Why is Pharmacist Counseling Needed?
E2 Dispensing studies follow state dispensing laws and regulations requiring that patients be counseled by licensed pharmacists to ensure compliance and adherence with their medication. Licensed pharmacists also ensure that patients receive and understand the instructions on the proper storage and handling of their clinical supplies. It is important to note that all pharmacists providing counseling are blinded and do not have access to the dispensing pharmacy records.
How are Clinical Supplies Dispensed to Ensure Blinding?
The central-fill pharmacy is responsible for ensuring that blinded clinical supplies information remains secure, protected, and confidential. Only the central-fill pharmacists and pharmacy technicians will have access to the blinded clinical supplies information for dispensing and unblinding purposes, unless otherwise required or contracted. The counseling pharmacist or pharmacy technician, as well as any clinical sites, clinical healthcare providers, the local pharmacy, if used, and the sponsor all remain blinded.
Does E2 Dispensing Use Randomization Schedules?
Blinded E2 Dispensing trials still use randomization schedules to ensure equal distribution among treatment groups and to prevent bias. With E2 Dispensing, however, there is no need to ship clinical supplies in blocks or to create blocking factors related to clinical site shipments.
How is the Disposition of Clinical Supplies Tracked?
In accordance with standard practice requirements for dispensed medications regulated by the state boards of pharmacy, the dispensing pharmacy’s system is used for administration, tracking, and record-keeping of control, disposition, and documentation of used and unused clinical supplies. Some additional data elements may be added to tie randomization (e.g., the randomization number or code, etc.) and return information to the patient.
If required by the clinical protocol, an Interactive Response Technology (IRT) can be used in addition to or in place of the pharmacy’s dispensing system.
How are Clinical Supplies Labeled?
For clinical supplies dispensed in the US and as required by 21 C.F.R. §312.6, container labels will include the statement: “Caution: New Drug–Limited by United States law to investigational use.” In addition, the clinical supplies are properly labeled in accordance with state pharmacy laws and regulations. For example, North Dakota law states the following requirements for prescription labels:
N.D. Admin. Code §61-04-06-01. The prescription label. Controlled drugs and noncontrolled drugs dispensed pursuant to a prescription must bear a label, permanently affixed to the immediate container in which the drug is dispensed or delivered and which is received by the purchaser or patient, which must include the following:
1. The name and address of the dispenser or pharmacy;
2. The serial number of the prescription;
3. The current date of its filling or refilling;
4. The name of the prescriber;
5. The name of the patient;
6. The directions for use, including precautions, if any, as indicated on the prescription;
7. The initials or name of the dispensing pharmacist;
8. The telephone number of the pharmacy; and
9. The drug name and strength and quantity.
The prescription label for controlled drugs, in addition to the above, must comply with the label requirements of the Federal and State Uniform Controlled Substances Act, including the transfer warning auxiliary label.
How Does the E2 Dispensing Model Ensure Clinical Supplies are Properly Received, Stored, and Returned?
All mail-order prescriptions require that a licensed pharmacist be available to speak with patients or caregivers to answer questions, provide advice, and offer pharmacist counseling. With E2 Dispensing, a pharmacist proactively calls patients to ensure that medication is received, stored, used, and returned according to the clinical protocol as well as the pharmacy manual.
E2 Dispensing eliminates the potential of clinical sites mishandling supplies and incorrect clinical supply storage conditions during transport from the clinical site to the patient’s home.
How are Returns, Accountability, and Reconciliation Handled?
The counseling pharmacist or pharmacy technician verifies receipt of supplies with the patient, documents how much they used or did not use, and discusses how to return their supplies either to the central-fill pharmacy or to their RxE2-contracted local pharmacy. If a discrepancy is noted, the counseling pharmacist will follow up with the patient and local pharmacy if used. If a local pharmacy is used, it will forward patient accountability information to the central-fill pharmacy.
The dispensing pharmacist or pharmacy technician at the central-fill pharmacy will reconcile clinical supplies by accounting for bulk clinical supplies and by performing patient accountability verification.
The central-fill pharmacy documents all accountabilities and reconciliations and is responsible for follow-up and documentation of discrepancies. The central-fill pharmacy also provides accountability and reconciliation reports as needed.
How are Retain Samples Handled?
Retain samples are a GMP requirement for the packaging and labeling of GMP-produced material. As such, the manufacturer of the bulk clinical supplies will keep a retain sample of the packaged and labeled bulk clinical supplies produced and shipped to the central-fill pharmacy.
Retain samples of the clinical supplies dispensed to patients are not required.
Do E2 Dispensing Pharmacies Have to Follow GMP Requirements?
No. However, E2 Dispensing Pharmacies are considered clinical sites and, as such, follow GCP requirements in addition to state pharmacy regulations. GMP requirements apply to GMP manufacturing sites where GMP trained individuals may manufacture, package, label, and ship clinical supplies.
Will E2 Dispensing Cost More Than Traditional Packaging and Labeling?
E2 Dispensing is a cost-effective option for packaging, labeling, and dispensing clinical supplies. For most of today’s clinical studies, E2 Dispensing will reduce direct costs by eliminating waste of clinical supplies and will reduce indirect costs by eliminating the complexity associated with packaging and labeling supplies for clinical sites. For example, E2 Dispensing no longer requires upfront planning, such as label and kit design and creation, site-seeding forecasting, and pooling or just-in-time clinical supply strategies needed for traditional packaging and labeling.