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Published on 16 October 2015

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Belgian experiences with drug shortages

 

 

Drug shortages remain a time-consuming issue for (Belgian) hospital pharmacists, however as long as pharmacists find good alternative treatments, clinical impact on patients seems minimal
Elfi De Weerdt
Kim Pauwels
Steven Simoens
Isabelle Huys
KU Leuven Department of Pharmaceutical and Pharmacological Sciences,
Herestraat 49, Box 521, 3000 Leuven, Belgium
Email: Elfi.deweerdt@pharm.kuleuven.be
In the past few years, drug shortages have been a daily reality in hospital pharmacies.1 The causes of drug shortages are multi-factorial, for example, quality-related causes are often associated with economic decisions.2 Whatever the cause, all stakeholders (patients, healthcare providers, pharmaceutical companies and national authorities) encounter disadvantages of drug shortages.
Pharmacists and medical doctors try to minimise the clinical and economic impact of drug shortages by searching for the best alternative treatment possible.3,4 In the best case scenario, the presence of generic medicines can minimise the clinical impact, but still the use of a generic medicine can be inconvenient for patients.5 In the worst case scenario (i) there is no alternative available, (ii) the drug requires a specific dosage form or (iii) the active pharmaceutical ingredient (API) of the drug has a small therapeutic window or a non-linear kinetic.5 In these examples, drug shortages can have severe consequences for patients.
Different factors contribute to the economic impact of drug shortages. Higher costs of the medication, longer duration of hospitalisation, treatment of adverse drug events, etc. are just a few examples of potential factors that might contribute to a financial burden on patients, hospitals and other healthcare providers.6,7 Additionally, hospital pharmacists spend a lot of time on drug shortages, which could otherwise be used to improve patient care. Searching for alternative treatments, informing other healthcare providers, changing stocks, etc. are just a few examples of time-consuming tasks for hospital pharmacists.7
In 2013, Hospital Pharmacy Europe in collaboration with KU Leuven carried out an online survey investigating the characteristics, clinical and economic impact, and management of drug shortages in European hospital pharmacies.7 This article aims to describe a Belgian study on drug shortages and compares the Belgian responses with the European responses of the Hospital Pharmacy Europe survey. The Belgian study is based on the work of five pharmacy students in the context of their Master’s theses.8
Methods
In the Belgian study, medical doctors and pharmacists were questioned separately through two online surveys. Both surveys included 23 questions querying the background and the experiences of the participants with drug shortages, perceived causes of drug shortages, the clinical and economic impact of drug shortages and communication channels to obtain information about drugs in short supply. Though clinical and economic impact were questioned in both surveys, the hospital pharmacist questionnaire focused more on the economic impact of drug shortages, while the medical doctor questionnaire was more concentrated on the clinical impact. Results were collected between 20 November 2014 and 31 March 2015. The results were compared with the results of a European survey of hospital pharmacists distributed by Hospital Pharmacy Europe.7 Data were analysed using descriptive statistics.
Results
In total, 236 hospital pharmacists started the Belgian survey, of which 65 pharmacists correctly filled in the survey. The survey for medical doctors was initiated by 141 respondents, of which 49 medical doctors completed the survey and thus were included for analysis. The majority of the participants (pharmacists as well as medical doctors) worked in general hospitals.
Most hospital pharmacists indicated to be confronted with drug shortages on a daily (40%) or weekly (57%) basis, only 3% were confronted monthly. Medical doctors on the other hand are less frequently exposed to drug shortages according to this survey; only 4% were confronted daily with drug shortages. Only 25% were confronted weekly and the majority (71%) pointed out that they were subjected monthly or yearly to drug shortages. The reason why hospital pharmacists are more often exposed to drug shortages is probably because hospital pharmacists are responsible for a broader range of medicines compared to medical doctors.
Belgian medical doctors as well as hospital pharmacists agree that mostly originator drugs (75%) are affected by drug shortages. This differs with the results of the Hospital Pharmacy Europe survey, which demonstrates that mainly generic medicines are affected by shortages.7 The difference between the two surveys might be explained by differences in the generic market share; for example, Belgium has one of the smallest generic markets compared with other European countries.7 The ratio of market share of generic and originator medicines is determined by national policies.
Respondents were asked for their opinions about the main causes of drug shortages. Although the sequence between the Belgian hospital pharmacists and medical doctors is slightly different, both agree that quality problems and manufacturing problems are main causes of drug shortages, together with market withdrawal of drugs (Figure 1 and Figure 2). Manufacturing problems were also indicated as the main cause of drug shortages at European level.7 Even though hospital pharmacists and medical doctors suggest the same main causes for drug shortages (this is also experienced at European level), at this moment, only manufacturers are aware of the true causes of drug shortages.
Information about drug shortages is obtained through different channels, more than 90% of the Belgian hospital pharmacists indicated “manufacturers” as their main source of information about drug shortages (Figure 3). Other useful sources were other “hospitals”, “websites of the Federal Agency of Medicines and Health Products” or the “Flemish Society of Hospital Pharmacists”. On the question  aboutwhen they are informed, 89% of the hospital pharmacists specified that they are informed at the point of no delivery, while 11% were informed in advance. Similar results were also observed at European level, where 92% indicated to be informed at the time of no delivery by the manufacturer or the wholesaler.7 Apparently, medical doctors are often warned via “other healthcare providers”, because 45% of the medical doctors indicated that they are informed in advance. Other important sources of information for medical doctors are “manufacturers” and “websites of national authorities” (Figure 4).
When questioning the clinical impact, small differences were observed between the answers of the hospital pharmacists (Figure 5) and medical doctors (Figure 6). Both agree on the fact that for a drug in shortage and where a drug with the same API is available, the availability of different strengths might endanger patients’ safety. Different dosage forms is the second most dangerous condition for patients. Hospital pharmacists complete their top three with “communication about the changes between healthcare providers”, while medical doctors believe “different manufacturers” might threaten patients’ safety.
However, when there is no medicine with the same API on the market for the drug in short supply, pharmacists and doctors agree that patients’ safety is in the most danger when no alternative is available. Dosing differences (dosage forms, different strengths, etc.) and communication about the changes to other healthcare providers are two other risk factors according to hospital pharmacists (Figure 7). After dosing differences, medical doctors believe sound-alike look-alike medicines are of higher risk to patients’ safety (Figure 8).
Time spent by pharmacists on drug shortages is one of the aspects that contribute to the economic impact of drug shortages. Identifying and purchasing alternative treatments together with changing stocks in the pharmacy and departments demand the most time, according to Belgian hospital pharmacists (Figure 9). The same stages of managing drug shortages were identified as time consuming at European level.7 Patients’ budget is a second aspect of the economic impact of drug shortages and is, according to 65% of the Belgian hospital pharmacists, affected by drug shortages. Fourteen percent believed the opposite and 21% abstained. Everyone who indicated that patients’ budgets are affected, agreed that patients will have to pay for a more expensive treatment.
Conclusions
Drug shortages remain an important problem for hospital pharmacists in Belgium and Europe. Most hospital pharmacists are confronted weekly with drug shortages and spend a lot of time searching for and purchasing alternative treatments. As long as a treatment is available with the same API, healthcare providers should pay attention to administering the right dose of medication because the availability of different doses is an important hazard for patients’ safety. However, for some drug shortages no alternative treatments exist and this will have an enormous impact on patient care. Drug shortages can also lead to higher costs for the patient, as the alternative treatment is often more expensive. Currently, Belgian as well as European hospital pharmacists are notified too late, namely at the time of no delivery. Hospital pharmacists can provide better healthcare when they are informed about drug shortages in good time, therefore actions should be taken to improve this communication. Belgian medical doctors seem to experience less problems with drug shortages.
Key points
  • Drug shortages remain an important problem for hospital pharmacists.
  • Medical doctors experience less problems with drug shortages.
  • When no alternative drug exist, the impact on patient care might be enormous.
  • The time of notification of drug shortages is too late.
  • Improved communication about drug shortages is necessary.
Acknowledgements
The authors would like to thank S Coppens, E Creemers, M Nysten, E Schotsmans and N Vantilt for their contribution to the study design, data collection and analysis of results. We are also indebted to the pharmacists and medical doctors who participated in the Belgian survey.
References
  1. European Association of Hospital Pharmacists. Medicines Shortages in European Hospitals – The evidence and case for action. 2014.
  2. De Weerdt E et al. Causes of drug shortages in the legal pharmaceutical framework. Regul Toxicol Pharmacol 2015;71(2):251–8.
  3. Bible JR et al. Impact of drug shortages on patients receiving parenteral nutrition after laparotomy. JPEN J Parenter Enteral Nutr 2014;38(Suppl 2):65S–71S.
  4. Kaakeh R et al. Impact of drug shortages on U.S. health systems. Am J Health Syst Pharm 2011;68(19):1811–9.
  5. Schippers EI. Impact van geneesmiddelentekorten voor patiënten. 2013.
  6. Havrilesky LJ et al. Economic impact of paclitaxel shortage in patients with newly diagnosed ovarian cancer. Gynecol Oncol 2012;125(3):631–4.
  7. Pauwels K et al. Insights into European drug shortages: a survey of hospital pharmacists. PLoS One 2015;10(3):e0119322.
  8. Coppens S et al. Geneesmiddelentekorten in ziekenhuizen: ziekenhuisapothekers en artsen. KU Leuven; 2015.


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