Pharmaceutical care in Italy and other European countries: between care and commerce?

KEYWORDS:

• Pharmaceutical care
• pharmacy graduation
• distribution margin
• European Union

Pharmaceutical care (PhC) has been a highly debated concept since the first American definition in the early 1990s [1]. PhC was soon adopted internationally and many definitions have followed in other continents (including Europe), rapidly acknowledging the pharmacist’s pivotal role in PhC, and community care as its main setting of application [2].

After a brief summary of the debate in the literature on the definition of PhC and its activities in Europe, we discuss the potential implications of its introduction in countries like Italy, where PhC is backed by the Italian Association of Private Pharmacies (Federfarma) [3]. Italy has at the same time a ‘Beveridgian’ public service for healthcare funding (the Italian National Health Service) and a predominance of private pharmacies (around 90% of the total), traditionally hereditarily owned by single pharmacists, for the delivery of reimbursed drugs in community care [4].

PhC definition and activities

Hepler and Strand originally defined PhC as the responsible provision of drug therapy for achieving definite outcomes that improve a patient’s quality of life [1], recommending pharmacists to switch their focus from product compounding and delivery to a patient-centered philosophy of practice and eventually to contribute to ensuring safe and effective drug therapies for individual patients. Soon the PhC definition seemed to somewhat overlap that of clinical pharmacy in Europe [5], despite attempts to stress a conceptual difference between the former (more ethical and philosophical) and the latter (more technical and practical). Since the PhC philosophy encompasses the practice of clinical pharmacy regardless of the definitions adopted [6], and the two concepts mainly differ for the setting of reference (community and hospital respectively), the European pragmatic understanding was that PhC is mainly the pharmacist’s professional care provided in a community pharmacy to the individual patient [7]. In 2013 the Pharmaceutical Care European Network defined PhC as ‘the pharmacist’s contribution to the care of individuals in order to optimize medicines use and improve health outcomes’ [8]. Although recommending a multidisciplinary approach in accordance with other healthcare professionals (starting with physicians and nurses), the pharmacist was explicitly defined as the PhC primary provider. More recently, a survey by the European Society of Clinical Pharmacy [9] confirmed that PhC was primarily associated with community pharmacies, although not necessarily limited to a specific setting.

Activities related to PhC range from provision of additional services (e.g. health screening and patient monitoring) and routine use of clinical databases in pharmacy to participation in multidisciplinary team meetings and patient counseling [10]. Many studies have set out to assess the effectiveness of PhC activities for years, and several have shown some positive impact of educational intervention (verbal or written information) on patients’ health outcomes compared to non-intervention, mainly by improving compliance and adherence to drug therapy [11,12]. For European studies in particular, we conducted a specific literature search¹ and found seven studies on PhC in the community [13–19], all from northern countries (Table 1). Only one study involved general practitioners (in addition to pharmacists) [14], and all but one [16] concluded in favor of PhC and were only co-authored by pharmacists.

Table 1. Main characteristics of the selected studies on PhC in community.

First author, year	Country	Disease/Type of patients	Pivotal role	Main conclusion
Stewart, 2017 [13]	The UK	Patients in rural areas	Pharmacist	PhC was both needed and valued highly by staff and patients
Geurts, 2016 [14]	The NL	Elderly cardiovascular patients on polypharmacy	Pharmacist and GP	PhC plan in primary care reduces drug-related problems
Stuurman-Bieze, 2014 [15]	The NL	Osteoporosis	Pharmacist	PhC contributes to more optimal use of osteoporosis medication
Olesen, 2014 [16]	Denmark	Elderly polypharmacy patients	Pharmacist	PhC has no significant impact on medication adherence, hospitalization or mortality
Tommelein, 2014 [17]	Belgium	Chronic obstructive pulmonary disease	Pharmacist	PhC improves the pharmacotherapeutic regimen and could reduce hospitalization rates
Stuurman-Bieze, 2013 [18]	The NL	Lipid-lowering therapy patients	Pharmacist	Pharmacists can contribute to optimal use of chronic medication reducing healthcare costs
Schröder, 2012 [19]	Germany	Parkinson’s disease	Pharmacist	PhC improves age-related quality of drug treatment

GP: general practitioner; PhC: pharmaceutical care; NL: Netherlands.

Critical issues

From its inception, the primary goal of PhC was to give pharmacies the opportunity to move beyond the role of merely dispensing the right drug [12] and to help make a positive impact on a patient’s preventable drug-related morbidity and mortality by ensuring safe and effective drug therapy [1]. Not by chance, only pharmacists – no other professionals – acknowledged the importance of PhC initially [7] and recently even the term itself has been perceived as an intrinsic limit that discourages the spread of PhC beyond their professional world [20].

Since the patient is the ‘core’ of PhC, establishing a caring relationship with her/him involves not only technical information and communication skills but also emotional aspects and empathy [7]. It is not enough just to be nice to patients [21]: a narrative approach for counseling is recommended to raise the quality of PhC [22], so pharmacists must listen closely to patients as an important part of PhC activity and low-health-literate patients (who are more likely to have poorer health outcomes) might be the best ‘target’ to illustrate the effectiveness of PhC [23]. This new approach would imply substantial changes in the classic training for pharmacy graduates, still focused on scientific disciplines like chemistry, physics, and biology [24], regardless of the different duration of undergraduate studies throughout Europe (e.g. 4 years in the UK, 5 in Italy, even 6 in France).

Once a physician has made a diagnosis and prescribed a drug, if necessary, even the task of selecting the most appropriate drug to optimize the safety, effectiveness, and cost-effectiveness of therapies could ideally be assigned to the pharmacist according to the PhC approach [25]. This would enable the pharmacist to exploit to the best her/his pivotal role of health professional specialized in pharmaceuticals, potentially generating considerable savings in pharmaceutical expenditure [26]. Since drug prescribing and dispensing are still rigidly separated functions in most European countries [7], PhC is likely to give rise to role conflicts, especially with general practitioners in the community pharmacy setting, so smooth collaboration with them is highly recommended [27].

Last but not least, pharmaceutical regulation of distribution margins can substantially affect the credibility of PhC activities. A still open issue in European countries like Italy is that community pharmacies are mainly remunerated through a (still high) proportion of prices to the public for dispensing reimbursable drugs [28], differently from countries like the Netherlands and the UK where distribution margins have been ‘fees for service’ unrelated to retail prices for decades. The widespread adoption of this type of remuneration in all the EU countries would drastically reduce concern about PhC in community pharmacies being driven by commercial incentives when intervening on prescriptions.

Policy implications

Regardless of the still ongoing debate on the definition of PhC, one can presumably expect positive results from this ‘philosophical approach’ – at least in theory – since PhC seems to be the natural ‘evolution’ of the pharmacist’s role in community care, historically rooted in drug development, production, and compounding.

However, moving from theory to practice, the regulation adopted in each country for drug reimbursement and delivery is the crux of the matter for the appropriate introduction of PhC. In general, community pharmacists always have a potential ‘conflict of interest’ when employed in a private pharmacy, on account of their dual role of health professional and commercial agent. This becomes paramount when the pharmacist is also the shopkeeper in continental countries like Italy, France, and Spain – and possibly others – where the vast majority of pharmacies are still private [4]. The clear evidence that commercial reasoning (unavoidably) prevails over the obligations of the health profession is the wide range of products besides drugs sold in most private pharmacies (around 4.5 billion euros in Italy, 17.4% of the total turnover), including some which should in fact conflict with the pharmacist’s training, such as homeopathic products (around 255 million euros in Italy). Since the real marketing plus of the pharmacy as a shop is to attract additional customers for other products [29], thanks to the monopoly on reimbursable drugs (still around 60% of the total turnover in Italian pharmacies), we feel this intrinsic feature makes it hard to consider the introduction of PhC reliable in settings where the monopoly still generates a considerable income for a large number of small pharmacies obligatorily owned by individual pharmacists.

To conclude, besides the need for updating pharmacist’s training, the introduction of a credible PhC approach in community pharmacies still calls for far-reaching reforms of pharmaceutical policy in many European countries, especially those like Italy where the ‘one pharmacist–one pharmacy’ rule still largely holds. Otherwise PhC will remain either a mere illusion in theory or a disputable concept in practice.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This manuscript was not funded.

Notes

1. We searched the PubMed international database to select studies focused on PhC activities on a specific patient population in community, published in English from January 2010. We used ‘pharmaceutical care’ as search terms. From the 180 articles initially identified, 173 were discarded because they were: not conducted in EU settings (116); not focused on specific patient populations (13); conducted in hospitals (14); surveys (12); commentaries, editorials, or letters (8); reviews (4); and congress reports and research protocols (6). We finally selected seven studies and screened their main characteristics.