1.3 Judge the storing of medication against legislative requirements..pdf

By the end of this lesson, participants will be able to evaluate and judge the storage of medication against legislative requirements, ensuring compliance with relevant regulations and standards.

1. Judge the storing of medication
against legislative requirements.
Pharmacology 4

2. Objective:
•By the end of this lesson, participants will be able to evaluate and
judge the storage of medication against legislative requirements,
ensuring compliance with relevant regulations and standards.

3. Introduction:
•Medication storage is a critical aspect of healthcare, and it plays a
significant role in ensuring patient safety, medication efficacy, and
regulatory compliance.
•In this lesson, we will focus on the importance of judging medication
storage against legislative requirements.

4. Medication storage is a critical aspect of
healthcare
•Patient Safety: Proper storage of medications helps ensure that
patients receive medications that are safe and effective. Improper
storage can lead to degradation of medications, potentially rendering
them ineffective or even harmful.

5. Medication storage is a critical aspect of
healthcare
•Medication Efficacy: Many medications are sensitive to factors such
as temperature, humidity, and light. Proper storage conditions help
maintain the efficacy of medications, ensuring that patients receive
the intended therapeutic benefits.

6. Medication storage is a critical aspect of
healthcare
•Prevention of Contamination: Proper storage helps prevent
contamination of medications, which can occur if they are exposed to
environmental pollutants, microorganisms, or other substances that
could compromise their safety and efficacy.

7. Medication storage is a critical aspect of
healthcare
•Regulatory Compliance: Healthcare facilities are required to comply
with regulations and guidelines regarding the storage of medications.
This includes requirements related to temperature control, security,
labeling, and documentation.

8. Medication storage is a critical aspect of
healthcare
•Cost Considerations: Improper storage of medications can lead to
waste, as medications may need to be discarded if they become
compromised or expire prematurely. Proper storage practices can
help minimize waste and reduce costs for healthcare facilities.

9. Key Legislative Requirements:
•Good Storage Practice (GSP):
•GSP emphasizes proper storage conditions to maintain the quality, safety, and
efficacy of medications.
•Medications should be stored at the correct temperature, humidity, and light
conditions as specified by manufacturers and regulatory guidelines.

10. Key Legislative Requirements:
•Controlled Substances Act:
•Controlled substances, including certain medications with the potential for
abuse, have specific storage requirements.
•Compliance with the Controlled Substances Act is crucial to prevent diversion,
theft, and unauthorized access.

11. Key Legislative Requirements:
•National Health Act (South Africa):
•In South Africa, the National Health Act may specify storage
requirements for medications to ensure compliance with quality and
safety standards.
•Adherence to these requirements is essential to meet regulatory
expectations.

12. Steps in Judging Medication Storage:
•Understanding Legislative Requirements:
•Familiarize yourself with relevant legislative documents, including the
National Health Act and specific regulations applicable to medication storage.
•Regular Audits and Inspections:
•Conduct regular audits and inspections of medication storage areas to assess
compliance.
•Check temperature logs, storage conditions, and security measures in place.
•Documentation Review:
•Review documentation related to medication storage, including standard
operating procedures (SOPs), temperature records, and any deviation reports.
•Ensure that records are accurate, up-to-date, and easily accessible.

13. EXAMPLE

14. Steps in Judging Medication Storage:
•Staff Training:
•Ensure that healthcare staff involved in medication storage are adequately
trained on legislative requirements.
•Provide ongoing education to reinforce proper storage practices.
•Security Measures:
•Evaluate security measures in place to prevent unauthorized access and theft.
•Controlled substances should be stored in secure areas with restricted access.

15. Security measures Examples
•Authentication Technologies: Employing various authentication
technologies such as holograms, barcodes, RFID (Radio Frequency
Identification), and serialization to ensure the authenticity of
pharmaceutical products.
•These technologies allow for tracking and tracing of products
throughout the supply chain.

16. Security measures Examples
•Tamper-Evident Packaging: Using tamper-evident seals, labels, or
packaging that reveal if a product has been tampered with or opened
prior to reaching the end-user.

17. Security measures Examples
•Track and Trace Systems:
Implementing track and trace
systems that enable the
monitoring of pharmaceutical
products from manufacturing
facilities to the point of
dispensing or consumption.
•These systems help identify and
prevent the distribution of
counterfeit or diverted products.

18. Security measures Examples
•Secure Supply Chain Management: Establishing secure supply chain
practices to ensure the integrity of pharmaceutical products at every
stage of production, transportation, and distribution.
•This includes conducting background checks on suppliers, securing
transportation routes, and implementing stringent storage conditions.

19. Security measures Examples
•Access Control Measures:
Implementing access control
measures such as restricted
entry to manufacturing facilities,
warehouses, and storage areas
to prevent unauthorized access
and theft of pharmaceutical
products.

20. Security measures Examples
•Surveillance and Monitoring:
Utilizing surveillance cameras,
alarm systems, and security
personnel to monitor
manufacturing facilities, storage
areas, and transportation routes
for any suspicious activities or
unauthorized access.

21. Security measures Examples
•Employee Training and Awareness: Providing training to employees
on security protocols, counterfeit detection methods, and reporting
procedures to ensure they are equipped to identify and respond to
security threats effectively.

22. Security measures Examples
•Regulatory Compliance: Adhering to regulatory requirements and standards set
forth by regulatory bodies such as the FDA (Food and Drug Administration) in the
United States or the EMA (European Medicines Agency) in Europe to ensure the
security and quality of pharmaceutical products.
•South Africa:
•SAHPRA
•Medicines and Related Substances Act (Act 101 of 1965):
•GMP
•Product registration
•Pharmacovigilance
•Advertising and promotion
•Controlled substances
•Inspections and audits
•Compliance documentation
•Training and education

23. Security measures Examples
•Collaboration with Law Enforcement: Collaborating with law
enforcement agencies to investigate and prosecute cases of
pharmaceutical counterfeiting, theft, or diversion, thereby deterring
illicit activities within the pharmaceutical supply chain.
•Consumer Education: Educating consumers about the importance of
purchasing pharmaceutical products from reputable sources,
recognizing counterfeit medications, and reporting suspicious
products to the authorities.

24. Steps in Judging Medication Storage:
Examples in nursing
•Review Medication Orders:
•Example:Before assessing storage, nurses should review medication orders to
ensure they are familiar with specific storage requirements for each
medication.
•Verify Expiry Dates:
•Example:Check the expiration dates on medication packaging. Remove and
discard any medications that have expired to prevent administering
ineffective or potentially harmful drugs.
•Check Packaging Integrity:
•Example:Inspect medication packaging for signs of damage or compromise.
Damaged packaging can expose medications to environmental factors that
may affect their stability.

25. Steps in Judging Medication Storage:
Examples in nursing
•Ensure Proper Temperature:
•Example:Confirm that medications requiring refrigeration are stored in the
refrigerator. Examples include certain antibiotics or insulin. Medications sensitive to
temperature changes should be stored according to manufacturer guidelines.
•Assess Light Sensitivity:
•Example:Medications that are sensitive to light should be stored in opaque
containers or packaging. For example, some oral contraceptives may lose
effectiveness if exposed to light.
•Organize and Label Storage Areas:
•Example:Maintain a well-organized medication storage area with clear labels
indicating the contents and storage requirements. This helps prevent errors and
ensures easy identification of medications.

26. Steps in Judging Medication Storage:
Examples in nursing
•Separate Incompatible Medications:
•Example:Separate medications that are known to be incompatible when
stored together. For instance, certain medications may interact negatively if
stored in close proximity, leading to reduced efficacy or potential harm.
•Monitor for Environmental Conditions:
•Example:Be aware of environmental conditions such as humidity, as some
medications may be sensitive to moisture. Ensure that medications
susceptible to humidity are stored in appropriate containers or areas.
•Check for Tampering:
•Example:Inspect medication packaging for signs of tampering or
unauthorized access. If there are any doubts about the integrity of a
medication package, it should not be used.

27. Steps in Judging Medication Storage:
Examples in nursing
•Document and Report Issues:
•Example:Document any deviations from proper storage conditions and
report them to the appropriate personnel. This documentation is important
for maintaining accountability and addressing potential risks.
•Educate Staff:
•Example:Provide ongoing education to nursing staff about proper medication
storage practices. Regular training sessions help reinforce the importance of
adherence to storage guidelines.
•Follow Facility Policies and Regulations:
•Example:Adhere to institutional policies and regulatory guidelines related to
medication storage. Compliance with these standards is essential for
maintaining patient safety and meeting legal requirements.

28. Scenario:
•You are a nurse responsible for medication storage in a healthcare
facility. During a routine audit, you notice that the temperature in the
medication refrigerator has been consistently outside the
recommended range.
•Questions:
•Which legislative requirements are being violated in this scenario?
•What immediate actions should be taken to address the issue and
ensure compliance?

29. •Whichlegislativerequirementsarebeing
violatedinthisscenario?
•TheviolationinvolvesGoodStoragePractice(GSP),
afundamentalrequirementformaintainingthe
qualityandefficacyofmedications.GSPincludes
ensuringthatmedicationsarestoredwithinthe
recommendedtemperaturerange.

30. •What immediate actions should be taken to address
the issue and ensure compliance?
•The nurse should take the following actions:
•Temporarily Halt Medication Storage:Temporarily cease
storing medications in the affected refrigerator to prevent
further compromise of medication quality.
•Investigate the Cause:Determine the cause of the temperature
deviation. It could be due to a malfunctioning refrigerator,
improper monitoring, or other issues.
•Rectify the Issue:Repair or replace the refrigerator, address
any monitoring or procedural deficiencies, and take corrective
actions to prevent a recurrence.

31. •What immediate actions should be taken to address
the issue and ensure compliance?
•The nurse should take the following actions:
•Review and Update Procedures:Review and update SOPs
related to medication storage, ensuring they align with GSP and
legislative requirements.
•Document and Report:Document the incident, actions taken,
and any corrective measures implemented. Report the incident
to relevant authorities, if required.
•Re-Train Staff:Provide additional training to staff on proper
medication storage practices and the importance of adhering
to legislative requirements.