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Immunisations

There has always been some confusion over the process for administering immunisations in occupational health.  NHS staff assume 'NHS rules' apply, but they don't.  For the benefit of OH practitioners I have included extracts from a letter received from the MHRA in June 2009 which very helpfully outlined the various regulations:

Medicines legislation already provides for the supply and/or administration of medicines as part of an occupational health scheme (OHS). The two sets of  relevant legislation are the  Prescription Only Medicines (Human Use) Order 1997 (SI 1997 No. 1830) and the Medicines (Pharmacy and General Sale – Exemption) Order 1980, as amended. Both carry definitions of:

"occupational health scheme" means a scheme in which a person, in the course of a business carried on by him, provides facilities for his employees for the treatment or prevention of disease”

Below are the relevant extracts covering Prescription Only Medicines (POMs), Pharmacy (P) and General Sale List (GSL) medicines. Within the context of the definition of an OHS, “person” covers companies and would, for example, include companies that provide OHS schemes to other corporate bodies. An OH provider could therefore obtain stocks of licensed POMs, P or GSL medicines from a wholesale dealer or from the relevant marketing authorisation holder, provided they are to be used in the course of an OHS, via a written order signed by a doctor or a registered nurse. The supply/administration of POMs to employees as part of the OHS scheme either needs to be made by a doctor or, if not by a doctor, by a registered nurse acting in accordance with the written directions of a doctor as to the circumstances in which the POMs are to be used under the Scheme. The supply of P and GSL medicines as part of an OHS can be made by a doctor or, if not by a doctor, by a registered nurse but the directions do not have to be written.

However, if the material supplied is not a product licensed in the UK,  the importer must hold a Wholesale Dealers Licence (WL) which enables them to handle unlicensed medicines and the importer must notify the MHRA about the proposed import of an unlicensed product. The maximum volume normally permitted per notification is 25 courses of not more than 3 months (currently accepted to be 125 packs of 10 capsules of Tamiflu. Quantities might differ for other imported medicines).

EXTRACT FROM POM ORDER 1997

PART II

Article 11(1)(b) - EXEMPTIONS FROM THE RESTRICTION ON SUPPLY

PART III

Article 11(2) - EXEMPTIONS FROM RESTRICTION ON ADMINISTRATION

EXTRACT FROM MEDICINES (PHARMACY AND GENERAL SALE – EXEMPTION) ORDER 1980

PART II

Article 5(1)(b) and (2) – EXEMPTIONS FROM RESTRICTIONS ON SALE AND SUPPLY