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manufacturing problems. A glitch often means a facility has to close down because they don’t have extra capacity if there’s a problem. The generic manufacturing lines typically make many products on the same line, so a problem on one line can affect 20 products.” It is unclear how many patients have been harmed or died as a result. “There’s no system for tracking it”, Coopersmith notes. “It’s almost impossible, because frankly, shortages are always changing and varying.…It’s important that there be more formal studies on patient safety. Every one of us believes there are important issues for patient safety but there have been no broad-based studies of just how impactful it is.” Supplying code carts has been a “constant problem”, Carson is quick to note: epinephrine injection systems were in short supply, so code carts are stocked instead with multidose vials that must be measured during life-saving efforts.
“In the urgency and confusion of a code, you can imagine the potential for drug errors.” The costs to hospitals of drug shortages have been substantial, but are difficult to quantify precisely, experts say. Personnel costs are mounting, notes Carson. “The ordering and reordering and investigating what suppliers have, is a constant job for one of our senior pharmacists. Pharmacists have to constantly attend meetings to come up with creative workarounds to deal with the next shortage, or multiple shortages that occur simultaneously.” There are no easy solutions. “If it were simple, it would’ve been fixed already”, says Carson. The FDA can speed up approvals and inspections, encourage increased production, or extend expiration dates. “But they cannot require somebody to increase production or even continue production, or to disclose why there’s a shortage”, Coopersmith notes.
The FDA advocates improved transparency through the use of quality matrices for manufacturers, with which hospitals might make purchasing decisions that help to reduce the risk of supply disruptions. “ISPE is leading a data-driven approach, signing up 18 companies” for a pilot study to identify what metrics best predict the reliability of a manufacturing facility, Famulare says. A final report of the pilot project should be released in June, 2015. The FDA can allow importation of drugs produced abroad but that’s a stopgap, says Benjamin: “Importation is never a magic bullet because the US uses a tremendous number of drugs—think about the dialysis patient population alone; it gives manufacturers a chance to work harder to ramp up production.” Industry, not hospitals and regulators, must ultimately find solutions, Benjamin says. “The ball is in their court now.”
Bryant Furlow
The number of people dying from chronic obstructive pulmonary disease (COPD) in England and Wales has fallen in the past 6 years, but new data reveal that many aspects of care are still not good enough. The National COPD Clinical Audit report, commissioned by the Healthcare Quality Improvement Partnership and published by the Royal College of Surgeons, describes the care of 13 414 patients admitted to hospital for their COPD between Feb 1, and April 31, 2014. Positive improvements were noted since the previous audit was done in 2008, such as a fall in mortality from 7·8% to 4·3% in 2014, and a reduction in the median length of hospital stay from 5 to 4 days. However, the audit identified basic deficiencies in care around assessment, www.thelancet.com/respiratory Vol 3 March 2015
management of respiratory failure, and access to respiratory specialists. One in five patients were not seen by a respiratory expert at all during their hospital stay, an issue that occurred frequently at weekends. Only 47% of patients reported being seen by the respiratory team within 24 h of admission on Fridays, dropping to 39% for Saturday admissions. Only 51% of patients were under the care of a respiratory consultant at the time of discharge, and just 42% of patients received their care on a respiratory ward. Important diagnostic information was often poorly recorded, with records of spirometry findings available in only 46% of cases, compared with 54% in the 2008 audit. Hospitals were also reported to be missing an opportunity to offer smoking cessation advice to patients
with COPD, with only 58% of smokers receiving advice. Penny Woods, of the British Lung Foundation (London, UK), told The Lancet Respiratory Medicine that the number of patients not seen by a respiratory expert at all during their hospital stay was concerning. She said: “As the audit shows, COPD patients receive much better evidencebased care when they are seen by a respiratory specialist. All patients should be given this level of care within 24 h of admission, 7 days a week”. Woods added: “It is important that we enable those affected by COPD to self-manage their condition better— we would like to see the figures for patients being given smoking cessation advice improve significantly”.
Jim Varney/Science Photo Library
Basic deficiencies noted in COPD care in England and Wales
Published Online February 11, 2015 http://dx.doi.org/10.1016/ S2213-2600(15)00046-6 For the National COPD Clinical Audit report see https://www. rcplondon.ac.uk/projects/ national-copd-auditprogramme-starting-2013 For more on COPD care in the UK see Editorial Lancet Respir Med 2015; 3: 1
Sanjay Tanday 183
manufacturing problems. A glitch often means a facility has to close down because they don’t have extra capacity if there’s a problem. The generic manufacturing lines typically make many products on the same line, so a problem on one line can affect 20 products.” It is unclear how many patients have been harmed or died as a result. “There’s no system for tracking it”, Coopersmith notes. “It’s almost impossible, because frankly, shortages are always changing and varying.…It’s important that there be more formal studies on patient safety. Every one of us believes there are important issues for patient safety but there have been no broad-based studies of just how impactful it is.” Supplying code carts has been a “constant problem”, Carson is quick to note: epinephrine injection systems were in short supply, so code carts are stocked instead with multidose vials that must be measured during life-saving efforts.
“In the urgency and confusion of a code, you can imagine the potential for drug errors.” The costs to hospitals of drug shortages have been substantial, but are difficult to quantify precisely, experts say. Personnel costs are mounting, notes Carson. “The ordering and reordering and investigating what suppliers have, is a constant job for one of our senior pharmacists. Pharmacists have to constantly attend meetings to come up with creative workarounds to deal with the next shortage, or multiple shortages that occur simultaneously.” There are no easy solutions. “If it were simple, it would’ve been fixed already”, says Carson. The FDA can speed up approvals and inspections, encourage increased production, or extend expiration dates. “But they cannot require somebody to increase production or even continue production, or to disclose why there’s a shortage”, Coopersmith notes.
The FDA advocates improved transparency through the use of quality matrices for manufacturers, with which hospitals might make purchasing decisions that help to reduce the risk of supply disruptions. “ISPE is leading a data-driven approach, signing up 18 companies” for a pilot study to identify what metrics best predict the reliability of a manufacturing facility, Famulare says. A final report of the pilot project should be released in June, 2015. The FDA can allow importation of drugs produced abroad but that’s a stopgap, says Benjamin: “Importation is never a magic bullet because the US uses a tremendous number of drugs—think about the dialysis patient population alone; it gives manufacturers a chance to work harder to ramp up production.” Industry, not hospitals and regulators, must ultimately find solutions, Benjamin says. “The ball is in their court now.”
Bryant Furlow
The number of people dying from chronic obstructive pulmonary disease (COPD) in England and Wales has fallen in the past 6 years, but new data reveal that many aspects of care are still not good enough. The National COPD Clinical Audit report, commissioned by the Healthcare Quality Improvement Partnership and published by the Royal College of Surgeons, describes the care of 13 414 patients admitted to hospital for their COPD between Feb 1, and April 31, 2014. Positive improvements were noted since the previous audit was done in 2008, such as a fall in mortality from 7·8% to 4·3% in 2014, and a reduction in the median length of hospital stay from 5 to 4 days. However, the audit identified basic deficiencies in care around assessment, www.thelancet.com/respiratory Vol 3 March 2015
management of respiratory failure, and access to respiratory specialists. One in five patients were not seen by a respiratory expert at all during their hospital stay, an issue that occurred frequently at weekends. Only 47% of patients reported being seen by the respiratory team within 24 h of admission on Fridays, dropping to 39% for Saturday admissions. Only 51% of patients were under the care of a respiratory consultant at the time of discharge, and just 42% of patients received their care on a respiratory ward. Important diagnostic information was often poorly recorded, with records of spirometry findings available in only 46% of cases, compared with 54% in the 2008 audit. Hospitals were also reported to be missing an opportunity to offer smoking cessation advice to patients
with COPD, with only 58% of smokers receiving advice. Penny Woods, of the British Lung Foundation (London, UK), told The Lancet Respiratory Medicine that the number of patients not seen by a respiratory expert at all during their hospital stay was concerning. She said: “As the audit shows, COPD patients receive much better evidencebased care when they are seen by a respiratory specialist. All patients should be given this level of care within 24 h of admission, 7 days a week”. Woods added: “It is important that we enable those affected by COPD to self-manage their condition better— we would like to see the figures for patients being given smoking cessation advice improve significantly”.
Jim Varney/Science Photo Library
Basic deficiencies noted in COPD care in England and Wales
Published Online February 11, 2015 http://dx.doi.org/10.1016/ S2213-2600(15)00046-6 For the National COPD Clinical Audit report see https://www. rcplondon.ac.uk/projects/ national-copd-auditprogramme-starting-2013 For more on COPD care in the UK see Editorial Lancet Respir Med 2015; 3: 1
Sanjay Tanday 183
