There are several important factors to
consider when called upon to compound a sterile ophthalmic preparation .In many cases, the drugs involved have a narrow therapeutic range
and even small errors when introduced have the potential to cause
irreversible damage to the eye. Unfortunately, it is not difficult to
locate court cases that have centered aroundloss of sight of a patient due to a compounding error.The following considerations are recommended whenever you prepare
such a product.
Ensure that there is adequate
support in the literature for the product that is prescribed and that
the requested concentration is within an acceptable range. Also make
sure that there is not a suitable commercial product available that
would eliminate the need to extemporaneously prepare a product.
The advent of new formulations in the past few years has already
drastically reduced the need for many previously compounded items.
Sterility of the final product
is a must: strict adherence to aseptic technique as well as any other
preventative measures must be in place.
The pH of the final product
must be within an acceptable range.
Anticipated stability of the
final product must be known, as well as the recommended storage
Adequate knowledge of
potential diluents or vehicles is required in order to ensure proper
tonicity, viscosity, or dissolution of the final product.
Establishment of written
procedures that fully document each step is an important consideration
in order to reduce the likelihood of errors. Whenever calculations
are required, there should be a secondary source available to verify the
accuracy. Also, if multiple dilutions are needed, it is
recommended that a new syringe be used for each step in order to
minimize the impact of residual contents. One should also use the
smallest possible syringe for each measurement in order to
If the preparation of a
product requires the breaking of an ampule or the reconstitution of a
powder (e.g. cefazolin), it is recommended that the final product be
filtered prior to packaging in order to eliminate any particulate
The preparation of
intra-ocular products requires the use of preservative-free ingredients.
Many preservatives have been found to be toxic to the inner ocular
Finally, before dispensing
the finished product, always indicate the storage requirements,
concentrations of ingredients, and the expected expiration date.
American Society of
Hospital Pharmacists, Inc. ASHP technical assistance
bulletin on pharmacy-prepared ophthalmic products. Am J
Hosp Pharm. 1993; 50:1462-3.
Guidelines for preparation of sterile ophthalmic products.
Am J Hosp Pharm. 1991; 48:2438-9.
a later date, I will be reviewing the various
protocols and guidelines available in the literature regarding
extemporaneously prepared ophthalmic products.
you have any guidelines you would like to submit , please use the
form at the bottom of this page.