Abstract
Frequent and often prolonged shortages of various drugs appear to be the “new normal” in Canada and worldwide — a situation that is both frustrating Canadian pharmacists and spurring them to action.
While the causes of the drug shortages are complex and rooted in global trends, the Canadian Pharmacists Association (CPhA) is working with other stakeholders to hammer out solutions to a problem that has affected this country for the past 2 years. This work includes development of new mechanisms to help pharmacists and other health care professionals better plan around shortages and reduce negative effects.
“The CPhA has been leading efforts to create a national drug-shortages monitoring system, similar to what already exists in the United States,” says Jeff Morrison, CPhAs director of government relations and public affairs. “Of course, a monitoring system won't stop shortages from occurring but it will mean more predictability.”
Planning for a national monitoring system is underway, says Mr. Morrison, and he also points to progress linked to some of the factors behind the shortages themselves.
— Jeff Morrison, CPhA, Director of Government Relations and Public Affairs
Difficult to pinpoint drug shortage causes
On August 18, 2011, Health Canada announced that more than a dozen drugs, including several oncology drugs, may be in short supply indefinitely because of manufacturing deficiencies identified at the facilities of an Ohio-based contract manufacturer. Manufacturing problems are one possible reason for shortages but there are many others, Mr. Morrison says. It is difficult to pinpoint accurate causes of specific shortages because the private companies and other parties in the drug supply chain are not obligated to provide such information.
Through discussions with manufacturing associations and independent research, CPhA has identified other leading causes of drug shortages globally: a lack of active pharmaceutical ingredients (APIs), especially those sourced internationally; government regulations that may be barriers to ramping up production and may also delay approval of new generic drugs; and the overall increased international demand for drugs. In addition, although there is no independent verification, there is widespread speculation that in Canada, the various provincial generic drug-pricing reforms have led manufacturers to suspend or cut back on the production of certain drugs due to lack of profitability.
Because the causes are multiple, complicated and difficult to ascertain, finding solutions is “an incredibly daunting task,” says Mr. Morrison. “Trying to fix the problem when you have such complexity and fragility in the drug supply chain is very difficult.”
Some progress being made
CPhA efforts have included raising the profile of the drug-shortage issue among political players and the public. In December 2010, the association released a survey that revealed 81% of pharmacists polled had dealt with a drug shortage in their last shift, and 93% had dealt with one in the past week. According to Mr. Morrison, the heightened public awareness is having an impact on manufacturers. “We know they have received the message that this is a serious concern, that there is a need for greater accountability on their part to ensure supply of these drugs.” He points to the fact that in June 2011, Teva Canada took out a full-page ad in The Globe and Mail to say it was adding manufacturing capacity to help address shortages.
The federal government is also contributing to solving the problems. Health Canada has, for example, taken steps to streamline its notifiable-changes regulations, to speed approval of changes to manufacturers' chemical or production processes; sometimes this approval can take as long as 18 months.
Increased monitoring will provide benefits
A working group with members representing CPhA, manufacturers, wholesalers and associations for hospital pharmacists and physicians is looking at developing a national drug-shortages monitoring system modelled after the one in the US (and some countries in Europe).
“The monitoring system is not intended to have a direct impact on the drug shortages,” says Mr. Morrison. “But it will address the fact that currently, doctors, pharmacists and patients have no idea of which drug is in shortage, when or for long. Trying to prescribe or dispense a certain drug is basically a shot in the dark; you are assuming a drug is available, but you don't know because there is no oversight mechanism.”
The working group is examining the possibility of a public website, which would provide information from manufacturers about drugs in short supply, the reasons, the anticipated resumption date and alternative treatments.
“This is probably the most difficult initiative we are pursuing, because it will involve the partnership and participation of a lot of different stakeholders,” says Mr. Morrison. “It's taking a bit of time but we are hoping to see some results in the near future.”