Fight for survival

Crimes against pharmacies have been rampant in recent years, with almost 700 armed robberies occurring in 2010 alone. From 2006 to 2010, armed robberies of pharmacies rose 81%, jumping from 380 to 686. Since 2010, more than 1,800 pharmacy thefts and a number of pharmacy murders have resulted from acts committed by drug-seeking individuals.

Small independent pharmacies are particularly vulnerable, because they may lack the resources to fund the services of a security guard or to install and maintain a security system, said Joe Harmison, RPh, owner of two pharmacies in Arlington, Texas, and president of the National Community Pharmacists Association (NCPA) from 2009 to 2010.

“About five to six years ago, the street value of prescription drugs climbed, and more and more [people] were abusing,” said Harmison, who has been advocating for 15 years for legislation to make pharmacy burglary and robbery federal crimes with longer sentences for pharmacy criminals.

Harmison testified on behalf of NCPA in July 2012 before the U.S. Senate Caucus on International Narcotics Control about legislative efforts to combat pharmacy crime. NCPA also supported the Safe Doses Act (S. 1002), which increased the penalties for theft and diversion of prescription drugs. In October 2012, President Barack Obama signed the legislation into law, increasing the maximum sentence of pharmacy thefts from 10 to 20 years in prison.

Harmison is proud that after his years of advocacy, tougher penalties for these criminals are now a reality.

“Now there is a price to pay for harming people,” he said. His own pharmacy has been burglarized three times.

How to advocate for pharmacy

Drawing upon his years of experience in championing a cause, Harmison had this advice for his colleagues. Pharmacists who want to become advocates for their profession can start with their state pharmacy associations. First, contact the government affairs department and get to know individuals within the association. It is important to be interested and willing to listen and learn, he said.

“Go out and start building relationships with the legislators within the government who write the policies,” Harmison told Drug Topics. “It is not really all that difficult. It is building personal relationships with individuals, as you do with patients and neighbors.”

Pharmacists can advocate at any level - local, state, or federal - by letting community groups, state associations, or the national associations know that they are willing and able to participate, Harmison said.

“Do your homework. Know who are your state and federal representatives and senators and how to get ahold of them,” he said. “You can start by writing a letter to your state representative and go to fundraisers. Then they will be able to associate a name and a face, and your profession.”

Get involved

Beverly Schaefer, RPh, co-owner of Katterman’s Sand Point Pharmacy, Seattle, Wash., believes that one good way for independents to learn about pharmacy issues is to join NCPA. The association has developed a strong, collegial network of pharmacists who understand what the issues are and can help pharmacists and future pharmacists convey this information to state or federal legislators as well as to employer groups.

“It is important that we educate individuals within our communities about the benefits of community pharmacy,” Schaefer said.

M. Keith Hodges, RPh, owner of Gloucester Pharmacy, Gloucester, Va., believes that community pharmacists should get involved at the community, state, and national levels, because being knowledgeable about pharmacy issues helps with running a pharmacy business more effectively.

“If you just stay in the pharmacy, you only see what is going on in the pharmacy,” Hodges said. “When you network with others and you advocate for your profession, you learn what is going on within the industry, which helps you with your business.”

Hodges, who was elected to the Virginia House of Delegates in 2011, said that, speaking as a state legislator, he values the time he spends with individuals who are working within their profession over time spent with paid lobbyists.

 “We need to hear from experts who give us good information,” he said.

For a number of years, Hodges has been an active advocate within the profession at both the state and national levels. He has been involved with the state association in Virginia, has chaired the national legislative committee for NCPA and served on NCPA’s board of directors, and is a board member for Epic Pharmacy.

In his current elected position, Hodges serves as an advisor to other legislators on pharmacy matters.

“When pharmacy bills come up in the state legislature, other legislators look to me for guidance. You [the pharmacy owner and pharmacist] can’t introduce legislation for pharmacy, because it can be self-serving, but you can offer advice to other legislators.”

More pharmacists need to run for political office, Hodges urged. While there are no pharmacists serving in Congress, a number of pharmacists have been elected to state legislatures, including Hodges and another pharmacist in Virginia.

Pharmacists who run for political office have a good change of winning.

“Typically pharmacists are apolitical. People don’t see me as a Republican or a Democrat. They see me as Keith Hodges,” he said. “They trust you, as you are considered one of the most trusted health professionals, and they trust you to make the decisions in government as well.”

Represent pharmacy

Schaefer, who started out making deliveries for Katterman’s Pharmacy and working her way up to pharmacy store manager before purchasing the drugstore with a partner in 1996, has been a strong, successful advocate for independents as a spokesperson for the profession.

Pharmacists who want to get involved, she said, should try to tap specific groups to speak to about legislative issues that are important to independents, including legislators, payers, employer organizations, public service groups, local colleges of pharmacy, their students, and the media.

“Prepare your message ahead of time, before you talk to the media. I figure out the message that I want to deliver to them, not the other way around,” said Schaefer, who is active with Seattle media.

For pharmacists who want to connect with legislators, Schaefer suggested attending any local events, such as town hall meetings or coffee hours, where they can introduce themselves and present their business cards.

“Offer to be a resource on any pharmacy issues that your legislators encounter. Sometimes they don’t understand pharmacy issues,” Schaefer said. “Explain that you would be willing to talk with their assistants.”

Campaign for provider status

In the state of Washington, pharmacists have been able to make some inroads into the issue of provider status, but it is important to keep advocating for the profession.

“It is a constant battle - a constant vigilance on the part of pharmacy - to be recognized as providers and let people know that we are performing a valuable service for the community,” Schaefer said.

With the development of accountable care organizations (ACOs), it is important for pharmacists to be recognized as providers as these provider models take shape. Pharmacists were not specifically mentioned in the ACO accreditation standards developed by the National Committee for Quality Assurance. However, “pharmacy could be a big help in meeting some of their goals, in serving more patients and lowering costs. We want to be at the table,” Schaefer said. “Without provider status, it marginalizes us.”

In connection with ACOs, pharmacists need to advocate for patient choice, which would allow patients to continue to use their own community pharmacies. It is unknown at this point whether ACO pharmacy networks will be open or closed, Schaefer said.

Schaefer has been on the cutting edge of progress for many years. In 1996, Schaefer’s pharmacy became one of the first pharmacies in the country to offer mass immunizations administered by a pharmacist. Before that, patients received their flu shots only in doctors’ offices.

“We did over 1,200 flu shots that year. This was major change for pharmacists,” she said.

Create collaborative agreements

In March 2012, Schaefer testified before FDA on behalf of NCPA, advocating for a third class of drugs. FDA invited comments on implementation from all interested stakeholders, including pharmacists, doctors, and nurses. The turf battles were evident, with pharmacists favoring a third class of drugs and doctors and nurses against it.

When Schaefer returned to Washington state, she realized that establishing collaborative practice agreements with physicians would be the best approach to becoming a pharmacist prescriber of specific prescription drugs. Collaborative practice agreements with physicians have been part of the state’s pharmacy practice acts since the 1970s.

“So if you write up a protocol with specific parameters about what would fall under this protocol, and you find a physician who agrees to letting you follow this protocol, then you - the pharmacist - become the prescriber of the drug,” said Schaefer.

Schaefer worked through the summer of 2012, writing 30 protocols for the prescription of specific drugs on a one-time basis or in an emergency situation. In the fall she developed the patient assessments and forms to accompany the protocols. Then, after four months of negotiation with a physician, she obtained prescriptive authority for 30 prescription drugs in the state of Washington.

“There are a lot of ailments that need acute care, like a bee sting, a dog bite, renewing an outdated EpiPen, a urinary tract infection, a cold sore, the start of shingles. These are things that people come to the pharmacy for anyway, so if we had a little bit of prescriptive authority, we could help these people. It would prevent a trip to the ER and prevent them from getting worse,” she said.

What really convinced the physician and the state board of pharmacy to accept this collaborative agreement was the stipulation of when to refer a patient to a physician or emergency department (ED), Schaefer said. In the case of a dog bite, for a pharmacist to prescribe, the wound must be new and the skin cannot be torn so that it would leave a scar upon healing. The wound cannot be red or filled with pus. Otherwise, the pharmacist must refer to a physician or the ED, she said.

Schaefer said that she has made a gift of the protocols, patient assessments, and forms to the Washington State Pharmacy Foundation. The foundation is working on a toolkit and a 10- to 12-hour CE program, which will contain all the protocols and written material, to share with interested pharmacists.

“I’m advocating to practice at the top of my license. Pharmacists are so well trained in clinical skills. We really don’t get to use those clinical skills and be recognized and paid for those clinical skills. This would change how people would access pharmacies,” Schaefer said.

Push for fair PBM audits

NCPA has been at the forefront of those advocating at the state and federal levels for fairer standards for pharmacy audits. Hodges, who has been active with NCPA for more than 9 years, knows firsthand how important these standards are, having been through a PBM audit just 6 months ago.

Despite some fair business practices for PBMs that have been instituted in Virginia, the auditor came on a Monday, the busiest day of the week for pharmacies, and complained that Hodges wasn’t pulling and copying the 100 prescriptions and 50 signatures fast enough. A few weeks later, he received the results, a payback of $17,000.

“We jumped through hoops to bring the amount down to zero. We shouldn’t have to jump through hoops over clerical issues. These are valid prescriptions. The average prescription price was over $700,” he said. “So clearly it is a predatory audit where they are looking for clerical errors. These audits should be random samplings of your business that you are doing with them, unless there is suspected fraud.”

In January 2014, Hodges will present his comments on Virginia’s PBM issues to his legislative colleagues. He said he isn’t sure whether his colleagues will introduce legislation or try to work out problems administratively.

Support compounding issues

Both Hodges and Harmison have been advocating against Senate bill 959, the Pharmaceutical Quality, Security, and Accountability Act, which calls for greater FDA oversight of compounding pharmacies.

In addition to mandating FDA supervision of compounding manufacturers who compound sterile drug products without a prescription and offer or sell them across state lines, the legislation requires traditional compounding pharmacies to report to FDA when they compound medications in response to a drug shortage. This could cause delay for patients who may need to receive medications quickly.

The act also allows FDA to create a “do not compound” list, which could give FDA authority to “impede patient access to vital medications,” according to Hodges, who wrote a commentary about his opposition that was published in the Roanoke Times. 

Along with Harmison, Hodges supports House bill 3089, the Compounding Clarity Act, introduced by Congressman Morgan Griffith (R-VA), Congressman Gene Green (D-TX), and Congresswoman Diana DeGette (D-CO) in September. This legislation would give FDA authority over compounding manufacturers such as the New England Compounding Center (NECC), which was was responsible for the multistate fungal meningitis outbreak last year. However, state boards of pharmacy would continue to have oversight of traditional compounding pharmacies. The Compounding Clarity Act also preserves the right of traditional pharmacies to compound for multiple patients who are receiving the same medications at hospitals, doctor’s offices, and other health facilities.

Harmison said he thinks it is reasonable for FDA to have some power, specifically over pharmacies that masquerade as pharmacies when they are really manufacturers.

However, “The state boards know much more about what is going on in pharmacy in their states than anybody else. They are the best ones to know how to handle [traditional compounding pharmacies],” Harmison said. “FDA doesn’t have the manpower or the budget to do that in every place that there is a pharmacy in the U.S.”