From Mr D. Wright
SIR,-We have today had our attention drawn to the letter from Val Haylor of the Royal Hallamshire hospital about the need for agreement on the use of colour in labelling (PJ, February 19, p296) and feel that our experience, particularly in terms of parallel-imported ophthalmic solutions, might be of interest to your readers.
At the International Glaucoma Association, we are experiencing increasing levels of patient contacts as a result of the poor and variable presentation of parallel-imported glaucoma eye-drops. An apparent lack of accountability and audit in the supply and distribution logistics of such products has the potential seriously to undermine patient safety, compliance and confidence in what is lifelong treatment for a sight-threatening disease.
Glaucoma is the leading cause of preventable blindness in the UK. Medical treatment usually requires the topical administration of one or more eye-drops to help arrest or delay visual loss due to glaucomatous damage. Effective compliance with prescribed regimens is recognised by clinicians as a key element in ensuring the efficacy of topical glaucoma therapy.
We are faced with growing evidence of an increasing incidence of patient unease and anxiety among an elderly population, a significant proportion of which is as a result of the distribution of parallel-imported glaucoma eye-drop bottles. We generally try to allay the fears of the patient and suggest that next time they see their ophthalmologist, they request that the prescribed medication is specified as being in the original UK pack.
Non-standardisation of packaging of the same ophthalmic solution creates confusion among many elderly patients, some already suffering from impaired vision and other ailments such as arthritis. Many glaucoma patients are receiving multiple treatments for a range of medical conditions - the majority are used to looking for the same style bottle with the same coloured cap for a particular medicine. There is tremendous variation in the quality and design of parallel-imported eye-drop bottles, even when they contain the same medicine.
Poor packaging and routine relabelling of many parallel-imported ophthalmic solutions can panic patients, some of whom may think that the product has been tampered with. There was one instance where a parallel import from France carried a shelf-life statement of 14 days on opening rather than the usual 28 day shelf life. The medicine was prescribed as a 28-day supply and the two-week shelf life statement terrified the patient. In some instances the print on the over-labelling is illegible, and product information leaflets have been supplied in foreign languages only. Parallel-imported products may have different batch numbers on different packaging components. Information on the expiry date of the product's shelf life may not be available on the packaging.
Ocular side effects associated with topical eye-drops are clearly of concern to both physician and patient. There have been patient reports where particular batches of parallel imported prescribed medicines have been associated with increased levels of stinging and ocular discomfort. The patient may doubt that he is taking the right medicine, or may lose confidence in the treatment regimen itself, threatening effective control of the disease.
Now with the encroachment of parallel importers into more specialist medical areas, it should be remembered that, unlike pills, specialist ophthalmic solutions have specific pharmaceutical storage requirements, both in transit and when dispensed. The beta-adrenergic antagonist timolol, for example, has to be kept out of the light, has a shelf life of two years and must be kept at room temperature. Latanoprost, the popular once-daily eye-drop, has to be stored in the refrigerator. We understand that there would appear to be no transparent audit control ensuring that the proper pharmaceutical storage requirements are fulfilled by the parallel importing agent during transit and local distribution.
I am sure that you will agree that accountability in terms of presentation, labelling, product information and quality control of topical pharmaceutical preparations is of the utmost concern. In the interests of patient safety and compliance, we would urge reconsideration of the wisdom of allowing parallel imports of these specialist medications. If they are to continue, we would recommend implementation of a monitoring system to ensure that the appropriate pharmaceutical quality and safety control measures are strictly adhered to with regard to parallel imports of glaucoma eye-drops.
David Wright
Chief Executive, International Glaucoma Association, King's College Hospital, London SE5