As you can imagine, pharmacists have a lot of oversight when it comes to dispensing and disposing of prescription drugs. There are strict ethical rules that Pharmacists must abide by which were enacted by the licensing board. The NC Board of Pharmacy enacted ethical rules under 21 NCAC 46 .1201-.3501. The Board, through the NC Pharmacy Practice Act, is tasked with licensing and disciplining pharmacists in NC. If you are a pharmacist, you probably remember applying to the Board for a pharmacist license after you graduated. Today we will discuss a number of ethics rules that must be complied with in order to avoid strict penalties.
Pursuant to 21 NCAC 46 .1703 a nurse practitioner and/or a physician’s assistant can dispense a drug that a respective NP or PA is lawfully allowed to prescribe However, when this occurs a pharmacist is required to “prepare a plan to ensure that there are adequate amounts of each of the drugs dispensed by a nurse practitioner or physician assistant..” That’s not all folks. The pharmacist who is consulting with the NP or PA needs to be available for consultation at all times when drugs are being dispensed. Now, the consultation can take place by phone, in person or other means of direct contact. A pharmacist is responsible for prepackaging the drugs to be dispensed by the NP or PA. Also, a pharmacist is required to properly label the prescription dispensed by the NP or PA. The lone exception being putting the patient’s name and directions for use on the prescription label. The NP or PA is responsible for putting the patient’s name and directions for use on the prescription label.
Prescription drugs, for obvious reasons, have to have identifying information on every order. 21 NCAC 46 .2301 sets forth what information must be on each prescription drug order. Valid prescription orders must have following. Date of issuance, name and address of patient, the name, address, and telephone number of the prescriber among other things. If the prescription is a controlled substance, then the DEA number of the prescriber must be on the order. If a prescription order does not have what is required under .2301, then the pharmacist cannot fulfill the order. It’s that simple, avoid making it complicated. Just contact the prescriber and have them fix their order.
Record keeping of what drugs have been dispensed is codified in .2302. The information required to be kept is the quantity dispensed as well as date. Serial number (or equivalent), ID of the dispensing pharmacist and records of refills to date are also required when dispensing. 21 NCAC 46 .2303 covers records pertaining to prescription filling and refilling. A dispensing pharmacist must indicate by date and initial the filling or refilling of a prescription on the recording document. However, a pharmacist has the option to use an automated data processing system. More on the automated data processing system can be found here.
Not just yet. In order for a pharmacy to open it must be permitted. The permit holder must have a licensed pharmacist-manager on staff. The Board’s form application is the only application accepted. These requirements can be found under NCGS 90-85-21. Once you have your pharmacy permit, then have a grand opening.
Pharmacists must dispose of unwanted drugs one of three ways in order to comply with the Board’s disposal requirements. Those three ways laid out in 21 NCAC 46 .3001 are return them to the drug manufacturer, incinerate the drugs at a properly permitted facility, or by other means approved by the Board. Those “other means” should assure protection against unauthorized possession or use. If you are unsure if a specific way qualifies under “other means” then ask a representative from the Board. Make sure you have their permission in writing.
Pharmacists with a pharmacy permit are also required to have policies and procedures for disposing of unwanted drugs and containers. Prior to disposing of drugs, containers, or labels, a pharmacy permit holder must file a written request with the Board. This request must be via a specific form provided by and sent to the Board. Make sure all documentation is kept for three years.
That is all the information that we have time to provide today. As always, please check out our other blogs here.
**Nothing in this post is intended as legal advice and nothing herein establishes an attorney-client relationship**. If you have questions or need assistance, please call us at 919-521-8810.