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Drug Shortages On The Rise

Drug Shortages On The Rise

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Drug Shortages On The Rise

Global shortages of drugs are causing unnecessary surgeries, relapses of cancer, and even fatalities in the U.S. This is an ever-increasing problem that could affect you, your business, and your loved ones. In just five years, the shortage of drugs in the U.S. has risen to an amazingly high, 74%. The shortage has a broad coverage of drugs, from saline and anti-inflammatories to cancer treatments and anesthesia (Loftus, 2015). Even treatments as simple as a Vitamin A injection and pain medication can be hard to come by (Eban, 2014).

According to the Infectious Diseases Society of America, it is highly probable that in the near future, the U.S. will suffer from a drug shortage of five important injectables to prevent infection, which can have a significant negative impact on the care of our patients and the healthcare system as a whole. The FDA currently has 64 drugs on its Shortage list. To view a current list of drug shortages visit https://rx.trxade.com/drug-shortages/.

The FDA focuses on shortages of medically necessary products since these shortages have the greatest impact on public health. The FDA lists shortages primarily of medically necessary products. Shortages that are expected to be resolved quickly or which involve only a particular strength or package size, are not usually listed on FDA’s Drug Shortage list.

Trxade Helps Acquire Drugs in Short Supply

Ketorolac Tromethamine is an example of an important anti-inflammatory medication that is in short supply. Trxade currently has 6 suppliers representing 3 different manufacturers of Ketorolac Tromethamine on its online comparison shopping platform. Trxade is a great resource to search multiple suppliers, price compare, and acquire drugs in short supply and high demand.

Causes of U.S. Drug Shortages

There are multiple factors that contribute to drug shortages, both due to a lower supply and a higher therapeutic demand. Some of the specific factors are quality requirements, internal or external price referencing, manufacturing process requirements, and even noncompliance (Weerdt, Simoens, Hombrockx, Casteels, & Huys, 2015). Knowing the exact cause of a shortage in drug supply can be difficult to determine “because manufacturers have no legal obligation to transparency” (Valquette & Laupland, 2015).

The FDA states the top reported reason a drug shortage occurs is due to quality/manufacturing issues. On their website they explain “However there have been other reasons such as production delays at the manufacturer and delays companies have experienced receiving raw materials and components from suppliers. Discontinuations are another factor contributing to shortages. FDA can’t require a firm to keep making a drug it wants to discontinue. Sometimes these older drugs are discontinued by companies in favor of newer, more profitable drugs.

With fewer firms making older sterile injectable drugs, there are a limited number of production lines that can make these drugs. The raw material suppliers the firms use are also limited in the amount they can make due to capacity issues at their facilities. This small number of manufacturers and limited production capacity for older sterile injectables, combined with the long lead times and complexity of the manufacturing process for injectable drugs, results in these drugs being vulnerable to shortage. When one company has a problem or discontinues, it is difficult for the remaining firms to increase production quickly and a shortage occurs.”

References:

Eban, K. (2014, June).  Drug shortages: the scary reality of a world without meds. Reader’s Digest.

Loftus, P. (2015, May). U.S. drug shortages frustrate doctors, patients. The Wall Street Journal.

Valquette, L., & Laupland, K. (2015). Antimicrobial shortages: another hurdle for clinicians. The Canadian Journal of Infectious Diseases & Medical Microbiology, 26 (2), 67-68. Retrieved from: search.proquest.com

Weerdt, E., Simoens, S., Hombroeckx, L. Casteels, M., & Huys, I. (2015, March). Causes of drug shortages in the legal pharmaceutical framework. Science Direct-Regulatory Toxicology and Pharmacology, 71 (2), 251-258. doi:10.1016/j.yrtph.2015.01.005.

Is Increased Government Regulation the Answer for High Drug Cost?

Is Increased Government Regulation the Answer for High Drug Cost?

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Is Increased Government Regulation the Answer for High Drug Cost?

The Pharmaceutical industry is a highly regulated submarket in terms of what drugs get approved for national, safe, and legal consumption, however, drug pricing still remains mostly a free market. There have been some proposals to drug cost regulation, such as Clinton’s 1993, Health Security Act. Its purpose was keep pharmaceutical price increases below or steady at the average consumer price inflation. This resulted in pharmaceutical companies pledging to do so. The House Bills 2951 and 3486, discussed in an earlier post are two other proposals that focus on lowering drug prices through capitation and cost transparency. Some even propose we adopt the highly stringent regulations of the European Union (E.U.) that has increased control over drug prices since the 1980’s.

Would E.U. Price Regulations Work In The U.S.?

A 19-year sample period study was done that compared the pharmaceutical drug price regulations of the E.U. and the U.S. It’s easy to see why price control would benefit the patient in the short term, due to them saving money and being able to afford their medications. What about the long term benefits? Are there any potential risks to patients in the long term? Something to consider regarding drug price regulation is, “price constraints affect the profitability, stock returns, and R&D [research and development] of E.U. and U.S. firms. Had the U.S. used controls similar to those used in the E.U., a study estimates it would have led to 117 fewer new medicines and 4,368 fewer research jobs in the U.S.” (Golec & Vernon, 2010) during the 19 year study.

This proposes an interesting viewpoint for patients, U.S. economy, and the U.S. being a leader in R&D. Should the Government increase their regulation over the Pharma industry? A study published this week by PublicAgendaArchives.org shows that over 50% of Americans say there’s not enough government regulation when it comes to prescription drugs, 39% about right, 8% say too much, and 3% had no opinion. USNews.com also reported this week “so far in the U.S., we have not been willing to run the risk of government regulation of drug pricing, just because there are so many conflicting interests and no bright line to lead government officials to choose a better price.”

Office of Pharmacy Affairs’ 340B Drug Pricing Program:

Programs like the Office of Pharmacy Affairs’ 340B Drug Pricing Program where drug manufacturers are required to provide outpatient drugs to eligible non-profit entities at significantly reduced prices to stretch scarce Federal resources as far as possible could be implemented at many levels of the Pharma supply chain, including specific programs focused solely on independent pharmacies. This allows them to reach more eligible patients and provide more comprehensive services.

The Federal government is not the only one trying to balance a checkbook and make the best of each dollar spent, if they can create programs for themselves, they can do the same for us! They have the power to create change. Will they take action? Who will lead the way? We are waiting! Stay tuned! The next few years with price transparency and big data being on the forefront change is inevitable.

References:

Golec, J., & Vernon, J. (2010). Financial effects of pharmaceutical price regulation on R&D spending by EU versus U.S. firms. PharmacoEconomics, 28 (8). 615-628.

Is the Concept of Biosimilars Feasible

Is the Concept of Biosimilars Feasible?

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Is the Concept of Biosimilars Feasible?

With the introduction of the Biologics Price Competition and Innovation Act that was included in the Patient Protection and Affordable Care Act, drug prices have been changing. This legislation allows companies to produce medications that are similar to brand drugs and use these medications interchangeably. There must be clinical evidence that the biosimilar product produces the same medical result as the brand medication.

In March of 2015, Zarxio, a biosimilar for Neupogen, was the first biosimilar medication approved by the FDA. These medications are granulocyte colony stimulating factors (G-CSF) that treat Neutropenia. A PBM estimates that the introduction of this biosimilar could reduce US Drug costs by $5-7 billion over the next ten years. The release of Zarxio has now been put on hold due to the U.S. Court of Appeals approving an injunction to block the launch of this medication due to a possible patent infringement.

In the short-term drug prices may go down, but as seen with the wave of generics, this could result in drug prices spiking in the long term. The price of biosimilars could increase as the generic drug prices have increased. Is this really an effective way to control drug costs? Short term it is a great solution! It makes sense… Immediate gain for all! Long term, the old saying “learn from your mistakes” (aka generic pricing all over the place) comes to mind. Will this just be another round of smoke and mirrors of steps taken to help lower drug costs?

Will Manufacturers play the same games to control the cost of biosimilars as they have with generics? Only time will tell although combined with new proposed legislations and a big push for industry transparency, we are hopeful that these positive changes will take place!

References:
Burki, T., (2015). First biosimilar drug approved in the USA. Lancet Oncology, 16 (4), 161. Retrieved from: http://proquest.com
Maas, A. (2015). Biosimilars update: appeal date is set; FDA finalizes guidance. Speciality Pharmacy News, 12 (5). Retrieved from: http://aishealth.com | http://www.dpc.senate.gov/healthreformbill/healthbill70.pdf

You Have a Friend in Trxade

Did you know that Trxade is a pharmacist-led team of business and technology professionals working together to help independent pharmacies save money and improve cash flow by taking back control of their profit margins? We understand first-hand the issues independent pharmacies experience and work together with our members and industry partners to do our part to ensure independent pharmacies thrive by saving thousands at no cost.

If there is anything that we can do to help, as a member of the Trxade family we will do our part to go above and beyond to help. Just let us know how we can help. We care about your pains, and most importantly we genuinely care about your success. That is what motivates us! Share with us what Trxade has done for your Pharmacy. We love to make a difference and hear success stories.

How PBM’s Control Formularies and Affect Market Pricing

How PBM’s Control Formularies and Affect Market Pricing

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How PBM’s Control Formularies and Affect Market Pricing

Independent Pharmacies at a Disadvantage

As you all know, Formularies are lists of drugs that are preferred by a health plan or employer. ‘Closed’ formularies are lists of drugs that are available for coverage by the organization. Coverage for medications not on the list may be available only if the physician believes that the drug is clearly preferable and obtains a waiver” (Huskamp, Epstein, & Bluementhal, 2003).

Financial incentives can be offered to physicians and patients for prescribing and taking medications, respectively, that are on the formulary (Huskamp, Epstein, & Bluementhal, 2003). Is this ethical? How does this affect independent pharmacies that have no say in what medications are offered? It puts independent pharmacies at a disadvantage and unfairly dictates what medications they sell and the high prices they have to pay to stock those medications.

Negative Reimbursements

We won’t even get started on the topic of negative reimbursements and a PBM’s role in that process. Or lack of… But since we know you are thinking about it we have to at the very least mention it. We have posted blogs about the frustrations of PBMs and negative reimbursements. Keep in mind that is one way Trxade can save you a lot of money. Review the drugs you are getting negative reimbursements on now and comparison shop on Trxade.

If you could buy the drugs you get negative reimbursements on cheaper, you would right? We all would… That is one major way Trxade helps Independent Pharmacies thrive. If you have a minute watch this quick testimonial from Shellman Pharmacy in Georgia addressing this very issue where they are now seeing PROFITS on drugs they were getting negative reimbursements on by using Trxade.

What Do You Think?

How sufficient is this process? Can we trust big PBM’s to do what is best for us, our patients, and our businesses? What do you think is their main driver in including a medication on the formulary… Money, or the health of the patient? I don’t know about you, but I’d be curious to see what incentives they receive.

How Do PBM’s Determine What Medications Are Listed on the Formulary?

Formularies are just one way that Pharmacy Benefit Managers (PBM’s) control and manage drug benefits for insurance companies. After a drug has been approved by the U.S Food and Drug Administration (FDA) PBM’s then follow a multi-step process to determine what medications are listed on the formulary.

One large PBM follows a 3-step process:

  1. The first step is to evaluate the safety, dosage, and effectiveness of a medication, taking into account the negative side effects.
  2. The second step is to review the findings in the first step and compare cost with other clinically comparable drugs.
  3. The last step is to review the findings from the first two steps, decide whether the drug will be listed on the formulary, and if so, determine what tier the drug will be placed in. (http://www.mass.gov/anf/employee-insurance-and-retirement-benefits/manage-your-health/prescription-drugs/drug-formularies-are-determined-through.html).

References:

Huskamp, H., Epstein, A., & Bluementhal, D. (2003). The impact of a national drug formulary on prices, market share, and spending: lessons for Medicare? Health Affairs, 22 (3), 149-158. Retrieved from: http://search.proquest.com.ezp.waldenulibrary.org/nursing/docview/204641530/59440EC7C1EE4A2FPQ/2?accountid=14872

http://www.mass.gov/anf/employee-insurance-and-retirement-benefits/manage-your-health/prescription-drugs/drug-formularies-are-determined-through.html