non-company) views. potentially making them more vulnerable to shortage. I think once we find out what the problem is, we can kind of guestimate whether it’s going to be short term or long term. .ispeak-filters .form-item { The task force noticed that when drug producers were limited in production, they chose to produce drugs that were more marketable and more consistently in demand. Troy Trygstad, PharmD, MBA, PhD: This interconnectedness is fascinating to think about from a drug-supply-chain perspective. Is this an issue that is discussed in Washington? The American Journal of Pharmacy Benefits. /* default color for event banner links when there is no secondary color selected */ They can have all the product they want, but if you don’t have power, there’s nothing arriving. .section-about .region--featured-bottom .form-submit { /* fix file attachment spacing */ Physicians enumerate the ways drug shortages begin, with an emphasis on the McPherson, Kansas, facility shutdown, a lack of active pharmaceutical ingredients, and market consolidation. margin: 0; .section-about .region--featured-bottom .block-webform-block { Having a certain amount of supply is cost saving to a company, but if they are short, there’s a multifactorial effect. The manufacturer is in charge of making sure it has good supplies of all its products, including the raw materials. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. .featured-tabs .hp-view-row .node--type-training-courses .icon { border-radius: 0; Do we not have an early-warning system for this? } When a manufacturing problem happens, it almost always results in a drug shortage. Causes of drug shortages appear to be multi-factorial (Birgli®, 2013, Costelloe et al., 2014, Instituut voor Verantwoord Medicijngebruik, 2012, Pauwels et al., 2014a). As more patients receive specific regimens like branded biosimilars or precision medicine, there’s more chance for disruption. You’ve had Ben Venue Laboratories Inc or Bedford Laboratories, which dropped out and left a big hole to patch up. For example: A business decision to stop producing a drug due to a lack of financial return or poor demand for a product; or. Prevalence of Drug Shortage Today and Community Awareness. Erin Fox, PharmD, BCPS, FASHP: That’s a great question. Supply-Chain Communication and Drug Reallocation, 12. You have a drug shortage. .banner-content .field-name-field-event-banner-links .field-item a { background-color: #e5f7fb; Richard Montgomery, RPh, MBA: Sure. Complete anonymity was assured for all respondents. border: solid 2px #ececec; -ms-flex-direction:column; .tabs.tabs-strip .tabs-title a[aria-selected='true'] { Different causes of drug shortages can be linked to the pharmaceutical legal framework, such as: parallel trade, quality requirements, economic decisions to suspend or cease production, etc. } But you’re right, there are many other components as well. A break in one area of the supply chain will lead to a drug shortage, whether short or long term. 30 See Chart 3 for a Palliative Fixes, Drug Essentiality, and Collateral Effects, 6. @media (max-width: 860px) { Troy Trygstad, PharmD, MBA, PhD: It’s interesting. } padding: 2rem 5rem; Troy Trygstad, PharmD, MBA, PhD: Erin, you’re widely known in the press and in a circle of folks who live and breathe drug shortages. How does this affect patients’ lives? font-size: 1rem; Troy Trygstad, PharmD, MBA, PhD: So you’re catching up. There are other causes of drug shortages, such as issues with wholesalers or distributors, delays in transportation, poor ordering practices at healthcare facilities, or if too many facilities are using the same distributor in one region. } flex-direction: column; /* view for ispeak top filter */ We’ve had some consolidation mergers in which products lines had to be divested, after which there was a whole other process. /* fix file attachment spacing */ While no single technical or manufacturing cause for drug shortages was identified, the key findings include: ISPE plans to further analyze the survey findings, and present and publish additional reports in the future. margin-bottom: 15px; What are the pragmatic results of these shortages? line-height: 120%; Richard Montgomery, RPh, MBA: They come from China and India for the most part. } display: flex; 3% stemmed from product discontinuations. .homepage-feature-banners .field-items .field-item:nth-child(2) .banner-text::before { When you look at what goes into making a sterile product, with all of the checkpoints, validations, and testing, everything comes to a halt because the manufacturer can’t get the glass to make the vial or has an insufficient number of labels, or the rubber stopper doesn’t work with the drug because the supplier changed its formulation. padding: 0; padding-right: .5rem; /* fix flex col 3 */ Troy Trygstad, PharmD, MBA, PhD: Erin, you’re widely known in the press and in a circle of folks who live and breathe drug shortages. 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