Drug Shortages and Implications for Pediatric Patients

Abstract

Drug shortages in the United States continue to be a significant problem that negatively impacts pediatric patients of all ages. These shortages have been associated with a higher rate of relapse among children with cancer, substitution of less effective agents, and greater risk for short- and long-term toxicity. Effective prevention and management of any drug shortage must include considerations for issues specific to pediatric patients; hence, the Pediatric Pharmacy Advocacy Group (PPAG) strongly supports the effective management of shortages by institutions caring for pediatric patients. Recommendations published by groups such as the American Society of Health-System Pharmacists and the American Society for Parenteral and Enteral Nutrition should be incorporated into drug shortage management policies. PPAG also supports the efforts of the Food and Drug Administration (FDA) to not only address but prevent drug shortages caused by manufacturing and quality problems, delays in production, and discontinuations. Prevention, mitigation, and effective management of drug shortages pose significant challenges that require effective communication; hence, PPAG encourages enhanced and early dialogue between the FDA, pharmaceutical manufacturers, professional organizations, and health care institutions.

A challenge for healthcare but just another opportunity for illegitimate online sellers: Dubious market of shortage oncology drugs

“…For drugs in short supply, providers and hospitals search beyond conventional sources to obtain the medications. Thus, shortages of key medicines have created opportunities for illegitimate traders for price markups, while also increasing the chance of infiltration of counterfeits to the market [ 82 , 83 ].…”

“…Healthcare systems, institutions and patients are facing new challenges with the increasing number of shortage drugs [ 82 , 84 , 85 , 91 , 92 – 98 ] and the possibilities of purchasing medicines outside the traditional drug-supply-chain [ 46 ]. Currently international legislation and national authorities cannot guarantee continuous drug supply in several therapeutic areas affected by shortages and also the effective measures assuring safe internet sale of pharmaceuticals are still lacking.…”

“…Currently international legislation and national authorities cannot guarantee continuous drug supply in several therapeutic areas affected by shortages and also the effective measures assuring safe internet sale of pharmaceuticals are still lacking. However, these problems are strongly related as the unavailability of medications, especially in the case of life saving therapies, can be a driving factor to procure pharmaceuticals from online vendors [ 82 , 86 ]. Health institutions, clinicians and pharmacists may not be aware that patients can buy drugs from uncertain and illegitimate sources and these products are likely to influence the success of therapies [ 51 ].…”

Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries

“…Despite this, and surprisingly, in the second decade of the twenty-first century, shortages of pharmaceuticals have increasingly become an issue in many countries for a number of reasons. Drug shortages has been the focus of academic and practitioner research, initially in the USA and Canada, but subsequently in a number of European countries and other continents (Morrison, 2011 ; Ventola, 2011 ; Birgli, 2013 ; McBride et al, 2013 ; Costelloe et al, 2014 ; Goldsack et al, 2014 ; Bogaert et al, 2015 ; Butterfield et al, 2015 ; De Weerdt et al, 2015b , 2017b ; Pauwels et al, 2015 ; Alsheikh et al, 2016 ; Awad et al, 2016 ; Yang et al, 2016 ; Heiskanen et al, 2017 ; Mazer-Amirshahi et al, 2017 ; Walker et al, 2017 ). Some medicines are simply not available on the market in certain countries, even if there is sufficient money to pay for them.…”

Physician approaches to drug shortages: Results of a national survey of pediatric hematologist/oncologists

“…In addition, chemotherapy medications often have no equivalent for substitution, whereas other drugs may have several alternatives within a medication class[ 5 ]. Unique issues arise when dealing with drug shortages in pediatric oncology due to the increased use of off-label drugs in pediatrics compared to adult medicine and dosing based on weight and size[ 2 , 3 , 7 , 14 ]. In addition, pediatric patients have surrogate decision makers, usually parents, determining the child’s best interest in a situation in which no alternative may be ideal.…”