Delaware Regulations

Delaware State Regulatory Update April 2019

HB 441-Prior Authorizations:

To reduce the delays and hardships of the waiting process from waiting on prior authorizations by pharmacy benefits managers (PBMs), this bill puts into place specified time tables to fill emergency prescriptions and make subsequent prior authorizations for chronic and long-term conditions filled more readily. This bill was signed into law on August 28, 2018.

HB 425-Transparency of prescription costs and alternatives:

This act establishes that a contract between a PBM and a pharmacy may not prohibit a pharmacy or pharmacist from doing any of the following because of a "gag clause":

• Providing to, or discussing with an insured person with information regarding the retail price of a prescription drug or the amount of the cost share for which the insured person is responsible for paying for a prescription drug;
• If a more affordable, therapeutically equivalent prescription drug is available, selling the more affordable, therapeutically equivalent prescription drug to the insured person. This includes if a prescription drug could be purchased at a lower cost if consumers paid out of pocket rather than through their health insurance plan.

This bill was signed into law on August 28, 2018.

HB 331-Benzodiazepine dispensing:

This bill requires practitioners to obtain consent from a minor's parent or guardian prior to prescribing these drugs and requires the pharmacist to include a cautionary statement explaining the risks associated with the long-term use of these drugs. This bill was signed into law on September 4, 2018.

SB 157-Expedited Partner Therapy for STDs:

Expedited partner therapy (EPT) is the clinical practice of treating the sex partners of patients diagnosed with a sexually transmitted disease without clinical assessment of the partners. In August 2006, the Centers for Disease Control and Prevention recommended EPT as an evidence based option to manage chlamydial infections and gonorrhea by treating index patients' sex partners to prevent reinfection and curtail further transmission. This act makes EPT clearly permissible in Delaware and requires health care professionals to provide information developed by the Delaware Department of Health and Social Services when providing EPT. It also provides immunity to health care practitioners and pharmacists acting in compliance with the statute and provides immunity to health care practitioners who do not provide EPT and pharmacists who do not fill a prescription written under this statute if doing so would violate any of the laws that govern pharmacies and pharmacists. This bill was signed into law on August 29, 2018.

What does this mean to pharmacists practicing in the state of Delaware?

• PBMs now have more stringent requirements to provide prior authorization results to patients and prescribers, avoiding potentially dangerous interruption in critical therapy.
• Pharmacists can now provide information and guidance to patients about the cost of their medication, and potential solutions. This will result in more positive health outcomes and improved adherence to prescribed therapy.
• Pharmacists must include cautionary guidance about the risks of long term benzodiazepine use during patient counseling.
• Pharmacists participating in the prescribing and dispensing of prescriptions for STDs must understand the new guidelines and the potential immunity, as it pertains to the treatment and reporting of extended partners in these cases.

Delaware BOP Regulations Update November 2018

HB441: Prior Authorization of Emergency Prescriptions and Prescriptions for Chronic and Long Term Conditions (Section 3333A)

• A prior authorization form for a prescription medication shall include a question regarding whether the prescription medication is for a chronic or long-term condition for which the prescription medication may be necessary for the life of the patient.
• If a prescriber indicates on a prior authorization form that the prescription medication is for a chronic or long-term condition for which the prescription medication may be necessary for the life of the patient, the pharmacy benefit manager may not request a reauthorization for the same prescription medication more frequently than every 12 months.
• A pharmacy benefit manager or the pharmacy benefit manager's agent shall provide alternative medications for therapeutically equivalent medications to the pharmacy that require prior authorization on the National Council for Prescription Drug Programs response transaction to a denied claim for prior authorization.

HB 425: Permitted disclosures related to prescription drugs (section 3332A)

A contract between a pharmacy benefits manager and a pharmacy may not prohibit a pharmacy or pharmacist from doing any of the following:

• Providing and discussion with an insured information regarding the retail price of a prescription drug or the amount of the cost share for which the insured is responsible for a prescription drug.
• If a more affordable substitute is available, selling the more affordable substitute to the insured.

SB157: Expedited Partner Therapy for Sexually Transmitted Diseases (Section 703A)

• Expedited partner therapy is limited to a sexual partner who may have been exposed to a sexually transmitted disease within the previous 60 days and who is able to be contacted by the patient.
• Notwithstanding any other provision of law or regulation to the contrary, a pharmacist licensed to practice pharmacy in this State may recognize a prescription authorized by this section as valid.
• A pharmacist or pharmacy is not subject to civil or professional liability for filling a prescription ordered under this section unless it is established that the pharmacist or pharmacy acted with unreasonable care, willfully, wantonly, or by gross negligence.
• The label of any drug prescribed, or records created under this section are not required to contain the name of the patient's sexual partner.

HB331: The Use, Distribution and Education of Benzodiazepines and Non-benzodiazepine Hypnotics (Section 4740B).

The Secretary shall produce and distribute either in written or electronic form to pharmacies, not including institutional pharmacies, pamphlets for consumers relative to benzodiazepines and non-benzodiazepine hypnotics that includes educational information about: (i) misuse and abuse by adults and children; (ii) risk of dependency and addiction; (iii) proper storage and disposal; (iv) addiction support and treatment resources; and (v) a telephone helpline. A pharmacist shall distribute the pamphlet when dispensing a benzodiazepines or a non-benzodiazepine hypnotic.

SB225: Registration requirements. (Section 4732)

• Any pharmacy, distributor, manufacturer, practitioner, researcher or other controlled substance registrant who has or proposes to engage in activities accordingly within this State must obtain biennially a registration issued by the Secretary in accordance with the Secretary's rules.
• As a condition of biennial renewal of registration, an applicant shall complete continuing professional education relating to all the following:

• The prescribing, distributing, dispensing or delivery of controlled substances.
• The detection and recognition of symptoms, patterns of behavior, or other characteristics of impairment and dependency resulting from the abusive or illegal use of controlled substances.
• The risks of using opioids and effective alternatives to the use of opioids.

What does this mean for pharmacists practicing within the state of Delaware?

• Prescription drug orders for qualified therapies that require a prior authorization from the prescriber and/or pharmacy will receive notification of alternative therapies that are covered by the insurer; as well as allowing that medication to be refilled for a 12-month period without the need of reauthorization. This allows for improved therapy initiation and adherence and reduce a potential interruption of therapy for these patients; all result in an improved level of patient care.
• Pharmacists must complete continuing education on controlled substance prior to license renewal; ensure that all CE completion reflects this new requirement, to prevent potential loss of professional license.
• Pharmacists can now provide information to patients around cost savings alternatives to their prescription medications, without penalty from the pharmacy benefit manager. This will help to cultivate a strong pharmacist- patient relationship and allow the pharmacist to provide options to promote positive outcomes through medication adherence for their patient.
• Pharmacists may see new prescriptions for STD partner treatment within their daily practice. Ensure that all staff understands the new regulatory allowances and ensures that proper and prompt dispensing occurs with these products, while meeting privacy guidelines for that patient.
• New and expanded information must be provided to patients receiving benzodiazepines. Ensure that your practice includes this new information during patent counseling.

Delaware State Regulatory Summary- 2017

The following regulations were enacted or updated on June 11, 2017:

24 Del. C., Section 2506(a)(1):

Subsection 1.4.1

All Delaware licensees must now complete two hours of continuing education in 1) the distribution, dispensing, or delivery of controlled substances, or 2) the detection and recognition of symptoms, patterns of behavior, or other characteristics of impairment and dependency resulting from the abusive or illegal use of controlled substances as part of their continuing education requirement for licensure or renewal.

Subsection 5.1.7

The regulation addressing compounded medications for office use has been revised to delineate standards for both human use and animal use. The proposed changes allow veterinarians to administer and dispense compounded preparations for animal patients subject to certain specified requirements.

What do these new regulations mean for pharmacists practicing within the state of Delaware?

• All pharmacists licensed to practice in the state of Delaware must complete all continuing education requirements prior to renewal; this includes all topic-specific requirements to maintain competency standards with current practice needs outlined by the state. Ensure that all pharmacists understand these requirements and complete all required CE prior to license renewal biannually. Proper documentation of all completed activities must be retained as proof, if audited.
• If your practice includes the care of veterinary patients, communicate the new changes to your staff as it pertains to compounded preparations for animal patients; different standards may apply.

For full regulatory language, refer to Delaware Division of Professional Regulations.