In the US, low-concentration atropine is prepared by compounding pharmacies. Be sure to assess their quality standards and do not hesitate to ask questions before buying atropine from one.
Are you a parent of a child with myopia living in the US? Has your eye doctor recommended atropine eye drops to help control your child's myopia? If so, you're not alone. Myopia, or nearsightedness, is on the rise, and atropine is often recommended to slow down or halt its progression in children.
However, buying atropine can be a confusing process due to variations in pricing and how they are prepared. In this article, we will explore the factors to consider, how to locate a reputable pharmacy, and the questions you should ask when purchasing atropine for your child's myopia.
Atropine and myopia control in children
Atropine is a pharmaceutical medication with extensive research supporting its effectiveness in managing myopia in children. Numerous studies have investigated different concentrations of atropine, revealing that high concentration atropines (0.5%-1%) are the most effective. However, it is associated with significant side effects such as photophobia and difficulty with close-up vision, resulting in high discontinuation rates.1
Conversely, low concentration atropines (0.01% to 0.05%) have been demonstrated to be effective, but with fewer and more tolerable side effects, making them the preferred choice for myopia control in children.1
Why low concentration atropine need to be prepared by compounding pharmacies?
In the United States, the only concentration of atropine ophthalmic solution that has received FDA approval is 1%. There is no FDA-approved low concentration of atropine (0.01% to 0.05%). While a company, Vyluma Inc., is actively working on developing low-concentration atropine for myopia control in children and has submitted a New Drug Application for its 0.01% atropine to FDA for review, it is not expected to be available until at least 2024.5
This leaves parents in the US with the only option of buying low concentration atropines prepared by compounding pharmacies. However, it's important to note that the method of preparing low concentrations of atropine and the quality control and standards can significantly vary among different compounding pharmacies. And this variance can lead to differences in preservatives, impurities, storage conditions, expiration dates, and even deviations in atropine concentrations.
The quality concerns of compounded low-concentration atropine
A recent study conducted a comparison of various compounded 0.01% atropine products, examining 24 samples from nine pharmacies to assess their consistency in terms of ingredients, potency, and labeling. The results of the study raised some concerns.2
Approximately 25% of the samples contained less than 90% of the target concentration, and 21% had over 10% impurities. Additionally, the pH, thickness, and formulation of the eye drops varied among the different pharmacies. Moreover, labels and instructions differed – likely due to whether they contained preservatives, with some recommending refrigeration and others room temperature storage, and use-by dates ranging from 1 week to 6 months.2
These findings highlight potential issues related to efficacy, contamination risks - safety, and concerns related to quality control.
Considerations when buying atropine from a compounding pharmacy
When buying atropine, it is important to consider the pharmacy's licensure, certifications, and quality standards. Here are some key areas to consider:
- Licensure and Certifications: Compounding pharmacies fall under the regulation of state boards of pharmacy, which may enforce varying levels of compliance with United States Pharmacopeia (USP) guidelines. Traditional compounding pharmacies (503A pharmacies) are subject to state board regulations and adhere to USP compounding standards. Some of these pharmacies may have limitations on serving out-of-state customers. On the other hand, outsourcing facilities (503B pharmacies) engage in larger-scale sterile compounding and are regulated by the FDA, allowing them to distribute nationally across States.2
- Quality Standards and Accreditation: Seek out compounding pharmacies accredited by the Pharmacy Compounding Accreditation Board (PCAB). PCAB accreditation involves thorough site inspections and audits, ensuring the practice of high-quality compounding. This accreditation also signifies that their pharmacists and technicians have received essential training and certifications.2
- LegitScript Certification: If you are purchasing atropine online, verify if the compounding pharmacy holds LegitScript certification. This third-party program evaluates and certifies businesses' online-related activities, including those selling healthcare products. It assesses a compounding pharmacy's legitimacy, authenticity, transparency, and compliance with laws and regulations.3
Identifying a suitable compounding pharmacy
If you wish to evaluate compounding pharmacies before selecting one for the long term, here are two ways that you can find these specialized pharmacies.
- Utilize the PCAB Accredited Pharmacy List:4 The Accreditation Commission for Health Care (ACHC) offers an online list of PCAB-compounding accredited pharmacies.
- Visit the URL: https://www.achc.org/find-a-provider/
- Select "PCAB Compounding Pharmacy."
- Apply filters for “PCAB sterile compounding,” “United States,” and “State.” (from my experience, you can skip the ones with infusion-related services when clicking viewing the listed company.)
- Search for the company's website to gather information about the products they sell and their contact details.
- Ask your eye doctor: Your eye doctor may carry or may recommend a pharmacy for atropine. Getting the medication from your doctor may be more convenient and reassuring. If your doctor recommends one, the below questions can be valuable for you when ordering.
Questions to ask before ordering
When buying atropine from a compounding pharmacy, it is essential to inquire about the following important details:
- What atropine concentrations does the pharmacy offer?
- What accreditation or quality standards do they adhere to? When was the accreditation/certificate obtained and is it still effective?
- Are the compounded medications periodically tested by a third-party lab as part of the quality assurance process?
- Is the pharmacy licensed to dispense or ship to your location?
- How is the atropine prepared? Does it contain preservatives? What sterility testing is conducted?
- What testing procedures are performed on the products, and how are expiration dates and storage conditions determined?
- What measures are taken to ensure the quality of atropine during shipping and delivery?
- What is the price, and what is the expected duration of use for each vial?
- What ordering frequency and quantities are recommended?
- What is the overall cost, encompassing shipping and handling fees?
Conclusion
When evaluating and buying atropine from compounding pharmacies, you can refer to the considerations outlined in this article. The quality of atropine may impact its effectiveness, safety, storage condition, and expiration date. By posing the appropriate questions and selecting a trusted compounding pharmacy with good quality standards, you can have peace of mind keeping your child's myopia under control.
Always keep in mind that, when it comes to your child's vision, quality should never be compromised.
- Huang, Jinhai et al. “Efficacy Comparison of 16 Interventions for Myopia Control in Children: A Network Meta-analysis.” Ophthalmology vol. 123,4 (2016): 697-708. doi:10.1016/j.ophtha.2015.11.010
- Richdale, Kathryn et al. “Compounded 0.01% Atropine-What's in the Bottle?.” Eye & contact lens vol. 49,6 (2023): 219-223. doi:10.1097/ICL.0000000000000990
- LegitScript. Accessed Oct 8, 2023. https://www.legitscript.com/
- Accreditation Commission for Health Care. Accessed Oct 8, 2023. https://www.achc.org/
- Vyluma inc. Jun 6, 2023 press release. Accessed Oct 8, 2023. https://vyluma.com/press_release/vyluma-announces-fda-acceptance-of-new-drug-application-for-nvk002-its-novel-investigational-treatment-for-pediatric-myopia/
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