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Pharmacy Act, 1974 (Act No. 53 of 1974)

Board Notices

Rules Relating to Good Pharmacy Practice

Chapter 2 : Professional Standard for Services

2.14 Minimum Standards for Immunisation Services

 

Although the pharmacist's involvement with immunisation varies with each practice setting, the pharmacist can be actively involved in the following activities:

(a) educating the public and other health care professionals about immunisation;
(b) advocating paediatric immunisation;
(c) providing immunisation for international travel;
(d) screening patients who are at risk of preventable infectious diseases by occupation, life-style or an underlying disease state;
(e) administering immunisation agents;
(f) recording immunisation data; and
(g) using the immunisation database to generate reminder letters for booster doses.

 

 

2.14.1 Physical facilities and equipment

 

If immunisation services are provided the following standards are applicable:

(a) Counselling and administration of immunisation agents must be done in a private allocated area in the pharmacy. The consultation area must comply with the requirements described in section 1.2.13 of this manual.
(b) The correct storage procedures for vaccines must be adhered to according to the standards for the cold storage of pharmaceuticals described in Chapter 2 of this manual.
(c) The following equipment must be available:
(i) syringes and administering devices; and
(ii) biohazardous materials and sharps disposal containers).
(d) Adequate drugs for use in emergencies such as adrenaline 1:1000 solution, antihistamine (e.g. chlorpheniramine) injection, hydrocortisone injection and equipment (e.g. plaster, gauze, cotton wool, sterile wound dressings, etc.) must be available.

 

2.14.2 Procedure

 

(a) Pharmacists must be familiar with the instructions, requirements and guidelines of the National Expanded Programme on Immunisation (EPI) policy.
(b) Pharmacists must be familiar with the instructions and requirements of individual vaccines and human immunoglobulins on the market. Instructions pertaining to one product will not necessarily be applicable to another.
(c) The storage requirements of the different products must be noted and products must be stored according to the manufacturer's instructions. Refer Chapter 2 for standards for the storage of vaccines.
(d) The cold chain (system of ensuring that a product is stored at the correct temperature during transport and storage up until the moment of immunisation) must be maintained.
(e) Live virus vaccines may be used after they have been frozen, but repeated freezing and thawing must be avoided. The National open vial policy must be followed, namely:

Opened vials of DPT, DT, TT, HepB and Oral Polio which are used in a pharmacy, may be used at more than one immunisation session, providing that the cold chain is maintained. The same vaccines, taken on an outreach, must be destroyed at the end of the day. No reconstituted vaccines may be kept for re-use. Reconstituted measles and BCG must be discarded after six hours or the end of a session, whichever is the shorter.

(f) Vaccines must never be used beyond the expiry date.
(g) If required, reconstitution of vaccines must be done immediately prior to their use, and only with the diluent provided by the manufacturer. The diluent should be at the same temperature as the vaccine which is being reconstituted. If unused, reconstituted vaccines must be discarded at the end of the working day.
(h) Prior to the administration of immunisation agents, patients must be questioned about:
(i) previous reactions to vaccines;
(ii) sensitivity to eggs, antibiotics and preservatives;
(iii) possibility of pregnancy;
(iv) concurrent medication such as immuno-suppressive agents;
(v) presence of other diseases, for example febrile conditions, active untreated tuberculoses, eczema, leukaemia, lymphoma, other malignancies, etc.; and
(vi) general health status of the patient, including the immune status of the patient (e.g. immuno-suppression).
(i) Pharmacists performing immunisations must be familiar with the handling of syringes and administration devices.
(j) Pharmacists performing immunisations must have the necessary skills to administer injections.
(k) Pharmacists performing immunisations must be familiar with the National and Provincial schedules for immunisation of infants, children and travellers.
(l) Pharmacists performing immunisations must be familiar with the WHO guidelines for the prevention of HIV and Hepatitis virus. The WHO has recommended that 'universal' precautions be taken with all patients, i.e. all patients be treated as if potentially infected and all body fluids and specimens from all patients must be treated as potentially infectious. Infection control precautions existing in health care settings for Hepatitis B are sufficient to prevent transmission of HIV.
(m) The following general injection procedures must be followed:
(i) Ensure privacy.
(ii) Strict aseptic technique must be applied.
(iii) Locate the injection site anatomically.
(iv) Prepare medication. Determine the correct syringe capacity, needle gauge and needle length.
(v) Check the dosage.
(vi) Get the patient to relax.
(vii) Get assistance if the patient is very young or nervous.
(n) Pharmacists must be familiar with:
(i) The possible adverse reactions to vaccines.
(ii) The recommended time and route of administration of the different vaccines.
(iii) The contra-indications for injections in general and for vaccines in particular.
(iv) The local effects of injections.
(v) The management of anaphylaxis including the prevention of anaphylaxis.
(vi) The management of cardio-pulmonary resuscitation.
(o) The pharmacist must carefully review package inserts before deciding to administer a vaccine as some contain preservatives (e.g. thiomersal) or trace amounts of antibiotics (e.g. neomycin) to which patients may be hypersensitive.
(p) After immunisation the pharmacist must complete the patient immunisation card.

 

2.14.3 Documentation and record keeping

 

(a) Immunisation cards must be completed to keep a record of immunisations. This information must be kept for a period of at least five years. The record cards must contain the following details:
(i) patient name, and address, and ID number;
(ii) date of birth of patient;
(iii) date of administration of vaccine;
(iv) name of manufacturer;
(v) batch number of vaccine;
(vi) expiry date;
(vii) route of administration;
(viii) date of next injection;
(ix) signature of pharmacist/nurse who administered vaccine; and
(x) other important information, e.g. previous reactions to vaccines and sensitivity to eggs, antibiotics and preservatives which may be contained in vaccines.
(b) Immunisation of children must be noted on the growth chart supplied by the Department of Health ('Road to Health card').
(c) Should it be requested that all patient records be made available to doctors, this must be complied with.
(d) Co-operation with local clinics must be maintained.
(e) The pharmacist must provide immunisation statistics to the local District Health Co-ordinator for epidemiological purposes and for proper stock control.

 

2.14.4 Ethical aspects

 

(a) Confidentiality of patient information must be ensured throughout. Patient information must only be disclosed with the consent of the patient or, in the case of a minor, with the consent of the parent or guardian, or where such information must be furnished to a person authorised by law to request it, unless such disclosure is in the interest of the patient.
(b) In the provision of the service, the pharmacist must always act in the best interest of the patient.

 

2.14.5 Training

 

(a) Pharmacists must ensure that they have adequate training, knowledge and skills to provide the service.
(b) Pharmacists must be competent in cardio-pulmonary resuscitation techniques.
(c) Pharmacists involved in this service must be aware of:
(i) the importance of a professional manner;
(ii) confidentiality of patient information;
(iii) the benefits and risks associated with the use of immunisation agents;
(iv) the instructions and requirements of individual vaccines;
(v) the necessity of record keeping.