[Effects of changing the appearance of medications in safety and adherence in chronic patients over 65 years of age in primary care. CAMBIMED Study]. / Efectos del cambio de apariencia de medicamentos en seguridad y adherencia en pacientes crónicos mayores de 65 años en atención primaria. Estudio CAMBIMED.

OBJECTIVE: To study whether the changes in bioequivalent drugs with different appearances are associated with an increase in lack of adherence and medication use errors, in patients >65years old treated with antihypertensive and lipid-lowering medications. DESIGN: Observational longitudinal prospective cohort study with a one-year follow-up period between 1 January 2013 and 31 December 2014. LOCATION: Primary Healthcare Centres in the Community of Madrid. PARTICIPANTS: Patients ≥65years-old with a diagnosis of hypertension and/or dyslipidaemia receiving treatment with Enalapril and/or Amlodipine and/or Simvastatin. MAIN MEASUREMENTS: Variables collected during a Primary Care consultation by means of a personal interview were: sociodemographic (age, gender, level of education), clinical variables, adherence (Morisky-Green test and direct counting), medication errors (number and type), medication changes and number, analytical (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) and combined variable (error and/or adherence). There were 1 baseline and 4 quarterly visits. RESULTS: The study included 274 patients with a mean age 72 (6.6) years, of whom 47.8% were female. Some medication changes were observed in 134 patients (48.9%), with a median of 3 (IQR 1-5) and a maximum of 11 changes. The risk of presenting with a medication use error or decreased adherence was increased in patients exposed to changes in all visits with RR 1.14 (1.16-1.69) at one year of follow-up. The most frequent error was the loss of dose. For each change in medication, the probability of a combined event increases by 41%. CONCLUSIONS: The changes made in bioequivalent drugs with different appearance could increase the number of medication use errors and decrease the adherence. More studies should be carried out to assess how much this affects the control of the disease. The intervention section is not considered because it is an observational study.

Study CAMBIMED: Effects of changes in medication appearance on safety of antihypertensive and hypolipidemic treatments in chronic patients older than 65 years in primary health care.

BACKGROUND: Different studies have investigated the effects that changes in drug appearance have on the control of chronic diseases and drug safety. The main objective of the proposed study is to evaluate if changes in the appearance of the packaging and presentation of drugs having the same active ingredient are related to a decrease in adherence and an increase in usage errors for chronic treatment using antihypertensive (enalapril and amlodipine) and hypolipidemic agents (simvastatin) in patients ≥65 years old, over a one-year follow-up period. METHODS/DESIGN: We propose a multicentric observational longitudinal cohort study with a one-year follow-up period in 8 primary health care centers (PHCC) in the Community of Madrid. 259 patients who are ≥65 years old, hypertensive and/or dyslipidemic, undergoing treatment with enalapril and/or amlodipine and/or simvastatin, and under formal follow-up of chronic patients in primary health care will be selected by simple random sampling. The main outcome variable will be a final combined variable (adherence and medication usage errors). Other included variables will be: sociodemographic and clinical variables of the patient, degree of disease control, drug taken, number of changes in the appearance of each drug by the pharmacy, and the type and frequency of both avoidable and non-avoidable adverse effects during the follow-up period. A descriptive and a multivariate analysis of the variables will be carried out by means of a logistic regression model, using the final combined variable as the dependent variable (error and/or inadequate usage of the drug), and variables shown to be related to it during the bivariate analysis as the independent variables. DISCUSSION: For drugs of the same active ingredient, the effect that different package appearances and presentation may have on the safety of patients undergoing chronic treatments is unknown under the new legislative framework. There are various initiatives that promote the iso-appearance of drugs: "If they are the same, make them look the same". It is to be expected that older, multi-medicated patients with chronic pathologies will be the ones under a greater risk of suffering from this problem.