Health Canada goes to public for input on drug access

Initiatives to help ensure the integrity of Canada's drug supply and enhance the safety of drug prescription system

As the Canadian government wraps up its call for the public's view on measures proposed to ensure access to prescription drugs, the Canadian Medical Association and a group of allied health professionals are response-ready.

The deadline for comment was Nov. 7, but the CMA, working with pharmacists and nurses, among others, has been formulating its thoughts since June.

The federal government has sought "the advice of health professionals, regulators, the pharmaceutical industry, provincial and territorial governments and the public as we develop initiatives to help ensure the integrity of Canada's drug supply and enhance the safety of Canada's drug prescription system," federal Health Minister Ujjal Dosanjh said.

"The possible legalization of bulk imports of Canadian drugs in the U.S. has underlined the need for measures aimed at protecting the health and safety of Canadians and to support continued access to an adequate supply of safe and affordable drugs," he added.

When announcing the consultations, Ottawa also released two discussion papers. One deals with a proposed drug supply network and export restriction scheme, the other with a proposed regulatory amendment requiring an established patient-practitioner relationship as a condition of prescription drug sales in this country. The consultations included face-to-face meetings and a dedicated session with medical and pharmacy regulatory authorities.

Ottawa plans to create and maintain a list of drugs that would be prohibited from bulk and retail export when necessary to protect the health of Canadians.

Controls would only be implemented, a Health Canada release stated "in response to a shortage or the risk of a shortage of a drug or class of drugs and would only be maintained for a specified period, subject to renewal, or for such time as the risk persists."

Also proposed is a strengthening of existing federal provisions under the Food and Drug Act requiring drugs to be sold only after a patient-physician relationship has been established to avert misuse through electronic prescribing and telemedicine.

"The proposed amendment is directed toward pharmacists, who are knowingly participating in questionable conduct by selling prescription drugs where there is reason to believe the prescription was not issued within an established patient-practitioner relationship," the Health Canada release also states.

CMA president Dr. Ruth Collins-Nakai told the Medical Post physicians also have some ideas of their own, and the CMA has shared them with allied health professionals. Saying "most of us are singing from the same hymnbook," she doesn't think the CMA's views will be drowned out by all the other players.

Sales of Canadian drugs to the U.S. amount to more than $1.3 billion a year. At least 8% of Canadian prescription drugs are dispensed to U.S. citizens, according to CMA briefing materials.

Most cross-border sales require prescriptions signed by a physician licensed to practise medicine in Canada, but the U.S. government is considering legislation to legalize drug imports and eliminate the need for a Canadian prescriber as an intermediary.

"That could seriously affect the security and affordability of prescription drugs for Canadians," the CMA document indicates. "The federal government must develop a strong, effective monitoring system that can analyse the state of Canada's drug supply, identify shortages and respond quickly to correct them," it states. "Canada does not have such a system at present . . . to ensure decisions are founded on accurate and reliable knowledge."

The CMA has a three-pronged, board-approved strategy:

• Respect professional regulatory authorities: Most physicians only prescribe for patients in the context of a professional relationship, CMA officials say. Those who don't, contravene CMA policy and standards of practice enforced by provincial and territorial colleges of physicians and surgeons. Some doctors have already been disciplined for inappropriate cross-border prescribing, and the CMA wants Ottawa "to respect and support" medical groups working "to ensure high standards of prescribing behaviour."
• Investigate trade-related solutions: Bulk importation of drugs by the U.S. poses "a more serious threat" to Canada's drug supply than even large numbers of individual U.S. patients purchasing Canadian medications. "It's a large-scale problem that should be addressed through large-scale solutions, such as export bans or two-tier pricing policies," according to the CMA statement.
• Go outside the Food and Drug Act if necessary: "Health Canada has proposed using the Food and Drug Act to control the cross-border trade. Solutions might also, or instead, be found in other laws and departments, such as the Department of International Trade."

Source: RefillPill.com Editors' Choice