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A Best Practice Guideline about Dialysis fluid purity was developed under the leadership of the Spanish Society of Nephrology in 2004. The second edition revised Guideline considered new evidences and International Standard. The Guideline has established recommendations for standards for preparing dialysate: water, concentrates and hemodialysis proportioning systems. This Guideline is based on the ISO13959, European Pharmacopoeia, the Real Farmacopea Española, the AAMI Standards and Recommended Practices, European Best Practice Guidelines for Haemodialysis, literature reviews, according to their level of evidence, and the opinion of the expert Spanish group. Two levels of quality of water were defined: purified water and high purified water (ultra pure) and for dialysate: ultra pure dialysate. Regular use of ultra pure dialysate is recommended for all type of hemodialysis to prevent and delay the occurrence of complications: inflammation, malnutrition, anaemia and amiloidosis. Water, concentrates and dialysate quality requirements are defined as maximum allowable contaminant levels: chemicals (4.1.2), conductivity, microbial and endotoxins (4.1.1): Monitoring frequency, maintenance and corrective actions were specified. Methods of sampling and analysis were described in appendix (anexos). For microbiological monitoring, R2A medium is recommended, incubated during 7-14 days at a temperature of 17-23°C. The dialysate quality assurance process involves all dialysis staff members and requires strict protocols. The physician in charge of hemodialysis has the ultimate responsibility for dialysate quality. All suggestions and questions about this Guideline are wellcome to www.senefro.org., (Copyright © 2016 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.)

Objective: To establish indicators for the evaluation of the quality of the storage and dispensing processes related to semiautomatic vertical (SAVCS) and horizontal (SAHCS) carousel systems., Material and Methods: Descriptive observational study conducted between January-December 2012. Definition of quality indicators, a target value is established and an obtained value is calculated for 2012., Results: Five quality indicators in the process of storage and dispensing of drugs were defined and calculated: indicator 1, error filling unidose trolleys: target (<1.67%), obtained (1.03%); indicator 2, filling accuracy unidose trolleys by using an SAVCS: target (<15%), obtained (11.5%); indicator 3, reliability of drug inventory in the process of drug entries using an SAHCS: target (<15%), obtained (6.53%); indicator 4, reliability of drug inventory in the picking process of orders replacement stock of clinical units using an SAHCS: target (<10%), obtained (1.97%); indicator 5, accuracy of the picking process of drug orders using an SAHCS: target (<10%), obtained (10.41%)., Conclusions: Establishing indicators has allowed the quality in terms of safety, precision and reliability of semiautomatic systems for storage and dispensing drugs to be assessed., (Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.)

Objective: To develop an updated guide about the stability of thermolabile drugs included in the Pharmacotherapeutic Guide that,according to product information sheet, should be stored under refrigeration or freezing, when are accidentally exposed to temperatures outside the range recommended by the manufacturer., Methods: It was reviewed the information about storage temperatures recommended in the product information sheet and the available stability data at different temperatures of thermolabile drugs included in the Pharmacotherapeutic Guide of a 400-bed hospital that, according to the manufacturer, should be stored under refrigeration or freezing. Drugs of clinical trials were excluded. Stability data were obtained from the product information sheet, the last two guides published in Spain about thermolabile drugs and through consultations to laboratories(via phone or e-mail)., Results: It was created a table with the storage temperatures recommended in the product information sheet and currently available stability data at different temperatures of 209 presentations of several drugs. Stability data were requested to laboratories in 172 cases., Conclusions: The stability guide is a tool that facilitates decisions of pharmacists when they are faced with an accidental interruption of the cold chain, when it is necessary to know whether the drug can be used and it is not possible to contact the laboratory., (Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.)

Objective: Measures for controlling the expiry date and storage conditions of the drugs is a standard used in the accreditation program. The present paper has two principal aims: to identify the critical points in the clinical units evaluated, and to find out the different actions for improvement introduced in these areas., Materials and Methods: A descriptive-retrospective study was used. For analysing the critical points, the units that did not achieve the referred standard (n=64) during the accreditation process were selected. All the information analysed on the units (n=48) that had introduced improvements was obtained from the computer application that supports the accreditation processes., Results: The critical points (drug expiry date and storage conditions, were found in 32.98% of the units evaluated. These were mainly due to associated with lack of responsibility, absence of refrigeration control records and standard procedures. The 241 improvement actions made in the 48 units analysed were recorded in the computer program. The deficiencies were resolved, which enabled them to achieve accreditation., Conclusions: The actions introduced to resolve the critical points regarding drug storage and expiry in clinical units, can be easily implemented by other healthcare units in order to achieve accreditation., (Copyright © 2010 SECA. Published by Elsevier Espana. All rights reserved.)

Objective: Describe the transport and storage of privately purchased vaccines., Method: A descriptive cross-sectional observational study. We analysed all doses of pneumococcal conjugate vaccines, rotavirus and varicella acquired and administered between January-September 2009, in a Primary Care Health Centre (CAP) in an urban area., Variables Studied: type of vaccine circuit used (circuit A: pharmacy-CAP, circuit B: pharmacy-home-CAP), time between purchase and administration, receipt of information, mode of transport and storage at home. Data collection by questionnaire. Statistical strategy: absolute and relative frequencies, Pearson Chi-square and Fisher exact statistics., Results: Of a total sample of 148 doses, 115 (77.7%) were pneumococcal, 28 (18.9%), rotavirus and 5 (3.4%) varicella. Circuit A was used for 45.5% (67) of the doses administered and 54.7% (81) used circuit B. Circuit A vaccine took less than an hour between their acquisition and administration in 89.6% (60) of cases and those using Circuit B took longer than 7 days in 14.8% (12) cases. A total of 85.1% (111) of parents received information on transportation and storage of the vaccine. Refrigerated means of transport were not used for 85.1% (57) of Circuit A vaccines or for 93.8% (76) in B. The refrigerator door was used to store 59.3% (48) of the vaccines., Conclusions: The pneumococcal vaccine was the most given. Circuit B is more commonly used. Most parents received information about the transportation and storage of vaccines, although more than half were transported non-refrigerated and kept in the refrigerator door., (Copyright © 2010 Elsevier España, S.L. All rights reserved.)

Objective: To evaluate storage conditions of two thermolabile drugs, etanercept and adalimumab, in patients' homes, and the possible influence over the average storage temperature of variables such as the number of people living at home, age of the patient or age of the refrigerator., Materials and Methods: Prospective observational study. The sample consisted of 60 patients treated with Enbrel or Humira. Data loggers cards were used, with an integrated thermal sensor VarioSens, which were placed on the outer packaging of the product, programmed to record temperatures every 90 min for approximately 30 days. The average storage temperature recorded in refrigerators was used as the main variable., Results: It was shown that there is a greater risk of not maintaining adequate storage when the mean temperature of the refrigerator is outside a range of 2-8 degrees C, RR = 3.9 (95% CI = 1.95-7.93), P = 0.0001. A total of 35 patients (58.3%) stored medicines outside the correct temperature range. There were significant differences in average storage temperatures depending on the whether the age of the refrigerator was greater or less than 5 years, P = 0.029. Older than 5 years represents a risk factor for inadequate storage, RR = 1.68 (95% CI = 1.04-2.71), P = 0.023 with the Pearson chi-squared test., Conclusions: Procedures need to be established to ensure traceability of the storage of heat-labile drugs in patients' homes. New technologies allow this to be done, by providing advice to patients and for making decisions regarding dispensing and reuse in the event of return, thus improving our quality of care., (Copyright 2009 SECA. Published by Elsevier Espana. All rights reserved.)

Hospital pharmacists, according to the Ley del Medicamento 25/1990 of 20th December, should ensure appropriate drug preservation within the Pharmacy Department and in hospital stocks. The storage and preservation of thermolabile drugs according to manufacturer recommendations guarantees stability and optimal use conditions until the expiration date. Cold chain disruption may significantly affect the activity and toxicity of these drugs. Pharmacists should make quick decisions in case of cold chain-related events, hence the relevance of up-to-date information on stability under temperatures differing from those recommended. A review of the information available on the stability of drugs commonly used in the hospital setting that require a fridge for storage has been carried out.

In order to evaluate the quality of the measles vaccine, it was carried out a study in three states of Mexico (Durango, San Luis Potosi and Yucatan) during the intensive vaccination campaign in 1986. Edmonston-Zagreb measles vaccine vials were obtained from the different administrative-sanitary levels of the Ministry of Health in Mexico. Interviews were performed to the vaccine responsibles. Questionnaires had the following aspects of the cold chain: storage, preservation, control and transport of measles vaccine. Answers were evaluated through a system, where 100% indicated the necessary and sufficient level to get a good operating of the cold chain. The vaccine potency did not have variations under the minimum titre recommended for the World Health Organization (W.H.O.). The three states had the following compliment of the cold chain norms: 1) Central state level: 83% in storage, 80% in preservation, 100% in control and 100% in transport norms; 2) Regional level (jurisdiction): 87% in storage, 51% in preservation, 93% in control and 100% in transport norms; 3) Local level: 83% in storage, 64% in preservation, 83% in control and 33% in transport norms.

An evaluation of the cold chain used during the "National Vaccination Days Against Poliomyelitis" in January and March of 1987 and 1988 was performed in 32 states of Mexico, both the potency of the trivalent Sabin vaccine and completion of requirements for the maintenance of the cold chain were evaluated at each level in the Ministry of Health's structure. Only 56 percent of the refrigeration units exclusively stored vaccines, more than 10 percent of refrigerators were broken, and 44 percent of the persons responsible for the cold chain system considered the storage capacity inadequate. A correlation was found between non-fulfillment of maintenance requirements for cold chain and a decreased in vaccine potency.