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Many medicines can be destroyed by storage and transportation at the wrong temperature. Joe Fudge, service manager at ABB Measurement Products, examines how proper monitoring supports best practice.

Background: Cold chain maintenance is an essential activity to maintain the potency of vaccines and to prevent adverse events following immunization. One baseline study highlighted the unsatisfactory cold chain status in city of Kolkata in India., Objectives: To assess the changes which occurred in the cold chain status after the intervention undertaken to improve the status and also to assess the awareness of the cold chain handlers regarding cold chain maintenance., Methods: Intervention consisted of reorganization of cold chain points and training of health manpower in Kolkata Municipal area regarding immunization and cold chain following the guidelines as laid by Govt of India. Reevaluation of cold chain status was done at 20 institutions selected by stratified systematic random sampling after the intervention. The results were compared with baseline survey., Results: Significant improvement had been observed in correct placing of cold chain equipment, maintenance of stock security, orderly placing of ice packs, diluents and vaccines inside the equipment, temperature recording and maintenance. But awareness and skill of cold chain handlers regarding basics of cold chain maintenance was not satisfactory., Conclusions: The success of intervention included significant improvement of cold chain status including creation of a designated cold chain handler. The gaps lay in non-availability of non-electrical cold chain equipment and separate cold chain room, policy makers should stress. Cold chain handlers need reorientation training regarding heat & cold sensitive vaccines, preventive maintenance and correct contingency plan.

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.)

Purpose: On 1 March 2010, the US Pharmacopeial Convention released into commerce Lot P1I300 of its Prednisone Tablets Reference Standard for use in periodic performance verification testing (PVT) of dissolution Apparatus 1 and 2. This report presents the collaborative study data, development of the acceptance limits, and results from supporting work for this Lot., Methods: The collaborative study involved 25 collaborators who provided data for Apparatus 1 and 31 who provided data for Apparatus 2. These limits are for the geometric mean and percent coefficient of variation (%CV) instead of per-individual results as for prior lots. Stability of results and sensitivity to test performance parameters were also studied., Results: To determine new PVT acceptance limits, the authors calculated geometric mean and variance components as percent coefficient of variation. The move to the geometric mean and %CV criteria brings the acceptance criteria in line with current accepted statistics and provides a more realistic assessment of the system's performance. Results for Apparatus 1 are stable over time, but for Apparatus 2, the mean decreases over time. Acceptance criteria are adjusted for this trend. Lot P1 demonstrates sensitivity to test performance parameters (vessels and degassing)., Conclusions: Apparatus 1 results are stable over time. Those in Apparatus 2 show a decrease over time in the geometric mean but show no trend in variability. The current tablets are shown to remain sensitive to two operational parameters, degassing and vessel dimensions, not covered by mechanical calibration. The new acceptance limits for Lot P1 are based on geometric mean and %CV for Prednisone Tablets Reference Standard Lot P1I300. The limits better control variability than the prior per-individual-result limits.

This study characterizes the expertise and updated knowledge on immunization of nursing team responsible for vaccine rooms; it describes the work conditions in that sector from the team's view, and identifies the procedures and daily activities performed by such professionals. This cross-sectional study conducted in 2007 in vaccine rooms of 11 Family Healthcare Centers (CSF) in Fortaleza (CE, Brazil), involved 22 nursing team professionals and used a checklist and self-applicable questionnaire as the survey instrument. Among the participants, 44.4% were nurses and 30.8% technicians/assistants have an experience of more than five years; 55.6% of the nurses had attended no training on vaccines; and 76.9% of all other professionals keep themselves updated by referring to books, manuals and the Internet. Gaps in physical structure, examination and record of temperature maps, and guidance on post-vaccine effects were detected in most rooms under study. The study indicates that managing any vaccination work requires knowledge of the area and specific training to allow the professionals to provide a quality service to the population in a way to ensure the eradication and control of immunopreventable diseases.

Structural and qualitative evaluation of Revised National Tuberculosis Control Programme (RNTCP) is important to determine actual status of the programme in the field settings and to uncover the concealed gaps. The present cross-sectional study assessed the infrastructural facilities and quality of services provided through microscopy and directly observed treatment (DOT) centers at Nanded city of Maharashtra. The investigator made on spot observation on the activities at microscopy and DOT centers and assessed the infrastructural facilities using an observational checklist. Expert microbiologist cross checked the microscopy report done by the laboratory technicians. It revealed that retrieval mechanism was not functioning in more than half of the DOT centers. Only 5 DOT providers were trained in RNTCP. Stock of sputum containers, methylene blue, and carbol fuchsin was found to be inadequate at some microscopy centers. Half of the laboratory technicians reported high false positive result in spite of being trained. Improvement of infrastructural and logistic support along with the refreshing training for the workers are needed for effective implementation of RNTCP.

The study aim to deal with problem of manage potassium chloride concentrate solution after the introduction of a new protocol on correct use (storage and handling) of these drugs in a high specialization-teaching hospital. The study, conducted from January 2009 to March 2009, was divided in two part: observation of the compliance of concentrated electrolytes solutions storage in 14 wards and prospective observational study on the compliance to the new protocol in the steps of prescription, preparation and administration of these drugs. 49 preparations and administrations of electrolytes solutions were observed. Medical prescriptions were made in a dedicated schedule in 40.8% (20/49), in therapy sheet in 36.7% (18/49), in 14.3% (7/49) the prescription was verbal and after written. Patient identified data was present in 85.7% of cases, solvent type in 61.2%, prescription date in 69.4%, prescription hour in 10.2%, signature of prescriptor in 77.6%, administration speed in 57.1%, administration date in 71.4%, administration hour in 32.7%. Data show a scarce knowledge of the protocol by the physicians or a difficulty in using an additional schedule respect to the existent. Lack of the prescriptor's signature was an important problem such as the absence of speed, date and hour of administration.

Monocyte chemoattractant protein-1 (MCP-1) is commercially available in a form of recombinant protein. This makes it more convenient to study the functions of MCP-1 and its involvement in many cell functions. However, when using MCP-1 in experimental studies, if the analysis is not performed immediately, the stability of recombinant MCP-1 may become an issue. In this study, the stability of recombinant MCP-1 at different concentrations and storage conditions was investigated. Results show that no significant loss of MCP-1 is observed when MCP-1 solutions were stored at non-freezing condition (4 °C) for seven days. However, for storage at freezing conditions (-20 °C or -81 °C), it appears that the first freeze-thaw cycle may contribute to some loss of MCP-1 in the solutions, and such loss may be concentration and time dependent. The effect of multiple freeze-thaw cycles for storage at freezing conditions was also examined. Data reveal that the second freeze-thaw cycle causes approximately 50% loss of MCP-1 in the solutions. This finding confirms that multiple freeze-thaw cycles should be avoided. The findings of this study provide an outline of how storage can affect the stability of recombinant proteins and should be taken into account during the evaluation of the concentration of recombinant proteins., (Copyright © 2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.)

Objective: The aim of this study was to determine the influence of time, temperature and light exposure on ranibizumab (Genentech, San Francisco, USA) in plastic syringes., Methods: Samples of ranibizumab were drawn from the original vials into plastic tuberculin syringes, capped and analyzed after different storage intervals under varying temperature conditions (4 °C and room temperature) and light exposure (protected and room light). The samples were tested for the pH value, protein stability and concentration as well as for the binding affinity to VEGF-165 in an ELISA (enzyme linked immunoassay). Additionally, original freshly drawn samples were compared to commercially available ready to use ranibizumab syringes analyzed up to 14 days after sampling., Results: Samples stored under the described conditions retained a stable pH. Both SDS-PAGE analysis as well as protein concentration measurements shows slightly decreasing values over time that were not additionally influenced by light exposure or room temperature. The binding affinity to VEGF-165, however, was significantly decreased (p<0.05) over time starting from the first day after sampling. A similar effect could be observed in commercially available ready to use syringes. Exposure to light and room temperature led to additional decreases in the binding affinity to VEGF-165., Conclusion: Until now different socioeconomic and legal aspects have influenced the choice whether to use original vials or pre-sampled ranibizumab. A new aspect is the effect of storage in plastic syringes on the quality and biological efficacy of the antibody fragment.

Background & Aims: Two ready-to-use parenteral nutritions (PN) have been developed, for the first days of life of the premature newborn, along with syringes of lipid emulsion with or without vitamins. Long-term physico-chemical stability for storage in wards was assessed., Methods: Physico-chemical stability of PN: visual inspection, particle size, pH, osmolarity measurement, amino acids, glucose, and electrolytes dosages. Physico-chemical stability of lipid emulsion: visual inspection, globule size, peroxide level and vitamins A, E, and C dosages. Stability was studied for 12 weeks on refrigerated (2-8 °C) and room temperature (30 ± 2 °C) samples., Results: No precipitation was detected in any PN. A brown coloration was observed in PN stored for four weeks at room temperature but not in the refrigerator. Concentrations of all the nutrients remained constant over the 12 week-study period. Phase separation of the lipid emulsion occurred after three weeks, but particle size complied with the USP limits for 12 weeks. Peroxide content increased only in the samples without vitamins at room temperature. Vitamins remained stable for one week under refrigeration., Conclusion: The PN did not present a detectable change of the tested properties when refrigerated for 12 weeks. The lipid emulsion with vitamins is stable for one week when refrigerated., (Copyright © 2010 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

In this qualitative study, we adapted photographic research methods from earlier nursing research to identify factors related to organization, storage and distribution that could lead to errors in the selection, preparation and administration of medications. The research excerpt presented here was developed in a clinical unit of an urban Brazilian public hospital. The research participants were nurses working at that unit and students from the two final semesters of the Undergraduate Nursing Course. We collected digital photographs of the medication system and subsequently used photo elicitation to review the images with research participants, so as to obtain their perceptions and narratives of working with medications in the unit. We report selected findings here on the organization, storage and distribution of medications, which indicate there is room to improve the safety of the medication system.

Thiomersal has been used as preservative in multi-dose vials of hepatitis B vaccine (Engerix-B). Due to safety concerns, thiomersal was replaced with 2-phenoxyethanol (2PE) as preservative in multi-dose vials. The potency of 2PE preserved hepatitis B vaccine multiple use vials was measured over the shelf-life in terms of immunogenicity, reactogenicity and safety. This single-blind, randomized study was conducted with the assistance of employees of GlaxoSmithKline Biologicals, makers of the Engerix-B vaccine. Four hundred twenty subjects aged > or =18 years were randomized to receive three doses (0, 1, 6 months) of 2PE preserved hepatitis B vaccine kept on the shelf <12 months (2PE New group), 2PE preserved hepatitis B vaccine kept on the shelf >18 months (2PE Old group), or thiomersal preserved hepatitis B vaccine [HBV(Thio) group]. Anti-HBs was measured by GlaxoSmithKline Biologicals post-vaccination; the reactogenicity and safety of the vaccines were assessed. Protective anti-HBs levels (> or =10 mIU/ml) were measured one month after dose 3. The results showed protective levels in 86.8% (2PE New), 89% (2PE Old) and 95.3% [HBV(Thio)]. There was no difference detected between the 2PE New and 2PE Old groups in terms of anti-HBs seroprotection rates and geometric mean concentrations one month after dose 3. However, both 2PE groups had significantly lower seroprotection rates than the HBV(Thio) group and the number of non-responders was higher in the 2PE groups than in the Thio group. A antibody response rates over time were similar between the 2PE New and Old groups. The reactogenicity profiles were acceptable and the ranges were similar for each group. The shelf-life of the vaccines had no impact on immunogenicity or reactogenicity and 2PE preserved hepatitis B vaccine can be considered stable over time.

Aim: The aim of this study was to prepare an orally fast-disintegrating tablet (FDT) by direct compression, containing a poorly soluble drug (perphenazine, PPZ) formulated as a stable solid dispersion., Methods: The stability studies of the fast dissolving 5/1, 1/5, 1/20 (w/w), PPZ/polyvinylpyrrolidone K30 (PVP) or polyethylene glycol 8000 (PEG)) solid dispersions, and amorphous PPZ were conducted with differential scanning calorimetry, X-ray powder diffraction, Fourier-transform infrared spectroscopy, small-angle X-ray scattering, and dissolution rate studies., Results and Discussion: It was found that 1/5 PPZ/PEG was the most stable dispersion under elevated temperature and/or humidity. FDTs containing 60% of mannitol, 15% of calcium silicate, 15% of crospovidone, and 10% of 1/5 PPZ/PEG solid dispersion exhibited fast disintegration times (37 +/- 3), sufficient hardness (1.28 +/- 0.06 MPa), and fast onset of drug dissolution (34% of PPZ dissolved in 4 minutes), and these properties were found to be retained with storage. Thus, by optimizing the drug/excipient ratio of the solid dispersion and tablet composition, it was possible to produce FDTs that possessed fast disintegration and satisfactory drug dissolution in addition to adequate tensile strength, so that they can be handled and packed normally.

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.)

Due to colonization (1895-1960) Mali has been submitted, on the legislative and regulation plan to a corpus of numerous and scattered texts relative to pharmacy. It is essentially the Law AN XI of 21 Germinal or the 11 April 1803 Law; the content of Book V of the Public Health Code relative to pharmacy practice, of which some disposals have been extended to Overseas Territories, Togo and Cameroon in 1953; the 1955 Ministerial Order about the dispatching of the Retail Pharmacy in AOF; the 1960 Law creating the Board of Pharmacists in the Federation of Mali etc. After independence, the new Malian State while renewing the pharmacy legislation issued by the old tutor State which was not opposed to the new fundamental Law, has also set up, according to the political orientations of the moment, some new texts. In the framework of this work, we have collected all the legislative and regulation texts that have been allowed in Mali in the pharmacy area and in that of Studies in Pharmacy. We have examined those texts and proceeded to codify the legislative part. The present Code consists of 189 articles divided in 5 titles layed out in chapters and sections.

Objective: To check compliance of anaesthetist to current policies set for the use of medication within operation room and for induction room floor stock., Methods: The initial audit was conducted from 1st October to 31st November 2006 and reaudit after dissemination and sharing of results within the department repeated in July-August 2007. In each audit four operating rooms were visited twice a week. Syringes were checked for standard drug labelling for narcotic and non narcotic preparations. Drug trolley was checked for any expired drugs and whether the trolley was locked in case of operating room (OR) where list was ended or was on hold. Any unattended drug was noted and Induction room was checked twice weekly for accurate drug inventory and for standard drug storage recommendations., Results: Labels were according to standard in non narcotic drugs on 25% syringes in first audit and 63% in second audit, likewise, narcotics labels were according to standards in 41% in first and 57% in second audit. Unattended drugs were present once in first and twice in second audit. There was 100% compliance in other drug storage policy parameters in both audits., Conclusion: Poor compliance of drug labelling standards for both narcotic and non narcotic drugs was present. However, second audit revealed improvement in all areas of drug handling. Dissemination of policies and reminders are important for continuing improvement in use of medication within operation room and within induction room floor stock.

Background: In Thailand there is no regulation and standard guideline to control the quality of drug transportation, including cold storage drugs., Objective: To explore the condition of cold storage drugs transportation and delivery to general public hospitals, community hospitals and private hospitals., Material and Method: This is a cross-sectional survey research. There were 301 questionnaires returned from 720 questionnaires sent (41.8% response rate), Results: The serious problems of cold storage drugs on delivery were (1) Cold storage drugs (2 degrees C - 8 degrees C) were delivered to the hospitals without controlled temperature boxes, was found in private, public and community hospitals at the rate of 46.7%, 48.3% and 72.9% respectively. (2) Cold storage drugs (-20 "C), i.e., polio vaccine came to the hospitals with a temperature higher than 8C or ice melting in the box, was found in private, public and community hospitals at the rate of 22.9%, 12.7% and 35.0% respectively., Conclusion: There are differences in quality of cold storage drug transportation and delivery among types of hospitals. It is highly recommended that Thai FDA should develop a standard and implement the control system for logistics management of cold storage drugs.

Purpose: Current guidelines call for nitroglycerin to be prescribed in patients with coronary heart disease, including those with stable angina and those recovering from acute coronary syndromes and myocardial infarction. These patients are at risk for coronary events, and nitroglycerin may be required to treat acute symptoms of myocardial ischemia. Nitroglycerin rapidly loses potency when stored improperly, compromising effectiveness. Previous studies indicate that patients frequently fail to store nitroglycerin properly. Accordingly, pharmacists routinely advise patients to renew nitroglycerin tablets every 6 months. The purpose of this study was to determine frequency of prescription of nitroglycerin and the relationship to potency in patients participating in exercise-based cardiac rehabilitation programs., Methods: A survey was performed over a 3-month period of 617 patients enrolled in 9 exercise-based cardiac rehabilitation centers in New York, Michigan, and Rhode Island. Patient data were evaluated according to cardiac diagnoses and the use of sublingual nitroglycerin., Results: A total of 38% of patients did not have a prescription for nitroglycerin. Patients with potentially subpotent nitroglycerin tablets included 23% whose prescription was older than 1 year and an additional 15% whose tablets were between 6 and 12 months old., Conclusions: The prescription of nitroglycerin is frequently omitted in patients with coronary heart disease. Those who are prescribed nitroglycerin frequently carry a potentially subpotent medication. Education is necessary for both patients and physicians. The findings have implications for counseling patients who are enrolled in exercise-based cardiac rehabilitation programs.

To help preserve in-theater strength within deployed military units, commercially available, rapid, user-friendly ABO-Rh blood typing kits were evaluated to determine their stability in storage conditions commonly encountered by the warfighter. Methods for environmental exposure testing were based on MIL-STD-810F. When Eldon Home Kits 2511 were exposed to various temperature/relative humidity conditions, the results were comparable to those obtained with the control group and those obtained with industry-standard methods. For the ABO-Rh Combination Blood Typing Experiment Kits, 2 of the exposure treatments rendered them unusable. In addition, a third set of exposure treatments adversely affected the kits, resulting in approximately 30% blood type misclassifications. Collectively, this evaluation of commercial blood typing kits revealed that diagnostic performance can vary between products, lots, and environmental storage conditions.

Compounding parenteral nutrition, either manually or with an automated compounding device, requires aseptic conditions and trained personnel. The revised version of United States Pharmacopeia Chapter <797> is a comprehensive document that describes standards and procedures to minimize the risk of contamination of compounded parenteral products. The chapter includes evidence-based instructions for pharmacy design, washing, garbing, cleaning, quality assurance, and personnel training and evaluation designed to improve compounding practices in all pharmacies that compound parenteral products. Because parenteral nutrition is a compounded product mixed from multiple additives, it is important to maintain these standards, especially when using an automated compounding device. This article is an overview of United States Pharmacopeia Chapter <797>, with special emphasis on parenteral nutrition.

Background: Traditionally anaesthetic drugs for obstetrics are prepared as a contingency and stored until they are required for emergency use or have expired. Expiry is based on presumed reduction in sterility and efficacy although evidence for this is inconsistent. Preparation in advance introduces the risk of error and potential for tampering by a third party. Discarding and re-preparing drugs daily represents significant wastage with associated cost implications. We predicted that practice of drug preparation would differ widely across the UK, so conducted a national survey., Method: A postal questionnaire was sent to lead consultant obstetric anaesthetists at each of the 223 consultant-led UK obstetric units enquiring about the preparation of anaesthetic drugs for obstetric emergencies., Results: The response rate was 75%; 87% of units routinely draw up emergency drugs, most commonly thiopental and succinylcholine. Only 10% routinely use commercially-prepared succinylcholine syringes, although a further 8% would use them if available. Thiopental is prepared by anaesthetists in 78% of units, operating department practitioners in 8% and pharmacy in <7% of cases. Drugs are changed every 24h in 80% of units and weekly in 6%. With one exception, all units changing drugs weekly use pharmacy-prepared thiopental., Conclusion: The majority of UK obstetric units routinely draw up emergency drugs every 24h. With conflicting evidence regarding sterility and efficacy this represents tremendous wastage and potential for drug error and tampering. We propose that nationwide introduction of commercially- and pharmacy-prepared drugs with long shelf lives would improve safety and cost effectiveness.

Objectives: To describe (a) Food and Drug Administration (FDA) regulations and guidelines issued by several professional organizations to ensure appropriate storage, handling, and distribution of temperature-controlled prescription drugs from manufacturer to wholesaler to pharmacy to patients; (b) pharmacy business practices that ensure the dispensing of high-quality temperature-controlled drug products; and (c) education that facilitates patients' important role in maintaining product quality., Data Sources: PubMed from 1950 to 2007 using the search terms drug stability in transit, drug stability storage tablet, drug stability testing, drug stability transportation, drug stability relative humidity, and drug storage high temperature. Nonprimary sources included the FDA website (www.fda.gov), presentations from meetings or workshops, and websites of professional organizations. Additional resources were identified from bibliographies collected by the authors., Data Extraction: Relevant data were extracted independently by the authors., Data Synthesis: The important role of pharmacists in ensuring the quality of drugs dispensed to and handled/stored by patients is supported by business practices that (a) promote purchase of quality temperature-controlled drugs (including quality agreements with providers), (b) ensure appropriate handling and storage upon receipt, (c) ensure proper packaging for receipt by patients, (d) provide relevant information to patients, and (e) evaluate issues associated with possible compromised transit, handling, and storage of temperature-controlled drug products., Conclusion: The transit, handling, and storage of temperature-controlled drug products within complex supply chains provide opportunities for exposure of such drugs to temperatures above or below those recommended by the manufacturer. Pharmacists have opportunities to integrate business practices that facilitate the proper receipt, handling, and storage of temperature-controlled drug products. These practices will enhance the dispensing of high-quality, efficacious drug products to patients and proper handling and storage by patients.

Objective: To determine the effects of temperature and light over a 35-day period on stability of pergolide mesylate after compounding in an aqueous vehicle., Design: Evaluation study., Procedures: Pergolide was compounded into a formulation with a final target concentration of 1 mg/mL. Aliquots of the formulation were then stored at -20 degrees, 8 degrees, 25 degrees, or 37 degrees C without exposure to light or at 25 degrees C with exposure to light for 35 days. Samples were assayed in triplicate by means of high-pressure liquid chromatography immediately after compounding and after 1, 7, 14, 21, and 35 days of storage., Results: Mean+/-SD concentration of pergolide in the formulation immediately after compounding was 1.05+/-0.086 mg/mL. Samples exposed to light while stored at 25 degrees C had undergone excessive degradation by day 14, samples stored at 37 degrees C had undergone excessive degradation by day 21, and samples stored at 25 degrees C without exposure to light had undergone excessive degradation by day 35. The decrease in expected concentration corresponded with the appearance of degradation peaks in chromatograms and with a change in color of the formulation., Conclusions and Clinical Relevance: Results indicated that pergolide mesylate was unstable after compounding in an aqueous vehicle and that storage conditions had an effect on stability of the compounded formulation. Compounded pergolide formulations in aqueous vehicles should be stored in a dark container, protected from light, and refrigerated and should not be used >30 days after produced. Formulations that have undergone a color change should be considered unstable and discarded.

Purpose: The droplet-size distribution (DSD) and stability of multiple lots of lipid injectable emulsions were studied., Methods: A total of 234 commercial batches of Intralipid (Fresenius Kabi, Uppsala, Sweden) were characterized, and the influence of the emulsions' oil content on samples packaged in single- and three-chamber bags was tested. Larger-sized lipid particles were quantified using a single-particle optical sensing device. For this test, a 1-mL sample of each product was analyzed using a dilution factor of 90-400, depending on oil concentration. Analyses were performed in triplicate. Measurements were also performed in single-bag products after up to six months of storage at 23-27 degrees C and 40 degrees C. DSD measurements were determined by laser light scattering. Droplet sizes were determined using laser diffraction, with aliquots of emulsions carefully dispersed step by step applying gentle agitation. Standard deviation analyses were performed using analysis of variance., Results: The volume-weighted percentage of fat droplets greater than 5 mum (PFAT(5)) values of all samples were below the large-globule size limit (0.05%) established by the United States Pharmacopeia for lipid injectable emulsions. Container volume did not significantly influence globule size, though a slight tendency for larger bag volumes to have larger PFAT(5) values was apparent. PFAT(5) and mean volume diameter values increased with oil concentration in the emulsion. Storage time and temperature had no significant effect on PFAT(5) and mean droplet-size values., Conclusion: Multiple lots of a lipid emulsion were found to have acceptable PFAT(5) and mean droplet-size values, regardless of oil content, container size, or storage time and tempearture.

Objective: To describe poison prevention practices for a range of substances and explore the relationship between prevention practices and perceptions of toxicity., Design: Cross-sectional study using a validated postal questionnaire., Participants: Parents with children aged 12-35 months on 23 health visitors' caseloads., Setting: Areas of various levels of deprivation in Nottingham, UK., Main Outcome Measures: Possession and storage of substances, putting substances away immediately after use, and perceptions of toxicity., Results: Dishwasher tablets (68%), toilet cleaner (71%), bleach (74%), oven cleaner (78%), oral contraceptives (80%), and essential oils (81%) were least likely to be stored safely. Children's painkillers (69%), cough medicine (72%), and essential oils (77%) were least likely to be put away immediately after use. More than 50% of parents perceived antibiotics and oral contraceptives as harmful in small quantities and cough medicines as harmful only in large quantities. Six substances perceived by parents to be more harmful were more likely to be put away immediately after use. Parents perceiving dishwasher tablets (OR 1.96, 95% CI 1.05 to 3.66), essential oils (OR 2.80, 95% CI 1.35 to 5.81), turpentine (OR 14.54, 95% CI 2.75 to 76.95), and rat/ant killer (OR 15.33, 95% CI 2.01 to 116.82) as more harmful were more likely to store these substances safely., Conclusions: Parents' perceptions of toxicity of substances were sometimes inaccurate. Perceived toxicity was associated with putting substances away immediately after use for six substances and with safe storage for four substances. The effect of addressing perceptions of toxicity on poison prevention practices requires evaluation.

Purpose of Review: Clinical research has identified blood transfusion as an independent risk factor for immediate and long-term adverse outcomes, including an increased risk of death, myocardial infarction, stroke, renal failure, infection and malignancy. New findings have called into question the traditional assumptions clinicians utilize in evaluating the risks and benefits of blood transfusion. Appreciation of newly recognized risks is important for conserving scarce resources and optimizing patient outcomes., Recent Findings: Recent clinical outcomes research has examined the impact of blood transfusion on critically ill patients, trauma patients, patients undergoing cardiac surgery, patients experiencing acute coronary syndromes, oncology patients and others. These studies provide additional evidence of adverse outcomes associated with blood transfusion in a wide variety of clinical contexts., Summary: The benefits of blood transfusion have never been conclusively demonstrated, but evidence of transfusion-related harm continues to accumulate. Given the transfusion triggers that currently predominate in clinical practice it appears that clinical outcomes could improve significantly with more widespread adoption of restrictive transfusion strategies.

* Nearly half (43%) of surveyed hospitals in the first half of 2007 were not compliant with the standard requiring medications be properly and safely stored. * One of the top issues The Joint Commission sees is facilities not ensuring medications are stored acceptably for product stability. * Review occurrence reports with risk managers and ask frontline staff what procedures they find difficult.

Objective: To validate self-reported possession and storage of a range of substances within the home., Participants: 30 families with children aged 12-35 months on health visitor caseloads in Nottingham, UK., Methods: Self-reported possession and storage of potentially hazardous substances were validated by observations. Sensitivity, specificity, and predictive values were calculated for possession, storage, and exposure to substances., Results: Self-reported low exposure to substances had high sensitivities (87-100%) and positive predictive values (75-100%) for all substances, except toilet cleaner (positive predictive value 62%) and high negative predictive values for commonly owned household products. Specificity and negative predictive value could not be estimated reliably for medicines and less commonly owned household products, as few families stored these unsafely., Conclusions: A measurement of exposure that combines self-reported possession and storage may be sufficiently accurate to identify families with safer poison prevention practices.

Purpose: The chemical and physical stability of a flavored solution of acetylcysteine stored at room temperature or under refrigeration for up to 35 days in amber plastic prescription bottles were studied., Methods: The flavored acetylcysteine solution was prepared by adding a sweetener and a strawberry creamsicle flavoring to acetylcysteine solution 10% to a final nominal acetylcysteine concentration of 86.5 mg/mL. Six identical samples of the formulation were prepared in amber plastic prescription bottles. Three bottles were stored at room temperature (23-25 degrees C) and the other three were stored in the refrigerator (3-5 degrees C). Immediately after preparation and at 7, 14, 21, 28, and 35 days, each sample was assayed in duplicate by high- performance liquid chromatography. Stability was defined as the retention of at least 90% of the initial drug concentration., Results: On day 35, the refrigerated acetylcysteine samples retained 96.7% of their initial concentration. The samples stored at room temperature retained 92.5% of their initial concentration., Conclusion: A flavored oral formulation of acetylcysteine 86.5 mg/mL was stable for at least 35 days when stored at room temperature and in the refrigerator in amber plastic bottles.

Acute poisoning with medicines in Brazil has various causes, including a deficient national drug policy. The current study thus aimed to analyze socioeconomic variables, prescription characteristics, and forms of purchase or acquisition and storing of medicines by victims of acute unintentional poisoning. The data were collected during home visits to patients with a record of acute unintentional drug poisoning according to the Poison Control Center in Maringá, Paraná State, in 2004. The variables were related to the victim, the poisoning event, the product, and its household storage. For the 97 poisonings recorded during the study period, 72 families were interviewed, with the majority of the victims under 10 years of age (73.6%), males (54.2%), and from lower-income groups (63.9%). Many interviewees reported not having received information about the drug (76.5%). There was a significant association between lower-income status and inadequate drug storage (p < 0.05). A larger proportion of poisonings in higher-income families involved expired products (p < 0.05). Inadequate acquisition and storage of drugs may thus have facilitated the occurrence of poisonings.

An effective cold chain maintenance system is the backbone of success of any immunization program. This study compares the state of cold chain maintenance during intensive pulse polio immunization campaign in union territory of Chandigarh in the year 2001 with that of 2006. The study was conducted during pulse polio rounds of December 2001 and January 2002 and another in April and May 2006 by Department of Community Medicine, Govt. Medical College, Chandigarh. Data was collected from different levels of cold chain maintenance; OPV vials were also collected and sent for potency testing at Central Research Institute, Kasauli in all the rounds. Cold chain sickness rate has decreased from 9.8% in year 2001 to 6% in year 2006. Icepacks were neatly stacked in all the deep freezers (DF) and ice-lined refrigerators (ILR). 94.71% DF's & ILR's were defrosted periodically, 95.36% temperature charts were up-to-date and signed by supervisors and no day carriers were being used in 2006 round. Whereas in 2001, the periodicity of defrosting ILR & DFs was 76.9%, vaccines were stacked neatly in only 38.46% and day carriers were being used. All the randomly selected vaccine samples were reported potent.

Purpose: The stability of codeine phosphate in an extemporaneously compounded syrup is described., Methods: Codeine phosphate 3-mg/mL syrup was prepared using commercially available Codeine Phosphate, USP, Sterile Water for Irrigation, USP, and Ora-Sweet syrup vehicle. Samples were stored in amber polyethylene terephthalate bottles with child-resistant caps. A second batch of codeine phosphate 3-mg/mL syrup was prepared and drawn into amber polyethylene oral syringes with silicon elastomer tips. All samples were stored at room temperature and in the dark. Samples were analyzed immediately and at 7, 14, 28, 42, 56, 70, and 98 days. Codeine phosphate concentrations were measured using a modified stability-indicating high-performance liquid chromatographic method. At each test interval, the density of the syrup was determined gravimetrically using a 10-mL amber oral syringe. Excessive degradation was defined as a greater than 7% loss of the initial concentration., Results: The stock internal standard was stable for at least 98 days at room temperature. The compounded syrup retained more than 93% of the initial codeine phosphate concentration for at least 98 days at 22-25 degrees C. No changes in color, clarity, or odor and no visible solids or microbial growth were observed in any sample. The pH of the syrup was initially 4.2 and remained unchanged throughout the study., Conclusion: Codeine phosphate 3 mg/mL in Ora-Sweet syrup vehicle was stable in both amber polyethylene terephthalate bottles and amber polyethylene oral syringes for at least 98 days when stored at 22-25 degrees C and protected from light.

Purpose: The stability of a mixture of technetium Tc 99m sulfur colloid and lidocaine hydrochloride for up to eight hours was studied., Methods: Three vials of technetium Tc 99m sulfur colloid were compounded according to the manufacturer's instructions. From each of the three vials, five samples were withdrawn into syringes with needles: 0.4, 0.45, 0.5, 0.63, and 1 mCi for testing after storage for zero, one, two, four, and eight hours, respectively. Each syringe contained the customary patient dose of 0.4 mCi at the time of testing. Fresh 0.9% sodium chloride injection was used to bring the volume of each syringe to 0.2 mL, and 0.2 mL of lidocaine hydrochloride 1% was added to bring the final volume to 0.4 mL. Measurements of pH, radiochemical purity, and particle size were conducted after the indicated storage times for each group of samples., Results: The pH of samples showed no substantial change over the eight-hour storage period, with individual values in the range of 4.5-5.5. Radiochemical purity did not change substantially, with values ranging from 98.9% to 99.9%. There was no meaningful change in the amount of radioactivity retained by filtration and no increase in particle size., Conclusion: Adding lidocaine hydrochloride 1% to syringes containing technetium Tc 99m sulfur colloid and storing the syringes for up to eight hours had no effect on the pH or radiochemical purity of the mixture or on the radioactivity retained by a filter.

Purpose: To determine if there is a difference in the efficacy of refrigerated (previously reconstituted) versus freshly reconstituted botulinum toxin (Botox Cosmetic, Allergan, Irvine, CA, U.S.A.) in the treatment of lateral periorbital rhytids., Methods: This is a randomized, double-blind, controlled, prospective study. Participants included individuals who were interested in the treatment of their lateral periorbital rhytids (crow's feet) and responded to signs posted in ophthalmology clinics at our institution. Patients were randomized to receive fresh botulinum toxin on 1 side and refrigerated (reconstituted 2 weeks prior) botulinum toxin on the other. Photographs were taken at the pretreatment visit and at the 2-week, 6-week, and 3-month post-treatment visits. Patients were asked to describe any improvement in the appearance of the rhytids at the 2-week visit, the appearance of the rhytids at the 6-week visit, the appearance of the rhytids at the 3-month visit, and finally, the duration of effect at the 3-month visit as well as whether any intervening loss of efficacy had been noted subjectively. The subjective information was recorded by 1 investigator (JIH) at each of the follow-up visits. At the conclusion of the study, the photographs were shown to an ophthalmic plastic and reconstructive surgery fellow, who did not participate in the interventional portion of the study, to determine the response to treatment. This physician was masked to the study protocol and purpose and looked at each photograph without knowledge of treatment arm or timeline. The physician used the Wrinkle Assessment Scale developed by Lemperle et al. to grade the lateral periorbital rhytids on a 0 to 5 scale., Results: Forty-five patients were included in the final analysis. One patient felt there was a difference in the time of onset with the refrigerated toxin taking effect on day 3 versus day 4 for the fresh toxin. Unmasking revealed the following: 5 patients felt there was a greater effect on the freshly reconstituted side while 6 patients felt there was a greater effect on the refrigerated side. The independent physician evaluator determined there was a difference in effect between sides in 4 patients with the greater effect on the fresh side in 2 patients and the refrigerated side in 2 patients., Conclusions: This study demonstrates that 2 weeks of refrigeration does not appear to significantly affect the time of onset or efficacy of botulinum toxin in the treatment of lateral periorbital rhytids.

The aim of this study was to compare two preparations of recombinant human GH (rGH) in the treatment of GH deficient patients. Ten prepubertal GH-deficient children were followed during 6 months. They received injections with syringe for 3 months, followed by pen administration for the subsequent 3 months. Acceptability was evaluated through a questionnaire. Waste of medication was calculated by the difference between the number of used bottles or refills and the calculated amount for the period. Treatment response was evaluated by SDS gain of height measured each 3 months. After 6 months, 90% of patients/family members declared they preferred the pen regarding technical facility and local pain, and all patients considered the pen easier to transport and store. The waste of medication was lower with pen administration, as was the final cost. We concluded that pen-administered rGH treatment is more convenient, better accepted by the patients, and leads to less waste of medication when compared to the syringe administration.

It is required that shelf life be determined based on the lower limit of the confidence interval of the estimate from the stability tests. Simulations indicate that a 1-year prediction of shelf life will have approximately 1 month of error. However, this is product specific and is related to the uncertainty of measurement and experimental design. Factors associated with product and experimental design, such as degradation rate, number of time points, implementing a full versus a reduced design, etc., can significantly affect the error of shelf life. Uncertainty in measurement is positively correlated to the amount of error through the manufacturing lot-to-lot variability, precision of the analytical method and calibrator. Experimental design can control random variability and actually can reduce error by increasing number of lots and replicates in stability tests. The decision on the number of lots and replicates will be a balancing act between the uncertainty of the measurement, design and other practical considerations.

Purpose: Data regarding the recommended maximum duration that refrigerated medications available in hospital pharmacies may be stored safely at room temperature were collected and compiled in a tabular format., Methods: During May and June of 2006, the prescribing information for medications labeled for refrigeration as obtained from the supplier were reviewed for data addressing room-temperature storage. Telephone surveys of the products' manufacturers were conducted when this information was not available in the prescribing information. Medications were included in the review if they were labeled to be stored at 2-8 degrees C and purchased by the pharmacy department for uses indicated on the hospital formulary. Frozen antibiotics thawed in the refrigerator and extemporaneously compounded medications were excluded. Information was compiled and arranged in tabular format. The U.S. Pharmacopeia's definition of room temperature (20-25 degrees C [68-77 degrees F]) was used for this review., Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a refrigerator, 89 were present in the pharmacy department's refrigerator. Since six manufacturers were unable to provide information for 10 medications, only 79 medications were included in the review. This table may help to avoid unnecessary drug loss and expenditures due to improper storage temperatures., Conclusion: Information regarding the room-temperature storage of 79 medications labeled for refrigerated storage was compiled.

Purpose: In an effort to minimize barriers to compliance and adherence and to improve the accuracy of dosage measurement, sugar-containing and sugar-free sodium phenylbutyrate suspensions were formulated, and the stability of these products over a 90-day period was determined., Methods: An oral suspension of sodium phenylbutyrate 200 mg/mL was prepared by thoroughly grinding 12 g of Sodium Phenylbutyrate Powder, USP, in a glass mortar. Thirty milliliters of Ora-Plus and 30 mL of either Ora-Sweet or Ora-Sweet SF were mixed and added to the powder to make a final volume of 60 mL. Three identical samples of each formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and were stored at room temperature. A 500-microL sample was withdrawn from each of the six bottles with a micropipette immediately after preparation and at 7, 14, 28, 60, and 90 days. After further dilution to an expected concentration of 100 microg/mL with the mobile phase, the samples were assayed by high-performance liquid chromatography. Stability was defined as the retention of at least 90% of the initial concentration., Results: At least 95% of the initial sodium phenylbutyrate concentration remained throughout the 90-day study period in both preparations. There were no detectable changes in color, odor, taste, and pH and no visible microbial growth in any sample., Conclusion: Extemporaneously compounded suspensions of sodium phenylbutyrate, 200 mg/mL, in a 1:1 mixture of Ora-Plus and Ora-Sweet or Ora-Sweet SF were stable for at least 90 days when stored in 2-oz amber plastic bottles at room temperature.

Objective: A refrigerator-stable formulation of ProQuad has been developed to expand the utility of ProQuad to areas in which maintenance of a frozen cold chain (-15 degrees C or colder) during storage and transport may not be feasible. The objective of this study was to demonstrate that the immunogenicity and safety profiles of a refrigerator-stable formulation of ProQuad are similar to the recently licensed frozen formulation., Methods: In this double-blind, randomized, multicenter study, healthy 12- to 23-month-old children with negative vaccination and clinical histories for measles, mumps, rubella, varicella, and zoster were vaccinated with either the refrigerator-stable formulation of ProQuad (N = 1006) or the frozen formulation of ProQuad (N = 513). Patients were followed for 42 days after vaccination for adverse experiences. Immunogenicity was evaluated 6 weeks after vaccination., Results: The refrigerator-stable formulation of ProQuad was generally well tolerated. The incidence of adverse experiences was similar between groups. No vaccine-related serious adverse experiences were reported. For both groups, the response rate was > or = 97.7% for measles, mumps, and rubella, and the percentage of patients with a varicella zoster virus antibody titer of > or = 5 U/mL glycoprotein antigen-based enzyme-linked immunosorbent assay after vaccination was > or = 88.8%. The geometric mean titers for all antigens were numerically slightly higher in patients who received the refrigerator-stable formulation., Conclusions: The refrigerator-stable formulation of ProQuad is generally well tolerated, highly immunogenic, and noninferior in terms of postvaccination antibody responses. This refrigerator-stable formulation may improve ease of vaccine administration, increase use of the vaccine throughout the world because of its improved storage conditions, and replace the frozen formulation of ProQuad or any dose of M-M-RII and Varivax in routine practice.

Background: Deliberate self-poisoning by ingesting pesticides is a serious health problem among farmers, especially in low- and middle-income countries. Preventing these suicides is a priority for a public mental health agenda., Objective: To examine the role of pesticide poisoning in suicide and nonfatal deliberate self-harm, and clarify awareness of risks, safe practices concerning storage and use of pesticides, and associated self-injury, both unintentional and intentional, within farmer households of the Sundarban region, India., Methods: Retrospective record review of adult cases of deliberate self-poisoning at the Block Primary Health Centres of 13 Sundarban Blocks was performed to analyze the relative roles of various methods of self-harm and their lethality. Focus group discussions, questionnaires, and in-depth interviews were undertaken in a community study of farmer households to examine pesticide-related views and practices, with particular attention to storage, use, and health impact., Results: Pesticide poisoning was the most common method of deliberate self-harm in both men and women. Pesticide storage in most households was unsafe and knowledge was inadequate concerning adverse effects of pesticides on health, crops, and the environment., Conclusions: An intersectoral approach linking the interests of public health, mental health, and agriculture is well suited to serve the collective interests of all three agendas better than each in isolation. Such an approach is needed to reduce morbidity and mortality from unintentional and intentional self-injury in low-income agricultural communities like those of the Sundarban region.