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doi: 10.1136/ejhpharm-2011-0000026, 2012

2012 19: 19-21 originally published online FebruaryEur J Hosp Pharm Gilbert J Burckart pharmacy: a marriage of necessityClinical pharmacology and clinical

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Comment

European Journal of Hospital Pharmacy February 2012 Vol 19 No 1 19

Clinical pharmacology andclinical pharmacy: a marriageof necessityThe relationship between clinicalpharmacology and clinical pharmacy hasbeen periodically discussed over the past40 years.14 The goal of this commentaryis not to rehash old arguments but ratherto point out how acutely each professionneeds the other in 2012 and beyond. Globaleconomics, a demand for quality costeffective drug therapy, a pharmacologicalarmamentarium of increasing complexityand new choices for the best and brighteststudents combine to drive clinicalpharmacology and clinical pharmacytogether.

This commentary was invited on thebasis of a presentation at the AmericanCollege of Clinical Pharmacology AnnualMeeting in Chicago, Illinois, USA in

September 2011. The presentation focusedon the US situation, so I apologise inadvance for any comments that mightnot pertain to the situation in the UK andEurope. However, I think that the situationthat I will discuss very much pertains to theAmerican and the UK/European situation.

The focus of this discussion is criticalproblems facing both professions that shoulddrive them together at the present time. In thecase of clinical pharmacology, the lack of acritical mass of practitioners to deliver clinicalpharmacologys public health commitmentmay very well serve to weaken and ultimatelydestroy the profession. In the case of clinicalpharmacy, the struggle to bring cuttingedge science into clinical pharmacy practice

commitment for providing expertise for themost complex drug therapies in a hands-onmanner. A quick check of the mission andvision statements of the two US clinicalpharmacology organisations, ASCPT and theAmerican College of Clinical Pharmacology,confirms that clinical pharmacology has aresponsibility to patient care. The EuropeanAssociation for Clinical Pharmacology andTherapeutics is a bit more subdued in its aims,but still suggests that improvement of drugtherapy in patient care is a major tenet held bythe organisation.

Clinical pharmacology certainly had itsroots in innovative patient care and clinicaltrials. Sir Dollery describes this as The ageof excitement for clinical pharmacology,and the list of clinical pharmacologists

leading new hospital services at thattime reads like a list of legends of theprofession. However, this was during the1950s and 1960s, and Sir Dollery himselfadmits that the expansion of clinicalpharmacology was fuelled by expandingclinical service and research budgets. The1990s brought the restructuring of thehealthcare industry, and the disappearanceof clinical pharmacologists from hospitalwards. Given the current global economicsituation, which is leading to new restrictiveeconomic healthcare models, the suggestionmade in 20067 that the government fundthe traditional physician model of clinicalpharmacologists in hospitals is beyondconsideration now and in the future.

Clinical pharmacists are the newclinical pharmacologists in thepatient care settingAlthough the origins of clinical pharmacywere different than that of clinicalpharmacology, the two professionsessentially reside in the same spacetoday. The American College of Clinical

Pharmacys definition of clinical pharmacy8

embraces all of the parts of Sir Dollerys

may sentence the profession to mediocrityin a decade that will see large numbers ofdoctorate level practitioners in nursing andother health professions.

What is clinical pharmacology,and does clinical pharmacologyhave a public healthcommitment?Professions are best represented by theirsocieties, so the vision, mission anddefinition of clinical pharmacology cancome from a website such as the AmericanSociety for Clinical Pharmacology andTherapeutics (ASCPT). ASCPT is one of thelargest organisations in the world dedicatedentirely to clinical pharmacology. The

ASCPT definition of clinical pharmacologyis provided on their website,5 and directlyrefers to a 2006 British Journal of Clinical Pharmacology article written by Sir ColinDollery.6

I would encourage you to read thisexcellent history of clinical pharmacology.The answer to What is clinicalpharmacology? is directly addressedby Sir Dollery, and it is (a) a laboratorydiscipline of pharmacokinetics, drugmetabolism and pharmacogenomics, (b)a design and data analysis profession ofexperimental protocols, drug utilisationand pharmacovigilance and (c) a clinicalprofession of hands-on patient care, clinicalinvestigation of drug interactions and adverseeffects, and consultancy as an expert in drugtherapy. As Sir Dollery explains, this wideexpanse of knowledge and expertise is botha strength and a weakness. As an example,the US Food and Drug AdministrationOffice of Clinical Pharmacology consist of150 clinical pharmacologists/pharmacists,and we continue to struggle with havingthe expertise to address new and emergingscience and therapies.

So there is little question that clinicalpharmacology has a public health

GJB is a former P resident of the American College ofClinical Pharmacy (19901991) and a former Presidentof the American College of Clinical Pharmacology(20032004).

Correspondence to Dr G J Burckart, Office ofClinical Pharmacology, Center for Drug Evaluationand Research, US Food and Drug Administration,10903 New Hampshire Ave, Building 51, Rm 3184,

Silver Spring, MD 20993, USA;[email protected]

Gilbert J Burckart

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Comment

20 European Journal of Hospital Pharmacy February 2012 Vol 19 No 1

definition of clinical pharmacology, withthe exception of being a laboratory baseddiscipline. Clinical pharmacologys emphasison a laboratory based research is replacedby clinical pharmacys emphasis on anindependent patient oriented practice andcost effectiveness. In other aspects related togenerating new knowledge and improving

drug efficacy and safety, the two professionshave identical goals.Advanced models of clinical pharmacy

practice were developed in the US in the1970s and 1980s, and clinical researchdirected by clinical pharmacists was beingfunded by the National Institutes of Healthin the USA from the 1980s onward. TheUK Clinical Pharmacy Association and theEuropean Society of Clinical Pharmacywere forming about that same time, and theEuropean Society of Clinical Pharmacysdefinition of clinical pharmacy matches theAmerican definition, with the exception ofresearch involvement.9

The dramatic change that may notbe well known to people outside of thepharmacy profession is the growth of thenumber of people educated at the doctoratePharmD level in the USA. In 1990, theAmerican Association of Colleges ofPharmacy mandated that the PharmDwould be the entry level degree, resultingin about 8000 PharmD graduates yearlyin the USA at this time. Since more than90% of pharmacy students enter pharmacyschool in the USA with a bachelors degree,

the 8 year educational programme parallelsphysician training in the USA. On a global

basis, the PharmD degree is now beingoffered in Africa, Asia, the Middle East,Europe and throughout North Americapresently, and there are many other entrypoints into clinical pharmacy, includingmasters degrees and specialised residenciesor other training programmes.

This growth is reflected in the number

of clinical pharmacists who are academicallybased, who have residency and fellowshiptraining, and who offer sophisticated clinicalservices for patients. Many of these clinicalpharmacists in the USA are members of theAmerican College of Clinical Pharmacy,which now has over 12 000 members. Incontrast, membership in the US clinicalpharmacology organisations has beenstagnant for at least a decade (figure 1).Clinical pharmacology organisations haveall but closed their eyes to this development,despite their inability to mount any plan tomeet their public health commitment. TheAmerican College of Clinical Pharmacologyhas about 100 PharmD members, andASCPT does little better with about 300PharmDs.

Why should clinical pharmacyembrace clinical pharmacology?While clinical pharmacy includes clinicalresearch and has a number of highlyrespected researchers, clinical pharmacologystill represents the majority of drugdevelopment pharmacologists in the

world. Information on new drugs, basicstudies of drugdrug interactions and

dosage adjustments required by renal orhepatic dysfunction are primarily generatedduring drug development by clinicalpharmacologists. Solving complex patientdrug problems requires cutting edge scientificknowledge, and increased opportunities existfor clinical pharmacists to collaborate withclinical pharmacologists to address theseproblems. The marriage of clinical pharmacyand clinical pharmacology keeps the sciencein patient oriented pharmacy services, andthat is essential for delivering the highestquality services and for recruiting the bestpeople to clinical pharmacy/pharmacology.

An unstable future lies ahead if wedo not keep science at the forefront ofpharmacy practice and research. Otherhealth professions are quickly movingtoward full doctorate programmes. Nursesparticularly see the professional doctorate(Doctor of Nursing Practice or DNP) asthe best route forward. In 2008 there were375 794 nurses in the USA with a mastersdegree and 28 369 nurses with professionaldoctorates of nursing. In 2010, 153 schoolsof nursing gave out 7037 doctor of nursingdegrees, and the number of studentsgraduating with DNP degrees will soonsurpass the number of PharmD degreesin the USA. Doctors of nursing will beinvolved in managing drug therapy throughevidence based patient management.Bringing pharmacology and the newbreakthroughs in drug developmentinto patient care is essential, and clinical

pharmacists are uniquely positioned to dothis.Clinical pharmacology similarly needs

clinical pharmacy. Clinical pharmacologyhas already been deleted from many medicalschool curriculums, and few physicians seeclinical pharmacology as a viable careeroption. Most clinical pharmacologists todayare our PhD colleagues, and while theydrive the science of clinical pharmacology,they will not be able to take care of thepublic health commitment of clinicalpharmacology.

How can the courtship of clinicalpharmacology and clinicalpharmacy proceed?I think that our professional societies canhave a leadership role in this interaction.Clinical pharmacology organisationscan have immediate benefits in jointprogramming with clinical pharmacyorganisations by increased attendanceat their training programmes and intheir membership. Clinical pharmacyorganisations benefit through joint

programming by bringing the highestquality regulatory, academic and industry

Figure 1 The growth of membership in the American College of Clinical Pharmacy (ACCPharmacy) versus thegrowth of the two major US clinical pharmacology organisations, the American Society of Clinical Pharmacology andTherapeutics (ASCPT) and the American College of Clinical Pharmacology (ACCPharmacology).


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Comment

European Journal of Hospital Pharmacy February 2012 Vol 19 No 1 21

speakers to their meetings and educationalprogrammes.

Many clinical pharmacists wantto distinguish themselves, and trainingwith and collaborating with top clinicalpharmacologists is certainly one method ofdoing that. I would recommend that clinicalpharmacists attend clinical pharmacologyprogramming and consider membership inclinical pharmacology organisations. Clinicalpharmacology organisations should seek outclinical pharmacists who have a high level ofclinical practice and clinical research.

A critical axiom of strategic planning

for any profession or organisation is that if

Key messagesClinical pharmacy and clinicalpharmacology have many reasons towork together to further patient carerelated to drug therapy.

you are not moving forward, you are in factmoving backwards. Clinical pharmacologyand clinical pharmacy should carefullyconsider their current situation, and makethis a marriage that society and patientseverywhere will benefit from.

Acknowledgements The opinions includedin this commentary are those of the author, andshould not be interpreted as the position of the USFood and Drug Administration.

Competing interests None.

Provenance and peer review Commissioned;externally peer reviewed.

European Journal of Hospital Pharmacy2012;19:1921.doi:10.1136/ejhpharm-2011-000002

References 1. Francke DE. Relationship between clinical phar-

macology and clinical pharmacy. J Clin Pharmacol

New Drugs 1972;12:38492.

2. Miller RR . An overview of clinical pharmacyand clinical pharmacology. J Cl in P harmacol 1981;21:23840.

3. Park GD . A proposal for clinical pharmacyand clinical pharmacology collaborationthe timehas come. Drug Intell Clin Pharm 1986;20:31011.

4. Golocorbin-Kon S , Lalic M, Raskovic A,et al .Clinical pharmacology and clinical pharmacy:competition or collaboration?Ther Pharmacol ClinToxicol 2009;13:3340.

5. American Society of Clinical Pharmacology andTherapeutics. 2011; What is clinical pharmacol-ogy? http://www.ascpt.org/KnowledgeCenter/WhatisClinicalPharmacology/tabid/6665/Default.aspx (accessed 24 Jan 2012).

6. Dollery C. Clinical pharmacologythe first 75years and a view of the future. Br J Clin Pharmacol 2006;61:65065.

7. Breckenridge A , Dollery C, Rawlins M,et al. The future of clinical pharmacology in the UK. Lancet 2006;367 :1051.

8. American College of Clinical Pharmacy: Thedefinition of clinical pharmacy. http://www.accp.com/docs/about/ClinicalPharmacyDefined.pdf (accessed 24 Jan 2012).

9. European Society of Clinical Pharmacy: What isclinical pharmacy? http://www.escpweb.org/cms/Clinical_pharmacy (accessed 24 Jan 2012).

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