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Farmacéutico especialista en farmacia hospitalaria (Spain)

  • Proportionality information

    1. Have you examined whether the requirements under your national legal system are
    directly or indirectly discriminatory on the basis of nationality or residence?
       There is no discrimination as the requirements are applicable to individuals from any Member State according to Royal Decree 1837/2008, 8th November, which incorporates into Spanish legislation the requirements under Directive 2005/36/EC. There is no rule that discriminates on the basis of nationality or residence.

    2. Which of the following overriding reasons relating to the general interest justifies the measure(s)?
    • Public health
    • Protection of consumers and recipients of services
    • Other, please specify
       Sustainability and equity in the National Health System.

    3. What specific risks or benefits have you identified that your measure(s) is designed to, respectively, minimise or maximise?

       Please try to be specific in describing the nature of the risks/benefits you have identified
       Where you have selected more than one overriding reason relating to the general interest in question 2 please be sure to address each of these in your response. Wherever possible please include evidence.

    • Ensure proper control of professional practice in the best defense of consumers.
    • Minimize the risks associated with the effect that medicines can have on the citizens' health.
    • Minimize the risk, to the general population and to the public health system, that could result from the improper use of medicines in hospitals and in primary care settings.
    • Ensure continuity of care through the coordination among the different healthcare levels (coordination between primary, specialized, community and mental health and other health & social care structures).

    4. How specifically do your measures operate to minimise the risk(s) or maximise the benefit(s) identified in question 3?

       When addressing this question please try to explain how the measures prevent the risks or guarantee the benefits.
       Where you have selected more than one overriding reason relating to the general interest in question 2 please be sure to address each of these in your response. Wherever possible please include evidence.

       These measures guarantees the control of professional practice to consumers. The ECJ has recognized that compulsory registration is compatible with the European Union Law and is justified by means of general interest. It guarantees to citizens that the pharmacist has the professional qualifications attesting his/her education and training as well as the ethical and disciplinary control and promotes professional development. It minimizes the risks associated with the incidence on citizens' health of medicines and medical devices and minimizes the risk, for the general interest and the public health, that could result from the improper use of medicines both in hospitals and primary care. It serves to the participation and coordination in medication reconciliation programmes with other healthcare stuctures.

    5. In so far as you are able, please provide information that you have gathered regarding the concrete effects of the measure(s).

       For example, through impact assessments or information gathered during implementation or review of a measure. Member States who have recently undergone reforms may in particular be able to contribute helpfully to this field. Where you are able to provide cost-benefit analyses this would be particularly valuable.
       Information on whether the measures indeed successfully prevented risks from being realised (e.g. the number of sanctions imposed, a drop in transgressions since the measure was introduced or consequences from previous modifications of the regulation) would equally be helpful.
       Where you have selected more than one overriding reason relating to the general interest in question 2 please be sure to address each of these in your response. You may also wish to include evidence on consumer satisfaction or other measurements of the impact.


    The pharmacist specialist in hospital and primary care pharmacy improves the quality, safety and efficiency of patient care processes and the rational use of medicines. The role of the pharmacist in the Pharmacy & Therapeutics Committe is to foster the prevention of medication errors. In the medication reconciliation, pharmacological adequacy and adherence to treatment, the pharmacist improves pharmaceutical care in high risk, pluripathological, paediatric patients or those assisted by the clinical services with inherent risk to their own nature.

    The 20% of hospital admissions are a direct result of a negative medicine outcome resulting in an expense of 237,377 euros; 65% of the admissions are avoidable. The hospital pharmacist integration in the healthcare team serves to detect problems related to medicines and reduces the risk of increased lenght of stay and healthcare costs. A prospective styudy shows that 32.5% of patients required intervention avoiding a cost of 60,000 euros. It has been seen that the quality of the intervention by a clinical pharmacist shows a high adherence to clinical practice guidelines with high recommendation degree, evidence and theoretical reduction of the morbi-mortality associated.

    6. Is the general interest objective you indicated in question 2 pursued in a consistent and systematic manner?.

       In approaching your response to this question please consider examples where you have addressed similar risks for comparable professions, not necessarily within the same sector. Is the approach you have adopted in this particular profession comparable or distinct from such similar cases and why?


    Pharmacists specialists in hospital and primary care pharmacy guarantee and take responsibility for the procurement, quality, proper storage, coverage needs, custody, magistral compunding and dispensing of medicines for hospital use and for others in the benefit of public health and consumer protection. The pharmacist specialist is critical to ensure efficacy and safety of medicines distribution ensuring traceability, proper administration, custody and dispensing of medicines. This pharmacist specialist has been trained in areas such as medicines information, acqusition, pharmaceutical technology, individualized dispensing, oncological pharmaceutical care, intravenous therapy and enteral nutrition, clinical pharmacokinetics, toxicology, pharmacogenetics advice and pharmacotherapy monitoring, provision of pharmaceutical care to outpatients, management, use and dispensing of medical devices, radiopharmacy, substances, medicines and medical devices used in clinical research and management of the pharmacy department, pharmacoeconomics, education/training and research.

    7. Please explain in how far the degree of complexity or the nature of the activities
    which are reserved justify that these activities can be exclusively performed by professionals possessing a specific professional qualification?

       For example: when the tasks are essentially of a straightforward nature (such as preparing and printing pay slips etc.), or involve essentially the execution of instructions, specific professional aptitudes should not be required.


    In most Member States, as in Spain, phamacists specialists in hospital and primary care pharmacy are in charge of ensuring that citizens have access to medicines - in hospital settings - that are necessary for the restoration of health, with effective guarantee for the rational use and pharmaceutical care.

    Royal Legislative Decree 1/2015, defines the specific functions developed by the regional regulations on pharmaceutical planning. In this context, it is important to mention Directive 2005/36/EC on the recognition of professional qualifications which has been recently amended by Directive 2013/55/EU, 20th November, particularly Article 45 paragraph 2, that regarding the pharmacy degree, established the minimum training and knowledge mentioned before.

    8. Where you have indicated several measures in place in the screening tab,
    have you reviewed the cumulative effect of all these measures on professional activities?

       If not, why not?
       If yes, please outline for us how you approached assessing this issue as well as the results and conclusions or any learning you drew from this. Where possible please include evidence.


    Yes. The cumulative effect of the measures arising from the reservation of activity, the registration and regulation of the activities performed by pharmacists specialists in hospital and primary care pharmacy in Spain, represent a maximum guarantee for the public health and citizens' safety.

    The regulation of the activity and associated measures have allowed for a development  model for the Spanish hospital and primary care pharmacy that is based on improving the quality, safety and efficiency of care processes for the population in the area of hospital influence and the rational use of medicines, medical devices and healthcare resources. This model meets the standards set by international organisations (International Pharmaceutical Federation - FIP -) and European (European Association of Hospital Pharmacists). At national level, tools such as the definition of a Professional Strategic Plan (Plan 2020) associated to surveys to measure the time evolution (2010, 2013 and ongoing 2015) have been created.

    9. Have you considered the use of alternative mechanisms to achieve your objective(s)?
    • Other, please specify

       Please briefly explain. Where you have selected more than one option, please be sure to address each of these in your response.


    No, the use of alternative mechanisms to achieve our objective has not been considered.

    The alternative mechanism in the field of registration/licensing would be to eliminate compulsory registration/licensing to a professional body. We understand that this mechanism cannot have the same efficacy as the current system due to the limitations that in the performance of the above functions would present not to select the entire collective but only those who voluntarily want to join the organisation, and in terms of material means, it would offer less protection and fewer guarantees to citizens. The reservation of activity as pharmacist specialist in hospital and primary care pharmacy is determined by Law 44/2003, on the Regulation of Healthcare Professions.

    10. Conclusion

       Following your internal examination of this regulated profession, which of the following have you concluded?

    •    Maintain current system

       Explain where relevant:

       The current system must be mantained.

    11. Any other comments?
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