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Drugs and medical devices area

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Drug and device monitoring

  • PA 14 Pharmacovigilance
    • Attachment 1 Suspected Adverse Reaction Report Card – Compilation Guide
    • Attachment 2 Seizure or revocation report form
    • Attachment 3 Defect reports form
  • PA 29 Device-monitoring
    • Attachment 1 Incident or near miss report for medical devices
    • Attachment 2 Incident or near miss report for in vitro diagnostic devices
    • Attachment 3 Seizure or revocation report form
    • Attachment 4 Operating instructions of the Hospital Pharmacy Unit for withdrawal communication or safety notices on medical devices (MD) or in vitro diagnostic medical devices (IVD MD) and communications or safety notices on electromedical equipment

 

Information and Documentation

  • Treatment Plans
    • Treatment Plan for prescription of Prasugrel
    • Treatment Plan for prescription of Ticagrelor 90 mg
    • Treatment Plan for prescription of Ticagrelor 60 mg
    • Treatment Plan for prescription of Dronedarone
    • Treatment Plan for prescription of Indacaterol/Glycopyrronium (Ultibro)
    • Treatment Plan for prescription of Mepolizumab (Nucala)
    • Treatment Plan for prescription of incretin/DPP-4 inhibitor
    • Treatment Plan for prescription of Iloprost (Ventavis)
    • Treatment Plan for prescription of Rivaroxaban 2.5 mg
    • FTGM ⁠Diagnosis and Treatment Plan Form
  • Local peri-operative prophylaxis protocol
  • Local Bacterial endocarditis prophylaxis protocol (information note to patient on discharge)
  • Information for the off-label use of drugs with consolidated use in paediatrics (Law 648/96)
    • Off-label anti-infective drug list in paediatrics (AIFA March 2020)
    • Off-label anaesthetic drug list in paediatrics (AIFA February 2020)
    • Off-label genito-urinary system drug list in paediatrics (AIFA April 2019)
    • Off-label respiratory system drug list in paediatrics (AIFA July 2012)
    • Off-label blood and erythropoietic organ drug list in paediatrics (AIFA January 2019)
    • Off-label dermatological drug list in paediatrics (AIFA July 2012)
    • Off-label gastrointestinal drug list in paediatrics (AIFA April 2020)
    • Off-label nervous system and skeletal muscle drug list in paediatrics (AIFA July 2019)
    • Off-label cardiovascular drug list in pediatrics (AIFA February 2017)
    • Off-label palliative care drug list in paediatrics (AIFA November 2018)
  • Regional Guidelines on Therapies
    • Regional Guidelines on Drug Therapy of Hypertension 09/2010
    • Regional Guidelines on Drug Therapy of Hypercholesterolaemia 12/2010
    • Regional Guidelines on Drug Therapy of Proton Pump Inhibitors 03/2011
    • Regional Guidelines on Drug Therapy of Proton Pump Inhibitors 03/2011
    • 2011 Tuscany COPD Guidelines
    • Care pathway for the treatment of difficult wounds (negative pressure topical therapy) Resolution RT no. 568 of 21.05.2010
    • Regional Guidelines on the Use of Human Albumin Solutions (July 2012)
    • Regional Guidelines on the Use of Immunoglobulin (August 2012)

 

Clinical Galenics

  • PA 20 Dispensing of galenic preparations
    • Attachment 1 PA 20 Cleaning of the premises and detection form
    • Attachment 2 PA 20 Instrument Card
    • Attachment 3 PA 20 Raw materials quality control form
    • Attachment 4 PA 20 Ac preparation request form. Acetylsalicylic cartridges for desensitisation protocol
  • Forms for Non-sterile Galenic Laboratory
    • Form for the prescription of magistral galenic preparations during hospitalisation and at discharge
    • Ac preparation request form. Acetylsalicylic cartridges for desensitisation protocol (PA 20)
  • Forms for Sterile Galenic Laboratory
    • Neonatal total parenteral nutrition solution preparation request form

 

Outgoings monitoring and reporting

  • Medicines
    • Blood products consumption report
    • Antibiotic consumption report
    • Monitoring adherence to the perioperative prophylaxis protocol in adults
  • Medical devices
    • Valve, valved tube and valve ring consumption monitoring
    • Innovative MD consumption report – TAVI

 

Procurement and logistics

  • Procurement of medicines, medical devices and other pharmaceutical products
    • PA 13 Procurement of medicines, medical devices and other pharmaceutical products
      • Attachment 1 Non-conformity and complaint reporting form
      • Attachment 2 Reporting of non-conformities related to the execution of the contract
      • Attachment 3 Reporting of medical devices close to expiry
  • Narcotics and Psychotropic Substances
    • PA 15 Management of narcotics and psychotropic substances
      • Attachment 1 Verification of management of narcotics and psychotropic substances
  • Therapeutic Gases
    • PA 22 Therapeutic Gases
      • Attachment 1 Reporting minimum stock and safety stock of medical gas cylinders-Massa Heart Hospital
  • Management of pharmaceutical products in stock
    • PA 26 Thermal monitoring
      • Attachment 1 Monthly measurement of ambient temperature in the pharmacy
      • Attachment2 Monthly measurement of temperature of the pharmacy refrigerator (Annex 2a, Annex 2b, Annex 2c)
    • PA 27 Procurement, inventory and warehouse control management
    • PA 28 Transport of pharmaceutical material – economical
      • Attachment 1 Portable refrigerator temperature measurement
      • Attachment 2 Drug transport temperature measurement (T less than 30°C)