Something strange is going on in the world of prescription drugs. Hospital and community pharmacists are seeing ever-more-frequent and troublesome shortages.
The medications missing in action are not obscure potions for rare diseases or popular lifestyle drugs such as Viagra. They are everyday staples that have been around for decades.
Here are some examples:
*Penicillin: the granddaddy of antibiotics has been in use since the 1940s; it is used to treat certain infections ear, skin and throat infections
*Tetracycline: an antibiotic used to treat bacterial infections such as pneumonia and to kill the bug that causes stomach ulcers ( Helicobacter pylori)
*Erythromycin: an antibiotic used to treat bacterial infections such as bronchitis, whooping cough and pneumonia
*Hydrocortisone lotion: a product used to treat various skin infections and rashes and the discomfort of hemorrhoids
Cephalexin: an antibiotic used to treat ear and skin infections;
Doxycycline: an antibiotic used to treat bacterial infections, such as urinary-tract infections and chlamydia
Metoclopramide (brand name Maxeran): a drug used to relieve heartburn and speed the healing of ulcers and sores in the esophagus in people who have gastroesophageal reflux disease
Heparin: an anticoagulant (blood thinner) used to prevent clots from forming in catheters worn by people with a number of conditions
Twinrix: a combination hepatitis A and hepatitis B vaccine
Amitriptyline (Elavil): a tricyclic antidepressant used to treat depression and pain from shingles
Prochlorperazine (Stemetil): an antipsychotic used to treat schizophrenia; it is also used to treat nausea and vertigo in cancer patients
Thiopental sodium (Pentothal): an anesthetic used to put patients under for surgery.
A recent survey of pharmacists showed that virtually all of them - 93 per cent - are currently dealing with drugs shortages, on average 10 products a week.
What exactly is going on here?
The explanations are many and varied: scarce raw ingredients, manufacturing glitches, reduced production (or discontinuation) of a particular drug, changing government monitoring and stricter price regulation (particularly lower generic prices that provinces have imposed).
In other words, there doesn't seem to be a single underlying cause, but a cocktail of problems.
There are, however, some trends that are worrisome because they suggest that drug shortages are not going away; if anything, they will probably grow worse.
The pills we pop and the drugs we inject, inhale and suppose (as in suppository) all contain a multitude of components, including the active ingredient, binding agents and preservatives.
Increasingly, manufacturers get the raw ingredients from countries such as China and India, where standards are not always up to snuff. For example, contamination at a large heparin-manufacturing plant in China led to a worldwide shortage.
That sparked stricter regulation, which, in turn, has slowed production and is probably the root of shortages.
There has also been a major consolidation of the pharmaceutical industry - brand-name and generic - in recent years. That means that fewer companies are producing drugs, even commonly used ones, and that means the impact of manufacturing glitches is magnified.
It is not a coincidence either that the most acute drug shortages involve products that are cheap (read: not excessively profitable). If you have limited capacity, are you going to use it to make an antibiotic that sells for pennies a pill or one that sells for dollars a pill?
In Canada, drug prices are strictly regulated and this also creates a disincentive for production and distribution. This is especially true in the generic field, where provincial governments (led by Ontario's) have slashed drug prices by half - to 25 per cent of the price of the brand-name drug from 50 per cent).
But those who blame pharmacists for creating the shortages because they are angry with the price cuts are misguided because the shortages have added tremendously to their workload.
One little talked-about issue is the fact that when shortages are resolved, there are usually financial repercussions. When the cancer drug prochlorperazine disappeared, pharmacists, physicians and patients made a fuss. It soon returned, but the price was 56 per cent higher.
The problem isn't unique to Canada, either. The U.S. is in the midst of the worst drug shortage in the country's history, with some pharmaceutical companies and industry experts citing problems with raw active ingredients as a major reason.
Patients are being inconvenienced and, in some cases, harmed by drug shortages.
Unfortunately, there is no fast or simple solution. But the starting point has to be information.
The U.S. Food and Drug Administration requires manufacturers to notify them of drug shortages (even potential ones) and the information is publicly available in a detailed list.
Health Canada has no such regulation and no such list. But if you don't have a sense of the magnitude of a problem, how can you possibly hope to resolve it?Report Typo/Error