The Cancer Drug Repository Program Act

What is the purpose?

To allow unused cancer drugs to be re-dispensed by approved pharmacies to cancer patients who are poor and PA residents

What are the requirements of patient eligibility?

1. Cancer diagnosis

2. Limited or no prescription drug coverage

3. Ineligible under the State Medical Assistance Program

4. Financially eligible as indigent patient

What are the requirements for drug eligibility?

• to treat cancer or it’s side effects

• to treat the side effects of a prescription drug used to treat cancer or its side effects

• in the original unopened, sealed, and tamper-evident unit dose packaging

• packaged in single unit doses, when the outside of original packaging is opened but the single unit doses are unopened

What are counted as ineligible drugs?

• bears an expiration date that is early than 6 months after the date the drug will be restocked

• has evidence of being adulterated or misbranded

• designated as a controlled substance

• restricted distribution by the FDA

• requires refrigeration, freezing , or other temp requirements

• has been previously compounded

What must a pharmacy do to participate?

Any pharmacy holding an unrestricted permit may apply for approval

they must delegate a pharmacist to be responsible to receive donated cancer drugs

they must agree to comply with the law

What needs to be on the cancer drug repository donor form to be considered for donation?

• needs to be signed by the entity’s authorized representative

• states that to the best of the donor’s knowledge that the donated drug has been properly stores and that it hasn’t be opened, used, tampered with, adulterated, or misbranded

Can the drug be stored with the rest of the stock?

No. It must be stored separately

Can cancer drugs be distributed to other locations?

Yes. It may be distributed to other participating physician’s office, pharmacy, hospital, health care facility

Can cancer drugs in the program be resold?

No.

Can you charge a handling fee?

Yes. But it can not exceed 250% of the Medical Assistance dispensing fee

Does the pharmacy have to inform the patient that the drug was donated?

Yes

Can you dispense the drug if the patient did not sign the informed consent form?

No

What does the informed consent form have to include?

• drug being dispensed has been donated

• drug was unused, although previously dispensed

• in original unopened, sealed and tamper-evident packaging to be restocked and redistributed

• a visual inspection was conducted by the pharmacist

• there is no guarantee the safety of the drug, but it has been inspected by the pharmacist

• must be kept for 2 years

What are the requirements for the disposal of donated drugs?

Must destroy or dispose donated drugs in a way compliant with federal and state law.

A record must be have:

• date of destruction

• name, strength, and quantity of the cancer drug destroyed

• name of person or firm that destroyed the drug

• source of the drugs destroyed

• must be maintained for 2 years

What other information must be recorded?

Pharmacy must account for every dose— record receipt of the drug on repository donor from and record dispensing the drug on a repository dispensing form

• name and strength

• quantity

• expiration date

• lot number

• name of pharmacy originally dispensed

• name of donor of cancer drug

• name of person for it was originally prescribed

• name to who it was dispensed

• name of prescribing practitioner who wrote the prescription

• date the drug was disposed of or destroyed

• whether a handling fee was changed and its amount

must keep records for 2 years