M.J. Faus

Interacciones medicamentosas en pacientes infectados con el VIH: aproximación para establecer y evaluar su relevancia clínica

Objetivo: Sistematizar informacion sobre interacciones medicamentosas en pacientes con VIH/sida, y verificar la funcionalidad de una propuesta para definir y evaluar la relevancia clinica de las interacciones, especialmente las farmacocineticas. Metodo: Se realizo una revision en PubMed de articulos publicados en ingles o espanol, entre enero de 1995 y junio de 2007, sobre interacciones de antirretrovirales en humanos. La estrategia de busqueda fue: drug interactions and anti-retroviral agents (or drugs), en el titulo y resumen. La busqueda fue complementada con la revision de interacciones de medicamentos utilizados frecuentemente en pacientes con VIH/sida y de referencias de articulos considerados relevantes. Finalmente, se siguio una propuesta para definir y evaluar la relevancia clinica, basada en la probabilidad de ocurrencia y en la gravedad de la interaccion. Resultados: Se identificaron 378 articulos, de los que se pudo acceder al texto completo de 296. Para pacientes con VIH/sida, se desarrollo el tipo y mecanismo de las interacciones; se evaluo y definio la relevancia clinica de las interacciones, con base a una propuesta definida previamente. Entre las interacciones farmacocineticas de relevancia clinica, cerca de un 80% estuvieron relacionadas con cambios en el aclaramiento sistemico [debidos a la inhibicion o a la induccion sistemica de la actividad metabolica del citocromo P-450 3A4 (CYP3A4)]; mientras que un 15% con cambios en la biodisponibilidad [variaciones en el pH gastrointestinal, en el aclamiento presitemico (mediado por la CYP3A4) o en la actividad de la glicoproteina-P (Gp-P)]. Conclusiones: En los pacientes infectados con el VIH/sida, la mayoria de las interacciones farmacocineticas de relevancia cinica se deben a la inhibicion o induccion de la actividad metabolica sistemica del higado.

Negative results related to drugs required in hospitalisation

OBJECTIVE To assess the prevalence of negative clinical outcomes associated with medication as a cause of hospital admission and to determine their characteristics (types, categories, avoidability, severity and the drug groups involved.) To determine possible risk factors related to the appearance of this problem. METHOD An observational study carried out over a three month period in a department of the university hospital, 163 patients were selected at random. The information obtained from the patient interview, the revision of clinical records and clinical sessions were used to then identify negative clinical outcomes using the Dader method. RESULTS In 27 cases (16.6 %; 95 % confidence interval [CI], 1.6 to 23.0), negative clinical outcomes associated with medication were considered to be the main cause of hospital admission. The most frequent negative clinical outcomes associated with medication were untreated health problems, non-quantitative ineffectiveness and quantitative safety problems respectively. The overall prevalence of preventable admissions due to negative clinical outcomes associated with medication was 88.9 %; (95 % CI, 71.9 to 96.1 %.) With regards to severity, 74.1 % (95 % CI, 55.3 to 86.1 %) of the total admissions were moderate. The most common drugs implicated in hospital admissions were: antibacterial for systemic use, cardiovascular and non steroidal anti-inflammatory agents. Apart from age, no other factors were found for hospital admissions due to negative results associated with medication. CONCLUSIONS Negative clinical outcomes associated with medication as cause of hospital admission are a prevalent problem and most of them are avoidable with pharmacotherapeutic follow-up.

Application of the SCORE and Wilson–Grundy methods for the assessment of cardiovascular risk in community pharmacies

Background:  The assessment and follow‐up of patients with risk factors, or with cardiovascular disease (CVD), involves estimating and monitoring their CVD risk (CVDR). There are different opinions about the most appropriate method for this.

Efecto del seguimiento farmacoterapéutico en pacientes con hiperparatiroidismo secundario tratados con cinacalcet

OBJECTIVES To assess the effect of pharmaceutical intervention in the identification of drug-related problems, to improve desired clinical outcomes, and to evaluate the effectiveness of cinacalcet in achieving clinical outcomes recommended by the KDOQI Clinical Guidelines. METHOD Quasi-experimental pre-post intervention study. Patients with Secondary Hyperparathyroidism due to Chronic Kidney Disease, aged ≥18 years and under treatment with cinacalcet were recruited at the hospital outpatient pharmacy between 2007 and 2009. Dáder follow-up method and SMAQ and Moriski questionnaires were used to verify adherence at the first interview. Then, the pharmacist analyzed each case and designed an adequate intervention. Clinical parameters were consulted in the hospital laboratory data base. RESULTS Thirty four patients were included, 29 drug-related problems were found before pharmacist intervention, and among these, non-adherence was the most common (15). After the intervention, 9 drug-related problems remained, which means that 68.9% of them were resolved (P<0.001), reaching an adherence of 80%. Parathyroid hormone, calcium and calcium-phosphorus product serum levels decreased significantly after 3 months of treatment (P<0.001, <0.001 and 0.045, respectively), achieving the KDOQI Clinical Guideline recommendations. CONCLUSION These results suggest that this simple and easy-to-apply intervention was effective in preventing and resolving drug-related problems in these patients. Moreover, it improved patient adherence and confirmed that cinacalcet treatment is effective for achieving the clinical outcomes recommended by KDOQI clinical guidelines.

Pharmacist interventions focus in high impact journals

A significant professional development of pharmacy practice has taken place over recent years. Pharmacists have taken on a challenging new role in patient health care, and accordingly, have assumed the responsibility to ensure the possible best patient outcomes with drug therapy. Several major trends have converged with the shared objective of raising pharmacist’s level of responsibility. The role of the clinical pharmacy, which is defined as “the area of pharmacy concerned with the science and practice of rational medication for the purpose of ensuring optimal patient outcomes”, was the foundation for the development of the actual philosophy of practice, which consists in adopting a patient-centred pharmaceutical care. The role of pharmaceutical care, defined by Hepler and Strand as “the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve the patient’s quality of life” has been rapidly extended. In this context pharmaceutical care could be considered as similar to pharmacotherapy follow-up. However, other approaches have been made, such as medicines management, medication review, or more general like cognitive pharmacy services, which are not dissimilar concepts but introduce notable discrepancies in the terminology. Therefore, although there is not a uniform definition of pharmaceutical care, it is clear that the process of ensuring the safe and effective drug therapy of the individual patient requires that the pharmacists accept their professional responsibility for patient outcomes. Furthermore, to attain the mentioned therapeutic goals, pharmacist intervention should be carried out on the basis of monitoring both effectiveness and safety parameters of ongoing drug therapy, followed by a subsequent assessment of the outcomes achieved. Recent publications in high-impact medical journals examine the implementation of pharmacist-led interventions. This fact confirms the growing interest of the scientific community in the development of pharmaceutical care and pharmacy practice. Moreover, the different studies carried out have shown contradictory results (Table I); a number of randomised clinical trials demonstrated beneficial outcomes, and whereas others concluded that pharmacists-led intervention did not significantly improve patients’ outcomes. Specifically, several articles published in three major medical American journals have reported positive effects on admissions, mortality, quality of life, and length of hospitalisation. The FAME study obtained a marked improvement in both patient adherence and health outcomes. Intervention in this study was clearly defined, consisting of the provision of individual patient education, customized medication provision, as well as appropriate outcomes measurements. As in the SCRIP study, which showed that a pharmacy community-based intervention enhances cholesterol management in high-risk patients, interventions were characterized by a regular follow-up of patients, which allowed pharmacists to outline modifications when the outcome was not being achieved. Lastly, in Pharmacist intervention to improve medication adherence in heart failure study, patients in the intervention group had greater medication adherence and fewer exacerbations resulting in emergency department visits or hospitalisations than patients in the usual care group. Intervention involved a pharmacist providing verbal and written education, icon-based labelling of medicine containers, and therapeutic monitoring during 9 months. On the contrary, several other articles published by two British journals with high impact factor maintain that pharmacist intervention has little to no impact in patient outcomes, since they did not find significant changes either in hospital readmissions or in mortality over the study period. For these studies, namely the Homer, the Medman, and the Heartmed trials, intervention design consisted of isolated interventions by community pharmacists aimed at patients discharge from the hospital. As a consequence, there is currently some controversy among health professionals about the effect of the pharmacist intervention in patient health care. A variety of arguments have in fact been put forward by means of letters, concerning issues such as sample size, inadequate main outcome measures, health professionals who carry out the interventions, and design of the intervention. Based on this, there is a perceived need to seek out answers that support the different views provided. When analysing the possible reasons for these unexpected results it makes sense to take into account the foundations of pharmaceutical care practice. In that respect, we believe that the lack of beneficial effects is due less to flaws in the study’s design than to the following factors: a) The interventions approach (since they focus exclusively on the process but not on the outcomes); and b) The lack of monitoring of medication outcomes within the framework of well-defined parameters. To begin with an intervention dealing with patient’s results is a key element of success, of any program intended to improve outcomes for patients with chronic illness. As it can be seen in the table below, the contradictory results across studies are seemingly connected with substantial differences in the intervention approaches; “process” vs. “results and process together”. Those approaches centred on the process entail measurement of patient adherence and detection of errors such us taking the wrong medications, expired medications or therapeutic duplications. This kind of results can be used to support the importance of developing and using quality indicators and parameters in order to achieve the outcomes of pharmacotherapy, regarding the effectiveness, safe, and appropriate of medication. To sum up, the implementation of effective tailored pharmacist-led interventions should be characterized by a series of key elements, which involve that the pharmacist set patient outLetters to Editor 1130-6343/2007/31/6/379 FARMACIA HOSPITALARIA Copyright

Systematic review of the implementation and evaluation of Pharmaceutical Care in hospitalised patients (Pharmaceutical Care implementation in hospitalised patients. Systematic review)

Abstract Introduction The persistence of drug-related morbidity and mortality of patients admitted to hospital means scientific criteria need to be identified for implementing and evaluating Pharmaceutical Care (phC) in a hospital setting. Objective To conduct a systematic review of the literature to identify, select and analyse studies on the implementation and evaluation of phC in hospitalised patients. Material and methods A search for articles related to clinical pharmacy (CP) and phC published between 1990 and 2006 was performed using a restricted search strategy combining all descriptors. The databases searched were Medline, Embase, Drug & Pharmacology and Cochrane Library. Original and review articles, available in English or Spanish, describing CP and phC programmes which had a participating pharmacist and were carried out on hospitalised patients were selected. Results Sixty-six articles were found, of which 49 (74.2%) were included and 17 (25.8%) excluded. 15 (22.7%) regarding the integration between CP and phC in hospitals were selected, as well as 18 (27.3%) on implementing phC and 16 (24.2%) related to the evaluation of phC programmes. Conclusions In the studies described, pharmacists have managed to incorporate phC programmes in the care activities of pharmacy services. Efforts to unify CP and phC criteria should be a common plan for the future in this profession. Patients treated must obtain specific health benefits from phC and medical institutions must recognise they have beneficial effects at a reasonable cost.

Free software to analyse the clinical relevance of drug interactions with antiretroviral agents (SIMARV®) in patients with HIV/AIDS

Background: Highly active antiretroviral therapy has extended the expected lifespan of patients with HIV/AIDS. However, the therapeutic benefits of some drugs used simultaneously with highly active antiretroviral therapy may be adversely affected by drug interactions. Objective: The goal was to design and develop a free software to facilitate analysis, assessment, and clinical decision making according to the clinical relevance of drug interactions in patients with HIV/AIDS. Methods: A comprehensive Medline/PubMed database search of drug interactions was performed. Articles that recognized any drug interactions in HIV disease were selected. The publications accessed were limited to human studies in English or Spanish, with full texts retrieved. Drug interactions were analyzed, assessed, and grouped into four levels of clinical relevance according to gravity and probability. Software to systematize the information regarding drug interactions and their clinical relevance was designed and developed. Results: Overall, 952 different references were retrieved and 446 selected; in addition, 67 articles were selected from the citation lists of identified articles. A total of 2119 pairs of drug interactions were identified; of this group, 2006 (94.7%) were drug‐drug interactions, 1982 (93.5%) had an identified pharmacokinetic mechanism, and 1409 (66.5%) were mediated by enzyme inhibition. In terms of clinical relevance, 1285 (60.6%) drug interactions were clinically significant in patients with HIV (levels 1 and 2). With this information, a software program that facilitates identification and assessment of the clinical relevance of antiretroviral drug interactions (SIMARV®) was developed. Conclusions: A free software package with information on 2119 pairs of antiretroviral drug interactions was designed and developed that could facilitate analysis, assessment, and clinical decision making according to the clinical relevance of drug interactions in patients with HIV/AIDS.

Approach to establishing and evaluating clinical relevance of drugs interactions in HIV patients: 2009 update

Abstract Objective To update information on drug interactions in patients with HIV/AIDS. Method PubMed was used to review English and Spanish articles published between 1 July 2007 and 30 April 2009 on antiretroviral drug interactions in humans. The search included a review of interactions between commonly-used medications in patients with HIV/AIDS and references from articles considered to be relevant. Results Fifty two new interactions were identified having to do with CYP3A4 metabolism and competition for intestinal absorption. New pharmacokinetic interactions were identified for medications that were already on the market, and we report interactions for drugs that were recently introduced: Tipranavir, Fosamprenavir, Darunavir, Raltegravir, Maraviroc and Etravirine. Conclusions There is evidence of 52 new interactions between medications using metabolic routes in the CYP450 enzymatic system, and an explanation is given for others in the intestinal absorption process.