Drug Shortages: Hospital Pharmacists Can Play A Key Role In Maintaining Supplies Concludes Amgen Report at EAHP 2012
ZUG, Switzerland, March 21, 2012 /PRNewswire/ --
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, an Amgen report(1) revealed at the 2012 European Association of Hospital Pharmacists (EAHP) annual meeting in Milan, Italy.
"Shortages of drugs, particularly oncology treatments, are an increasing problem across Europe," explained Richard Lit, Vice President, Regulatory Affairs and Safety. "There are reports that countries such as Germany, Hungary, The Netherlands and the UK(2) are suffering from shortages of originator(3), biosimilar and generic drugs,(4)causing problems for patients, prescribers, and pharmacists."
"Denied on demand access to the drug of choice, hospital pharmacists and physicians are forced to compromise by using different drugs, rationing and even postponing critical treatments. It is unacceptable that patients are deprived of proven or chosen treatments because of avoidable supply chain issues," he added.
In the poster presented at the EAHP meeting (Drug Availability: Considerations for the Hospital Pharmacist) the authors referred to biologics (medicines created using biologic processes) as an example to show how pharmacists can use supply chain parameters to help them identify those manufacturers with the capability to maintain a continuous supply of drugs.
Drug shortages occur for a number of reasons including scarcity of raw ingredients, shut downs due to line contaminations, voluntary recalls and changes in formulation. Furthermore, the practice of tendering, in which hospitals grant contracts to the pharmaceutical company with the best bid, may exacerbate the problem by switching volume demanded from one manufacturer to another - leading to temporary shortages.(4)
In Europe, manufacturers are required to give two months' notification to the European Medicines Authority if supply of a product is temporarily or permanently interrupted.(5) In the US, there is no law requiring manufacturers to report shortages.(6) Regulatory agencies are trying to develop processes but while this helps to manage shortages, it won't prevent them.(1)
By evaluating how a manufacturer manages its drug supply, pharmacists can make considered formulary decisions that will maximise their chances of a constant supply of drugs.
The following practices enhance a biologic manufacturer's capability of maintaining uninterrupted production and continuous supply:(1)
- Linking patient demand to production through integrated manufacturing and distribution information systems
- Dual supplier system for sourcing of raw materials and use of certified suppliers
- Maintaining safety stocks to offset potential manufacturing delays or interruptions
- Strategic capacity management and provision of redundant manufacturing capabilities to counteract any delay in production
- Active management of robust and secure distribution networks - a pharmaceutical company's distribution network dealing with moving products that need to be kept secure
"Access to effective, high quality medicines is fundamental to successful medical management," commented Richard Lit. "By taking these factors into consideration during a thorough evaluation of a potential supplier, hospital pharmacists can improve their chances of avoiding shortages of essential medicines," he added.
About biologics
Biologic medicines are made from living organisms or organic substances and include therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins as well as new experimental modalities such as gene therapy, stem cell therapy, antisense nucleotides, and RNA viruses. They are made by using living cells to produce proteins that can be used to treat disease. By harnessing the natural process of cells, viruses, and other microscopic living organisms, scientists alter the genetic make-up of the organisms to bring about specific results.
Unlike small molecule drugs, biologics are usually proteins manufactured in genetically-engineered living cells where even small variations in a cell, its nutrients or environment can cause differences in the end product.
About biosimilars
Biosimilars are similar copies of innovator biologic medicines. The active substance of a biosimilar medicine is similar to the original reference medicine but, because of the complexities of biologic manufacturing, it is not possible for a biosimilar to be an exact copy of the original product.
When a patent expires on a medicine, other manufacturers can make copies. In the case of small molecule drugs, analytical tests can show pharmaceutical equivalence to the innovator product. But with biologic medicines (large molecule drugs), an array of analytical, non-clinical and clinical studies can only demonstrate similarity not sameness. This is due to biologic products' complex structures, use of different cells and distinct manufacturing processes.
About Amgen
Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and vital medicines, visit http://www.amgen.com.
Forward-Looking Statements
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of 21 March 2012 and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments, domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.
The scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the FDA for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.
References
(1) Mica, A. & Green, L. Drug availability: considerations for the hospital pharmacist. Presented at European Association of Hospital Pharmacists, Milan, March 2012
(2) Generics and Biosimilars Initiative (Gabi). Biosimilars and cancer drug shortages in Europe. Gabi Online, November 18, 2011. http://www.gabionline.net/layout/set/print/content/view/full/1555.%20Accessed%202011-11-29, last accessed 12 March 2012
(3) Generics and Biosimilars Initiative (GaBI), Roche encounters manufacturing issues with epoetin-beta. GaBI online, January 27. 2012. http://www.gabionline.net/Biosimilars/News/Roche-encounters-manufacturing-issues-with-epoetin-beta/(highlight)/mircera
(4) Generics and Biosimilars Initiative (Gabi). Biosimilars and cancer drug shortages in Europe. Gabi Online, November 18, 2011. http://www.gabionline.net/layout/set/print/content/view/full/1555.%20Accessed%202011-11-29, last accessed 12 March 2012
(5) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). Brussels: European Commission; 2001.
(6) Piana, R. Drug Shortages Hit Oncology Hard: Experts Weigh in on Challenges and Solutions. Asco Post, February 15, 2012, Volume 3, Issue 3. http://www.ascopost.com/articles/february-15-2012/drug-shortages-hit-oncology-hard-experts-weigh-in-on-challenges-and-solutions/, last accessed 12 March 2012
Share this article