Medicines legislation: what does it mean for podiatrists?
Access to medicines is determined by law, and the underpinning primary legislation for this is enshrined in the Medicines Act (1968).
From time to time, however, the provisions of the Medicines Act (1968) are modified by the introduction of further legislation which ‘amends’ certain features of the Act. This includes rights to access, supply, administer and prescribe medicines.
Amending legislation (where the provisions of the primary Act of Parliament, the Medicines Act 1968, are changed slightly) is enabled by means of ‘secondary legislation’. Secondary legislation (sometimes known as delegated legislation) is laid in Parliament in the form of a Statutory Instrument. Statutory Instruments (commonly called ‘SIs’) allow certain parts of the primary Act (the Medicines Act 1968) to be altered. Each time this occurs, a further Statutory Instrument is introduced, superceding previous versions, or augmenting them.
Over time, this has meant that podiatrists have been granted powers to access and use medicines on several occasions, each time changing (expanding) slightly the range of medicines and changing rights to access, supply, administer or prescribe medicines. This has occurred incrementally over a period of more than 30 years.
A Statutory Instrument is given a number alongside the year of publication, for example “2013 No. 1855”. Podiatrists have had rights conferred, expanded and adjusted several times over the years, in many SIs.
In 2012 all the relevant Statutory Instruments were brought together within one over-arching SI, known as the Human Medicines Regulations 2012. Podiatrists wishing to consult existing rights to the access, supply and administration of medicines should consult these regulations. There has been one modification since 2012 to the Human Medicines Regulations (2012), by means of another SI: to allow independent prescribing by podiatrists (SI 2013, No. 1855).
For archival purposes, all the relevant and available SIs are included in this resource. However, the key legislation outlining current rights to access, supply, administration and prescribing of medicines is contained in the Human Medicines Regulations (2012) (SI 2012, No 1916) and the Human Medicines (Amendment) Regulations (2013) (SI 2013, No. 1855).
You can read a little more about Statutory Instruments here: http://www.parliament.uk/business/bills-and-legislation/secondary-legislation/statutory-instruments/
A chronological list of Statutory Instruments relating to the access, supply, sale, administration and prescription of medicine by podiatrists is identified here:
The Medicines (Pharmacy and General Sale – Exemption) Order 1980 (SI No. 1924)
The Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 (SI No. 1923)
The Prescription Only Medicines (Human Use) Order 1980 (SI No. 1921)
The Medicines (Pharmacy and General Sale – Exemption) Amendment Order 1998 (SI No. 107)
The Prescription Only Medicines (Human Use) Exemption Order 1998 (SI No.108)
The Prescription Only Medicines (Human Use) Amendment (No.3) Order 1998 (SI No.2081)
The Prescription Only Medicines (Human Use) Order 1997 (SI No. 1830)
Podiatrists able to access, supply and administer certain specified POM medicines via patient group directions (PGDs) (Health Services Circular 2000/026). PGDs were given legal force via:
The Prescription Only Medicines (Human Use) Amendment Order (2000)
The Medicines (Pharmacy and General Sale- Exemption) Amendment Order (2000)
The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment No. 2 Regulations (2000).
Podiatrists (alongside physiotherapists and radiographers) were granted supplementary prescribing rights under:
The Medicines for Human Use (Prescribing) Order 2005 (SI No 765)
The Medicines (Pharmacy and General Sale – Exemption) Amendment Order 2005 (SI No 766)
The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 2005 (SI No 764)
The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (SI No. 2807)
The Medicines (Miscellaneous Amendments) Order 2011 SI 2011 No. 1327
The Human Medicines Regulations, SI 2012, No.1916
The Human Medicines (Amendment) Regulations, SI 2013, No. 1855
Dangerous Drugs, England and Wales, Dangerous Drugs, Scotland
The Misuse of Drugs (Amendment) (No.2) (England, Wales and Scotland) Regulations 2015, SI 2015, No 891
The Misuse of Drugs (Amendment) Regulations (Northern Ireland) 2019: SI 2019, No 208.
Electronic copies of the relevant Statutory Instruments are enclosed (where available electronically. The College possesses paper copies and these may be obtained on request – there may be a small fee attached for postage).
You may also search for electronically available Statutory Instruments here: http://www.legislation.gov.uk/browse
The Medicines Act (1968)
HMRs (Exiting EU) 2019
SI 2014 No 1275 Tramadol becomes CD
SI 2013 No 235 PGDs authorised by CCG NHS Enfland p 73-4