Standard Operating Procedure (SOP) for Pharmacy

Standard Operating Procedure (SOP) is a documentation that describes how to perform various routine operations. It contains a step by step instructions.

In pharmacy settings various activities are performed everyday, each task should be under a standardized process that everybody must follow. Personnel must submit themselves to these procedures to have organized and synchronicity in the work place. Food and Drug Administration (FDA) has imposed it as a requirement to every pharmacy workplace to have and make its own SOP. They are requiring the following tasks of SOP - Product Complaints, Product Recalls, Procurement of Stocks, Good Dispensing Practice, Good Storage Practice, Cold Chain Management, Disposal of Expired, Damaged, Returned or Rejected Products. The pharmacist/s, individual who can knowledgeably review the procedures or somebody higher up in the hierarchy of the department are the ones who can create, review and approve the SOP. All businesses that falls under pharmacy, either manufacturing, distributing, trading, laboratories or drugstores are mandated to make their own SOP.

Here's an illustration of SOP that should be followed when creating it for your drugstore. Hope it can help you.

ANSWERS A-04

Answers to the Questions:

1. D. Adverse Drug Reaction, Definition.
        The term adverse drug event is used to describe an injury resulting from administration of drug.

2. B. Pharmacovigilance, definition.

3. A. Thiazide-type diuretics should be used as initial therapy for most patients with hypertension. They can be used either alone or in combination with other anti-hypertensive drug classes which have demonstrated to be beneficial in randomized controlled outcome trials ( E.g. ACE inhibitors, aldosterone receptor blockers, beta blockers, and calcium channel blockers).

4. B. Angina is usually a marker for underlying heart disease. It is a symptom of myocardial ischemia that fibroproliferative response. The functional status of the vascular endothelium also contributes to plaque formation.

5. A. Mild renal dysfunction develops in up to 25% of patients receiving aminoglycosides for several days or more. This is due to the accumulation of these drugs in the proximal tubule. Streptomycin remains to be the least nephrotoxic aminoglycoside.

Yellow Prescription

Yellow Prescription is used to purchase dangerous drugs. Should be filled out completely by the doctor and should present with duplicate when trying to buy medicines in drugstore. Dispensing dangerous drugs are very critical. Pharmacist must know the expiration date of the the S2 license of the doctor, and the S2 and license no. should be genuine.

Drug Companies' Stratagem

Have you noticed why some drugs are sold out in the market? How does this happen even the company is not known and not famous? What strategies they are taking to sell out their products? I could give some reasons why some drug products are salable, but in fact it should not be.

1. Discounts, freebies and deals are the regular and casual preference of saleability.  The higher discounts the drug company gives the lower will be the retail price of the products, same as to deals. Deals  are dependable to the number of free products that will be added to the regular order. The highest that a drug company can bid is 1+1 or buy one take one; moreover, freebies has been used to attract costumers, because of the free item that within the product such as toys, samples and etc. But these kind of transactions are price dependent and more on pushing in the part of drugstores, due to its commonality in the all business.

2. Incentives, rebates, box retrieval and food treat. These is a form of simple bribery to the drugstore's personnel to ensure drugs' movement and turn-over. A lot of small drugstores are engaged into this business.

3. Sponsoring and donating. Some drug companies sponsor and donate money, goods, fixtures and training to drugstores. In return the drugstore should push and sell the products of sponsoring company that serve as gratitude to have they shared.

4. Engaged to agreement and contract. The drug company will enter into agreement and sign a contract with drugstore to assure that their products will be sold and pushed, in return the drug company will guarantee the drugstore that a certain amount of the profit will be given to them. This is modified form of rebate. 10-30 percent is the usual range of rebate.

2. Favoring and gaining the physician's trust. This is the main reason why drugs are being patronized and bought by the consumers. Doctors are big factor. They have the power to prescribe what drug brands they want their patients to take. Patients are confident to what the doctor prescribes and tells, so they are following the drug order written in their prescription. Obviously, the medical representatives are always gaining and favoring physicians, so that they will prescribe their handled drugs.  Some agreed with rebates and incentives. Some ask for sponsorship to their conventions and seminars. And the most expensive drug company can provide is to sponsoring their trip to abroad with free plane fare, allowance and hotel accommodations that are all fully paid by drug company. What could a physician ask for when all these things are provided to him. However, the drug company is not crazy to spend lots of money. The company is looking forward that its products will be moved in the market with fast turn-overs to get back the loss and profit on it. They are relying to the physician's promise to prescribe their drugs. If not possible the physician will be liable for breaching the agreement.

I know a drug company who hit its target profit last year, because of all the above mentioned strategies were applied. The drug company's investments hit  PHP 400M+. I may conclude that strategies are important to drug companies to sell their products in the market. Physicians and drugstores should be prioritized. These things are normal in pharmacy business, but they have also limitations.
 

Distributors on the Go!

Pharmaceutical world is so dynamic, it means that this business is so active and that everyone needs medicines to outwit diseases. Such business is also undergone series of transfer for medicines to reach the consumer. Because of that brokers are involved, and retailers are importing their products through them. Distribution is the proper term to define the outreach of the medicine products to the drugstores and outlets. In the Philippines, distributors are very alive and an expand of them are near unaccountable. Most of them distribute generic drug products and locally made drugs. But what pharmaceutical company distributor is flagging away in distributing and wholesaling branded drug, and trusted by major international pharmaceutical companies?

It seems there is only one to be selected. As a pharmacist and purchaser, I have top five major distributors selected, whereas, I usually place an order and procure. They are:

1. Zuellig Pharma
2. Metro Drug, Inc
3. GB Distributors, Inc
4. RBC-MDC Pharmacy
5. Apollo Plus Distributor

Zuellig Pharma has been the top most choice, because it provides most of the extensive branded products that are marketable and physician-prescribed in the market today. Zuellig Pharma can be easily reached through their salesmen, phone calls, internet transactions and SMS. It is also the leading distributor that distributes and supplies branded drug products for small business drugstores and top drugstores - such as Mercury Drugstores, Watsons, South Star Drugstore - in the country. I found them so complete, because I can say that almost all major branded drug products are solely offered through it and cannot be sought in other distributors, unless you go directly to the principal company to purchase.

QUESTIONS A-04

Questions:

1.Any anxious, unintended, and undesired effects of a drug that occurs at doses used in human for prophylaxis, diagnosis or therapy:
A. Adverse Drug Event
B. Allergy
C. Hypersensitivity
D. Adverse Drug Reaction
E. idiosyncracy

2. Study of the use of and effects of drugs in a large number of people:
A. Pharmacoepidemiology
B. Pharmacovigilance
C. Pharmacoinformatics
D. Pharmcogenetics
E. Pharmacogenomics

3. Which of the following diuretics should be used as initial therapy for most patients with hypertension, either alone or in combination?
A. thiazide diuretics
B. loop diuretics
C. potassium-sparing diuretics
D. osmotic diuretics
E. Both A and B

4. A clinical syndrome characterized by discomfort in the chest, jaw, shoulder, back or arm:
A. Atrial fibrillation
B. Angina pectoris
C. Myocardial infarction
D. Deep vein thrombosis
E. Ischemic heart disease

5. Which of the least nephrotoxic aminoglycoside?
A. Streptomycin
B. Tobramycin
C. Neomycin
D. Amikacin
E. Netilmicin

ANSWERS A-03

Pharmacology Category:

Here are the answers to the questions last January 6, 2012.

1. D. Calcium

2. E. The primary mechanism of neurotransmitter release is exocytosis.

3. C. Tyrosine is the amino acid precursor in the synthesis of catecholamines.

4. B. In the biosynthesis of Norepinephrine, the rate-limiting step is the conversion of tyrosine to                        dihydroxyphenylalanine by the enzyme Tyrosine Hydroxylase.

5. E. Norepinephrine

BFAD Strengthening Law (RA 9711)

Bureau of Food and Drugs (BFAD) which recently changed its name into Food and Drug Administration has already strengthened its enforcement through the new Republic Act No 9711. The synopsis of this new law is to strengthening and rationalizing the food and drugs (BFAD) by establishing adequate testing laboratories and field offices, upgrading its equipment, augmenting its human resource complement, giving authority to retain its income, renaming it the Food and Drug Administration (FDA), amending certain sections of Republic Act No. 3720, as amended and appropriating funds thereof.  It also goes with its Implementing Rules and Regulations (IRR) to make it possible to enforce and consummate the new law. To show the whole Law and IRR..

UNBEATABLE BRANDS

Drugs are automatically known through their brand names. Brand name goes always with its generic name. Generic name has been used universally to recognize the identity of the drug, and utilized by health professionals to distinguish the drug pertained, if the prescription order of the doctor is contained in brand name only. The trend in world market today is that brand names are usually bought, because medical professionals prescribed them, of their known efficacy and short term regimen.

In the Philippines setting, the law enforces and implements  that all medical doctors must prescribe generic drugs to their patients, with or without brand names, especially those who are destined in hospital, due to the fact that all patients are incapable to purchase high cost drugs. Drugstores revamped their strategy by increasing generic drug products in their establishments, rather than that of branded drugs. Having this changed, consumers can afford already the medicines they needed by purchasing generic drug products. But their was a controversy regarding generic drugs. Generic drugs are mostly manufactured by not known and local manufacturers. For this reason, a possibility that the production of the drugs is undetermined and overlooked. The cGMP is also questionable whether is observed or followed. Inefficacy, substandard and low quality products are the main intrigues to the generic drugs. The reason why most of the time the ailment cannot be cured, long term medication usage and hospitalization, and the most terrifying is to get worsen.

But there are products that are choice of the most of physicians. They were chose because of the effect they provide and facilitate activity such as surgical operation, childbirth and recuperation. Enumerated below are the trusted brands of medicines that have bioequivalent generic products, but still prescribed by physicians (unofficial):

1. Sensorcaine  (Astrazeneca)
2. Nubain amps (Invida)
3. Methergin amps (Novatis)
4. Syntocinon amps (Novartis)
5. Diazepam  (Roche)
6. Midazolam amps (Roche)
7.Ponstan  (Pfizer)
8. Xylocaine (Astrazeneca)
9. Serc (Solvay Pharma)
10. Ventolin products (GlaxosmithKline)

These drugs are unbeatable and widely used in every hospital in the country.

QUESTIONS A-03

Pharmacology Category:

1. In synaptic neurotransmission, which of the following ions plays a significant role in neurotransmitter release?
a. Sodium
b. Potassium
c. Magnesium
d. Calcium
e. Chloride

2. The primary mechanism of neurotransmitter release is accomplished by what process?
a. Diffusion
b. Carrier-mediated
c. Active transport
d. Facilitated transport
e. Exocytosis

3. What is the amino acid precursor in the synthesis of catecholamines?
a. Phenylalanin
b. Glycerine
c. Tyrosine
d. tryptamine
e. Glutamic acid

4. In the biosynthesis of Norepinephrine, what step is considered as rate-limiting?
a. Active uptake of tyrosine
b. Conversion of tyrosine to dihydroxyphenylalanine
c. Conversion of DOPA to Dopamine
d. Uptake of Dopamine in presynaptic storage vesicles
e. Conversion of Norepinephrine to Epinephrine

5. Which of the following substances exert a negative feedback control on Tyrosine Hydroxylase which serves as the mechanism for moment-to-moment regulation of the rate of catecholamine synthesis?
a. Dopamine
b. Acetylcholine
c. DOPA
d. Epinephrine
e. Norepinephrine

Answers to the Questions A-02

Questions-Answers:

Pharmaceutical Calculation Category:
1. You have a vial of magnesium sulfate solution with concentration of 4.06 mEq/ml. Express this concentration as mg/ml and mOsmol/liter. Molecular weight of magnesium sulfate is 120.

 Solution to the Answers:
A) 4.06mEq/1ml x 120mg/2mEq = 243.6 mg/ml
 B) 243.6mg/1ml x 2mOsmol/120mg x 1,000ml/1L = 4,060mOsmol/L

2. Extra strength Alka-Seltzer effervescent tablets contain 1,985 mg Sodium bicarbonate per tablet. How many millimoles of sodium bicarbonate are obtained in each tablet? Molecular weight of Sodium bicarbonate is 84.

 Solution to the Answers:  
1,985mg/1tablet x 1mmol/84mg = 23.63mmol/tablet

3.Half normal saline is 0.45% sodium chloride. Express this concentration in mEq/ml.

 Solution to the Answers:  
0.45g/100ml x 1,000mg/1g x 1mEq/58.5g = 0.077mEq/ ml

4. Calculate the NaCl equivalent for glycerin, a non-electrolyte with a MW of 92.

 Solution to the Answers:  
i factor for sodium chloride = 1.8
i factor for glycerin = 1.0

58.5/1.8 x 1.0/92 = 0.3533

5. Zinc sulfate is a 2-ion electrolyte, dissociating 40% in weak solutions. Calculate its dissociation factor.

 Solution to the Answers: 
 On the basis of 40% dissociation, 100 particles of zinc sulfate yield:

40 zinc ions
40 sulfate ions
60 undissociated particles
140 total particles

PDEA SEMI-ANNUAL REPORTING

From this week the reporting of the semi-annual reports of Dangerous Drugs have been started. The months covered were July to December 2011. This is a biannual procedure conducted by PDEA to ensure that all dangerous drugs that obtained and dispensed by a registered-drugstores are compliant and abode to the law. See you there!

PHARMACY

Proactive in sharing current and substantiate information.
Honorable advices come from a good heart.
Augment and update knowledge everyday.
Resourceful in the bout of ingredients insufficiency.
Mnemonics are identical to him.
Austere in regiments and instructions.
Companion in social and personal life.
Yearn to develop and achieve. 

Nalbuphine

INCLUSION OF NALBUPHINE HYDROCHLORIDE IN THE LIST OF DANGEROUS DRUGS

Here is a copy of the Board Regulation No. 1 from Dangerous Drugs Board through Philippine Drug Enforcement Agency (PDEA), which stated the reasons why Nalbuphine HCl 10mg/ml amp was included in the List of Dangerous Drugs.

Page 1

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Questions A-02

Pharmaceutical Calculation Category:
1. You have a vial of magnesium sulfate solution with concentration of 4.06 mEq/ml. Express this concentration as mg/ml and mOsmol/liter. Molecular weight of magnesium sulfate is 120.
2. Extra strength Alka-Seltzer effervescent tablets contain 1,985 mg Sodium bicarbonate per tablet. How many millimoles of sodium bicarbonate are obtained in each tablet? Molecular weight of Sodium bicarbonate is 84.
3.Half normal saline is 0.45% sodium chloride. Express this concentration in mEq/ml.
4. Calculate the NaCl equivalent for glycerin, a non-electrolyte with a MW of 92.
5. Zinc sulfate is a 2-ion electrolyte, dissociating 40% in weak solutions. Calculate its dissociation factor.

Answers will be given this week.