Animal Health Solutions

13 Q3 2021 | Animal Health Solutions How do I know compounds are high-quality and safe? From receipt to disposal, all ingredients must be tracked and handled according to state and federal regulations. USP/National Formulary grade bulk chemicals with Certificates of Analysis and Material Safety Data Sheets that document identification, source, strength, and purity of the substance are preferred for active pharmaceutical ingredients. How are sterile products monitored? Sterile products must have accompanying documentation to support true sterility. Veterinarians should use compounders who additionally perform pyrogen and bacterial endotoxin testing of sterile products. Isotonicity, osmolarity, and pH should also be confirmed with new sterile formulations. On-site or outsourced testing is acceptable, as long as critical safety parameters are confirmed before patient use. Compounding records Each compounded product must have records citing the original master formulation, each ingredient used, accurate calculations, date of preparation and expiration, and who performed the compounding. There must also be evidence that a pharmacist quality-checked all crucial steps and evaluated the finished product. Beyond-use dates Pharmacists must assign beyond-use dates (BUDs), which are analogous to expiration dates, to each completed compound in accordance with USP recommendations. Generally, compounds that include aqueous ingredients have shorter shelf lives (~14 days), and oil-based products have longer shelf-lives (~180 days). In-house or third-party stability data may be cited to show potency with prolonged BUDs. Labeling Finished compounds must be adequately labeled to meet federal state regulations, including a declaration that clearly states that the drug product was compounded specific to the pet. Details such as drug name, strength, instructions, quantity, BUD, patient name, veterinarian, and pharmacy information must be displayed. Auxiliary labels are often applied to highlight pertinent storage information (e.g., refrigerate), common adverse effects (e.g., may cause sedation), and helpful guidance (e.g., do not give with cheese). High-alert medications, which have extreme risks if administered improperly, receive additional warning labels. Counseling All pharmacists working in a licensed pharmacy are required to counsel or make a reasonable attempt to counsel. A quality-assurance component itself, counseling patients/pet owners is a basic tenet of pharmacy practice; pharmacists use this important opportunity to provide basic medication (e.g., drug name, when to contact the veterinarian) and prescription information (e.g., how to use a syringe, frequency of use) to the pet owner. Counseling is a great way to support the TRIAD: the pharmacist–patient–prescriber relationship. Veterinary-trained pharmacists can be a valuable resource for veterinarians who need to find effective yet practical ways to treat exotic species or difficult cases. Veterinarians and pharmacists can and should work as a team and pool their knowledge and experience to problem-solve. Adverse effects reporting Drug product feedback is among the most important quality-assurance components. Problems with small-scale compounded drug products are not required to be reported to state or federal authorities, but doing so is considered standard of practice. Large-scale compounders (i.e., 503B facilities) are required to report adverse effects to the FDA as part of their registration requirements. When counseling pet owners, pharmacists highly encourage them to report adverse effects and/or unexpected problems to both the compounding pharmacist and veterinarian. Good compounding requires team-based care and communication; the pharmacist and veterinarian should work together if the drug product did not produce satisfactory outcomes. Therapeutic failure can arise due to many potential causes that both the drug maker and prescriber can investigate and possibly fix. Recall plans The compounding pharmacy should have clear procedures in place for when a single product or batch has been identified as adulterated or misbranded. If the product was dispensed, the pet owner and veterinarian should be immediately notified and properly guided. Veterinary-trained pharmacists can be a valuable resource for veterinarians who need to find effective yet practical ways to treat exotic species or difficult cases.

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