Drug shortages may compromise patient safety: Results of a survey of the reference pharmacies of the Drug Commission of German Pharmacists.

Drug shortages are a complex problem and of growing concern. To evaluate implications of drug shortages in terms of outpatient and inpatient safety, the Drug Commission of German Pharmacists surveyed its two nationwide reference pharmacy networks: 865 community and 54 hospital pharmacies. Participants were asked to complete a six-question online survey, covering relevance and challenges of drug shortages in everyday practice as well as consequences for patient safety. Answers were given in the context of the last three months prior to the survey. In total, 482 community (55.7%) and 36 hospital pharmacies (66.7%) participated. Occurrence of drug shortages were confirmed by 88.6% of community and 80.6% of hospital pharmacies. Thus, for example, a substitute was dispensed more than 15 times (60.7% of community, 44.8% of hospital pharmacies) during the 3-month-period. Comparing community and hospital pharmacies, differences in the incidence or severity of consequences for patient safety were apparent. Community pharmacies mainly confirmed adverse effects on patients' medication adherence (60.4%) and treatment discontinuation (25.8%). A delay or deny of a life-saving treatment (39.4%) was largely reported by hospital pharmacies. Medication errors were reported by 20.1% of the community and 21.2% of the hospital pharmacies, respectively. Taken together, sustainable solutions are needed to counteract drug shortages and to ensure adequate treatment for patients.

Non-prescription dispensing of emergency oral contraceptives: Recommendations from the German Federal Chamber of Pharmacists [Bundesapothekerkammer].

BACKGROUND: Emergency hormonal contraceptives (EHC) are contraceptives used to prevent unintended pregnancy following unprotected sexual intercourse (USI) or contraceptive failure. The EHCs available without a prescription include medicines containing levonorgestrel (LNG) in more than 80 countries and, recently, based on an EU-switch ellaOne®, which contains ulipristal acetate (UPA). EHCs work by stopping or delaying ovulation. Those containing LNG can be used up to 72 hours after USI or contraceptive failure, while UPA can be used up to 120 hours. In the context of the UPA implementation process, Germany switched LNG to non-prescription status as well. OBJECTIVES: To develop recommendations, a protocol, and a continuing education program for pharmacists to assure quality when giving advice and dispensing EHCs in community pharmacies without a medical prescription. METHODS: The recommendations were developed by an iterative process of drafting, recognizing, and discussing comments and proposals for amendments as well a seeking agreement with a number of stakeholders such as the Federal Ministry of Health (BMG), Federal Institute for Drugs and Medical Devices (BfArM), Federal Chamber of Physicians (BÄK), Drug Commission of German Physicians (AkdÄ), professional organizations/associations of gynaecologists, pharmaceutical OTC-industry as well as government-controlled, private, and church-based organizations and centres providing advice on sex education and family planning. RESULTS: The recommendations were eventually endorsed by the BMG in consultation with the BfArM. CONCLUSIONS: The recommendations were made public, published in the professional journal and used in an uncounted number of continuing education programs based on the curriculum and provided by the State Chambers of Pharmacists.

Non-prescription dispensing of emergency oral contraceptives: recommendations from the German Federal Chamber of Pharmacists [Bundesapothekerkammer]

Background: Emergency hormonal contraceptives (EHC) are contraceptives used to prevent unintended pregnancy following unprotected sexual intercourse (USI) or contraceptive failure. The EHCs available without a prescription include medicines containing levonorgestrel (LNG) in more than 80 countries and, recently, based on an EU-switch ellaOne®, which contains ulipristal acetate (UPA). EHCs work by stopping or delaying ovulation. Those containing LNG can be used up to 72 hours after USI or contraceptive failure, while UPA can be used up to 120 hours. In the context of the UPA implementation process, Germany switched LNG to non-prescription status as well. Objectives: To develop recommendations, a protocol, and a continuing education program for pharmacists to assure quality when giving advice and dispensing EHCs in community pharmacies without a medical prescription. Methods: The recommendations were developed by an iterative process of drafting, recognizing, and discussing comments and proposals for amendments as well a seeking agreement with a number of stakeholders such as the Federal Ministry of Health (BMG), Federal Institute for Drugs and Medical Devices (BfArM), Federal Chamber of Physicians (BÄK), Drug Commission of German Physicians (AkdÄ), professional organizations/associations of gynaecologists, pharmaceutical OTC-industry as well as government-controlled, private, and church-based organizations and centres providing advice on sex education and family planning. Results: The recommendations were eventually endorsed by the BMG in consultation with the BfArM. Conclusions: The recommendations were made public, published in the professional journal and used in an uncounted number of continuing education programs based on the curriculum and provided by the State Chambers of Pharmacists (AU)

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