Hub on policy and advocacy, March 2013

Hosting pharmacy visits; FDA's risk-based compounding framework

Build relationships: How to host a pharmacy visit

Incoming APhA President-elect Matt Osterhaus, BSPharm, FASCP, FAPhA, and the concept of political involvement go back a long way. His father, Bob Osterhaus, BSPharm, a former APhA President, has been very active in Democratic politics in Iowa for decades, even serving in the state legislature from 1996 to 2004. So a lot of state representatives and state senators have come through their pharmacy, Osterhaus Pharmacy, in Maquoketa, IA.

On the national level, many politicians have stopped by, including presidential candidates during the run-up to the Iowa caucuses. Rep. Bruce Braley (D-IA) has been to the pharmacy several times. And in October 2012, Sen. Chuck Grassley (R-IA) came in. “It was nice to have somebody from the other side of the aisle visit us,” Matt Osterhaus told Pharmacy Today.

When Grassley visited the pharmacy, Osterhaus “really wanted to get across to him the level of care-based services that we provide.” So Osterhaus’s primary objective was to convey the role of the pharmacist. Another goal, in the wake of the fungal meningitis outbreak, was to deliver a message on compounding. “The service we provide our patients is on a one-to-one basis, very unlike the process that brought on this national scandal,” he said. “Any [legislation] that the House or Senate puts out shouldn’t deter pharmacists from taking care of the needs of our patients with specialty compounded prescriptions.”

A third takeaway for Grassley ended up being mail-service waste. A widow of a patient who had died in a nursing home coincidentally came in that morning with bags of drugs that a mail-service pharmacy had kept shipping to him under a federal employee plan, even after he was in a nursing home and didn’t need them—and Osterhaus was able to show Grassley the bags of drugs.

“Show and tell is really a very effective method to get a point across and have it stay with that representative or that senator,” Osterhaus explained. “I don’t think there’s anything more effective than talking about the issues when you’ve got your patients right around you. Demonstrating how your team works together to take care of patients is powerful. It further cements relationships … and it gives you more name recognition in that office when you go to make an ask.”

Advocacy can feel overwhelming

Hosting a pharmacy visit by a Member of Congress, state lawmaker, or other policy maker fits into a spectrum of pharmacist advocacy. And pharmacist advocacy is important for the future of the profession.

Just ask Trish Rippetoe Freeman, BSPharm, PhD, Clinical Associate Professor and Director of the Center for Advancement of Pharmacy Practice, University of Kentucky (UK) College of Pharmacy—and the 2012 recipient of APhA’s Good Government Pharmacist of the Year Award. “If we want to expand our practices and achieve provider status recognition, advocacy is of the utmost importance,” she said. “Nothing changes unless we change it!” Getting people over the hump to be involved in advocacy can be very difficult, she added. “This whole idea of advocacy is overwhelming for folks who haven’t been politically active over the years.”

In Kentucky, a low percentage of pharmacists are involved in politics. In that state, owners of independent pharmacies are the most willing to host pharmacy visits, and the most politically motivated group of pharmacists. At UK, said Freeman, student pharmacists “really want to show legislators they are patient care providers.” The legislative committee at the UK College of Pharmacy partners with local pharmacies to host visits; busy pharmacy owners may be happy to have a site visit but not willing or able to deal with the logistics, the talking points, and so on. Those involved in upcoming visits by Members of Congress contact APhA for guidance beforehand to be certain their message is consistent with the national message.

At the state level, advocacy is key. Often, it’s easier to expand practice at the state level and have it diffuse through states before it can be addressed at the federal level, Freeman said. Jim Mathews, BSPharm, MSA, Chief Operating Officer of the Michigan chain HomeTown Pharmacy Inc., said his pharmacies are just beginning to have visits. So far, they’ve hosted a state senator and a state representative, as part of advocacy efforts including recent meetings with state and federal lawmakers. “Start with your local legislators first,” Mathews suggested. “Speak to their chief of staff or their scheduler. When they come, just be yourself. Pick one or two topics to discuss. Do not overwhelm them. Have fun.”

Advice on hosting a pharmacy visit

“A lot of it starts at the state level,” said Lynn Connelly, BSPharm, owner of Medicine Mart Pharmacy in West Columbia, SC, and a former President of the South Carolina Pharmacy Association. “You need to work with your state representatives and get comfortable in doing that.” It’s easiest to build from those relationships, he continued. “And then with the congressional folks from Washington, oftentimes you’re working with the staffers to begin with. But you build relationships, you build credibility with them.”

The biggest thing, Connelly said, is to know your topics pretty well. The other thing is to make sure your talking points are as short and sweet as possible. “If they do visit you in the pharmacy, have concrete, short examples that you can show them,” he said. “Don’t make it real complicated.” Osterhaus offered similar advice. “Be prepared,” Osterhaus said. “If you’re offering a concept to that representative, … give it to them in a very simple fashion, a soundbite-type fashion that he’s going to be able to carry home with him.”

And reinforce that concept. “If you have your one message that you really want to get through, don’t hesitate to talk about it in two or three ways to reinforce the fact that this is really important,” Osterhaus added. In the case of Grassley’s visit, Osterhaus reinforced that the services pharmacists provide should enable them to be providers under Medicare by talking about it back in the dispensing area, and then again in the patient consultation areas.

Pharmacists sometimes approach Dennis Galluzzo, BSPharm, President of Family Medical Pharmacy in Williamsville, NY, and Executive Director of the Pharmacists Association of Western New York, asking how to get a lawmaker to visit their pharmacy. “The process for building those relationships and issuing an invitation works both ways. They sometimes reach out to us. More often, we reach out to them,” said Galluzzo, whose pharmacy has hosted Sen. Charles E. Schumer (D-NY) and former First Lady and Secretary of State Hillary Clinton, then the other Democratic senator from New York. “Pick the issue that is a linchpin issue for them at the particular time.”

From the beginning, Osterhaus said, establish a relationship that shows caring and interest beyond wanting something from the politician. Get involved in associations such as APhA, which know who on the politician’s staff is the health care contact. And inform the politician on issues and provide financial and volunteer support. For example, the Osterhaus family has been a big supporter of Braley, including helping to coordinate his campaigns in their county. But Grassley’s visit was set up by a national association. “All these things help set it up so you can see somebody or get somebody to come visit the pharmacy,” he added. “The basis for success in politics is all about relationship building.”

Step-by-step instructions on “How to Set Up Your Pharmacy Visit,” complete with a sample invitation letter and a sample thank-you letter, are available at

For questions or assistance, please contact APhA Senior Lobbyist Michael Spira.

APhA supports FDA's concept of risk-based compounding framework

Addressing FDA’s proposed regulatory framework for pharmacy compounding and the role of state and federal oversight, APhA has submitted a comment letter to FDA following the agency’s December 19, 2012, intergovernmental meeting.

FDA is considering a risk-based framework that would create two categories of compounding: “traditional” and “nontraditional.” As proposed, traditional compounding—as discussed by FDA in testimony at the November 2012 congressional hearings and the December 2012 stakeholder meetings—would remain under state jurisdiction. Nontraditional compounding would be subject to federal standards based on higher-risk factors such as the amount of product being made or whether the drug is being dispensed to someone other than the ultimate user.

APhA believes that this tiered regulatory approach “has its merits, generally supports the concept, and is very interested in continuing dialogue with FDA, Congress, States and other stakeholders to explore potential solutions,” according to its January 18, 2013, comment letter to FDA.

The Association recommended considering the following areas for further clarifications and additions:

  • Compounding standards: APhA supports efforts to ensure proper resources and funding for state boards of pharmacy for compounding regulatory activity.
  • Sterile compounding licensure: APhA supports consideration of enhanced standards and state licensure for sterile compounding to ensure consistent standards across all states and providers in all practice settings.
  • Manufacturer versus compounder: APhA agrees with ongoing dialogue that the definition of compounding versus manufacturing needs to be clearly defined.
  • Amount/quantity
  • Compliance policy guide
  • Education and training resources
  • Communication
  • Accreditation

The Association’s January 18 letter to FDA built on the December 2012 intergovernmental meeting; APhA’s discussions with FDA at the December 2012 pharmacy stakeholders listening session; APhA’s comments to the Senate Health, Education, Labor, and Pension Committee in November 2012; meetings with House Energy & Commerce Committee staff; and APhA’s ongoing dialogue with congressional and agency staff, the pharmacy community, and other stakeholders.