Why more pharmacists should become qualified persons in the industry

A typical salary for a new qualified person (QP) is £40,000 a year. Senior positions including QP status pay up to £80,000. These often exceed salaries of pharmacists in other spheres. Moreover, a demographic time bomb is ticking as more QPs are retiring than are being produced. This suggests that incomes and status are unlikely to fall. So why do so few pharmacists practise as QPs in industry?

This article outlines what QPs do, how to become one and some history about conflict with non-pharmacists, and suggests a strategy to boost pharmacist numbers.

The QP is the quality assurance professional for medicines defined by British law, based upon European Union directives. The QP ensures that every batch released to the market complies with its specification and has been made according to good manufacturing practice. Medicines from outside the EU also often have to be analysed and assessed as suitable for use on EU patients.

“Judgement day” for any batch is when the QP decides whether or not to certify approval for release on the batch’s “birth certificate”. Before such approval, the QP will need to be comfortable with aspects such as safe working systems, internal audit, training and analytical results. A QP who delays, let alone stops, the release of a batchworth £1m may be unpopular with top management so certain personal qualities are required. The dispensing pharmacist erring during checking a prescription may place one patient’s life at risk; the QP certifying, in error, an industrial batch may put thousands of lives at risk. Next time you receive a defective medicine recall for a batch, reflect that the company’s QP has been involved.

Variety of QP role

However, are you a pharmacist who cannot resist smelling any medicine while dispensing? Could you distinguish, by smell alone, between open containers of cimetidine, metformin and phenoxymethylpenicillin? Did you love your chemistry set, the fizzing and crackling? Would you like to fabricate medicines by the ton? Does overseas travel appeal? Are you discontent with the same four walls, knowing that you will be doing the same things next week, next year? Has your romantic vision of autonomous practice in your pharmacy solidified into something akin to serving in McDonalds? If so, the variety of a QP role might interest you. For example, you might find yourself reviewing medicines for humans, chickens, sheep, rabbits or salmon. By May 2004, human investigational medicinal products (phases 1, 2 and 3) will also require QP certification.

To become a QP, today requires satisfying oral examiners representing the Institute of Biology, the Royal Pharmaceutical Society and the Royal Society of Chemistry. You must complete an application form, including work experience and sponsorship details and probably a course lasting two to four years; generally, employers pay the expensive course fees. Each professional society maintains a register of persons eligible for nomination as QPs. A company needing a QP selects an individual from a register and submits the name to the regulatory authority. It decides whether that individual is suitable for that application. Only after that individual has been approved is QP status granted.

Medicines experts

Student QPs being examined by biologists and chemists may surprise some pharmacists. After all, pharmacists claim to be the medicines experts; all their training concerns medicines — unlike those other occupations. Chemists, for example, may embrace explosives, metallurgy and water. Biologists, chemists and pharmacists, each wanting to be QPs, illustrate how professions jostle, routinely, for market share. Sociologists perceive this as one case study of one market niche where pharmacists are losing their battle; that is not good or bad, but just the way it is.

Initially in Belgium, France, the Netherlands and Luxembourg, QPs could only be pharmacists. In Germany, Ireland, Italy and the UK, QPs could either be chemists or pharmacists. A survey in the UK showed that many were chemists. When Britain entered the Common Market, a draft directive, nearly completed, would have applied the French system, giving a monopoly to pharmacists, except for a grandfather clause, giving anyone undertaking QP duties at that time to continue. The Royal Institute of Chemistry (now part of the Royal Society of Chemistry) strongly opposed that and fought it through the Department of Health; the directive should allow not only pharmacists but also chemists. Eventually, a compromise was agreed: the “competent authority” (government) should decide whether a course covered certain topics. The Pharmaceutical Society maintained that only a pharmacy degree fulfilled the criteria; the Royal Institute of Chemistry disputed that.

The outcome was that QPs can be biologists, chemists and pharmacists. In 1998 these comprised about 8, 44 and 48 per cent, respectively. Today they comprise 10, 48 and 42 per cent, representing swings of +25, +9 and –13 per cent, respectively. Pharmacy’s opportunity of having a QP register entirely comprised of pharmacists was lost one generation ago.

QPs from any discipline are able, and patients benefit from the breadth of disciplines. However, as a pharmacist, I am concerned that, today, pharmacists are so preoccupied with clinical pharmacy and prescribing that they lack commitment to industrial pharmacy, including the QP role. Witness the Royal Pharmaceutical Society’s lack of commitment to The Industrial Pharmacist, and publication only restarting after pharmaceutical companies sponsored it. Witness the chemists’ society publishing its QP register on its website while the pharmacists’ society does not. Witness those swings above.

Suppose that present trends continue. If pharmacist numbers, as QPs, fall below a “critical mass”, they may be perceived as poachers, misfits, in what will become biologists’ and chemists’ territory. Then, one day, if a newly registered pharmacist says, “I want to make my career in technical work producing or quality controlling medicines”, he or she may be looked at askance. Scientists, such as biologists and chemists, are QPs; pharmacists are health professionals. Their strength is in direct contact with patients. To make, also, the medicine that pharmacists prescribe and dispense is greedy and quirky: it is at, or beyond, the fringe of their competence.

Tactics

How can pharmacists hold on to the QP role to which they are currently entitled? I suggest three tactics as a contribution to debate.

First, the pharmacists’ role as a QP should be publicised more when competing for applicants to schools of pharmacy.

Second, during undergraduate studies, tuition in good manufacturing practice and quality assurance should be increased and injected deep into pharmacists’ attitudes. Movers and shakers in academia should address this; it may be a particular marketing opportunity for the new schools of pharmacy.

Third, pharmacists outside the industry should review how satisfied they are with their career. If they are discontent, if practicable they should leave and try the industry. Initially, they might earn less. But not for long. All pharmacists should agree a good strategy, execute it vigorously and do so soon.