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St. Vincent de Paul Charitable Pharmacy Good Samaritan Free Health Center Collaborative Practice Agreement with Good Samaritan Free Health Center Effective: March 8, 2018 Expiration: March 8, 2020 1
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Page 1: Pharmacy Policies and Procedures Manual · Web view2.1 Quantity Adjustments Pharmacists may adjust drug quantities on prescriptions for the treatment of diabetes to dispense at least

St. Vincent de Paul Charitable Pharmacy Good Samaritan Free Health Center

Collaborative Practice Agreement with Good Samaritan Free Health Center

Effective: March 8, 2018

Expiration: March 8, 2020

1125 Bank Street

Cincinnati, Ohio 45214

(513) 562-8841

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Table of Contents1.0 Introduction..............................................................................................................................6

1.1 Background....................................................................................................................6

1.2 Authority and Purpose...................................................................................................6

1.3 Collaborating Professionals...........................................................................................6

1.4 Patients..........................................................................................................................7

1.5 Goals..............................................................................................................................7

2.0 Diabetes Management............................................................................................................8

2.1 Quantity Adjustments.....................................................................................................8

2.2 Formulation Interchange................................................................................................8

2.2.1 Combination Products....................................................................................................8

2.2.2 Time-Release Products.................................................................................................8

2.3 Therapeutic Interchange................................................................................................8

2.3.1 Insulin.........................................................................................................................8

2.3.2 Sulfonylurea...............................................................................................................8

2.3.3 DPP-4 Inhibitors.........................................................................................................9

2.3.4 SGLT-2......................................................................................................................9

2.3.5 GLP-1.........................................................................................................................9

2.4 Adjustments for Drug Optimization................................................................................9

2.4.1 Metformin Titration.....................................................................................................9

2.5 Initiation of Over-the-Counter Products by Prescription................................................9

2.5.1 Blood Glucose Testing Supplies................................................................................9

2.5.2 Injection Supplies.........................................................................................................10

2.5.3 Hypoglycemia Treatment.............................................................................................10

2.5.4 Aspirin..........................................................................................................................10

3.0 Tobacco Cessation Management..........................................................................................11

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3.1 Initiation of Nicotine Replacement Therapy.................................................................11

3.2 Initiation of Varenicline (Chantix).................................................................................11

4.0 Asthma/COPD Management.................................................................................................12

4.1 Quantity Adjustments...................................................................................................12

4.2 Formulation Interchange..............................................................................................12

4.2.1 Combination Products..................................................................................................12

4.2.2 Time-Release Products...............................................................................................12

4.2.3 Drug Delivery Device...................................................................................................12

4.3 Therapeutic Interchange..............................................................................................12

4.3.1 Single-Agent Inhalers...............................................................................................12

4.3.2 Combination Inhalers...............................................................................................13

4.4 Adjustments for Drug Optimization..............................................................................13

4.4.1 Inhaler Dose Titration...............................................................................................13

4.5 Prescription Initiation....................................................................................................13

4.5.1 SABA Inhaler...........................................................................................................13

4.5.2 ICS Inhaler...............................................................................................................14

4.5.3 Montelukast..............................................................................................................14

4.5.4 Respiratory Devices & Supplies...............................................................................14

5.0 Allergy Management..............................................................................................................15

5.1 Quantity Adjustments...................................................................................................15

5.2 Formulation Interchange..............................................................................................15

5.2.1 Combination Products..................................................................................................15

5.2.2 Time-Release Products...............................................................................................15

5.2.3 Oral Products...............................................................................................................15

5.3 Therapeutic Interchange..............................................................................................15

5.3.1 Oral Antihistamines..................................................................................................15

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5.3.2 Ophthalmic Antihistamines......................................................................................16

5.3.3 Intranasal Products..................................................................................................16

5.4 Prescription Initiation....................................................................................................16

5.4.1 Oral Antihistamines..................................................................................................16

5.4.2 Ophthalmic Antihistamines......................................................................................16

5.4.3 Intranasal Products..................................................................................................17

5.4.4 Emergency Injectable Epinephrine..............................................................................17

6.0 Acid Reflux Management......................................................................................................18

6.1 Quantity Adjustments...................................................................................................18

6.2 Formulation Interchange..............................................................................................18

6.2.1 Combination Products..................................................................................................18

6.2.2 Time-Release Products...............................................................................................18

6.2.3 Oral Products...............................................................................................................18

6.3 Therapeutic Interchange..............................................................................................18

6.3.1 Proton Pump Inhibitors............................................................................................18

6.3.2 Histamine H2 Antagonists........................................................................................18

7.0 Organization..........................................................................................................................19

7.1 Provider Eligibility.........................................................................................................19

7.2 Training/Education.......................................................................................................19

7.3 Liability.........................................................................................................................19

7.4 Informed Consent of the Patient..................................................................................19

7.5 Documentation.............................................................................................................20

7.6 Communication............................................................................................................20

7.7 Quality Assurance and Improvement...........................................................................20

7.8 Period of Validity..........................................................................................................20

7.9 Retention of Records...................................................................................................21

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7.10 Rescindment and Amendment.....................................................................................21

8.0 Signatures of Approval..........................................................................................................22

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St. Vincent de Paul Charitable Pharmacy Good Samaritan Free Health Center

1.0 Introduction 1.1 Background

St. Vincent de Paul Charitable Pharmacy has collaborated with the Good Samaritan Free Health Center since 2011. This mutually beneficial relationship has provided free primary care as well as free prescription medications to the indigent of Cincinnati and surrounding communities.

House Bill (HB) 188 was signed into law on March 23, 2016. This law expanded opportunities for physicians and pharmacists to work together to improve patient outcomes through consult agreements, often referred to as collaborative practice agreements (CPA). HB 188 opened the door for multiple pharmacists to establish consult agreements with multiple physicians for multiple patients and disease states in order to optimize patient outcomes.

The procedures will be in accordance with Ohio Revised Code (ORC) chapter 4729.39 and Ohio Administrative Code (OAC) 4729-29-02 (Appendix 1.1).

A collaborative practice agreement (CPA) must be a written document that specifies what disease states pharmacists can help manage; what drugs or drug categories pharmacists can utilize; what protocol pharmacists will follow when adjusting medication therapy; and how pharmacists and physicians will communicate.

1.2 Authority and Purpose I, Dr. R. Stephen Eby, authorize the pharmacists named herein, who hold an active

license to practice issued by Ohio, to manage and/or treat patients pursuant to the parameters outlines in this agreement. This authority follows the laws and regulations of Ohio.

St. Vincent de Paul (SVDP) Charitable Pharmacy and Good Samaritan Free Health Center (GSFHC) are committed to providing high quality care in the most affordable, efficient way. Creation of multi-disciplinary teams who can function as physician extenders are one way to achieve these goals and provide excellent patient care. The purpose of this agreement is to enhance collaborative patient care and optimize medication-related outcomes for mutual patients of SVDP and GSFHC.

1.3 Collaborating Professionals Physicians of Good Samaritan Free Health Center

3727 St. Lawrence AveCincinnati, OH 45205Phone: 513-246-6888Fax: 513-246-6887

Pharmacists of St. Vincent de Paul Charitable Pharmacy 6

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St. Vincent de Paul Charitable Pharmacy Good Samaritan Free Health Center

1125 Bank Street 3015 Glenhills WayCincinnati, OH 45214 Cincinnati, OH 45238Phone: 513-562-8841 ext. 220 Phone: 513-347-0743Fax: 513-345-1779 Fax: 513-347-0820

1.4 Patients Patients whose therapy may be managed pursuant to this agreement include those who

are currently receiving primary care by a physician of Good Samaritan Free Health Center and pharmaceutical care by a pharmacist of St. Vincent de Paul Charitable Pharmacy for the medical indications detailed in this agreement.

1.5 Goals To optimize drug therapy

To reach clinical health targets and quality metrics

To improve patient adherence and medication access

To increase access and efficiency of primary care physicians

To decrease preventable emergency room visits and hospital readmissions

To improve the health of patients and their quality of life

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2.0 Diabetes Management2.1 Quantity Adjustments

Pharmacists may adjust drug quantities on prescriptions for the treatment of diabetes to dispense at least a 30-day supply (i.e. quantity of insulin vials).

2.2 Formulation Interchange

2.2.1 Combination Products Pharmacists may combine individual prescriptions medications into combined

formulations when available. (i.e. Januvia + Metformin = Janumet)

Pharmacists may separate prescription combination products into their individual components when the combination product is not available. (i.e. Janumet = Januvia + Metformin)

2.2.2 Time-Release Products Pharmacists may interchange immediate release products for extended-release products

(including sustained, delayed, and controlled) based on medication availability and tolerability. (i.e. Metformin = Metformin ER)

Pharmacists may interchange extended-release products (including sustained, delayed, and controlled) for immediate release products based on medication availability and tolerability. (i.e. Metformin ER = Metformin)

2.3 Therapeutic Interchange

2.3.1 Insulin Pharmacists may interchange between short-acting and rapid-acting insulin products at

equivalent dosing 1:1.

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o Insulin glulisine (Apidra), insulin lispro (Humalog), regular human insulin (Humulin R), and insulin aspart (Novolog)

Pharmacists may interchange between mixed insulin products at equivalent dosing 1:1.

o Insulin lispro/NPH (Humalog 75/25), regular human insulin/NPH (Humulin 70/30, Novolin 70/30), and insulin aspart/NPH (Novolog 70/30)

Pharmacists may interchange between basal insulin products at equivalent dosing 1:1.

o Insulin glargine (Lantus, Basaglar, Toujeo), insulin detemir (Levemir), and insulin degludec (Tresiba)

Standard dosing conversation (see Appendix 2.3.1)

2.3.2 Sulfonylurea Pharmacists may interchange between sulfonylureas at equivalent dosing.

o Glipizide (Glucotrol), glimepiride (Amaryl), and glyburide (Glynase)

Standard dosing conversions (see Appendix 2.3.2)

2.3.3 DPP-4 Inhibitors Pharmacists may interchange between dipeptidyl peptidase-4 (DPP-4) inhibitors at

equivalent dosing.

o Alogliptin (Nesina), linagliptin (Tradjenta), saxagliptin (Onglyza), and sitagliptin (Januvia)

Standard dosing conversions (see Appendix 2.3.3)

2.3.4 SGLT-2 Pharmacists may interchange between selective sodium-glucose transporter-2 (SGLT-2)

at equivalent dosing.

o Canaglifozin (Invokana), empagliflozin (Jardiance), and dapaglifozin (Farxiga)

Standard dosing conversions (see Appendix 2.3.3)

2.3.5 GLP-1 Pharmacists may interchange between glucagon-like peptide 1 (GLP-1) at equivalent

dosing.

o Exenatide (Byetta, Bydureon), liraglutide (Victoza), albiglutide (Tanzeum), dulaglutide (Trulicity), and lixisenatide (Adlyxin).

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Standard dosing conversions (see Appendix 2.3.5)

2.4 Adjustments for Drug Optimization

2.4.1 Metformin Titration Pharmacists may authorize metformin titration to achieve target hemoglobin A1C of less

than 7.0%.

For patients currently using metformin, metformin dose may be adjusted up to 2,550mg/day in divided doses based on blood sugar response and patient tolerability.

Pharmacists may convert metformin to an extended-release formulation to improve patient tolerability.

ADA guidelines (see Appendix 2.5.4)

2.5 Initiation of Over-the-Counter Products by Prescription

2.5.1 Blood Glucose Testing Supplies Pharmacists may prescribe blood glucose testing supplies, including blood glucose

monitors, test strips, lancets, alcohol swabs, control solution, and lancing devices.

Pharmacists may authorize 30-day supply with one-year refills at a testing frequency adequate for optimal blood glucose control.

2.5.2 Injection Supplies Pharmacists may prescribe syringes and pen needles for use with anti-diabetic

medications.

Pharmacists may authorize 30-day supply with one-year refills at an injection frequency adequate for optimal blood glucose control.

2.5.3 Hypoglycemia Treatment Pharmacists may prescribe glucose products (tablets, gel, etc.) for the acute treatment of

hypoglycemia.

Pharmacists may authorize 30-day supply with one-year refills at frequency adequate for optimal blood glucose control.

2.5.4 Aspirin Pharmacists may prescribe Aspirin 81mg once daily for primary and secondary heart

attack and stroke prevention for patients with diabetes aged 50 years or greater with the following considerations:

One additional major risk factor (family history of premature ASCVD, hypertension, dyslipidemia, or tobacco use)

Not currently using other antiplatelet or anticoagulant therapy

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Not at an increased risk of bleeding

No allergy or intolerance to NSAIDs

Pharmacists may authorize 30-day supply with one-year refills to be used once daily.

Current treatment guidelines (see Appendix 2.5.4)

3.0 Tobacco Cessation Management 3.1 Initiation of Nicotine Replacement Therapy

Pharmacists may prescribe all strengths and formulations of nicotine replacement therapy, including patches, lozenges, gum, inhalers, and nasal sprays.

Pharmacists may prescribe up to 4 weeks of nicotine replacement therapy with no refills.

Patients may return to the pharmacist for tobacco cessation counselling, re-evaluation, and prescriptions for appropriate next course of therapy.

Current treatment guidelines (see Appendix 3.1)

3.2 Initiation of Varenicline (Chantix) Pharmacists may not prescribe varenicline for the treatment of tobacco cessation for

patients with any history of mental health conditions.

Pharmacists may prescribe varenicline after conducting the Patient Health Questionnaire (PHQ-9) with the patient to assess for undiagnosed mental health conditions. Patients with a PHQ-9 score of less than 10 will be considered eligible for varenicline therapy.

Patients using prescription medications for the treatment of mental health conditions will be excluded from pharmacists’ prescribing of varenicline.

Patient Health Questionnaire (PHQ-9) (see Appendix 3.1, 3.2)

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4.0 Asthma/COPD Management4.1 Quantity Adjustments

Pharmacists may adjust drug quantities on prescriptions for the chronic treatment of respiratory diseases to dispense at least a 30-day supply.

4.2 Formulation Interchange

4.2.1 Combination Products Pharmacists may combine individual prescriptions medications into combined

formulations when available.

Pharmacists may separate prescription combination products into their individual components when the combination product is not available.

4.2.2 Time-Release Products Pharmacists may interchange immediate release products for extended-release products

(including sustained, delayed, and controlled) based on medication availability and tolerability.

Pharmacists may interchange extended-release products (including sustained, delayed, and controlled) for immediate release products based on medication availability and tolerability.

4.2.3 Drug Delivery Device Pharmacists may interchange between drug delivery devices provided the therapeutically

equivalent dose of the prescribed medication is delivered (i.e. Spiriva Handihaler = Spiriva Respimat).

4.3 Therapeutic Interchange

4.3.1 Single-Agent Inhalers Pharmacists may interchange between different brands of short-acting beta-2 agonists

(SABA) within the same dose range based on product availability.

o Albuterol (Ventolin, ProAir, Proventil), Levalbuterol (Xopenex)

Pharmacists may interchange between different inhaled corticosteroids (ICS) within the same dose range based on product availability.

o Beclomethasone (QVAR), Budesonide (Pulmicort), Ciclesonide (Alvesco), Flunisolide (Aerospan), Fluticasone Furoate (Arnuity), Fluticasone Propionate (Flovent), Mometasone (Asmanex)

Pharmacists may interchange between different inhaled long-acting muscarinic antagonists (LAMA) within the same dose range based on product availability.

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o Tiotropium (Spiriva), Aclidinium (Tudorza), Glycopyrrolate (Seebri) and Umeclidinium (Incruse)

Pharmacists may interchange between different inhaled long-acting beta-2 agonists (LABA) within the same dose range based on product availability.

o Formoterol (Foradil), Indacaterol (Arcapta), Olodaterol (Striverdi), and Salmeterol (Serevent)

Standard dosing conversation (see Appendix 4.3)

4.3.2 Combination Inhalers Pharmacists may interchange between different combination inhaled corticosteroids

(ICS)/long-acting beta agonists (LABA) within the same dose range based on product availability.

o Budesonide/Formoterol (Symbicort), Fluticasone/Salmeterol (Advair), Fluticasone Furoate/Vilanterol (Breo), and Mometasone/Formoterol (Dulera)

Pharmacists may interchange between different combination inhaled long-acting beta-2 agonists (LABA)/long-acting muscarinic antagonists (LAMA) within the same dose range based on product availability.

o Glycopyrrolate/ Formoterol (Bevespi), Indacaterol/Glycopyyolate (Utibron), Tioptropium/Olodaterol (Stiolto), and Umeclidinium/Vilanterol (Anoro)

Standard dosing conversation (see Appendix 4.3)

4.4 Adjustments for Drug Optimization

4.4.1 Inhaler Dose Titration Pharmacists may authorize dose titration for inhaled corticosteroids (ICS) and/or long-

acting beta-2 agonists (LABA) per clinical guidelines to achieve control of asthma or COPD when the following conditions apply:

o The patient is adherent to the current prescribed regimen in both inhaler technique and frequency.

o The patient reports using a SABA rescue inhaler > 2 days/week for at least 4 weeks.

Current treatment guidelines (see Appendix 4.4.1, 4.4.2)

4.5 Prescription Initiation

4.5.1 SABA Inhaler Pharmacists may initiate a prescription for a short-acting beta-2 agonist (SABA), albuterol

rescue inhaler, for patients with a diagnosis of asthma or COPD verified by a valid prescription for a maintenance inhaler.

Pharmacists may authorize one albuterol rescue inhaler for a 30-day supply with refills for one year.

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4.5.2 ICS Inhaler Pharmacists may initiate a prescription for an inhaled corticosteroid for patients with

uncontrolled asthma based on clinical guidelines when the following conditions apply:

o The pharmacist has confirmed a diagnosis of asthma.

o The patient is adherent to the current prescribed regimen in both inhaler technique and frequency.

o The patient reports using a SABA rescue inhaler > 2 days/week for at least 4 weeks.

A low-dose ICS inhaler will be prescribed with typical adult dosing with 5 refills.

Current treatment guidelines (see Appendix 4.4.1)

4.5.3 Montelukast Pharmacists may initiate a prescription for a leukotriene-receptor antagonist, montelukast

(Singulair), for patients with uncontrolled asthma based on clinical guidelines when the following conditions apply:

o The pharmacist has confirmed a diagnosis of asthma.

o The patient is adherent to the current prescribed regimen in both inhaler technique and frequency.

o The patient reports using a SABA rescue inhaler > 2 days/week for at least 4 weeks.

For patients > 10 years of age, pharmacists may authorize montelukast 10mg, 1 tablet every night at bedtime, #30, 11 refills.

Current treatment guidelines (see Appendix 4.4.1)

4.5.4 Respiratory Devices & Supplies Pharmacists may initiate a prescription for a nebulizer and related supplies when a

prescription for a nebulizer solution has been prescribed.

Pharmacists may initiate a prescription for a spacer when a prescription for an inhaler has been prescribed by a physician.

Pharmacists may initiate a prescription for a peak flow meter for the evaluation of severity of asthma and/or COPD.

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5.0 Allergy Management5.1 Quantity Adjustments

Pharmacists may adjust drug quantities on prescriptions for the treatment of seasonal allergies to dispense at least a 30-day supply.

5.2 Formulation Interchange

5.2.1 Combination Products Pharmacists may combine individual prescriptions medications into combined

formulations when available.

Pharmacists may separate prescription combination products into their individual components when the combination product is not available.

5.2.2 Time-Release Products Pharmacists may interchange immediate release products for extended-release products

(including sustained, delayed, and controlled) based on medication availability and tolerability.

Pharmacists may interchange extended-release products (including sustained, delayed, and controlled) for immediate release products based on medication availability and tolerability.

5.2.3 Oral Products Pharmacists may interchange between solid and liquid drug formulations of equivalent

dosing based on medication availability and tolerability.

5.3 Therapeutic Interchange

5.3.1 Oral Antihistamines Pharmacists may interchange between first generation antihistamines within the same

dose range based on product availability.

o Diphenhydramine (Benadryl), Chlorpheniramine (Chlor-Trimeton), and Doxylamine (Unisom)

Standard Dosing Conversions (see Appendix 5.3.1.1)

Pharmacists may interchange between second generation antihistamines within the same dose range based on product availability.

o Cetirizine (Zyrtec), Loratadine (Claritin), Fexofenadine (Allegra), and Levocetirizine (Xyzal)

Standard Dosing Conversions (see Appendix 5.3.1.2)

5.3.2 Ophthalmic Antihistamines16

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Pharmacists may interchange between ophthalmic antihistamines within the same dose range based on product availability.

o Ketotifen (Zaditor), Pheniramine and Naphazoline (Naphcon-A), Olopatadine (Patanol, Pataday, Pazeo), Azelatine (Optivar), Emadastine (Emadine), Epinastine (Elestat)

Standard Dosing Conversions (see Appendix 5.4.2)

5.3.3 Intranasal Products Pharmacists may interchange between intranasal antihistamines within the same dose

range based on product availability.

o Cromolyn (NasalCrom), Azelastine (Astelin, Astepro), Olopatadine (Patanase)

Pharmacists may interchange between intranasal decongestants within the same dose range based on product availability.

o Oxymetazoline (Afrin), Phenylephrine (Neo-Synephrine)

Pharmacists may interchange between intranasal corticosteroids within the same dose range based on product availability.

o Beclomethasone (Qnasl), Ciclesonide (Zetonna), Fluticasone furoate (Veramyst), Fluticasone propionate (Flonase), Mometasone (Nasonex), Budesonide (Rhinocort Allergy), Triamcinolone (Nasacort Allergy)

Pharmacists may interchange between different brands/delivery devices of intranasal saline products based on product availability.

o Saline (Ocean Spray, Simply Saline, Neti Pot, etc.)

Standard Dosing Conversions (see Appendix 5.4.3)

5.4 Prescription Initiation

5.4.1 Oral Antihistamines Pharmacists may initiate a prescription for oral antihistamines for adult patients with

symptoms consistent with seasonal allergies.

Pharmacists may authorize a 30-day supply with typical adult dosing with refills for one year.

Current treatment guidelines (Appendix 5.4.1)

5.4.2 Ophthalmic Antihistamines Pharmacists may initiate a prescription for ophthalmic antihistamines for adult patients

with symptoms consistent with seasonal allergies.

Pharmacists may authorize a 30-day supply with typical adult dosing with refills for one year.

Current treatment guidelines (Appendix 5.4.2)

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5.4.3 Intranasal Products Pharmacists may initiate a prescription for intranasal antihistamines and/or intranasal

corticosteroids for adult patients with symptoms consistent with seasonal allergies.

Pharmacists may authorize a 30-day supply with typical adult dosing with refills for one year.

Current treatment guidelines (Appendix 5.4.3)

5.4.4 Emergency Injectable Epinephrine Pharmacists may initiate a prescription for emergency injectable epinephrine when a

patient reports history of severe anaphylaxis to a known allergen.

Pharmacists may authorize one injectable epinephrine package with typical adult dosing with no refills.

Current treatment guidelines (Appendix 5.4.4)

6.0 Acid Reflux Management18

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6.1 Quantity Adjustments Pharmacists may adjust drug quantities on prescriptions for the treatment of acid reflux to

dispense at least a 30-day supply.

6.2 Formulation Interchange

6.2.1 Combination Products Pharmacists may combine individual prescriptions medications into combined

formulations when available.

Pharmacists may separate prescription combination products into their individual components when the combination product is not available.

6.2.2 Time-Release Products Pharmacists may interchange immediate release products for extended-release products

(including sustained, delayed, and controlled) based on medication availability and tolerability.

Pharmacists may interchange extended-release products (including sustained, delayed, and controlled) for immediate release products based on medication availability and tolerability.

6.2.3 Oral Products Pharmacists may interchange between solid, disintegrating, and liquid drug formulations

of equivalent dosing based on medication availability and tolerability.

6.3 Therapeutic Interchange

6.3.1 Proton Pump Inhibitors Pharmacists may interchange between proton pump inhibitors within the same dose

range based on product availability.

o Omeprazole (Prilosec), Lansoprazole (Prevacid), Omeprazole/sodium bicarb (Zegerid), Esomeprazole (Nexium), Pantoprazole (Protonix), Dexlansoprazole (Dexilant)

Standard Dosing Conversions (see Appendix 4.3)

6.3.2 Histamine H2 Antagonists Pharmacists may interchange between histamine H2 antagonists within the same dose

range based on product availability.

o Famotidine (Pepcid), Ranitidine (Zantac), Nizatidine (Axid)

Standard Dosing Conversions (see Appendix 4.3)

7.0 Organization 19

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7.1 Provider Eligibility Physicians of GSFHC and pharmacists/pharmacy interns of SVDP, whether staff or

volunteer, are considered qualified providers to participate in patient-care activities related to this agreement.

All providers must be licensed in good standing with their respective board and follow established standards for entering and managing a collaborative practice agreement.

Pharmacy interns may participate in patient-care activities related to this agreement, but must receive signed approval by an SVDP pharmacist.

Each provider will have an ongoing physician-patient relationship with each patient whose drug therapy is managed by a pharmacist.

The diagnosis for which each patient has been prescribed drug therapy under the collaborative practice agreement must be within the scope of each physician’s practice.

7.2 Training/Education All qualified personnel will receive sufficient training for their role by a member of the

management team, either pharmacy manager or medical director.

All qualified personnel are expected to maintain up-to-date competencies and knowledge of current guidelines for disease states covered under this agreement.

7.3 Liability Providers are not required to but are highly recommended to maintain liability insurance.

A physician is not liable for damages in a tort or other civil action for injury or loss to person or property allegedly arising from a pharmacist’s change in a drug for a patient whose drug therapy the pharmacist is managing under a consult agreement unless the physician authorized the specific drug change.

A pharmacist is not liable for damages in a tort or other civil action for any injury or loss to person or property allegedly arising from the physician’s change in a drug for a patient whose drug therapy the pharmacist is managing under a consult agreement.

7.4 Informed Consent of the Patient Patients are required to provide written consent enrollment into this agreement upon

certification and recertification into the charitable pharmacy program.

Consent will be documented by patient signature on intake forms with this statement:

o I understand that St. Vincent de Paul Charitable Pharmacy may enter into a collaborative practice agreement with my physician for the purpose of managing my drug therapy. As allowed by the state of Ohio (pursuant to ORC4729.39) and my physician, I consent to allow pharmacists to manage my drug therapy when appropriate as indicated by my signature below. I understand my right to opt out of this program at any time by providing withdrawal of consent in writing.

7.5 Documentation20

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St. Vincent de Paul Charitable Pharmacy Good Samaritan Free Health Center

At SVDP Charitable Pharmacy, all patient-care interventions resolved by a pharmacist within this agreement will be documented in the Outcomes MTM software

All patient-care interventions resolved by a pharmacist will be documented in writing on a standardized facsimile signed by the pharmacist and patient.

Health center support staff will receive facsimiles and document all patient-care interventions taken under this agreement in the electronic medical record.

Facsimile forms will be scanned into the pharmacy’s prescription processing database, serving as the hard-copy prescription. The prescribing physician will be documented as Eby (CPA), R. Stephen.

7.6 Communication Interventions resolved by an SVDP pharmacist will be faxed to GSFHC within 72 hours of

the patient-care action taken using a standardized facsimile. (Appendix 7.6)

The rationale for each intervention and a recommendation for a timeline for physician follow-up will be documented on the facsimile.

The physician must review the actions of the pharmacist within a timely manner. In the event a physician disagrees with a decision made by the pharmacist under this agreement, the referring physician is permitted to override that pharmacist’s decision by communicating the overridden action via fax.

Routine communication will be conducted through telephone, fax, or secure email as is appropriate for the situation.

The pharmacy manager and medical director will meet quarterly for quality assurance and annually for quality improvement.

7.7 Quality Assurance and Improvement The pharmacy manager and medical director will meet quarterly to review the activities

related to this agreement for quality assurance. Policies and procedures will be revised as needed to promote safe, effective, and efficient patient care. (Appendix 7.7)

The pharmacy manager and medical director will meet annually to complete a minimum of 10 chart reviews that utilized this agreement. Strategies for improvement will be discussed, and the pharmacist will develop a quality improvement plan based on the review. (Appendix 7.7)

7.8 Period of Validity This agreement is valid for up to 2 years following signatures of all parties.

7.9 Retention of Records All records, whether physical or electronic, must be maintained for at least 3 years.

7.10 Rescindment and Amendment21

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The physician, pharmacist, or patient may withdraw from the agreement at any time with a written notice of termination.

Prescribers may override this agreement whenever they deem such action necessary or appropriate for a specific patient intervention without affecting the agreement relative to other patients.

This agreement may be amended prior to the 2-year expiration date.

Amendments must include detailed policies and procedures of changes to this agreement. Amendments must be dated and signed by both parties.

8.0 Signatures of ApprovalI, Dr. Robert Stephen Eby, a licensed healthcare provider authorized to prescribe medication in the State

of Ohio, delegate prescriptive authority to the pharmacists listed below to initiate, modify, refill, and

discontinue drug therapy for patients shared by the Good Samaritan Free Health Center (GSFHC) and St.

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St. Vincent de Paul Charitable Pharmacy Good Samaritan Free Health Center

Vincent de Paul Charitable Pharmacy (SVDP). This authority pertains to the protocol established in this

agreement in accordance with the laws and regulations (ORC 4729.39) of the State of Ohio.

SVDP pharmacists shall document all drug therapy adjusted under this protocol and communicate with

the healthcare team at GSFHC. As the authorizing prescriber, I or authorized staff under my supervision,

will be available to review drug therapy adjustments by SVDP pharmacists.

This protocol will be in effect for two years unless rescinded earlier in writing by either party. Any

modification of the protocol shall be treated as a new protocol, requiring signed approval from responsible

parties.

Signatures of Responsible Parties:

______________________________________ 35.044783__________________ ______________

Dr. Robert Stephen Eby, MDMedical DirectorGood Samaritan Free Health Center

License Number Date

______________________________________ 03232882-2_________________ ______________

Dr. Russell Curington, RPhPharmacy ManagerSt. Vincent de Paul Charitable Pharmacy

License Number Date

______________________________________ 03334430-3_________________ ______________

Dr. Lydia Bailey, RPhClinical PharmacistSt. Vincent de Paul Charitable Pharmacy

License Number Date

______________________________________ 03110884-1_________________ ______________

Mr. Mike Espel, RPhPharmacy DirectorSt. Vincent de Paul Charitable Pharmacy

License Number Date

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