U.S. PHARMACOPEIA

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PATIENT OR CAREGIVER TRAINING
A formal training program is provided as a means to ensure understanding and compliance with the many special and complex responsibilities placed upon the patient or caregiver for the storage, handling, and administration of CSPs. The instructional objectives for the training program includes all home care responsibilities expected of the patient or caregiver and is specified in terms of patient or caregiver competencies.
Upon the conclusion of the training program, the patient or caregiver should, correctly and consistently, be able to do the following:
  1. Describe the therapy involved, including the disease or condition for which the CSP is prescribed, goals of therapy, expected therapeutic outcome, and potential side effects of the CSP.
  2. Inspect all drug products, devices, equipment, and supplies on receipt to ensure that proper temperatures were maintained during transport and that goods received show no evidence of deterioration or defects.
  3. Handle, store, and monitor all drug products and related supplies and equipment in the home, including all special requirements related to same.
  4. Visually inspect all drug products, devices, and other items the patient or caregiver is required to use immediately prior to administration in a manner to ensure that all items are acceptable for use. For example, CSPs must be free from leakage, container cracks, particulates, precipitate, haziness, discoloration, or other deviations from the normal expected appearance, and the immediate packages of sterile devices must be completely sealed with no evidence of loss of package integrity.
  5. Check labels immediately prior to administration to ensure the right drug, dose, patient, and time of administration.
  6. Clean the in-home preparation area, scrub hands, use proper aseptic technique, and manipulate all containers, equipment, apparatus, devices, and supplies used in conjunction with administration.
  7. Employ all techniques and precautions associated with CSP administration, for example, preparing supplies and equipment, handling of devices, priming the tubing, and discontinuing an infusion.
  8. Care for catheters, change dressings, and maintain site patency as indicated.
  9. Monitor for and detect occurrences of therapeutic complications such as infection, phlebitis, electrolyte imbalance, and catheter misplacement.
  10. Respond immediately to emergency or critical situations such as catheter breakage or displacement, tubing disconnection, clot formation, flow blockage, and equipment malfunction.
  11. Know when to seek and how to obtain professional emergency services or professional advice.
  12. Handle, contain, and dispose of wastes, such as needles, syringes, devices, biohazardous spills or residuals, and infectious substances.
Training programs include a hands-on demonstration and practice with actual items that the patient or caregiver is expected to use, such as CSP containers, devices, and equipment. The patient or caregiver practices aseptic and injection technique under the direct observation of a health professional.
The pharmacy, in conjunction with nursing or medical personnel, is responsible for ensuring initially and on an ongoing basis that the patient or caregiver understands, has mastered, and is capable of and willing to comply with all of these home care responsibilities. This is achieved through a formal, written assessment program. All specified competencies in the patient or caregiver's training program are formally assessed. The patient or caregiver is expected to demonstrate to appropriate health care personnel their mastery of their assigned activities before being allowed to administer CSPs unsupervised by a health professional.
Printed material such as checklists or instructions provided during training may serve as continuing post-training reinforcement of learning or as reminders of specific patient or caregiver responsibilities. Post-training verbal counseling can also be used periodically, as appropriate, to reinforce training and to ensure continuing correct and complete fulfillment of responsibilities.