| This week the Royal Pharmaceutical Society continues its process
of modernisation with the publication of a revised draft
Charter. On the other side of the world, the Pharmaceutical Society of
New Zealand is being transformed.
In Canada, Australia and the United States, pharmacists are represented
and regulated by separate bodies. And the changes in New Zealand will
result in a similar situation there. So the system in the United Kingdom,
of having one body with both representative and regulatory functions,
is becoming more unusual.
Pharmacy in New Zealand
Change is the key word in New Zealand. The Pharmaceutical Society of
New Zealand (PSNZ) is undergoing a major reorganisation.
The set-up in New Zealand used to be similar to that in the United Kingdom.
As both the statutory registration body and the professional body for
pharmacists, the PSNZ had similar functions to the Royal Pharmaceutical
Society of Great Britain.
All that is about to change: the PSNZ is to be split in two. The regulatory
function will be carried out by a newly created Pharmacy Council and
this will leave the PSNZ to be reformed as a new voluntary professional
organisation to be known as the
Pharmaceutical Society of New Zealand (Incorporated).
The reorganisation is the result of a government bill: the Health Practitioners’ Competence
Assurance Act. It is intended to provide a framework for the regulation
of all health care professionals, not just pharmacists. The act was passed
in the New Zealand parliament last month and received Royal assent on
18 September 2003. There will now be a transition period of one year
before the act comes into force in September 2004.
The detail of how the new bodies will operate is still being determined.
The founding principles of PSNZ (Inc) will be based upon advocacy and
representation for pharmacy. It will provide membership services such
as advice about pharmacy practice, awards and scholarships, training,
library services, an annual conference, a branch network and other forms
of support.
The Pharmacy Council will be established by 18 December and it will operate
in tandem with the PSNZ for nine months. It is anticipated that pharmacists
will form the majority on the new regulatory body. The PSNZ says that
it expects that the composition of the Pharmacy Council will be six health
practitioners and two lay people.
Not surprisingly, the split of the PSNZ has raised concerns and the debate
looks set to continue until the new bodies are in place.
Cost is an issue. The PSNZ says that there will be big costs in setting
up the two new bodies and the assets of the current PSNZ will be divided
between the Pharmacy Council and PSNZ (Inc).
An increase in fees for pharmacists is anticipated. Earlier this year,
the PSNZ said: “We estimate that annual fees to maintain professional
and statutory services for pharmacists will double under this legislation.”
Are pharmacists in New Zealand happy with the changes? Chief executive
and registrar of the PSNZ, Dr Joan Baas, says: “The president of
the society and I are about to embark on a series of meetings around
the country to fully inform pharmacists of what is happening. From that
we shall be able to gauge how they feel about the changes.” But
she added: “We know that the costs for pharmacists for [joining]
the new organisations will be an issue. We will be seeking their views
on what they are prepared to pay for and how we can work to make it as
affordable as possible.”
However, the fact that under the new structure pharmacists will know
exactly where they stand in terms of receiving support is a clear benefit,
according to Dr Baas. “The Pharmacy Council’s role will be
public safety so, therefore, not always supporting the pharmacist. The
voluntary organisation, however, will always provide professional support,
advice, and advocacy for the pharmacists. It will be a professional organisation
that is there for them.”
Perhaps cautious optimism is the way to describe how Dr Baas interprets
the changes. She comments: “It is hard to know whether, on balance,
this division is the best thing for the profession and the public. Like
the RPSGB, the PSNZ working for both the profession and for pharmacists
has, over the years, positioned pharmacists well in terms of professional
standards, competence programmes and continuing professional development.
It has been this mandatory body working to advance the profession that
has developed pharmacy to where it is today.”
Dr Baas adds: “It may be hard to maintain the professional impetus
in the future when membership will be voluntary.”
Other countries are not experiencing this level of change, but perhaps
it is worth looking at how pharmacy and pharmacists are regulated and
represented elsewhere.
Pharmacy in the United States
Pharmacists in the US have to consider decisions made at both state and
national (federal) levels. As a general rule, the day-to-day regulation
of pharmacy is conducted at a state level.
Michael Posey of the American Pharmacists Association has recently written
a book about pharmacy in the US called “Pharmacy: an introduction
to the profession”. He explains: “Some of the laws vary from
state to state, and many state laws differ from federal pronouncements.
A key rule to remember is that the more stringent law is the one that
should be followed, regardless of its origin.”
In terms of federal regulation, the agencies that have the greatest impact
on
pharmacy are the Food and Drug Administration (FDA), the Drug Enforcement
Administration (DEA) and the Centers for Medicare and Medicaid Services
(CMS). The FDA approves and regulates the licensing of drugs and medical
devices. The DEA regulates Controlled Drugs. Meanwhile, the CMS is responsible
for public health care cover and is important to pharmacists because
prescriptions for these patients are often determined by an approved
list of drugs.
Much of the regulation of pharmacy falls to state government. Mr Posey
comments: “The area of drug and pharmacy regulation has been one
in which the federal government has creatively enlarged its role when
it felt that the public health was at risk, but the states remain an
integral part of the regulatory framework.”
It is state law that controls the regulation of health professionals
and this is done though boards composed of members of the profession
and consumers. State boards of pharmacy issue licences to pharmacists
and pharmacies and have the authority to withdraw licences when necessary.
Activities of state boards are co-ordinated by the National Association
of Boards of Pharmacy which provides an examination that is used in all
states.
“It is important to remember that state boards of pharmacy have as
their primary mission the protection of the public from the profession — not
vice versa. Pharmacy associations, conversely, exist to promote the profession,
which sometimes leads them along paths that are not necessarily in the
best interests of the public,” comments Mr Posey.
The three biggest US associations in terms of membership are the American
Pharmacists Association, the National Community Pharmacists Association
and the American Society of Health-System Pharmacists.
The American Pharmacists Association (APhA) was formed in 1852 as the
American Pharmaceutical Association. It changed its name in December
last year. The change was voted for by nearly 90 per cent of APhA members
and was encouraged by the APhA board of trustees who said that the old
name “conveyed a focus on drug products rather than a focus on
the health professionals and scientists who make up the association’s
membership”.
The APhA has 53,000 members including pharmacists, pharmaceutical students
and pharmacy technicians. The APhA represents the whole of pharmacy and
its mission is to provide “information, education and advocacy
to help all pharmacists improve medication use and advance patient care.”
Meanwhile, the National Community Pharmacists Association has 25,000
members. It represents the interests of owners and employees in independent
community pharmacy.
The American Society of Health-System Pharmacists has 30,000 members,
the majority of whom work in hospital care, but also includes members
in other care settings such as long-term
care homes. The ASHP changed its name from the American Society of Hospital
Pharmacists in 1995 to reflect this diversity of members.
Many other organisations exist to represent the interests of smaller
groups within the pharmacy profession in the US.
Pharmacy in Canada
Pharmacy in Canada is also regulated locally and represented on a national
level.
Jeff Poston, executive director of the Canadian Pharmacists Association,
explains: “Pharmacy is regulated by provincial legislation. Each
province has a self-regulating pharmacy licensing body usually designated
as a ‘College of Pharmacy’.” The provincial regulatory
authorities grant pharmacist licences and assess the competency of pharmacists.
An umbrella organisation — the National Association of Pharmacy
Regulatory Authorities — was established in 1995 to harmonise the
activities of the provincial regulatory authorities and to enable a national
approach to be taken on common issues. Its functions include representing
the interests of member organisations, providing resources and promoting
implementation of progressive regulatory standards.
Also at a provincial level are organisations that negotiate with provincial
governments on behalf of pharmacists and act as advocacy bodies. Membership
is on a voluntary basis. Dr Poston explains: “They negotiate terms
and conditions with provincial governments for services provided in provincial
drug plans. About 50 per cent of scripts in Canada are public drug plans
and 50 per cent are private plans.”
Several representative bodies exist on a national level. The Canadian
Pharmacists Association (CPhA) is the national professional body with
voluntary membership. Its vision is “To establish the pharmacist
as the health professional whose practice, based on unique knowledge
and skills about drug therapy, ensures optimal patient care.” The
association provides members with advocacy — aiming to raise pharmacists
profile with policy makes and consumers — and is also a publisher.
The CPhA was established in 1907 as the Canadian Pharmaceutical Association
but changed its name to the Canadian Pharmacists Association in 1997.
Other national organisations in Canada include the Canadian Association
of Chain Drug Stores (a trade association) and the Canadian Society of
Hospital Pharmacists.
Pharmacy in Australia
Pharmacy in Australia has a similar set-up to the US and Canada in terms
of national representation and local regulation.
Representation is the function of the Pharmaceutical Society of Australia
(PSA). The PSA is in the process of reform. It was established in 1977
as a federation of state professional pharmaceutical societies which,
until then, had represented pharmacists at a state level. The PSA now
represents nearly 10,000 pharmacists in Australia.
Kerry Deans of the PSA explains: “The PSA is a federation consisting
of state branches and the national office in Canberra. At the moment
we are working through a process of investigating the possibility of
becoming a single national organisation and will reach a decision at
the end of this year about whether we wish to continue to pursue that
goal.” She adds that it is too early to predict the outcome.
Regulation of pharmacy in Australia happens at a state or territory level.
Kerry Deans says: “Pharmacists must be registered in the state
or territories in which they practise but the jurisdictions within Australia
operate under a mutual recognition arrangement so that if you are registered
in one state/territory there are usually no barriers to becoming registered
in another. The boards are currently moving to competency based re-registration
process.”
Unusual situation
Although the Royal Pharmaceutical Society is retaining its dual role
of regulation and representation, this system is not reflected elsewhere
in the English-speaking world. The developing model in New Zealand,
and the different systems in other parts of the world, might influence
the UK landscape in years to come.
Further information on the internet
Further information about the bodies that regulate and represent
pharmacy can be found at the following websites.
• Royal Pharmaceutical Society of Great Britain www.rpsgb.org.uk
• Pharmaceutical Society of New Zealand www.psnz.org.nz
• Details about the Health Practitioners’ Competence Assurance
Act can be found on New Zealand’s ministry of health website
www.moh.govt.nz
• American Pharmacists Association www.aphanet.org
• National Community Pharmacists Association (US) www.ncpanet.org
• American Society of Health-System Pharmacists www.ashp.org
• Canadian Pharmacists Association www.pharmacists.ca
• National Association of Pharmacy Regulatory Authorities (Canada)
www.napra.org
• Canadian Association of Chain Drug Stores www.cacds.com
• Canadian Society of Hospital Pharmacists www.cshp.ca
• Pharmaceutical Society of Australia www.psa.org.au |
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