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Finished products are transferred directly to quarantine storage area. www.revolutionpharmd.comREFRIGERATION FACILITIES: REFRIGERATION FACILITIES A review of storage requirements for drugs in the National Formulary (xiii) shows that the storage requirements vary from “cold place”, “store in refrigerator”, to “avoid excessive heat or temperature”. List of storage temperature terms and definitions are: Cold place-A cold place is one having a temperature not exceeding 8 0 www.revolutionpharmd.comPowerPoint Presentation: 2.Refrigerator- A refrigerator is a cold place in which the temperature is held between 2 0 and8 0 . 3.Cool place – A cool place is one having temperature between 8 0 and 15 0 . 4.Room temperature- It is between 15 0 and 30 0 . 5. Excessive heat- It designates temperature above 40 0 . www.revolutionpharmd.comPowerPoint Presentation: Pharmacists should make every effort to see that the proper storage facilities are available . In most hospitals for storage a large biological refrigerator and a freezer is employed. As the refrigerator is too small to accommodate the products , it is more convenient to build a cold room. A cold room is defined as an artificially cooled room with a regulatory temperature range of 12 0 and 15 0 . www.revolutionpharmd.comCONSTRUCTING A COLD ROOM: CONSTRUCTING A COLD ROOM If windows are present, they should be bricked up or at least double paned and sealed against outside temperature with caulking compound. A required number of electrical outlets should be installed with the switch controlling the light fixture should be on outside wall nearest to the entrance. www.revolutionpharmd.comPowerPoint Presentation: The necessary additional walls of the room may be constructed of concrete, concrete blocks. The door should fit tightly. The blower is mounted in the cold room. In general a room is approximately 10´×10´×10´ would require one ton of refrigeration to maintain a temperature range of 5⁰to 60⁰F. Once constructed, the room must be equipped with necessary shelving, store bins, cabinets. www.revolutionpharmd.comDRUG RECALLS: DRUG RECALLS Prescription and over the counter drugs are used by millions of consumers for various ailments, diseases and medical conditions. For most, prescription drugs can provide great benefit or relief. A consequence of the development of many drugs and the marketing to millions of consumers, are serious side effects or other undesired results. In extreme cases, the U.S. Food & Drug Administration (FDA) or manufacturer may recall or withdraw a drug. www.revolutionpharmd.comCLASSIFICATION OF DRUG RECALLS: CLASSIFICATION OF DRUG RECALLS Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. www.revolutionpharmd.comPowerPoint Presentation: Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal. www.revolutionpharmd.comPowerPoint Presentation: Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls. www.revolutionpharmd.comNEED FOR DRUG RECALLS: NEED FOR DRUG RECALLS High cost of drug is a problem to the consumers and third parties. Many patients , with disabilities, do not take their medications as prescribed because of cost; as a result, more than half reported subsequent health problems. Severe disability, poor health, low income, lack of insurance , increase the odds of cost-related noncompliance. www.revolutionpharmd.comDRUG RECYCLING: DRUG RECYCLING New (and proposed) advances in packaging, preserving, labeling, and verifying product integrity of individual tablets and capsules may allow for the recycling of certain expensive medicines. Previously sold, but unused, medication, if brought back to special pharmacies for resale or donation, may provide a low-cost source of patent-protected medicines. Need for Medicine Recycling is the high cost of medicines (both to consumers and third parties) that seems to be getting worse rather than better. www.revolutionpharmd.comPowerPoint Presentation: Leftover drugs prescribed for American patients with HIV are already being recycled for use overseas . Manhattan — a nonprofit group with branches in Italy, Spain and Switzerland — collects drugs after US patients with HIV switch prescriptions, stop medications, or die . The group passes these very expensive retroviral medicines along to more than 500 people with HIV throughout Africa, the Caribbean, and Latin America. The pharmacist in the receiving pharmacy also must examine and ensure the integrity of the product . www.revolutionpharmd.comSUPPLY SOURCES FOR MEDICINE RECYCLING PROGRAM: SUPPLY SOURCES FOR MEDICINE RECYCLING PROGRAM Nursing homes and other healthcare facilities are not the only possible sources of recyclable medicines . A more important source may be medication in consumers' homes that is unused. Many prescriptions are frequently switched or simply stopped in midstream by prescribers. Patients are also likely to stop medication on their own . Not more than 50% of patients adhere to a chronically prescribed antipsychotic medication. Antidepressants, another costly and widely used medication class, are discontinued even more frequently www.revolutionpharmd.comPublic Health Benefits of Recycling Medicines: Public Health Benefits of Recycling Medicines when consumers do not properly dispose of medicines, there is also the problem of accidental or, purposeful over dosage . Suicide attempts take is with over dosages of medicine . Another benefit from a recycling program would be information about why patients prematurely stop their medication. Pharmacists might also notify prescribers about the early return of vital medication and/or directly educate patients about the need for continuing medication for chronic indications such as diabetes, hypertension, dyslipidemia , major depression, schizophrenia, AIDS, etc www.revolutionpharmd.comEXPIRATION DATING : EXPIRATION DATING To assure that a drug product meet applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date. Expiration dates shall be related to any storage conditions stated on labeling, as determined by stability studies. If the drug product is to be reconstituted at the time of dispensing, its labeling shall bear expiration information for both the reconstituted and unreconstituted drug products. www.revolutionpharmd.comPowerPoint Presentation: Expiration dates shall appear on labeling in accordance with the requirements Homeopathic drug products shall be exempt from the requirements www.revolutionpharmd.comPowerPoint Presentation: THANK YOU www.revolutionpharmd.com You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.