Legal Aspects in Intravenous Nutrient Therapy. Nayan Patel PharmD

Transcription

1 Legal Aspects in Intravenous Nutrient Therapy Nayan Patel PharmD

2 Objec;ves Understand state to state varia4on in laws to regulate office use Compounded IV Products. HR 3204; FDA jurisdic4on over compounding pharmacy and its effects on your medical prac4ce. Basic requirement to comply with the law to provide IV nutrient therapy in office

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4 Purchase of Sterile products Commercial products can be purchased from a wholesaler and a limited amount can be purchased from a pharmacy. Compounded sterile products can be purchased as office use but there are state to state varia4ons.

5 Purchase of Sterile products States that allows to buy compounded sterile products for office use AL, AR, CA, DE, ID, IN, IA, KS, KY, ME, MD, MS, MO, MT, NV, NH, NC, ND, OR, SD, TN, TX, VA, VT, WA, WI, WV, WY. States that doesn't allow to buy compounded sterile products for office use are (can only write pa4ent specific RX s) AZ, CO, CT, FL, GA, HI, IL, LA, MA, MI, MN, NE, NJ, NM, NY, OH, OK, PA, RI, SC, UT. States that are not sure what to do at this 4me are AK.

6 H.R Compounding Quality Act was approved in November, This act give FDA the jurisdic4on over compounding medica4on in USA. Currently, it s not mandatory to register with the FDA but rather a voluntary registra4on as an outsourcing facility. States that doesn t allow to buy compounded sterile products will be able to buy from these outsourcing facili4es.

7 H.R Compounding sec4ons 503A and 503B will be into effect. 503A: Talks about pa4ent specific compounds would have to confirm to USP chapter <797>. 503B: Talks about bulk manufacturing (non-pa4ent specific) / compounding products where FDA is asking for voluntary registra4on and have to comply with GMP (Good Manufacturing Prac4ce).

8 Compounding in Medical Prac;ce Any mixing or making a piggy bag is considered compounding Everyone compounding sterile products should be complaint with USP chapter <797> Currently State Board of Pharmacy has the jurisdic4on over any compounding prac4ce within the State.

9 Compounding in Medical Prac;ce USP chapter <797> defines prac4ce to prevent harm to pa4ents that could result from þ Microbial contamina4on þ Excessive bacterial endotoxins þ Correct strength þ Free of chemical and physical contaminants þ Quality of raw materials for CSPs

10 Compounding Sterile Products Immediate Use CSPs Low-Risk Level Low-Risk Level w/12 hour or less BUD Medium-Risk Level High-Risk Level Based on harm poten.al Contamina.on poten.al (primarily microbial) Number and complexity of steps involved Level determined by PIC High level requires steriliza.on

11 Compounding Sterile Products Low Risk Level All ingredients, devices, and equipment are sterile Asep4c manipula4ons are prepared in an Interna4onal Organiza4on for Standardiza4on (ISO) Class 5 or higher air quality Transfer, measuring, and mixing manipula4ons only. No more than three sterile products and entries into one package of sterile product E.g. single transfers of sterile dosage forms using sterile needles, other administra4on devices, and sterile containers, such as transfer into an intravenous (IV) bag Most IV protocols require more than 3 products for which medium risk level compliance will be required.

12 Compounding Sterile Products Medium Risk Level All ingredients, devices, and equipment are sterile Mul4ple products and packages are combined or pooled to prepare a CSP for administra4on to mul4ple pa4ents or to 1 pa4ent mul4ple 4mes Complex asep4c manipula4ons other than single-volume transfers are required Process may be of long dura4on E.g. making transfers from mul4ple containers into a final sterile container or product No final product tes4ng is required if the final product is administered within an hour of prepara4on.

13 Compounding Sterile Products If the mixing 4me + storage 4me + administra4on 4me is more than 1 hour then in-line filtra4on is required to ensure sterility of the product. All pa4ent specific IV prepara4ons need to be tested for contamina4on as well as for bacterial endotoxin if not used within 6 hours (at room temperature) or 12 hours refrigerated.

14 In-Line Filtra;on IV set

15 Requirement for Medium Risk Compounding IV bags prepared in an controlled environment i.e. ISO 5 hoods. Hoods can be horizontal or ver4cal flow pasern. ISO 5 hoods are placed in an ISO 7 room. Hepa filtered air in the room and ceiling 4les are nonporous. Preferrably there should not be a sink in this room Floor, walls & ceiling should be intact and washable. Glove box/isolator is another op4on that can be installed in a regular room. Isolators can avoid having a ISO 7 room.

16 Ver;cal vs Horizontal Flow Hood

17 Glovebox or Isolator

18 <797> Microbiological BUD There is an ever-present chance, indeed likelihood, that some CSPs will be inadvertently contaminated Time and warm temperatures are the enemy, speeding the poten4al for growth of dangerous amounts of microbial contamina4on Guidance for limits is needed to avoid unacceptable risks of harming pa4ents

19 Microbiological Beyond-Use Da;ng Risk Category Immediate Use Room Temp Refrigerator Freezer 1 hour 1 hour N/A ( -10 C) Low 48 hours 14 days 45 days Low w/ 12-hr BUD 12 hours or less 12 hours or less N/A Medium 30 hours 9 days 45 days High 24 hours 3 days 45 days

20 Single/Mul;ple (SDV/MDV) Dose Vials Defini4ons of SDV and MDV are in the USP General No4ces and Requirements Single dose vials Opened or punctured in ISO 5 environment may be used for up to 6 hours. Opened or punctured in worse than ISO 5 must be used within 1 hour or discarded. Single dose ampules must be discarded aver opening and not stored for any 4me period

21 Single/Mul;ple (SDV/MDV) Dose Vials Mul4ple dose vials Contain an4microbial preserva4ve(s) Designed for entry on mul4ple occasions. BUD 28 days aver ini4al entry unless specified otherwise by the manufacturer. BUD of 28 days based on USP <51> An4microbial Preserva4ve Tes4ng Expira4on date on vial is based on an unopened, properly stored vial. Vent ed Need le

22 Compounding in Medical Prac;ce Need to have SOP (Standard Opera4ng procedure) for any compounding happening at the medical clinic. Standard SOP s should include policies on: Environmental quality and control Personnel cleansing and garbing Personnel training and competency Finished products release checks and tests. Storage and beyond use da4ng Pa4ent monitoring and adverse events repor4ng.

23 Conclusion Besides having a legal protec4on against your license by having consent forms and other related documents, you need to: Have a hood to prepare sterile IV bags. Have SOP for your office and employees trained on it. Know your state pharmacy laws and get your supplies accordingly from your choice of compounding pharmacy. Mixing >3 vitamins in a single piggy bag is considered medium level compounding and requirements are lisle stricter. Only properly trained staff on asep4c techniques can make the IV bags Be careful with SDV (single dose vials) as there are no preserva4ve to hide minor mistakes in compounding techniques.

24 Conclusion Prepare bags and administer them in less than 1 hours to avoid addi4onal documenta4on/tes4ng/ liability as well as potency.

25 Ques;ons???