Letter on Compounding Pharmacies
We are writing on behalf of the American Academy of Ophthalmology, the
largest membership association of ophthalmologists in the United States, as well
as the American Society of Retina Specialists, the American Glaucoma Society,
the American Association for Pediatric Ophthalmology and Strabismus, and the
Cornea Society, in response to the recent actions to enforce patient-specific
prescription requirements for special drugs produced by compounding
pharmacies.
Ophthalmologists are committed to ensuring the safety and integrity of the medications our patients receive. However, we are concerned that strict implementation of patient-specific prescription requirements would preclude access to essential drugs necessary for the treatment of patients with vision-threatening conditions, particularly in emergency situations.
We agree that, in general, compounded pharmaceuticals should be dispensed according to a prescription for a specific patient. However, outpatient use of compounded agents has become essential to many ophthalmology practices, where our members frequently need to have certain sterile and non-sterile medications on hand to treat potentially disastrous situations on an emergent or urgent basis. If medication is not on hand when our members encounter an emergency situation, patients with certain conditions face serious vision loss or permanent blindness due to delay in obtaining medications needed for treatment. A further complicating factor is that most ophthalmologists practice in office settings and do not have the ready access to a hospital pharmacy that many inpatient or hospital outpatient providers have. This makes the impact of restrictions on access to compounded medications more significant to ophthalmology practices and patients than to many other medical providers.
Examples of clinical conditions treated on an ambulatory basis for which it is imperative that ophthalmologists have a supply of medication on hand include:
A second and very common issue is associated with the urgent care of patients with age-related macular degeneration. These patients are treated monthly with intravitreal injections of VEGF-inhibitor medications if their disease is still active. Many practitioners have been able to provide a same day injection of the medication if it is needed from a stock of medication, reporting the name of the recipient at that time. This practice avoids a clinically important delay in the patient receiving the compounded medication and likely improves the outcome of treatment. Lack of same-day medication availability will reduce access to care when a return visit is necessary in this cohort of elderly patients who often require transportation assistance. Restrictions on the ability of ophthalmologists to provide treatment in an efficient manner may significantly impact the prognosis of patients with this condition.
We recognize the complexities of this issue, but respectfully request that your state:
1) Consider regulatory or legislative framework that balances the need to ensure the safety of compounded medications with the critical need of providers to have ready access to the same, sometimes in the absence of a patient-specific prescription. Specifically, we encourage you to immediately provide a framework that ensures access to compounded medications for emergency and office use where a patient can be assigned within 72 hours.
2) Adopt USP 797 guidance for sterile compounds (if your state has not already done so).
3) Engage national and state provider associations as regulations and legislation affecting provider access to compounded medications are considered and maintain an open dialogue with providers to ensure the needs of their patients are not adversely affected by any Board action.
We thank you in advance for your consideration of these important issues. The Academy and its members look forward to working with you to find a solution that ensures the safety and integrity of compounded mediations while preserving access to these important drugs.
Sincerely,
Ruth D. Williams, MD
President
American Academy of Ophthalmology
20 F Street NW Suite 400
Washington, District of Columbia 2001
202-737-6662
Contact: Rebecca Hyder, Director of Congressional Affairs, rhyder@aaodc.org or 202-737-6662
John Thompson, MD
President
American Society of Retina Specialists
20 North Wacker Drive, Suite 2030
Chicago, Illinois 60606
312-578-8760
Contact: Jill Blim, Executive Vice President, jill.blim@asrs.org or 312-578-8760
David K. Epley, MD
President
American Association for Pediatric Ophthalmology and Strabismus
P.O. Box 193832
San Francisco, California 94119
415-561-8505
Contact: Christie Morse, MD, Executive Vice President, cmorse@crhc.org, 603-224-2020
Jeffery M. Liebmann, MD
President
American Glaucoma Society
P.O. Box 193940
San Francisco, California 94119
415-561-8587
Contact: Cynthia Mattox, MD, Patient Care Committee Chair, cindiem@gmail.com, 415-561-8587
Donald Tan, FRCS
President
The Cornea Society
4000 Legato Road Suite 700
Fairfax, Virginia 22033
703-591-0196
Contact: Gail Reggio, Executive Director, greggio@corneasociety.org, 703-591-0196
Ophthalmologists are committed to ensuring the safety and integrity of the medications our patients receive. However, we are concerned that strict implementation of patient-specific prescription requirements would preclude access to essential drugs necessary for the treatment of patients with vision-threatening conditions, particularly in emergency situations.
We agree that, in general, compounded pharmaceuticals should be dispensed according to a prescription for a specific patient. However, outpatient use of compounded agents has become essential to many ophthalmology practices, where our members frequently need to have certain sterile and non-sterile medications on hand to treat potentially disastrous situations on an emergent or urgent basis. If medication is not on hand when our members encounter an emergency situation, patients with certain conditions face serious vision loss or permanent blindness due to delay in obtaining medications needed for treatment. A further complicating factor is that most ophthalmologists practice in office settings and do not have the ready access to a hospital pharmacy that many inpatient or hospital outpatient providers have. This makes the impact of restrictions on access to compounded medications more significant to ophthalmology practices and patients than to many other medical providers.
Examples of clinical conditions treated on an ambulatory basis for which it is imperative that ophthalmologists have a supply of medication on hand include:
- Compounded intravitreal antibiotics for treatment of endophthalmitis, a serious infection of the eye requiring emergent antibiotic intervention. Delayed treatment can result in permanent loss of vision, and even loss of the eye itself.
- Compounded fortified topical antibiotics for bacterial corneal ulcers, where delayed treatment can result in corneal perforation, corneal scarring, or partial or complete blindness within a short period of time.
- Compounded intravitreal vascular endothelial growth factor (VEGF) inhibitors (e.g., bevacizumab) for emergent treatment of conditions such as neovascular glaucoma, where immediate and aggressive treatment is imperative and delayed treatment can result in complete loss of vision.
- Compounded Mitomycin C for emergency treatment of failing glaucoma filtration procedures and intraoperative treatment at the time of glaucoma filtration surgery. Preventing fibrosis and scarring is crucial for the long term success of glaucoma filtration procedures to prevent blindness from glaucoma.
- Compounded combination dilating drops for diagnostic use in pediatric patients. Pediatric patients sometimes have difficulty in receiving multiple eye drops, making the combination drop essential to pediatric ophthalmology practices.
A second and very common issue is associated with the urgent care of patients with age-related macular degeneration. These patients are treated monthly with intravitreal injections of VEGF-inhibitor medications if their disease is still active. Many practitioners have been able to provide a same day injection of the medication if it is needed from a stock of medication, reporting the name of the recipient at that time. This practice avoids a clinically important delay in the patient receiving the compounded medication and likely improves the outcome of treatment. Lack of same-day medication availability will reduce access to care when a return visit is necessary in this cohort of elderly patients who often require transportation assistance. Restrictions on the ability of ophthalmologists to provide treatment in an efficient manner may significantly impact the prognosis of patients with this condition.
We recognize the complexities of this issue, but respectfully request that your state:
1) Consider regulatory or legislative framework that balances the need to ensure the safety of compounded medications with the critical need of providers to have ready access to the same, sometimes in the absence of a patient-specific prescription. Specifically, we encourage you to immediately provide a framework that ensures access to compounded medications for emergency and office use where a patient can be assigned within 72 hours.
2) Adopt USP 797 guidance for sterile compounds (if your state has not already done so).
3) Engage national and state provider associations as regulations and legislation affecting provider access to compounded medications are considered and maintain an open dialogue with providers to ensure the needs of their patients are not adversely affected by any Board action.
We thank you in advance for your consideration of these important issues. The Academy and its members look forward to working with you to find a solution that ensures the safety and integrity of compounded mediations while preserving access to these important drugs.
Sincerely,
Ruth D. Williams, MD
President
American Academy of Ophthalmology
20 F Street NW Suite 400
Washington, District of Columbia 2001
202-737-6662
Contact: Rebecca Hyder, Director of Congressional Affairs, rhyder@aaodc.org or 202-737-6662
John Thompson, MD
President
American Society of Retina Specialists
20 North Wacker Drive, Suite 2030
Chicago, Illinois 60606
312-578-8760
Contact: Jill Blim, Executive Vice President, jill.blim@asrs.org or 312-578-8760
David K. Epley, MD
President
American Association for Pediatric Ophthalmology and Strabismus
P.O. Box 193832
San Francisco, California 94119
415-561-8505
Contact: Christie Morse, MD, Executive Vice President, cmorse@crhc.org, 603-224-2020
Jeffery M. Liebmann, MD
President
American Glaucoma Society
P.O. Box 193940
San Francisco, California 94119
415-561-8587
Contact: Cynthia Mattox, MD, Patient Care Committee Chair, cindiem@gmail.com, 415-561-8587
Donald Tan, FRCS
President
The Cornea Society
4000 Legato Road Suite 700
Fairfax, Virginia 22033
703-591-0196
Contact: Gail Reggio, Executive Director, greggio@corneasociety.org, 703-591-0196