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May 2, 2018
Mr. Kyle Steiger
VP Ophthalmology Franchise
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, QC H9S 1A9
Mr. Stu Fowler
GM Alcon Canada
Alcon Canada Inc.
2665 Meadowpine Blvd.
Mississauga, ON L5N 8C7
Dear Mr. Steiger and Mr. Fowler,
Following the letter that the Canadian Ophthalmological Society (COS) sent you on March 26, 2018 regarding the impact Novartis/Alcon’s decision to discontinue Isopto Atropine 1% (Atropine) will have on Canadian ophthalmologists, the COS has been discussing the impact this discontinuation will have on other Canadian medical specialties, specifically the Canadian Psychiatric Association (CPA) and the Canadian Society of Palliative Care Physicians (CSPCP). Our joint response to the discontinuation follows.
We understand that Novartis/Alcon have decided to discontinue the manufacturing of Atropine due to a December 2017 update issued by the United States Pharmacopeia (USP), of which Health Canada is a Member Organization. We also understand that complying with the new requirements would require extensive changes to the facility where Atropine is manufactured.
Atropine is a critical drug for many of our members’ patients. As you know, there is no substantially equivalent drug currently approved in Canada. Atropine is widely used by ophthalmologists, psychiatrists, and palliative care physicians; its discontinuation will have a significantly negative impact on their patients.
Members of the COS regularly use Atropine in the practice of the following ophthalmological subspecialties: a) Pediatric ophthalmology: for the treatment of amblyopia, to slow the progression of myopia, and for the management of pediatric cataracts, glaucoma, and uveitis; b) Glaucoma: to prevent blindness in ciliary block or malignant glaucoma, in patients with inflamed eyes and iris bombe or pupil block, and in choroidal effusions and hypotony, and for permanent dilation to decrease the risk of rebleeding in hyphemas; c) Retina: in vitreoretinal surgery dilation and postoperatively to help in cases where a patient has a gas- or oil-filled eye; and d) Uveitis.
Members of the CPA regularly use Atropine in the treatment of patients with schizophrenia. Clozapine is the best medication for treatment-resistant schizophrenia, but excessive salivation is a very common and troubling side effect of clozapine. Psychiatrists use Atropine, administered orally, to control this side effect and improve quality of life for these patients.
Members of the CSPCP rely on the use of Atropine to manage end-of-life secretions in palliative care settings. Secretions are a normal part of the dying process, as the muscles of the head and neck do not clear saliva as well as they did earlier in life. This can manifest as a gurgling sound as a patient is breathing in and out in their final hours or days of life. Atropine dries up the formation of new secretions and reduces the gurgling sound, which can be frightening for family members and caregivers (who often erroneously think that their loved one is drowning). Administering Atropine drops is easy for family members and caregivers to do, negating the need for an extra subcutaneous site to be installed by a nurse for medications such as Scopolamine and Glycopyrrolate. Atropine is also much cheaper, for the family and for the health care system, and is just as efficacious. In addition, palliative care physicians use Atropine in certain conditions, such as amyotrophic lateral sclerosis (ALS), to help dry up normal oral secretions that patients are unable to clear them themselves.
As you can see, Atropine is widely used across ophthalmology, where it is critical in preserving sight and preventing irreversible visual loss. Ongoing access to Atropine will ensure the best possible outcomes for ophthalmology patients. It is also used in psychiatry, where it helps patients with treatment-resistant schizophrenia. Given the challenges that these vulnerable patients already face in managing their symptoms, the loss of Atropine would be a significant blow. Finally, Atropine is regularly used by palliative care physicians, in community palliative care and in hospice, where it is essential in making the dying process more comfortable for patients and less frightening for family members and caregivers.
Given how broadly Atropine is used by Canadian physicians, and how important it is to ensuring quality of life for our patients, we strongly urge you to consider all possible alternatives to discontinuing Atropine. We would be pleased to work with Novartis/Alcon and other stakeholders to find a solution.
Dr. Guillermo Rocha
President, Canadian Ophthalmological Society
Dr. Nachiketa Sinha, MBBS, MBA
President, Canadian Psychiatric Association
Dr. J. David Henderson
President, Canadian Society of Palliative Care Physicians