Experts issue 'blueprint for action' to combat shortages of life-saving drugs

February 3, 2014, Johns Hopkins University School of Medicine

A group of prominent healthcare experts including bioethicists, pharmacists, policymakers and cancer specialists have proposed concrete steps for preventing and managing a nightmare scenario that is becoming all too common: shortages of life-saving drugs.

In a consensus statement published in the journal Pediatrics, the experts say they sought to move away from the current strategy of reaction to shortages once they have occurred and focus instead on prevention. Using the example of shortages of used for treating children with cancer—therapies proven to have high survival rates for the most common childhood cancers—the group developed "a comprehensive blueprint for action" they say is critical for managing and preventing future drug shortages.

"Although our recommendations were developed with pediatric oncology in mind, and serve as a blueprint for preventing children with cancer from lacking access to essential life-saving medications, we believe that they apply more broadly across medicine to include pediatrics and adult medicine in general," says Yoram Unguru, a pediatric hematologist/oncologist at the Herman and Walter Samuelson Children's Hospital at Sinai and faculty member at the Johns Hopkins Berman Institute of Bioethics. Unguru, a coauthor of the consensus statement, was the principal organizer of meetings that led to its creation, bringing together representatives from the Food and Drug Administration (FDA), leadership of the Children's Oncology Group and The American Society of Pediatric Hematology/Oncology, patient advocacy groups, legal scholars and clinicians.

Some recommendations would represent new norms for healthcare practice, including the sharing of scarce drugs between healthcare institutions and not giving preferential access to patients participating in research studies.

"This statement is significant both for the consensus found by such a diverse group of experts, and for being the first to take seriously the ethical rationale to prevent shortages in the first place," says Matthew DeCamp, a Johns Hopkins professor at the Berman Institute of Bioethics and Division of General Internal Medicine, and lead author of the .

Included in the statement's six recommendations is a call to develop policies that give equal priority to patients regardless of whether they are participants in research. The authors acknowledge this "may be controversial," due to the sentiment that fairness requires giving research participants high-priority access to drugs because of their contribution to medical knowledge and future patients. However, the statement's authors explain that "concerns over undue inducement, public perception, and the imperative to use drugs for indications for which evidence of benefit exists outweigh arguments for giving priority access to research participants."

For each recommendation the statement also includes potential barriers to its implementation. A centralized information source of drug supply information, for instance, faces the risk that such information will encourage hoarding of existing supplies, including so-called "gray market" suppliers that sell scarce drugs for inflated prices. The statement calls for new policies for both reporting and avoiding these markets, though acknowledges the temptation of healthcare providers to use them in a shortage, when their patients are in need.

The authors also note the marketplace economy as an obstacle to implementing their recommendations and preventing drug shortages. Drug manufacturers do not like to disclose manufacturing problems that lead to shortages, nor are competitive healthcare institutions accustomed to cooperating to share resources. Nonetheless, the statement calls for an exploration of "ways to facilitate interinstitutional and interstate transfer of drugs, especially during shortages," as well as the ethical obligation to patients inside vs. outside a healthcare institution when there is a drug shortage.

"The reasons for are complex, but we must not lose sight of the fact that without access to these life-saving drugs, children and adults with cancer will almost certainly die," Unguru says. "It is untenable for this situation to continue any longer. We have a clear moral obligation to act to address this critical issue."

Explore further: Newly published survey shows drug shortages still have major impact on patient care

Related Stories

Newly published survey shows drug shortages still have major impact on patient care

January 9, 2014
According to newly published results from a survey of pharmacy directors, drug shortages remain a serious problem for patient safety. Nearly half of the responding directors reported adverse events at their facilities due ...

Most oncologists experience chemotherapy drug shortages

December 19, 2013
(HealthDay)—Four out of five doctors who treat cancer were unable to prescribe their medication of choice at least once during a six-month period because of a drug shortage, according to a new survey.

FDA enlists companies to head off drug shortages

October 31, 2013
The Food and Drug Administration is announcing a new proposal designed to head off more shortages of crucial medications that have disrupted care at hospitals and health clinics nationwide.

Cancer drug shortages mean higher costs and greater risk for patients

March 21, 2013
A national survey of health professionals showed that drug shortages are taking a heavy toll on cancer patients, forcing treatment changes and delays that for some patients meant worse outcomes, more therapy-related complications ...

Canada needs national approach to protect against drug shortages

August 20, 2012
Canada needs a national approach to managing its supply of pharmaceutical drugs, starting with a mandatory reporting system for drug shortages, argues an editorial in CMAJ (Canadian Medical Association Journal) and CPJ (Canadian ...

Drug shortage linked to greater risk of relapse in young Hodgkin lymphoma patients

December 26, 2012
A national drug shortage has been linked to a higher rate of relapse among children, teenagers and young adults with Hodgkin lymphoma enrolled in a national clinical trial, according to research led by St. Jude Children's ...

Recommended for you

Baby brains help infants figure it out before they try it out

January 17, 2018
Babies often amaze their parents when they seemingly learn new skills overnight—how to walk, for example. But their brains were probably prepping for those tasks long before their first steps occurred, according to researchers.

NeuroNext biomarker study explores natural history of infantile-onset SMA

January 9, 2018
Research led by The Ohio State University Wexner Medical Center to define the natural history of infantile-onset spinal muscular atrophy (SMA) has been "critical" to accelerate the development of effective therapies and hasten ...

No link between childhood lead levels, later criminality

December 27, 2017
(HealthDay)— Exposure to higher levels of lead during early childhood can affect neurological development—but does that mean affected kids are doomed to delinquency?

Early puberty in girls may take mental health toll

December 26, 2017
(HealthDay)—A girl who gets her first menstrual period early in life—possibly as young as 7—has a greater risk for developing depression and antisocial behaviors that last at least into her 20s, a new study suggests.

Technology not taking over children's lives despite screen-time increase

December 21, 2017
With children spending increasing amounts of time on screen-based devices, there is a common perception that technology is taking over their lives, to the detriment and exclusion of other activities. However, new Oxford University ...

Higher blood sugar in early pregnancy raises baby's heart-defect risk

December 15, 2017
Higher blood sugar early in pregnancy raises the baby's risk of a congenital heart defect, even among mothers who do not have diabetes, according to a study led by researchers at the Stanford University School of Medicine.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.