Solutions?

Solutions to the drug shortage are elusive, mostly because we do not understand the causes.

There are of two types of solutions. — mitigating and preventive. Only the first has received much attention or action.

Mitigating solutions — these are intended to help decrease the effects of the drug shortage. They may be helpful, but they are “inside the box.”

  1. Advance reporting of future shortages —  legislated as “mandatory” since Feb 2015–however, in Canada reporting is not always practised in advance, and it is not always penalized when it fails. This solution would give patients, pharmacists, and doctors warning to start looking for alternatives. It does not fix the shortage. The Netherlands set up such a centre in 2017 after a shortage of thyroxine.
  2. Alternatives and Substitutes. Some sites offer suggestions as to which drug(s) to use instead of the one(s) in short supply. Along these lines, in March 2016, the U.S. FDA, offered to speed up applications to manufacture drugs which currently have only one supplier. But fast-tracking can result in danger and/or legal action, as for example in the US meningitis outbreak of 2012 that led to a jail-term for a pharmacist, and accusations of misuse of funds in Guyana, both in 2017.
  3. Ethical decision making to help decide who gets what when drugs are in short supply. See for example, this pediatric advice, which appeared in early 2016. Again, it does not fix the shortage; it only helps to manage it.
  4. Fast tracking approvals of substitutes and “sole-source” products. The US FDA implemented this process in March 2016  See here and here.
  5. Manufacturing technologies to introduce flexibility in the supply system that would answer to increased demand. See for example, MIT’s portable machine announced in April 2016.

Preventative solutions — these are intended to help prevent drug shortages.

  1. Creation and maintenance of Essential Medicines Lists (EML) to establish the most important drugs and to make a commitment to stocking them at all times. Canada does not have an EML. See here. A policy with commitment to maintaining essential medicines promises to end shortages in Gambia. But why are such policies reserved for developing nations only?
  2. Study and control of the appropriate price for generic drugs–some argue that prices are too low to make the drugs profitable; some argue that generic prices soar inappropriately taking advantage of shortages. Bulk buying has become popular to generate cost-savings — but this mechanism, together with the effect of large American Group Purchasing Organizations, may drive the cost of drugs so slow that companies will stop making them.
  3. Forcing manufacturers to respect the “duty to supply” clause of their licences. So far this angle has not worked, the  US Supreme Court refused to hear the arguments of Jennifer Lacognata and the widow of William Fabry that companies have a duty to supply (see Consequences) This result affirms the idea that “medicine manufacturers have no legal duty to continue selling medicines when they want to stop.” Such a duty to keep selling “would compete far too fundamentally with the essential premise of the American free enterprise system.” William M. Janssen in Am J Law and Medicine 2014 40:330-92. But at what cost?
  4. Consider creating a nationally owned pharmaceutical manufacturing entity. Former CPSO President Dr. George Miller agrees. See his post at this site.
  5. Encouraging more competition between manufacturers, and expediting approvals, two bills introduced in early 2017 and supported by group purchasing organizations. See here and here.
  6. Since manufacturing problems are the cause most frequently cited by industry, in 2017 the US FDA proposed to track quality issues. But this plan is opposed by the pharma industry.

In all cases, to solve the drug shortage problem we need to understand its Causes. We also need to measure it. Canada is not measuring the rate, duration, frequency, or nature of the drug shortages through time. Without this information, it is difficult to fully understand its nature, impact and causes.