Pharmaceutical Care As A Strategy To Improve The Safety .
Pharmaceutical care as a strategy to improve the safety andeffectiveness of patients’ pharmacotherapy at a pharmacy school:a practical proposalClarice Chemello1,*, Fernanda de Souza2, Eliziane de Souza Patricio3, Mareni Rocha Farias¹¹Department of Pharmaceutical Sciences, Center for Health Sciences, Federal University of Santa Catarina, Florianopolis,Brazil, ²University Hospital of Federal University of Santa Catarina Professor Polydoro Ernani de São Thiago, Florianopolis,Brazil, ³Biochemistry Department, University of São PauloSeveral patients experience at least one drug-related problem and Pharmaceutical Care can changethis reality. This work describes a model for structuring the pharmaceutical care service at a pharmacytraining unit of the Brazilian Public Health System based on pharmacotherapy follow-up program ofParkinson’s disease patients’ results. From the follow-up results (phase 1), a Therapy ManagementScheme was designed (phase 2). Of the 57 patients followed-up, 30 presented at least one drug-relatedproblem and 42% were non-adherent to treatment, which supported the need of pharmacotherapymanagement. The Pharmacotherapy Management Scheme was proposed as a pharmaceutical care servicemodel, which presents 6 steps: first, the pharmacist fills out the dispensing form and assesses patient spharmacotherapy, if there is a suspect problem, he is invited to the follow-up (steps 1 and 2) and theyagree the first appointment. After that, pharmacist studies the patient’s case (study phase, steps 3 and4). At the second meeting, the pharmacist proposes the intervention needed, and at the third, assessesthe intervention results and new problems (steps 5 and 6, respectively). The process ends when alltherapeutics outcomes are reached. This practical model can significantly contributed to the developmentand organization of pharmaceutical care services.Uniterms: Pharmaceutical care. Pharmacotherapy follow-up. Community pharmacy. Patients/safety.Parkinson’s disease/treatment.Muitos pacientes vivenciam pelo menos um problema relacionado ao medicamento e à atençãofarmacêutica pode mudar este fato. Este trabalho descreve um modelo para estruturar o serviçode atenção farmacêutica numa farmácia escola do Sistema Único de Saúde brasileiro baseado nosresultados de um programa de seguimento farmacoterapêutico de pacientes com Doença de Parkinson.A partir dos resultados do seguimento, um esquema de gerenciamento da farmacoterapia foi desenhado.Dos 57 pacientes acompanhados, 30 apresentaram um problema relacionado ao medicamento e 42%não aderiram ao tratamento, o que reforça a necessidade de gerenciar a farmacoterapia. O esquemaproposto apresenta 6 passos: primeiro, o farmacêutico preenche o formulário de dispensação e avaliaa farmacoterapia do paciente; caso haja suspeita de um problema, ele é convidado a participar doseguimento farmacoterapêutico (passos 1 e 2) e marcam a primeira consulta. Após esta, o farmacêuticoestuda o caso (fase de estudo, passos 3 e 4). Na segunda consulta, o farmacêutico propõe as intervençõesnecessárias e, na terceira, avalia seus resultados e novos problemas (passos 5 e 6, respectivamente). Oprocesso termina quando todos os objetivos terapêuticos são alcançados. Este modelo de prática podecontribuir significativamente para o desenvolvimento e organização de serviços de atenção farmacêutica.Unitermos: Atenção farmacêutica. Seguimento farmacoterapêutico. Farmácia comunitária. Pacientes/segurança. Doença de Parkinson/tratamento*Correspondence: C. Chemello. Department of Pharmaceutical Sciences,Center for Health Sciences, Federal University of Santa Catarina Florianopolis Campus Trindade, 88040-900 – Florianópolis – SC, Brasil. E-mail:clachemello@gmail.com; clachemello@yahoo.com.brArticleBrazilian Journal ofPharmaceutical Sciencesvol. 50, n. 1, jan./mar., 019
186INTRODUCTIONPharmaceutical Care (PC), described as “theresponsible provision of drug therapy for the purpose ofachieving definite outcomes that improve patient’s qualityof life” (Hepler, Strand, 1990), has been applied in manydifferent clinical fields to manage and improve treatmentoutcomes using a follow-up method (Chisholm-Burnset al., 2008; de Lyra et al., 2007; Lee, Grace, Taylor,2006; Koshman et al., 2008). The Brazilian Consensusin Pharmaceutical Care, which was created in 2002,had considered Pharmacotherapy Follow-up (PF) asone of the Pharmaceutical Care components, definedas a professional practice in which the pharmacist isresponsible for patient medication needs. This is carriedout by means of detection, prevention and solution of aDrug Related Problem (DRP) and implies a continuous,systemized and documented commitment on behalf ofthe pharmacist, in collaboration with the patient and otherhealthcare professionals, with the objective of reachingconcrete results that improve the patient’s quality oflife (Pan American Health Organization, 2002; Grupode Consenso, 2001). Furthermore, Brazilian Resolutionnumber 44 of the National Agency of Sanitary Vigilance(ANVISA), an agency which monitors and advocatesfor good pharmaceutical practice, regulated PC as oneof the pharmaceutical services that can be carried out incommunity pharmacies (Brasil, 2009a).Parkinson’s disease (PD) is a chronic neuro degenerative disease that usually causes severe disabilityafter 10 to 15 years. Its social and financial impact ishigh, particularly among the elderly, with a prevalenceof 1% of the population older than 60 (Martin, Dawson,Dawson, 2011). It is estimated that the annual globalcost of antiparkinsonian drugs is around 11 billion USdollars, and it is about 3 to 4 times more expensive forpatients in advanced stages of the disease (Bialecka etal., 2008). Furthermore, these patients are polymedicatedand normally present multi-morbidity, increasing the riskof experiencing problems related to medicines (Schröderet al., 2011).These patients normally have a complex pharmaco therapy, as they need to take a number of differentmedicines several times per day, thus, non-adherenceand drug-drug interactions are common DRP (ObreliNeto et al., 2012). Furthermore, as the disease worsensthe number of doses taken per day increases in orderto maintain control over the physical symptoms.Moreover, the probability of the occurrence of either anAdverse Drug Reaction (ADR) or treatment resistanceincreases. On the other hand, non-motor symptoms (suchC. Chemello, F. Souza, E. S. Patricio, M. R. Fariasas depression, hallucinations, etc) have an importantimpact on quality of life and on treatment complianceand effectiveness (Chaudhuri, Schapira, 2009). Allthese factors indicate the need for follow-up for thesepatients.Pharmaceutical assistance policy and clinicaland patient-centered care are part of the undergraduatecurriculum of the Faculty of Pharmacy of the FederalUniversity of Santa Catarina and, in order to put thisknowledge into practice, the Pharmacy Training Unit hasdeveloped a partnership with the local city government.The Training Unit (called Pharmacy School UFSC/PMF)is part of the Brazilian Public Health System (SUS) andmedicines - selected from a drugs list based on guidelinesand therapeutics protocols for chronic diseases so as toguarantee the most complete treatment coverage throughthe rational use of medicines known as “specializedcomponent” of the National Pharmaceutical AssistancePolicy - are dispensed monthly without direct cost to thepatients (Brasil, 2007, 2009b). A median of 7000 patientsare assisted per month and, among these, 170 are sufferingfrom Parkinson’s disease.Thus, our objective was to propose a practicalmodel for structuring the pharmaceutical care service at apharmacy training unit based on the results derived froma previous experience of a pharmacotherapy follow-upprogram of Parkinson’s disease patients.PATIENTS AND METHODSThe present study was performed in two phasesdescribed as follow:Phase 1Study design and clinical settingThis study is a description of a pharmacotherapyfollow-up of Parkinson’s disease patients carried out atthe School of Pharmacy UFSC/PMF, which is a pharmacytraining unit of the university.Previous Pharmacotherapy Follow-upPatients were enrolled in the follow-up betweenMay and August of 2011 when they came to receive theirantiparkinsonian treatment and included after acceptingand signing the informed consent form. They had anappointment once a month with the pharmacist for a periodof 4 months or until the DRPs were solved, however onlythe data from the first interview was used in this study.Follow-up data were statistically analyzed by ANOVAusing SPSS version 15. The study was approved by the
Pharmaceutical care as a strategy to improve the safety and effectiveness of patients’ pharmacotherapy at a pharmacy schoolEthical Committee in Human Research of the FederalUniversity of Santa Catarina.Follow-up methodThe Dáder pharmacotherapy follow-up methodwas adapted to this study (GIAF-UGR, 2005a). Thisinvolves a structured clinical questionnaire based oninformation retrieval about patient’s health problemsand pharmacotherapy. The questionnaire is applied at thefirst appointment and allows the clinical pharmacist toevaluate the patient’s clinical history and identify DRPs,formulate an individualized and adequate action plan forthe patient and put in place pharmacotherapy interventionsthat may be required. The method design is continuous anddocumented, thus, the pharmacist performs successiveinterviews during a period of time with each patient andarchives all clinical, pharmacological and demographicinformation. At the second meeting, the pharmacist canreview the treatment and apply the intervention and atthe third meeting he/she can evaluate the interventionresults and the necessity of continuing the follow-up.All information was recorded in a specific database forthis study. DRPs were classified according to the ThirdConsensus of Granada in DRP (Consensus Committee,2007).Adherence measurementTo evaluate treatment adherence, the MoriskiGreen-Levine validated adherence questionnaire wasapplied (Morisky, Green, Levine, 1986).PD severityHoehn & Yahr stage scale (H&Y) was used to assessdisease severity (Hoehn, Yahr, 1967).Quality of life measurementQuality of life was evaluated using the Parkinson’sDisease Questionnaire (PDQ39) (Souza, 2007). As thereis no validated range score to interpret the PDQ39 (0 isconsidered the best and 100 the worst) (Peto, Jenkinson,Fitzpatrick, 2001) the global score in this study wasdivided into two categories: scores 50 and scores 50,the lower the value under 50, the better the quality of life.Phase 2Pharmaceutical care service modelAs a proposal to put in practice the pharmaceuticalcare service, a pharmacotherapy management scheme tomanage patient s pharmacotherapy was designed based onprevious pharmacotherapy follow-up results.187RESULTSPhase 1Previous pharmacotherapy follow-up of PD patientsFifty seven patients were followed-up, 54.4% men,mean age of 71.4 9 years old, 61.4% did not have acaregiver and 61.4% were married. Regarding schooling,67% (38) had studied at least eight years (includinggraduates) and 12.3% (7) were illiterate. The meandiagnostic age was 6.4 4 years and the majority of them(53%) presented stage 1 on the Hoehn & Yahr stage scale,followed by 32% on stage 2.The first appointment with the pharmacist lastedabout 33 10 minutes. The main issues reported by patientswere: lack of information about disease progression,prognosis and antiparkinsonian medication, druginteraction, nauseas, the occurrence of nightmares andhallucinations, difficulties in complying with treatmentregimen and depression.The results from the pharmacotherapeutic historyrecorded are described as follows:Medication and Drug Related ProblemsThe average dosage of antiparkinsonian andconcomitant drugs taken per day are listed in Table I. Inaddition to Parkinson’s disease the majority of patientspresented other chronic health problems treated withmedication, such as hypertension (38.6%) and hypertensionplus diabetes mellitus (15.8%). Regarding DRPs, 30patients (52.6%) presented at least one and amongst these,26 (45.6%) had ADRs due to levodopa combinations(levodopa/carbidopa or levodopa/benserazide). The mostcited DRPs were ADRs, hallucinations and constipation.AdherenceFrom these patients, 42% were non-adherent to theirtreatment. The treatment regimen and ADRs were the maincauses for this. PDQ 39 scores, duration of disease, age,PD severity and patient schooling did not present statisticalassociation with adherence. Table I contains these resultsin detail.Quality of lifeThe quality of life of Parkinson’s patients is stronglyaffected by motor and non-motor signs and symptoms.These patients presented a global score on the PDQ39 of39.2 19.3, which is considered good. Older patients (15,median age of 76.7 years) presented a worse score ( 50%)than the others (p 0.005). Regarding the subscales, bodilydiscomfort presented the worst ranking with a mean of
188C. Chemello, F. Souza, E. S. Patricio, M. R. FariasTABLE I - Patients baseline study data (n 57)Age (years, mean SD)Gender (male/female, %)Schooling (%)Retired (%)Duration of disease (years, mean SD)Caregiver (Yes, %)Parkinson Disease medication (mean SD)Concomitant medication (mean SD)H&Y stage (%)PDQ39 total scale (%)Moriski-Green-Levine (%)DRP (%)ADR (%)51.6 25.3, followed by mobility problems (48.4 3) anddaily activities (47.5 28.5). Patients reported social stigmaand social support as the factors that least affected them(19.5 25 and 19.2 23, respectively). Total PDQ39 scorein communication, bodily discomfort, daily activitiesand mobility were affected by PD severity (p 0.02,0.021, 0.03, 0.001 and 0.005, respectively), as stage 1patients presented a better score compared with stage 2or above patients. Apart from these results, the total scoreand subscales were related to the duration of the disease(p 0.001 for all).PHASE 2: PHARMACEUTICAL CARE SERVICEPROPOSALAs part of the improvement of the quality ofpatient-centered care services, during the follow-up, ascheme of Pharmacotherapy management was developedto support the implementation of the PharmaceuticalCare service at the pharmacy. This scheme was designedtaking into account both the service and patients’ needs71.4 954.4/45.6Illiterate – 12.3Just read and write – 3.5Incomplete elementary school – 17.5Complete elementary school – 14Incomplete high school – 1.8Complete high school – 28.1Graduate – 22.8806.44 438.62.3 0.74.7 31 – 52.62 – 31.63 – 8.84 – 5.35 – 1.8 50 – 68.4 50 – 31.6NA – 421 – 52.62 – 8.8None – 38.6Yes – 45.6and specificities. This service began with treatmentdispensation (which included the pharmacist actionsregarding the analysis of the prescription, patientcounseling and medicine provision), evaluation of patients’follow-up needs (by filling out the dispensation form everythree months, as not all patients presented a DRP) andthe follow-up itself (individualized and specialized care).This whole process was called the Pharmacotherapymanagement scheme and comprises 6 steps: first, whenpatients come to the pharmacy to collect their treatment,the pharmacist asks some questions evaluating theirpharmacotherapy and fills out the dispensing form, andif he/she notices that patients have a need, he/she invitesthem to participate in the pharmacotherapy follow-up(steps 1 and 2); then, they agree on the first appointment(first interview). After the first meeting, the pharmaciststudies the patient’s case and identifies DRPs (thestudy phase, steps 3 and 4). At the second meeting, thepharmacist proposes an intervention to the patient or tothe physician, and at the third the pharmacist evaluatesif the intervention was effective and if there are any new
Pharmaceutical care as a strategy to improve the safety and effectiveness of patients’ pharmacotherapy at a pharmacy schoolproblems (steps 5 and 6, respectively). If there are any newproblems, the pharmacist arranges a new appointment withthe patient and the process starts again until all DRPs aresolved and therapeutic outcomes reached (see Figure 1).FIGURE 1 - Pharmacotherapy management scheme.189DISCUSSIONBecause Parkinson’s disease is a neurodegenerativedisease it includes, besides the classical symptoms,
190psychosocial and non-motor problems which can stronglyaffect these patients’ quality of life (Tedrus, Fonseca,Kange, 2010). Thus, these patients require more attentionfrom health professionals to ensure the correct and safe useand the adherence of medicines to attain desired clinicaloutcomes. In this study, PD patients’ data were used todemonstrate the importance of specialized care (followup) for any person with a chronic disease and to support thedevelopment of pharmaceutical care service by designinga pharmacotherapy management scheme.It has already been shown that pharmacotherapyfollow-up programs can improve adherence, decreaseadverse effects and generate better clinical outcomes aswell as promote the rational use of medicines (de Lyra etal., 2007; Lee, Grace, Taylor, 2006; Viktil, Blix, 2008).However, in Brazil, this service is still in development (deCastro, Correr, 2007; Pan American Health Organization,2002; Pereira, Freitas, 2008) and pharmacists who workin schools of pharmacy have the responsibility to sharetheir knowledge and contribute to the development of thisarea, the results of which should improve patient’s healthand the public health system itself, in relation to the costeffectiveness of treatments provided. Furthermore, thedevelopment of a pharmacotherapy management schemeis necessary to provide appropriate training and knowledgeto pharmacists, and to encourage the development of aPF guide, as is the case for other chronic health problems(Sabater-Hernández, 2011; GIAF-UGR, 2005b; GIAFUGR, 2009).The results of Phase 1 revealed a PD population withsimilar demographic characteristics to the epidemiologydata previously reported (Davis, Edin, Allen, 2010)and describe the need for individualized care due topolymedication and DRPs presented. Complex treatmentposology and ADRs are likely reasons for the large numberof DRPs, as well as a delayed perception of improvementin clinical symptoms.Problems related to non-adherence appear to be themost common DRP among patients with chronic diseasesand are related to the increasing costs of healthcareservices (Grosset D, European PD Therapy ComplianceStudy Group, 2010; WHO, 2003; Stuart et al., 2011). Thepresent results agree with these data, showing that 42% ofthe patients studied did not adhere to their pharmacologicaltreatment. Non-adherence could be responsible for theineffectiveness of medication leading to misconceptions onthe part of physicians when prescribing a drug regimen anddose titration and, sometimes, leading to the prescriptionof a new medication that increases costs. Furthermore, themajority of these patients are polymedicated, have sufferedan ADR, a fact that could accentuate non-adherence. It isC. Chemello, F. Souza, E. S. Patricio, M. R. Fariasimportant to note that differently to other studies, nonadherence in this group was not associated to PDQ 39scores, duration of disease, age, PD severity and schooling(Grosset, Reid, Grosset, 2005).Non-adherence can arise from prescriber-patientcommunication, thus a good communication betweenthem is important to attain clinical objectives and avoidmisunderstandings. However, sometimes this is notthe case. To manage patients’ treatments, physiciansassume that they are adherent and make decisions basedon this; on the other hand, sometimes patients do notunderstand the information and the reason for taking somany medicines, and the consultation time is insufficientfor effective communication (Grosset D, European PDTherapy Compliance Study Group, 2010). Furthermore,patients’ experience with medication and their routinehave to be taken into account in decision-making and inorder to prevent new
Several patients experience at least one drug-related problem and Pharmaceutical Care can change this reality. This work describes a model for structuring the pharmaceutical care service at a pharmacy training unit of the Brazilian Public Health System based on pharmacotherapy follow-up program of Parkinson’s disease patients’ results.
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