By: Valentina DiGangi,PharmD Candidate c/o 2017, Brandon Hu, PharmD Candidate c/o 2018, Sang Hyo Kim, Staff Editor, Samantha Lau, PharmD Candidate c/o 2018, and Seowoo Yoon, PharmD Candidate c/o 2018

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What does a clinician do when there is limited access to a particular drug, such as morphine? Should they treat a patient who is suffering from extreme leg pain or should they save it for a future emergency? Such scenarios are what ambulance squads experience because of the drug shortage crisis in the United States.¹ Because of the diverse factors that lead to drug shortages, more government regulations are being implemented to improve communication amongst different parties that are involved. Some examples of include requiring the manufacturers to notify the FDA when there is a disruption in supply, or informing other manufacturers to increase production to compensate for the shortage.

 

Significance of Drug Shortages

It is shocking to see that a major problem like drug shortage exists in the United States, where drug treatment is more prevalent than anywhere else. Discussing and searching for practical solutions to the drug shortage issue is important because the drugs that are scarce are “essential for treating most critical health conditions, and shortages in any of them inevitably [cause] disruptions in patient safety and quality of healthcare.”² Furthermore, this issue is becoming more crucial than ever before, since there has been a sharp increase in the rate of drug shortages (Figure 1).

 

Factors of Drug Shortages

Drug shortages are multi-factorial—some of them predictable while others are not—making it difficult to pinpoint an exact cause. According to the American Society of Health-System Pharmacists (ASHP) drug shortage program, the most common causes of shortages in 2011 included manufacturing problems, constituting 23%, supply/demand issues at 13%, and unknown causes at 55%.³ Drug Shortages Federal officials attribute the delays of the drugs to the plants that make sterile injectable, which account for about 80% of the scarce medicines. Further, one third of the manufacturing capacity is not reached because of factory closures due to quality issues.¹ Some of the unpredictable factors include natural disasters, raw materials, non-compliance with regulatory standards, and voluntary recalls.⁴ Natural disasters such as floods, fires, and hurricanes affect drug product availability in the following ways: finished products become damaged, and in situations where there is only one producer, site damage to facilities result in long term shortages.³ Raw material is also another factor. A drug, for example, may rely specifically on one major raw material, which may be produced only by a sole-source supplier. In addition, if there is a disruption in the chain of production of the material, problems arise, and multiple manufacturers of the drug are affected.⁵

When the FDA decides to stop manufacturer production because of quality control issues, practices shortages also occur; and reimbursement issues force the drugs to be set at such low prices that it discourages companies from making the drug.⁴ Private physicians are also affected because they have a shortage on drugs to refer the patients to. The shortages have even forced the FDA to release drugs which have been actually recalled in the past. For example, single dose vials of Sodium Thiosulfate, used for chemotherapy, contained glass particles. Under normal circumstances, these would have been recalled, but due to a shortage in the drug, healthcare professionals were informed to filter the drug before administering it to patients.¹

 

Economic Reasons for Drug Shortages

Manufacturing difficulties, supply and demand, business and economics, regulations, supply chain, and healthcare systems all affect drug shortage. When a company shifts its resources from manufacturing to research or to the production of an alternative product, it results in loss of production, which may lead to layoffs.³ Drug supply is also affected by insufficient profits, introduction of generic alternatives, market shares, clinical demand, and mergers. These factors can cause permanent or temporary product reduction depending on the shift in production, delay in allocating new resources, or the time it takes to begin production in a new facility.

Supply and demand issues occur when drug demand increases beyond expectations or production capacity. For example, the responsiveness of prescription drug prices do not change drastically in either the short or the long run because these medically necessary drugs have few substitutes and are mostly purchased by consumers with pre-established rates through health insurance.⁵ Lastly, supply chain issues affect drug supply depending on the end users’ decisions. Wholesalers or hospitals may have poor ordering practices, delivery delays, restrictive distribution methods, and methods of inventory based on increased cash flow resulting in drug shortages.³

 

Impact of Drug Shortages

Shortages occurring in the prescription drug and vaccine market can have a negative impact on both healthcare providers and patients. Shortages in drug supply lead to higher hospital expenses. A survey conducted in 2010 by Premier Healthcare Alliance found that drug shortages cost hospitals around $200 million yearly due to having to resort to more expensive alternatives. There are also suppliers that buy up the remaining drug stock and try to sell it to hospitals at extremely high prices. A survey conducted by the ASHP estimated that yearly labor costs to manage shortages average to about $216 million nationwide.⁵ Pharmacists also have to spend more hours dealing with drug shortages. They have to talk to manufacturers and keep their electronic databases up to date, which takes away time from providing direct patient care. Using alternatives for drugs in short supply can bring increased risk. Pharmacists have to make sure there are no multi-drug interactions when giving alternatives to patients. Also, alternative drugs may have different side effects or may be less effective than what was originally prescribed. Prescribing alternative drugs may lead to medication errors such as wrong dosage. Some patients may need drugs urgently, but shortages in drug supply would lead to rationing to patients who “need it more.” Another problem that comes with drug shortages is quality control. When there are shortages in drug supply, substitute medications may not live up to required standards. Hospitals or pharmacies may have to buy drugs from less reputable sources. And buyers are at increased risk of purchasing counterfeit drugs.

 

Strategies in Managing Drug Shortages

According to many experts and authorities including Scott M. Mark Pharm.D., M.S., from ASHP, the best solution to the drug shortage problem is to foster prompt communication among different levels of regulators, medical practitioners, and healthcare institutions, such as wholesalers, distributers, drug manufacturing companies, hospitals, pharmacies, and the FDA. It has been advised that all small and large organizations establish a department or nominate someone to supervise the drug distribution process and drug shortage situation.³ Several other strategies include validating drug shortages, assessing inventory of drugs in short supply, establishing contact with other health systems, identifying alternative drugs or therapeutic equivalents, determining primary patients to receive drugs in short supply, adjusting or reconstructing clinical guidelines and policies, and finally, developing timely communication systems and strategies.⁴ In addition to these possible solutions, it would also help if the FDA had more control in forecasting and preventing drug shortages so that it could terminate the gray market activities, the import and sale of goods by unauthorized dealers.²

 

In the Future

Although a higher number of potential drug shortages have been prevented in recent years, the total number of existing drug shortages still continues to rise. Much more has to be done in order to ensure that these numbers decrease. In the long run, drug shortages can be predicted and prevented if the FDA not only has the ability to track which drugs are running low in supply, but also if it deciphers the patterns behind drug shortages. In order to do this, the FDA must be given more power to regulate the determinants leading up to drug shortages. Some problems that may be better managed include the following: a single production line producing too many drugs despite limited space, or manufacturers deciding not to produce certain drugs because they do not bring in sufficient profits.⁶ FDA can ensure that all drugs are being produced sufficiently. This will play a crucial role in preventing shortage of drugs as well as providing drug substitutes.

Although drugs that have higher demand warrant priority in terms of production and distribution, all drug shortages should be acknowledged and reported to the FDA. The FDA can then take appropriate actions to prioritize and address the shortages. When certain drugs are scarce due to manufacturing problems, the FDA should be able to hasten the drug review process for substitute drugs, as well as relax drug importation laws.⁴ These changes can be carried out in emergencies, such as during a shortage of high-demand drugs, because the medical needs and safety of the people must always be the first priority of the drug industry.

 

 

SOURCES

1. Thomas K. Drug shortages Persist in U.S., Harming Care. New York Times. November 2, 2012. http://www.nytimes.com/2012/11/17/business/drug-shortages-are-becoming-persistent-in-us.html?pagewanted=all&_r=0. Accessed April 27, 2014.
2. Brown B, Gu A, Shaya FT, Wertheimer, AI. Drug Shortages in the United State–Causes, Impact, and Strategies. Innovations in Pharmacy. 2011;2(4):60. http://conservancy.umn.edu/bitstream/11299/120058/1/%2811-085%29%20Drug%20Shortages%20in%20the%20US%20article%2060.pdf. Accessed April 24, 2014.
3. Tyler LS, Mark SM. Understanding & Managing Drug Shortages. Proceedings of 37th ASHP Midyear Clinical Meeting; December 9, 2002; Atlanta, Georgia. http://www.ashp.org/DocLibrary/Policy/DrugShortages/DShort-abbott-drug.aspx. Accessed April 14, 2014.
4. Ventola CL. The Drug Shortage Crisis in the United States. P&T. 2011; 36(11): 740-742, 749-757.
5. Haninger K, Jessup A, Koehler K. ASPE. ASPE Issue Brief: Economic Analysis of the Causes of Drug Shortages. http://aspe.hhs.gov/sp/reports/2011/DrugShortages/ib.shtml. Updated October 2011. Accessed April 14, 2014.
6. Tavernise S. Drug Shortages Continue to Vex Doctors. New York Times. February 10, 2014. http://www.nytimes.com/2014/02/11/health/shortages-of-critical-drugs-continue-to-vex-doctors-study-finds.html?_r=0. Accessed April 26, 2014.

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