Veterinary pharmacovigilance: between regulation and science

Veterinary pharmacovigilance has shown a remarkable development in recent years. After presenting briefly the regulatory context, this paper considers the scope of veterinary pharmacovigilance, causality assessment of suspected adverse drug reactions (ADRs), the systems existing in different countries and the evolution for the coming years. The involvement of veterinary research and teaching institutions should certainly become more important in this cross-road activity.     

Adverse Drug Reactions: Report of the Australian Veterinary Association Adverse Drug Reaction Subcommittee, 1993

SUMMARY Fifty-nine reports of suspected adverse drug reactions (ADRs) were received by the Adverse Drug Reaction Subcommittee of the Australian Veterinary Association from April 1992–March 1993 inclusive. The number of reports received/number of animals involved per species was: dogs (30/43); cats (11/14); horses (8/10); cattle (9/30); ferret (1/1). Of these, 37 (63%) were classified as definite ADRs and 12 (20%) as probable ADRs. In 10 (17%) reports an ADR could not be substantiated or there was insufficient information available to make a decision. Twenty-three reports involved apparent hypersensitivity reactions and 5 reports were associated with ‘off-label’ use. Of the definite and probable reports of suspect ADRs the most frequent types of drugs involved were antimicrobials (9 reports), anthelmintics (9 reports), vaccines (7 reports), insecticides (6 reports), vitamin preparations (6 reports), topical anti-inflammatory/antimicrobial/antifungal skin preparations (3 reports) and nonsteroidal anti-inflammatory preparations (3 reports). Single reports concerning definite or probable ADRs to an anticholinergic, an anaesthetic agent, a corticosteroid, an anabolic steroid and a chondroprotective drug were received.     

Adverse drug reactions: Report of the Australian Veterinary Association Adverse Drug Reaction Subcommittee, 1994

Seventy-seven reports of suspected adverse drug reactions (ADRs) were received by the Adverse Drug Reaction Subcommittee (ADRSc) of the Australian Veterinary Association from April 1993 to December 1994 inclusive. The number of reports received/number of animals involved per species were: dogs (32/44), cats (18/31), horses (17/48), and cattle (10/21). Of these, 49 (64%) were classified as definite ADRs and 9 (12%) as probable ADRs. In 11 (14%) reports an ADR could not be substantiated or there was insufficient information available to make a decision. Eight reports were not classified because the manufacturer and the ADRSc disagreed as to the appropriate classification. Sixteen reports involved apparent hypersensitivity reactions, which resulted in death on 6 occasions. Six reports were associated with ‘off label’ use and 1 report with use of an expired product. Of the definite, probable and unclassified reports of suspect ADRs, the most frequent types of drugs involved were antimicrobial drugs (13 reports), anthelmintics (13), insecticides (11), vaccines (10), nonsteroidal anti-inflammatory preparations (5), chondroprotective agents (4), anaesthetic/sedative agents (4) and vitamin preparations (2). Single reports concerning definite, probable or unclassified ADRs to a vasodilator, a corticosteroid, a local anaesthetic and a disinfectant were received.     

Pharmacovigilance in veterinary medicine in Chile: a pilot study

Iragüen, D., Urcelay, S., San Martín, B. Pharmacovigilance in veterinary medicine in Chile: a pilot study. J. vet. Pharmacol. Therap. 34 , 108–115. In Chile, there is no present government policy to survey and analyse adverse drug reactions (ADRs) in the field of veterinary medicine. The intent of this study is to assess, for the first time, ADR frequency in treated animals. To this purpose, a 6‐month period pilot study based on WHO recommendations was conducted to monitor ADRs in cats and dogs for frequently used drugs and common labelled signs. Of a total of 149 detected ADRs, 29 (6 in cats and 23 in dogs) were notified by means of ADR report forms, while the rest was identified after reviewing patient clinical records, thus evidencing strong under‐reporting problems. More than 70% of ADRs were related to antimicrobials, vaccines and tranquilizers. In dogs, there was a significant effect on ADRs’ presentation when acepromazine, amoxicillin, carprofen, ivermectin, sextuple vaccine (polyvalent vaccine that confers immunity against canine distemper virus, canine parvovirus, Leptospira canicola, L. icterohemmoragiae, canine adenovirus type 2 and canine parainfluenza virus) and phytomenadione (subcutaneous injection) were administered. In the case of cats, a significant influence on ADRs was detected when acepromazine, amoxicillin or vitamin K was administered. Present results suggest the need for a pharmacovigilance programme in veterinary medicine for timely ADR‐presenting drug detection and drug safety improvement.     

Adverse drug reactions: Report of the Australian Veterinary Association Adverse Drug Reaction Subcommittee, 1992

Fifty-nine reports of suspected adverse drug reactions (ADRs) were received by the Adverse Drug Reaction Subcommittee of the Australian Veterinary Association from February 1991-March 1992 inclusive. The number of reports received/number of animals involved per species was: dogs (23/24); cats (20/30); horses (4/4); cattle (7/10); sheep (3/745); poultry (1/580); pigs (1/8). Of these, 38 (64%) were classified as definite ADRs and 9 (15%) as probable ADRs. In 10 (17%) reports an ADR could not be substantiated or there was insufficient information available to make a decision. Two reports involved veterinarians inadvertently overdosing animals. Eighteen reports involved apparent hypersensitivity reactions and 6 reports involved probable drug interactions. Four reports involved the use of drugs at appropriate doses but in inappropriate clinical situations, and 3 reports were associated with 'off-label' use.     

Vigilance for veterinary medicinal products: declarations of adverse reactions in the year 2009

During the year 2009, 134 reports of suspected adverse drug reactions (ADRs) to veterinary medicinal products (VMPs) were received (106 in the year 2008). The distribution according to species and drug classes remained in line with previous years. Companion animals were involved in most of the reports (46 % dogs, 19 % cats), followed by cattle or calves (22 %). Antiparasitic drugs made the biggest part with 30 % of the reports, followed by antiinfectives (19 %) and hormones (13 %). Some reactions following their use are specifically discussed. 95 additional enquiries about ADRs of VMPs were received by the Swiss Toxicological Information Centre in Zürich. Most of them concerned dogs or cats and antiparasitics or anti-inflammatory drugs. In the vaccinovigilance program, a total of 1020 reports were received, of which 1000 were related to the vaccination against blue tongue disease. The most frequently reported adverse reactions were aborts, mastitis or alterations of milk quality and they are specifically discussed.     

Animals go to the veterinarian,people go to the dentist

The Dutch law and other regulations provide that only registered veterinarians can treat animals. Moreover, by law only registered individuals may use the title veterinarian or dentist. The veterinary professional should be open to advice, help, and technical assistance from other professionals working with human or animals patients. The dental treatment of animal patients must not be carried out in a dental surgery or hospital used by human patients.     

Vigilance for veterinary medicinal products: declarations of adverse reactions in the year 2010

In 2010, we observed again an increase in the number of declarations reported to the vigilance system for veterinary medicinal products up to a total of 160. The species and drug classes reported remained the same as in previous years: the majority of adverse drug reactions (ADRs) concerned either dogs or cats and the most frequently involved drugs were either antiparasitic products or antiinfectives. Adverse reactions following reconversions and 8 cases of suspected allergic reactions following the use of amoxicillin-clavulanic acid combinations in dogs were reported. Additional enquiries were processed by the Swiss Toxicological Information Centre and transmitted to Swiss medic. 11 of these reported accidental ingestions of flavoured tablets in overdose by dogs and some cats. The vaccino vigilance program received 179 declarations following immunization against blue tongue disease as well as 82 declarations following the application of other vaccines. The vigilance system increases the chance to identify rare reactions or interactions and thereby contributes to the security of veterinary medicinal products.     

Drug hypersensitivity reactions targeting the skin in dogs and cats

Adverse drug reactions (ADRs) can be dose dependent or idiosyncratic. Most idiosyncratic reactions are believed to be immune-mediated; such drug hypersensitivities and allergies are unpredictable. Cutaneous reactions are the most common presentation of drug allergies. In veterinary medicine it can be difficult to assess the true prevalence of adverse drug reactions, although reports available suggest that they occur quite commonly. There are multiple theories that attempt to explain how drug allergies occur, because the pathogenesis is not yet well understood. These include the (pro)-hapten hypothesis, the Danger Theory, the pi concept, and the viral reactivation theory. Cutaneous drug allergies in veterinary medicine can have a variety of clinical manifestations, ranging from pruritus to often fatal toxic epidermal necrolysis. Diagnosis can be challenging, as the reactions are highly pleomorphic and may be mistaken for other dermatologic diseases. One must rely heavily on history and physical examination to rule out other possibilities. Dechallenge of the drug, histopathology, and other diagnostic tests can help to confirm the diagnosis. New diagnostic tools are beginning to be used, such as antibody or cellular testing, and may be used more in the future. There is much yet to learn about drug allergies, which makes future research vitally important. Treatment of drug allergies involves supportive care, and additional treatments, such as immunosuppressive medications, depend on the manifestation of the disease. Of utmost importance is to avoid the use of the incriminating drug in future treatment of the patient, as subsequent reactions can be worse, and ultimately can prove fatal.     

Faculty expectations of veterinary students in clinical rotations

Expectations of veterinary students during clinical rotations should be developed with the goal of bettering the veterinary profession as a whole. This article outlines five areas of expectations for the veterinary professional: treating colleagues with respect, providing excellent care for patients and clients, developing and maintaining skill sets to support intellectual curiosity and continued professional development, and improving upon and using self-care and life-balance skills.     

The professions: a critical review

The professions have recently been subjected to intense scrutiny in the media. Increasingly, criticism is levelled at the professions collectively rather than at individual professions. Even when difficulties afflict a particular profession the resulting public debate affects other professional bodies. The changes that one profession makes to meet such criticisms inevitably influence the others. If, for example, a professional group decides to permit advertising by its members, the case of those who prefer to retain a restriction is weakened. If barristers may at some future date be consulted without the intermediation of a solicitor, why should not surgeons receive patients who have not visited a general practitioner?     

Cutaneous and ocular adverse reactions in a dog following meloxicam administration

The present report addresses the development of cutaneous and ocular reactions possibly related to meloxicam administration in a dog. Based on clinical signs and absence of laboratory data compatible with the other differential diagnoses considered, the possibility of an adverse drug reaction (ADR) due to meloxicam was considered. Skin biopsy revealed haemorrhage of the superficial and deep dermis, associated with hyperplasia of endothelial cells and epidermal sloughing. Vasculitis in the deep dermis was also noted. Such lesions were considered compatible with an ADR. Although the owner was not aware of any previous allergic reaction to drugs, the animal had a clinical history of atopic dermatitis. Meloxicam is a nonsteroid anti-inflammatory drug (NSAID) in the oxicam family, indicated for the control of inflammation and pain in acute and chronic musculoskeletal disorders in dogs. Although meloxicam is usually well tolerated, the present clinical case represents an alert to practitioners about the potential role of NSAIDS in ADRs in dogs with a history of allergic cutaneous diseases.     

Predictors of owner response to companion animal death in 177 clients from 14 practices in Ontario

OBJECTIVE: To identify predictors of grief and client desires and needs as they relate to pet death. DESIGN: Cross-sectional mail survey. SAMPLE POPULATION: 177 clients, from 14 randomly selected veterinary practices, whose cat or dog died between 6 and 43 days prior to returning the completed questionnaire. PROCEDURE: Veterinary practices were contacted weekly to obtain the names of clients whose pets had died until approximately 200 clients were identified. Clients were contacted by telephone, and a questionnaire designed to measure grief associated with pet death was mailed to those willing to participate within 1 to 14 days of their pet's death. The questionnaire measured potential correlates and modifiers of grief and included three outcome measures: social/emotional and physical consequences, thought processes, and despair. Demographic data were also collected. RESULTS: Approximately 30% of participants experienced severe grief. The most prominent risk factors for grief included level of attachment, euthanasia, societal attitudes toward pet death, and professional support from the veterinary team. CONCLUSIONS AND CLINICAL RELEVANCE: Bivariate and multivariate analyses highlighted the impact owners' attitudes about euthanasia and professional intervention by the veterinary team had on reactions to pet death. Owners' perceptions of societal attitudes, also a predictor of grief, indicate that grief for pets is different than grief associated with other losses.     

基于职业能力的高职药学专门化培养方向实践探索

高职教育作为高等教育的一个新兴类型,其培养目标和课程设置必须体现出就业岗位对职业能力的要求。医药产业生产、管理、营销一线岗位对职业能力的要求差异较大,应针对生产、管理、营销岗位职业技能,在药学大专业中,根据区域医药产业发展现状和前景,设置若干专门化培养方向,调整课程体系,以培养出具备可持续发展能力的高端技能型药学人才。     

理性开展高校动物医学类专业课程的双语教学

分析双语教学的目标和动物医学类专业课程的特点,结合我国高校双语教学现状和存在问题,对动物医学类专业课程实施双语教学进行理性的分析和探讨,提出双语教学的关键是拥有英语应用水平（尤其是口语是否标准和熟练）过关的专业教师,根据学生英语基础和意愿实行分班授课的教学方法 ,以期为高校开展专业课程双语教学提供参考。     

Veterinary Products Committee working group report on feline and canine vaccination

* The working group was set up by the Veterinary Products Committee in response to current concern in both the public domain and in the scientific community about possible health risks related to the routine vaccination of cats and dogs. The working group concluded that vaccination plays a very valuable role in the prevention and control of the major infectious diseases in cats and dogs. Although adverse reactions to vaccination, including lack of efficacy, occasionally occur, the working group concluded that the overall risk/benefit analysis strongly supports their continued use. * Although for some diseases there is evidence of a longer duration of immunity following vaccination than the one year which is typically recommended on the product literature, there is currently insufficient information to propose revaccination intervals other than those proposed by the manufacturer and approved by the regulatory process. * Notwithstanding this, in view of the occasional occurrence of adverse reactions, the working group recommends that the product literature indicates that the regime for booster vaccinations is based on a minimum duration of immunity rather than a maximum. The working group further recommends that the product literature should state that a risk/benefit assessment should be made for each individual animal by the veterinary surgeon in consultation with the owner with respect to the necessity for each vaccine and the frequency of its use. * The evidence suggests that cats appear to be susceptible to the occasional development of sarcomas at sites of injection and there is some further evidence to suggest that, although other products may be involved, this may be more associated with the use of vaccines containing aluminium-based adjuvants. The working group therefore recommends that a generic warning to this effect should appear on the product literature for all feline vaccines administered by injection. The working group also highlighted the need for professional and educational bodies in the UK to bring to the attention of veterinary practitioners appropriate methods for prevention, diagnosis and treatment of this serious condition. * The working group considered in depth the monitoring of adverse reactions, including the advantages and disadvantages of surveillance schemes. A range of options for carrying out further epidemiological (analytical) studies was also considered. However, the working group emphasised that surveillance schemes, and the UK Veterinary Medicines Directorate (VMD) Suspected Adverse Reaction (SAR) Surveillance Scheme in particular, provided a very valuable resource. The large database within the VMD scheme (collected since 1985) was analysed as part of this report. Figures were derived in terms of incidence (reporting rate) of certain clinical signs per 10,000 doses, and risk factors as identified by statistical analysis. However, due to a number of constraints, the analysis was not fully comprehensive and the interaction of possible risk factors was not determined. * Product-related control charts were developed in order to detect changes in incidence rates of adverse reactions (per 10,000 doses sold) both within and between different vaccines. Such charts provide a powerful way to detect changing trends in incidence and, when used in conjunction with product characteristics, they may identify possible causes. In general, the data showed that the incidence of adverse reactions to cat and dog vaccines per 10,000 doses of product sold was relatively low. Although under-reporting is a feature of such surveillance schemes, it does appear that, overall, vaccination of cats and dogs should be considered safe and effective. * Finally, the working group was conscious, while preparing this report, of the extensive media coverage that has been given to the issue of the safety of human vaccines, in particular the mumps, measles and rubella (MMR) vaccine. The working group emphasises that the conclusions and recommendations included in this report relate only to the vaccines used in cats and dogs. The issues identified are specific to the diseases and species examined and no attempt should be made to draw analogous conclusions in relation to vaccines administered to humans.     

From a philosopher's perspective, how should animal scientists meet the challenge of contentious issues?

This article reviews how professional ethics can be useful in helping animal scientists meet new responsibilities. The transition to a postindustrial period in animal production signals a shift in the nature of contentious issues that animal producers face. Whereas farm income was once the most controversial issue in animal production, producers and animal scientists now face complex risk issues that have overlapping constituencies. Animal scientists need to develop a professional ethic that will stress open and active debate on these issues. Discussion of these issues must take place in the animal science classroom. The new professional ethic should be based on core values required for scientific research. However, departments and professional societies must develop institutions that will permit the values and methods of rationality and truth seeking to be applied in areas where measurement and experimental method are unlikely to resolve disputes, (i.e., to controversial issues that require public discussion and debate). Several specific proposals for such institution building are discussed.     

Fatal thrombocytopenic hemorrhagic diathesis associated with dapsone administration to a dog

Dapsone was given for six days to a dog with chronic skin disease. The dog then became weak and anorectic, and it vomited and had purpura caused by severe thrombocytopenic hemorrhagic diathesis. Despite treatment, the dog died a week later. There were clinical and pathologic evidence that the dog's platelets and megakaryocytes had been destroyed during the first few days of dapsone therapy. It was concluded that the syndrome was dapsone-induced and that thrombocytopenia should be considered among the adverse reactions to dapsone in the dog.     

Offering the best to patients: ethical issues associated with the provision of veterinary services

Veterinary surgeons have long been perceived as animal advocates and yet their income is usually dependent on a third party: the owner. Given the ever-increasing options now available to treat complex clinical conditions, it is important to consider which services should, rather than could, be offered to clients. Does the professional obligation to act as an animal advocate conflict or concord with the desire to operate a successful business? David Main discusses the ethical issues associated with the provision of professional services to clients and their animals.     

Bovine superfetation by natural conception secondary to an embryo transfer pregnancy

There was only one embryo transferred to the recipient female. There was no chance for natural service to occur from 21 days prior to the transfer of the embryo to 31 days after the transfer of the 7 day old blastocyst. The surrogate female was palpated as being 38 days pregnant 31 days after the transfer of a 7 day old embryo by an experienced professional before being exposed to the natural service sire. The second fetus was of a different sex than the first and was approximately 60 days less mature. All other pregnancies within this well managed herd were accounted for and no other cows calved within the area close to that time. The remaining recipients carried pregnancies to the approximate expected calving date. Conclusion. This case report should support earlier evidence that superfetation in the bovine can and does occur.