Wednesday, January 23, 2013

Things the FDRO Requires and Observes When an Unexpected Inspection Is Taken Place

I do not know if you have experienced or going to experience it yet regarding the unanticipated inspection of FDA in to your drugstore. As he goes inside your drugstore or pharmacy, he will require you to provide what he asks and commands. Sometimes you might not know he observes your drugstore according to its cleanliness, organization, condition, ventilation and etc. But importantly you must prepare each day, because the enemy comes only when you are not prepared and ready!

Things to do each day:
  1. Always update your prescription book and keep your filed prescriptions always. This book should update each day and proper filling is needed. When any missed or not written even one day you shall be reproached and violation is made! FDA warns you to file many prescription in you book, even no much costumers are presenting their prescription or at times they do not want to leave their prescription to you. They get irate and you will be the villain, however you still do your part. But FDA does not care about that. 
  2. Be careful of a pretentious FDRO who pretends to be a buyer just to get you in act of dispensing without proper prescription and telling your violation. I do not know if this act of catching a violators is right or wrong. If FDA wants to impose their regulation about proper handling and presentation of prescription of consumers they must directly reach the consumer to inform and teach them why prescription and check up are very important. Do not put the blame to drugstores and pharmacists, because even a million times you inform the customer about that they would not listen. The power is with them also to educate consumers about prescription and importance of attending physician when an ailment is felt, and not just giving the burden to pharmacists alone.

  3. Always monitor your refrigerator's temperature where vaccines and biological are stored not doing so would be a violation.

  4. If boxes and cases are available in your drugstore be sure to provide any wood, metal or plastic platforms to place them. Not doing so is a violation.

  5. Be sure to maintain proper cleanliness and organization in your drugstore. If not a reproach will be heard.

  6. Prepare Dispensing apparatus and thermometers that they might be asked.

  7. Provide a Standard Operating Procedure (SOP) Manual of your pharmacy.

  8. References such as books, RAs, and laws are always available. They must be complete. If you want to see the complete lists of RAs and laws click here.

  9. Menu cards, MDRP, GMAP and lists of generics and branded drugs must be present and easily accessed by customers. Not showing any of them is a violation.

  10. Do not purchase or obtain smuggled, unregistered, peddled and counterfeit drugs. When caught it is a big case against pharmacist, the owner and the drugstore itself. This might cause to revocation of your licenses.

  11. Business permits, tax registration and DTR/SEC registration must be available.

  12. Pharmacist's documents must be available always, photocopy will do. But the PRC ID should be shown in original card. Documents such as PTR and PRC ID must be updated and current.

  13. Proper disposal, removal and keeping of expired and returned drugs. Drug samples must not be mixed with the good stock and salable drugs.

  14. See to it the that permits, the FDA LTO, and other business documents are properly displayed in an conspicuous area.

  15. Original FDA LTO must be presented in the inspection. Not showing will lead to violation.

  16. Approach the FDRO properly and let him enter your drugstore. Entertain him well! Not doing so will make him irate and gives you but reviews giving you violation.

  17. See to it that your ventilation and room temperature are with in the required standard.

  18. Buy generator when biological and vaccines are available in you drugstore. FDRO are looking for generator/s when these products are present. Rationale: In case a power interruption is occurred, required temperature is maintained for the vaccines and biological.

  19. Sales invoices, delivery receipt and other invoices must be duly organized, because sometimes FDRO looks for them. 
  20. The Senior citizen's book and Persons with disability book should always be available in the pharmacy. Should always be updated and prescriptions are also kept and filed.

  21. Duly labeling of drugs' category or naming the used of drugs must be placed in shelves and cabinets to facilitate acquisition and organization of drugs when dispensing or replenishing.

  22. The most important of all is the Pharmacist must be present when the time of inspection is upheld. Non appearance will be a violation not only for the drugstore but also for the pharmacist itself. So be present always in your drugstore or, if not possible, a shifting pharmacists might be advisable.
The following situations and preparations are only case to case basis. They do not represent the actual and standard unexpected inspection. But they might serve as a basis for such situation. Some predicaments are not same to those in the list and might be changed. These serve as your guidance only.