Professional Regulation and Criminal Liability

1 Professional Regulation and Criminal Liability: Pharmacists Professional Regulation and Criminal Liability: Pharmacists Introduction A profession is “an occupation based on the mastery of a complex body of knowledge and skills. It is a vocation in which the practice of an art is used in the services of others” (Schmitz & Martin, 2008, p. 1). Belonging to a certain profession requires one to agree to demonstrate integrity, selflessness, competency as well as morality. This becomes the foundation on which the medical profession gets autonomy of practice from the society and a chance to experience self-regulation. Pharmacy is one of the medical professions whose practitioners help people to utilize medications to the best. It is notable that since professionals own specialized knowledge which the client does not have, the possibility of the professional exploiting the client exists. It is however important to note that such exploitation leads to very severe consequences since it has violated the guiding regulations for pharmacists.

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While executing the duties of a pharmacist, it is possible to make mistakes that have serious consequences. In Australia, a customer or a patient may pursue an alleged misconduct against him or her, for instance when a patient suffers injury due to negligence by a pharmacist, through several means. Customers may lodge their complaints to the institution where the pharmacist is practicing and the institution’s internal complaints department handles the matter. The patient may also take his or her complaints to the pharmacy registration board which then takes the appropriate disciplinary action. Low (2009) explains that the patient can lodge the “complaint with the independent statutory complaints unit or commission established in each of the states or territories” (p. 95) or initiate action “through the adversarial court system; for example, a civil claim for damages” (Low, 2009, p. 95) It is possible to pursue more than one of the above processes at the same time. Low (2009) advises that for legal or disciplinary processes initiated by consumers to be successful, the public should have enough confidence in the legal processes.

Complaints against pharmaceuticals are supposed to be handled depending on whether it is a matter of competence, impairment or disciplinary. These approaches are helpful in safeguarding the public from harm likely to be inflicted by pharmacists. This is done by identifying practitioners who have potential of harming the public as well as looking into cases where harm has been caused or was likely to have been caused. As earlier mentioned, distinguishing less serious misconduct from serious cases is important and serious misconduct should be addressed by tribunals at the state or territory levels. A client initiates a complaint prompting the relevant board to investigate

3 the pharmacist’s conduct and practice. Disciplinary proceedings are then launched and the disciplinary action depends on whether the pharmacist has professional misconduct, unprofessional conduct, substance addiction, impairment (physical or mental) as well as criminal convictions in a court. Even failing to adhere to the governing rules of a regulatory board may be considered as an offence (Low, 2009).

Pharmacy registering bodies have a mandate of launching investigations on misconduct among pharmacists and execute necessary disciplinary action. The public can take their complaints regarding services received from pharmacists thereby prompting the registration authorities to investigate pharmacists’ conduct. There are existing legislative guidelines that are used to manage complaints as a way of recognizing consumer rights. Every jurisdiction in Australia has its governing Act that provides the legal process of addressing complaints from consumers against pharmacists. Jurisdictions differ in the way they define professional misconduct of pharmacists as well as the degree by which a pharmacists is inconsistent with the terms of professional conduct. It is however important to note that in all jurisdictions, the legal process of addressing complaints follows that less serious misconducts are streamlined whereas serious breaches are taken before committees or panels. Most serious breaches are presented before a tribunal where a judge presides over the case.

In the Australian Capital Territory, the Health Professionals Act 2004 empowers the Pharmacy Board of the Australian Capital Territory to discipline pharmacists who have violated any of the provisions of the Act once a complaint is launched. The pharmacists may be cautioned, reprimanded or his or her registration may be suspended or cancelled. The Pharmacy Board of New South Wales is guided by the

4 Pharmacy Practice Act 2006 in handling customer complaints against pharmacists. The Health Practitioners Act 2004 guides the Northern Territory Pharmacy Board whereas Queensland Pharmacist Board is guided by the Professional Standards Act 1999. In South Australia, the Pharmacy Board of South Australia is guided by the Pharmacy Practice Act 2007 in addressing complaints against pharmacists whereas Tasmania is governed by the Pharmacy Practice Act as applied by the Pharmacy Board of Tasmania (Low, 2009).

It should be noted that pharmacists have a responsibility of making sure that they have written information regarding all information pertaining prescription drugs. These include risks associated with certain drugs, the adverse effects of the drugs as well as the contraindications for the drug. When such accurate information is provided to the patients, the likelihood of pharmacists encountering liability when patients get harmed is very high. Burns (2008) explains that the public should be made aware about safe use of prescription drugs using Medication Guides and the pharmacists are the primary providers of the Medication Guides. It is identified that not all pharmacists comply with this requirement thus exposing patients to inaccurate information thus increasing potential liability.

There are several possible liabilities that pharmacists face due to disregard of providing Medication Guides to patients. These include misbranding and civil liability hence lawsuits. Burns (2008) explains that misbranding is an offense as described by the Federal Food, Drug and Cosmetic Act (FDCA) and it is a strict liability type of violation. The pharmacist’s ignorance about misbranding violation does not exempt him or her from the legal implications. Misbranding by pharmacists happens when the drug

5 is labeled wrongly or if the labeling is misleading. A good example of a misbranding violation occurs when a pharmacists fails to include patient package insert when dispensing drugs. The FDCA subjects pharmacists who are found guilty of misbranding to a possible jail term in addition to a fine of up to $1,000. In the U.S. misbranding violations can be addressed by either state laws or federal statutes.

Civil tort liability also faces pharmacists who fail to provide patients with Medication Guides. Pharmacists have to be patient-centered and this responsibility implies that professional liability for pharmacists have increased more so with pharmacists having a ‘duty to warn’. If patients are injured after taking prescription drugs, they tend to claim that the pharmacists had a role in warning the patient of potential harmful effects of the prescription drugs. The pharmacist is considered to have a duty of warning the patients about possible adverse effects of a drug through provision of Medication Guides. It therefore follows that a patient can file a lawsuit against a pharmacist if the patient gets harmed by taking a prescription drug yet the injury would have been avoided if written information was provided. Burns (2008) provides an example of court case that predisposed a pharmacist to possible liability on the grounds of failing in the “duty to warn” role. The Stanley v. Wyeth involved a patient who died after taking amiodarone (under prescription). The family of the deceased claimed that the patient died from the adverse effects resulting from the drug since the pharmacist did not provide a Medication Guide thus it was failure in duty to warn.

Despite the fact that the court did not find the pharmacist liable, the case is a clear indication of possible civil liability against pharmacists.

6 There possibility of pharmacists facing manslaughter charges due to carelessness also exists. Chi (1998) maintains that other than lawsuits due to drug errors, pharmacists can be jailed with manslaughter offence since most patients charge pharmacist directly with manslaughter charges due to careless mistakes. This is a form of revenge against negligent pharmacists since patients are supposed to go through the pharmacy board is such cases or file a lawsuit against the health provider. Chi (1998) explains that a criminal case has its purpose as “vengeance and punishment…with the result of a fine or incarceration” (p. 85). People file criminal charges against pharmacist instead of filing civil or administration actions in cases of medical errors or negligence.

In 1947, a criminal suit (People v. Greenwald) was filed in New York with a pharmacist being implicated with second degree manslaughter due to dosing miscalculation. Chi (1998) also provides an example of a 1995 case in Maryland where a pharmacist injured 3 babies after using morphine instead of heparin to wash syringe. Even though these lawsuits were not successful, they are enough evidence of potential criminal liability that may face pharmacists due to recklessness.

It is possible to resolve patient complaints through conciliation and there is no need to go to court or appear before a tribunal but conciliation does not enhance public protection hence a disciplinary action is more appropriate. Comparing professional misconduct with unprofessional conduct, it is clear that professional misconduct has more serious implications compared to unprofessional conduct. Professional misconduct is a disgrace to the pharmacy profession whereas unprofessional conduct is inadequate adherence to professional standards. Natural justice is also a way of addressing customer complaints where proceedings against a pharmacist are

7 conducted fairy. In other cases, the charges may be heard in an oral presentation with legal representatives being present if the complaint is serious.

Conclusion Pharmacists as professionals who serve the public through providing information on the best use of drugs can find civil law suits and disciplinary actions if they have misconduct issues. Consumers/patients may lodge complaints against pharmacists due to negligence, medical errors or any other form of unfair treatment on clients. Even though there are institutional means of handling professional misconduct, regulatory boards are also central in implementing disciplinary actions in professional misconduct cases. Serious cases are handled in courts of law and the tendency of patients filing criminal law suits is very likely as demonstrated by various examples of lawsuits.

Pharmacists ought to adhere to the professional regulations otherwise such lawsuits and summons by regulatory bodies may cost them a career in addition to possible financial costs and jail terms.

8 References Burns, K. (2008). Pharmacist responsibilities regarding Medication Guides. Drug Topics, 152(4): 72+. Web. Retrieved 21 Nov. 2010 from Questia.com.

Chi, J. (1998). Careless pharmacists can face manslaughter, lawyer warns. Drug Topics, 142(8): 84+. Web. Retrieved 22, Nov. 2010 from Questia.com Low, J. (2009). Australian pharmacy and law practice. Melbourne: Elsevier Australia.

ISBN 0729539164, 9780729539166 Schmitz, P. G. and Martin, K. J. (2008). Internal medicine: just the facts. McGraw-Hill Professional. ISBN0071468870, 9780071468879