US Pharm. 2019;43(10):33-35.
ABSTRACT: Pharmacists belong to one of the most regulated professions in the United States. Company policy often provides pharmacists with specific guidance for various situations. However, pharmacists may find themselves in difficult scenarios where company policy conflicts with the laws in their jurisdiction. Scenarios in which company policy is either stricter than the law or less strict than the law are discussed. The facts of each situation can impact how laws are applied.
Pharmacists belong to one of the most regulated professions in the United States. The list of governing bodies that can create laws or regulations that impact pharmacists directly—or the products they handle—on both the state and federal levels is quite extensive. As such, maintaining compliance with all pharmacy laws, including situations when laws conflict, can prove to be a difficult task. To compound matters further, across all disciplines and contexts of the pharmacy profession, company policy can add an additional layer of complexity. Company policy often provides pharmacists with specific guidance for various situations, such as billing insurance companies, labeling of prescriptions, refusing to fill prescriptions, recordkeeping, and other documentation requirements. As a result, company policy may be beneficial to pharmacists since it can indeed help fill in the uncharted or gray areas created by federal and state drug law. However, pharmacists may find themselves in difficult scenarios where company policy conflicts with the laws in their jurisdiction, leaving them hesitant and uncertain about how to act. This article will provide sample scenarios illustrating when company policy is stricter or less strict than the law, and whether the company policy is appropriate or inappropriate.
COMPANY POLICY IS STRICTER THAN THE LAW
A staff pharmacist in a chain pharmacy is confused as to why he has to keep a perpetual inventory of Schedule II medications when state or federal law does not have this requirement.
Federal Law: “After the initial inventory is taken, the [DEA] registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years.”1
State Law: No relevant statutes or regulations.
Company Policy: The pharmacist must keep a log of every Schedule II medication dispensed and perform an exact count of the remaining inventory of the medication immediately after verifying each prescription for a Schedule II substance.
Discussion: In this scenario, it is appropriate for company policy to be stricter than federal (and state) law requiring that a pharmacist maintain a perpetual inventory of Schedule II medications. Assuming the pharmacy is in compliance with inventorying all of the controlled substances according to federal law, the company policy allows the pharmacy to meet (and exceed) the legal requirements for keeping an inventory of Schedule II medications. As a result of the stricter company policy, the company is able to readily identify discrepancies and investigate potential loss or diversion of Schedule II medications.
A pharmacy technician wonders why certain technicians are allowed to transfer noncontrolled substance prescriptions and other technicians are not allowed.
Federal Law: No relevant statutes or regulations for transferring noncontrolled substance prescriptions.
State Law: Pharmacy technicians may send and receive transfers of noncontrolled substance prescriptions.
Company Policy: Pharmacy technicians must be certified by the Pharmacy Technician Certification Board (PTCB) in order to transfer prescriptions for noncontrolled substances.
Discussion: This scenario highlights another instance where company policy is stricter than the law. Since federal law only regulates the transfer of controlled-substance prescriptions, state law may make the determination about transfer of noncontrolled substance prescriptions.2 While pharmacy technicians who are not PTCB-certified may view the policy as unfavorable, the company policy in this instance is permitted to require additional certifications since most would not interpret the state law as a mandate (i.e., pharmacists must allow all technicians to transfer prescriptions). Furthermore, since pharmacists are ultimately responsible for the activities that take place in the pharmacy, a pharmacist could exercise his or her professional judgment and not permit a pharmacy technician to transfer a prescription if the pharmacist has concerns over the technician’s ability to perform this task.
A pharmacist is trying to determine if a patient can request a 90-day supply of blood pressure medication even though the prescription was written for a 30-day supply with two refills.
Federal Law: No relevant statutes or regulations exist for consolidation of noncontrolled substance prescriptions.
State Law: If requested by the patient and determined to be appropriate by the pharmacist, the patient may receive in excess of the quantity prescribed on the face of the prescription, up to the total amount authorized (i.e., if a prescription was written for a 30-day supply with 11 refills, a patient may request a 90-day supply per fill). This is applicable only to noncontrolled substances.
Company Policy: Patients must obtain a new prescription from their provider if they request a quantity in excess of the amount prescribed on the face of the prescription.
Discussion: Here, state law provides patients the freedom to obtain a quantity that exceeds the amount prescribed for one fill, since the practitioner in essence authorized the patient to receive 90 days’ worth of the medication, when taking refills into account. In situations where a patient is well controlled on a medication for a chronic disease state, receiving a greater supply of medication may be desirable to them. As written, the company policy appears to be denying the patient’s legal right granted by state law or, at the very least, causing more difficulty for the patient by requiring them to obtain a new prescription. In addition, this company policy conceivably may have been written with the intent of collecting more dispensing fees by encouraging dispensing of the prescription more frequently. If that is the case, the company could be at risk for insurance fraud and abuse.
COMPANY POLICY IS LESS STRICT THAN THE LAW
A patient in a grocery-store pharmacy is paying for her prescriptions with a check and asks the pharmacy technician if she can take her prescription to the front checkouts with her groceries.
Federal Law: “A covered entity must train all members of its workforce on the policies and procedures with respect to protected health information … as necessary and appropriate for the members of the workforce to carry out their functions within the covered entity.”3
State Law: No relevant statutes or regulations.
Company Policy: Patients may pay for their dispensed prescriptions together with their groceries at the front registers.
Discussion: In general, it is not acceptable for a company policy to be less strict than the law. Most pharmacists should very appropriately have an issue with this company policy for a number of reasons. First, many community pharmacies have their pharmacy department physically separated from the rest of the business, as occurs in many grocery or drug stores. Pharmacies with this structure are also granted the ability to exempt certain personnel from the appropriate Health Insurance Portability and Accountability Act (HIPAA) training. As such, if a patient pays for their prescription outside of the pharmacy, the employee at the front register may not have completed training in HIPAA and, as expected, would be able to view protected health information (i.e., patient and medication name). Furthermore, there may be issues with diversion, collecting the patient’s copay, and compliance with signature logs and counseling requirements. When weighing the potential conflicts with the HIPAA Privacy Rule and other typical pharmacy regulations, the less strict nature of this company policy could result in compliance issues with strict federal and state patient-confidentiality rules.
A pharmacist is trying to determine the expiration date to include on the label of the dispensed prescription.
Federal Law: “The dispenser shall label a container with a suitable beyond-use date to limit the patient’s use of the article.… the beyond-use date shall be not later than (a) the expiration date on the manufacturer’s container or (b) 1 year from the date the drug is dispensed, whichever is earlier.”4
State Law: The label on the vial for every prescription drug dispensed must contain an expiration date that is either 1 year from the date of dispensing, or the expiration date on the manufacturer’s container, whichever is less, when dispensed in a container other than the manufacturer’s original container.
Company Policy: The label for every dispensed drug must contain an expiration date that is 1 year from the date of dispensing.
Discussion: In this final example, the pharmacy is not in full compliance with the law. While the pharmacy’s software program may set a default expiration date of 1 year to be included on the label, this may not accurately reflect the appropriate expiration date in a number of scenarios. Pharmacies may retain stock bottles of medication on their shelves that expire in less than 1 year. In this situation, entering an expiration date of 1 year to be printed on the label would be inappropriate, as the medication would definitively expire before that 1-year timeframe. Additionally, if the medication is dispensed in the unopened manufacturer’s container, a 1-year expiration date may be inappropriate if the expiration date on the manufacturer’s container is longer than 1 year. Hopefully, the patient would have completed taking the medication well before the expiration date; however, that may not be the case for epinephrine autoinjectors or topical preparations, which may remain unused by the patient well past their expiration date.
Pharmacists must often contemplate the various sources of rules they must follow in practice. Failure to follow federal or state law could result in disciplinary action from the respective board of pharmacy. Alternatively, refusing to comply with company policy could lead to poor performance reviews, a reputation as an insubordinate employee, and possibly even termination. Pharmacists can also face an ethical dilemma when a company policy prevents a patient from receiving a right granted to them by the government. If such a situation occurs, pharmacists should discuss the policy with their supervisors and voice their concerns about the conflict between company policy and the risk of abridging patients’ rights. The facts of each situation can impact how laws are applied, and it would be very reasonable to have exceptions to the company policy in context of the government rule concerning a patient right. Accordingly, pharmacists can and should play an active role when it comes to developing company policies.
The authors received no financial support from any sources including pharmaceutical manufacturers. The authors have no conflicts of interest.
1. Title 21 Code of Federal Regulations §1304.11 Inventory requirements.
2. Title 21 Code of Federal Regulations §1306.25 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes.
3. 45 CFR § 164.530 (b)(1) Administrative requirements.
4. USP-NF General Chapters: <7> LABELING.
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