What Pennsylvania Physicians Should Know About the New Collaborative Drug Therapy Management Regulation

Last Updated: Sep 4, 2015

By Angela Boateng, Esq., PAMED Legal Counsel

Collaborative drug therapy management is not a new concept; this strategy has been around at least since the late 1970s. And, now, we have it in the Commonwealth.

(Okay. So, it’s actually not really new to Pennsylvania. The Pharmacy Act was amended in 2002 to permit pharmacists practicing in an institution setting to manage drug therapy by means of a written protocol. The Act was amended again in 2010 to allow for collaborative drug therapy management via a written collaborative agreement between a physician and a pharmacist in a setting other than an institutional setting.)

On July 9, 2015, the Independent Regulatory Review Commission (IRRC) approved the State Board of Pharmacy’s regulation, implementing the 2010 amendment to the Pharmacy Act, for the Collaborative Management of Drug Therapy.

What does this mean for Pennsylvania physicians? Good question.

The passage of the regulation is one more opportunity for physicians to engage in patient-centered, team-based care. As a result of collaborative drug therapy management, researchers have also noted improved patient outcomes for chronic diseases, resulting in an overall cost savings due to the appropriate management of these diseases. What’s not to like about that?

Despite its prevalence and (…some would argue) popularity across the nation, Pennsylvania physicians are not required to participate in collaborative drug therapy management with pharmacists; it’s totally voluntary. Should they choose to do so, however, there are a couple of rules that must be followed. (This wouldn’t be a regulatory blog if I didn’t talk about the rules, right? Right.) 

Physicians and pharmacists that engage in collaborative drug therapy management must have a collaborative agreement that: 

Documents the identity of the physician responsible for authorizing and the pharmacist authorized to perform the management of drug therapy. 

Makes clear that the physicians initiate the regimens for drug therapy management for patients referred to a pharmacist. 

Identifies the types of decisions the pharmacist is authorized to make, regarding drug therapy management, within the physician’s scope of practice and the types of management of drug therapy authorized. 

Specifies when the pharmacist is allowed to adjust the drug regimen, the drug strength, and the frequency of administration; adjust the route of administration; administer drugs; order laboratory tests and perform other diagnostic tests necessary in the management of drug therapy without prior written or oral consent by the collaborating physician. 

Lists the functions and tasks the pharmacists must follow, including the method of documenting decisions made and a plan for communication or feedback to the authorizing physician concerning specific decisions made. The pharmacist is required to document each intervention as soon as practicable, but no later than 72 hours after the intervention, and must be recorded in the pharmacist’s record. 

Requires that the pharmacist notify the authorizing physician of changes in dose, duration or frequency of medication prescribed as soon as practicable, but no later than 72 hours after the change. 

Explains how the collaborative agreement will be implemented when the physician or pharmacists who is party to the collaborative agreement is temporarily unavailable to participate in its implementation. 

Describes how the physician will notify affected patients of the role of the pharmacist in the management of their drug therapy. And, the opportunity for the patients to refuse drug therapy management by a pharmacist.

In this partnership, collaborating physicians will have access to the patient’s pharmacy records and pharmacists will also have access to patient records.

The collaborative agreement must be effective for no more than two (2) years from the date of execution and must reviewed at least every two years to determine renewal, modification, or termination. The agreement must be filed with the Department of State’s Bureau of Professional and Occupational Affairs and maintained on the pharmacy premises.

And, recognizing the increased exposure to risk, the regulation requires that pharmacists maintain professional liability insurance in the minimum amount of $1 million per occurrence or claims made. So, there you have it—a quick summary of Pennsylvania’s new(ish) tool in our continuing effort to promote team-based, patient care. We’d love to hear your thoughts about it! Please feel free to provide comments below.

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