Expedited Partner Treatment (EPT) Toolkit for Minnesota Pharmacies

Expedited Partner Treatment (EPT) Toolkit for

Minnesota Pharmacies

GUIDANCE FROM THE MINNESOTA DEPARTMENT OF HEALTH

Expedited Partner Therapy (EPT) Toolkit for Minnesota Pharmacies

Minnesota Department of Health

P.O. Box 64975

St. Paul, MN 55164-0975

www.health.state.mn.us

Updated 5/9/2023

To obtain this information in a different format, call: 651-201-5414

EPT TOOLKIT: MINNESOTA PHARMACIES

Contents

Purpose Statement and Legal Disclaimer .............................................................................. 1

Introduction to Expedited Partner Therapy (EPT) .................................................................. 1

Background and Rationale................................................................................................ 1

Impact on Antimicrobial Resistance .................................................................................. 2

Limitations of Evidence Supporting EPT ............................................................................ 2

MDH Antimicrobial Treatment Recommendations for EPT .................................................... 2

Limits on Providing EPT in Minnesota ............................................................................... 2

Antimicrobial Treatment Regimens for Partners of Patients Diagnosed with Qualifying

Sexually Transmitted Infections ........................................................................................ 3

Penicillin and Other β-lactam Allergies.............................................................................. 3

Allergies to Other Antimicrobials Used for EPT.................................................................. 5

Minnesota State Law Regarding Dispensing EPT ................................................................... 6

Statutory Authority .......................................................................................................... 6

Pharmacist Refusal........................................................................................................... 7

EPT Prescription Requirements......................................................................................... 7

Generic Substitution and Cost Minimization ..................................................................... 9

Index Patient and/or Partner Required Prescription Counseling .......................................10

Providing EPT to Minors (under the age of 18) in Minnesota ............................................11

Filling EPT Prescriptions for Partners Enrolled in the Minnesota Restricted Recipients

Program (MRRP) .............................................................................................................11

Pharmacist Liability When Dispensing EPT .......................................................................12

Development of EPT-specific Pharmacy Processes ...............................................................13

EPT Education for Pharmacy Employees ..........................................................................15

EPT Treatment in Unit Dose Packages ..............................................................................16

Best Practices Regarding Payment and Insurance Claim Adjudication ...............................17

EPT Patient Education and Reference Documents for Minnesota Pharmacies .......................17

References .........................................................................................................................18

EPT TOOLKIT: MINNESOTA PHARMACIES

Purpose Statement and Legal Disclaimer

The purpose of this document is to provide Minnesota pharmacies, pharmacists, pharmacy

technicians, and other pharmacy staff comprehensive and clear guidance regarding the

practice, clinical appropriateness, and dispensing requirements of expedited partner therapy

(EPT) in the state of Minnesota. Legal advice is not provided within this document.

Consultation with your and/or your organization’s legal counsel is recommended if there are

questions about the law, rules, statutes, and practices presented herein.

Introduction to Expedited Partner Therapy (EPT)

Background and Rationale

Expedited partner therapy (also known as EPT, expedited partner treatment, or partner-

delivered partner treatment) is a harm reduction strategy and is defined as:

The practice of treating sexual partners of patients diagnosed with certain qualifying

sexually transmitted infections by providing antimicrobial treatment and education for their

partner(s) without a formal medical examination by a healthcare provider.

The potential public health benefits of EPT include:

 To reduce the number of reinfections and persistent infections, especially amongst index

patients

 To reduce complications associated with untreated sexually transmitted infections (STIs)

 To decrease the probability of acquisition of other STIs, including HIV

 To decrease overall antimicrobial exposure and thus, slow the development of antimicrobial

resistance (AMR)

To address the increasing incidence of preventable sexually transmitted infections and their

complications, the use of EPT in Minnesota is endorsed by the following agencies and

professional organizations that are a part of the multidisciplinary medical community:

 Centers for Disease Control and

Prevention

 American Osteopathic Association

 American Medical Association

 American Academy of Family Physicians

 American College of Obstetrics and

Gynecology

 The Society for Adolescent Medicine

 American Academy of Pediatrics

 Minnesota Department of Health

 Minnesota Medical Association

 Minnesota Public Health Association

 Minnesota Pharmacists Association

 Minnesota Society of Health-System

Pharmacists

 Minnesota Academy of PAs

 Minnesota Nurse Practitioners

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 University of Minnesota College of

Pharmacy

 University of Minnesota Medical School

While the ideal approach would all partners being promptly notified of their exposure(s) and

being evaluated, tested, and treated with preferred treatment regimens, this may not always

be feasible. The CDC and/or MDH recommend that when partners of patients diagnosed with

the following qualifying STIs are unable or unlikely to seek timely evaluation and treatment,

EPT is recommended:

 Chlamydia

 Gonorrhea

 Trichomoniasis*

* The 2021 CDC STI guidelines note “EPT might have a role in partner management for trichomoniasis, however no

partner management intervention has been demonstrated to be superior in reducing reinfection rates.” Some, but

not all states offer EPT for infections due to T. vaginalis. Due to the potential consequences of untreated T.

vaginalis infections, MDH allows licensed providers to prescribe EPT for trichomoniasis in Minnesota.

Impact on Antimicrobial Resistance

It is important to remember that recipients of EPT have a reasonable indication for

antimicrobial therapy and that untreated STIs can have devastating consequences, many of

which require more aggressive antimicrobial therapy such as pelvic inflammatory disease (PID).

Concerns of EPT’s potential impacts on bacterial ecology and antimicrobial resistance have

been raised, however recall above that one of the goals of EPT is to reduce the number of

reinfections and persistent infections, both of which would require additional antimicrobial

therapy. Additionally, considering the number of incident cases of STIs amenable to EPT each

year and the already staggering number of antimicrobials prescribed for a variety of other

indications, the potential impact of EPT on antimicrobial resistance would not be expected to

be significant. As treatment recommendations for index patients continue to evolve, we

anticipate that the regimens recommended for EPT will evolve as well. Optimizing the

pharmacokinetics and pharmacodynamics (PK/PD) of antimicrobials can play a significant role in

deterring the future development of resistance. Further research to elucidate the optimal dose,

frequency, and durations of the antimicrobials that are used in the treatment of both index

patients and partners via EPT will be important to ensure any contribution to AMR by using EPT

is minimized. It should be noted that drug resistant Neisseria gonorrhoeae has been identified

as an urgent threat in the 2019 CDC Antimicrobial Resistance (AR) Threat Report

. EPT is one

mechanism that might decrease the number of N. gonorrhoeae infections and thus the

pathogen’s exposure to antimicrobials resulting in slowing the further development of

resistance.

Limitations of Evidence Supporting EPT

Published studies of EPT effectiveness primarily included heterosexual individuals. There is less

certainty of the effectiveness of EPT due to limited evidence and complexity in certain aspects

of care in the following populations:

 Men who have sex with men (MSM)

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 Adolescents*

 Pregnant women

*Minnesota Statutes, Sec tion 144.343 says, “[a]ny minor may give effective consent for medical, mental and other

health services to determine the presence of or to treat pregnancy and conditions associated therewith, venereal

disease, alcohol and other drug abuse, and the consent of no other person is required), see the section entitled

“Providing EPT to Minors (under age 18) in Minnesota” below.

EPT is permissible in the above populations, however healthcare clinicians should make a good

faith effort to educate the index patient and their partner(s) about the importance of timely

medical evaluation, testing, and treatment using preferred treatment regimens, and use their

best judgment to determine whether EPT is appropriate.

MDH Antimicrobial Treatment Recommendations for

EPT

Limits on Providing EPT in Minnesota

The following partner quantity and time limits are imposed on EPT in Minnesota:

The Minnesota legislation regarding EPT (Minnesota Statutes, Section 151.37 Subd. 2(g)) was

written to meet people where they are and accommodate various life situations, including

scenarios in which the index patient may have a significant number of sexual partners (e.g., sex

work). EPT may be offered to all the sexual partners of the index patient within the 60 days

preceding the diagnosis. There is no limit on the number of EPT prescriptions can be issued

within this 60-day period. If the index patient reports not having any sexual partners within the

last 60 days, EPT may be offered to the single most recent sexual partner.

ALL sexual partners within the last

60 days may be offered EPT

If no sexual partners in

last 60 days:

The single most recent sexual

partner may be offered EPT

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Antimicrobial Treatment Regimens for Partners of Patients Diagnosed

with Qualifying Sexually Transmitted Infections

Infection

Preferred Regimen

Alternative Regimens

Safe in Pregnancy*

Chlamydia

Doxycycline 100 mg orally

twice daily for 7 days

Azithromycin 1 gram orally

for one dose

Azithromycin 1 gram orally

for one dose†

Gonorrhea

Cefixime 800 mg orally for one

dose

Cefpodoxime 400 mg orally

for one dose

Either the preferred or

alternative regimen

Trichomoniasis

Female

Metronidazole 500 mg

orally twice daily for 7

days

Tinidazole 2 grams orally for

one dose‡

Metronidazole 500 mg orally

twice daily for 7 days

Male

Metronidazole 2 grams

orally for one dose

*ALL pregnant partners of index cases should be linked to prenatal care in addition to receiving the recommended

antimicrobial treatment regimen(s) listed above

†For pregnant persons who have contraindications for azithromycin being used for chlamydia EPT, amoxicillin 500 mg

orally three times daily for 7 days is an acceptable alternative for EPT

‡For females in whom a 7 day course of metronidazole is not feasible for Trichomoniasis, 2 grams of metronidazole

orally for one dose is an acceptable alternative for EPT

For a printable version of the above table, refer to EPT Regimen Quick Reference.

For recommendations on the management of index cases, please refer to the MDH STD

Information for Health Professionals page and/or the 2021 CDC Sexually Transmitted Infection

Treatment Guidelines.

Penicillin and Other β-lactam Allergies

At least 10% of patients in the United States have a penicillin allergy listed on their medical

record, however when evaluated fewer than 1% of the population are truly allergic to

penicillin

. Additionally, about 80% of patients with a true penicillin allergy confirmed by skin

testing lose their sensitivity to the same penicillin after a period of 10 years

. Part of the

discrepancy between reported allergy and actual allergy may be due to labeling expected side

effects or intolerances as allergies and/or reporting of vague childhood reactions where details

are unavailable. These seemingly small details can result in patients not being prescribed

optimal antimicrobial treatment when they need it. The presence of a penicillin allergy on a

All patients should be educated to abstain from ANY

sexual activity for 7 days after FINISHING their

treatment regimen(s) even if their symptoms improve

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patient’s medical record has been associated with poor health outcomes including increased

overall antibiotic exposure and use of healthcare resources, increased prevalence of methicillin-

resistant Staphylococcus aureus (MRSA) and Clostridioides difficile (“C. diff”) infections,

increased prevalence of vancomycin-resistant Enterococci (VRE), and even an increased cost to

both inpatient and outpatient care

. Alternatives to penicillins and other β-lactam antibiotics

typically have a broader spectrum of activity than is needed, are less effective, have more side

effects, and selects for organisms with resistance to many antibiotics

It was previously thought that the shared β-lactam ring was the only explanation for cross-

reactivity between the various β-lactam antibiotics. However, more recent research suggests

that the R1 and R2 side chains contribute the most to immunological recognition and are most

frequently responsible for cross-reactivity

4,5

. This information supports the idea that β-lactam

allergies should not be considered a class effect

and that early estimates of the rates of cross-

reactivity between penicillins and cephalosporins are significantly overestimated. The table

below describes the β-lactams used in EPT (cefixime and cefpodoxime) and the other β-lactams

that should be used with caution or avoided based on similarities in their R1 and/or R2 side

chains. Note in the following table that neither cefixime nor cefpodoxime share any side

chains with any of the penicillins and only have side chain similarities to a select few

cephalosporins.

β-lactam Antibiotic Used in EPT

USE WITH CAUTION if documented

severe allergy to any of the following

β-lactams (similar side chains):

AVOID USE if documented allergy

to any of the following β-lactams

(identical side chains):

Cefixime Ceftaroline Cefdinir

Cefpodoxime Cefuroxime, ceftazidime

Cefditoren, cefotaxime,

c ef tr ia xo n e,

cefepime

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Allergies to Other Antimicrobials Used for EPT

Macrolides

Despite the decades long history of macrolide use for a variety of infections due to their

spectrum activity that includes gram positive, gram negative, and atypical bacteria,

documented allergic reactions to any of the macrolides in the literature are very rare

Azithromycin has largely replaced clarithromycin and erythromycin as the macrolide of choice

owing to better pharmacokinetics and tolerability

. Since 1958, only 31 reports exist (including

a total of only about 220 patients) detailing potential azithromycin allergic reactions ranging

from mild itching to severe IgE-mediated or delayed hypersensitivity reactions

. In the context

of countless courses of macrolides taken on an annual basis around the world, it is clear the risk

for an allergic reaction to macrolides is incredibly low. There is limited information regarding

the potential cross-reactivity between the individual macrolides

. Consider using alternatives (if

possible) or using azithromycin with caution in patients with well-documented severe

reaction(s) to any of the macrolides, including fidaxomicin.

Tetracyclines

Despite widespread use of tetracyclines since the 1940s, documented allergies to these

antimicrobials have only very rarely been reported in the literature. Experience with these

allergic reactions is limited to case reports and post-marketing surveillance and demonstrate an

exceedingly rare incidence of immediate-type IgE-mediated hypersensitivity reactions to the

tetracyclines

. Tetracycline is no longer widely available in the United States. Doxycycline is

considered to be the best tolerated, least immunogenic, and most widely available tetracycline

antibiotic. In contrast, minocycline appears to have more reports of non IgE-mediated

dermatologic, pulmonary, and/or autoimmune adverse effects possibly owing to the

metabolism of the parent compound into iminoquinone metabolites

. Most reports of adverse

reactions to doxycycline and tetracycline, which do not get metabolized into iminoquinone

derivatives, involve mostly mild non IgE-mediated dermatologic effects consisting of fixed

erythematous drug eruptions

. Based on available information, it is clear the risk for an allergic

reaction to tetracyclines, especially doxycycline, is incredibly low. Limited, conflicting evidence

exists regarding potential cross-reactivity between the individual agents in the tetracycline

class. Of note, an early concern regarding potential cross-reactivity between penicillins and

tetracyclines has been disproven

. Consider using alternatives or using doxycycline with

caution in patients with well-documented serious reaction(s) to other tetracyclines,

glyclglycines (e.g., tigecycline), and/or aminomethylcyclines (e.g., omadacycline, eravacycline).

EPT TOOLKIT: MINNESOTA PHARMACIES

Nitroimidazoles

Nitroimidazoles are a versatile class of anti-infectives that have activity against a variety of

pathogens, including obligate and facultative anaerobic bacteria and various protozoa including

T. vaginalis. Documented hypersensitivity reactions to nitroimidazoles are exceedingly rare and

limited to a small number of case reports in the literature

. Single digit numbers of IgE-

mediated reactions have been reported for both metronidazole and tinidazole. Other possible

delayed hypersensitivity reactions are also limited to single digit case reports each and include

contact dermatitis, erythematous drug eruptions, serum sickness-like reaction, Stevens-

Johnson Syndrome, acute generalized exanthematous pustulosis, and a possible case of drug

rash with eosinophilia and systemic symptoms (DRESS) syndrome

. Due to the limited

therapeutic options and evidence of potential cross-reactivity between metronidazole and

tinidazole via patch testing

, a patient or partner with well-documented severe reaction(s) to

any nitroimidazole should be referred to a physician for testing and evaluation of potential

need for desensitization to metronidazole and would not be an appropriate patient for EPT. It

should also be noted that more recent evidence had shed significant doubt on the concept that

mixing alcohol with nitroimidazoles yields a disulfiram-like reaction and must be avoided

Minnesota State Law Regarding Dispensing EPT

Statutory Authority

Statutory authority expressly AUTHORIZES EPT in the State of Minnesota under Minnesota

Statutes, Section 151.37, Subd. 2(g): Legend Drugs; Who May Prescribe, Possess. Nothing in

this chapter prohibits a licensed practitioner from issuing a prescription or dispensing a

legend drug in accordance with the Expedited Partner Therapy in the Management of

Sexually Transmitted Diseases guidance document issued by the United States Centers for

Disease Control, which references the most CDC’s most recent STI prevention and treatment

guidelines (found here).

EPT is considered standard of care and broadly endorsed by the interprofessional medical

community in Minnesota, therefore prescriptions for EPT should be dispensed from

Minnesota pharmacies when prescriptions are issued. Pharmacies are strongly encouraged to

process, dispense, and educate patients on EPT medications as outlined in MDH’s EPT

guidance document (Minnesota Board of Pharmacy News, October 2018). Former Executive

Director stated “EPT prescriptions should be considered an order that may reasonably be

dispensed by a Minnesota pharmacy, ideally with a name provided, but also without a

partner name provided.” Under MN Rule 6800.2250 Subp. 1(c), “[r]efusing to compound or

dispense prescription drug orders that may reasonably be expected to be compounded or

dispensed in pharmacies by pharmacists,” (including EPT prescriptions) except as provided for

in Minnesota Statutes, sections 145.414 and 145.42 is unprofessional conduct and could result

in disciplinary action by employers and/or the Board of Pharmacy.

Additionally, pharmacists were involved in developing the EPT legislation language that is found

within MN Rule 4605.7700 Subp. B: Sexually Transmitted Disease; Special Reports.

“Notwithstanding any previous report, a health care practitioner who treats persons infected

EPT TOOLKIT: MINNESOTA PHARMACIES

with chlamydial infection, syphilis, gonorrhea, or chancroid shall ensure that contacts are

treated or provide the names and addresses of contacts who may also be infected to the

commissioner. If known, persons named as contacts to a person with human

immunodeficiency virus (HIV) infection, including acquired immunodeficiency syndrome

(AIDS), shall be reported to the commissioner.”

Pharmacist Refusal

There is no exception for EPT under MN Rule 6800.2250 Subp. 1(c). Subsequently, Minnesota

licensed pharmacists that refuse to dispense EPT prescription drug orders could be subject to

disciplinary action for unprofessional conduct, however legal counsel should be consulted with

questions about this possibility. Additionally, since EPT is considered the standard of care,

pharmacist refusal could make the pharmacist vulnerable to liability for choosing not to provide

the established standard of care to their patients. This is further discussed below in the section

entitled “Pharmacist Liability When Dispensing EPT.”

EPT Prescription Requirements

Prescribers are required to follow the requirements for a valid prescription as specified in

Minnesota Statutes, Section 151.01 Subd. 16(a) with few allowable exceptions for EPT as shown

in the example above and explained in bold below:

1. The name of the location with address and phone number at which the EPT prescriber

can be reached

2. The date the EPT prescription is issued

EPT TOOLKIT: MINNESOTA PHARMACIES

3. The name of the patient – for EPT: if the partner’s information is available, this should

be included otherwise as shown above, it is NOT required in order to fill and dispense

an EPT prescription according to former Board of Pharmacy executive director Dr.

Cody Wiberg. Generic dummy names acceptable. The format of generic dummy names

is flexible and will vary based on software capability. However, in order to make

matching EPT prescriptions to the correct patient as easy as possible, best practice

would be to include initials of the index patient (e.g., EPT Partner AB) in the dummy

name. Prior to EPT legislation passed in 2008, the patient’s name was required.

4. The date of birth of the patient – for EPT: if the partner’s DOB is available, this should

be included otherwise as shown above, it is NOT required in order to fill and dispense

an EPT prescription. Blank, “n/a”, or generic dummy birthdays (e.g., 1/1/01) are

acceptable.

5. The address of the patient – for EPT: if the partner’s address is available, it should be

included otherwise as shown above, it is NOT required in order to fill and dispense an

EPT prescription. Blank, “n/a”, or generic dummy addresses (e.g., 111 EPT Drive,

Minneapolis, MN 55404) are acceptable.

6. For EPT: while not required, best practice is to indicate somewhere on the prescription

that the intent is the issued prescription will be used for EPT. This indication would

explain potentially missing information that would otherwise be required under the

statute.

7. The usual details about the drug being prescribed including full name of the drug

including the drug strength, the “sig” or directions which should be as specific as

possible to ensure the patient uses the medication properly, the quantity to dispense

ideally written both numerically and alphabetically, and the number of refills – for EPT:

refills are not allowed.

8. Signature of the prescriber (either manual if it is a written prescription or electronic if it

is an electronic prescription)

9. The DEA is not required as none of the medications ordered for the purposes of EPT are

controlled substances, however including the NPI number of the prescriber is

recommended as a best practice (but not required)

For a printable version of the above figure & information, refer to EPT Prescription

Requirements Quick Reference.

Transferring EPT Prescriptions Between Pharmacies

A prescription order that meets the above criteria is considered a valid prescription that may be

transferred between pharmacies under Minnesota Rule 6800.3120. Potential scenarios in which

this may occur include: if the recommended antimicrobial indicated per the guidance herein is

not stocked at the pharmacy receiving the EPT prescription, if the EPT recipient is restricted to a

particular pharmacy (see the section on providing EPT to partners enrolled in the Minnesota

Restricted Recipients Program), and/or based on the index patient or EPT recipient preference.

Can Obstetricians and Gynecologists Issue EPT Prescriptions for Male Partners?

EPT TOOLKIT: MINNESOTA PHARMACIES

Yes. A prescription order for EPT for a male patient issued by a board-certified obstetrician and

gynecologist (OB/GYN) or another licensed medical professional practicing in the specialty is

considered valid if the provider is appropriately licensed. This practice is encouraged by the

American College of Obstetricians and Gynecologists (ACOG)

. Recall that one of the primary

goals of EPT is to reduce recurrent and persistent infections (particularly amongst index

patients), thus treating the male partner(s) of the index patient is an intervention to reduce the

chance of recurrent and/or persistent infection in the index patient (e.g., the OB/GYN

provider’s patient).

Generic Substitution and Cost Minimization

Minnesota Statutes, Section 151.21, Subd. 4. states that a pharmacist shall not dispense a drug

of a higher retail price than that of the drug prescribed and requires the pharmacist to dispense

the least expensive available therapeutically equivalent and interchangeable drug product. This

is especially important as it pertains to EPT as many partners may not wish to provide their

personal information and will be paying out-of-pocket. Other strategies for minimizing cost of

EPT prescriptions include:

 Asking the partner(s) for personal information so that it may be billed to their insurance (if

applicable)

 Encouraging and accepting the use of prescription coupon cards

 Use of institutional or foundation grant funding for cases in which index patients and/or

their partner(s) cannot afford to pay out-of-pocket for EPT

2022 Approximate Cost of Common EPT Regimens in Without Insurance

EPT Condition EPT Regimen

Approximate Cost in 2022*

(w/o insurance)

Comments

Chlamydia

Doxycycline 100 mg orally

twice daily for 7 days

$12.00 (tablets)

$19.75 (capsules)

Pharmacists legally obligate

to dispense cheapest option

in stock

Cost of hyclate vs.

monohydrate may fluctuate,

be significantly different

Chlamydia

Azithromycin 1 gram orally for

one dose

$12.00

Cost of 250 mg vs. 500 mg

tablets may be significantly

different

Gonorrhea

Cefixime 800 mg orally for

one dose

$44.86

Less widely available and

stocked by pharmacies

Review section of this

guidance re: β-lactam

allergies

Gonorrhea

Cefpodoxime 400 mg orally

for one dose

$20.48

Less widely available and

stocked by pharmacies

Review section of this

guidance re: β-lactam

allergies

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EPT Condition EPT Regimen

Approximate Cost in 2022*

(w/o insurance)

Comments

Trichomoniasis

Metronidazole 500 mg orally

twice daily for 7 days

$13.24

Affordable, widely available

Review EPT regimen

variations based on biological

sex given at birth

Trichomoniasis

Metronidazole 2 grams orally

for one dose

$12.00

Affordable, widely available

Review EPT regimen

variations based on biological

sex given at birth

Trichomoniasis

Tinidazole 2 grams orally for

one dose

$38.06

Less widely available and

stocked by pharmacies

More expensive than

metronidazole

*Does not reflect potential savings due to the use of prescription discount coupons and/or differences between

pharmacies that may be due to differences in dispensing fees or AWP

Index Patient and/or Partner Required Prescription Counseling

Under MN Rule 6800.0910, Minnesota pharmacists must consult with the patient or patient’s

agent or caregiver and inquire about the patient’s understanding of the use of the drug,

including the elements described in Subp. 2(a). Subp. 2(b) says that the pharmacist may vary or

omit the patient information, if in the pharmacist’s professional judgment, it serves the best

interest of the patient. The law also requires that if there is any material variation from the

minimal information required by this subpart in the information provided or, if consultation is

not provided, that fact and the circumstances involved shall be noted on the prescription, in the

patient's records, or in a specially developed log. Elements of the consultation procedure as

defined by the rule include:

 Name and description of the drug

 Dosage form, dose, route of administration, and duration of therapy

 Intended use of the drug and expected action

 Special directions and precautions for preparation, administration, and use by the patient

 Common severe side effects, adverse effects,

 Techniques for self-monitoring of drug therapy

 Proper storage

 Prescription refill information (no refills are allowed on EPT prescriptions)

 Action to be taken in the event of a missed dose

 Pharmacist comments relevant to the patient’s drug therapy

If the partner presents to the pharmacy, the consultation procedure described herein must

occur. However, if the index patient presents to the pharmacy and will deliver the EPT

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prescription to their partners, the index patient should be counseled on the partner’s

prescription. If the index patient or partner refuse the consultation procedure required by MN

Rule 6800.0910 Subp. 2, the refusal must be documented as already required in MN Rule

6800.0910 Subp. 2(b). In this situation, best practice is to give the index patient or partner

written education documents that can be referenced by the EPT recipient if there are

questions. Additionally, a phone number in which the EPT recipient can contact a pharmacist

should be emphasized. Patient friendly and translated materials are available on the Minnesota

Department of Health EPT website and linked towards the bottom of this document.

Providing EPT to Minors (under the age of 18) in Minnesota

Minnesota Statutes, Sections 144.341-347 allow minors to consent to certain types of health

care services without parent or guardian permission. A provision exists specifically for the

purposes of determining the presence of or treatment of sexually transmitted diseases

(Minnesota Statutes, Section 144.343 Subd. 1), which says, “[a]ny minor may give effective

consent for medical, mental and other health services to determine the presence of or to treat

pregnancy and conditions associated therewith, venereal disease, alcohol and other drug

abuse, and the consent of no other person is required. According to Minnesota Statutes,

Section 144.335 Subd. 1(a) and the Minnesota Health Records Act (Minnesota Statutes, Section

144.291 Subd. 2(g)), pharmacists are not allowed to provide a minor’s health records to a

parent or guardian in the event they are requested). However, Minnesota law (Minnesota

Statutes, Section 144.346) allows a medical professional to inform the parent or legal guardian

where, in their judgment, failure to inform the parent or guardian would seriously jeopardize

the health of the minor. In these cases, best practices encourage a discussion with the minor

about why confidentiality is being broken. Consult with your and/or your organization’s legal

counsel with questions about these provisions.

Filling EPT Prescriptions for Partners Enrolled in the Minnesota

Restricted Recipients Program (MRRP)

The Minnesota Restricted Recipient Program (MRRP) is authorized by federal regulations and

was developed to improve safety and the quality of care, as well as reduce costs for Minnesota

Health Care Program (MHCP) recipients who have misused or abused services. MRRP recipients

are required to receive health services only from their designated providers and/or facilities

and pharmacies. As of 2021, there were approximately 2,000 Minnesotans enrolled in the

program.

MRRP recipients may either be managed by the Minnesota Department of Human Services

(DHS) or by managed care organization (e.g., Blue Cross Blue Shield, HealthPartners, UCare).

Specific policies relating to the level of restriction and exceptions (e.g., in the event of the need

for emergency care or if the recipient’s designated provider is not available) vary by the entity

that the recipient is managed through. In general, MRRP recipients must get their EPT

prescriptions filled at their restricted pharmacy. Some entities may require the primary

restricted provider to write the prescription while others may issue exceptions and allow other

providers (e.g., an emergency department provider) to issue to the prescription.

The MN-ITS system shows the current restriction status of recipients and lists their designated

provider, pharmacy, and facility(ies). Only eligible providers (which can include pharmacists or

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pharmacies) who are enrolled with MHCP and registered with the MN-ITS system maintain

access. If an eligible and registered user is not readily available and you have questions relating

to the care of an MRRP recipient at your pharmacy or institution, call DHS at 651-431-2648 or

the patient’s managed care organization.

Pharmacist Liability When Dispensing EPT

Civil Liability and Standard of Care

As mentioned in previous sections, EPT has been legal in Minnesota since 2008 under

Minnesota Statutes, Section 151.37, Subd. 2(g) and has since become the standard of care with

nothing prohibiting Minnesota pharmacies from filling EPT prescriptions when issued, according

to the Board of Pharmacy. As further evidenced by the guidance herein, including the broad

endorsement of the practice of EPT by numerous organizations representing the

multidisciplinary medical community in Minnesota, EPT is considered the standard of care in

Minnesota. Additionally, pharmacists who refuse to provide their patients services that are

consistent with the established standard of care may be responsible for potential harms that

result from that standard not being provided. Pharmacists should consult with their personal

and/or organization’s legal counsel for legal advice and/or questions regarding this issue.

Duty to Warn and the Learned Intermediary Doctrine

A specific area in which pharmacists might minimize any potential liability is through ensuring

that any theoretical duty to warn requirement is met, even though an STI may not

automatically trigger a legal requirement for duty to warn

. In the case of the practice of EPT

where the prescriber issues a specific prescription for the partner (even in the absence of

identifying information, an established relationship, and/or medical evaluation), the transfer of

liability to the drug manufacturer under the learned intermediary doctrine may not apply, and

the prescriber or pharmacist may have a duty to warn

. According to the CDC Legal/Policy

Toolkit for Implementation of Expedited Partner Therapy, this duty to warn may be

accomplished through either in-person counseling or providing written educational

documents

. For further clarification or questions on this issue, consult with your and/or your

organization’s legal counsel. This requirement is discussed in further detail above in the “Index

Patient and/or Partner Required Prescription Counseling” section.

Liability Resulting from Adverse Reactions to Antimicrobials Used in EPT

This document gives pharmacists the tools they need to critically evaluate drug allergies as they

pertain to antimicrobials used in EPT. Additionally, the risk of adverse reactions to the

antimicrobials used in EPT is minimal and can be managed with reasonable care and

precautions (which are included in MDH’s partner education documents). This results in a low

threat of malpractice claims, especially in the setting of practicing the standard of care. It

should be noted that a lack of reported judicial decisions does not mean that liability claims

have not been filed or that they have not been settled outside of court. One systematic review

of professional liability when prescribing β-lactams for a patient with a known penicillin allergy

suggests that clinicians are unlikely to be found liable when prescribing a penicillin or

carbapenem for a patient with a known penicillin allergy but avoiding cephalosporins with

EPT TOOLKIT: MINNESOTA PHARMACIES

similar side chains to the agent that caused the allergy is likely legally prudent

. However, you

should consult with your organization or legal counsel for legal advice.

Development of EPT-specific Pharmacy Processes

Due to significant heterogeneity in workflows between pharmacies based on several factors, it

is encouraged that each pharmacy develops their own EPT-specific pharmacy processes in order

to efficiently and appropriately process and dispense EPT prescriptions. Standardized processes

will help reduce confusion and ensure that pharmacies are prepared to participate in this

important public health program.

Examples of EPT-specific pharmacy processes that may be developed include:

 Development of a standardized method of handling EPT prescriptions without partner

personal information (e.g., dummy patient information, leaving DOB and address fields

blank, using “n/a” for fields in which partner information is not available, etc.)

 Collection of EPT-specific educational materials to be given to patients at the point of

dispensing

 Ensure typical antimicrobials used in the treatment of qualifying STIs are stocked in the

pharmacy

 Develop a chart that provides transparency relating to out-of-pocket prices of the

recommended EPT regimens listed above to that they can be relayed to patients on request

EPT TOOLKIT: MINNESOTA PHARMACIES

EPT Education for Pharmacy Employees

EPT-Specific Education

In a recently published survey-based study of 623 healthcare providers who reported providing

STI treatment in the past year in Minnesota

 Only 76% of the providers had heard of EPT prior to taking the survey

 Only 70% of the providers thought EPT was legal

 Only 37% of healthcare providers currently provide EPT as a prescription or direct

medication

 Of those who do not currently provide EPT, 78% said they would provide the service under

certain circumstances

This underscores the importance of healthcare professional education, visibility, and awareness

of EPT as a public health program. Pharmacies are encouraged to provide standardized

processes as referenced above and expected to provide adequate education for their pharmacy

employees surrounding the role and use of EPT in Minnesota. This will ensure unnecessary

confusion and barriers to providing the standard of care are minimized. Examples of methods

of education about EPT that could be used to educate pharmacists, pharmacy technicians, and

other pharmacy staff include:

 Guidance from local and/or state departments of health (e.g., this document)

 EPT should be included in every healthcare professional program curriculum (e.g., nursing,

medicine, physician assistant/associate, nurse practitioner, pharmacy, etc.)

 Outreach and partnerships with the Minnesota Department of Health STD/HIV/TB Section

and/or local health departments

 Informational presentations about EPT at organizational conferences and meetings

 Partnerships with local academic institutions to create continuing education (e.g., CME,

CEU, ACPE, etc.) opportunities via webinars or live lectures for healthcare professionals

 Consideration of required or elective electronic learning modules

 Inclusion of EPT as part of an on-boarding or orientation checklist for new employees

 Required attestation of commitment providing equitable healthcare via vision statements,

mission statements, and/or official policy that includes a provision for EPT

 Expand responsibility for STI awareness and care by appointing an EPT champion at each

practice location or institution

 Encourage healthcare professionals who provide EPT services and/or learners (e.g.,

students, residents, fellows) to share knowledge and experiences or educate others

Education Regarding Taking a Meaningful Sexual History

Minnesota pharmacists may have a scope of practice that includes patient assessment,

including patients with concerns for STIs, which necessitates the ability to take a meaningful

EPT TOOLKIT: MINNESOTA PHARMACIES

sexual history. A sexual history should involve discussing specific risk factors, behaviors and

practices, prevention measures, past history of STIs, and pregnancy intention however these

conversations can be awkward or embarrassing for both patients and providers and thus

ignored or skipped. Following a standardized framework can be helpful to ensure providers

elicit meaningful information from their patients without getting too distracted by the

emotions that may be produced by the discussion. One of the most common frameworks for

taking a sexual history is the “5 P’s” which include:

 Partners

 Practices

 Protection from STIs

 Past History of STIs, including HIV

 Pregnancy

Useful resources for clinicians looking to improve their ability to take a sexual history include:

 The CDC National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention provides an

in-depth guide to taking a sexual history that is based on the “5 P’s” which can be found

here

 The California Prevention Training Center provides an example provider-patient interaction

in which a physician uses the “5 P’s” framework to take a comprehensive sexual history

which can be found here

 The New York City Department of Health and Mental Hygiene adapted a quick reference for

taking a sexual history using the “5 P’s” framework which can be found here

EPT Treatment in Unit Dose Packages

Under MN Rule 6800.3200, if a pharmacy is prepacking medications, they must be dispensed by

that pharmacy. Prepacking medications by a pharmacy for dispensing in a different setting

(such as a clinic) is considered manufacturing and is not allowed.

Unit dose packs for EPT treatment courses would be allowed if the drugs were bought and

packaged for dispensing by the clinic under the practitioner dispensing rules in MN Rules

6800.9950-9954. Clinics engaging in practitioner dispensing of EPT treatment must follow

applicable drug storage (MN Rule 6800.9951), dispensing (MN Rule 6800.9952), and labeling

(6800.9953) requirements. The clinics must also keep the following information on file and

readily retrievable for a period of at least 2 years (MN Rule 6800.9954):

 A record or invoice of all drugs received for purposes of dispensing to patients

 A prescription record of the drugs dispensed, filed by prescription number or date, showing

the patient’s name and address (the aforementioned exceptions regarding this information

for EPT applies), date of the prescription, name of the drug, strength of the drug, quantity

dispensed, directions for use, signature of the provider

 Refills should not be provided for EPT prescriptions as to avoid potential insurance fraud

and/or encourage follow-up, so MN Rule 6800.9954 Subp. C does not apply

EPT TOOLKIT: MINNESOTA PHARMACIES

 Patient profile requirements under MN Rule 6800.3110

Best Practices Regarding Payment and Insurance Claim Adjudication

Handling insurance and cost of medications is nothing new for Minnesota’s pharmacies.

However, due to the allowable exceptions to the EPT dispensing process afforded by Minnesota

Statutes, Section. 151.37, Subd. 2(g), the availability of patient information may be limited or

absent.

Currently, most pharmacy benefit managers (PBMs) do not provide coverage of EPT

prescriptions for partners of their enrolled beneficiaries. Patients are encouraged to ask their

PBMs if this is a benefit that they offer. Pharmacies are not allowed to accept prescriptions for

treatment of index patients with refills to give to their partner(s).

Pharmacists and pharmacy technicians are encouraged to ask index patients and their partners

for personal information for the purposes of filling the prescription, billing to their respective

insurance plans, and/or to aid in the clinical review of the prescription, however for the

purposes of EPT, this information is not required according to the Board of Pharmacy.

If personal information from the partner(s) is obtained:

 The EPT prescription may be run through the partner(s) personal insurance as long as the

prescription is in their name

 The partner(s) may pay for the prescription out of pocket (e.g., without insurance)

If personal information from the partner(s) is not available and a dummy patient is used:

 The EPT prescription cannot be run through any type of insurance

 Encourage the use of prescription discount cards to reduce the out-of-pocket cost

 Consider use of institutional or foundational grant funding to provide EPT prescriptions at

no cost

EPT Patient Education and Reference Documents for

Minnesota Pharmacies

Link to printable version of recommended antimicrobial treatments quick reference

Link to printable version of EPT prescription requirements quick reference

Link to partner education documents

EPT TOOLKIT: MINNESOTA PHARMACIES

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