Drug shortages are reported worldwide and the major cause seems to be economic. Due to the pressure on price resulting in a too-low return on investment, pharmaceutical companies are deciding to take older drugs permanently off the market. Centralised production is efficient but runs the risk of temporary shortages in case of a production failure or calamity. Overcoming drug shortages is a major challenge for the foreseeable future. In this issue’s Benchmark, local initiatives are reported.
Drug shortages are reported worldwide and the major cause seems to be economic. Due to the pressure on price resulting in a too-low return on investment, pharmaceutical companies are deciding to take older drugs permanently off the market. Centralised production is efficient but runs the risk of temporary shortages in case of a production failure or calamity. Overcoming drug shortages is a major challenge for the foreseeable future. In this issue’s Benchmark, local initiatives are reported. It is paramount to realise that international initiative and coordination are of vital importance
The Netherlands:
Paul PH LeBrun
PharmD PhD
Hospital Pharmacist and Clinical Pharmacologist,
Central Hospital Pharmacy,
The Hague,
The Netherlands
Email: [email protected]
More and more simple drugs are unavailable – either temporarily or permanently – in The Netherlands – digoxine could not be delivered for several weeks only recently; a suspension of amoxicillin was not in stock during the flu season. In 2010, 174 drugs could not be delivered and, in 2011, the number increased to 242 (source: Farmanco, see below). To date, no consequences have been reported in patient care. This is mainly due to the professional efforts of pharmacists in organising alternatives. For example, logistics are centralised, therapeutic alternatives are considered or imports are made available. In some cases, production by hospital pharmacists is a solution. For example, procainamide is not available but an injection is produced by several hospitals and delivered between pharmacies. In recent years, we have produced lorazepam injections in our hospital pharmacy because Temesta™ could not be delivered.
Already in 2004, The Royal Dutch Society of Pharmacists (KNMP) launched a website “Farmanco” (www.farmanco.knmp.nl) to facilitate actions in case of drug shortages. Farmanco is the national source of information on drug availability. It informs pharmacists on which drugs are not available, the reason why, the period of non-availability and the alternatives. Furthermore, the KNMP sometimes mediates between the authorities and the industry or tries to apply pressure to make drugs available.
Still, it is recognised that this system is vulnerable. In 2012, the Ministry of Health started a project to guarantee availability of drugs. The reasons for shortages were investigated and categorised. A model was developed, which qualified those circumstances leading to possible shortages and the means to estimate the possible impact of such a drug shortage. With this model, anticipation of how to act in specific situations is made possible. It was concluded that national and international handling is necessary. A risk model can identify high-risk medication and help to develop strategies to prevent shortages. In 2013, a follow-up of the project with specific actions is expected.
Pro-active European (or perhaps global) cooperation between authorities, industry and professional organisations is mandatory if we are to develop a system of continuous drug availability.
Italy: Anna Carollo
PharmD PhD MS
Hospital Clinical Pharmacist,
ISMETT Hospital,
Palermo, Italy
Email: [email protected]
International drug shortages are on the increase. Approximately 150 medically necessary drugs were in short supply in early 2011, according to the American Society of Health System Pharmacists (ASHSP): that’s twice the number of medically necessary drugs that were in short supply in 2006. Pharmaceutical companies are encouraged to notify the FDA of any anticipated drug shortage but are not legally required to do so. In Europe, there are reports that countries such as Germany, Hungary, The Netherlands and the UK are suffering from shortages of originator, biosimilar and generic drugs, causing problems for patients, prescribers and pharmacists.
In Italy, the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation, monitors the activities of any suspension and/or revocation of marketing authorisations for medicinal products. In all cases where the lack of perceived quality can lead to serious health risk, even regarding the medicinal products marketed abroad, AIFA is responsible for activating an International alert through the network of information exchange in the production and quality (Rapid Alert System, RAS). In addition, the Agency carries out the monitoring and management of drug shortages and establishes a Drug Shortage Program to manage product shortages.
In particular, local regulatory authorities implement an emergency plan in case of drug shortages. The role of hospital pharmacists is key to maintaining a continuous supply of drugs at a time when shortages are putting patients’ lives at risk. In hospitals and healthcare systems, the pharmacy department can play an important role in developing and implementing appropriate strategies and processes for informing practitioners of shortages and ensuring the safe and effective use of therapeutic alternatives.
Czech Republic: Stanislav Synek
PhD PharmDr
Faculty Hospital sv. Anna,
Brno, Czech Republic
Drug shortages in the Czech Republic? Three years ago we did not use this term often. There were occasional failures but only very rarely. Today, a drug shortage is a daily reality and a nightmare for all oncological pharmacists. Instead of devoting most of our time to the patient’s drug therapy, solving drug interactions and side effects, we spend more and more time with drug supplies. Previously we had supplies of drugs for two or three weeks in our pharmacy.
Today, this is impossible for cytostatic drugs: we have to maintain standard supply for two or three months. The larger the supplies, the higher the cost. There are several causes of the drug shortages, all of which are very closely related. Regulatory authorities in the Czech Republic reduce the price of drugs to achieve availability for more patients and, if the price of the drug is significantly lower than in our neighbouring countries, the drug is very quickly re-exported. As pharmaceutical companies fix quotas of production for each country, the drug becomes unavailable very quickly. Another reason is related paradoxically to tenders for the supply of hospitals with specific drugs. During competition, it is often offered at a low price that is unbearable for the majority of producers for a long-term supply. It leads to the destruction of competitors. The winning producer remains in the market alone and often cannot satisfy all requirements. Another important cause is the merger of pharmaceutical manufacturers, which basically means a smaller number of suppliers of the drug.
If one manufacturer fails, the other one hardly meets the increased demand. What to do? It is very difficult to find a solution acceptable for all partners. In the Czech Republic, a system limiting distribution has been recently used, where each pharmacy has individually set shopping quotas by distributors, for example, selected cytostatics are delivered within a certain quantity for each pharmacy. Some medicines are supplied directly by manufacturers who sell cytostatics to contractors. Although one solution is to increase the inventory of cytostatic drugs in the pharmacy, it is the least desirable.
Spain: María José Tamés
PhD
Hospital Pharmacy Specialist, Assistant Manager Pharmacy Department, Onkologikoa Foundation,
San Sebastian, Spain
Email: [email protected]
Unfortunately, medication shortages are nowadays a hot topic all around the world. Procurement of medicines is a key component of patient care and discontinuation of the supply might have serious consequences in the outcomes of specific pathologies.
The scope of this problem has pushed different stakeholders to gather around in order to tackle and discuss the problem. As a result, different recommendations, guidelines, statements and actions have been published by international organisations or groups, such as ASHP
(http://www.ashp.org/DocLibrary/
Policy/DrugShortages/ASHP_shortage_guide09.pdf), FIP (https://www.fip.org/files/fip/news/
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20INTERNATIONAL%20SUMMIT1.pdf ), CPhA (http://www.pharmacists.ca/index.cfm/cpha-on-the-issues/advocacy-government-relations-initiatives/drug-shortages/drug-shortages-international-summit/), EAHP (http://www.eahp.eu/sites/default/files/files/
EAHPStatement%20on%20Medicines%20Shortages.pdf) and other European pharmacist associations (http://www.eahp.eu/press-room/european-pharmacist-organisations-make-joint-call-action-medicines-shortages), FDA (http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm313121.htm).
All of them agree on the relevance of the problem, and that it occurs as a result of one or several factors in the supply chain, affects different stakeholders, requires extra time spent at different levels and by different professionals, needs fluid communication among different stakeholders and should be accessible to all; all parties concerned should work in a collaborative and coordinated way to mitigate effects. If unresolved, it can impact on the safety of the patient, who is the last link of the chain.
Regarding the way this problem is running at the moment in Spain, the hospital pharmacists (as a group) are on the way to approaching the problem and establishing some kind of document, but it is still an idea and a future project. Our Aemps (Agencia española de medicamentos y productos sanitarios, Spanish Agency of drugs and medical devices) offers some information links in its website (http://www.aemps.gob.es/medicamentosUsoHumano/
problemasSuministro/home.htm) but very often the update of the list comes too late.
As hospital pharmacists, we can play a leadership role in approaching shortages as we are implicated in different steps of the process, some of them with important consequences for the patient in case of errors, such as the use of therapeutic alternatives. It is important that we participate in a collaborative and active way in all the initiatives and actions developed, joining forces in order to deal with this problem in our daily practice.
Germany: Martin J Hug
PhD
Pharmacy, University Medical Centre,
Freiburg, Germany
Email: [email protected]
Shortages have been a problem affecting virtually every product that was commercially available at some point in history. In the healthcare sector, however, lives may be at stake, when live-saving medicinal products cannot be supplied to the patients in need. During the past couple of years, it appears that, even in Germany, where prices for drugs are considered to be higher than in most other European countries, shortages are getting more frequent and persist over longer time periods. At the same time, mass media are picking up the problem and recognise that the hospital sector is predominantly affected. In German hospitals, drug shortages should normally not be such a problem: it is mandatory for every pharmacy to maintain a two-week supply of every essential drug in their formulary.
In the past, however, that supply has dried up many times due to the fact that a given drug was not available for months or even years. The issue has become such a pressing matter, that the German Society of Hospital Pharmacists (ADKA) e.V. chose the subject ‘drug shortages’ as a motto for their annual meeting. In a collaborative fashion, representatives of the authorities, the boards of pharmacists and physicians, the pharmaceutical industry and, of course, the hospital pharmacists themselves were addressing the problem in plenaries and workshops. It comes as no surprise that pharmacists are very versatile in dealing with drug shortages.
The mailing list of the ADKA has helped many colleages within Germany to obtain temporarily unavailable drugs from other hospital pharmacies or to seek information on what other substance could be used instead. With their broad expertise, hospital pharmacists are best qualified to consult physicians and nurses on what to do when a given drug turns out to be impossible to obtain. Drug shortages might therefore be yet another example to prove that hospital pharmacists are always willing to go the extra mile to achieve the best drug therapy for their patients.
UK: Michael Scott
BSc PhD FPSNI
Head of Pharmacy and Medicines Management,
Northern Health and Social Care Trust,
Antrim, UK
Email: [email protected]
In the UK, medicine shortages are occurring on a more frequent basis than was previously the case. In a number of instances, such problems can be managed relatively easily. However, in other cases, the unavailability of a medicine can cause significant problems for patient care in respect of the use of the optimal choice of therapy for their condition
In terms of medicines and their supply at a country-wide level, there are two key bodies for hospital pharmacy, who work closely with the Commercial Medicines Unit of the Department of Health Medicine, Pharmacy and Industry Group, namely, the National Pharmaceutical Supply Chain Group and the Pharmaceutical Market Support Group. A prime function of the former is to develop national procurement strategy that will maintain continuity of supply of medicines for all patients.
It acts as a focal point for the Department of Health and the NHS in England but also has representatives from Northern Ireland, Scotland and Wales. The latter group has a key objective to ensure that secondary care patients have access to high-quality cost-effective medicines. In addition, the group provides advice in terms of product discontinuation and shortages in order to minimise the impact on patient care.
Recently, the Royal Pharmaceutical Society, in conjunction with the NHS, has produced a document entitled Best Practice Standards for Managing Medicines Shortages in Secondary Care in England, which could be readily adapted to suit other systems. It highlights overarching principles, such as doing nothing to exacerbate the problem and collaboration, together with the standards necessary to manage shortages and minimise the impact on patients. The intention in the NHS is to develop and manage a national website for medicines shortages,including nature, likely duration and recommendations for action.
Medicine shortages and their resolution are an issue for all stakeholders in the supply chain comprising the industry, wholesalers, pharmacists and prescribers, with good and early communication being a critical component.
