“The Need for Clinical Pharmacy”
Introduction
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"Clinical Pharmacy" is a commonly used term in pharmacy practice and pharmacy literature. Nevertheless, the name is still incorrectly interpreted and applied. In many instances, only the hospital pharmacist is believed to perform clinical pharmacy activities, while community pharmacist is not. Moreover, some believe that the only clinical task is patient counselling. For this reason, ESCP through its Executive Committee feels the need to define the correct meaning of clinical Pharmacy, pointing out the objectives and the activities related to the discipline.
"Narration”
Clinical Pharmacy includes all the services performed by pharmacists practicing in hospitals, community pharmacies, nursing homes, home-based care services, clinics and any other setting where medicines are prescribed and used. The term "clinical" does not necessarily imply an activity implemented in a hospital setting. A community pharmacist may perform clinical activities as well as a hospital practitioner. While, on the one hand, the discipline of Pharmacy embraces the knowledge on the synthesis, chemistry and Preparation of drugs, clinical Pharmacy is more oriented to the analysis of the population needs with regards to medicines, ways of administration, and patterns of use and drugs effects on the patients. The focus of attention moves from the drug to a single patient or population receiving drugs.
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· Maximizing the clinical effect of medicines, i.e., using the most effective treatment for each type of patient;
· Minimizing the risk of treatment-induced adverse events, i.e., monitoring the therapy
· Minimizing the expenditures for pharmacological treatments born by the NHS (National
Health System) and by the patients, i.e., trying to provide the best treatment alternative for the highest number of patients.
Level of action
Clinical pharmacy activities may influence the correct use of medicines at three different levels: before, during and after the prescription is written.
1 - Before the prescription
· Clinical trials
· Formularies
· Drug information
Clinical pharmacists have the potential to implement and influence drug-related policies, i.e.
Making decisions on which drugs deserve to be marketed, which drugs should be included in national and local formularies, which prescribing policies and treatment guidelines should be implemented?
Moreover, clinical pharmacists are actively involved in the conduction of clinical trials at different levels: participation in Ethical Committees; study monitoring; dispensation and preparation of investigational drugs.
2 - During the prescription
· Counselling activity
Clinical pharmacists can influence prescribers' attitudes and priorities in choosing the correct treatments. Activities in this sense include a continuous comparative feedback service on physicians' prescribing practice, organization of educational activities and, ultimately, the direct professional contribution of the pharmacist at the time the prescription choice is made. The clinical pharmacist monitors detect and prevent harmful drug interaction, adverse reactions ad medication errors through evaluation of prescriptions' profiles. The clinical pharmacist pays special attention to the dosage of drugs which need therapeutic monitoring. Community pharmacists also have the possibility of making prescribing decisions directly, when over the counter, drugs are counselled.
3 - After the prescription
· Counselling
· Preparation of personalized formulation
· Drug use evaluation
· Outcome research
· Pharmacoeconomic studies
After the order is written, clinical pharmacists play a crucial role in communicating and counselling patients. Pharmacists can improve patients' awareness of their treatments, monitor treatment response, check and improve patients' compliance with their medications. Working in a multidisciplinary team, clinical pharmacists can also provide an integrated care from hospital to community and vice versa, assuring continuity of information on risks and benefits of drug therapy.
In several cases, the clinical pharmacist handles special preparations like parenteral nutrition bags or chemotherapy mixtures. This task requires clinical skills since a single patient's characteristics and needs are taken into account.
Drug use review (DUR) is another critical activity. DUR offers useful information to the prescribers and the health authorities on the penetration at the local level of the scientific guidelines highlights prescribing errors, and it represents valuable research and audit the instrument in areas with lack of scientific evidence.
Clinical pharmacists play an essential role in the post-marketing clinical studies, the so– called effectiveness studies. It is common knowledge that randomized controlled trials (RCTs) are conducted in selected populations, both in terms of characteristics and number. These patients may have very different features from the patients evaluated and cured by doctors in daily practice. Inclusion criteria in RCTs are very selective in terms of age, disease, concomitant drugs used etc. These studies are critical to evaluate drug efficacy (e.g., the effect of a drug in an experimental trial setting). Still, they do not give information neither on effectiveness (e.g., the impact of a drug in a "real world" situation) nor on the safety of large populations [1]. Effectiveness adjusts the results on the "real effect" by variables present in the daily practice, like accessibility to health care services and drugs, patient compliance, drug-drug interaction, among many others.
Drug dispensing is an ideal activity to start building prescription databases and, at the same time, collaborate with clinicians on planning studies and surveys on specific patient populations. The integration of such databases with data related to patient's outcomes makes it possible to perform the so-called "outcome research". The main objective of outcome research is the evaluation of the effectiveness of alternative therapies.
The integration of patient's outcomes (clinical, humanistic or both) with cost information constitutes the basis for performing Pharmacoeconomic studies. In these studies, incremental costs of treatment alternatives are compared with their additional benefits. Without results on outcomes of real patients, Pharmacoeconomic studies can only be performed with the modelling technique, with the consequent possible bias.
Background knowledge of Clinical Pharmacist
prescription sign To make appropriate and correct interventions during the prescribing process, clinical pharmacists need both a strong clinical background, as well as evaluative tools to correctly judge the shreds of evidence available for the treatments. Thus, they need to know very well the diseases characteristics and their progression; the characteristics of medicines, their mechanism of action, their formulations and the way they interact with the human body.
In addition, they need to be able to evaluate the real value of a drug, analyzing randomized controlled trials; they need to assess risk, analyzing epidemiological studies; and they need to assess the economic burden of a treatment-related to its advantages for the patients. Schools of Pharmacy in Europe do not satisfy the minimal requirements for an appropriate education in clinical Pharmacy, since they are still linked to an old model of pharmacy activity, e.g., based on chemistry and basic sciences knowledge.
A few universities have modified their curriculum including topics as epidemiology, Pharmacoeconomic, clinical medicine, communication skills, the latter being particularly indicated for community pharmacists.
The majority of new graduates in Pharmacy will work either in the community or the hospital setting. The curricula should reflect this trend, including topics of interest and innovation for practicing pharmacists. In the US, it is common practice in many universities to teach clinical pathology and medicine to Pharmacy and medical students in the same class.
The impact of pharmacy services has been proven as effective
Several studies have been published on the effect of clinical pharmacy services on different patient's outcomes: humanistic (e.g., quality of life, satisfaction), clinical (e.g., better control and management of chronic diseases), economic (e.g., reduction in health care costs).
A recent study published on Social Science and Medicine this year reviewed all published papers from 1984 to 1995 on the impact of pharmacy services on patient's outcomes [2].
Forty-one papers were evaluated, of which 31 regard hospital pharmacy services while the remaining 10 are on community pharmacy services. The most frequently studied activities of hospital pharmacists were prescription monitoring and adverse drug reaction reporting.
Concerning community pharmacists, prescribing errors identification was the most common topic studied. The review concludes that clinical pharmacy services are effective in reducing health care costs in improving the services and quality of care.
From recent medical literature, the following studies have reported that clinical Pharmacy services can reduce hospital mortality rates, preventable adverse drug events and medical costs.
Reduction of hospital mortality rates
A multi-center observational study conducted in 3763 hospitals in the United States showed that hospital mortality rates decreased as particular categories of hospital staff increased. The staff categories were pharmacists, medical residents, registered nurses and medical technologists. (Bond et al., Pharmacotherapy 1999) [3].
Reduction of medical costs
An extensive review of the literature on measuring the impact of clinical pharmacy services on economic outcomes showed that clinical pharmacy activities are effective in reducing health care costs [6]. Commonly, results were expressed as net savings or costs avoided for a given period or per patient. Seven studies expressed results as a benefit-cost ratio. They differed in the type of clinical pharmacy services, site of the provision of services and resources invested in the service. Nevertheless, the results were impressively positive, with calculated average benefits to the cost of 16.7 to 1. In other words, for the dollar invested in clinical services, on average, $ 16.70 was saved thanks to the presence of these activities.
Improve efficacy and ADR reduction
A recent study analyzed the impact of community pharmacists' interventions [7]. During a 12- week period, fourteen community pharmacies recorded all the responses on prescriptions beyond drug dispensing, generally requiring contact with the prescribes. A total of 1.503 responses on 201.000 orders were recorded.
The most frequent interventions were on modalities of drug administration, followed by drug substitution and generic substitution. The multidisciplinary panel then evaluated the impact of responses, demonstrating that efficacy was improved in 24% of cases, an ADR prevented in 32% of cases, and hospitalization was avoided in 16% of cases.
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