The role of hospital and community pharmacists in pharmacovigilance

1. Introduction 

According to the World Health Organization, pharmacovigilance is “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem.”1 Reports of suspected adverse drug reactions (ADRs) are the basis of postmarketing surveillance of drugs. The occurrence of phocomelia related to thalidomide use by pregnant women in the 1960s brought an increased awareness of the necessity to detect, in as early a stage as possible, effects of marketed drugs which are unknown at the time a drug goes to market.

In a number of countries the pharmacist plays an important role in the reporting of suspected ADRs, but in other countries, mainly the Nordic countries, reports from pharmacists are not accepted by registration authorities.2

This article provides an overview regarding the pharmacists' role in collecting reports of ADRs and more widely in pharmacovigilance.

2. The changing role of the pharmacist 

The position of the pharmacist within the health care system has continually been subject to discussion and change. The pharmacist's primary mission traditionally has been to dispense drugs as prescribed by a physician and to ensure that these drugs meet the required standards. Nowadays the pharmacist also frequently acts as a consultant on pharmacotherapy. In the United Kingdom and United States, pharmacists are, to a degree, also authorized to write out prescriptions, which incidentally has been a long-standing practice in many countries where doctors are in short supply.2, 3 Whereas initially the pharmacist's role focused on the chemical aspects and raw materials of drugs, the local production of medicines, and the dispensing role, today it has shifted more toward reducing the prevalence of ADRs and drug-drug interactions, and providing information and instruction about appropriate drug use. The pharmacist has become a consultant on drug therapy, both for physicians and patients. In the Netherlands a legislative bill is being prepared to award the pharmacist the official status of co-consultant, thus making him jointly responsible for pharmacotherapy. The term pharmaceutical care is often used to describe the more comprehensive interpretation of the occupation, although the term is given different meanings and often thought to be too vague.4, 5 The role pharmacists play or are given to play also depends on the circumstances in which they exercise their profession.2 Nevertheless, the fundamental role of the pharmacist will always be to ensure that medicines are used safely.6

The literature mentions several other ways pharmacists can contribute to the safe use of drugs. In addition to their responsibilities relating to drug dispensing and compliance, pharmacists can play a prominent role in areas such as record keeping, education, and monitoring over-the-counter products and alternative therapies.7, 8 And because computerized dispensing drug systems are becoming more prevalent, the pharmacist's role is becoming more important, both as a user and in his/her capacity of system manager. The reporting of ADRs is one of the roles pharmacists could have.

3. The pharmacist as a reporter of adverse drug reactions 

This article specifically focuses on the significance of the pharmacist as a reporter of ADRs. In some countries their contribution is substantial, such as is the case of community pharmacists in the Netherlands and hospital pharmacists in the United States, Canada, and the United Kingdom (Table 1). In some countries, mainly in Scandinavia, pharmacists are not always authorized to report ADRs, and in most countries where they are, their contribution is often still relatively small.2, 9, 10

Table 1. Percentage of professional ADR reports originating from pharmacists by country

	Country	%	Hospital pharmacistsb	Community pharmacistsb
	Canada	88.3	+	−
	USA	68a	+	−
	Australia	40.3	+	±
	Netherlands	40.2	−	+
	Japan	39	?	+
	Spain	25.9	+	+

See reference 2.

a See reference 17. b “+” Indicates that it is primarily pharmacists from this setting who originate the reports; “−” indicates that pharmacists do not typically originate the reports; “±” indicates that some but infrequent reports originate from pharmacists practicing in this setting; “?” indicates unknown data.

In an international review, Griffin11 noted in 1986 that many countries have had accepted pharmacists' reporting ADRs as standard practice. In 1989 Fincham12 commented: “Exclusion of pharmacists simply does not make sense.” In their article in 1993 on the differences between European countries, Lindquist and Edwards13 remarked: “Pharmacists who advise patients directly … are the most likely to detect adverse reactions.” Roberts et al14 concluded in 1994: “It is hoped that pharmacists in other countries will also be encouraged to participate in ADR reporting, a procedure that could only lead to better patient care.” The literature on the actual contribution of pharmacists in ADR reporting often applies to the hospital pharmacist in the United States, Canada, and the United Kingdom,15, 16, 17 with scarce mention of similar such reporting among community pharmacists. Many publications emanating from the United Kingdom have focused on a 10-year ongoing debate concerning the desirability of direct reporting by pharmacists.6, 14

Various textbooks on pharmacoepidemiology and pharmacovigilance give the pharmacist little attention. An exception to this lies with Inman7 who, as early as in 1986, devoted a chapter to the role of the pharmacist. The authors of this chapter, Poston and Parish, examine their contribution in relation to nonprescription drugs and also point to the medication history that pharmacists keep and the edge that pharmacists have through the use of computer technology. They conclude by stating: “It is to be hoped that protection of professional territories will not prejudice such a contribution.”

The take away message should be mutual respect and acknowledgment of professional expertise. In the literature it has been widely reported that physicians fully subscribe to a prominent role for pharmacists in drug policies.18

4. The contribution of the hospital pharmacist 

Hospital pharmacists can play a significant role in ADR reporting. The most serious adverse drug events occur in hospitals. In addition, several publications underscore the fact that adverse drug events account for a substantial percentage of all hospital admissions. The percentages that vary because of differences in adverse drug events are operationally defined and range somewhat widely by country, from 3.2% in France, to 6.7% in the United States, to 12% in Sweden.19, 20, 21 Recently, a prospective analysis of ADRs as the cause of hospital admissions in the United Kingdom was published and it reported 6.5% of the hospital admissions as ADR-related.22

The previous reports demonstrate the importance of prevention and recording of adverse events occurring in hospitals, to control both the harmful effects and the costs resulting from these events.23 Oversight for this process could best be accomplished by hospital pharmacists, particularly when they are directly involved in patient care.23 The literature further suggests that pharmacists could actually help in substantially reducing the ADR incidence rate.15, 24

The following prerequisites need to be fulfilled to ensure that pharmacists' contribution will indeed help to decrease the number of adverse events and improve ADR reporting: direct involvement in patient care, and a functional, widely supported hospital reporting system in whose management the hospital pharmacist should have a key role. Apart from their quantitative relevance, ADR reports from hospitals also raise the quality of ADR monitoring because of their high-quality documentation.8, 17 More ADR reports originating from hospitals would also enhance the surveillance of those drugs that are chiefly used in hospital settings.8 Moreover, hospital pharmacists have more advanced means at their disposal to monitor drug safety, such as sophisticated computer systems and databases, as well as the possibility to investigate deviant lab test results, methods which are not available or less available elsewhere.25, 26

The contribution hospital pharmacists make to ADR reporting in the United States is by far the largest. Most of the reports the Food and Drug Administration receives directly from health professionals originate from hospital pharmacists.27, 28, 29 The Food and Drug Administration particularly encourages this professional group to report because of the high standard of their reports.29, 30 The fact that they play such a key role is the direct result of a stipulation of the Joint Commission on Accreditation of Health Care Organizations requiring hospitals to sustain an ADR monitoring program.31, 32 Evidently, they view such hospital reporting systems as a crucial element of the national reporting system. A similar situation applies to Canada, where the Canadian Society of Hospital Pharmacists took the initiative.33

In the United Kingdom there has been a long-lasting discussion over the position of the (hospital) pharmacist within the reporting system. As early as 1982, Hardman and Lloyd34 proposed to give hospital pharmacists an active role in the monitoring of ADRs. A structural collaboration between clinicians and hospital pharmacists was proposed by Irvin et al.35 Wistanley et al16 have demonstrated that the initiation of a pharmacy-based reporting scheme led to a substantial increase in the number of ADR reports, a finding that was later confirmed by Lee et al.27 Nevertheless, it was not until 1997 that the hospital pharmacist was officially allowed to report ADRs to the national reporting system.

5. The contribution of the community pharmacist 

In an overview covering a large number of countries participating in the World Health Organization International Drug Monitoring Program, it was demonstrated that the quantitative contribution community pharmacists make to the national systems is small.9 In some countries, however, as is the case in the Netherlands, community pharmacists play a significant role in ADR reporting.36 Pharmacist-generated ADR reports in the Netherlands, chiefly originating from community pharmacists, have their own specific characteristics, which make them a valuable addition to the reports received from physicians. Community pharmacists report more on eye and skin diseases because these disorders are more likely to be observed by the patients themselves. They also have a special position in the reporting of ADRs of over-the-counter products. When we look at the way the pharmacists perceive their role in ADR reporting, we find that they are not only highly motivated but also consider it an integral part of their professional duties.37, 38

To date, little is known about the position or contribution of pharmacists in other countries, because this has only been described for Cuba, where community pharmacists in health centers have a systematic role in ADR reporting.39 In the literature their potential role in relation to nonprescription medicines (over-the-counter drugs) has received attention.40, 41 This concerns not only nonprescription drugs but also alternative therapy; pharmacists are uniquely placed to learn about these ADRs and report them.8

6. Conclusion and future developments 

By profession, pharmacists are the experts when it comes to drugs. An in-depth knowledge of the mechanisms and behavior of drugs in the human body is often crucial to gain insight into the actual effects a drug has, and may also help explain a (suspected) ADR. On a global scale, major improvements can be made and the extent of underreporting can be considerably reduced by actively involving pharmacists in the surveillance of drug safety within the context of the pharmaceutical care that they provide.2 It is recommended to increase their participation especially in those countries where they are not authorized to report or where their contribution is limited. Modifications of the pharmacy curriculum as well as changes in the interpretation of the pharmacist's scope of duties are required. Knowledge about risks of ADRs should be part of the curriculum and ADR reporting part of a pharmacist's basic tasks. The attitude physicians take toward the profession is also sometimes in need of change. Over 3 decades ago it was argued that “doctors should learn to make use of the pharmacist's knowledge and skills.”42

The contribution of the pharmacist to pharmacovigilance should not be limited to ADR reporting. The pharmacists' understanding of the various pharmaceutical disciplines could also greatly enhance our understanding of the nature of ADRs. For the detection and assessment of possible ADRs, pharmacokinetics, pharmacodynamics, and knowledge of chemical relations are often indispensable. However, within these fields ADRs have not received systematic attention from pharmacists and their contribution to pharmacovigilance is consequently still rather limited. Here, again, there is room for improvement. If those involved in pharmaceutical disciplines can rise to this challenge, they will significantly help deepen our insights into ADRs and widen the scope of pharmacovigilance. Regarding the potential role of the pharmacist in relation to ADR reporting, Fincham12 stated quite rightly: “Efforts must be expanded to include pharmacists in every ADR surveillance activity.”