Communicating the new ABPI code to NHS customers
It is important that health care professionals are aware of the new
Association of the British Pharmaceutical Industry code of practice,
Martin Anderson, director NHS policy and partnerships at the ABPI, told
delegates. Although the changes to the code are well known within the
pharmaceutical industry, they are not as well known outside the industry
as the ABPI would like them to be, he said, and a communications plan
is under way to help inform NHS customers.
Mr Anderson described the key messages in the new code, that was agreed
in
November 2005 following a comprehensive consultation process. The code
is a mandatory document affecting almost every pharmaceutical company
in the UK. It is designed to prevent unethical and inappropriate practices,
and ABPI member companies have had to be compliant with it from this
spring.
The code comprises a number of clauses, covering aspects including marketing
authorisations, gifts and inducements, distribution of promotional material
and hospitality and meetings. Mr Anderson explained that one of the most
serious offences a pharmaceutical company can commit is to be in breach
of clause two — discrediting the industry. Staff training is also
covered in the code. For example, it is a mandatory requirement that
all pharmaceutical representatives pass the ABPI examination within 12
months of starting their job.
Some of the main changes to the code include:
· Further restrictions on what can be provided to health professionals
in the way of promotional aids, hospitality, subsistence, travel and
accommodation
· All new material to enter the market will now contain information to
the patient about reporting adverse drug reactions
· Stronger sanctions if companies are found to be in breach of the code
· Promotional competitions are no longer allowed
· Pharmacists can now certify certain promotional material in place of
a
medical signatory
· Delegates sponsored to attend meetings are limited to economy air travel,
(although they may pay for an upgrade themselves)
Expanding on clause 19, which covers hospitality, Mr Anderson explained
that a reasonable expense for a guest is defined as what you would expect
the guest to spend on themself. Lavish or deluxe venues are not to be
used, and companies should avoid using venues renowned for their entertainment
facilities.
He explained that a “memorandum of understanding” has been
put together by the Medicines and Healthcare products Regulatory Agency,
the ABPI and the Prescription Medicines Code of Practice Authority (established
by the ABPI to administrate the code) setting out the responsibilities
of each group. He noted that self-regulation should be the first means
of dealing with complaints, with the MHRA stepping in “when there
is a clear case for protection” or if self-regulation fails.
Sanctions
It was decided that companies in breach of the code would not be subject
to a monetary fine. Instead, severe breaches of the code will now be
published in the press by the ABPI, and might adversely affect the share
prices of the company in question.
Companies must now withdraw any offending items more quickly than was
required under the previous code. Furthermore, the PMCPA will increase
the number of audits and visits they will make, and companies may be
suspended or expelled from the ABPI. Mr Anderson pointed out that, should
a company be removed from the ABPI, the MHRA would scrutinise every promotional
activity which that company undertook with the NHS, taking a large amount
of time. “If you are trying to launch a product and you have to
have every step certified by the MHRA before you can put it into the
market place, that really does slow down your launch and that costs millions
of pounds,” he explained. Mr Anderson noted that these sanctions
and restrictions may be increased if the code is not adhered to.
He added, “It is important that customers understand the code and
do not ask us to do inappropriate things, and if you do think we are
doing inappropriate things, complain. It is only through this self-regulatory
process that we will actually manage the behaviour in a way that is acceptable
to you as customers and to ourselves as the industry.”
He reminded delegates that anybody who thinks a company is breaking the
code can put in a complaint. “You do not have to be a health professional
or a senior person,” he said.
Impact of the new EU regulations on procurement in England and Wales
An overview of procurement in the
NHS in Wales in the past, at present and as it may look in the future
was presented by Gunther Kostyra, contracts
manager at Welsh Health Supplies.
The NHS All-Wales Procurement strategy is currently being updated, Mr
Kostyra said, but the key elements of electronic working, sustainable
development and alignment of contracting will remain.
Welsh Health Supplies has had to rework its procedures to comply with
the new EU directives which came into force at the end of January, Mr
Kostyra explained. The main issues for them have been around the criteria
for awarding contracts, ensuring transparency, and building matters such
as sustainable development into the procurement process. “I really
believe that we ought to look at the impact our purchasing decisions
have on the social, economic and environmental issues relating to the
country,” he said. There is now scope in the EU regulations to
include sustainable development criteria, and although the new directives
have necessitated a lot of work, they reinforce good practice in procurement,
he said.
Turning to web tendering, Mr Kostyra said that Welsh Health Supplies
has been using this technology for two years and that it is catching
on in most of the public sector. It is a simple process which allows
quantitative information to be downloaded onto contract management systems.
This gives more time to look at qualitative issues and also saves on
paperwork.
In terms of transparency, the new regulations leave nowhere to hide,
he said. The Freedom of Information Act obliges them to release meeting
notes, details of attendees and overall contract values. “We are
spending public money and you should know how we are spending public
money,” he said.
According to Mr Kostyra, in the future there will be greater consideration
of the impact that decisions made in secondary care might have on primary
care. “The penny is finally dropping with the Welsh Assembly Government
that we are spending a lot more on pharmaceuticals in primary care than
we are in secondary, yet we put a lot more resources into managing secondary
care costs.” He said that he expects greater collaboration in public
sector procurement in the future, and an even more professional approach. New assessment tool
V'Iain Fenton-May: a product’s suitability for robotic
dispensing is taken into account |
V’Iain Fenton-May, quality assurance pharmacist for Welsh Hospitals,
at St Mary’s Pharmaceutical Unit, Cardiff, described a new contract
assessment tool being used in Wales.
After an initial filtering of items has been carried out by the All Wales
Drugs Contracting Committee’s quality assurance group (considering
factors such as how the company is rated and the strategic need), value
for money is then assessed depending on acquisition costs and risks.
In addition, the pharmacy purchasing group, representing Welsh trusts,
will give an ongoing assessment of each company and product. Each item
is assessed for suitability for robotic dispensing, and classed as being
an item that is “essential” to be put into the robot (ie,
likely to prevent known picking errors), “desirable”, or “not
necessary”. This is then taken into account when calculating the
product quality assessment score. When scoring suppliers, companies are
rated on aspects such as past reliability, acceptable returns policy,
price changing history and complaints handling.
During quality assessment, the products are scored on factors including
ease of opening, consumer satisfaction and readability of the label.
The barcodes on the product are also checked for readability. Mr Fenton-May
explained that some barcodes are smudged and some products even have
the same barcodes for different strengths of drugs. If companies reuse
barcodes of discontinued lines this can lead to errors, since the old
codes may still be in the computer memory, leading to issue of the wrong
product.
Mr Fenton-May explained that products are allocated scores that are only
relevant against competing lines and have no relevance elsewhere or to
another line. Each line will be scored and the adjudication document,
including the scores, will be submitted to the Drug Contracting Committee
for a final decision.
Transparency
Ian Allen, category manager, NHS Purchasing and Supply Agency (PASA),
described how, unlike in Wales, in England framework agreements are used
for purchasing, as allowed by the new directives.
Similarly to the situation in Wales, it is the award criteria aspect
of the new legislation that has most challenged PASA. Dr Allen explained
how, in England, award assessment is a two stage process. In the first
stage, the commercial stage, PASA considers the cost of the items, the
risk associated with awarding each contract, and supplier performance.
He said that PASA is starting to improve its monitoring of supplier performance
and feeding this information back to local adjudicating groups and suppliers.
In the second stage, the technical stage, PASA looks to the NHS hospital
pharmacy service to assess quality assurance, and, again, risk and supplier
performance.
There is now a greater focus on being able to demonstrate transparency,
and mechanisms must be in place to explain exactly why each supplier
did or did not win the business. There is also the opportunity for a
further debrief if requested, Dr Allen explained. He described how PASA
is currently developing a descriptive document to provide a full explanation
to any potential supplier of what processes they will use to award contracts.
Turning to e-procurement, Dr Allen explained that PASA uses a web provider
to deliver the tender package. Electronic auctions have also been used
successfully in the past, and the new directives provide guidance on
this.
Re-opening competitions from those companies with whom PASA has framework
agreements (known as “mini competitions”) is now an option
to help purchasers choose between eligible suppliers if the framework
does not provide sufficient detail for them to make their decision. Some
guidance on this is offered in the directives, but there is limited information
on how to practically do it since it is a new process. What the new directives
attempt to do is to provide legislation that foresees future technological
developments, Dr Allen said. |
Hospital Pharmacist
