Compounded Atropine Eye Drops: Uses and Information
Have you heard of nearsightedness? Do you have trouble seeing things far away? This eye condition affects 25% of Americans.
For decades, eye doctors have prescribed glasses. New forms of treatment are now used in specific cases. One form of therapy in children is low-dose atropine eye drops, usually one of three strengths: Atropine 0.01%, Atropine 0.02% or Atropine 0.05%.
Low-dose atropine eye drops are not commercially available. They require compounding in a pharmacy. Continue reading to learn more about compounding and atropine eye drops.
Why Is Compounding Used for Some Prescriptions?
Pharmaceutical compounding involves creating a new strength, concentration, or dosage form of a medication. A compounded medication isn’t available on a general commercial basis. It’s made to meet the needs of a specific patient or group of patients.
The State Board of Pharmacy oversees and enforces the standards applying to the production of compounded medications. The FDA has a very limited role that circumvents equipment, materials, containers and labeling.
Common examples of compounded medications include capsules, creams, or gels. They may create a medication in liquid form for injection or swallowing. They can also flavor medications to increase patient compliance with the prescription.
These compounds are often made by local pharmacists. Compounding companies also specialize in making these individualized medications. Compounding requires pharmacy professionals to follow many guidelines specifically listed in USP <795> and USP <797> .
This ensures that medications meet state and federal standards. Adherence to applicable quality standards ensures the patient’s safety.
Why Is Sterility Important?
Several years ago, some compounded medications became contaminated and people got sick. Some individuals died from the illness. Implementation of revised Regulations and procedures are now in place to help prevent contamination of compounded products. However, carefully selecting a compounding pharmacy with a proven record of process validation, including potency, sterility, endotoxin and training are critical.
Compounded eye drops meet the criteria for a Risk Level III preparation. This is the highest risk standard for sterile medications available. It’s imperative that the compounding pharmacy’s process has undergone validation with an in-depth potency and sterility verification program for aseptic preparations.
What Is Myopia?
Myopia is most often called nearsightedness. This means that you can see close up but not far away.
Myopia is seen in individuals whose eyes are longer than normal. This impacts the focusing power of the cornea and lens. This makes the focus at a point further in front of the retina instead of right on its surface.
Nearsightedness can also be caused by the cornea and/or lens being too curved for the length of the eyeball. In some cases, myopia occurs due to a combination of these factors.
Myopia occurs when the eye does not bend or refract light in the correct way. Since the light doesn’t focus as it should, images appear blurry.
This isn’t a disease. It is a disorder or problem with the eye’s ability to focus.
Children inherit myopia from their parents. It’s most often diagnosed between the ages of 8 and 12 years. However, early childhood myopia is now seen between the ages of 5 and 7 years.
When the body rapidly grows during the teenage years, myopia may get worse. There tends to be little change between the ages of 20 and 40. But, it is possible for adults to develop myopia.
What Do Atropine Eye Drops Treat?
Low-dose atropine eye drops are showing promise in the treatment of childhood myopia. Studies have demonstrated that atropine eye drops given at bedtime significantly slows the progression of nearsightedness. This helps prevent the development of severe myopia.
It’s important to understand that there is no cure for myopia. Children treated with atropine eye drops will still need glasses.
About 90% of children treated with atropine drops experience a decrease in the progression of their myopia by 50%. The earlier treatment starts, the less nearsighted they become.
Studies have also shown that stopping the atropine treatment can lead to faster progression of myopia. Thus, early diagnosis and consistent adherence to the treatment plan must continue throughout the eye-growth years.
Understanding Atropine
Atropine occurs in nature as a component of some poisonous plants. It’s refined and concentrated for medical purposes.
Atropine eye drops themselves are not new. They help to dilate the pupil for a variety of purposes. Lazy-eye has also benefited from atropine treatment.
The use of low-dose atropine for children’s myopia was accidentally discovered by researchers in Singapore. Their study involved the evaluation of larger doses of atropine.
Each study group received different doses of atropine. The control group received the lowest dose. The researchers discovered that the control group showed less increase in their myopia.
This lowest dose was 0.01% of atropine which is now the dose used for childhood myopia. One drop is put in each eye once a day. It’s often recommended to do this at bedtime. This allows the child to be sleeping during the time that redness or itching may occur.
Treatment often begins with evaluation at 1 week, 1 month, 3 months, and 6 months to evaluate effectiveness. If the myopia progression seems to decrease, then it will be initially continued for one year. Regular checkups will determine ongoing treatment plans.
Once treatment stops, the patient should see their doctor every 6 months for a year and then yearly. Further treatment may be considered if there a change in the myopia progression.
Ophthalmologists aren’t sure why this small amount of atropine seems to limit the progression of myopia. Some speculate that the atropine binds to certain growth receptors in the eyes. This may stop the stimulating cause of this condition.
Increasing Incidence of Myopia in Children
Many countries, worldwide, including the United States, are noting unprecedented rates of myopia diagnosis among children. The greatest increase is occurring in Asian countries. Today, 25% to 42% more American children have myopia compared to 30 years ago.
Researchers have identified a genetic link in families for myopia. Yet, the recent dramatic increase isn’t fully known. Some question if children’s play activities may contribute to developing myopia.
Studies have looked at sun exposure and the incidence of myopia. Children exposed to less daylight developed myopia at a higher rate. Some believe that increased screen-time is the culprit.
As a result, ophthalmologists are now recommending that children spend at least 90 minutes outside in the daylight every day. Also, limit your child’s time in front of the TV, computer, and phones.
Be sure to have your child checked by a pediatric ophthalmologist if you are worried about myopia. They have more experience with childhood myopia than those who treat adults.
People with myopia are at increased risk of developing glaucoma and retinal detachment later in life.
Side Effects of Low-Dose Atropine Eye Drops
Most children who receive low-dose atropine eye drops experience no side effects. About 1% of children will have a little redness or itching in or around the eye. Some dilation of the pupil and blurry vision has been reported.
Do You Need Compounding Services?
Our pharmacy has been fully verified and credentialed to perform sterile compounding. We routinely practice Risk Level III compounding, including atropine eye drops.
We are not a teaching facility. We do not allow students, shadowing students, or interns in the compounding rooms. Contact us for more information about the services we offer.