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Collaborative Practice Agreements
Collaborative Practice Agreements and EC
Collaborative Practice Agreements refer to the practice where prescribers (generally physicians, in some states includes nurse practitioners) authorize pharmacists to engage in specified activities including adjusting and/or initiating drug therapy.
Authority for a collaborative practice agreement is generally incorporated in the state pharmacy practice act, frequently within the definition section describing the authorized scope of practice. Alternatively, some boards of pharmacy have promulgated regulations creating collaborative practice agreements based on broad authorizing language or in the absence of an explicit prohibition against them.
In the context of emergency contraception (EC), pharmacists operating under supportive collaborative practice agreements can enhance access to a very beneficial and time-sensitive drug therapy.
Definitions
| 1. |
Collaborative Practice Agreement: a voluntary agreement between one or more prescribers and pharmacists establishing cooperative practice procedures under defined conditions and/or limitations. |
| 2. |
Collaborative Drug Therapy Management (CDTM) refers to the practice where prescribers authorize pharmacists to engage in specific activities such as initiating, adjusting, or evaluating drug therapy. “CDTM” is used interchangeably with “collaborative practice agreement” in this document. |
| 3. |
A written guideline or protocol documents the collaborative practice agreement. The agreement, between a licensed practitioner and licensed pharmacist, may include the initiation, modification and administration of drug therapy, ordering and evaluating lab work, making physical assessments, and any other provision of drug therapy and patient care management within the scope of practice and practice skills of the parties involved. The documents often authorize activity for a specific duration of time (usually not exceeding two years). |
Components of a Collaborative Practice Agreement
Traditional collaborative practice agreements generally include the following elements:
| 1. |
One or more pharmacists agrees to work with one or more prescribers under a written and signed agreement to perform certain patient care functions under specified conditions |
| 2. |
Possession on the part of pharmacists of the knowledge, skills and ability to perform authorized functions (determination of competence is usually left up to the individuals who are party to the agreement) |
| 3. |
Authority to document activities in a medical record |
| 4. |
Accountability for the same quality measures for all health professionals involved in the collaborative agreement |
| 5. |
Provisions to allow compensation for drug therapy management activities |
Collaborative Practice Agreement Activities
Under mutually agreeable practice protocols and guidelines, collaborative practice agreement activities may include:
- Initiating, modifying, and monitoring a patient’s drug therapy
- Ordering and performing laboratory and related tests
- Assessing patient response to therapy
- Counseling and educating a patient on medications
- Administering medications
These agreements may also include:
- procedures for initiating, modifying, continuing or stopping drug therapy
- collecting or reviewing patient history
- measuring or reviewing patient vial signs
- reviewing and performing physical assessment
- ordering and evaluating laboratory test.
In the context of emergency contraceptive drug therapy, physicians (or other prescribers) and pharmacists would establish a collaborative practice agreement detailing the appropriate patient population to use emergency contraception. Pharmacists would evaluate patients interested in emergency contraceptive drug therapy according to the agreement, and initiate use of the medication in specific situations.
Typical Collaborative Practice Agreement Authorization
Authorization for collaborative practice agreements can be accomplished by amending the definition of the practice of pharmacy at the state level. The statute can be revised to define the practice of pharmacy to include the practice of and responsibility for:
- “initiating, modifying, or discontinuing drug therapy in accordance with written protocols or agreements established and approved by a practitioner authorized to prescribe drugs”
or
- “drug therapy management pursuant to a written protocol or agreement between a pharmacist and practitioner.”
In the latter case, “drug therapy management” is subsequently defined to include initiating, modifying, or discontinuing drug therapy.
Consistent with the State Board of Pharmacy’s role in regulating the practice of pharmacy and ensuring public health and safety regarding the use of drugs, the Board promulgates regulations
to define the content of collaborative drug therapy protocols or agreements, providing the detail for implementing collaborative practice agreement-authorizing legislation. Regulations typically require statements that:
- Identify the prescribing practitioner(s) and the pharmacist(s) who are participating in the protocol or agreement
- Identify the type of drug therapy management decisions the pharmacist is allowed to make. This is defined through two statements: (1) a detailed statement about the diseases, drugs, or drug categories involved; and (2) a detailed statement about the methods, procedures, decision criteria, and the plan the pharmacist is to follow.
- Describe the manner in which the pharmacist’s activities are documented and the method of communication, feedback, and reporting to the authorizing practitioner.
- Outline how the practitioner will supervise the pharmacist(s) and perform quality assurance of the drug decision-making process.
- Describe the time period for the protocol or agreement (usually one or two years) and the ability to make any adjustments to the protocol
- Additionally, some state regulations require that a copy of the protocol be filed with the Board of Pharmacy and be maintained on file at the practice site.
State Variances
Currently more than 40 states allow collaborative practice agreements. These agreements vary significantly from state to state, especially regarding:
- Who is eligible to participate in collaborative practice agreement. Some states limit authority to pharmacists with specified training or education.
- Scope of practice authorized. Some states specify the types of medications or specific disease states which may be authorized in a collaborative practice agreement, such as immunizations. Some states require that protocols be “patient-specific”, limiting the utility of these agreements in expanding direct access to therapy to pharmacists.
- Practice environments. Some states limit collaborative practice agreement authority to specific pharmacist practice settings or to patients in certain settings, such as hospitals or long-term care facilities.
- Level of review or approval. Some states require registration of participating pharmacists and prescribers, protocols, and other information with the state boards of pharmacy or medicine.
In some cases, collaborative agreements between physicians and pharmacists are limited: they permit the pharmacist to make specific types of alterations in the drug therapy of a specific patient or group of patients, following a written protocol approved by the pharmacist and physician.
For example, an agreement covering a patient receiving therapy with an anticoagulant might enable the pharmacist to carry out tests to monitor the patient’s International Normalized Ratio (INR) and to modify the drug dosage according to treatment goals and accepted guidelines.
Other agreements are designed to achieve larger public health goals and cover broad populations of patients: an example is a collaborative prescribing protocol that allows pharmacists to prescribe and administer vaccines.
State Environments for Collaborative Practice Agreements
Authority for collaborative practice agreements varies from state-to-state, and use of this authority to expand access to emergency contraception varies accordingly. The optimal regulatory situation for emergency contraception would include:
- Collaborative practice agreement practice available for any pharmacist licensed to practice in the state
- Few limits on the scope of practice Or emergency contraception explicitly authorized
- Collaborative practice agreement practice authorized in any pharmacy practice setting
- Review of standard protocol (no patient-specific review or protocols required)
Not all pharmacists have been authorized to
participate in collaborative practice agreements and to initiate
drug therapy. As of June 2003, more than 40 states and the territory
of Guam authorize collaborative practice agreements between pharmacists
and physicians, although the scope of authority varies widely.
- Optimal Environments: No Revision to Authority Necessary
- In 13 states, existing statutes and regulations accommodate pharmacists’ initiation of emergency contraception.
- Possible Environments: Revision to Existing Authority Required
- In 30 states, the practice of pharmacy permits pharmacists to administer medication pursuant to collaborative practice agreements or a prescriber’s “order”. However, these states would require modification of existing statutes and regulations to allow pharmacists to provide EC direct to the public.
- Unfriendly Environments: New Authority Required
- In 7 states, no authority exists for collaborative practice agreements. Any initiative to provide direct pharmacy access to EC would require significant advocacy activity to secure statutory and/or regulatory authority.
Frequently Asked Questions about Collaborative Practice Agreements
1. What is a collaborative practice agreement?
A collaborative practice agreement is a voluntary, written agreement between a physician and a pharmacist outlining a plan of cooperative practice for drug therapy management. These agreements are limited to care within the scope of practice of the participating physician, or in some states nurse practitioners, and pharmacist.
2. Who can initiate such an agreement?
Physicians (and other prescribers) and pharmacists work together to establish the written agreement.
3. What is the purpose of the collaborative practice agreement?
To support the collaboration by a physician and a pharmacist to
- ensure optimal management of a patient’s drug therapy
- provide a framework for physicians to voluntarily enter into protocol style agreements with pharmacists
- allow for the efficient and effective management of drug related problems; to provide an option for improving and optimizing drug therapy outcomes
- facilitate access to appropriate drug therapy.
4. What are the benefits to the public?
- Improved access to healthcare through pharmacists
- Enhanced patient care through optimized drug therapy management
- Decreased drug-related problems (adverse drug reactions, drug interactions, poor compliance, etc.) through the use of scientifically designed drug therapy protocols and management
- Reduced costs through optimal use of medications and minimization of drug related problems
- Pharmacist identification of individuals who require the care of a physician.
5. What are the benefits to physicians?
- Reduced costs of care
- Reduced visits for chronic disease patients, freeing more time for acute care visits
- Delegation of medication management to the drug specialist — the pharmacist, who has unique skills and knowledge that can be used to support the physician’s therapy strategies
6. What are the benefits to pharmacists?
- Allows pharmacists to move from a product oriented service to a patient-focused practice using their unique knowledge to improve clinical outcomes
- Allows pharmacists to demonstrate their value as an integral part of the healthcare team
7. What are some examples of where these agreements are being used successfully?
- Immunizations
- Emergency Contraception
- Asthma Therapy Management
- Dyslipidemia Therapy Management
- Warfarin Anticoagulant Therapy Management
- Diabetic Therapy Management
- Smoking Cessation Therapy
- Flu/Antiviral Therapy
8. I am a pharmacist in an EC pharmacy access state and I want to become an EC provider. What do I need to do?
- California pharmacists, please visit our main website at www.pharmacyaccess.org to learn how to become an EC provider.
- Pharmacists in other states, please contact the State Board of Pharmacy or other EC contacts in your state to find out specific requirements. Some state contact information is available at State Profiles.
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