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    "textoCompleto" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">Dear Editor&#44; </span>&#160;</p><p class="elsevierStylePara">&#160;Until a few months ago&#44; renal transplantation patients received their immunosuppressant therapy from community pharmacies&#44; after prescription validation by the pharmacist responsible for health certification&#44; as these drugs are prescribed based on hospital diagnosis&#46; Most patients were treated with immunosuppressive therapy regimens that&#44; although not listed on the technical data sheet&#44; were indeed recommended in clinical practice guidelines&#46; In June 2009&#44; the Servizo Galego de Sa&#250;de &#40;SERGAS&#41; sent an informational notice to pharmacists responsible for approval&#44; reminding them that treatments with sirolimus&#44; mycophenolate sodium&#44; and mycophenolate mofetil&#44; in conjunction with drugs other than cyclosporine&#44; should not be validated&#46; This measure assumed these prescriptions to be compassionate use of these medication combinations and that their dispensing should take place in hospital pharmacy services&#46; These regulations remained in effect until September of that year &#40;Instruction 8&#47;09 of the Regional Ministry of health of the Government of Galicia&#41;&#44; at which time the previous rule was reinstated&#44; following the drafting of a new report on specific approval for these combinations&#46; This study aims to analyse the repercussion that this measure had on the quality of life of patients&#44; to understand their economic implications&#44; and to assess the burden of care on pharmacy and nephrology services&#46; We use our experience in our hospital as an example&#44; which is a level 2 hospital complex with a catchment area of 223&#44;000 inhabitants&#44; of whom more than 50&#37; live in a rural area and about 30&#37; are over 64 years of age&#46; <span class="elsevierStyleBold">&#160;</span></p><p class="elsevierStylePara"><span class="elsevierStyleBold">&#160;Method </span>&#160;</p><p class="elsevierStylePara">&#160;The influence on the quality of life of patients was quantified as disruption caused by the shift to the hospital setting and expressed as distance in kilometres &#40;km&#41;&#46; Atravel distance of more than 5km was considered to be serious medication acquisition difficulty&#46; &#160;</p><p class="elsevierStylePara">&#160;The economic implications were analysed from two standpoints&#46; The first was to consider whether or not they were medication cost reduction measures&#46; For this we calculated the difference in cost to SERGAS between the purchase of medications via the hospital or by reimbursement to community pharmacies&#46; The second was to assess the magnitude of budgetary adjustment relating to dispensing outpatient pharmacy services as a percentage of increase in spending&#46; &#160;</p><p class="elsevierStylePara">&#160;We analysed the increase &#40;net or percentage&#41; in the hospital workload at three levels&#58; nephrology clinic&#44; medical administration&#44; and outpatient pharmacy service dispensing area&#46; Patient data were obtained from medical record software applications from SERGAS and from the pharmacy&#8217;s SILICON<span class="elsevierStyleSup">&#174; </span>software&#46; A data collection sheet was created in Excel for Windows and statistical analysis was performed with SPSS 15&#46;0&#46; We used measures of central trending &#40;mean&#41; and dispersion &#40;standard deviation&#41;&#44; and estimated means and proportions with 95&#37; confidence intervals &#40;95&#37; CI&#41;&#46; <span class="elsevierStyleBold">&#160;</span></p><p class="elsevierStylePara"><span class="elsevierStyleBold">&#160;Results </span>&#160;</p><p class="elsevierStylePara">&#160;During the period from June to October 2009&#44; 72 compassionate use or off-label medications were transmitted&#44; corresponding to 63 patients &#40;68&#37; male&#44; mean age 51&#46;84 years&#44; 95&#37; CI 48&#46;94 to 54&#46;64&#41;&#46; The most commonly prescribed medication was mycophenolate mofetil &#40;74&#46;6&#37;&#41;&#46; The increase of care in the outpatient setting was 3&#46;15 patients per day&#46; The direct cost savings for drug acquisition to SERGAS was <span class="elsevierStyleItalic">&#8364;</span>16&#44;296&#46; The increase in cost to the pharmacy service was <span class="elsevierStyleItalic">&#8364;</span>7&#44;344&#47;month&#46; The average distance travelled by patients to acquire their treatment was 32&#46;27km &#40;range&#58; 0-85&#41;&#46; Sixty-eight point two percent of patients had serious difficulties in acquiring their treatments&#46; <span class="elsevierStyleBold">&#160;</span></p><p class="elsevierStylePara"><span class="elsevierStyleBold">&#160;Discussion </span>&#160;</p><p class="elsevierStylePara">&#160;Patients undergoing renal transplantation are those who have certainly seen their health become compromised over the course of their lives&#46; Thus&#44; it is the duty of the health system&#44; the same way as with the general population but more emphatically in these patients&#44; to provide the highest possible quality of life&#46; Travelling even 85km to pick up a portion of their treatment&#44; during the morning from Monday to Friday carries a heavy penalty on the quality of life&#44; especially when compared with picking up medications at a pharmacy that is likely located just a few metres from the home&#46; &#160;</p><p class="elsevierStylePara">&#160;From an ethical point of view&#44; this measure becomes a problem for the nephrologist&#46; The doctor&#44; as the person responsible for prescribing the drug&#44; has had to ask the patient for an informed consent&#44; communicating the potential risks to their health from being treated with a drug that is not legally recognised in Spain for that indication&#44; except for the patient who has been taking the drug for several years&#46; &#160;</p><p class="elsevierStylePara">&#160;In economic terms&#44; this is an effective measure of cost containment&#46; Such measures are essential to the sustainability of the health system&#44; but must be accompanied by an increase in the pharmaceutical expenditure budget for hospitals&#46; &#160;</p><p class="elsevierStylePara">&#160;We must not forget the burden of care&#44; whose main disadvantage is the reduction of average time for patient care&#44; since the measure was not accompanied by an increase in staff&#46; In recent times&#44; in which the sustainability of the health system is continually being debated&#44; we need to be aware that economic measures are necessary and essential to the welfare state&#44; but only if they are not accompanied by a decrease in the patient&#8217;s quality of life&#46; <span class="elsevierStyleBold">&#160;</span></p>"
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Change in regulations for dispensing immunosppressants to patients who have undergone a kidney transplant
CAMBIO EN LA NORMATIVA DE DISPENSACIÓN DE INMUNOSUPRESORES EN EL TRASPLANTADO RENAL
Jaime Gulín Dávilaa, Inmaculada López Rodrígueza
a Servicio de Farmacia, Complexo Hospitalario Xeral-Calde, Lugo, Galicia, España,
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Atravel distance of more than 5km was considered to be serious medication acquisition difficulty&#46; &#160;</p><p class="elsevierStylePara">&#160;The economic implications were analysed from two standpoints&#46; The first was to consider whether or not they were medication cost reduction measures&#46; For this we calculated the difference in cost to SERGAS between the purchase of medications via the hospital or by reimbursement to community pharmacies&#46; The second was to assess the magnitude of budgetary adjustment relating to dispensing outpatient pharmacy services as a percentage of increase in spending&#46; &#160;</p><p class="elsevierStylePara">&#160;We analysed the increase &#40;net or percentage&#41; in the hospital workload at three levels&#58; nephrology clinic&#44; medical administration&#44; and outpatient pharmacy service dispensing area&#46; Patient data were obtained from medical record software applications from SERGAS and from the pharmacy&#8217;s SILICON<span class="elsevierStyleSup">&#174; </span>software&#46; A data collection sheet was created in Excel for Windows and statistical analysis was performed with SPSS 15&#46;0&#46; We used measures of central trending &#40;mean&#41; and dispersion &#40;standard deviation&#41;&#44; and estimated means and proportions with 95&#37; confidence intervals &#40;95&#37; CI&#41;&#46; <span class="elsevierStyleBold">&#160;</span></p><p class="elsevierStylePara"><span class="elsevierStyleBold">&#160;Results </span>&#160;</p><p class="elsevierStylePara">&#160;During the period from June to October 2009&#44; 72 compassionate use or off-label medications were transmitted&#44; corresponding to 63 patients &#40;68&#37; male&#44; mean age 51&#46;84 years&#44; 95&#37; CI 48&#46;94 to 54&#46;64&#41;&#46; The most commonly prescribed medication was mycophenolate mofetil &#40;74&#46;6&#37;&#41;&#46; The increase of care in the outpatient setting was 3&#46;15 patients per day&#46; The direct cost savings for drug acquisition to SERGAS was <span class="elsevierStyleItalic">&#8364;</span>16&#44;296&#46; 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especially when compared with picking up medications at a pharmacy that is likely located just a few metres from the home&#46; &#160;</p><p class="elsevierStylePara">&#160;From an ethical point of view&#44; this measure becomes a problem for the nephrologist&#46; The doctor&#44; as the person responsible for prescribing the drug&#44; has had to ask the patient for an informed consent&#44; communicating the potential risks to their health from being treated with a drug that is not legally recognised in Spain for that indication&#44; except for the patient who has been taking the drug for several years&#46; &#160;</p><p class="elsevierStylePara">&#160;In economic terms&#44; this is an effective measure of cost containment&#46; Such measures are essential to the sustainability of the health system&#44; but must be accompanied by an increase in the pharmaceutical expenditure budget for hospitals&#46; &#160;</p><p class="elsevierStylePara">&#160;We must not forget the burden of care&#44; whose main disadvantage is the reduction of average time for patient care&#44; 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ISSN: 20132514
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