§ Mr. Carter-Jonesasked the Secretary of State for Social Services (1) what information his Department has concerning the resistance of rubella vaccine to both heat and light; and what is the maximum period of time during which the vaccine maintains its potency;
(2) what advice has been given by his Department to general practitioners concerning the susceptibility of rubella vaccine to both heat and light and, therefore, the precautions that should be taken in the administration of the vaccine;
(3) if rubella vaccine is issued in containers which are light resistant; and whether clear instructions are given as to its temperature requirements,
(4) if the packaging of rubella vaccine shows contra-indications to pregnancy, and clearly states the importance of avoiding pregnancy for at least three months following a rubella vaccination; and if he will make a statement;
(5) what specific instructions are given to women who themselves purchase rubella vaccine on their doctors' instructions, to safeguard the properties of the vaccine.
§ Dr. Vaughan[pursuant to his reply, 20 December 1979, c. 362–3]:The two available rubella vaccines have been in use for many years and have product licences of right under the Medicines Act 1968.
Information available to the Department indicates that rubella vaccines in their unconstituted form are resistant to temperature of between 2° and 8°C. In the interests of safety it is recommended that they should be protected from light whilst in storage. The primary containers of the vaccine are not light resistant but they are supplied in cardboard boxes which effectively exclude light. In accordance with the requirements of the Medicines (Labelling) Regulations 1976, details of special storage requirements including temperature levels are shown on labels and packaging. The packages also contain a leaflet giving details of contraindications and warnings associated with the product. The contra-indications include pregnancy and there is a warning that pregnancy should be avoided for at least eight weeks after vaccination.
666WProvided that it is stored in accordance with the manufacturer's directions, the unconstituted vaccine retains potency for two years. After reconstitution it should be kept cool and used within the hour.
In January and July 1970, the then chief medical officer of the Department wrote to all general practitioners about rubella prophylaxis. These letters included mention of the temperature requirements for storage of the vaccine and the correct method of administration. The vaccine is administered by subcutaneous injection as soon as possible, and in any event within one hour at room temperature, after reconstitution.
Similar information was contained in a departmental booklet entitled "Immunisation Against Infectious Disease", which was prepared by the Standing Medical Advisory Committee and published in July 1972.
In addition, the manufacturers of the vaccines have supplied detailed information to practitioners by means of data sheets which comply with the requirements of the Medicines Act 1968. These data sheets are included in the data sheet compendium of 1979–80 issued by the Association of the British Pharmaceutical Industry to all doctors. The data sheets include the pharmaceutical precautions necessary for the proper storage of the products as well as details on dosage and administration, and on contra-indications and warnings.
When a doctor asks a patient to obtain rubella vaccine, the nature of any specific instructions given to the patient will depend on the particular circumstances and must be left to the clinical judgment of the doctor concerned in the light of the information generally made available to the profession.