Tranylcypromine: a red flag for broader reflection

Drug shortages are quite literally a lethal problem. Pharmaceuticals are essential health products, subject to health regulations, and cannot be treated as mere commodities within the lucrative financial system. On November 8, 2023, psychiatrists in Brazil were alarmed by the news – confirmed by the Brazilian National Health Surveillance Agency (Anvisa) – of the temporary discontinuation of tranylcypromine (Parnate^®, registration no. 1010701460035) sales in the country. Used in patients with treatment-resistant depression, this monoamine oxidase inhibitor is irreplaceable in the market, and its absence poses a significant challenge. Given the risk of shortages, a guaranteed supply of 12 months post-notification is required; however, this is insufficient.

Effective medications can sometimes be replaced by proven, superior substances. In this case, are such alternatives available? Which ones? How can we address this gap? Merely stating that other medications exist is too vague to be useful. We must consider the impact of shortages on the quality and safety of affected patients as well as the possibility of increased healthcare costs, as newer therapeutic alternatives tend to be more expensive.¹ Beyond the profit-driven system, low-turnover ethical drugs should be viewed as a social responsibility, especially since many physicians suspect market manipulation to be involved in some shortages.²

The grave issue of drug shortages is not unique to Brazil; it is a global problem,³ “from Afghanistan to Zimbabwe.”⁴ It also extends beyond psychiatry, which has already seen the discontinuation of Orap^® (pimozide), Semap^® (penfluridol), Melleril^® (thioridazine), Olcadil^® (cloxazolam), and Tofranil^® (imipramine), and now faces the potential loss of Parnate^® (tranylcypromine) and Stelazine^® (trifluoperazine). Since the 1950s, the “golden decade” of psychopharmacology, there have been minimal advancements in the form of novel, expensive medications. All healthcare levels, both public and private, suffer with the halting of production and sales of drugs.⁵ Therefore, integrated and committed action between government institutions and manufacturers is necessary to minimize public health damage, as therapy is often modified for reasons other than clinical needs, increasing the risk of errors and treatment failure.²,³

If “good fences make good neighbors,” as the poet Robert Frost said, then Anvisa, with its regulatory role, can and should intervene in cases like that of Parnate^®, a drug used for treating serious medical conditions for which alternative drugs are not as effective and no other manufacturer exists in the country. Government intervention in preventing and managing drug shortages is a crucial control measure,¹ as drugs, particularly those of last resort like MAOIs, play a unique social and individual role in sustaining health and life. They are essential tools for survival.

References

• ¹
  Reis AMM, Perini E. Drug shortage: determinants, consequences and management. Cienc Saude Colet. 2008;13:603-10.
• ²
  Provisional observations on drug product shortages: effects, causes, and potential solutions. Am J Health Syst Pharm. 2002;59:2173-82.
• ³
  Van Oorschot KE, van Wassenhove LN, Jahre M, Selviaridis K, Vries H. Drug shortages: A systems view of the current state. Decis Sci. 2021;53:969-84.
• ⁴
  Gray A, Manasse Jr HR. Shortages of medicines: A complex global challenge. Bull World Health Organ. 2012;90:158-A.
• ⁵
  Rosa MB, Reis AMM, Perini E. Drug shortage: a public health problem. Cad Saude Publica. 2016;32:e00086916.

Edited by

Handling Editor: Andre Brunoni

Publication Dates

• Publication in this collection
  09 Sept 2024
• Date of issue
  2024

History

• Received
  04 Dec 2023
• Accepted
  10 Jan 2024