Stephen F. Eckel,  PharmD, MHA, BCPS,  FASHP, FAPhA

Have you ever thought about whether there could be a universal definition of a pharmacist? A statement that succinctly captures how they are trained and what they do? One that would encompass activities that are observed in pharmacists located in North and South America, Europe, Africa, and Asia, including the educational structure that trained them and the governmental regulation that defines their practice capabilities?

If you have ever had the opportunity to observe pharmacy practice or education in different parts of the world, you will recognize that there are tremendous variations. Some schools of pharmacy emphasize research, others focus on pharmaceutical manufacturing, and some concentrate on clinical pharmacy.

Besides the educational infrastructure, laws granting pharmacist practice privileges differ. And there is a wide spectrum in the number of pharmacists per capita, mostly arising from limited financial resources or educational systems.

These are all issues being contemplated by the leadership and membership of the International Pharmacy Federation (FIP). The 73rd FIP International Congress in Dublin, Ireland, was recently held with the main theme of “Towards a Future Vision for Complex Patients: Integrated Care in a Dynamic Continuum.”

While these practice and education issues will not be answered quickly, FIP has established structures and forums where these practical concepts are being raised and addressed. Let me highlight a few of these that occurred during the recent Congress.

—Created in 2008, these 75 statements describe the preferred vision of pharmacy practice in the hospital setting. Pharmacists representing 98 different nations were involved in developing and voting in support of these statements. The hospital pharmacy section has worked to keep these statements alive and schedules an educational session at each conference to highlight their deployment in countries and hospitals.

	A review and update of these statements is planned at the next FIP meeting in Bangkok, Thailand. I highly encourage all hospital pharmacists to plan on attending, as these guidelines have impact on the global practice of hospital pharmacy.

—For the first time, a symposium at the recent congress was held to explore and better understand the current roles that pharmacy technicians play, how they can be strengthened when working with the health care teams, and how they support the care of complex patients.

—This program aims to strengthen pharmaceutical services and pharmacy education in developing and transitional countries. This is usually accomplished through pairing a pharmacist from a developing country with a host for 4 weeks.

	I have participated in this program for the past 3 years, working with pharmacists from Nigeria, Kenya, and Ghana. While there is large interest of people wanting to go, it is limited by finding host families. I would highly encourage you to contact me if this is of interest at all. I have thoroughly enjoyed it and have continued to engage with my colleagues from developing countries professionally.

—Pharmacy schools have the opportunity to obtain academic institutional membership within FIP. Those schools that have joined are able to attend the dean’s forum, where the programming is based on educating the pharmacy and pharmaceutical sciences workforce of the future.

There are many great things happening in the global arena of pharmacy. I have found my involvement with FIP to be very educational and would highly recommend that you attend a future congress. I can promise you it will be worthwhile—and it might lead to your going each year.

Stephen F. Eckel, PharmD, MHA, BCPS, FASHP, FAPhA, is associate director of pharmacy, University of North Carolina Hospitals and clinical associate professor, University of North Carolina Eshelman School of Pharmacy.

He was elected the chair of the Acute Care Practice Forum and board member for the North Carolina Association of Pharmacists. He served for many years in the American Society of Health-System Pharmacists (ASHP) House of Delegates.

Articles

Pharmacy practice and education vary greatly across the world.

The Unification of Pharmacy

Over the past few months, there has been much media attention surrounding the 340B Drug Discount Program. Established more than 20 years ago, this legislation was enacted to assist different health care settings in providing excellent care for indigent and vulnerable patients. To allow this to happen, safety net providers have access to discounted outpatient drugs from manufacturers. By being able to purchase the discounted medications, these qualifying organizations are able to utilize the savings to provide care for those uninsured and underinsured patients.

Unfortunately, some of the safety net providers have been targeted with intimations that they have inappropriately taken advantage of opportunities that allow for beneficial financial terms. This money ends up benefitting organizations and executives, not the people it was intended to serve, suggest the critics. I am aware of these concerns as I am employed by an organization that qualifies for the 340B Drug Discount Program.

One example of abuse that is frequently mentioned by those highlighting the concerns is chemotherapy and specialty pharmacy drugs. It is well recognized that these medications are extremely expensive. If a safety net provider can get access to these medications at a significant discount, they might take advantage of these incentives to expand the number of oncology clinics and treat as many patients in the outpatient setting as possible. In addition, as opposed to having these patients receive their medications from a community pharmacy, a requirement could be implemented for the patients to receive their medications through a safety net provider’s mail order pharmacy as it benefits the hospital’s bottom line. Depending on the volume and type of medications dispensed, significant revenue could be realized.

Another recent noted abuse is through the use of contract pharmacies. In 2010, guidelines were issued that allowed for the establishment of multiple contract pharmacies with 1 covered entity. This has led some institutions to contract directly with chain drug stores. If a patient presents to one of these stores with a legitimate prescription that would qualify for a 340B-priced medication, that pharmacy can replenish that medication dispensation with a 340B-priced medication as opposed to the price usually paid. While there are numerous activities that need to occur behind the scenes to make this process legitimate to withstand an audit, this is another example that critics point to when they suggest that current practice has strayed from the original intent of the legislation.

If you can strip away all of the politics that lead to the tension around the topic, there are 2 things that everyone needs to remember—there are underserved patients among us, and the illegality of these activities. Anybody who gets sick in our country should be able to receive the best care available, even if they cannot afford it.

One way to stretch our limited resources is to subsidize those who have an expressed mission to care for those less fortunate. If they can do that while legitimately and legally following the regulations that are currently in place, these organizations should not be pressured to operate any differently or be highlighted in the popular press. They should not be made to feel guilty for doing what is allowed under the law and improving care for the less fortunate. Let these organizations utilize the opportunities to provide high-level care to the unfortunate, as none of us want to be in that situation.

Politics will continue to place scrutiny on the current regulations, and changes will probably occur, but if you work at an organization that qualifies for the 340B Drug Discount Program, you should be proud to work at a place that has a mission to serve the less fortunate. I know I do.

The Future of 340B: It's All About Perspective

As many pharmacists are aware, a major push by national pharmacy associations is to gain recognition as patient care providers within federal health care legislation. This is needed for our profession to further advance pharmacist responsibilities as providers and allow for consistent and fair reimbursement for medication management activities. The payment would be separate from the only consistent reimbursement that pharmacists currently receive—dispensing the drug product.

While there is broad consensus that this is a needed and positive step for the profession, there are many disagreements on what type of pharmacists should be able to do this. Should all pharmacists, no matter their training or practice location, be able to provide and receive reimbursement for patient care services? Or, should it be limited to those who have residency training, or board certification, or actively practice in a certain setting? Are these decisions best left up to state boards of pharmacy (which already have variability in continuing education hours needed for relicensure), or should a committee at the site manage the process?

A concept that is starting to get discussed more in pharmacy circles is the need for better credentialing. It is the idea that pharmacists would be allowed to only do certain things based on their training and skill set. While this idea is not new for the medical profession, it is not widely used in the pharmacy profession.

As we know, not all doctors are surgeons; only those who have been trained and credentialed are surgeons. Further, not all surgeons can operate on the heart—only cardiovascular surgeons can do so. There is a defined education and credentialing process to manage these practice differences.

In pharmacy, quite the opposite is true. All pharmacists’ licenses allow them to dispense medications, check chemotherapy, educate a patient on anticoagulants, and dose aminoglycosides. Every pharmacist might not feel comfortable doing these things, but all are eligible through pharmacy licensure.

As the pharmacy profession advances, many are hopeful that our scope of services becomes broader. Pharmacists are active in immunizing adults, conducting comprehensive medication reviews, and aiding in transitions of care. Future pharmacists could be involved in prescribing medications under protocol, ordering routine laboratory tests, and administering medications in clinics or hospitals.

If these opportunities do come true, should all pharmacists be allowed to do this? If not, how would a credentialing and privileging process be implemented that would allow it for those who are deemed competent, but prohibit it for those who are not?

As the profession continues to push for advanced roles of pharmacists, it needs to also provide technical guidance on how to implement a robust credentialing program with a hospital pharmacy department. Should board certification be enough to satisfy this, or should an annual peer review process be implemented? If so, how should the committee be organized, what type of information should be submitted, and how should it make and defend its decisions? I believe the profession should provide tangible solutions to this difficult process, as clear guidance is needed as laws expand to allow pharmacists to do more.

May our profession continue to advance so that a comprehensive credentialing and privileging program is needed in all hospital pharmacy departments across the country.

Stephen F. Eckel, PharmD, MHA, BCPS, FASHP, FAPhA

, is associate director of pharmacy, University of North Carolina Hospitals and clinical associate professor, University of North Carolina Eshelman School of Pharmacy.

	Stephen F. Eckel, PharmD, MHA, BCPS, FASHP, FAPhA, is assistant director of pharmacy, University of North Carolina Hospitals and clinical assistant professor, University of North Carolina Eshelman School of Pharmacy. - See more at: http://www.pharmacytimes.com/publications/health-system-edition/2013/May2013/The-Generic-Conundrum#sthash.BN39ErVX.dpuf

As the pharmacy profession advances, a credentialing system may be needed to determine which pharmacists are qualified to offer which services.

Credentialing Pharmacists

A question worth discussing was posed in the January 14, 2013, edition of 

: Are generics really the same as branded drugs?

 To many of you, the quick answer is “yes.” If the generic medication was determined by the FDA to be an Approved Drug Product with Therapeutic Equivalence,

 then it is appropriate to substitute the brand name prescription for a generic product when the prescriber or institutional policy has allowed for this. It is also apparent to all of us that generic medications are used frequently, comprising about 80% of all dispensed prescriptions in 2012.

A smaller group of people, albeit a growing one, will answer the question with a resounding “no.” These people usually have direct patient experience with someone who had difficulty when going from the branded product to a generic substitution. The expressed issues might be a different side effect not previously observed or a blunted therapeutic response from what was previously achieved with a different manufacturer’s product.

 was written by Katherine Eban, an investigative journalist. She discusses the FDA reversal of a medication it had previously granted bioequivalence. Bupropion XL, the generic made by Teva Pharmaceuticals, is the medication that was highlighted. The situation started when numerous individuals were calling the radio program “The People’s Pharmacy” to describe their concerns with generic medications. As discussed in Joe and Terry Graedon’s book, “Top Screwups Doctors Make and How to Avoid Them," a study was initiated to test the bioequivalence of the Teva Pharmaceuticals product.

Results demonstrated that the generic bupropion, on average, achieved 75% of the expected concentration within the blood compared with the standard. In addition, since this generic had a different time-release method, it dissolved 4 times faster within the first 2 hours than the standard. It is presumed that these differences led to the patient concerns that were expressed on the radio show. This product is not on the market.

Currently, bioequivalence is determined by detecting between 80% and 125% of the active ingredient within the blood.

 This is true for both the max concentration and the area under the curve. There is no required evaluation for time to peak concentration, but it could be reviewed as a part of the bioequivalence process.

With all of these known bioequivalence issues and concerns, should hospital pharmacy and therapeutics committees or pharmacy department purchasers approach the selection of products differently? How about group purchasing organizations? Many times, the decision process stops if the products are all AB-rated generics. After that, the cheapest one will be selected. With the move to bar-coded medication administration, some organizations limit their purchases to the same manufacturers or those that are bar-code ready.

However, as a clinical profession, are we comfortable with a bioequivalence range of 80% to 125%? Shouldn’t health care professionals expect a smaller range of variation? Should pharmacy departments review the bioequivalence information as a part of the purchasing selection of a medication as opposed to just accepting the FDA review? Do our patients deserve more individual product scrutiny before switching to a different manufacturer? Should the profession pressure the FDA for tighter standards?

While there are many steps that go into selecting and purchasing a medication to be used in the hospital setting, we probably should also consider bioequivalence in addition to all of the other safety measures. Our patients deserve no less.

Stephen F. Eckel, PharmD, MHA, BCPS, FASHP, FAPhA, is assistant director of pharmacy, University of North Carolina Hospitals and clinical assistant professor, University of North Carolina Eshelman School of Pharmacy.

		Eban K. Are generics really the same as branded drugs? 

		Approved Drug Products with Therapeutic Equivalence Evaluations. http://en.wikipedia.org/wiki/Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations. Accessed March 29, 2013.

		Bioequivalence. http://en.wikipedia.org/wiki/Bioequivalence. Accessed March 29, 2013.

Questions have arisen regarding the standards for determining whether a generic medication is bioequivalent to the branded version.