Optometrists: exemptions from Medicines Act restrictions

Under the Medicines Act 1968 medicines classified as Pharmacy (P) medicines may be sold or supplied only through registered pharmacies by or under the supervision of a pharmacist (section 52). Prescription only (POM) medicines are subject to an additional requirement: they may only be sold or supplied through pharmacies against a doctor's or dentist's prescription (section 58). General Sale List (GSL) medicines may be sold more widely through other retail outlets (sections 51 and 53).

Exemptions from the general rules are permitted for optometrists.  These are  provided for in the Prescription Only Medicine (Human Use Order) 1997 SI No 1830 (The "POM Order"), the Medicines (Pharmacy and General Sale- Exemption) Order 1980 SI No 1924, the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 SI No 1923. 

Registered optometrists
Provided it is in the course of their professional practice, registered optometrists may sell or supply the following medicinal products to a patient:

• All medicinal products on a General Sale List (Note: Under medicines  legislation products which are for use as eye drops or eye ointments are excluded from the GSL category.); and
     
• All P medicines .

Provided it is in the course of their professional practice and in an emergency, registered optometrists may sell or supply:         

POMs which are not for parenteral administration and which:
a. are eye drops and contain not more than 0.5 per cent chloramphenicol or
b. are eye ointments and contain not more than 1 per cent chloramphenicol 
c. contain the following substances:
     Cyclopentolate hydrochloride
     Fusidic Acid
     Tropicamide

The POMs to which this exemption applies may also be sold or supplied by a person lawfully conducting a retail pharmacy business on the presentation of an order signed by a registered ophthalmic optician.

Additional supply optometrists
In addition to being able to access the medicines listed in paragraphs 3 and 4 above,  those optometrists who have undergone additional training and are accredited by the General Optical Council (“additional supply optometrists”) will be able to sell, supply or write an order for an extended range of medicines.  

Provided it is in the course of their professional practice and in an emergency, additional supply optometrists can sell or supply prescription only medicines containing the following substances:

Acetylcysteine
Atropine sulphate
Azelastine hydrochloride
Dicofenac sodium
Emedastine
Homotropine hydrobromide
Ketotifen
Levocabastine
Lodoxamide
Nedocromil sodium
Olopatadine
Pilocarpine hydrochloride
Pilocarpine nitrate
Polymyxin B/bacitracin
Polymyxin B/trimethoprim
Sodium cromoglycate

The POMs to which this exemption applies may also be sold or supplied by a person lawfully conducting a retail pharmacy business on the presentation of an order signed by a registered ophthalmic optician.  

An order made under the Opticians Act 1989 provides that where it appears to a registered optometrist that a person consulting him/her is suffering from an injury or disease of the eye, the optometrist shall refer that person to a registered medical practitioner, except in specified circumstances including an emergency or where otherwise  it is impractical or inexpedient to do so or there is no justification for such a referral.   There is no legal definition of what is "an emergency" for the purposes of the Medicines Act exemptions or the specific criteria governing referral under the Opticians Act.  It is therefore for the optometrist to make a professional judgement as to whether there is in fact an emergency and what measures need to be taken in the best interests of the patient, bearing in mind the Opticians Act, the GOC rules and Medicines legislation.  

All POMs and P medicines to which Medicines Act exemptions apply may be sold to a registered optometrist by way of wholesale dealing. 

Also, under the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980, a registered optometrist may obtain the following medicinal products by way of wholesale dealing:
  

• P medicines for administration in the course of his business.
  
• POM medicines for administration (as opposed to sale or supply) containing the following substances:
      Amethocaine hydrochloride
      Lignocaine hydrochloride
      Oxybuprocaine hydrochloride
      Proxymetacaine hydrochloride.
  

An additional supply optometrist will also be able to obtain thymoxamine hydrochloride via wholesale dealing should a commercial preparation become available.       

An order for POMs should include: optometrist's name and address, the date, name and address of the patient (if applicable), the purpose for which the POM is to be supplied (eg use in professional practice, refraction, etc), name, quantity, and except where apparent from the name, the pharmaceutical form and strength of the POM, labelling directions (where applicable), the signature of the optometrist (which must be original).  The signed order must be written in indelible ink (includes typewritten and computer generated orders).

For the purposes of paragraphs 3 and 7 above, eye drops and eye ointments  containing the following substances are classed as P medicines: 
   
Antazoline (up to 1%)
Azelastine hydrochloride (up to 0.1% for the treatment of the signs and symptoms of allergic conjunctivitis
Dibromopropamidine isethionate
Fluorescein sodium
Levocabastine (up to 0.05% for the symptomatic treatment of seasonal allergic conjunctivitis
Lodoxamide (up to 0.1% for ocular signs and symptoms of allergic conjunctivitis
Phenylephrine hydrochloride
Propamidine isethionate
Rose Bengal
Sodium cromoglicate (Only for the treatment of acute seasonal allergic conjunctivitis or perennial allergic conjunctivitis and subject to a maximum strength of 2% for eye drops or 4% for eye ointment.  Products containing this substance are also subject to restrictions on maximum quantity which may be sold or supplied as a P medicine.  These are not more than 10ml for eye drops and 5g for eye ointment.) 
Various tear supplements and ocular lubricants
Xylometazoline hydrochloride

It should be noted that this list only contains substances most commonly used by     optometrists. 

Contact for further information
For further information on this part of our site, please contact our Sale and Supply section, MHRA, 16-142, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020 7084 2392, fax 020 7084 2121 or e-mail info@mhra.gsi.gov.uk.