What are the factors in evaluating A Compounding Pharmacy? Compounding pharmacies, through the dispensing of customized medications, provide important treatments that can have a dramatic impact on a patients health and well being. Because compounding pharmacies make unique medications tailored to a patients specific needs based on the Doctors prescription, they are regulated differently than drug manufacturers. Pharmacies that have good policies and procedures, top-of-the-line equipment and continual quality control can make a compounded medication that rivals a mass-produced pharmaceutical in its potency and purity. However, variation does exist in individual pharmacies quality assurance procedures. Therefore, it is important to critically evaluate the compounding pharmacy that is going to make your medications. 6 Key Questions To Ask When Evaluating A Compounding Pharmacy 1. Where does the pharmacy source its chemicals? A compounding pharmacy should source the highest quality chemicals from reputable FDA-approved suppliers that have surpassed global standards. A certificate of analysis of any chemical used in a compounded prescription should be readily retrievable and available. 2. What kind of equipment is used? Using the right equipment can mean the difference between receiving a compounded medication that works and one that doesnt. If a topical dosage form is being prescribed, i.e. a cream, ointment or gel, the pharmacy should use specialized machines, such as ointment mills and electric mortar and pestles (homogenizers). An ointment mill will pulverize the active ingredients, making them micro-sized, which improves penetration through the skin. A homogenizer will mix the cream at a high speed so that each teaspoonful will have the exact same amount of active ingredient. That is just one of the many key equipment that makes a high quality compounded drug. 3. What in-house procedures does the pharmacy follow to ensure quality? Compounding pharmacies must have specific procedures in place to ensure quality. This includes error calculations on all capsule batches, bar coding chemicals and integrating weight captures from the balance to the computer. Pharmacies should also have a rigorous Continuing Quality Improvement (CQI) program where frequent staff meetings are held to discuss ways of improving quality in the pharmacy. 4. What kind of outside testing does the pharmacy do to ensure quality? Pharmacies committed to quality need to test the final preparations of their products to ensure appropriate potency. Because compounded medications are made-to-order for a unique patients needs, it would be impossible for a pharmacy to test every batch it makes. To address this issue, pharmacies use a method called skip lot testing. This method assigns random finished products to be tested on a monthly basis based on the type of compounds a pharmacy makes. The number of samples a pharmacy tests every month should be roughly 10 percent of its daily volume of prescriptions. You can ask to see a pharmacys certificates of analysis on the products it tests. 5. How is the pharmacy accountable to the prescriber and to the patient? For optimal patient outcomes, the compounding pharmacy should be committed to close communication with both the prescriber and the patient. Due to the customized nature of compounded medications, the pharmacist must be readily available to the prescriber to act, as a resource for possible therapies and to make sure a compound will be formulated in the best possible way. The pharmacist should also be readily available to the patient to help answer questions or forward questions to the prescriber when appropriate. 6. Does the pharmacy have a License to Operate as a compounding facility? The Food and Drug Administration (FDA) as a regulatory agency under the Department of Health that evaluates and regulates pharmacies and grants accreditation once they have met strict standards and undergone a thorough on-site inspection. Requirements for accreditation include having documented and thoroughly reviewed policies and procedures as well as ongoing training and education programs for all pharmacy staff.
Posted on: Sun, 24 Aug 2014 12:32:27 +0000
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