Ophthalmologists' section

 
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Hot topics
› Committee on the Safety of Devices: New members required
› Proposals for amendments to medicines legislation to allow dispensing opticians access to certain prescription only medicines (POMs) - This consultation seeks views on proposals for amendments to medicines legislation to allow dispensing opticians access to certain prescription only medicines (POMs).

Ophthalmic Medical Device Alerts
Medical devices and equipment are items used for the diagnosis and/or treatment of disease, for monitoring patients, and as assistive technology. Medical Device Alerts (MDAs) are the MHRA's prime means of communicating safety information to medical device users in health and social care. Each MDA is designated either for Immediate action or Action. MDAs may also be used to provide updated information.
› 21 April 2008 - Faulty manufacturing of Merlin Medical Limited pen torch can result in the bulb exploding upon illumination
› 18 June 2007 - Acanthamoeba keratitis with COMPLETE® MoisturePLUS™ contact lens solution from Advanced Medical Optics (AMO)
› 31 May 2006 - Fusarium keratitis with ReNu with MoistureLoc® contact lens solution from Bausch & Lomb
› 5 April 2004 - Opacification of AQUA-SENSE Hydrophilic Intraocular Lens by Ophthalmic Innovations International Inc
› 5 April 2004 - Opacification of Bausch & Lomb HYDROVIEW H60M Intraocular Lens

Ophthalmic Drug Alerts
If a defective medicine is thought to be a risk to public health, the product is withdrawn from the market and information from the MHRA issued:
› 21 November 2007 - Chloramphenicol eye drops 0.5% recalled due to rough surface on dispenser
› 21 November 2007 - Hypromellose eye drops recalled due to rough surface on dispenser
› 21 November 2007 - Timolol eye drops 0.25 and 0.5% recalled due to rough surface on dispenser

Drug Safety Update - the monthly newsletter from the MHRA and Commission on Human Medicines
Our monthly electronic newsletter aims to give the latest advice for all medicines users to ensure the safe use of medicines:

Highlights:
› February 2008 - Varenicline: safety update
› January 2008 - Statins: interactions, and updated advice for atorvastatin
› December 2007 - Rosiglitazone and pioglitazone: cardiovascular safety
› October 2007 - Botulinum toxin products: rare but serious risk
› September 2007 - Corticosteroids: early psychiatric side-effects
› August 2007 - Extraneal and products that contain (or are metabolised to) maltose, xylose, or galactose: false glucose reading, α1-adrenoreceptor antagonists and intraoperative floppy iris syndrome, smoking-cessation aids

Recent ophthalmic MHRA publications

DB 2008(03) Guidance on the safe use of lasers, IPL systems and LEDs - Updated 14 November 2008
This guidance document relates to medical lasers and other types of optical radiation devices, including light emitting diodes (LEDs) and intense light/heat sources, referred to as intense pulsed light (IPL) (sources) systems.
› DB 2008(03) Guidance on the safe use of lasers, IPL systems and LEDs

Do you prescribe triamcinolone?
Subconjunctival, sub-Tenon, retrobulbar and intraocular injections of triamcinolone (Kenalog) are off-label uses.
› Serious adverse reactions associated with intra-ocular administration of Adcorty/Kenalog injections (42Kb)  

Intraoperative floppy iris syndrome (IFIS)
In April 2005, patients given tamsulosin for treatment of benign prostatic hyperplasia were identified as having an increased risk of IFIS. This syndrome that can lead to surgical complications during cataract surgery. The following report discusses the data used in the regulatory assessment of a potential class effect of α-1 adrenoceptor antagonists and development of IFIS.
› Intraoperative floppy iris syndrome

Do you prescribe atorvastatin?
Information about important interactions with atorvastatin and risk of haemorrhagic stroke in patients with recent stroke.
› Prescribing advice for atorvastatin (83Kb)

One Liners
All medical devices can fail, but many incidents that result in significant morbidity or mortality arise out of user/device interface problems or because of poor practices. The aim of One Liners is to outline these problems to make users more aware of what can go wrong - it is all too easy to take equipment for granted.

Crystal Clear?
The MHRA has received a report of Povidone Iodine (Betadine) staining intraocular lens material, resulting in opacification.
This solution should only be used to disinfect the eyes and surrounding skin prior to surgery, and should not be used on the open wound following intraocular lens implantation.
› One Liners

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

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

• Prescription only eye drops which contain not more than 0.5% of chloramphenicol;
• Prescription only eye ointments which contain not more than 1% chloramphenicol;
• Prescription only eye drops which contain cyclopentolate hydrochloride, fusidic acid and tropicamide;

In addition to the above medicines, those optometrists who have undergone additional training and are accredited by the General Optical Council, will be able to sell, supply or write an order for an extended range of medicines. The full list is available in our Optometrists: exemptions from Medicines Act restrictions section.

Have you thought about...

Are glasses medical devices?
Yes they are.
› Ophthalmic products

Herbal medicines
Are you unsure about a possible effect a patient’s herbal medicine may have?
› Herbal safety advice

NICE produces guidance in three areas of health:

• Public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector.
• Health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS.
• Clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

› National Institue of Clinical Excellence (external link)

Reporting of adverse incidents or adverse drug reactions
Any actual, suspected, potential or avoided adverse event should be reported. Further examples of cases which should be reported are available in the sections below. If in doubt, please report.

You can help us by reporting adverse incidents. These reports enable us to identify medical devices and medicines that are of concern and allow us to take appropriate action.

What should I report if I suspect a medicine is associated with an adverse reaction?
Please complete a Yellow Card to report suspected adverse reactions to prescription medicines, over-the-counter medicines, or herbal remedies. For further information, please see www.yellowcard.gov.uk.  We are particularly interested in receiving Yellow Cards that report serious adverse reactions to established medicines, or that report any reaction for a medicine that is new to the market and carries a black triangle. So that we can assess the Yellow Card, please ensure that you report the suspect drug(s); suspect reaction(s); and basic patient details if known (age, sex, weight, patient's initials, and local identification number for your reference).

Please clarify what a medical device is and what I should report?
Follow this link to a small Q&A session on what a faulty medical device is, and when it should be reported.