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.
How is the RxE2 model different/ more effective than the average Patient Recruitment vendor/ model?
- Every patient approached has their pharmacist as their advocate.
- From the start, every patient already has a trusted relationship established to with a HCP—their pharmacist. Rather than reaching out to thousands to get dozens of patients, RxE2 starts out with dozens of patients who are already willing to hear more about clinical trials.
- Most importantly, the pharmacist has continued access to the patient and has the ability to follow up with the patient in real time. This allows the collection of information never before captured. Specifically, with patients who were not randomized. Too many patients do not even get to the next level due to the recruitment process. RxE2 is the first company that is solving the recruitment problem by uncovering patient issues and process problems.
Why are RxE2 referrals are more qualified than other referrals?
RxE2 is the only company using pharmacists, the medication experts, to interview patients and go over inclusion/exclusion requirements – thereby only referring highly qualified patients to the clinical sites (that are already under-staffed and over-worked).
How does the RxE2 model help with "Patient Retention" once the patients have been recruited?
RxE2 has the only recruitment model where the “recruitment” company that has direct and REGULAR access to the patient. The patient’s pharmacist can be an extension of the clinical site where trust may not be as high as with the patient’s pharmacist. This ensures that patient concerns are being addressed real-time.
How does the patient get passed from the Pharmacist to the site?
Patients are referred to clinical sites via a HCP to HCP hand-off. Rather than texting or using a calendar, the pharmacist can work directly with the patient and the clinical site to make sure the patient is scheduled for their appointment.
How is RxE2 helping sponsors meet their diversity initiatives?
Local community pharmacies represent the communities in which they are located. For underrepresented populations, trust is one of the biggest issues why patients do not want to be involved in clinical trials. The local pharmacist can provide assurances for the patient’s safety and well-being. Just as they did for vaccinations when minority populations where not getting vaccinated. Local pharmacists were heavily involved in making sure underrepresented populations were inoculated.
You can also read our “Diversity Now” protocol.
How does RxE2 help with "Remote/ De-Centralized" components to clinical trials?
RxE2 can help sponsors identify patient populations in specific cities/regions, etc., using proprietary technology and pharmacy data. DCT companies can then focus their attention on specific cities, areas to get patients enrolled reducing DCT burden on nurses, phlebotomists, lab sample collection, DtP shipments, etc.
Does RxE2 act as a clinical trial site?
Yes, the goal is to one day move the focus of certain clinical trials from clinical sites to pharmacy sites that are much more operationally efficient to conduct trials than clinical sites. There are many services that pharmacists in local community pharmacies can perform currently under the 1572 that will help address site burden.