Pharmacy Statewide Protocols

Prior to initiating influenza testing and dispensing of antiviral therapy under this protocol, all individuals who will be involved in testing shall document successful completion of education and training in point-of-care CLIA-waived testing techniques appropriate to the test employed by the pharmacy.

Individuals who will be involved with patient specimen collection shall have documented hands-on training for specimen collection which includes infection control measures. Required training shall be successfully completed via a program accredited by the Accreditation Council for Pharmacy Education (ACPE) or pre-approved by the Board. A registered nurse who is licensed pursuant to Iowa Code Chapter 152 or Chapter 152E is deemed to have met the training requirement for patient specimen collection.

Additionally, a pharmacist shall document successful completion of at least one hour of ACPE-approved continuing education related to influenza during the pharmacist’s license renewal period during which the pharmacist is engaged in point-of-care testing and treatment for acute influenza.

The pharmacist shall be familiar with the current recommendations for the use of antiviral drugs in the treatment of influenza by the Centers for Disease Control and Prevention (CDC).

Any individual who meets ALL of the following criteria is eligible for CLIA-waived diagnostic testing:

1. Age six years or older (with consent of a parent/guardian if < 18 years old),
2. Complaint of ANY sign or symptom consistent with influenza (fever, myalgia, headache, malaise, nonproductive cough, sore throat, rhinitis), and
3. Reported symptom onset < 48 hours before time of presentation.

If an individual does not qualify for testing under this protocol, the pharmacist shall refer the individual to a primary care provider or urgent/emergency treatment facility as clinically appropriate.

1. Medical history. The pharmacist shall collect and evaluate the following medical history:
   1. Past medical history
   2. Current clinical comorbidities or disease states, including current mental status
   3. Current blood pressure, pulse, respiratory rate, temperature, and weight
   4. For females of child-bearing potential, pregnancy or breastfeeding status
   5. Current medication use
   6. Allergies and hypersensitivities
   7. Onset and duration of flu-like signs and symptoms
2. Exclusion criteria. Upon evaluation of the medical history in paragraph A, the pharmacist shall not dispense antiviral therapy to a patient who meets ANY of the criteria listed herein and shall refer the patient to their primary care provider or other urgent/emergency care facility as clinically appropriate:
   1. Pregnant or breastfeeding,
   2. Immunocompromised state (hematologic malignancy, immunosuppressant drug therapy including corticosteroids for greater than two weeks, HIV/AIDS),
   3. Long-term aspirin therapy in patients < 19 years of age,
   4. Antiviral agent for influenza prescribed currently or within the previous two weeks,
   5. Any condition requiring supplemental oxygen therapy,
   6. Known hypersensitivity to all antiviral therapies for influenza or to any common component of the products,
   7. Administration of FluMist or generic equivalent within the previous two weeks,
   8. Clinical instability based on the pharmacist’s clinical judgment or any of the following conditions:
      1. Acute altered mental status,
      2. Systolic blood pressure < 90mmHg or diastolic blood pressure < 60mmHg,
      3. Pulse > 125 beats/minute,
      4. Respiratory rate > 30 breaths/minute, or
      5. Temperature > 102 degrees (temporal), > 103 degrees (oral), or > 104 (tympanic) Fahrenheit.

The pharmacist shall evaluate the result of the test and provide the result to the patient or caregiver.

1. Negative test result. In the event that a patient’s test produces a negative result for influenza, the pharmacist shall counsel the patient or caregiver on the risk of a false-negative test result and on appropriate self-care (stay home for at least 24 hours after fever subsides, drink plenty of fluids, treat symptoms as needed, and consider influenza immunization) or shall refer the patient to a primary care provider or urgent/emergency treatment facility as clinically appropriate. Such referral shall be made when the pharmacist has a high suspicion of a false-negative result (i.e., when influenza activity in the community is high and the patient has clear signs and symptoms of influenza infection), determines that the patient is at high risk for complications, or otherwise considers additional care to be in the best interest of the patient.
2. Positive test result. In the event that a patient’s test produces a positive result for influenza, the pharmacist may proceed to consideration for antiviral therapy treatment.

The pharmacist is authorized to order and dispense the following antiviral agents, unless an identified contraindication applies for the patient, including selection of the product and dosage form deemed appropriate and in the best interest of the patient.

1. Oral oseltamivir (Tamiflu)
   1. Contraindications
      1. Known hypersensitivity to oseltamivir or any component
      2. Patients six to < 18 years with renal impairment
      3. Patients 18 years and older with CrCl < 10 ml/min
   2. Dosing – all doses to be administered x 5 days
      1. Patients 18 years and older: 75 mg twice daily
      2. Patients six years to < 18: weight-based
         1. 15 kg or less: 30 mg twice daily
         2. > 15 mg to 23 kg: 45 mg twice daily
         3. > 23 kg to 40 kg: 60 mg twice daily
         4. > 40 kg: 75 mg twice daily
      3. Patients 18 years and older with renal impairment
         1. CrCl > 60 ml/min: no dosage adjustment necessary
         2. CrCl > 30 to 60 ml/min: 30mg twice daily
         3. CrCl > 10 to 30 ml/min: 30mg once daily
2. Oral baloxavir marboxil (Xofluza)
   1. Contraindications
      1. Known hypersensitivity to baloxavir or any component
      2. Weight < 40 kg
      3. Age less than 12 years old
   2. Dosing – all doses to be administered as a single dose
      1. Patients aged 12 and older: weight-based
         1. 40 kg to < 80 kg: 40 mg
         2. 80 kg and above: 80 mg
3. Inhaled zanamivir (Relenza Diskhaler)
   1. Contraindications
      1. Known hypersensitivity to zanamivir or any component
      2. Underlying respiratory disease or asthma
      3. Age less than seven years old
   2. Dosing – all doses to be administered twice daily x 5 days
      1. Patients aged seven years and older: 10 mg (two 5 mg inhalations)

A prescription label shall be affixed to the antiviral product as required in IAC 481—552.21(155A).

The pharmacist shall counsel and educate the patient on influenza vaccination and appropriate self-care, including symptom control, hygiene, and infection control measures. A pharmacist ordering and dispensing antiviral therapy under this protocol shall provide the following:

1. Medication counseling consistent with state and federal requirements for prescription drug products and
2. Instructions on signs and symptoms that warrant emergency medical care.

No additional follow-up laboratory test(s) shall be required. A pharmacist shall follow up with the patient or caregiver within 36 to 72 hours of dispensing for evaluation of therapy, the need for additional medical intervention, clinical stability, onset of new symptoms, and medication adverse effects. The pharmacist shall refer the patient to a primary care provider or urgent/emergency treatment facility if any of the following are reported:

1. Significant deterioration in condition or new evidence of clinical instability,
2. Onset of symptoms inconsistent with influenza or indicative of serious complications from influenza, or
3. Medication adverse effects severe enough to warrant discontinuation of therapy.

A pharmacist who orders and administers CLIA-waived influenza testing and dispenses antiviral therapies pursuant to this protocol shall maintain a current copy of this protocol and an appropriately private area for patient testing and counseling at each location at which the pharmacist engages in the protocol activities. A pharmacist shall ensure that the following supplies are readily available when engaged in the activities identified in this protocol:

1. Testing equipment and associated supplies
2. Scale
3. Blood pressure cuff (appropriately sized for the patients treated)
4. Thermometer (oral, tympanic, or temporal)

The pharmacist shall maintain via patient record or electronic health record the following documentation for each patient who is tested for influenza under this protocol:

1. The presenting signs and symptoms that warranted influenza testing,
2. The parental/guardian consent for patients under the age of 18 years,
3. The patient’s medical history collected by the pharmacist,
4. The manufacturer, lot, expiration date, and result of the CLIA-waived test used to determine influenza status,
5. Required elements for the dispensing of prescription medication, if dispensed, pursuant to IAC 481—552.30(155A), and
6. The patient’s attestation that they received and expressed understanding of the required counseling and education.

1. Positive test result with medication dispensed. For patients who were dispensed antiviral therapy in response to a positive test result, the pharmacist shall provide the patient’s primary care provider with a summary of the encounter within two business days to include, at a minimum, the following:
   1. The patient’s name and date of birth,
   2. Influenza test result,
   3. Medication dispensed, and
   4. Follow-up plan.
2. Positive test result with no medication dispensed. For patients who received a positive test result, but who were ineligible for or declined antiviral therapy, the pharmacist shall provide the patient’s primary care provider with a summary of the encounter within two business days to include, at a minimum, the following:
   1. The patient’s name and date of birth,
   2. Influenza test result, and
   3. Contraindication or reason that antiviral therapy was not dispensed.
3. Negative test result. For patients who received a negative test result, the pharmacist may, but is not required to, provide the patient’s primary care provider with a summary of the encounter with information as determined by the pharmacist’s clinical judgment.
4. No primary care provider. In any of the situations in paragraphs 1 through 3, if the patient or caregiver does not identify a primary care provider, the pharmacist shall provide the patient with a written record of the encounter and advise the patient to consult with an appropriate health care professional of the patient’s choice.
5. Iowa Influenza Surveillance Network. While not currently subject to a mandatory reportable order, a pharmacy may report influenza test result data to the Iowa Influenza Surveillance Network.

This protocol is effective August 24, 2022, and shall be in effect for a period of one year and shall automatically renew for subsequent one year periods unless otherwise amended or terminated by the board.

Prior to initiating GAS pharyngitis testing and dispensing of antibiotic therapy under this protocol, all individuals who will be involved in testing shall document successful completion of education and training in point-of-care CLIA-waived testing techniques appropriate to the test employed by the pharmacy.

Individuals who will be involved with patient specimen collection shall have documented hands-on training for specimen collection which includes infection control measures. Required training shall be successfully completed via a program accredited by the Accreditation Council for Pharmacy Education (ACPE) or pre-approved by the Board. A registered nurse who is licensed pursuant to Iowa Code Chapter 152 or Chapter 152E is deemed to have met the training requirement for patient specimen collection.

Additionally, a pharmacist shall document successful completion of at least one hour of ACPE-approved continuing education related to streptococcal infection during the pharmacist’s license renewal period during which the pharmacist is engaged in point-of-care testing and treatment for GAS pharyngitis.

The pharmacist shall be familiar with the current Clinical Practice Guideline for the Diagnosis and Management of Group A Streptococcal Pharyngitis by the Infectious Disease Society of America (IDSA).

Any individual who meets ALL of the following criteria is eligible for CLIA-waived diagnostic testing:

1. Age six years or older (with consent of parent/guardian if < 18 years old), and
2. Complaint of ANY sign or symptom consistent with GAS pharyngitis (sore throat, pain on swallowing, fever, headache, swollen or tender cervical lymph nodes, inflamed or swollen tonsils or uvula).

If an individual does not qualify for testing under this protocol, the pharmacist shall refer the individual to a primary care provider or urgent/emergency treatment facility as clinically appropriate.

1. Medical and social history. The pharmacist shall collect and evaluate the following medical and social history:
   1. Past medical history,
   2. Current clinical comorbidities or disease states, including current mental status,
   3. Current blood pressure, pulse, respiratory rate, temperature, and weight
   4. Relevant social history,
   5. For females of child-bearing potential, pregnancy or breastfeeding status
   6. Current medication use, and
   7. Allergies and hypersensitivities (pharmacist shall assess reported allergies for validity by reviewing the patient’s pharmacy record, if applicable, and documenting the reported reaction).
2. Exclusion criteria. Upon evaluation of the medical and social history in paragraph A, the pharmacist shall not dispense antibiotic therapy to a patient who meets ANY of the criteria listed herein and shall refer the patient to their primary care provider or other urgent/emergency treatment facility as clinically appropriate:
   1. Pregnant or breastfeeding,
   2. Immunocompromised state (hematologic malignancy, immunosuppressant drug therapy including corticosteroids for greater than two (2) weeks, HIV/AIDS),
   3. History of rheumatic fever, rheumatic heart disease, scarlet fever, or GAS-induced glomerulonephritis,
   4. Antibiotic therapy prescribed for sore throat or upper respiratory infection within the previous 30 days,
   5. Clinical instability based on the pharmacist’s clinical judgment or any of the following conditions:
      1. Acute altered mental status,
      2. Systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg,
      3. Pulse > 125 beats/minute,
      4. Respiratory rate > 30 breaths/minute, or
      5. Temperature > 102 degrees (temporal), > 103 degrees (oral), or > 104 degrees (tympanic) Fahrenheit, or
   6. Presenting with overt viral features (rhinorrhea, cough, oral ulcers, and/or hoarseness).

Patients who do not qualify for antibiotic therapy in response to testing under this protocol shall be referred to a primary care or urgent/emergency treatment facility as clinically appropriate for additional evaluation when the pharmacist has a high suspicion of a false-negative result, determines that the patient is at high risk for complications, or otherwise considers additional care to be in the best interest of the patient.

The pharmacist shall evaluate the result of the test and provide the result to the patient or caregiver.

1. Negative test result.
   1. For patients aged 18 years and older, no back-up throat culture is needed. The pharmacist shall counsel the patient or caregiver on the risk of a false-negative test result and on appropriate self-care (get plenty of rest, drink plenty of fluids, treat symptoms as needed, etc.) or shall refer the patient to a primary care provider or urgent/emergency treatment facility as clinically appropriate. Such referral shall be made when the pharmacist has a high suspicion of a false-negative result, determines that the patient is at high risk for complications, or otherwise considers additional care to be in the best interest of the patient.
   2. For patients aged six to <18 years, back-up throat culture is required and the patient shall be referred to a primary care provider or urgent/emergency treatment facility as clinically appropriate.
2. Positive test result. The pharmacist may proceed to consideration for antibiotic therapy treatment.

The pharmacist is authorized to order and dispense the following antibiotic agents, unless an identified contraindication applies for the patient, including selection of the product and dosage form deemed appropriate and in the best interest of the patient. If the pharmacist has a recent patient creatinine level and current weight, the pharmacist may adjust the medication dose per the manufacturer package insert for patients with CrCl < 30.

1. First-line treatment
   1. Amoxicillin
      1. Contraindication
         1. Penicillin allergy
      2. Dosing
         1. 25 mg/kg (max 500 mg) PO twice daily x 10 days, or
         2. 50 mg/kg (max 1,000 mg) PO once daily x 10 days
2. Second-line treatment (for patients with mild allergic reactions, e.g. rash, to penicillin)
   1. Cephalexin
      1. Contraindications
         1. Cephalosporin allergy
         2. Severe penicillin allergy
      2. Dosing
         1. 20 mg/kg/dose (max 500 mg/dose) PO twice daily x 10 days
3. Third-line treatment (for patients with mild allergic reactions, e.g. rash, to penicillin or cephalosporins or severe reactions, e.g. anaphylaxis, to penicillin)
   1. Azithromycin
      1. Contraindication
         1. Macrolide allergy
      2. Dosing
         1. 12 mg/kg (max 500 mg) PO once daily x 5 days
   2. Clindamycin
      1. Contraindication
         1. Clindamycin allergy
      2. Dosing
         1. 7 mg/kg/dose (max 300 mg/dose) PO three times daily x 10 days
   3. Clarithromycin
      1. Contraindication
         1. Macrolide allergy
      2. Dosing
         1. 7.5 mg/kg/dose (max 250 mg/dose) PO twice daily x 10 days
4. The pharmacist may recommend the following adjunctive therapy for treatment of moderate to severe symptoms or control of high fever associated with acute GAS pharyngitis, unless contraindicated:
   1. Acetaminophen PO according to OTC dosing recommendations, and
   2. Ibuprofen PO according to OTC dosing recommendations.

A prescription label shall be affixed to the antiviral product as required in IAC 481—552.21(155A).

The pharmacist shall counsel and educate the patient on appropriate self-care, including symptom control, hygiene, and infection control measures, and IDSA guidelines which recommend the patient stay home from work, school, or daycare until they are afebrile and until 24 hours after initiation of appropriate antibiotic therapy. A pharmacist ordering and dispensing antibiotic therapy under this protocol shall provide the following:

1. Medication counseling consistent with state and federal requirements for prescription drug products, and
2. Instructions on signs and symptoms that warrant emergency medical care.

No additional follow-up laboratory test(s) shall be required. A pharmacist shall follow up with the patient or caregiver within 24 to 48 hours of dispensing for evaluation of therapy, the need for additional medical intervention, clinical stability, symptom burden, and medication adverse effects. The pharmacist shall refer the patient to a primary care provider or urgent/emergency treatment facility if any of the following are reported:

1. Significant deterioration in condition or new evidence of clinical instability,
2. Lack of improvement in symptoms or onset of symptoms indicative of serious complications, or
3. Medication adverse effects severe enough to warrant discontinuation of therapy.

A pharmacist who orders and administers GAS pharyngitis CLIA-waived diagnostic testing and dispenses antibiotic therapies pursuant to this protocol shall maintain a current copy of this protocol and an appropriately private area for patient testing and counseling at each location at which the pharmacist engages in the protocol activities. A pharmacist shall ensure that the following supplies are readily available when engaged in the activities identified in this protocol:

1. Testing equipment and associated supplies
2. Scale
3. Blood pressure cuff (appropriately sized for the patients treated)
4. Thermometer (oral, tympanic, or temporal)

The pharmacist shall maintain via patient record or electronic health record the following documentation for each patient who is tested for GAS pharyngitis under this protocol:

1. The presenting signs and symptoms that warranted GAS pharyngitis testing,
2. The parental/guardian consent for patients under the age of 18 years,
3. The patient’s medical and social history collected by the pharmacist,
4. The manufacturer, lot, expiration date, and result of the test used to determine GAS pharyngitis status,
5. Required elements for the dispensing of prescription medication, if dispensed, pursuant to IAC 481—552.30(155A),
6. The patient’s attestation that they received and expressed understanding of the required counseling and education, and
7. The rationale for the antibiotic selected.

1. Medication dispensed. For patients who were dispensed antibiotic therapy in response to a positive test result, the pharmacist shall provide the patient’s primary care provider with a summary of the encounter within two (2) business days to include, at a minimum, the following:
   1. The patient’s name and date of birth,
   2. GAS pharyngitis test result,
   3. Medication dispensed, and
   4. Follow-up plan.
2. Positive test result with no medication dispensed. For patient who received a positive test result, but who were ineligible for or declined antibiotic therapy, the pharmacist shall provide the patient’s primary care provider with a summary of the encounter within two (2) business days to include, at a minimum, the following:
   1. The patient’s name and date of birth,
   2. GAS pharyngitis test result, and
   3. Contraindication or reason that antibiotic therapy was not dispensed.
3. Negative test result. For patients who received a negative test result, the pharmacist may, but is not required to, provide the patient’s primary care provider with a summary of the encounter with information as determined by the pharmacist’s clinical judgment.
4. No primary care provider. In any of the situations in paragraphs 1 through 3, if the patient or caregiver does not identify a primary care provider, the pharmacist shall provide the patient with a written record of the encounter and advise the patient to consult with an appropriate health care professional of the patient’s choice.

This protocol is effective August 24, 2022, and shall be in effect for a period of one year and shall automatically renew for subsequent one year periods unless otherwise amended or terminated by the board.

A pharmacist shall document successful completion of a continuing education program approved by the Accreditation Council for Pharmacy Education (ACPE) of at least one-hour duration related to overdose-reversal opioid antagonist utilization prior to dispensing an opioid antagonist pursuant to this protocol.

This protocol is authorization for a pharmacist to order and dispense an opioid antagonist and devices for its administration.

Upon satisfactory assessment that the person to receive an opioid antagonist is an eligible recipient pursuant to this statewide protocol, and upon completion of training regarding recognizing and responding to suspected opioid-related overdose, the pharmacist may dispense one or more opioid antagonist that is FDA-approved for the treatment of opioid overdose. The pharmacist shall utilize an assessment form provided by the board. The assessment shall include an attestation that the recipient will make available all received training materials to any individual that may be in a position to administer the opioid antagonist. The pharmacist shall determine the appropriate opioid antagonist to be dispensed. Each opioid antagonist dispensed shall include step-by-step instructions for administration of the opioid antagonist.

Upon assessment and determination that the individual is eligible to receive and possess an opioid antagonist pursuant to this protocol, a pharmacist shall, prior to dispensing the opioid antagonist, provide training and education to the recipient including, but not limited to, the information identified herein. A pharmacist may provide to the recipient written materials that include, but may not be limited to, the information identified herein, but the written materials shall not be in lieu of direct pharmacist consultation with the recipient.

Training and education shall include:

• Calling 911 and performing basic life support as needed.
• Signs and symptoms of overdose.
• All possible adverse reactions, including withdrawal effects.
• Appropriate use and directions of opioid antagonists, including re-administration, proper storage, and expiration dating.
• If applicable, information about substance abuse or behavioral health treatment programs or use in pregnancy. 

A prescription label shall be affixed to the antiviral product as required in IAC 481—552.21(155A), except that the expiration date of the product shall not be rendered illegible. The prescription shall be dispensed in the name of the eligible recipient. 

Each pharmacy shall maintain the original record of each assessment, regardless of the eligibility determination following assessment, and dispensing of an opioid antagonist to each eligible recipient. These records shall be available for inspection or copying by the board or its authorized agent for at least two years from the date of assessment or the date of dispensing, whichever is later. Opioid antagonist dispensing shall be reported to the Iowa Prescription Monitoring Program pursuant to Iowa Code section 124.551(2)"a". As soon as reasonably possible, the pharmacist shall notify the recipient’s primary health care provider of the opioid antagonist product dispensed to the recipient. If the recipient does not have a primary health care provider, the pharmacist shall provide the recipient with a written record of the opioid antagonist product dispensed and shall advise the recipient to consult a physician

This protocol is effective July 1, 2023 and shall be in effect unless otherwise amended or
terminated by the board.