In terms of the National Health Act 61 of 2003 all information concerning patients, including information relating to his/her health status, treatment or stay in a health establishment is confidential.
Patient information is generally held under legal and ethical obligations of confidentiality. Information provided in confidence must not be used or disclosed in a form that might identify a patient without his or her consent. The exception to the above is contained in the Rules relating to code of conduct for pharmacists and other persons registered in terms of the Pharmacy Act 53 of 1974.
| (a) | Confidential information is defined as information accessed or maintained by the pharmacy, which contains personally identifiable information that could be used to identify the patient. This information may relate to but is not limited to: |
| (i) | the patient's name, address, telephone number, identity number and/or any other identifying number; |
| (ii) | the name, address and details of a prescriber; and |
| (iii) | medicines (i.e. prescription and/or non-prescription medicines) or medical devices, prescribed, dispensed, sold and/or supplied to the patient including information such as therapeutic effect, diagnosis, allergies, disease state, pharmaceutical services rendered, medical information, and drug interactions. |
| (b) | Confidential documents relating to patient information refers to personally identifiable data about an individual patient and such data is not generally considered to be public knowledge. Confidential documents relating to patient information includes but is not limited to the following documents: |
| (iii) | Prescription records and registers; |
| (iv) | Patient medication records; |
| (v) | Patient medical records; and |
| (vi) | Records relating to screening tests performed. |
The purpose of this standard is to ensure that a patient's records are maintained and disposed of in a confidential manner.
| 2.30.3 | General considerations |
| (a) | In order to protect personal information from improper disclosure and potential misuse, the responsible pharmacist of the pharmacy must take the necessary action to prevent the acquisition and misuse of personal information relating to patients. |
| (b) | The responsible pharmacist must ensure that there are policies and procedures in place in the pharmacy to protect documents relating to patient information from any unauthorised disclosure and use, whether or not it results from disposal. At a minimum, this means restricting access to documents relating to patient information to staff whose responsibilities do not require them to have this information i.e. persons who are not registered with council. |
| 2.30.3.1 | Maintenance of the patient's records |
| (a) | Any information stored about a patient must be pertinent, accurate and up-to-date. |
| (b) | To maintain the integrity and confidentiality of patient information contained in records and prescriptions for medicine, any system or computer utilised must have adequate security, including system safeguards designed to prevent and detect unauthorised access, modification, or manipulation of patient records and prescriptions. |
| 2.30.3.2 | Computer records |
| (a) | All computer records in the pharmacy must be secure. Any system used must be capable of restricting access. Suitable passwords, Personal Identification Number (PIN) or other restricted access systems must be in place. |
| (b) | PIN numbers or passwords should be changed at regular intervals (for example if a member of staff terminates employment at the pharmacy). The level of access that various members of the pharmacy team have to a patient's records should be appropriate to their duties. For example, a member of staff who is responsible only for ordering stock will not need access to patient medication records. |
| (c) | Computers must be situated so that data cannot be seen intentionally, or by accident, by those who are not authorised to have access to it. |
| (d) | Access to the database must be restricted at all times. In particular, it is important to ensure proper control over computer media such as flash sticks, compact disks and backup copies that may contain copies of medication records that are also maintained in paper files. |
| (e) | The responsible pharmacist must ensure that third parties such as software vendors, manufacturers, medical schemes and managed healthcare companies do not have access to the database without their authorisation. Disclosure of any patient's information must be within the legal and ethical obligations of confidentiality. |
| (f) | The responsible pharmacist must ensure that information given to software vendors and manufacturers concerning medicine usage does not contain personally identifiable data about an individual patient. Information given to software vendors and manufacturers must be anonymised i.e. the identity of the individual who is the subject of that information cannot be traced back to him/her or ascertained from the information. |
| 2.30.3.3 | Disposal of the patient's records |
| (a) | Disposal of patient records is defined as the day-to-day discarding of duplicate, extra or obsolete reports, which contain personally identifiable information that could be used to identify the patient. The records include but are not limited to items such as labels, prescriptions, prescription records and registers, patient medication records, patient medical records and records relating to screening tests performed. |
| (b) | Destruction of patient records is defined as the systematic permanent disposal of patient's records that have been maintained for the prescribed retention period. The purpose of disposal or destruction is to permanently remove records from active use, with no possibility of reconstructing the information contained in them, while maintaining the confidentiality of the information they may contain. |
| (c) | Disposal of any materials containing or including patient-specific or confidential information must be conducted in such a manner as to preserve patient confidentiality. Disposing may involve shredding documentation, or alternatively placing it in confidential waste or deleting the information by way of a permanent marker. |
| (d) | The following steps must be followed prior to disposing of confidential documents: |
| (i) | shred the entire record; |
| (ii) | erase the personal information contained in the record; |
| (iii) | modify the record to make personal information contained in it unreadable; and |
| (iv) | take action to ensure that no unauthorised person will have access to the personal information contained in the record from the time it is disposed of until the time it is ultimately destroyed. |
