Pharmacy Act, 1974 (Act No. 53 of 1974) Board Notices Rules Relating to Good Pharmacy Practice Chapter 2 : Professional Standard for Services 2.13 Minimum Standards for Screening and Monitoring Services in Pharmacies

 

Screening and testing biochemical and physiological parameters

 

[Rule 2.13(f) substituted by Board Notice 193, GG 40522, dated 23 December 2016]

 

 

 

The taking of samples, the performance of screening tests and blood pressure monitoring must be done in a private consultation area in the pharmacy. The consultation area must comply with the requirements described in 1.2.13 of Chapter 1 of this manual.

 

 

 

 

 

 

 

 

 

 

 

 

The following standards must be considered when a blood pressure monitoring service is established in a community pharmacy.

 

 

 

 

The following aspects must be considered in blood pressure monitoring:

 

 

For regular monitoring of a patient's blood pressure it is essential that a complete patient profile system is kept. Apart from information that must be kept as described earlier, the following information must also be available:

 

 

The performance of peak flow tests in a pharmacy has a dual function. The first is to identify patients with reduced lung function, for referral to a medical practitioner, and secondly it provides an opportunity to advise asthma patients and other patients with respiratory diseases receiving medication on a chronic basis, about the control of their condition with the help of peak flow tests. The following standards must be used when such a service is provided in the pharmacy.

 

 

 

 

The following aspects are of particular importance in the determination of peak expiration flow:

 

 

For regular monitoring of a patient's peak expiration flow it is essential that a complete patient profile system is kept. Apart from general information that must be kept, the following information must also be available:

 

 

Tests to detect HIV1 or HIV2 antibodies are now widely used in order to identify patients and to screen blood products. HIV infection is usually not noticed in the first few years after infection. Later signs and symptoms may suggest HIV infection or AIDS. The HIV antibody test is often the first and only definite evidence of HIV infection. The following standards must be applied when such a service is provided in the pharmacy.

 

 

• desk with seating;

• working surface of impermeable washable material;

• wash hand basin with hot and cold running water;

• an instrument cabinet or trolley with an emergency tray;

• a filing cabinet for keeping records;

• a mirror;

• a scale;

• facilities for the disposal of biohazardous materials;

• access to a fridge (for storage of test materials).

Note: It is advisable that the fridge is situated in the consultation area, so that observers / bystanders cannot link the client with the removal of test material from the fridge.

If the pharmacy sends the samples to local pathology laboratories, the pathologists should be satisfied that the clinic facilities comply with the applicable standards and that the person performing the tests (pharmacist or nurse) is competent to collect samples and to counsel the patients.

 

 

 

Change gloves or wash your gloved hands after contact with each patient.

 

Wear masks and protective eyewear or a face shield during procedures that are likely to generate droplets of blood or body fluids.

 

Wear plastic aprons and gowns during procedures where blood or body fluid splashes are likely.

 

Wash your hands and other skin surfaces immediately and thoroughly if they become contaminated with blood or body fluids.

 

Wash your hands immediately after removing gloves.

 

Do not recap, bend or break needles or other sharp objects.

 

Place large-bore re-useable needles in a puncture-resistant container for transport to reprocessing areas.

 

Make mouthpieces, resuscitation bags and other ventilation devices available in areas where the need for resuscitation is likely.

 

Do not treat patients yourself or handle patient care equipment if you have exudative lesions or weeping dermatitis.

 

If a glove is torn, replace glove with a new one as soon as possible.

 

Place all blood and body fluid specimens in sturdy containers with a secure lid. Avoid contaminating the outside of the container.

 

Suitable procedures must be adopted for the disposal of waste material, bearing in mind the risks associated with materials contaminated with blood or other body fluids.

 

Note: Circumstances which require Post Exposure Prophylaxis (PEP)

 

 

When a patient requests an HIV test, he/she must sign an informed consent form.

 

What is informed consent?

 

Informed consent is legal authorisation given to the pharmacist or other health care worker to proceed with the HIV testing.

 

Informed consent to HIV testing must be specific and explicit and means that the individual has been made aware of, and understands, the implications of the test.

 

Consent to HIV testing is not covered by the standard contractual agreement which is implied when a patient consults a doctor/pharmacist/nurse as the implications of a positive test may be extreme.

 

What does informed consent imply in the context of HIV testing?

 

Informed consent implies that the patient has received at least the essential amount of pre-test information and understands the following:

 

Proxy consent

 

Proxy consent is consent by a person legally entitled to grant consent on behalf of another individual. A parent or guardian of a child below the age of consent to medical treatment may give proxy consent to HIV testing of a child.

 

 

 

Pre-Test Counselling

 

Pre-test counselling is counselling given to an individual before an HIV test, to make sure that the individual has sufficient information to make an informed decision about having an HIV test. Pre-test counselling must include discussions on:

 

Post-Test Counselling

 

Post-test counselling is the counselling provided when an individual receives his or her HIV test result. Post-test counselling involves one or more sessions (ideally at least two) and must include discussions on:

 

 

 

Tests performed in pharmacies

 

Note: A doctor's signature is not required for an HIV test to be carried out.

The following precautions and procedures must be borne in mind:

[Rule 2.13.5(5) (Note(a)) substituted by Board Notice 193, GG 40522, dated 23 December 2016]

 

 

 

 

 

 

 

 

 

 

 

 

Accuracy and precision of blood cholesterol measurement, which are critical for the classification and referral of screening participants, depend on appropriate quality control and staff training. As these services are professional services, any publicity should comply with the Code of Conduct and Minimum Standards for screening and monitoring services. Before undertaking testing, pharmacists should ensure they are adequately covered by insurance in respect of themselves, their staff and the patients who are being tested.

 

The following standards must be applied when a cholesterol monitoring service is established in a community pharmacy.

 

 

 

 

 

 

 

 

 

 

 

 

The pharmacist must keep all information provided by the patient and the result of the test, confidential and only disclose information with the consent of the patient.

 

 

 

 

All procedures and arrangements should be in accordance with the requirements of the National Health Laboratories for clinical laboratories. The main counter-infection measures, where applicable, should include:

 

 

Definition

 

Blood glucose monitoring is the measurement of glucose in the blood that can be done at any time on a portable machine. It can be used as a self-test for the diabetic.

 

Alternative names:

 

Glucose monitoring;

Random glucose;

Glucose — random; and

Serum glucose — random.

 

Why the test is performed

 

The following standards must be considered when a glucose monitoring service is established in a community pharmacy:

 

 

 

 

The following aspects must be considered in glucose monitoring tests:

 

 

 

 

 

 

The pharmacist must retain a written record of the result of the test, together with information and the consent form provided by the client as well as the type of test and batch number of the test materials, for at least 3 years. Such records must be stored safely to preserve confidentiality.

 

 

The pharmacist must keep all information provided by the patient and the result of the test confidential and only disclose information with the consent of the patient.

 

 

The following standards must be considered when a service offering performance of pregnancy tests is established in a community pharmacy.

 

 

 

 

The following aspects must be considered in pregnancy testing:

 

 

The pharmacist must retain a written record of the result of the test, together with information and the consent form provided by the client as well as the type of test and batch number of the test materials, for at least 3 years. Such records must be stored safely to preserve confidentiality.

 

 

The pharmacist must keep all information provided by the patient and the result of the test confidential and only disclose information with the consent of the patient.

 

 

Urine analysis can be used to detect and measure the level of a variety of substances in the urine, including leucocytes, nitrite, urobilinogen, protein, pH, blood, specific gravity, ketones, bilirubin and glucose. These tests use a thin strip of plastic (dipstick) impregnated with chemicals that react with substances in the urine and change colour. For confirmation, the test may need to be repeated with more sophisticated and accurate laboratory analysis of the urine, in which case the patient should be referred to a medical practitioner. The following standards must be considered when a service offering performance of urine analysis is established in a community pharmacy.

 

 

 

 

The urine sample must be collected in a suitable clean container, which should be supplied to the patient.

 

 

The following aspects must be considered in urine testing:

 

 

The following information and procedure for obtaining a clean catch urine sample must be explained to the patient or the patient's caregiver, the:

 

 

 

 

 

Protein: Protein in the urine (proteinuria) can usually be detected quickly by using a dipstick. Protein may appear constantly or only intermittently in the urine, depending on the cause. Proteinuria is usually a sign of kidney disorders. Proteinuria may be benign or pathological.

 

Abnormal protein values may be indicative of:

 

Benign proteinuria

 

Pathological proteinuria

 

External

 

Renal

 

Glucose: Glucose in the urine (glucosuria) can be detected accurately by dipstick. The most common cause of glucose in the urine is diabetes mellitus.

 

Abnormal glucose values may be indicative of:

 

Ketones: Ketones in the urine (ketonuria) can be detected by dipstick. Ketones are formed when the body breaks down fats, rather than glucose which are used to produce energy. Ketones are harmful to the body if allowed to accumulate.

 

Abnormal ketones values may be indicative of:

 

Blood: Blood in the urine (haematuria) is detectable by dipstick and confirmed by microscopic examination of the urine, and other laboratory tests. Sometimes there is enough blood in the urine to be visible, making the urine appear red or brown. The patient must be referred to a medical practitioner when blood cells or haemoglobin are detected in urine, as it is of pathological significance.

 

Abnormal blood/haemoglobin values may be indicative of:

 

Haematuria (blood in urine)

 

Haemaglobinuria (haemoglobin in urine)

 

Myoglobinuria

 

Nitrites: Nitrites in the urine (nitrituria) are also detectable by dipstick. High nitrite levels indicate urinary tract infection.

 

Abnormal nitrite values may be indicative of:

 

Bacterial infection

 

Leukocyte Esterase: Leukocyte esterase (an enzyme found in certain white blood cells) in the urine can be detected by dipstick. Leukocyte esterase is a sign of inflammation, which is most commonly caused by a urinary tract infection.

 

Abnormal leukocytes values may be indicative of:

 

pH levels in urine: The acidity or alkalinity of urine is measured by dipstick. Certain foods and metabolic disorders may change the acidity of urine.

 

Abnormal pH values may be indicative of:

 

Persistent alkaline urine (pH 7–8)

 

Persistent acid urine (pH 5–7)

 

Concentration: The concentration of urine (also called the osmolality or specific gravity) may be important in diagnosing abnormal kidney function. The kidneys lose their capacity to concentrate urine at an early stage of a disorder that leads to kidney failure. In one special test, a person drinks no water or other fluids for 12 to 14 hours; in another, a person receives an injection of antidiuretic hormone. Afterward, urine concentration is measured. Normally, either test should make the urine highly concentrated. However, in certain kidney disorders (such as nephrogenic diabetes insipidus), the urine cannot be concentrated even though other kidney functions are  normal.

 

Abnormal specific gravity values may be indicative of:

 

Reduced specific gravity

 

Raised specific gravity

 

Constant specific gravity

 

Urobilinogen: When abnormal values of urobilinogen are found during a urine test, further investigation is required to ascertain patient's health status. In the intestines bacteria form urobilinogen from bilirubin. This is then absorbed and passes to the liver and urine.

 

Abnormal urobilinogen values may be indicative of:

 

Increased values

 

Low values

 

Bilirubin: Bilirubin levels in urine is a result of haemoglobin breakdown. In the liver, bilirubin is conjugated to an acid to make conjugated bilirubin. Conjugated bilirubin is water soluble and can therefore be excreted in urine.

 

Abnormal bilirubin values may be indicative of:

 

Pre-hepatic condition

Hepatic condition

 

Post-hepatic condition

 

 

 

 

The pharmacist must keep all information provided by the patient and the result of the test, confidential and only disclose information with the consent of the patient.

 

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11 Please note that at present the MCC does not register HIV tests, but recommends that these tests must be purchased from reputable companies. It is recommended that it be ascertained whether the test is registered in the country of origin.