Legal Responsibilities Assignment PDF

Running Head: LEGAL RESPONSIBILITIES
Legal responsibilities of administering schedule 8 medication.
Name
Affiliation
Instructor
Date

2
Legal Responsibilities
Legal responsibilities of administering schedule 8 medication.
CASE ONE
Janet has just completed a course in Pharmacology. She wants to open up a pharmacy and
has sought advice from you on what she has to consider before venturing into the
business. Advise her.
1. What are some of the restrictions imposed by Schedule8?
2. What are the Requirements by the Australian States for getting Authority to provide
a prescription of Section 8 medicines?
3. Importance of medical approvals.
What are some of the restrictions imposed by Schedule8?
According to the Poisons Standard. Section 8 drugs are known as drugs of addiction
and they include ketamine, buprenorphine as well as fentanyl. These drugs are mainly used
for analgesia and anesthesia. In Australia, these medicines are defined by the Standard for
the Uniform Scheduling of Medicines and Poisons and as such, they are under strict
regulations since they can be highly misused. Similarly, they have high rates if psychological
or physical dependence. This leads to the need for their restriction on prescription. As such,
they have to be documented, destroyed or dispersed in a specific manner especially in
compliance with regulations in every state. The restriction imposed in Section 8 medicines is

3
Legal Responsibilities
not similar to the one imposed in Section 4 medicines because the latter are under the
category of other prescription-only drugs. This means that the standardization of these
drugs varies from one state to the other, (Morgan, 2017).
In Australia, there is no centralized body that handles the regulation of Section 8
medicines. However, the Therapeutic Goods Administration governs the regulation of
medicines nationally and other states have their own regulations that are pegged on the
Therapeutic Goods regulation. As such, there are different legislations and interpretations
that relate to Section 8 drugs. It is worth noting that there are legal requirements that have
to be adhered to when getting authority and writing specific prescriptions for Section 8
drugs.
Question 2: what are the Requirements by the Australian States for getting Authority to
provide a prescription of Section 8 medicines?
In the Australian Capital Authority, a Chief Health Officer is tasked with giving
authority to medical personnel who need to prescribe a Section 8 drug for more than two
months, the patient that is receiving the prescription should also have received
prescriptions in a period of two months previously. This can also apply to the prescription of
drugs to drug-dependent patients. It is essential for one to have a clear indication that the
drugs have been authorized, this can be done by indicating the Clinical Health Officer’s
Approval number followed by an identifying number as part of the prescription. These
numbers are only given by a Clinical Health Officer.
Question 3: importance of medical approvals.

4
Legal Responsibilities
By having controlled medical approvals, a medical practitioner can prescribe Section
8 drugs to patients diagnosed with short-term illnesses and this should be for less than two
months. As such, one must indicate ‘Standing short-term approval ’, (Kluthe et al., 2018)
CASE 2
Peter operates a pharmacy in the Suburbs of Sydney. Recently, the local authority
requested to have records of stock within his pharmacy as well as classification of all
medicines he has. Should he present the records or go against the orders?
1. What are the existing Classification of Section 8 medicines?
2. Outline the existing Operative Directives
3. What is the importance of Keeping of Records?
Question 1: What are the existing Classification of Section 8 medicines?
Medicines under Section 8 can be classified as being restricted or unrestricted. Some
of the substances that have been restricted include buprenorphine, methadone liquid,
lisdexamfetamine, dexamphetamine, and methylphenidate. When it comes to their supply,
Clinical Health Officers that have authorization can only give authorization for patients to
receive such medications under Section 8. This has to be in writing. For one to start supply,
he or she has to be in the field of psychiatrists, pediatricians, neurologists as well as training
registers, (Maston et al., 2017). For other suppliers to undertake the supply, these

5
Legal Responsibilities
professionals have to be informed so that they can give consent. In case there is co-
management, patients should visit a specialist every two years. For supply that is more than
30 days, pediatricians can initiate supplies with the help of an authorization, (Munden,
2017, 1 83). In situations where there is a need to supply buprenorphine, methadone liquid
and Suboxone approved training has to be provided to medical professionals that give
pharmacotherapies in opioid dependence. As such, a continuous clinical involvement has to
be shown. This also needs adherence to authorization from an authorized clinical health
officer.
There are unrestricted drug substances provided in Section 8 and thy mainly include
oxycodone and morphine. Medical officers have the liberty to supply these drugs especially
for the purposes of surgical and medical conditions, and not for the purposes of addiction
treatment. The law requires that 15 patients should only be subscribed to the medication
within a single supply from a medical practitioner. For this to be put into perspective, the
number does not include hospital inpatients or those in palliative care. Similarly, a Clinical
Health Officer offers approval when the prescription is needed by more patients especially
for Section 8 drugs, (Naughton & Hayes, 2017, 50). Lastly, a medical notification has to be
presented to the Clinical Health Officer when a medical practitioner is making a supply of
Section 8 substances that are not restricted especially when the supply will exceed 8 weeks
or if the levels of dosage are exceeded and most especially if there are instances of abuse.
Question 2: Outline the existing Operative Directives
The Department of Health is tasked with giving directives that touch on the health
sector of the country. For instance, it set a code of practice which guides in the handling of
medicines under Schedule 8, (O’Brien, 2017). This is done medical practitioners can

6
Legal Responsibilities
prescribe drugs in accordance with the Poisons Regulations of the year 1965. In most cases,
what is covered is possession as well as storage of the drugs. In accordance to the
Operational directive, any individual issued with a Permit or Poisons Licence according to
the Act must store and secure the medicines in a correct way, (Khalil & Lee, 2018, 20173).
This also covers individuals or companies that have been authorized to manufacture sell,
distribute or even possess drugs that have been categorized under Section 8.
Question 3: what is the importance of Keeping of Records?
According to the poisons regulations, all forms of inventories and records especially
relating to drugs under section 8 have to be accurate, up to date and should not have any
evidence of tampering. Similar, a registrar of these medicines has to be maintained so that
all medicines under Section 8 can be procured. Supplied, used or stored by individuals that
have been authorized and this should be made apparent. In addition, all places that have
been allocated for the purposes of storage have to be registered separately, (Poter &
Maltais, 2018). Another directive is that all records such as invoices and registered have to
be maintained for a period of seven years and as such, they should be availed when
authorized officers request for them at the Health Department. It is hence essential for
medical facilities to indicate clearly where the drugs under Section 8 are located. Lastly, at
any given time, authorized officers form the department of health should have access to
records and physical location of the drugs and in doing so, their identifications have to be
seen before access is allowed, (Jardeleza, 2018, 994).
Storage
According to section 4.1 of the Operative Directive, storage of Schedule 8 medicines
has to be done is a secure way by keeping the drugs in a safe place. Access should also be

7
Legal Responsibilities
restricted to unauthorized personnel, (Prietsman, 2017, 228). In situations where an
individual has been appointed to safely keep the key, he or she has the duty of keeping the
area secure and this authority and power should not be transferred to a different person
unofficially. This helps in the prevention of theft and avoidance of insecurity issues that may
arise at any given time.
Stolen or lost schedule 8 medicines
Chief Executive Officers have to be notified immediately when one realizes that stock
inventories do not tally with the register balance. This can be done through writing an
official document to the office of Corporate Governance Directorate. As such, any missing
details or discrepancies have to be reported within a period of 24 hours after identifying the
discrepancy. It is at this instance that actions can be taken against those that participated in
the misplacement of records or discrepancies in the information being presented. Hospitals
mainly take part in undertaking the investigations which lead to the determination of the
personnel involved. However, reporting the incident does not put all burden if investigations
on the hospital since the corporate Governance Directorate is well placed to handle such
issues, (Schaefer et al., 2017, 708). In case the stock is recovered, supplementary reports
have to be provided to hospital directors and the Corporate Governance.
Destruction of drugs under Schedule 8.
Under Section 7.1 of the Operative directive, drugs under Schedule 8 are at times not
destroyed because of circumstances that have been outlined in the Poisons regulations Act.
As such, drugs that have not been used or those that have expired have to be taken back to
the pharmacy. In situations where the drugs were in a hospital and do not have available
pharmacists, a notification should be sent to the regional pharmacist, (Scherer et al., 2017,

8
Legal Responsibilities
540). In situations where internal audits are needed, audits can be carried on narcotics
records and not the physical stock of drugs available. It is only personnel that have been
authorized that have the capacity to carry out the internal audits.
Roles of Nurses when administering drugs.
It is essential to have a better understanding of what nurses should also do in
accordance with schedule 8. This also includes the need for adherence to legal structures
that have been put in place to govern the medical practice in Australia. When prescribing
drugs, one should know that his or her activity is governed by the 1984 Controlled
Substance Act. This regulation is mainly used in the attempt to prevent instances of drug
abuse, dependence, as well as diversion, (WHO, 2017). This is seen in cases where these
drugs have been taken for non-medical purposes. As such, revocation orders are provided to
authorities that subscribe drugs meant for dependence. There are guidelines that have to be
followed when prescribing these drugs, (Nanwesemael et al., 2018, 756). Prescribers are not
allowed to prescribe these drugs especially when there is no formal examination of the
patient, when instances of self-treatment are apparent and when one needs the medicine
to treat a spouse or family member without any form of authority.
It is also essential to have certain parameters that have to be adhered to when
prescribing these drugs. There should be included if prescriber’s names, address, signature
and contact number. Also, a date has to be clearly indicated showing when the prescription
was given. This is accompanied by the patient’s full address, names, date of broth and
amount of medicine will be given in numerals and words. It is important to adhere to these
factors because they help in managing the use of drugs mentioned under schedule 8,
(Vesikari et al., 2017, 455). Also, adherence to medical laws and regulations by professionals

9
Legal Responsibilities
has to be implemented so that dependency is avoided at all costs. Instances of corruption
have been known to be common and as such, medical practitioners have to desist from this
vice. By adhering to laws and regulations that govern the medical fraternity, we are able to
have smooth medical operations and a healthy nation at large.

10
Legal Responsibilities
References
Jardeleza, M. S. R., & Krigel, H. Y. (2018). U.S. Patent Application No. 15/735,994.
Khalil, H., & Lee, S. (2018). Medication safety challenges in primary care: Nurses’
perspective. Journal of clinical nursing, 27(9-10), 2072-2082.
Kluthe, C., Tsui, J., Spady, D., Carroll, M., Wine, E., & Huynh, H. Q. (2018). The Frequency of
Clinic Visits Was Not Associated with Medication Adherence or Outcome in Children
with Inflammatory Bowel Diseases. Canadian Journal of Gastroenterology and
Hepatology, 2018.
Maston, A., Holland, C., Terhune, J., & Warden, J. (2017). U.S. Patent Application No.
15/504,556.
Morgan, D. P. (2017). U.S. Patent No. 9,597,262. Washington, DC: U.S. Patent and
Trademark Office.
Munden, L. M. (2017). The covert administration of medications: legal and ethical
complexities for health care professionals. The Journal of Law, Medicine &
Ethics, 45(2), 182-192.
Naughton, C., & Hayes, N. (2017). Deprescribing in older adults: a new concept for nurses in
administering medicines and as prescribers of medicine. Eur J Hosp Pharm, 24(1), 47-
50.

11
Legal Responsibilities
O'brien, N. A., & Pederson, C. G. (2017). U.S. Patent No. 9,665,689. Washington, DC: U.S.
Patent and Trademark Office.
Poder, T. G., & Maltais, S. (2018). Systemic analysis of medication administration omission
errors in a tertiary-care hospital in Quebec. Health Information Management
Journal, 1833358318781099.
Priestman, T. I. (2017). Delegation and the legal, professional and ethical issues for
veterinary nurses: a case study. The Veterinary Nurse, 8(4), 226-229.
Schaefer, M. R., Rawlinson, A. R., Wagoner, S. T., Shapiro, S. K., Kavookjian, J., & Gray, W. N.
(2017). Adherence to attention-deficit/hyperactivity disorder medication during the
transition to college. Journal of Adolescent Health, 60(6), 706-713.
Schérer, H., Bernier, E., Rivard, J., Yu, L., Duchesne‐Côté, G., Lebel, D., ... & Ferreira, E.
(2017). Self‐administered medications in the postpartum wards: A study on
satisfaction and perceptions. Journal of evaluation in clinical practice, 23(3), 540-547.
Vanwesemael, T., Boussery, K., Manias, E., Petrovic, M., Fraeyman, J., & Dilles, T. (2018).
Self‐management of medication during hospitalization: Healthcare providers’ and
patients’ perspectives. Journal of clinical nursing, 27(3-4), 753-768.
Vesikari, T., Borrow, R., Da Costa, X., Richard, P., Eymin, C., Boisnard, F., & Lockhart, S.
(2017). Concomitant administration of a fully liquid, ready-to-use DTaP-IPV-HB-PRP-T
hexavalent vaccine with a meningococcal serogroup C conjugate vaccine in
infants. Vaccine, 35(3), 452-458.

12
Legal Responsibilities
World Health Organization. (2017). Critically important antimicrobials for human medicine:
ranking of antimicrobial agents for risk management of antimicrobial resistance due
to non-human use.