service provides, in response to a clinician's prescription, a sterile product prepared by the admixture of sterile components. If any aseptic dispensing service is provided, the following standards are applicable:
| (a) |
Aseptic dispensing must be carried out in a cabinet equipped with a high efficiency particulate air (HEPA) filter situated in a room with a clean air environment to prevent contamination with micro-organisms and particulate matter. |
| (b) |
A safe system of work must apply throughout preparation and there must be safeguards to ensure that the final product is stable and safe throughout its shelf life. |
| (c) |
Only staff trained in pharmaceutical aseptic technique must provide this service, provided that it falls within their scope of practice. |
| (d) |
Procedures must be introduced to ensure that dosage calculations are correct and that final containers are appropriate for the route of administration to be employed. |
| (e) |
Procedures must be established to ensure that principles of Good Manufacturing Practice are applied to the aseptic dispensing service. |
| (f) |
Particular attention must be paid to ensuring that validated procedures are used. Prescription details, work sheets, labels and ingredients must be checked prior to preparation. The final product, documentation and label details must be checked prior to release. |
| (g) |
Accurate records must be kept for each product prepared, including label details. These must include: |
| (i) |
Patient's name (hospital number) and ward; |
| (ii) |
name, form and strength of medicine; |
| (iii) |
recommendations for use; |
| (iv) |
appropriate warnings; and |
| (v) |
batch number, expiry date, date and time of preparation. |
| (h) |
Quality control procedures must ensure that new formulations undergo stability testing, preferably prior to use. Microbiological and participate monitoring must be carried out even though results may be retrospective. |
| 2.17.1 |
Intravenous additive service |
| (a) |
Standard policies and procedures must be established for IV preparation and administration. |
| (b) |
The minimum requirement must be the use of a cabinet equipped with a high efficiency particulate air (HEPA) filter, ideally situated in a room with clean air environment. |
| (c) |
Only staff trained in the pharmaceutical aseptic technique must handle such solutions, provided that it falls within their scope of practice. |
| (d) |
Procedures must be introduced to ensure that dosage calculations are correct and that the addition will not result in any chemical or physical incompatibility. |
| (e) |
Procedures must be instituted to ensure that safe systems of work are applied throughout the admixture process and there must be safeguards to ensure that the solution is stable and safe throughout administration to the patient. |
| (f) |
Policies and procedures must be established for the addition of medicines to intravenous fluids and their administration. The pharmacy must have access to adequate information sources concerning the intravenous administration of medicines and related compatibilities and stabilities. |
| (g) |
Accurate records must be kept of each admixture including label details. In addition to the requirements for labelling prescribed in regulation 8(4) of the General Regulations published in terms of the Medicine Act, the following information must be included on the label: |
| (i) |
patient's name, (hospital number) and ward; |
| (ii) |
name and amount of additive(s); |
| (iii) |
name, strength and quantity of the primary IV solution; |
| (iv) |
batch number, expiry date and date and time of preparation; |
| (v) |
method of IV administration — continuous or intermittent. If intermittent, the interval of administration must be stated; and |
| (vi) |
rate of administration. |
| (h) |
All admixtures must be inspected for particulate matter before they are supplied for administration. |
| (i) |
Quality control testing must be conducted to monitor IV additive procedures. The quality assurance programme must be designed to evaluate the performance of equipment, personnel and procedures and include testing of the final product and of remnants returned from the ward. |
| (j) |
The pharmacy must provide an efficient system for distribution of ready-prepared admixture solutions. |
| (k) |
The pharmacist should, where possible, ensure that intravenous additives are used appropriately, e.g. within the specified shelf life. Unwanted admixtures must be removed from the ward area. |
| 2.17.2 |
Total parenteral nutrition (TPN) preparation service |
| (a) |
The preparation of TPN solutions must be performed in a cabinet equipped with a high efficiency particulate air (HEPA) filter ideally situated in a room with a clean air environment to prevent contamination with micro-organisms and particulate matter. |
| (b) |
A safe system of work must apply throughout preparation and there must be safeguards to ensure that the solution is stable and safe throughout administration to the patient. |
| (c) |
Accurate batch control records must be kept of all TPN solutions issued for administration to patients. |
| (d) |
There must be a uniform standard for labelling TPN solutions. In addition to the requirements for labelling prescribed in regulation 8(4) of the General Regulations published in terms of the Medicines Act the following information must be included on the label: |
| (i) |
identification of the product, i.e. 'Parenteral Nutrition Solution'; |
| (ii) |
the patient's name and ward; |
| (iii) |
the name and amount of each constituent; |
| (vi) |
the time and date of preparation; |
| (vii) |
the rate of administration; |
| (viii) |
the batch control number; |
| (ix) |
statements to the effect that the solution remains sterile if unopened and that the bag must be used for the named patient only; |
| (x) |
the expiry date of the solution; and |
| (xi) |
that additives are prohibited. |
| 2.17.3 |
Cytotoxic preparation and reconstitution service |
| (a) |
Cytotoxic medicines have a potential for being mutagenic, teratogenic and carcinogenic. It is prudent that every reasonable precaution should be taken by staff handling cytotoxic medicines to ensure that absorption does not occur, especially as no adequate means of monitoring or measuring inadvertent absorption have been devised. |
| (b) |
Due to the potential hazards to patients, staff and visitors, staff involved in the preparation, administration and disposal of these agents must be adequately trained. |
| (c) |
Procedures must be established to ensure that the hazards associated with the handling, preparation and administration of cytotoxics are kept to a minimum by ensuring that: |
| (i) |
the correct technique is used; |
| (ii) |
staff are properly trained and aware of the various hazards; |
| (iii) |
appropriate protective clothing is provided and used; |
| (iv) |
correct action is taken following any accidental spillage or contamination of the person; and |
| (v) |
suitable equipment for waste is provided to minimise the risk of contamination. |
| (d) |
The responsible pharmacist must ensure that facilities are suitable for the type of preparation, irrespective of the scale of preparation and that proper records of prescribing, dispensing and administration are maintained. |
| (e) |
A nominated pharmacist must ensure that cytotoxic drug handling policies are regularly revised. |
| (f) |
The responsible person must ensure that facilities are suitable for the type of preparation. |
| (g) |
Equipment must be designed to minimise the risk of contamination of the product as well as the operator. Procedures must lay down standards for protective clothing as well as safety cabinets and single-use medical and surgical sundries. |
| (h) |
The preparation and reconstitution of cytotoxic medicines must be carried out by appropriately trained staff within an approved safety cabinet, designed to protect the operator from exposure to any concentration of the medicines and also to protect the product from microbiological contamination. This service must take place either within a designated area of the pharmacy or on a centralised basis within e.g. an oncology unit. |
| (i) |
Horizontal laminar flow cabinets must not be used. |
| (j) |
The pharmacist must ensure that there are procedures in place to control that final containers are suitable for the purpose and that they are adequately labelled. Full documentation of each preparation must be carried out according to standardised procedures so that individual constituents are readily traceable. |
| (k) |
Where reconstitution has to take place in a hospital ward a clean, quiet, well-lit and well-ventilated area must be chosen for the purpose, where the operation will be subject to the minimum of interruptions, be well away from food and passing people. Hot and cold water must be available and there must be immediate access to eye wash facilities and treatment agents. If possible, in wards, part of this area should be dedicated exclusively to the preparation of cytotoxic medicines. Strict aseptic technique must be employed throughout for injectable preparations. |
| (l) |
Protective clothing must include the following: |
| (i) |
gloves that are of material appropriate to the product being handled; |
| (ii) |
safety spectacles with side pieces or locally approved alternatives; |
| (iii) |
a single use plastic apron (specially designed coats, with long sleeves and cuffs are preferable); and |
| (iv) |
a single use surgical mask. |
| (m) |
The pharmacist must ensure that there are procedures in place to control that a broad-edged tray is used to contain any accidental spillage and Luer-lock syringes must be used. Whenever possible, for reconstitution purposes, a wide-bore needle (18 gauge) should be used and steps must be taken to ensure that excess pressure build-up does not cause leakage or the formation of an aerosol. Care must be taken to ensure that the operator is not at risk when reconstituting open vials or ampoules, opening ampoules or expelling air from syringes. |
| (n) |
The pharmacist must ensure that there are procedures in place to control that syringes are protected during transport to the patient. Individual syringes must be labelled. The label must contain at least the following information: |
| (i) |
the name and strength of the medicine; |
| (ii) |
the total quantity of the medicine; |
| (iii) |
the name of the patient; |
| (iv) |
the date of preparation; |
| (vi) |
the batch number of the preparation. |
| (o) |
Any special recommendations from the manufacturer must be observed. |
| (p) |
Any accidental spillage or contamination of the operator must be dealt with immediately and procedures must be established for treatment of the skin, eyes and other surfaces. |
| (q) |
The working area used for the preparation or reconstitution of cytotoxic medicines must be thoroughly cleaned immediately after use according to local procedures. |
| (r) |
All excess medicine, equipment and protective clothing used in the preparation must be disposed of and dealt with according to local procedures. |
| (s) |
Procedures for administration of cytotoxic medicines to patients must strike a balance between protecting the operator and alarming the patient. They must include details of action to be taken in the case of extravasation and for the disposal of excreta from patients receiving cytotoxic medicines. |
| (t) |
All procedures must be designed to ensure that all products achieve the required standard of quality. |
| (u) |
All personnel must receive special training in working with cytotoxic medicines and be monitored regularly to ensure compliance with all procedures. |
| (v) |
A permanent register must be maintained of all employees who routinely handle cytotoxic medicines. Acute exposure episodes must be documented and the employee must be referred for appropriate medical examination. Routine medical examination and blood tests must be performed on personnel handling cytotoxic medicine. |
| (w) |
Personnel working in a cytotoxic reconstitution service must be rotated regularly. |
Gas Regulator Levies Act, 2002
