{"id":45979,"date":"2019-11-01T17:31:28","date_gmt":"2019-11-01T16:31:28","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=45979"},"modified":"2019-11-08T16:44:56","modified_gmt":"2019-11-08T15:44:56","slug":"jeffrey-aronson-when-i-use-a-word-drug-shortages-solutions","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2019\/11\/01\/jeffrey-aronson-when-i-use-a-word-drug-shortages-solutions\/","title":{"rendered":"Jeffrey Aronson: When I Use a Word . . . Drug shortages\u2014solutions"},"content":{"rendered":"

\"\"<\/a>Over the last three weeks I have reported my analysis of over 800 published reports of drug shortages. I have reviewed the <\/span>history<\/span><\/a> of drug shortages, elucidated their <\/span>causes<\/span><\/a>, and <\/span>analysed<\/span><\/a> the harms and errors that can result. But what about solutions to the problem?<\/span><\/span><\/p>\n

The word solution comes from two IndoEuropean roots, SE and LEU.<\/span><\/p>\n

LEU means to loosen, divide, or cut apart. This gave the Greek word <\/span>\u03bb\u03cd\u03c3\u03b9\u03c2<\/span>, from which we get lysis and its many derivatives, analysis, autolysis, catalysis, dialysis, electrolysis, epidermolysis, fibrinolysis, glycolysis, hydrolysis, lipolysis, paralysis, proteolysis, thrombolysis, urinalysis, and many more. In Latin lues meant a plague, typically syphilis (lues venerea)\u2014organ dissolution from being dissolute. Via Old Norse and Old English we get simpler words, such as lose, loose, loss, and less. Add to LEU the reflexive prefix SE, as in self and suicide, and we get solve, soluble, solute, and solution, as well as absolute, dissolute and indissolute, resolute and irresolute. And the double derivative solvolysis.<\/span><\/p>\n

\"\"
Alexander the Great cut the Gordian knot in 33 BC, when he started to solve the problem of ruling the known world; an oracle had declared that he who loosened the knot would conquer Asia, and Alexander did just that; this engraving was prepared by Andr\u00e9 Castaigne for B I Wheeler’s serialized life of Alexander in the <\/em>Century Illustrated Monthly Magazine (November 1898 to October 1899)<\/em><\/figcaption><\/figure>\n

So, to solve is to reveal an answer by loosening or cutting the knots that bind it, like cutting the Gordian knot. But can we cut the Gordian knot of drug shortages?<\/span><\/p>\n

A drug shortage can be defined as a failure of the availability of a medicinal product to match the demand for it, driven by clinical need, locally, nationally, or internationally. Prevention is the ideal and methods to deal with shortages when they occur are needed.<\/span><\/p>\n

In many cases shortages cannot be prevented, because the causes are unpredictable. This includes natural disasters, conflicts and governmental diktats, difficulties with animals, impaired plant growth, and contamination, bacterial or chemical. Concerns over the quality of a product can lead a manufacturer to stop production or a regulator to close down a plant. Or a financial crisis can lead to closures, which may have at least partly explained the sudden major increase in shortages in 2011\u201312 following the financial crisis of 2007\u20138.<\/span><\/p>\n

However, some shortages are predictable. For example, a company that takes over another may abandon its products. Companies intending takeovers should give warning about such possibilities and highlight the products that are likely to be affected.<\/span><\/p>\n

Expiry dates<\/span><\/a> of medicinal products are highly conservative and underestimate the shelf lives of many products; they could be extended.<\/span><\/p>\n

When shortages occur, substitutes are often used. Me-too drugs may in this way find some use, although I have found very few reported instances of this, and often substitutes are not me-toos<\/span>. Adverse reactions<\/span><\/a> to substitutes have also been reported from time to time, when, for example, differences in potency are not recognized. The use of <\/span>biosimilars<\/span><\/a> when shortages of originator molecules occur has been occasionally <\/span>discussed<\/span><\/a>.<\/span><\/p>\n

In recent years several reports have made recommendations on how to prevent and deal with shortages. The European Medicines Agency (EMA) has prepared <\/span>documents<\/span><\/a>, including <\/span>reports<\/span><\/a> from the HMA\/EMA Task Force on Availability of Authorised Medicines for Human and Veterinary Use. [The HMA is a network of the Heads of Medicines Agencies, the National Competent Authorities, whose organizations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area.]. The US Food and Drug Administration (FDA) has issued a <\/span>report<\/span><\/a> titled \u201cDrug Shortages: Root Causes and Potential Solutions\u201d, on which the Healthcare Supply Chain Association (HSCA<\/a>) has <\/span>commented<\/span> at length. And the reports of the Association of Health-System Pharmacists, which I highlighted <\/span>last week<\/span><\/a>, also contain extensive recommendations. There are also provisions in the Food and Drug Administration Safety and Innovation Act (<\/span>FDASIA<\/span><\/a>; Title X). I have summarized some of the various recommendations in Table 1.\u00a0<\/span><\/p>\n

One of the derivatives of the IndoEuropean root LEU is the word lorn, meaning lost or abandoned, which is now itself obsolete but which survives in words such as lovelorn and forlorn. A forlorn hope was originally not a hope at all. The phrase comes from the Dutch verloren hoop (pronounced <\/span>hope<\/span><\/i>), meaning a lost troop, soldiers who were sent out as the vanguard of an attack, in the expectation that they would not survive. I suspect that many of the suggestions for preventing and dealing with drug shortages may share the same fate.<\/span><\/p>\n

Table 1.<\/b>\u00a0Some recommendations for preventing drug shortages and dealing with them when they occur; I report them here and do not necessarily endorse them\u200b<\/i><\/p>\n\n\n\n
Increasing awareness<\/b>
\n\u2022 quantification of the harms that shortages can cause<\/span>
\n\u2022 better data on actual shortages (frequency, intensity, and duration)<\/span>
\n\u2022 informing the public and the news media when shortages are expected or occur, including easily accessed websites (manufacturers and regulators)<\/span>
\nBetter use of medicines<\/b>
\n\u2022 longer expiry dates<\/span>
\n\u2022 use of me-toos and biosimilars<\/span>
\nModification of prescriptions<\/strong>\u200b
\n\u2022 allow hospital pharmacists to repackage medicines in order to share with other hospitals\u200b
\n\u2022 allow pharmacists to substitute alternative formulations, for example 28 tablets of 5 mg rather than 14 tablets of 10 mg, without consultation with the prescriber\u200b
\n\u2022 allow pharmacists to substitute alternative medicines expected to be equally efficacious and safe, after consultation with the prescdriber and patient\/carer\u200b
\nRequirements of manufacturers<\/b>
\n\u2022 to warn about expected difficulties in supply as soon as possible, including assessment of the impact of the expected shortage (see the EMA\u2019s <\/span>proposed template<\/span><\/a> for shortage notification)<\/span>
\n\u2022 to produce risk management plans<\/span>
\n\u2022 to warn about takeovers well in advance and specify medicines whose production may be stopped<\/span>
\n\u2022 to stock larger amounts (i.e. mitigating the “just in time” policy)<\/span>
\n\u2022 to provide the regulator with information on the volume of sales of the medicinal product when asked<\/span>
\n\u2022 to record and review all complaints about quality and to recall affected products; to inform the regulator of any defect detected that could result in a recall or abnormal restriction on supply and the likely countries affected<\/span>
\n\u2022 to ensure that sufficient supplies will be available for clinical trials before the trial starts<\/span>
\nIncentives to manufacturers<\/b>
\n\u2022 to produce medicines that are less profitable\u00a0<\/span>
\n\u2022 relaxed regulations when recovery is required<\/span>
\nRecognition and reward of manufacturers’ activities<\/b>
\n\u2022 rating good manufacturing practices, including quality management systems<\/span>
\n\u2022 financial incentives to continue producing older medicines<\/span>
\nDuties of purchasers<\/b>
\n\u2022 to keep well informed<\/span>
\n\u2022 to have contingency plans for purchasing, storage, preparation, and dispensing of the relevant medicine and possible alternatives<\/span>
\n\u2022 to predict cost implications<\/span>
\n\u2022 to have procedures in place for deciding on how to use substitutes, for approving them, and for advising about appropriate use and rationing in appropriate patients<\/span>
\n\u2022 to ensure widespread communication with prescribers and patients<\/span>
\n\u2022 to avoid speculative stockpiling<\/span>
\nGenerics suppliers<\/b>
\n\u2022 encourage local private suppliers<\/span>
\n\u2022 establish national suppliers<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

Jeffrey Aronson<\/strong>\u00a0is a clinical pharmacologist, working in the Centre for Evidence Based Medicine in Oxford’s Nuffield Department of Primary Care Health Sciences. He is also president emeritus of the British Pharmacological Society.<\/em><\/p>\n

Competing interests:<\/strong> None declared.<\/p>\n","protected":false},"excerpt":{"rendered":"

Over the last three weeks I have reported my analysis of over 800 published reports of drug shortages. I have reviewed the history of drug shortages, elucidated their causes, and […]<\/p>\n

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