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The PDA union - pages 6-7 in sight the magazine of the pharmacists’ defence association Spring/Summer 2007 inside this issue… The PDA is principal sponsor BPC 2007 Manchester 10th - 12th September 5 Page PDA conference report A special in-depth report on the third annual PDA conference in Birmingham. Investigator led clinical trials Do they put the pharmacist at risk who is expected to release the product? 5» » 8 15 hospital pharmacist edition » WITH MEMBERSHIP NOW AT 12,000 THE PDA APPLIES FOR UNION STATUS strength in numbers…

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The PDA union - pages 6-7

insightthe magazine of the pharmacists’ defence association

Spring/Summer 2007

insidethisissue…

The PDA is principalsponsor BPC 2007

Manchester 10th - 12thSeptember

5 Page PDAconference report

A special in-depth report onthe third annual PDAconference in Birmingham.

Investigator ledclinical trials

Do they put the pharmacist atrisk who is expected torelease the product?

5» »8 15

hospital

pharmacist

edition

»

WITH MEMBERSHIP NOW AT 12,000THE PDA APPLIES FOR UNION STATUS

strength innumbers…

Chairman’s letter

Unionisation of the PDA…There are 12,000 plus members of the PDA, of whichmore than 3,500 are working in hospital pharmacy;this is the majority of hospital pharmacists, a statisticof which we are immensely proud. We do much to support hospital pharmacistsin a variety of situations such as in coroners’ inquests, grievance procedures,agenda for change re-grading appeals (where our members are successful inalmost every case) and also in employment disciplinary meetings.

We are constantly reminded however, that because we are neither a union nor awork colleague, we should not be involved in employment matters. So whilst someforward-looking employers, as a result of PDA input, have improved their employ-ment arrangements, this is the exception rather than the rule. Others, appear towant little or no dialogue with the PDA and they exclude us from employment dis-ciplinary meetings because we have no legal justification to be there.

The announcement that the PDA is applying for union listing will enable the PDAto sweep away these barriers. Union listing will give us rights protected by leg-islation and will allow us into the very heart of employment disciplinary hearingsto provide support to our members at what for them is a truly difficult time. It willalso enable us to represent our members’ individual and collective concerns toemployers – this will be particularly helpful with the NHS which is experienced atcommunicating with unions.

And there will be much to talk to the employers about!

The PDA has already developed significant policies in many pharmacist employ-ment matters such as pay-scales, staffing levels, rest-breaks and reducing theincidence of violence in pharmacy. We hope that the outcome of these discus-sions with employers will impact positively on many PDA members.

All this will take some time but it is a very powerful vision and one to which we aretotally committed. However, it is a vision that can only become a reality if PDAmembers get behind it.

The result of this initiative is a defence association backed by solid insurance pro-tection and a union; and all for less than £100 per year (the usual costs ofhospital pharmacist PDA membership - more details on page 7).

Elections for the executive will be held in November and we earnestly hope tosecure some solid hospital pharmacist representation.

At the PDA we stand passionately behind our stated aim of supporting the needsof the individual pharmacist. We firmly believe that the union aspect will provide aformidable platform from which to deliver far greater benefits for our members.We urge all members to support this important initiative.

2 | INSIGHT

Mark Koziol, Chairman, The PDA

Insidethis issue…

Don’t forget!You can download the Insight onlinewww.the-pda.org/publications/pub_insight1.html

3-5

News

The PDA unionThe PDA goes for union status

Locum Payscale SurveyShena Patel, an advisory board member, reports

Professional disciplinaryLearn how you can help yourself

The splitting of the RPSGBWhy we support it.

Invetigator led trialsDo they put the pharmacist at risk?

Breaking OutA special five page report on the PDA conference

6-7

8-12

11

12

12

15

The PDA Advisory Board…

Dr. Gordon Appelbe,LLB, PhD, MSc, FRPharmS

Elizabeth Doran, MRPharmS

Dr. John Farwell, FRPharmS

Richard Flynn, MRPharmS

Bob Gartside, FRPharmS

Dr Duncan Jenkins,MSc, PhD, MRPharmS

Diane Langleben, MRPharmS

Alan Nathan, FRPharmS

Shenaz Patel, MRPharmS

Graham Southall-Edwards,MA(law), LLM, B.Pharm, MRPharmS

Paul Taylor, LLB (hons)

Professor Joy Wingfield,LLM, Mphil, FCPP, FRPharmS

www.the-pda.org

newsnewsFind out what’s happening…

‘Pharmacist specialist’ insurance policy launched…Three years ago, a temporary agreement withunderwriters was reached whereby cover forpharmacist prescribing and other “morerisky” roles, was provided under the tradi-tional Primary Care Consultant scheme until arisk assessment was undertaken.This assessment has now been completed

and as a result on 1 April 2007, the PDA launched

a new ‘Specialist Pharmacist’ insurance policy.The Specialist Pharmacist scheme is intended

for those pharmacists in both primary and sec-ondary care who are working at the more riskycutting edge of pharmacy practice. Althoughthere is no exhaustive list of what would be cov-ered, the kind of activities that would be moresuitably covered by this scheme today include

pharmacist prescribing (supplementary and inde-pendent), QP roles for clinical trials in a hospital,operating a clinic which involved significant inva-sive procedures such as collecting blood foranalysis (not pin-prick) and administer injections.This list is by no means exhaustive, indeed,

many roles that will ultimately be covered by thiscategory are not yet performed by pharmacists.

According to Mark Koziol, who is responsiblefor securing the insurance covers with under-writers:“Examining claims and incidents for both

doctors and pharmacists, indicates that therisk of liability from prescribing as opposed tomore routine pharmacist activities is 270%greater. Pharmacists may be relieved to learn

however, that the premium for the SpecialistPharmacist scheme is £204 (£284 if alsoinvolved in prescribing) this will only be mar-ginally more costly than the traditional PrimaryCare Consultant scheme of £174 (on-line pre-mium). We have worked hard to secure a goodpackage for our members.”The implications for the existing primary care

pharmacist scheme are that it will continue toprovide cover for those working as primary carepharmacists for a Primary Care Organisation, or aGP surgery either in an employed or a selfemployed sessional capacity.One implication of these changes is that the

underwriters have agreed to waive the need forprimary care pharmacists to send additionaldetails of their training etc to support their appli-cation. No doubt this will be a welcome reductionin paperwork.The new Pharmacist Specialist scheme how-

ever will still rely on these additional pieces ofinformation as underwriters will want to under-stand the types of risks that they are covering ingreater detail.Members who have queries about their spe-cific roles and suitability of cover are urged tocontact the PDA on 0121 694 7000 [email protected].

In line with other health professions, pharmacystudents now have the support of a defenceassociation. The PDA announced this new initia-tive at an inaugural National Student’sconference sponsored by the association at theICC Birmingham in February. The conferenceattended by students from five schools of phar-macy heard a number of risk managementlectures, the highlight of which was delivered byDr. Gordon Appelbe.At the conference students were told by Mark

Pitt the PDA Membership Services Manager thattheir demeanour, behaviour and conduct as stu-dents and human beings will be under morescrutiny than ever before in this regulatory culture

pharmacy and other health professionals arebeing dragged in to.He told the conference that the PDA was keen

to ensure that risk management education wasintroduced to potential pharmacists as early aspossible and was delighted to announce freemembership of the association. Students whojoin will be entitled to up to £5 million indemnitycover whilst for example performing vacationalor other work experience in pharmacies, and£300,000 worth of legal defence costs whichwould cover for example any legal support foruniversity or fitness to practice investigations.“But the major benefit” as Mr Pitt points out, “isaccess to experienced pharmacists and

lawyers at the end of a phone should they needinstant help support or advice”

Students at the PDA conference

PDA opens membership to pharmacy students

{ }In a restructuring of the risk categories, the Primary Care Policy is now exclusivelyreserved for pharmacists who are involved in central PCO and G.P. surgery activity

The more high-risk practices like prescribing will be covered by the scheme

| 3INSIGHT

4 | INSIGHT

news

Members who would like to contribute theircontribute:

Boots slated by employment tribunalA Boots opticians practice manager who suf-

fered from a depressive disorder has beenawarded £170,000 as a consequence of anaction she made against her employer.In a highly critical judgement of the company

an employment tribunal in Exeter describedBoots’ behaviour as “high handed and malicious”in so much as the company “hoped that she [theclaimant] would not last the course in the litiga-tion process”.Despite the claimant’s open declaration of her

previous condition, the health problems thatresulted in her absence from work were “not onlycaused but also aggravated by” the company’sbehaviour toward her. As a consequence of lack of

support, from senior management to change whatshe perceived to be a difficult culture in the work-place, her illness was affected. She becameincreasingly stressed, causing absence from work,and was eventually diagnosed with severe depres-sion. The situation deteriorated and eventually theclaimant was told by Boots not to return to work.Such a news story can be an employer’s worst

nightmare. In tribunals that can, on balance,favour employers, the PDA belives this could be awarning shot: that there are limits to their patienceshould an employer’s actions completely abro-gate their workers legitimate employment ordisability rights.In conceding their liability at the point at which

they (Boots) did, well into the hearing, in additionto other behaviours in their handling of the situa-tion previous to the hearing, the chairman of thetribunal was satisfied that Boots had hoped thatshe (the claimant) would not be able to last thecourse of her employment or the litigationprocess on the grounds of her mental health.It is not known at the time of going to press

whether or not the Company is to appeal.PDA Director John Murphy commented: “One

of the reasons we set up the PDA was to giveindividuals more strength and resources to pro-tect their rights and so that they would be ableto take on larger organisations that have unlim-ited funds at their disposal, if necessary,”

The PDA increases the extent and limits of insurance cover.From April 1st 2007, the limit of Professional

Indemnity (PI) cover is increased to £5 million forall member policies and in addition, all PDAmembers will now automatically enjoy £5 millionworth of Public Liability (PL) insurance.Further enhancements for members also

include a taxation investigation protection serv-ice which is provided under the Legal DefenceCosts insurance scheme. This will now automati-cally be extended to include protection forself-employed members. This will be a majorbenefit to any members who are self-employed

or who undertake odd-day locums.“This is great news for all our members, par-

ticularly in view of the recent case where apharmacist was implicated in a potential £5 mil-lion claim by a patient.” said PDA ChairmanMark Koziol.

Eid al-Fitr and Christmas: celebrations coincide this yearEid al-Fitr, the Muslim religious festival, coin-

cides with Christmas this year; celebrations willbe held on 20 to 22 December inclusive. Anypharmacist who works in community knows thatthere is a culture among retail employers to placeembargos on leave being taken by all employ-ees at what they consider to be the mostintensive and lucrative time of the year.Already, PDA members have been in contact

to clarify their position in relation to religious dis-crimination, should their employer refuse themleave. If you are in a similar position, the PDA rec-ommends that you start making representationsto your employer as soon as possible, to givethem the opportunity to put the necessary meas-ures in place.Religious discrimination is a very complex

piece of legislation, and not all possible scenarioshave been tested. Although Christians and Jewshave taken employers to tribunals for refusing torecognise their religious needs by allowing timeoff on their respective day’s Sabbaths, somehave won their action but others have lost theirclaim. This is because their employers had an

acceptable business aim which took precedentover their position. Employers successfullyargued that they would have to make conces-sions to many people over 52 weeks of the year,which would be impracticable and an unreason-able constraint.

Early advice from PDA lawyers suggests thatMuslims may be able to claim religious discrimi-nation should employers refuse leave for Eid. Theemployers’ decision, if it is as a consequence ofa policy applying to all staff, could be construedas indirectly discriminatory to a particular reli-gious group.Their decision could be seen as unreasonable

and discriminatory from the point of view of pro-portionality. The employer may have difficulty inusing previous lost claims for time off on the‘Sabbath’ as a precedent because this is aweekly event whereas Eid will not fall at Christ-mas time for another 12 years.The PDA is seeking further clarification on this

and will be communicating with its members byemail over the coming months. In the meantime,PDA urges members to ensure that it has yourmost recent email address and to make contactdirectly should you need urgent advice.

The PDA is seeking further clarification onthis and will be communicating with its mem-bers by email over the coming months. Inthe meantime, PDA urges members toensure that it has your most recent emailaddress and to make contact directly shouldyou need urgent advice.

moreinfo:

[email protected]

They compete with other agencies to attractLocums not only by finding them more work butalso by using other methods and strategies toengender loyalty.Agencies’ modus operandi is similar to that of

a dating agency. During times where demandoutstripped supply it had been in their commer-cial interests to try to act in the best interests ofboth their clients (locums and ‘engagers’) bybringing them together for a fee.The PDA has recently detected a trend which,

as a consequence of major employers consoli-dating and reducing the number of agencies thatthey are prepared to work with, agencies are suc-cumbing to the weight of their economic power.Locums are not sufficiently organised as a work-force to react even though there is a ‘shortage’of pharmacists.The contractual relationship for services ren-

dered is directly between the pharmacist and theuser of their pharmaceutical services – not thepharmacist and the agency that has brought thetwo parties together. Anything that the agencyagrees with the Locum, however, binds the‘engager’ in contract.So for instance, if the agency gets a pharma-

cist to agree to a contract and confirms that he orshe can claim travel time, then the ‘engager’ can-not refuse to pay. Whether or not they citereasons that “it is not company policy” or thatthey claim no knowledge of the contract is irrele-vant. The law of contract is clear; the agency hasheld themselves out as the engager’s agents andthey are bound to honour the contract. The locumcan bring an action for breach of contract if theydo not.Since the PDA has made a point of challeng-

ing employers who are in breach of contract andsecured thousands of pounds for locum phar-macists as a result, the engagers, particularly butnot exclusively multiples, and some agencies

have attempted to put in safeguards which con-siderably disadvantage the locum pharmacist.

Fixing fees and mileage claimsThere are agencies dictating, through their

terms of business, that ALL contracts that theyarrange with engagers will be subject to a definedfee and mileage claim (and other) restrictions.This impairs pharmacists’ freedom to negotiatebetter terms based on supply and demand. Arecent survey by the PDA showed that more than50% of pharmacists did not use an agency for alltheir bookings.

Shifting the balance of powerTo protect their own commercial position and

to satisfy the engagers - who pay their fees andkeep them financially viable - some locum agen-cies are stipulating contractual terms which arebalanced much more in the ‘engagers’’ favourthan that of the locum.The PDA have become aware of clauses that

indicate that any booking they [the agency]arrange with a locum is subject to termination atany time with no notice and that locums cannotterminate their contract at any time without agree-ment from the ‘engagers’. PDA advises thatlocums think very carefully before entering intoany such contractual terms.

Restrictive covenantsSome agencies are binding pharmacists to a

financial penalty clause should they take workfrom other agencies for the same employer. It hasalways been the case that agencies have a con-tractual arrangement with the engager, whichprotects them in the event that they (theengager) goes directly to the locum to avoid pay-ing the agency a fee. This is equivalent to anintroductory fee, but attempting to financiallypenalise the locum directly for taking on book-ings from another agency is a new andunreasonable departure from the norm. The PDAwarns its members that they should be aware ofagreeing to any such agreements. Not only arethey putting themselves at a potentially commer-cial disadvantage, but it also brings into questionthe employment relationship between the locumand the agent, in that they are attempting to dic-tate who the locum may engage with.Commenting on these new trends John Mur-

phy said “Users of locum services have alwaystried to manage the market place so as theircosts will not spiral out of control. There hasbeen a healthy dynamic which has largelyworked reasonably well. From our experience,some locum agencies, in an attempt to maintaintheir volumes and to protect their exclusivityarrangement with multiples are significantly load-ing the dice against the best interests of locums.”

The PDA has announced that it will be thePrincipal Sponsor of the British PharmaceuticalConference ‘The medicines maze: balancingrisks and benefits’, which will be taking place on

Monday 10th - Wednesday 12th September2007, at the Manchester International Confer-ence Centre”

“It is an important landmark for the PDA”, saidJohn Murphy PDA director. “We have alwayssupported the BPC since our inauguration in2003 but particularly as this year’s conference isrelated to risk, an area of our expertise, we felt itwas most appropriate that we associated our-selves with it in a major way”.The PDA will be encouraging its members to

attend this year. The topics should be very use-ful to pharmacists who are in direct contact withpatients and the session that the PDA is specif-ically involved in, on Monday 10th September,will be particularly relevant and full of practicalstrategies for minimising risk.

“We will keep our members informed as thespecifics of the conference unfolds” said MrMurphy.

Locum Agency - Friend or Foe?

The PDA becomes principal sponsor of BPC

Locum Agencies’ services are paid for by the pharmacy owners, but to fill their vacancies andto earn placement fees they need to keep a large data base of pharmacists.

”“Locums are easily manipulated as individual contractors and there

can be no better reason for them to consider joining the PDAunion to add strength to their negotiating power. Agencies that

continue to restrict locums’ individual freedom to negotiate wouldcertainly not receive our support.

JOHN MURPHY, PDA DIRECTOR

| 5INSIGHT

6 | INSIGHT

With 60 per cent of members joining the PDAthrough word of mouth recommendations, weat the PDA know only too well that it is ourfocus on service that has produced such ahealthy growth and that is why we constantlylook at ways of improving the service to ourmembers even further.One such improvement that has been consid-

ered, is the possibility of the PDA applying forunion status.The debate around union status for the PDA

was commenced in earnest with the membershipat the PDA annual conference in 2006. In adebate, in which officers of the PDA intentionallytook no part because they wanted to hear thegenuine views of members, the vast majority ofdelegates indicated that they would be keen forPDA to become a union if it meant better servicesfor members. Subsequently, in the half-dozenfocus-group meetings that were held with mem-bers on the subject, it was possible to explorethe various advantages that could accrue. Itbecame clear that members felt that union statuswould indeed be most advantageous to theorganisation and ultimately to its members.

How will union status benefit themembership?There are a number of potential benefits to

members that could accrue from union status, alist of just some of these follows:

Attendance rights at internal disciplinarymeetingsUnion status will plug a major gap in the PDA

operation because it will give it a legal entitlementto accompany its members to internal employ-ment disciplinary meetings. Last year, the PDAhandled more than 1,000 employment cases, butcould only attended disciplinary meetings if theemployers allowed this. Sadly, most employersactively sought to exclude the PDA and perhaps

this is because they would have found it moredifficult to control outcomes.Although it is true to say that sometimes, it is

the inappropriate behaviour of the employee thatcauses the problem, and on other occasions,both sides are at fault, nevertheless, in the major-ity of cases, the PDA is able to reach asatisfactory outcome for its members. Already,the PDA has managed to claim more than£200,000 compensation from some employers

on behalf of its members whom they may havetreated harshly or illegally.Despite these results, we at the PDA feel that

an exclusion policy puts our members at a dis-advantage when they attend any internaldisciplinary meetings which relate to serious, per-haps even job threatening issues.

Legal rights of consultation withemployersSince the launch of the PDA in 2003, the reac-

tion that it has had from employers has beenmixed; perhaps this is understandable. Manyemployers will never have dealt with a situationwhere their employees are not only beginning tostand up for their rights, but are being assisted byan organisation specifically set up to look aftertheir interests.Some employers use the PDA as a sounding

board for any new employment or locum policies– we at the PDA are proud of the fact that someof these proposed policies that we considered tobe dubious were never actually implemented as adirect result of our involvement at the earlystages. However, this is not the experience thatwe have had with all employers. Some employers

– even some very large companies – appear tohave a policy that assumes that the PDA doesnot exist. Letters are ignored, and a generalapproach that seems to be based on fear andmistrust prevails. Bearing in mind that some ofthese employers have suffered big compensa-tion payouts to employees that the PDA hassupported in employment disputes, perhaps thisis unsurprising. However, a big advantage ofunion status is that it will give the PDA certain

legal rights of consultation with employers. Thismeans that our Association will be able to dis-cuss matters related to the employment of itsmembers with employers; and employers will ulti-mately be required to consult the PDA if it isproposing any changes that will affect theemployment of PDA members.

A democratisation of the PDAThe PDA always consults with its members, via

surveys, focus groups and conferences; bybecoming a union, the PDA will also enjoy ademocratic dimension. PDA members will beable to elect its officers and representatives fromacross the whole pharmacy spectrum: commu-nity, hospital and primary care sectors, locumsand pre-registration students. A democratisationof the PDA will help it when it consults the gov-ernment on important matters. It will also be ableto apply for grants which will help support muchof its research on employment issues.

A stronger voice in pharmacyA PDA union could go a long way towards

addressing the imbalance of influence within theprofession between the vast majority of pharma-

In February 2007 the membership of the Pharmacists’ Defence Association (PDA)

grew beyond the 12,000 mark.

ThePDAgoesforunionstatus…

{ }It became clear that members felt that union statuswould indeed be most advantageous

cists who are employees or locums and whohave little say in the way they practice, and thesmall number of large employers (community orNHS) who have far too much influence.

What if PDA members don’t wantto be in a union?We know that members must always be given

a choice as to how they want the PDA to func-tion. Consequently, for those members whoprefer not to take part in the union aspect ofPDA, we will respect that decision and give theman option to stay exactly as they are – as full PDA

members enjoying all of their current, wide-rang-ing benefits.For those members who do choose to join,

then they will be entitled to even wider benefitsas described. Furthermore, because the insur-ance underwriters recognise that the risks ofemployment disputes for ‘union’ members arelower, they will reduce the insurance premiumsfor these members; in turn, we have allocatedthis reduction to pay the union fees. Conse-quently, there will be no increase in overall PDAmembership fees for those members whochoose the union option.

So, what happens next?In June 2007, PDA members will be sent

detailed information regarding union formationand will be invited to join the PDA union.PDA members will continue to be asked peri-

odically to join the union during the usualmembership renewal process. In November,those members who have already joined will beinvited to stand for election and will be invited tovote for their representatives. It is hoped that thePDA union will have its new executive in place byJanuary 2008.

Q. Can I expect that the normal service that Ihave come to rely upon from the PDA will con-tinue?

A. The intention is that the PDA will continue toact both reactively and pro-actively to support theindividual pharmacists’ agenda, as it has alwaysdone in the past. However, we at the PDA believethat union status will enable the Association toprovide an even wider range of benefits for mem-bers at no extra cost to members.

Q. What if my employer finds out that I am aunion member?

A. It would be illegal for your employer to takeaction or discriminate against you in any way if helearns that you are a union member. The penal-ties for such discrimination are significant.

Q. Will the PDA union be able to representcollectively the concerns of me and my col-leagues to our employer without specificallynaming those who are concerned?

A. If sufficient employees from your employingorganisation join the PDA union, then theemployer is legally required to allow thePDA union full consultation rights.

Q. What if I am already a memberof another union?

A. There is nothing to stop you from being amember of more than one union. However, weexpect that most members will consider whichunion is providing the widest benefits for themand become a member of just one.They may wish to think about which unionhas the greatest knowledge about phar-macy matters and whether it has full-timeofficers employed by the union and alwaysavailable to members. They may also wish toconsider whether their previous union had eversucceeded in taking on employers in the pastand whether it had managed to secure severalhundreds of thousands of pounds in compensa-tion on behalf of its members. There is no doubtthat if all current PDA members were to join thePDA union, then it would be by far the largest

solely pharmacist union in the UK and becauseof that, it would be very influential indeed.

Q. How can I be sure that the electedrepresentatives are nothing morethan senior employees (de factoemployers) who will toe theemployers’ line?

A. Some pharmacist unions areindeed run by senior employees. However,

the PDA membership is almost exclusivelymade up of non-employer and locum pharma-cists.Because of this, it is felt that the likelihoodof this problem occurring is remote. Nev-ertheless, PDA union members will have to

cast their votes wisely.

Q. What do I have to do if I want to stand forelection to the PDA union?

A. First, you need to exercise your right to join asa member. In November, you will be entitled toparticipate in the elections. You will receive adetailed pack of information at that time.

Questions and answers…We understand that you will have questions about this important development, so here are some answers…

Mark Koziol explains the unionisation of the PDA at the PDAconference in Birmingham.

| 7INSIGHT

8 | INSIGHT

A special 5 page report from the third annual PDA conference,held at the ICC in Birmingham on February 25th 2007.

One of the most substantial projects undertaken by the PDA is the organisation of

the Annual Conference, which now sees three meetings running simultaneously.

PDA Activity in 2006The year 2006 saw meteoric increases in PDA

activity across all fronts and also an increase inmembership to above 12,000. In these accom-panying graphs, we describe the levels of activityincurred in the defence of PDA members duringthe year 2006.

The third annual conference of the PDA took place in Birmingham on Febru-ary 2007. With three events running concurrently; one -for pharmacists,pre-reg’s and pharmacy students, the total number of delegates attendingwas in excess of 400 making the PDA annual conference the largest phar-macy day conference event in the UK. The various pharmacist conferencesessions are detailed over the following pages.

Total No. of incidents handled by the PDA

PDA Levels of activity

Employer / employee locum disputes

Money secured by the PDA for members from employers Number of civil claims from patients

SANDRA GIDLEY, MP LAMBASTS A REMOTE SOCIETYConference delegates treated to insights on pharmacy from an MP’s perspective

“Lambeth is remote and bashes us over ourheads with a hammer. It over-regulates andunder-represents,” according to Sandra Gidley,MP in her address to the PDA conference. Shebelieves that as far as the Royal PharmaceuticalSociety is concerned, things are no better nowthan they were when she was a student. She saidthat it is depressing that the Society does notstick up for her or do its best for her.Mrs Gidley, is the Liberal Democrat spokesper-

son for health and the only pharmacist Memberof Parliament.During a session that gave an interesting

overview of the current work that parliament isdoing with regard to pharmacy, she told dele-gates that pharmacy matters are discussed bythe All-Party Parliamentary Group on Pharmacy.In 2006, the group set up an inquiry to look intothe future of pharmacy. Among other things, theinquiry is assessing the uptake of the new con-tract, which so far has been disappointing. MrsGidley said that pharmacists wanted to get onand do the new things but barriers are in the way.There has now been a white paper on the reg-

ulation of the medical professions, as well as talkof a Society split. We have come to a fork in theroad,” said Mrs Gidley. She is quite concernedabout the idea of remote supervision andbelieves nothing can replace the personal con-tact between pharmacist and patient. She saidthat the interaction could even save a life. For MrsGidley, the idea of a pharmacist sitting in front oftwo or three CCTV cameras is not a vision, but anightmare.Turning to her perspective on the Society, she

told delegates about the time that she asked toattend a Society Council meeting in her capacityas an MP. She felt that anything on the agendathat was important but not regula-tory was glossed over and that alot of time was spent on minutiaeMrs Gidley thinks that it is possi-

ble that the majority of theSociety’s Council are now pro-split. Whether or not this is thecase, a split is inevitable. Shebelieves that pharmacists will needgood professional leadership.

She told delegates the best way for pharma-cists to lobby their MPs. She reminded theaudience that most MPs are men, and thereforeseldom visit a pharmacy. She said, “MPs know alittle about many things. You can’t expect themto understand pharmacist’s concerns. You mustwrite to them but don’t whinge. It is better to say,‘I have a problem, this is what we should do’.Politicians are quite cynical butif you can show how it willbenefit patients, they willbe more interested andmore willing to help”.

How satisfied are you with your grading?The PDA has successfully carried out a survey about Agenda for Changeamong its members who are involved in hospital or primary care practice.

Dr Farwell ended the session by telling theaudience that the PDA would be looking atcases as they came forward and that thedata would be published at a future date.

John Farwell, advisory board member to thePDA, told delegates that PDA had been alerted tothe problems that the Agenda for Change hadthrown up because there were now 100 cases onits books of pharmacists who are dissatisfied withtheir grading. The PDA is supporting them fromreview of job descriptions through to appeal.Dr Farwell said that as far as primary care phar-

macists are concerned, there is no national profileand that panels did not fully consider the breadthand depth of pharmacists’ roles. Although anational profile did exist for hospital pharmacists,feedback to the PDA suggests a considerablerange and number of problems exist.Dr Farwell explained that the PDA had suc-

cessfully instigated internal reviews and givenmembers support through formal appeal. How-ever, because those who approach the PDA areunhappy about a situation, the organisation canget a distorted view about how satisfied or other-wise most pharmacists are with their AfC grading.The only way to find out the extent and depth ofdissatisfaction is to investigate further. Dr Farwellwent on to talk in depth about the electronic sur-vey that the PDA conducted recently. There was aresponse from 580 pharmacists (385 hospital-based, 195 in primary care), of whom 12 per centwere non-members of the organisation.The areas investigated were: the demograph-

ics of job content and previous grades, the

satisfaction and acceptance ratios for initial pro-files, whether or not an internal review had beeninstigated, the satisfaction and acceptance ratiosbefore internal review, satisfaction ratios from theappeals, and the length of time taken to completethe process.Among the results, the survey shows that two-

thirds of the respondants had accepted theirgrading, although not all those in primary carehad yet received their grading. However, there aremany who had been totally dissatisfied with theirgrading although there was some improvement insatisfaction levels after the first review process.Claire Hollins, solicitor, took the floor to

describe the consequences and impact of AfC.For all NHS employees, there had been about10,000 claims for equal pay. She urged delegatesto put down as much description as possible ofthe jobs they did, especially if they are working ina narrow speciality. If they did not do so, the con-sequence could well be that they are not properlygraded. “If you are not happy with your grading,challenge the decision. As a last resort, considerresigning and claim constructive dismal,” sheconcluded.

The PDA continues to handle record levels ofincidents on behalf of members. The volume ofcases being handled was up by 69% over lastyear and came to 1,880 in the year 2006.Disputes between employers and employ-

ees / locums represent more than 50% of allof the incidents handled. The 68% growth inthe volume of these cases over the previousyear clearly indicates the increasingly hostileenvironment in which many employed phar-macists and locums are working in.The fact that more than £200,000 has been

successfully claimed by the PDA on behalf of itsmembers from employers who have treatedthem harshly/ illegally shows that remedies donow exist to deal with inequitable employmentsituations and that the PDA will not shy awayfrom handling these decisively if necessary.Two other startling statistics (not illustrated) is

that the number of cases where the PDA sup-ported members in situations that could haveled to, or did lead to RPSGB professional dis-ciplinary issues rose by 240% to 635. TheFitness to Practice directorate of the RPSGB isbecoming increasingly active. Finally, the valueof compensation payments made to patientson behalf of members who made dispensingand other errors rose by 231% and nowstands at more than £400,000.

What thegraphs say…

| 9INSIGHT

10 | INSIGHT

The PDA-sponsoredBPSA conference for pre-

registration graduatescontinues to grow from

strength to strength.Record numbers attended ‘Fin-

ishing First’, February’s dayconference held at the ICC in Birm-ingham.

Mark Pitt, the PDA MembershipServices Manager, said that it wasthe second of a series of two thatthe PDA supports and sponsorsevery year. “We get great feed-back from the graduates whobelieve that both conferences help

them to improve their chances of com-pleting a successful training year andpassing their exam,” said Mr Pitt.The PDA has been a long-time sup-

porter of BPSA and their graduate

members. Ever since the ‘Peppermint water’case, the PDA has felt it important that pre-reggraduates understand the importance of per-sonal liability and vulnerability to criminal andprofessional proceedings. As a consequence, allpre-reg graduates are eligible to join the PDA,free of charge. This includes up to £5 million ofindemnity and £300,000-worth of legal defencecosts cover.One pre-reg from Andover was complemen-

tary: “Overall a great productive day,” he said. “Ifeel more confident with what the exam entailsand other issues which we will face once quali-fied.” Another pre-reg, from Sussex agreed“Definitely worth attending” she said. “At this timeof the year you need all the support which I thinkthe conference provided.”Jen Deval, the BPSA president, said: “It’s a

great conference. We are delighted to have thePDA’s support in producing, delivering and fund-ing it. My advice to anyone who is reading thisarticle, whether a pre-reg or a tutor, is to encour-age any pre-reg colleagues you have contactwith in the future, to attend. It really does make adifference.”

Pre-registration PDA members are ‘Finishing First’

Pre-reg trainees sit a mock exam at the BPSAconference.

a global experience

evolvingpharmaceuticalcare

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Shenaz Patel discusses payscales (see article opposite) whileMike Ratcliffe discusses the benefits to members of unionisation

of the PDA in one of the afternoon sessions

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We were pleased that Shenaz Patel (an Advi-sory Board Member) has agreed to undertakethis important projects on the PDA’s behalf.From the outset it was evident that there was a

veil of secrecy as far as pay information fromemployers was concerned - with little in the pub-lic domain and for once the Internet was not thesource of all information. So Shenaz decided toharness one of our biggest assets, you - themembers of the PDA.Within minutes of the questionnaire appearing

online, the responses flooded in. In all wereceived nearly 1,300 responses and despite allthis information it only went to confirm that wehad only just scratched the surface. The informa-tion, when analysed, gave the basis for Shenaz’spresentation to this years’ Conference.

Shenaz established from the responses someinteresting and important facts:• There are slightly more males than femalesworking as locums, but significantly morefemales than males as employees.

• In the main the responses were evenly splitthroughout the country with slight peaksfrom respondents in the North East andSouth East.

• That male and female employees regularlyworked up to 9 hours per day which infersthat there is an element of unpaid hours.

• That male locums worked the longest hours.• That locums operating through an agencyoften obtained a higher hourly rate thanthrough direct negotiation.

We must continue to work with the data wehave and obtain further information from you.This is quite clearly just the start of the project.Its no use obtaining facts and figures unless

you start using them, and some of the practicalapplications were provided by Michael Radcliffefrom the Network Partnership. Michael, who deliv-ered the second part of the presentation hasbeen working with the PDA over the past year onthe unionisation project.

Michael advised the meeting that employeesespecially, had various courses of action open tothem, both individually and collectively.The Equal Pay Legislation states: “You have a

right not to be paid less than someone of theopposite sex doing the same, or nearly the same,work in the same organisation”. Also; “You havethe right to equal pay to a colleague of the oppo-site sex in the same employment, who may havea different job, but the two jobs are assessed tobe of equal value”. (Part-time workers are enti-tled to the same relative pay and conditions asfull-time workers of the opposite sex).

So if you are acting individually, you need tolook at the qualifiers:• Your comparator must be somebody of theopposite sex.

• They can work anywhere within the geo-graphical limits of the employer

• The comparator doesn’t have to do be doingan identical job, they can be doing a totallydifferent job, but that job must be assessedas being of equal value.

• The comparator doesn’t have to be a currentemployee – it can be your predecessor oryour successor.

• There is no service qualification

How do you know that somebody of the oppo-site sex is earning more than you? Well as ourresearch builds this will be an invaluable source,but in the meantime we can look at the data pro-vided by the Office of National Statistics in theirAnnual Survey of Hours and Earnings 2006.

In brief in 2006 male pharmacists earned anaverage of £38,995.00 pa and females,£28,443.00 – so on this it would appear that menearn a significantly higher percentage than theirfemale colleagues. On the face of it this loads the

dice in favour of male pharmacists but regionallythere are disparities where females are paid morethan males.Whereas the best source of information can be

chatting to your colleagues you need more posi-tive information should wish to challenge youremployer. This you do by requesting that theemployer completes an SD74 form that can bedownloaded from the Equal Opportunities web-site. The employer can refuse to complete theform, but a Tribunal can infer such a refusal or amischievous or vexatious answer as there beingan equal pay case to answer. You must have sub-mitted a form to your employer should you wishto go to Tribunal and there is also a 6 month timelimit in bringing a claim.If you find that your colleagues are in a similar

position then the above procedure is open to youas a group. Most employers have a separategrievance procedure that “fast tracks” groupgrievances. However, you may consider referringthe matter to your union who can obtain informa-tion not only using the SD74 but also inrequesting information for bargaining purposesunder the ACAS Code of Practice. Finally, as agroup you could use the Information & Consulta-tion of Employees Regulations.Unfortunately the Equal Pay Act only covers

employees, but that should not deter locumswhen negotiating an hourly rate, questioningwhether or not the rate offered constitutes equalpay were it to be compared to a locum of theopposite sex.With the invaluable work already undertaken

by Shenaz we have started on an extremely

important topic for all pharmacists and we arejust beginning to realise the enormity of the task.When asked: “How do you eat an Elephant?” theanswer is, “In small but regular bites!” – a bit likethis project.

PharmacyPayscalesurveyAt the 2006 PDA Conference it was agreed to look into pay and undertake a survey of

pay and conditions within the profession and good progress has been made.

…it would appear that men earn a significantly higherpercentage than their female colleagues

| 11INSIGHT

12 | INSIGHT

“We are now using sledgehammers to cracksmall nuts,” said John Murphy, the director of thePDA opening the session on professional disci-plinary action. All health professionals have beencaught up in over-zealous regulation as a resultof the Bristol Royal Infirmary and Shipmaninquiries, and, in Mr Murphy’s view, the result hasbeen disproportionate regulatory activity whichcan have the opposite effect to that intended, aswell as not being in the interests of patient safety.It has also left the professionals in fear.Mr Murphy stressed that regulation is impor-

tant so that standards and public confidence areupheld but we are now in a situation that has ledto an exponential growth in the number of inves-tigations by the Society’s InfringementsCommittee. The figure will probably reach 1,000by the end of the year.Mr Murphy described the process, beginning

with a complaint to the Society from a number ofsources. He said that of particular concern wasthe increasing tendency of employers to reporttheir employees as a pre-emptive measure. Foreach complaint, the Infringements Committeecan use a range of sanctions including referral tothe Statutory Committee.He told conference delegates that reports sent

to pharmacists by the Fitness to Practise Direc-torate before referral to the Committee can oftencomprise as many as 160 pages. “Sometimes,this can be the first time that the pharmacistknows that a compliant has been made againsthim or her,” he said. He recommended that legaladvice should be obtained as early as possibleThe PDA wants the process to reform and for

inspectors to have their power of ‘general author-ity’ reinstated

Minimising the riskMark Pitt, membership services manager for

the PDA, described how pharmacists can min-imise their risk if, and when they are involved inan incident.

Precipitating factorsWhen factors involve medicine errors, it is

often because of similar drug names or packs,so pharmacists could review their personalchecking protocol, use a near-miss log andshare their concerns with other staff. Mr Pittsaid that methotrexate continues to give rise tomany claims and urged pharmacists to beextra vigilant.Mr Pitt went on to say that poor staffing levels

can contribute to risk. In situations where thereare no staff, untrained staff or staff “gone wild”he urged pharmacists to telephone the superin-tendent of the company to inform him of thesituation. The pharmacist could manage therisks by dealing with the most urgent and redi-recting patients with non-urgent prescriptions togo to other pharmacies.Pharmacists should always remember to sign

their labels so that blame could not be appor-tioned to them on a wrongly-dispensedmedicine. Mr Pitt also warned that labels shouldnever be prepared days in advance.Care should also be taken in dispensing con-

trolled drugs, for example, identifying the rightpatient for supervised consumption. Mr Pitt advisedpharmacists not to be pressurised into makingpoor decisions, to only delegate to competent indi-viduals and be mindful of the risk of deception.

Handling the incidentMr Pitt stressed that patient welfare is the

absolute priority. He went to say that companiescan get things wrong, identifying the wrong phar-macist who is involved in an incident. “If you areresponsible when something goes wrong, then aprompt and comprehensive response is valuableas is a willingness to co-operate with the investi-gation,” he said.

After the eventWhen a complaint has been made about a

pharmacist, he/she should contribute to any writ-ten report but get advice before doing so.“Never go into an interview without representa-tion, because sometimes, pharmacists aremaking admissions without thinking if they reallyare liable,” concluded Mr Pitt.

…of particular concern was the tendency of employers toreport their employees as a pre-emptive measure

There is now a 1 in 45 chance of being involved in a professional complaint. One

conference session looked at the present reality and ways to avoid being implicated

Professionaldisciplinaryaction:howyoucanhelpyourself

PDA Director John Murphy voices his concerns about the fitness to practice directorate.

Our concerns revolve around these chainswhen discharging their responsibilities under theRPSGB’s Code of Ethics. There are indicationsthat some complaints to the Society are influ-enced by self-protection, spite or are intended tosupport a defence to civil proceedings, ratherthan for genuine reasons.For example, one of our members, who had

performed a long-term locum for a national phar-macy group, had his contract terminated abruptlywith no good reason or notice. Because of hispoor treatment by the company, and on legaladvice, he lodged a claim for unfair dismissalwith the employment tribunal. The company vig-orously defended this action and seemeddetermined to use all means necessary to win theclaim. The pharmacy superintendent lodged acomprehensive complaint to the RPSGB aboutthe professional behaviour of the pharmacist, cit-ing this as a reason for dismissing thepharmacist. This complaint was referred to theInfringements Committee, which deals with allcomplaints received by the Society. After robustwritten submissions from PDA lawyers, the Com-mittee decided that no further action be taken.The PDA was of the view that the only reason forthe complaint was to attempt to persuade the

employment tribunal that the company had agenuine reason to get rid of the pharmacist. Thisline of defence would have been strengthenedhad the complaint been upheld. As the Societydid not progress the matter any further, thisseems the most logical explanation for the com-pany’s behaviour.The PDA is often surprised by how hasty a

company is to instigate a professional investiga-tion into one of its own employee pharmacists bythe Fitness to Practise Directorate. Of course, inserious cases, there is a need to take actionpromptly, but sometimes pharmacy superintend-

ents act with almost indecent haste, perhaps intheir desire to “protect their own position”. In onecase, a respected employee pharmacist workingfor a multiple pharmacy was the subject of anunsubstantiated allegation by another member ofstaff with whom she was in dispute. The firstaction by this company, before any investigationwhatsoever had taken place, was to report thematter to the local inspector. This had theinevitable consequence of launching a formalenquiry into the matter. After reporting it to the

Society, the company conducted its own thor-ough internal investigation into the complaint andcompletely exonerated the pharmacist con-cerned. The outcome of this will mean thatalthough cleared of any wrongdoing, the phar-macist will end up with a complaint beingrecorded on her fitness-to-practise file. There is aprofessional duty on superintendents to report apharmacist if they have good reason to do so,but by acting with such haste in this case, theprofessional reputation of one of the company’semployees has been needlessly tarnished.Another long-serving and highly respected

pharmacist was subjected toappalling treatment by hisemployer. This pharmacist was sus-

pended for over eight weeks, during which timehis employment rights were repeatedly ignored.The company disregarded its own internal proce-dures and signalled its intention to report thepharmacist before the internal investigation wascomplete. The company had decided he wasguilty of the allegations it had made before thepharmacist had any opportunity to put his ownexplanation of events. After taking legal adviceand involving the PDA, the employee issued agrievance about his treatment at the hands of thecompany. On the same day the grievance waslodged with the company, the pharmacy superin-tendent chose to report the pharmacist to theRPSGB. The pharmacist was finally able to puthis version of events to a senior manager of thecompany, who decided that disciplinary actionwas not necessary and allowed him back to work.Members can make up their own minds as to thereason why this superintendent chose to make acomplaint on the same day the pharmacist exer-cised his employment rights.

Shootfirst,askquestionslaterby Mark Pitt MRPharmS. PDA Membership Services Manager

There is concern at the PDA about the motivation of pharmacy

superintendents of some major chains…

There is more information on our websiteabout how you can protect yourself againstthe issues raised in this article.

findoutmore:

www.the-pda.org

{ }After robust written submissions from PDA lawyers, theCommittee decided that no further action be taken.

A bitter pill? Some pharmacies are influencedby self-protection when dealing with complaintsagainst their employees or locums.

| 13INSIGHT

14| INSIGHT

The majority of those pharmacists and bod-ies that participated felt that the Society shouldcontinue as a dual-role body, delivering both reg-ulation and membership representation as it haddone for many decades.What we have ended up with however, is a

dual-role body, but sadly, one with an organisa-tional mindset that is much more comfortablewith the role of regulation.Under the regime of the new Fitness to Prac-

tise Directorate, the number of cases referred tothe Infringements Committee have soared. In1993, only 55 cases were referred to the Infringe-ments Committee; in 2005, this rose to anunprecedented 874!This relentless wave of regulation has seen

pharmacists, superintendents and now, eventechnicians, finding out what it is like to be inter-viewed under Police and Criminal Evidence(PACE) procedures and then waiting, sometimesfor almost a year, to hear the outcome. You may

think that they deserve whatthey get, but within that num-ber are many who havecommitted the most trivial oftechnical errors that couldnever cause harm to anyone;others have been disciplinedfor no more than an uncorrobo-rated complaint from a patient.It is the view of the PDA that

this kind of regulation is not onlyunnecessary, but it is damagingthe interests of both the publicand the profession.Already, we are aware of phar-

macists who will no longer goout of their way to help patients;instead, they find it safer to bejobsworths. This means areduced likelihood of an emer-

gency supply, or a supply of medicine on aprescription which while incomplete, would nev-ertheless pass the ‘common sense’ test. Entriesin the near miss or error logs are incompletebecause the inspectors have been using them todiscipline pharmacists.The PDA spends a lot of time in discussions

with various organisations and government offi-cials and it is its firmly held belief that the Fitnessto Practice Directorate’s success in discipliningsuch a large number of pharmacists has led tomuch concern and disquiet.It is hardly surprising that in a recent govern-

ment consultation on the future of healthcareregulation, many of those pharmacists and bod-ies had changed their minds and now prefer theSociety’s dual role to be brought to an end.Let us think about what it would be like if the

RPSGB could concentrate on membershipissues. Consider how much time the Societywasted needlessly considering its role in the Sec-tion 60 regulatory Order (a year or more) and

what it could have achieved if it had thrown itsresources behind the provision of medicines usereviews by pharmacists instead.Imagine if the RPSGB could properly support

leading-edge practice by evaluating and nurtur-ing, by creating the appropriate riskmanagement frameworks and by acting as theadvocate for pharmacists. The Society couldsucceed in moving far more innovative work intothe main stream of practice. Imagine how muchricher as a professional body we could be if wecould actively encourage experienced pharma-cists, who are currently discouraged from beingmembers because of regulation, not only toremain as members, but also to play an activerole in its affairs.The PDA is keen on such an outcome because

the painful experience of supporting pharmacistswho are in problem situations has shown us justhow much support they require to enable them todo their jobs safely and well. We want to see anew focus on safety and practice issues, and anew supportive culture emerge for pharmacistsfrom the RPSGB. We want pharmacists to beable to turn to their professional body confident inthe knowledge that they will receive encourage-ment and support and not a prosecution ordisciplinary investigation.We want pharmacists to receive help from the

Society when they undertake their CPD and not athreat of removal from the register if they fail. Wewant to see fewer pharmacists in front of the dis-ciplinary committee.

WhywesupportthesplittingoftheRPSGB

During the course of the Shipman debacle, when it was obvious that the

healthcare regulatory landscape would change dramatically, the

pharmacy profession was asked what it wanted to become in the future.

An RPSGB unshackled from the roleof regulation will be able to accom-plish far more for pharmacists andpatients alike…We are hopeful that such ascenario is barely a few ‘closed door’meetings away.

by Mark Koziol PDA Chairman

The splitting of the RPSGB?…

The Medicines for Human Use (Clinical Tri-als) Regulations 2004 have regulated clinicaltrials in the UK since they came in to force on 1May 2004. They replaced the clinical trials pro-visions of the Medicines Act 1968, and itssecondary legislation will transpose Directive2001.20 to UK law.

Provisions of this directive required:• That phase 1 studies require authorisationfrom the Medicines and Healthcare productsRegulatory Agency where previously onlyfavourable ethics committee approval wasneeded

• Investigational medicinal products (IMP)must be manufactured to good manufactur-ing practice (GMP) standards and thatmanufactures must have a manufacturinglicence. This will ensure that trail participantsare not exposed to poor quality or badly pre-pared medicines

• Each trial must have an identified sponsorwho takes responsibility for its initiation, man-agement and conduct

These regulations make provision for hospitalsand health centres to have an exemption fromthe need for a hospital or health centre to hold amanufacturing authorisation to assemble an IMPwhen the assembly is carried out by a doctor orpharmacist, or under the supervision of a phar-macist. The term ‘assembly’ refers to packagingand labelling and not the preparation of medi-cines, and the exemption only applies if theproduct is to be used exclusively in the hospital

or health centre in which it is assembled.

Last August, new regulations implementingthe provisions for Good Clinical Practice(GCP) were introduced and which areintended to:• Ensure harmonisation of GCP in the conductof all clinical trials

• Ensure GMP in the preparation of IMPs• Simplify the process of obtaining ethics com-mittee approval

• Standardise the records kept in a trial masterfile

• Establish a confidential EU database of infor-mation on every trial and on serious adverseevents

As an addendum to these regulations, a drafthas been circulated which modifies the extent ofthe provisions required if the trial is to be carriedout for non-commercial clinical trials; it alsomakes allowances for investigator-led trials to beundertaken with the participation of the pharma-ceutical industry.

Typically these trials are for:• Potential treatments for rare diseases• Comparative effectiveness as optimal use tri-als

• Paediatric trials with medicinal productsauthorised only for adult patients

Supplying an IMP free or at a reduced cost,and/or providing support under these provisionswill not be taken to imply that industry is partici-

pating in the clinical trial for the purpose of thedirective 2005/28.However, the liabilities for trials carried out in

this way are not clear, and it is likely that the hos-pital trust and/or the doctor and pharmacist maybe liable in the event of any claim for damages.An industrial commercial contract will specify

if the sponsor and/or QP has responsibility. TheQP has personal and professional responsibilityfor releasing the IMP for use in the trial, and willhave professional indemnity (PI) cover forclaims made concerning the possible adversequality of the IMP. In the case of the clinical trialTGN 1412 carried out at Nortwick Park Hospitallast year, the QP was questioned in order toestablish compliance with the registered speci-fication of the monoclonal antibody used in thePhase I trial.Fortunately for the QP, no fault was found with

the quality of the IMP, but had she not havereceived the specialised training to become a QPand not had appropriate PI cover, then this out-come may well have been different.Though the exemptions that exist for hospitals

reduce the bureaucracy associated with running aclinical trial, no QP is required to release the IMPfor use in the trial and as such, no indemnity coveror specialised training is given to the pharmacistwho is expected to carry out this task. Could thisbe another case of the NHS trying to get the serv-ices of the pharmacist on the cheap?

Theregulationsaffectinginvestigator-ledclinicaltrials inhospitals

If you have any further questions regardingthe issues raised in the article, John Jolleycan be contacted by email on

findoutmore:

[email protected]

{ }The QP has personal and professional responsibility forreleasing the IMP for use in the trial…

Simplification to the regulations governing clinical trials carried out in hospitals makes

no provision for a Qualified Person (QP) to release investigational medicinal products

for use in clinical trials. Does this put at risk the pharmacist who is expected to release

a product?

by John DR Jolley FRPharmS, FIQA. Pharma Consult (Europe) Ltd

| 15INSIGHT

The NHS is one of the largest employers in the world andwhen it decides to change its employment strategy, it tendsto have an impact on large numbers of people.

The catchy “Agenda for Change” title belies the real impact of what is being proposed. Jobs, terms and pay are all beingre-graded and as is usually the case; there will be winners and losers.

Whilst laws exist to protect the rights of employees, Hospitals have substantial HR departments to fall back on.

They will have their interests well covered – but will you?

We have provided our members with advice in many employment dispute situations including those related to Agenda for Change.

We have advised and supported more than 2,000 pharmacistsin such instances and in some cases have secured a bettergrading following appeals. To date, we have secured more than £200,000 worth of compensation payments from employers formembers who have been treated harshly or unfairly.

If you feel that you have been treated harshly or unfairly byhospital management, then why not do something about it?

Organise seminars and develop pro-active risk management toolsPharmacy employment specialists availableExperienced hospital Pharmacists availableBacked by £300,000 of Legal Defence Costs insuranceProfessional Indemnity Insurance - choice of limits

JUST WHOSE AGENDA IS IT?In the last two years the PDA has supported many pharmacists frustrated

by the agenda for change process.

AGENDAFORCHANGE…