The majority of patients do not store their biologic disease-modifying antirheumatic drugs within the recommended temperature range

OBJECTIVE: To monitor whether biologic DMARD (bDMARD) home storage temperatures comply with the manufacturers' Summary of Product Characteristics (SmPC) recommendations. METHODS: This observational study included consenting adult patients from eight Dutch pharmacies who received their bDMARDs with a validated temperature logger. Patients were instructed to store their packages according to standard label instructions and to return the temperature logger(s) after use. Primary outcome was defined as the proportion of patients that stored their bDMARDs within the SmPC recommended temperature range. In addition, the proportion of patients storing bDMARDs below 0°C or above 25 °C for longer than two consecutive hours was estimated. RESULTS: A total of 255 (87.0%) patients (mean age 53.2 (s.d.; 13.1) years, 51.4% female) returned their temperature logger(s) to the pharmacy. Of these, 17 patients (6.7%) stored their bDMARD within the recommended temperature range. The proportion of the patients that stored their bDMARD for more than 2 h consecutive time below 0°C or above 25°C was respectively 24.3% (median duration: 3.7 h (IQR 2.2 h; range 2.0-1,097.1 h) and 2.0% (median duration: 11.8 h (IQR 44.3 h; range 2.0-381.9 h). CONCLUSION: The majority of patients do not store their bDMARDs within the SmPC-recommended temperature range

Patient compliance with drug storage recommendations

Background: Elderly patients are often treated with many different drugs which can result in difficulties with adequate drug management and safe storage at home. Objectives: We aim to investigate to what extent elderly patients store drugs according to the drug product storage recommendations. Methods: Patients (≥65 years of age) were invited to participate and visited at home by their community pharmacist when consenting. Drugs were considered properly stored when all of the following criteria were fulfilled: 1) storage according to drug product label storage recommendations for temperature, light, humidity; 2) expiry date not passed; 3) in the original and intact package; 4) drug product insert or information leaflet present. A multivariate logistic regression model was used to assess the associations between non-compliance with storage conditions, number of drugs stored at home and storage locations. Results: 170 patients (53.5% female, mean age 74.9 [SD 7.3]) were included in the study. Patients' compliance with drug storage criteria could be assessed in 160 (94.1%) patients and 36.9% complied with all storage criteria [compliance with criterion 1) 64.4%; 2) 82.5%; 3) 83.8%; 4) 69.4%]. Non-compliance with one or more storage criteria was associated with having multiple drugs [≥10 drugs (ORadj) = 9.0; 95% CI:(2.6, 30.7)] and having three or more storage locations at home [(ORadj) = 4.4; 95% CI:(1.2, 16.0)]. Conclusions: Elderly patients using multiple drugs and having multiple storage locations do often not store drugs according to storage recommendations and could use advice from pharmacists to store drugs at home more adequately

Actual versus recommended storage temperatures of oral anticancer medicines at patients' homes

Background Substantial quantities of unused medicines are returned by patients to the pharmacy each year. Redispensing these medicines would reduce medicinal waste and health care costs. However, it is not known if medicines are stored by patients as recommended in the product label. Inadequate storage may negatively affect the medicine and reduce clinical efficacy whilst increasing the risk for side effects. Objective To investigate the proportion of patients storing oral anticancer medicines according to the temperature instructions in the product label. Methods Consenting adult patients from six Dutch outpatient hospital pharmacies were included in this study if they used an oral anticancer medicine during February 2014 - January 2015. Home storage temperatures were assessed by inclusion of a temperature logger in the original cancer medicines packaging. The primary outcome was the proportion of patients storing oral anticancer medicines as specified in the Summary of Product Characteristics, either by recalculating the observed temperature fluctuations to a single mean kinetic temperature or by following the temperature instructions taking into account a consecutive 24-h tolerance period. Results Ninety (81.1%) of the 111 included patients (47.8% female, mean age 65.2 (SD: 11.1)) returned their temperature loggers to the pharmacy. None of the patients stored oral anticancer medicines at a mean kinetic temperature above 25℃, one patient stored a medicine requiring storage below 25℃ longer than 24 h above 25℃. None of the patients using medicines requiring storage below 30℃ kept their medicine above 30℃ for a consecutive period of 24 h or longer. Conclusion The majority of patients using oral anticancer medicines store their medicines according to the temperature requirements on the product label claim. Based on our results, most oral anticancer medicines will not be negatively affected by temperature conditions at patients' homes for a maximum of three months and are likely to be suitable for redispensing

The Impact of Inadequate Temperature Storage Conditions on Aggregate and Particle Formation in Drugs Containing Tumor Necrosis Factor-Alpha Inhibitors

Purpose: To measure aggregate and particle formation in tumor necrosis factor-alpha (TNF-α) inhibitors etanercept, adalimumab and certolizumab pegol product samples after exposure to freezing temperature conditions similar to storage conditions previously observed in patients’ homes. Methods: TNF-α inhibitors in their original primary and secondary packaging were exposed to 32 freeze-thaw cycles (−10°C for 120min/5°C for 60 min) or continuous low storage temperature (−20°C for 96 h) before thawing at 2–8°C. Non-stressed products were used as controls. The products were analyzed by high pressure size exclusion chromatography (HP-SEC), dynamic light scattering (DLS), nanoparticle tracking analysis (NTA), micro-flow imaging (MFI) and second derivative ultraviolet (UV) spectroscopy. Results: Ten out of twenty-one stressed product samples (47.6%) showed increased particle numbers in the submicron and micron size range when compared to controls. For each product, DLS, MFI and NTA detected an increase in particle level in at least one stressed syringe (both continuous freezing and freeze-thaw), whereas HP-SEC and UV spectroscopy showed no differences between stressed and non-stressed products. Conclusion: TNF-α inhibitors are relatively resistant to freezing temperatures similar to storage conditions previously observed in patients’ homes. However, almost half of the stressed product samples showed formation of particles in the submicron and micron size range

Actual versus recommended storage temperatures of oral anticancer medicines at patients' homes

Background Substantial quantities of unused medicines are returned by patients to the pharmacy each year. Redispensing these medicines would reduce medicinal waste and health care costs. However, it is not known if medicines are stored by patients as recommended in the product label. Inadequate storage may negatively affect the medicine and reduce clinical efficacy whilst increasing the risk for side effects. Objective To investigate the proportion of patients storing oral anticancer medicines according to the temperature instructions in the product label. Methods Consenting adult patients from six Dutch outpatient hospital pharmacies were included in this study if they used an oral anticancer medicine during February 2014 - January 2015. Home storage temperatures were assessed by inclusion of a temperature logger in the original cancer medicines packaging. The primary outcome was the proportion of patients storing oral anticancer medicines as specified in the Summary of Product Characteristics, either by recalculating the observed temperature fluctuations to a single mean kinetic temperature or by following the temperature instructions taking into account a consecutive 24-h tolerance period. Results Ninety (81.1%) of the 111 included patients (47.8% female, mean age 65.2 (SD: 11.1)) returned their temperature loggers to the pharmacy. None of the patients stored oral anticancer medicines at a mean kinetic temperature above 25℃, one patient stored a medicine requiring storage below 25℃ longer than 24 h above 25℃. None of the patients using medicines requiring storage below 30℃ kept their medicine above 30℃ for a consecutive period of 24 h or longer. Conclusion The majority of patients using oral anticancer medicines store their medicines according to the temperature requirements on the product label claim. Based on our results, most oral anticancer medicines will not be negatively affected by temperature conditions at patients' homes for a maximum of three months and are likely to be suitable for redispensing

Older Patients’ Compliance with Drug Storage Recommendations

Background: Whereas storage conditions are regulated and closely monitored in every stage of the drug supply chain before drug dispensing, it is unknown if patients store drugs at home according to storage recommendations. Objective: The objective of this study was to investigate how older patients store their prescription drugs at home and to what extent they comply with drug storage recommendations. Methods: We conducted a cross-sectional study between October 2015 and March 2016. Forty-four participating Dutch community pharmacies selected four home-dwelling patients (aged ≥ 65 years) using at least one prescription drug. A complete drug inventory at patients’ homes was performed. Drugs were considered to fulfill the storage recommendation when these met all drug quality (Q) and information (I) criteria: adequately stored according to drug product label storage recommendations for temperature, light, humidity (Q1); expiry date not passed (Q2); integer primary package (Q3); drug identifiability (I1); drug package insert or information leaflet availability (I2). Results: One hundred and seventy patients [53.5% female, mean age 74.9 (standard deviation 7.3) years] were included and 1133 prescription drugs stored at home were registered. More than half of the patients (51.2%) complied with all storage quality and information criteria. Assessment of the individual criteria showed that 76.4% of patients were compliant with criterion Q1 while 90.6, 95.3, 97.1 and 71.2% of patients complied with criteria Q2, Q3, I1 and I2, respectively. 53.2% of drugs that should be kept refrigerated according to storage criterion Q1 were not stored between 2 and 8 °C. Conclusion: This study illustrates that more than half of the older patients comply with general drug storage recommendations

The majority of patients do not store their biologic disease-modifying antirheumatic drugs within the recommended temperature range

OBJECTIVE: To monitor whether biologic DMARD (bDMARD) home storage temperatures comply with the manufacturers' Summary of Product Characteristics (SmPC) recommendations. METHODS: This observational study included consenting adult patients from eight Dutch pharmacies who received their bDMARDs with a validated temperature logger. Patients were instructed to store their packages according to standard label instructions and to return the temperature logger(s) after use. Primary outcome was defined as the proportion of patients that stored their bDMARDs within the SmPC recommended temperature range. In addition, the proportion of patients storing bDMARDs below 0°C or above 25 °C for longer than two consecutive hours was estimated. RESULTS: A total of 255 (87.0%) patients (mean age 53.2 (s.d.; 13.1) years, 51.4% female) returned their temperature logger(s) to the pharmacy. Of these, 17 patients (6.7%) stored their bDMARD within the recommended temperature range. The proportion of the patients that stored their bDMARD for more than 2 h consecutive time below 0°C or above 25°C was respectively 24.3% (median duration: 3.7 h (IQR 2.2 h; range 2.0-1,097.1 h) and 2.0% (median duration: 11.8 h (IQR 44.3 h; range 2.0-381.9 h). CONCLUSION: The majority of patients do not store their bDMARDs within the SmPC-recommended temperature range