This section pertains to the responsibilities of the pharmacy for maintaining product quality and control after the CSP leaves the pharmacy for distribution and use within the organized health care system to which the pharmacy belongs. The pharmacy is responsible for the quality of all CSPs prepared by or dispensed from the pharmacy, throughout the life cycle of the CSP, regardless of where the CSP exists physically within the organized health care system. In fulfilling this general responsibility, the pharmacy is responsible for the proper packaging, handling, transport, and storage of CSPs prepared by or dispensed from it, including the appropriate education, training, and supervision of pharmacy personnel assigned to these functions. The pharmacy should assist in the education and training of nonpharmacy personnel responsible for carrying out any aspect of these functions.
Establishing, maintaining, and assuring compliance with comprehensive written policies and procedures encompassing these responsibilities is a further responsibility of the pharmacy. Where nonpharmacy personnel are assigned tasks involving any of these responsibilities, the policies and procedures encompassing those tasks should be developed by the pharmacy in consultation with other institutional departments as appropriate. Activities or concerns that should be addressed as the pharmacy fulfills these responsibilities are as follows.
PACKAGING, HANDLING, and TRANSPORT
Inappropriate processes or techniques involved with packaging, handling, and transport can adversely affect product quality and package integrity. While pharmacy personnel routinely perform many of the tasks associated with these functions, some tasks, such as transport, handling, and placement into storage, may be fulfilled by nonpharmacy personnel who are not under the direct administrative control of the pharmacy. Under these circumstances, appropriate written policies and procedures are established by the pharmacy with the involvement of other departments or services whose personnel are responsible for carrying out those CSP-related functions for which the pharmacy has a direct interest. The performance of the nonpharmacy personnel is monitored for compliance to established policies and procedures.
The critical requirements that are unique to CSPs and that are necessary to ensure product quality and packaging integrity must be addressed in written procedures. For example, techniques should be specified to prevent the depression of syringe plungers or dislodging of syringe tips during handling and transport. Additionally, disconnection of system components (for example, where CSPs are dispensed with administration sets attached to them) must be prevented throughout the life cycle of the product. Foam padding or inserts are particularly useful where CSPs are transported by pneumatic tube systems. Regardless of the methods used, the pharmacy has to evaluate their effectiveness and the reliability of the intended protection. Evaluation should be continuous, for example, through a surveillance system, including a system of problem reporting to the pharmacy.
Inappropriate transport and handling can adversely affect the quality of certain CSPs having unique stability concerns. For example, the physical shaking that might occur during pneumatic tube transport, or undue exposure to heat or light, have to be addressed on a product-specific basis. Alternate transport modes or special packaging measures might be needed for the proper assurance of quality of these CSPs. The use of tamper-proof closures and seals on CSP ports can add an additional measure of security to ensure product integrity regardless of transport method used.
Chemotoxic and other hazardous CSPs require safeguards to maintain the integrity of the CSP and to minimize the exposure potential of these products to the environment and to personnel who may come in contact with them. Special requirements associated with the packaging, transport, and handling of these agents include the prevention of accidental exposures or spills and the training of personnel in the event of an exposure or spill. Examples of special requirements of these agents also include exposure-reducing strategies such as the use of Luer lock syringes and connections, syringe caps, the capping of container ports, sealed plastic bags, impact-resistant containers, and cautionary labeling. Appropriate cushioning for pneumatic tube transport should be selected and evaluated to ensure that the products so conveyed can withstand the stresses induced by the system. Pneumatic transport of nonevaluated packaging alternatives should be avoided. Additional references should be consulted as necessary for further information on handling chemotoxic and other hazardous drugs.
Procedures essential for generally ensuring product quality, especially sterility assurance, when readying a CSP for its subsequent administration include proper hand-washing, aseptic technique, site care, and change of administration sets. Additional procedures may also be essential for certain products, devices, or techniques. Examples where such special procedures are needed include in-line filtration, the operation of automated infusion control devices, and the replenishment of drug products into the reservoirs of implantable or portable infusion pumps.
The pharmacy must have the sole authority for determining whether a CSP not administered as originally intended can be used for an alternate patient or under alternate conditions. All CSPs that are not used as originally intended must be returned to the pharmacy for appropriate disposition, which may include redispensing, but only if adequate continuing quality can be fully ensured. The following may provide such assurance: the CSP was maintained under continuous refrigeration and protected from light, if required; no evidence of tampering or any readying for use outside the pharmacy exists; and there is sufficient time remaining until the originally assigned beyond-use time and date will be reached. Thus, initial preparation and thaw times should be documented and reliable measures should have been taken to prevent and detect tampering. Compliance with all procedures associated with maintaining product quality is essential. The CSP must not be redispensed if there is not adequate assurance that product quality and packaging integrity (including the connections of devices, where applicable) were continuously maintained between the time the CSP left and the time that it was returned to the pharmacy. Additionally, CSPs must not be redispensed if redispensing cannot be supported by the originally assigned beyond-use time.
EDUCATION and TRAINING
The assurance of CSP quality and packaging integrity is highly dependent upon the proper adherence of all personnel to the pertinent written procedures. The pharmacy must design, implement, and maintain a formal education, training, and competency assessment program that encompasses all the functions and tasks addressed in the foregoing sections and all personnel to whom such functions and tasks are assigned. This program includes the assessment and documentation of procedural breaches, administration mishaps, side effects, allergic reactions, and complications associated with dosage or administration, such as extravasation. This program should be coordinated with the institution's adverse-event and incident reporting programs.