Pharmacy Times Editor, Health-Systems Pharmacy Section

describes anexperience of feeling that onehas previously witnessed orexperienced a new situation. I got thatfeeling recently after a colleague and Imet with a physician leader about expandingpharmacy services to ourFamily Medicine Clinic patients.

At University of North Carolina (UNC)Hospitals and Clinics, we have beenslowly expanding pharmacist presencein the ambulatory care environment.For the most part, we have accomplishedthis with partial financial supportfrom the School of Pharmacy, theDepartment of Medicine, and others.As the leader of our department, I havebeen less committed to the evolutionof pharmacy services in the clinic environmentthan to competing inpatientinitiatives. I have based this philosophyon the challenges for creating newor supplementing existing revenuestreams to "justify" the assignment ofstaff in ambulatory care.

A handful of clinical specialists practicein our Internal Medicine, FamilyMedicine, Heart Failure, and Oncologyclinics. I have followed the evolution oftheir practices, and I know they contributeto the improvement of thehealth of their patients. The success ofthese UNC practice pioneers has resultedin requests by multiple members ofthe medical staff to assign a pharmacistto many more clinics. It is a good problemto have!

As I reflected on the meetingwith the chairman ofFamily Medicine, I experiencedd&#233;jà vu. During theearly stages of my career,we were enabling pharmaciststo practice "clinically,"and we did so creatively.These early practice pioneersworked long and hardto maximize their contributionsand develop rapportwith patients and physicians.I remembered the physiciansupport we had andtheir demands for additionalstaff to collaborate on drugtherapymanagement onpatient-care units as theybecame familiar with thecontributions of clinicians on the pilotservices. Even though the pharmacycould not charge inpatients for theirnondistributive services, we foundways to enable the expansion of clinicalpharmacy services by selling the conceptof "clinical pharmacy" and itsvalue to hospital administration.

Health-system pharmacy leadersneed to realize that the time is here tomake ambulatory-care pharmacy servicesa much higher priority. We needto set aside the reimbursement challengesfor investing human resourcesin managing pharmacotherapy for outpatientsas we did in the days of thebirth of inpatient clinical practice. It willtake creativity, entrepreneurship, andvision to make this happen, but I amconvinced it can be done.

Health-system pharmacists havebeen shy about embracing wellness,health promotion, and disease preventionand managing our outpatients. Weneed to review the American Society ofHealth-System Pharmacists'2015 Initiatives,since 2 of the 6 primary goalsrelate to outpatients. We need to beleaders in our health systems to maximizepay-for-performance related tonational goals and standards.

Finally, we need to assume responsibilityfor medication reconciliation collaborativelywith 

pharmacist whocares for outpatients, regardless of thepractice setting. If we make these commitments,we will again be contributorsto the evolution of the practice ofpharmacy. 

Articles

Pharmacists in Ambulatory Clinics—D&#233;jà Vu

I have opined about leadership inprevious commentaries, but I havenever been more optimistic aboutour future leaders than I am now, havingjust returned from the AmericanSociety of Health-system PharmacistsMidyear Clinical Meeting in Anaheim,Calif. My optimism stems from ourrecruitment efforts at the MidyearMeeting. The University of NorthCarolina School of Pharmacy, in collaborationwith 3 nearby academic medicalcenters, has re-established its masterof science degree in health systempharmacy and will be enrolling 4 newresidents/graduate students in the fallof 2007. Several other new programs,including those in Minnesota andPennsylvania, have joined the longstandingprograms from the past. I wasquite impressed with the number andquality of students interested in pursuinga master's degree in pharmacy. Intalking to my friends and colleaguesfrom the other programs, my sentimentswere shared by all.

Sara White presented a compellingcase for the need for future leaders inher recent article entitled,"Will There Be a PharmacyLeadership Crisis?" Admittedly,with the decline inthe number of master's programsover the past decadeor more, many pharmacygraduates have pursued amaster's degree in healthadministration, public health,or business. Most of theseprograms are extremely reputablegraduate level programsthat prepare their studentsto assume leadershiproles in health care, but theyfall short in terms of focus onour professional issues anddo not enable the developmentof camaraderie andlifelong friendships among peers as do2-year programs which have multiplepharmacy students. I also wonder aboutthe mentoring that is available to roundout their pharmacy-specific expertiseand engender a commitment to lifelonglearning. Finally, they do not emphasizethe need for a commitment to servingthe profession (which supporters will tellyou is an advantage for upward mobilityin hospitals or the industry).

These excited, enthusiastic youngpeople who are interested in staying inpharmacy and practicing servant leadershipare critically necessary for thefuture. Health-system pharmacists needto find ways through involvement inschools of pharmacy and among theirnew recruits to continue to identify pharmacistswith leadership potential andinterests. Mentoring them will be criticallyimportant, not only during their program,but after they graduate as well. Allof us need to help them get the fundamentalexperience they need, and supportthem as they assume entry-levelleadership roles. It helps all of us toremember that they may well be ourfuture leaders, so it is in all of our bestinterests to ensure that they have theskills and interests to effectively representthe entire profession. 

Future Leaders

Pharmacists began talking aboutclinical outcomes when theterm "pharmaceutical care"was described. We talked in terms ofassuming responsibility for drug therapyoutcomes, and while the concepttook us closer to patient-centeredroles and responsibilities, I am not surewe really embraced the "assumeresponsibility for drug therapy outcomes"portion of the pharmaceuticalcare concept.

I would suggest that, in the past20-plus years, we have made littleprogress in adopting a true outcomefocus. I am aware of some notableexceptions at selected hospitals, but Ibelieve leaders have failed to inculcatean outcomes focus into pharmacypractice and even less into performanceexpectations. Hospital executivesand physician leaders have not mademanaging therapeutic outcomes anorganizational priority either.Considerable work needs to be accomplishedbefore we truly take the plungeto optimize pharmacotherapeutic outcomeson an individual patient basis.How should we define "optimal outcomes"?How will they be measured?Will a standardized approach be adoptednationwide? How can wemeasure real outcomes iftherapy is not completed atdischarge? What changes inpractice need to take place todocument therapeutic planswith outcomes targets? Howwill the efforts be documented?How will the results beused? Some of these questionshave been answered,but only by a relatively fewforward-thinking practitionersand health systems. Given allthis, we can afford to continueour procrastination, right?Wrong!

Many factors will promoteclinical outcomes measurementadoption as a priority.Patients are becoming increasinglysavvy consumers who rely less onword-of-mouth referrals (by physiciansor friends) and more on comparativeoutcomes data available in the publicdomain. Insurance companies andother payers will have a profoundimpact on assuming an outcomesfocus as the "pay for performance"phenomenon expands. Undoubtedly,pharmaceutical companies will jumpon board and tout their products ashaving superiority over productsoffered by their competitors.

In a recent survey of 50 health caresystems, hospital executives reportedthat they will make significant investmentsin their information technologysystems for measuring and reportingclinical outcomes. It seems to me thetime has arrived to invest pharmacyresources in developing plans to implementcomprehensive drug therapy outcomesmeasurement services. Wehave great opportunities to developnew tools and systems, conduct clinicalresearch to compare alternatives,and plan documentation strategiesthat further underscore the need forand value of comprehensive pharmacyservices.

We must seize the opportunity now,unless we would prefer other providers,the pharmaceutical industry, informationtechnology staff, or outside consultantsto do it for us. What do you think? 

Managing Outcomes

In early September, the Drug EnforcementAdministration (DEA) proposedan amendment to current regulationsto allow practitioners to providepatients with multiple prescriptions forCII substances, which would in effectallow patients to receive a 90-day supplyof a substance. I appreciate that theintent of the change is to enable patientswith chronic pain and other conditions toavoid unnecessary trips to a prescriber.Furthermore, I agree that a visit to thephysician just to have a prescription writtento comply with a federal regulation issomething that we should strive to avoid.If this proposed rule is adopted, however,what problems have we solved?

The 30-day limit for CII substances wasinitially imposed in an attempt to minimizeabuse and diversion. This proposedrule enables prescribers to write 3 prescriptionsto be filled sequentially with aspecified date, before which the secondand third prescriptions cannot be filledby any pharmacy. I suggest that while wemay have saved patients with chronicpain conditions a few trips to their physician,we have created a new cottageindustry in which even more prescriptionscan now be diverted for illegitimatepurposes. Instead of a singleprescription being used fordiversion purposes, the successful"entrepreneur" willreceive 3.

It seems to me that the originalintent of the amended rulecould be met through collaborativepractices establishedbetween pharmacist andphysician. The patient wouldthus be required to return tothe same pharmacy for fillingall 3 prescriptions. Based onthe collaborative relationship,the patient can be referredback to the physician if thepharmacist believes there is aneed to modify the prescription—whether it would includea dosage adjustment (up or down), orreassessment of pain managementbased on patient compliance. Requiringthe prescription to be filled at the samepharmacy all 3 times minimizes diversionpotential since the pharmacist can verifyidentical patient identification for refillsand ensure compliance with intendedrefill dates each time.

Even more enlightening is a quotefrom the DEA in a September 6, 2006,news release which acknowledges thatthey "...listened to over 600 physicians,pharmacists?," which resulted in its proposedrule making. This statement validateswhat we teach our professionalstudents. The voices of a relative few canoften have a profound impact on legislationand regulation. Comments to theDEA must be received by November 6,2006. If you have thoughts on this topic,let them be heard where you can make adifference. 

Controlled Substances Proposed Rule: Missed Opportunity?

You may have read an article inthe August 7, 2006, issue of 

entitled "Deaths SpurDebate about Drugs Made in Pharmacies."The article describes eventsover 10 months from 2004 to 2005,which suggest that sterile cardioplegiasolution compounded by a national compoundingorganization may have resultedin 11 patients contracting infections.The article was inflammatory and incompleteand in some ways failed to makeimportant points on the topic. Nevertheless,it was probably read by millionsof people and, in my opinion, tarnishedour professional image.

One important point was made, in thatresponsibility for the oversight of thequality of compounded products wasquestioned. The compounding pharmacythat allegedly was involved fell underregular FDA oversight, but the authoraccurately revealed that oversight ofsmaller compounding operations andhospitals are governed primarily by staterules and regulations, which vary substantiallyacross the country.A significantpoint that was 

made was thebreadth and depth of the compoundingthat is done, including compoundingthat is done 

Community and hospitalpharmacists always haveregarded it their right andresponsibility to compoundprescriptions to meet theirpatients' needs. Compoundedproducts go far beyond sterilepharmaceuticals, to includecapsules, topicals, ophthalmicproducts, and more. As pharmacyschool curricula havechanged, however, fewer newprofessionals have the interestand expertise to offer compoundingservices. As a result,many of us outsource thisresponsibility to compoundingpharmacies. In the majority of cases,these pharmacies uphold standards ofquality that we and our patients expect.We also assume that state regulatoryagencies provide the necessary oversightto protect the public.

Most of us know, however, that thereare far too many pharmacies that 

meet our standards for quality and accuracy.We know that state boards of pharmacy

monitor for the quality ourpatients expect, and they have beenreluctant to intervene proactively. Inmany cases, it is a matter of limitedresources. Most board inspectors, moreover,have limited expertise and experienceto ensure standard compliance andquality in all compounding pharmacies,but they do respond after alleged harm isdone. Boards themselves struggle withdeveloping guidelines and regulationsthat are intended to apply to compoundingpharmacies. I suspect that politics areinvolved in coming to grips with thisissue. Many independent pharmacistscontinue to offer basic (nonsterile) compoundingservices and do not encouragestate board involvement.

Something needs to be done. I amnot advocating more regulatory involvementat the federal level. I dobelieve that more of us need to partnerwith our state boards of pharmacy topursue a solution to this problem. If wefail to resolve the issue of compoundingpharmacies harming patients, wecan anticipate a loss for 

and a limit on patient andprovider choices with federal intervention.I also can guarantee that ourimage will continue to deteriorate inthe eyes of the public, and we willdeserve the criticism. 

Product Compounding: Who Should Monitor?

Our profession is one in whichour customers (patients, otherproviders, and hospital administrators)have needs and expectationsthat consistently exceed our capacity torespond to the extent that we would in aperfect world. We as pharmacists arechallenged by the expense associatedwith drug therapy, bureaucratic and regulatorybarriers, limited human resources,space, equipment, time wehave each day, and much more. As aresult, we approach each day knowingthat we will do the best we can and constantlybalance needs with our capacityto meet them.

The great news is that this balancingact is supported by many wonderfulpharmacists who "go the extramile" in more situations than isreasonable to expect. Thesepharmacists go beyond what isreasonable because of theirdedication to the patient andtheir own personal commitmentto uphold their oath toserve others in pursuit of maximizingdrug therapy outcomes.As the leader of more than 100pharmacists, it is unreasonablefor me to expect this level ofcommitment for each encounterin which they are involved. Itrust that each pharmacist recognizescritical situations, inwhich going the extra mile is

needed, and their abilityto give that extra effort wheneverthey can.

One of my staff members recentlyspent an inordinate amount of timeassisting a senior who was mired in theMedicare Part D debacle. She tirelesslymade numerous phone calls back andforth to Washington(DC) and Atlanta (Ga),as an advocate for thispatient in an effort toreestablish his eligibilityfor coverage, minimizehis out-of-pocketexpense, and ensurethat he was able to getthe drugs he needed. Icannot share moredetails because itwould exceed thespace allotted for thiscommentary.

Although this actionsounds "routine," youare blessed to workwith colleagues whoconsistently go theextra mile. I know Ihave that kind of staffat the University of North CarolinaHospitals and Clinics in both acute careand ambulatory care environments. I amlucky to have every member.

As in many similar situations, thepatient, the prescriber, and even the hospitaldid not really appreciate what ittook to meet this patient's needs. Evenmore tragically, these efforts take placenumerous times every hour of the day.As a profession, we need to strive to congratulateeach other and celebrate oursuccesses, even if only to each other.Leaders must find new and differentways to globally appreciate their staffmembers' high level of effort, while strivingto improve their personal touch thatmeans a great deal to their colleagues.

So, on behalf of all the pharmacy leadersand managers out there, I congratulatethe thousands of pharmacists whoconstantly go the extra mile for theirpatients and customers. You are essentialto the processes of delivering top-flightpatient care and maintaining theimage of our profession. Thanks so muchfor your dedication, sacrifice, and personalcommitment! 